Loading…
This event has ended. Visit the official site or create your own event on Sched.

View analytic

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Saturday, June 25
 

9:00am

Exhibitor Registration Open
Saturday June 25, 2016 9:00am - 5:00pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Sunday, June 26
 

8:00am

Registration for Full Day and Morning Preconference Tutorials Open
Sunday June 26, 2016 8:00am - 9:00am
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

Exhibitor Registration Open
Sunday June 26, 2016 8:00am - 6:00pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Understanding best practices is critical as you design a clinical program and regulatory strategy for a drug or biologic product. Identifying and obtaining the data actually needed for a product development program is key to the success of the program. Thinking ahead to the marketing application helps a sponsor avoid many of the common mistakes that are made in designing individual clinical trials and overall drug development programs. Even though it may be years before an NDA/BLA/MAA submission, the marketing application is the goal of each development program and should be kept in view throughout the program to avoid pitfalls and delays in submission and product approval.

This tutorial will cover common mistakes and solutions in the areas of drug development planning, clinical study design, statistical analysis planning, regulatory agency interactions, and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples and case studies that illustrate approaches to adopt or to avoid.

Who should attend?

This tutorial is designed for professionals with basic knowledge in regulatory affairs, agency submissions, and regulatory medical writing.

Learning Objectives

• Identify ways to increase the efficiency and success of product development programs;
• Describe key principles for successful regulatory interactions during drug development and marketing application preparation;
• Discuss best practices in developing successful clinical trial designs, statistical analysis plans, and regulatory submission documents.


Speakers
avatar for Elaine Taylor

Elaine Taylor

Exec Dir, Reg Consulting, INC Research
Elaine Taylor is Senior Director of Regulatory Consulting and Submissions at INC Research responsible for consultation and the development and management of regulatory interactions and submissions for sponsors. With over 25 years’ experience in pharmaceutical drug development, she has extensive knowledge of ICH and CTD guidelines, 505(b)(1), 505(b)(2), and ANDA drug programs. Her current responsibilities include regulatory strategy, overall... Read More →
avatar for Kathryn Wekselman

Kathryn Wekselman

Senior Director, Regulatory and Scientific Affairs, CTI Clinical Trial and Consulting Services
Kathryn Wekselman is Senior Director of Scientific and Regulatory Affairs at CTI Clinical Trial and Consulting Services in Cincinnati, OH. Before joining CTI in 2012, she worked for 5 years at CROs as a Director and Senior Director of regulatory consulting and submissions for pharmaceutical and biotechnology company clients and for 9 years at Procter & Gamble Pharmaceuticals, where she held positions as a Senior Scientist in medical writing... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-509-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials Register today for this tutorial.

The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. In 2015, Chinese good clinical practice (GCP) guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some GCPs are overturning common ways that were implemented since 2003. The CFDA is enhancing inspective forces on the quality and integrity of clinical trial outcomes. GCP requirements on medical devices and diagnostics have also been strengthened by CFDA. The procedures of investigator new drug/new drug application (IND/NDA) review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug and medical devices/diagnostic strategies in China. This tutorial will provide insights into critical considerations impacting IND/NDA practices involving drugs and medical devices/diagnostics development in China and upcoming CFDA reformations of regulatory submission review and approval.

Who should attend?

This tutorial is designed for professionals in regulatory affairs, drug development, medical device/diagnostics, clinical trial management, monitoring, data management or clinical operations who have some basic knowledge of the Chinese regulatory environment and will benefit from learning updates of IND/NDA drug and medical device trials.

Learning Objectives

• Describe basic CFDA regulatory requirements for an IND/NDA process;
• Explain Chinese regulatory practice and trends for reviewing and approving submissions of drugs;
• Discuss the updated Chinese GCP guidelines for IND drug trials;
• Explain how to be compliant with Chinese GCP standards in the implementation of clinical trial;
• State how to complete the IND/NDA application process to the CFDA.


Speakers
EH

Earl Hulihan

Professor, SUTCM
Professor Hulihan is Principal with ew hulihan and associates, inc. For over 35+ years, Hulihan has been active in the DIA, in Medicine, as well as providing regulatory consulting, auditing, and training services to the global pharmaceutical community and regulatory authority personnel worldwide.
DL

Daniel Liu

Chief Scientific Officer, Beijing Clinical Service Center
20 years in the pharmaceutical industry in the management of global clinical trials. A core expert in the Steering Committee of State Clinical Data Standardization, CDE CFDA; Associate Director of CDM China; Professor at CFDA Inst of Executive Development; Writer- in- chief of "Clinical Trial Methodology of Medicinal Products"; Co-author for books: "GCP: A Q&A Reference Guide", "New Drug Approval Process", "Computerized Systems in Clinical... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#20: The Sunshine Act: Understanding the Essentials of Compliance
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

As part of the Affordable Care Act of 2010, the Sunshine Act was enacted. This law is designed to inject greater transparency for the public to understand the relationship between pharmaceutical and medical device companies and the physicians and teaching hospitals that are most likely prescribing their products. The Sunshine Act imposes a duty on “applicable manufacturers” of “covered” drugs and devices to both track and disclose not only payments made to physicians and teaching hospitals in the form of consulting fees, honoraria, etc., but also any other provision of an item or service that has a value to such recipients, including meals, trips, research equipment, etc. And, annually all such payments need to be submitted to a website maintained by the Center for Medicare and Medicaid Services (CMS) for public review.

This tutorial will explore in detail the Sunshine Act’s requirements, including any potential exemptions, and also the unique way that the Sunshine Act deals with research-related payments, which overlaps in part with the separate provisions in 21 CFR Part 54 that FDA imposes for the disclosure of financial interests held by clinical investigators. The basics of the system and process for submitting the required disclosures to the CMS “Open Payments” database and suggestions on how to implement processes at their companies to ensure compliance with the Act’s requirements will be discussed.

Who should attend?

This tutorial is designed for all personnel responsible for ensuring compliance with the Sunshine Act.

Learning Objectives

• Discuss how the Sunshine Act is structured;
• Identify key definitions that impact duties under the Sunshine Act, including when a product is “covered” so as to potentially render the manufacturer responsible for disclosing payments;
• Identify the many different types of payments or provision of other things of value that must be tracked and disclosed under the Sunshine Act.


Speakers
avatar for Michael Swit

Michael Swit

Senior Director, Legal, Regulatory, Illumina, Inc.
Michael A. Swit, Esq., has solved vital FDA legal issues since 1984, with a focus on drug and device challenges. Before joining Illumina as its senior regulatory counsel in December 2014, he was a Special Counsel in the FDA Law Practice at Duane Morris, a global law firm. He also served for seven years as a VP at The Weinberg Group, a prominent FDA consulting firm; was with several major FDA law firms; general counsel of Par Pharmaceutical; and... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#23: How to Prepare for an FDA Inspection
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will provide information on how to build quality into a clinical trials program. A record number of FDA inspections, both domestic and international, and OHRP audits have resulted in an increased number of warning letters to sponsors, principal investigators, and IRBs. Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with good clinical practice expectations. Participants will also learn about the considerations for noncompliance and the types of findings in an audit that can lead to regulatory problems. This tutorial will describe the role of the FDA and the preparation of a site for an FDA inspection. We will cover the audit from different perspectives and focus on helpful hints and procedural issues regarding what to do in case they are chosen for an FDA inspection. There will be a discussion on how to host the audit and how best to prepare for the actual audit. The audience will be taught some of the do's and don'ts of a successful inspection.

Who should attend?

This tutorial is designed for QA and clinical staff in companies, pharmaceutical/biological companies that are involved in clinical trials and QA activities for clinical research.

Learning Objectives

• Describe how to prepare for an FDA inspection;
• Describe how to respond to an FDA inspection;
• Examine audit findings including their impact on quality research;
• Discuss possible outcomes of an FDA inspection.


Speakers
avatar for Michael Hamrell

Michael Hamrell

President, MORIAH Consultants
Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, contract research, government and biotech industries, in domestic and international regulatory affairs and clinical research. He also worked in the Division of AIDS in NIAID at NIH and as a reviewer at CDER at the FDA. Dr. Hamrell has published numerous papers in... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#25: Signal Detection: Identifying and Managing Safety Signals
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Signal detection is an essential element of the overall risk management process. This intermediate to advanced tutorial provides a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process. Emphasis is on practical pragmatic approaches. Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion. The tutorial also provides participants with the context to evaluate new research in the field.

Who should attend?

This tutorial is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities. The tutorial will also benefit participants who make risk management decisions based on signal detection results.

Learning Objectives

• Identify strengths and limitations of methods for signal detection;
• Interpret outputs from automated quantitative signal detection methods (data mining results);
• Discuss how to integrate signal detection methods into the larger signal and risk management process;
• Describe emerging methods for signal detection.


Speakers
avatar for James Buchanan

James Buchanan

Drug Safety Consultant, Covilance LLC
Dr. Buchanan is an independent drug safety consultant. He worked in clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General Hospital before starting at Genentech where he worked for 9 years in medical information and drug safety. He then established a drug safety department at Gilead Sciences and later at Tularik Inc, acting as Chief Safety Officer until it was acquired 5 years later by Amgen. He moved to... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#21: Leadership: How to Organize and Lead People in a Work Group
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; PDU 3.25 PMI 2166-000163; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This tutorial addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.

Who should attend?

This tutorial is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and are interested in learning how to exert influence on group behavior, and for individuals to whom project managers report.

Learning Objectives

• Identify the different types of work group structures and be able to predict the quality of work the group will produce;
• Identify ways to correct dysfunctional group dynamics;
• Create and maintain cooperation among team members, including cross-functional teams.


Speakers
avatar for Michael Laddin

Michael Laddin

Chief Executive Officer, LeaderPoint
Mike Laddin is CEO of LeaderPoint. Mike has over twenty five years of senior management experience has a BS in Psychology Chemistry, MS in inPsychology and an MBA from Rockhurst University.LeaderPoint has over 700 clients including; 3M, ADP, Pfizer, Electronic Arts, LucasFilms, Zynga, and WellPoint.


Sunday June 26, 2016 8:30am - 12:00pm
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#26: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

_x000D_
An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Payers play an important role in both national and global health care systems: their decision-making signals to manufacturers their likelihood to support the R&D required for innovative, new medicines. Only a small number of innovative medicines are approved annually. The large proportion of new drug candidates fail during the development, and the average R&D cost per approved new molecular entity is increasing. Providers and payers can be thought of as agents acting on behalf of patients and their covered beneficiaries. Payers are critical in expressing the willingness of health care systems to provide funds to support innovation. Manufacturers must understand, monitor, and anticipate the evolving payer environment to increase the likelihood of regulatory and commercial success for new products. Key tools such as pharmacoeconomic evaluation of cost-effectiveness and budget impact, as well as important processes such as health technology assessment are used in many developed countries. Understanding their varying role in different jurisdictions is critical for pricing and market access negotiations.

This tutorial, which is hosted with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), will introduce participants to the basic economics of drug development, pricing, contracting, and market access. It will address commonly used economic concepts, such as demand, supply, willingness to pay, monopoly, intellectual property, and value. Practical observations will be made on the similarities and differences in how health care systems approach these pricing and access practices and decisions, with an emphasis on the implications for stakeholder incentives. Examples will be used to illustrate key concepts as well as both routine and special cases.

Who should attend?

This tutorial is designed for industry professionals and academics with an interest to learn more about the economic perspective on drug development, incentives for innovation, and how different countries grapple with these difficult health sector resource allocation decisions.

Learning Objectives

• Explain what makes innovative medicines unique economic inputs into population health including how the patent system relates to the financing of global R&D;
• Describe in what way prices for innovative medicines are established, how this differs by system, as well as the evolving impact of pharmacoeconomics and health technology assessment;
• Discuss how the complex global network of public and private payers judge the value of innovative medicines.


Speakers
avatar for Louis Garrison

Louis Garrison

Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington
Dr. Garrison is Professor in the Pharmaceutical Outcomes Research and Policy Program in the School of Pharmacy, and Adjunct Professor in the Departments of Global Health and Health Services at the University of Washington, where he joined the faculty in 2004. He also co-directs the Global Medicines Program in Global Health. From 2007-2009, Dr. Garrison served on the ISPOR Board of Directors. He co-chaired two ISPOR Good Practice Task... Read More →
avatar for Jack Mycka

Jack Mycka

Global President and CEO, Medical Marketing Economics LLC (MME)
As MME’s Global President & CEO, Jack provides critical global support for strategic marketing and pricing decisions to clients in the biotech and pharmaceutical industries. As a recognized expert consultant since 2001, he has successfully completed engagements encompassing many product classes and therapeutic areas and markets, including chronic care, oncology, injectable, and other specialty products all centered on value and its... Read More →


Sunday June 26, 2016 8:30am - 12:00pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#43: Risk Management and Safety Communication Strategies
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-16-505-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Risk communication is increasingly important to everyone involved in our health care system, especially the patients whose lives we strive to improve. This tutorial will look at current initiatives and new strategies to advance the safe use of drugs. The current status and future of Risk Evaluation and Mitigation Strategies (REMS) in the US will be discussed, and compared with Risk Management Plans in Europe and Japan.

What You Will Learn:
• Current state of risk communication in the United States
• Health literacy, risk perception, and other safety communication issues
• New strategies to improve understanding of drug safety concerns among health care providers and to promote better communication to patients
• The development of risk evaluation and mitigation strategies (REMS) in the US
• How US REMS with risk management plans compare with those of Europe and Japan
• The importance of good communication during a crisis situation.

Who should attend?

This tutorial is designed for professionals who work in clinical safety and pharmacovigilance, regulatory affairs, medical writing, and marketing and communications.

Learning Objectives

• Describe current risk communication strategies;
• Discuss the development of REMS in the US;
• Explain new methods to improve the proper use of medicines to maximize patient benefit and minimize risk;
• Discuss the future of drug safety and risk communication especially during a crisis situation.


Speakers
avatar for Nancy Smith

Nancy Smith

Adjunct Professor, Temple University, FDA Alumni
Nancy Smith, PhD, retired from the FDA after almost 25 years in the Center for Drug Evaluation and Research. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and she served as a DIA board member of from 2002-2008. She was Chair of the DIA Annual Meeting in San Diego in 2009.


Sunday June 26, 2016 9:00am - 5:00pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#44: The Good Pharmacovigilance Practices in the EU: Global Applications
Limited Capacity seats available

Component Type: Tutorial
CE: CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

The objective of this tutorial is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:

    • Overview of the latest developments in the area of pharmacovigilance in the EU including related IT systems
    • Management and reporting of adverse reactions and signal management
    • Updates of GVP Module VI
    • The new EU E2B(R3) ICSR implementation guide
    • New process for marketing authorization holders regarding the monitoring of medical literature and entry of relevant information into the EudraVigilance database by the EMA
    • Updates to the EudraVigilance Access Policy.


Who should attend?

This tutorial is designed for professionals who work in the following areas: clinical safety and pharmacovigilance, regulatory affairs, risk management, quality and compliance.

Learning Objectives

• Describe recent developments on EU Good Pharmacovigilance Practices guidance;
• Examine principles for new literature monitoring and the revised EudraVigilance Access Policy;
• Discuss FAQs in signal management;
• Identify important aspects in preparing risk management plans and conducting postauthorization safety studies;
• Describe key principles for pharmacovigilance audits and inspections.


Speakers
avatar for Steve Jolley

Steve Jolley

Chief Executive Officer, SJ Pharma Consulting, LLC
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events. Steve has 30 years’ experience in drug safety and pharmacovigilance and has worked with over 100 clients in North America, Europe, Japan, India and China. He holds degrees in mathematics and computer science from Cambridge University, England. He is an Adjunct Professor at Rutgers... Read More →
avatar for Saad Shakir

Saad Shakir

Director, Drug Safety Research Unit
Prof. Shakir is Director, Drug Safety Research Unit (DSRU) Southampton, leading an active program for monitoring and studying the safety of medicines and risk management.


Sunday June 26, 2016 9:00am - 5:00pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#40: Analysis of Safety Data from Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-16-503-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

Who should attend?

This tutorial is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.

Learning Objectives

• Discuss how to utilize guidelines and regulatory requirements for clinical trials;
• Describe ways to contribute to safety analysis plans;
• Discuss the statistical safety analysis process and pitfalls that could occur;
• Identify impact of benefit-risk assessment in safety data.


Speakers
avatar for Jürgen Kübler

Jürgen Kübler

Global Head, Quantitative Safety Sciences, CSL Behring GmbH
Dr. Kübler has over 15 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the University of Dortmund, Germany.
avatar for Joachim Vollmar

Joachim Vollmar

Executive Consultant, International Clinical Development Consultants LLC (ICDC)
Mr. Vollmar has been an independent consultant since 2004 and founded International Clinical Development Consultants, LLC in 2005 and Preclinical Research and Scientific Consulting Services, LLC in 2008. From 1970-1992, he was with Boehringer Mannheim as a senior statistician in clinical trials, preclinical experiments and diagnostics. From 1992-2004, he was with PRA as Managing Director, Europe, EVP Quality and Process Management, Product... Read More →


Sunday June 26, 2016 9:00am - 5:00pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#42: Clinical Statistics for Nonstatisticians
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-16-504-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the tutorial will be on the application of statistical concepts to clinical investigation.

Who should attend?

This tutorial is designed for professionals in the pharmaceutical industry involved in clinical research, medical affairs, medical writing, and other disciplines, who need to be familiar with statistical concepts.

Learning Objectives

• Discuss basic statistical concepts such as variability, confidence intervals, hypothesis testing, and p-values;
• Compare various study designs including techniques to avoid bias;
• Use statistical terminology with ease;
• Distinguish information needed for determining sample size.


Speakers
avatar for Michael Mosier

Michael Mosier

Director, Biostatistics, EMB Statistical Solutions, LLC
Michael Mosier, PhD is co-founder and Director of Biostatistics for EMB Statistical Solutions, a data management and statistical CRO. He has served on the editorial board of the Drug Information Journal and serves as instructor for the DIA Clinical Statistics for Nonstatisticians training course.


Sunday June 26, 2016 9:00am - 5:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#41: A Rare Disease Program Case Study: Strategies for Successful Outcomes
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-16-507-L01-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials.  Register today for this tutorial.

Working through a multifaceted case study, this one-day, intensive tutorial will address heads-on the unique challenges associated with the development of rare disease therapies. Successful outcomes are a direct result of early planning, design and engagement with patients, patient advocacy groups, treating physicians, specialists, and regulators.

This interactive case study will emphasize how “spending” time in early planning assures appropriate study outcome measures, timely enrollment of clinical trials, and successful regulatory interactions which affect the bottom line and improve the potential for developing therapies for rare disease patients faster.

Who should attend?

This tutorial is designed for professionals working with rare disease therapies including by not exclusive to researchers from academia and industry, senior managers, regulatory affairs specialists, clinical trialists, government officials and investors focused on the future of rare disease and orphan product development.

Learning Objectives

• Examine rare disease clinical and regulatory program issues and challenges;
• Discuss special considerations for study endpoint identification and development;
• Distinguish differences between working with FDA on the development of rare disease therapies as compared to more common diseases;
• Develop ideas for educating, building visibility and understanding of a rare disease programs with key stakeholders.


Speakers
RB

Ronald Bartek

President/Co-Founder, Friedreich's Ataxia Research Alliance (FARA)
Co-founder/President, FARA, Board of Directors, NORD; NIH/NINDS National Advisory Council; partner/president, government affairs firm; 20 yrs federal service in defense, foreign policy & intelligence; U.S. Delegation to Intermediate-Range Nuclear Forces (INF) Treaty talks, Geneva; CIA analyst of East-West balance; graduate, U.S. Military Academy, West Point; Army officer, Korea & Vietnam; MA, Russian Area Studies, Georgetown
LD

Linda Deal

Head of Patient-Centered Outcomes Measurement, Pfizer Inc
avatar for Jessica Foley

Jessica Foley

Head of Regulatory Services, NovusLife, LLC
Jessica is a senior regulatory professional and consultant with 10 years of experience in the global biopharmaceutical industry. She provides strategic product development and approval strategies to pharmaceutical and biotechnology companies with a focus on investigational therapies for the treatment of rare, serious and life-threatening conditions.
avatar for Jonathan Goldsmith

Jonathan Goldsmith

Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Dr. Goldsmith is the Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to his federal service, he had an extensive career in academia as a tenured professor, in regulated industry where he focused on clinical drug development, at the NHLBI/NIH and with orphan disease foundations. Dr. Goldsmith earned his medical degree from NYU School of Medicine, received his post-graduate training in Internal Medicine at Vanderbilt... Read More →
avatar for David Schubert

David Schubert

Vice President of Regulatory & Quality, Stealth BioTherapeutics
David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc., a company developing novel and innovative mitochondrial targeted therapies for both rare and common diseases. Previously, Mr. Schubert was the Vice President of Regulatory Affairs and Quality Assurance for MediVector Inc. At MediVector, Mr. Schubert was responsible for the development and execution of US and EU regulatory and quality activities for a... Read More →


Sunday June 26, 2016 9:00am - 5:00pm
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

11:45am

Annual Meeting of Members
Hear DIA President and Chairman of the Board, Dr. Sandra Milligan and DIA Global Chief Executive, Barbara Lopez Kunz give an update on the association and ratify the election results. Learn how DIA is your essential resource that provides opportunities to extend debate and discussion to advance scientific and medical innovation.

Sunday June 26, 2016 11:45am - 12:00pm
Liberty Ballroom A Philadelphia Marriott

12:30pm

Registration for Afternoon Preconference Tutorials, Conference Attendees, and Speakers
Sunday June 26, 2016 12:30pm - 6:00pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-510-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (Consultations with PMDA and Clinical Trial Notifications), the integration of Japanese drug development with East Asian and global drug development, accelerated approval pathways (sakigake; regenerative medicine), orphan drug regulation and J-NDA review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

Who should attend?

This tutorial is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

• Explain the major elements of the Japanese regulatory system;
• Describe the regulatory procedures during development, registration, and post-approval;
• Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.


Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, PAREXEL International
Alberto Grignolo, PhD is Corporate VP, Global Strategy at PAREXEL Consulting, where he has worked for 24 years in various regulatory, drug development and management capacities. Most recently he relocated to PAREXEL's Tokyo Office for two years, establishing a new consulting unit there. He is currently engaged in initiatives that address clients' most significant opportunities and challenges in product development and commercialization. He is the... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety measure. He is also a rapporteur of ICH E17 (MRCTs) expert working group.


Sunday June 26, 2016 1:00pm - 4:30pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#31: Preparing for a US FDA Advisory Committee Meeting
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-16-511-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This tutorial teaches best practices for preparing for an FDA Advisory Committee meeting, and it is set up like an actual Advisory Committee meeting.

What You Will Learn:
• What is an advisory committee?
• What does an advisory committee “look like”?
• Critical factors for advisory committee preparation
• How to design the most applicable preparation program for your team
• Top ten “best practices” and “must avoids.”

Who should attend?

This tutorial is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

• Identify the critical factors in preparing for a successful advisory committee meeting;
• Recognize and evaluate those factors that are most applicable to your team;
• Design the most effective preparation for your team(s).


Speakers
avatar for Kaia Agarwal

Kaia Agarwal

Independent Regulatory Consultant, PharmApprove
Kaia Agarwal is an independent strategic regulatory affairs consultant working with PharmApprove. She helps teams prepare and implement global regulatory strategy for their products as they prepare for critical interactions with regulators, including EMA and FDA. For over 27 years she has led several teams to develop products in all major therapeutic areas, especially in preparation for agency meetings including CHMP Scientific advice, FDA... Read More →
avatar for Lisa Peluso

Lisa Peluso

Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
Lisa Peluso is a Communications Coach at PharmApprove, where she works with development teams to create and deliver clear, consistent, and convincing messages to regulators in the US and Europe. Lisa has coached individuals and provided presentation/Q&A training and workshops to teams in pharma and biotech, and has helped over 30 clinical development teams prepare for FDA Advisory Committee meetings. Prior to joining PharmApprove, Lisa worked... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#34: Ethical Issues in Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will provide an overview of the various ethical considerations associated with conducting clinical trials, including the history of ethical principles - Nuremburg Conventions, Declaration of Helsinki, The Belmont Report, and ICH. Topics will include obtaining ethics committee and regulatory authority clearance, subject informed consent, investigator conflict-of-interest, issues of fraud, authorship, and ensuring subject safety and well-being. In addition, consideration will be given to conducting studies in emerging economy populations where fair distribution of risks and benefits come into play. It will become evident, through case examples, that these issues are not always black-and-white, and that the situation in which these issues are considered result in many shades of gray.

Who should attend?

This tutorial is designed for pharmaceutical company clinical operations staff, clinical trial site investigators and study coordinators, ethicists, regulators and regulatory affairs staff.

Learning Objectives

• Discuss the foundations of ethics;
• Explain how ethical decisions may be influenced by context and experience;
• Discuss the viewpoint of the clinical study subject when educating clinical study site staff about ethical considerations.


Speakers
avatar for Art Gertel

Art Gertel

President and Principal Consultant, MedSciCom, LLC
Dr. Gertel has more than 35 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support.


Sunday June 26, 2016 1:00pm - 4:30pm
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#33: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-16-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

Risk evaluation and mitigation strategies (REMS) vary from simple to complex. Particularly for the complex Elements to Assure Safe Use (ETASU) REMS, data in the form of a REMS assessment report may greatly challenge team members as many may be new to the process. Creation of a REMS assessment report requires a high-functioning, coordinated and cooperative team (whether done all in-house or including vendors). During this workshop, participants will hear about relevant FDA regulations and guidances, recent status of REMS, and experiences in leading teams to successfully create REMS assessment reports. During hands-on activities, participants will receive case studies, discuss and role playing as key functional areas — data management, project writing, medical writing, pharmacovigilance, drug safety, epidemiology, and regulatory affairs, with an emphasis on providing a timely, high-quality deliverable. Time will be spent on refinement of the project plan, development of the table of contents, and how to coordinate disparate sections such as knowledge survey reports and adherence metrics. Discussion will also focus on topics such as the content of the REMS assessment as dictated by the REMS and REMS approval letter, determination of data cut-off dates, working with vendors, what to include in the report regarding survey design issues such as comprehension testing, special concerns for shared REMS, and FDA input and timing.

Who should attend?

This tutorial is designed for professionals involved in clinical safety and pharmacovigilance.

Learning Objectives

• Describe the key milestones needed to create a REMS assessment report;
• Identify who and how to engage in the multidisciplinary team required to create the report;
• Discuss the type of sections included in various types of REMS assessment reports.


Speakers
avatar for Mark Ammann

Mark Ammann

President, Catalyst Regulatory Services, LLC
Mark A. Ammann is the owner and President of Catalyst Regulatory Services, LLC. Prior to founding Catalyst, Mark established and built a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and provided strategic regulatory consulting to a range of clients from start-up pharmaceutical companies to large multinational corporations. He has over 25 years of... Read More →
avatar for Catherine Sigler

Catherine Sigler

Executive Director, Safety, Epidemiology, Registries and Risk Management, UBC: An Express Scripts Company
Dr. Catherine Sigler is a Senior Epidemiologist and Executive Director in United BioSource Corporation (subsidiary of Express Scripts Inc.) department: Surveillance, Epidemiology, Registries and Risk Management (SERRM). She provides technical expertise in pharmaceutical safety issues as relate to epidemiologic approaches and REMS. Since January 2015, she has also led the Value Demonstration Team that is focused on generating the real world... Read More →
avatar for Annette Stemhagen

Annette Stemhagen

Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UBC
Dr. Stemhagen has more than 30 years of research experience, 20 yrs in safety surveillance. She has expertise in design, conduct, and analysis of peri-approval registries, LSS, actual use studies, including >35 regulatory-mandated safety studies. She has developed REMS for more than 80 products.


Sunday June 26, 2016 1:00pm - 4:30pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#32: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial is designed to help you understand what culture, bureaucracy and innovation really are, and the impact they can have on actual business results — in concrete, clear terms. This requires stripping away the vagueness and assumptions that so commonly surround these topics. The discussion will include three primary components:
1) Understanding and influencing workplace culture and its impact on the results people get while working. Culture can either disrupt people’s ability to focus on the work, or it can reinforce and support clarity of focus, but culture is created by those working, not dictated by managers.
2) Avoiding and dealing with workplace bureaucracy, which almost always results from the creation of structure, a necessity as businesses and companies grow. Understanding and managing bureaucracy improves efficiency and economy.
3) Understanding and encouraging workplace innovation, and the direct benefits to efficiency and profitability that innovation brings about. Managers often attempt to drive innovation formally, but these efforts usually fail due to a lack of understanding what really encourages innovation at the work level — where it matters most.

Who should attend?

This tutorial is designed for designed for managers interested in directly impacting these three areas, generating greater business results through the efforts of others. It is designed for new and experienced managers seeking to understand and address these issues with planned deliberation.

Learning Objectives

• Define ways to create focus and direction for people in work groups or project teams;
• Identify an applicable set of tools to understand, diagnose and correct dysfunctional culture, bureaucratic inefficiency, and inadequate innovation.


Speakers
avatar for Michael Laddin

Michael Laddin

Chief Executive Officer, LeaderPoint
Mike Laddin is CEO of LeaderPoint. Mike has over twenty five years of senior management experience has a BS in Psychology Chemistry, MS in inPsychology and an MBA from Rockhurst University.LeaderPoint has over 700 clients including; 3M, ADP, Pfizer, Electronic Arts, LucasFilms, Zynga, and WellPoint.


Sunday June 26, 2016 1:00pm - 4:30pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#37: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on RBM, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This tutorial, hosted by TransCelerate BioPharma, Inc., will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.

Who should attend?

This tutorial is designed for professionals involved with clinical and data operations.

Learning Objectives

• Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
• Discuss the use of key tools in the RBM process;
• Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.


Speakers
avatar for Joanne Benedict

Joanne Benedict

Senior Advisor, Genentech, A Member of the Roche Group
Joanne Benedict is a Senior Advisor in Roche Genentech's Process, Training, and Systems group. She develops business strategies, processes, and systems which support continuous improvement and innovation in clinical trials. Specializing in operations, technology, and process optimization, she is also experienced with change management including training programs which maximize embedding of new business processes.
avatar for Lisa Horne-Lucero

Lisa Horne-Lucero

Consultant, RBM Operations, Clinical Risk Management, Eli Lilly and Company
Lisa is an RBM Operations Consultant in Eli Lilly’s Clinical Risk Management organization. She develops and implements RBM processes, procedures and training as she guides study teams through the RBM implementation process. She has been a key leader in the implementation of RBM at Lilly since its inception. She also continues to serve as a site monitoring subject matter expert for the business.


Sunday June 26, 2016 1:00pm - 4:30pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:45pm

#001: Powerful Presentations
Limited Capacity seats available

Component Type: Workshop
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Unlock the key to successful presentations in a powerful interactive workshop. Learn the critical elements to include and what to avoid in developing and delivering presentations in many different environments, and enhance your skills with practice.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss key skills for delivering successful presentations; Identify key communication mistakes to avoid during presentations; Practice presentation delivery skills.

Chair

Lynn King, MHA

Speaker

Facilitator
Karyn A. Lasky



Chair
avatar for Lynn King

Lynn King

Senior Director, Clinical Operations, TKL Research, Inc.
Clinical research professional with 24 years in the drug development industry working in large pharma, CRO and clinical site settings. 18 years experience in leadership and staff management. Certified trainer and professional coach with a passion for working with teams and creating and delivering training.

Speakers
KL

Karyn Lasky

Director, Clinical Operations, TKL Research, Inc.


Sunday June 26, 2016 2:45pm - 4:00pm
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:15pm

#002: Networking: It's Personal - Understanding Yourself and Others to Maximize Personal Interaction
Limited Capacity seats available

Component Type: Workshop
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Maximize your time at the Annual Meeting by getting a head start on networking skills. This workshop will address the value of networking, examining how to assess one’s own personality type, how an effective network needs a variety of personality types, and how to communicate effectively for personal and professional growth. Following the workshop, there will be an informal gathering at a local venue where you get to practice your new networking skills. This is a great way to meet other attendees and start off your week.

Would you like to attend this workshop? RSVP using this SURVEY LINK by June 3.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Identify personality traits of oneself; Identify personality types of others; Differentiate communication strategies based on personality type; Demonstrate how to optimize your network.

Chair

Chris Matheus, MBA

Speaker

Facilitator
Bob Muzerall



Chair
avatar for Chris Matheus

Chris Matheus

Executive Director, Business Development, Lexitas Pharma Services
Chris has 20+ years experience in the pharmaceutical and clinical research industry. He has focused on clinical trial technologies while working in large CROs and smaller technology companies. Chris is now working with Lexitas Pharma Services as Executive Director, Business Development.

Speakers
avatar for Bob Muzerall

Bob Muzerall

Vice President, Sales & Sales Training, AMPLEXOR Life Sciences, LLC
Bob has held managerial and executive positions in the publishing and medical fields for over 30 years. He is currently Vice President, Sales & Sales Training at AMPLEXOR Life Sciences. AMPLEXOR Life Sciences helps the pharmaceutical, medical device and biotechnology industries launch products. They offer consultancy, technical writing, language translation, linguistic validation, and the creation and management of marketing assets. Bob is a... Read More →


Sunday June 26, 2016 4:15pm - 5:30pm
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Monday, June 27
 

6:30am

CISCRP Medical Heroes Appreciation 5K
Component Type: Tutorial

Join us for the Medical Heroes Appreciation 5K Run and Walk in Philadelphia, PA to celebrate the study volunteers who give the gift of participation in clinical research.

All proceeds will provide education and outreach about clinical research participation to patients and their families in minority and under-served communities.

PrintPLUS The Greater Gift Initiative is teaming up with CISCRP again to offer a vaccine to a child in need on behalf of every registrant!

Prizes for top runners, top fundraisers, the team with the most spirit and more!

For more information and to learn about sponsorship opportunities, please email Ellyn at ellyngetz@ciscrp.org

Monday June 27, 2016 6:30am - 8:15am
TBD Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

7:00am

Coffee and Light Refreshments
Grand Hall and Room 108 Concourse 

Monday June 27, 2016 7:00am - 8:30am
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

7:00am

Attendee, Speaker, and Exhibitor Registration Open
Monday June 27, 2016 7:00am - 6:00pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

7:30am

Annual Meeting Orientation and Networking
Attending DIA 2016 for the first time? We encourage you to attend the Annual Meeting Orientation and Networking Session to learn how to make the most of your time at the meeting, and meet fellow first timers.

Monday June 27, 2016 7:30am - 8:15am
104A 104A

8:30am

#106: Fostering a Partnership to Advance Innovation: Niche Service Leads to Breakthrough in Patient Recruitment and Retention Challenges
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Patient recruitment and retention remains the Achilles heel of clinical trials. An innovative service model involving traveling nurses to conduct at-home or alternate site study visits has gained traction over the past years. While only a handful of global providers of ambulant care services are available, sponsors of all sizes and locations have been forming partnerships with these organizations to accelerate their development timelines by fostering patient-centric services to enhance patient recruitment and retention. We will explore how a large pharmaceutical company is driving innovation through its corporate silos. We will also explore how this innovative ambulant care service model was incorporated into specific studies and how the resulting benefits benefited all stakeholders including patient, investigator, sponsor, and consumer.

Learning Objectives

Identify three keys factors when selecting strategic partners; Articulate the cornerstones to a successful partnership; Describe the hurdles when changing culture and advancing innovation.

Chair

Gail Adinamis

Speaker

Breaking Through Corporate Silos to Promote Innovation
Denisa McKnight, MSc

Panelist
Matt Dobson



Chair
avatar for Gail Adinamis

Gail Adinamis

Chief Executive Officer, GlobalCare Clinical Trials
Ms Adinamis has >35 yrs of global clinical trials experience including tenures at Abbott and Astellas. She established & headed clinical trials divisions for 3 nat'l home infusion co's then started an independent ambulant care service company for clinical trials in 2004 where she served as president and CEO. In 2010 Adinamis became founder & CEO of GlobalCare Clinical Trials. Adinamis has 2x been among INC 5000’s fastest growing co's and... Read More →

Speakers
avatar for Matt Dobson

Matt Dobson

Patient Recruitment Strategist, Roche Products Ltd.
Matt has 20 years Pharma experience, working in small, med and large size pharma companies working on Phase II & III trials across a variety of different disease areas. Starting his career as a CRA he went on to hold positions in Clinical Operations Management, Feasibility and Patient Recruitment & Retention Strategy. For the least 5 years he has been working for Roche, based in Welwyn (UK), working in Global Patient Recruitment and Operational... Read More →
avatar for Denisa McKnight

Denisa McKnight

Patient Engagement and Media, Roche Products Limited
Denisa McKnight has >10 yrs of experience in the pharma industry covering a broad range of areas, including all lifecycles of clinical development, research and academia. She currently works at Roche where she is leading Patient Engagement & Media global category implementing innovative collaborative sourcing models by partnering with preferred and niche suppliers breaking through corporate silos. She also established sponsor/x-partner HIVE... Read More →


Monday June 27, 2016 8:30am - 9:30am
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#117: IDMP: A Compliance Project or a New Way of Conducting Business?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will present different solution scenarios on how to approach the identification of medicinal products (IDMP) based on two very different starting points and discuss the mapping of the mandatory ISO IDMP data fields to the risk management plan (RMP), the EU integrated format, and explore the challenges of document life cycle management impacted by this new worldwide standard.

Learning Objectives

Discuss how you could approach the identification of medicinal products (IDMP) from the angle of integration and convergence to ensure that your IDMP project will become the first stepping stone on a journey towards an integrated company, tying strings to the regulations, clinical trial regulation, ISO ICSR etc; Discuss potential benefits you can alleviate from IDMP; Describe the mapping of mandatory ISO IDMP data fields and controlled vocabularies that directly impact the risk management plan.

Chair

Niels Gronning, MSc

Speaker

ISO IDMP Impact Assessment on the Risk Management Plan
Debbie Persaud, MSc

IDMP: A Compliance Project
Bernie Coney, MA



Chair
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more recently the implementation and impact assessment of ISO IDMP.

Speakers
avatar for Debbie Persaud

Debbie Persaud

Regulatory Affairs SME, NNIT Inc.
Debbie Persaud is a RA SME at NNIT US. Prior to joining NNIT, she worked as a RA Manager at Pfizer and Ethicon specializing in global regulatory submission strategies for biologics and medical devices. She has a MSc. in Biomedical Sciences from the University of Medicine and Dentistry of NJ and a patent introducing a new anticoagulant. Debbie is excited about how big data is advancing personalized medicine and enjoys helping companies get their... Read More →


Monday June 27, 2016 8:30am - 9:30am
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#101: Opportunities for Improving Informed Consent of Clinical Research Volunteers
Limited Capacity seats available

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Learn about new strategies for improving the informed consent process. Recommendations and tools for re-focusing on the informed consent process will be provided. Examples, opportunities and future directions related to use of eConsent will be shared. Finally, the challenges and solutions for consenting adult and pediatric patients in antibacterial clinical trials will be discussed.

Learning Objectives

Describe recommendations for improving the informed consent process in clinical research; Discuss the TransCelerate eConsent project including benefits for research volunteers as the industry moves from paper to eConsent; Recognize actions that can be taken to encourage site eConsent adoption and proactively address issues that commonly surface during eConsent site implementation; Identify opportunities for improving consent in challenging situations.

Chair

Jennifer Lentz

Speaker

Transforming Informed Consent: Initiatives of the Clinical Trials Transformation Initiative and TransCelerate BioPharma, Inc.
Jennifer Lentz

Engaging Investigators and Site Staff in Adoption and Implementation of e-Consent: A World View
Susan Brink, DrPH

Applicable Lessons Learned from the CTTI Antibacterial Drug Development Program
Pamela Tenaerts



Chair
JL

Jennifer Lentz

Global Informed Consent Consultant, Global Clinical Operations, Eli Lilly and Company
Jennifer Lentz has been the Global Informed Consent Process Owner at Eli Lilly and Company for the last 3.5 years. Currently, she is also involved in consent projects with Clinical Trials Transformation Initiative, Transcelerate, and Innovative Medicines Initiatives. Prior to joining Lilly, Jennifer worked as a study monitor, study coordinator, disease field investigator, and lab researcher. She became interested in informed consent during her... Read More →

Speakers
avatar for Susan Brink

Susan Brink

Executive Vice President, e-Consent Products and Services, Enforme Interactive
Dr. Brink has been involved in creation of e-consent since 2003. As PI on a NIH SBIR grant to develop an electronic informed consent, she led the team in vision, guidance and research for SecureConsent. Her Enforme portfolio includes expansion of SecureConsent e-consent system into use by biobanks and medical procedures.. She brings her patient education and decision making expertise to the conceptualization and development of patient education... Read More →
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI)
Dr. Tenaerts provides senior level oversight of CTTI and directs efforts to effectively engage all stakeholders to improve conduct of clinical trials. She is a member of PCORI's CTAP expert post-award subcommittee and MIT Collaborative Initiatives Clinical Trials Process Expert Advisory Board. With > 25 years’ experience in clinical trials, she also practiced medicine in the emergency room and private practice. She received her MD from Catholic... Read More →


Monday June 27, 2016 8:30am - 9:45am
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#102: Digital Health Debate
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

The Digital Debate will bring together expert representatives from sponsor, site, CRO and marketing perspectives to debate the merits of digital media for patient recruitment and retention. We will discuss the challenges and optimal scenarios for utilizing digital channels to recruit patients.

Learning Objectives

Discuss insights from sponsors, CROs, and sites on their past and planned use of digital media for patient recruitment; Describe the challenges faced in implementing digital media for patient recruitment; Address issues in coordinating digital media campaigns among the entities and in integrating digital with traditional campaigns; Identify possible methods to overcome organizational barriers to effectively implement digital campaigns for patient recruitment.

Chair

Nariman Nasser

Speaker

Move from Pilot to Platform: Four Strategies to Enable Digital Health Approaches to Scale in Research Programs
John Reites

mHealth in Clinical Research and Development: Is It All Hype?
Brett Villagrand

Site Perspective
Joshua R. Korzenik, MD



Chair
avatar for Nariman Nasser

Nariman Nasser

Digital Strategist, Operational Intelligence and Innovation, Roche
Nariman Nasser is Digital Strategist of Operational Intelligence and Innovation at Roche/Genentech. She previously was the Senior Director of Participant Recruitment & Study Management Services at UCSF's Clinical & Translational Science Institute. Ms. Nasser’s prior experience also includes molecular immunology and stem cell biology bench research, as well as industry-sponsored clinical research project and portfolio management, marketing... Read More →

Speakers
JK

Joshua Korzenik

Director, Crohn's and Colitis Center, Brigham and Women's Hospital
avatar for John Reites

John Reites

Senior Director, Head of Digital Health Acceleration, Quintiles Inc.
As the Head of Digital Health Acceleration, John Reites is focused on partnering and executing digital health innovation programs with biopharmaceutical companies, established innovators, start-ups and VC firms. Mr. Reites is a speaker and author of various publications, providing subject matter expertise for direct-to-patient research, patient recruitment, patient communities, direct-to-patient observational research and digital health... Read More →
avatar for Brett Villagrand

Brett Villagrand

Principal, Carethings
Brett’s passion is for how innovation in technology can impact outcomes for patients. Most of his career was with Pharmaceutical companies Novartis and Genentech in product development and marketing roles. Until recently, was hired as an industry subject matter expert at Oracle advising Health & Life Science companies on how technology can address their business R&D challenges.


Monday June 27, 2016 8:30am - 9:45am
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this session, we will display a tool that helps integrate recruitment planning into the fabric of a trial’s operational design. We will also debate the most appropriate usage of the tool and how to integrate it into the planning process.

Learning Objectives

Describe a new tools developed by sponsors to determine the best recruitment strategy for any given protocol; Show the impact these tools have had on developing budgets and tactics for recruitment planning; Discuss the positives and potential pitfalls of using these tools.

Chair

James Kremidas

Speaker

Matchmaking: Systematizing Best Fit Tactics for Study Needs
Lewis Millen

The Art and Science of Site Level Recruitment Planning: Tools, Tactics, and Tips?
Beth D. Harper, MBA



Chair
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is currently the Executive Director of the Association of Clinical Research Professional (ACRP). Earlier in his career he developed the patient enrollment team at Eli Lilly where he worked for 24 years. Most recently he spent for 6 years at a global CROs. He is on the Steering Committee for the Center for Information and Study on Clinical Research Participation (CISCRP).

Speakers
avatar for Beth Harper

Beth Harper

President, Clinical Performance Partners, Inc.
Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. She has passionately pursued solutions for optimizing protocols, enhancing patient recruitment and retention and improving sponsor and site relationships for over 30 years. Beth is an Adjunct Assistant Professor at George Washington University, a member of the CTTI Recruitment Team, and... Read More →
avatar for Lewis Millen

Lewis Millen

Operational Intelligence Leader, Roche Products Limited


Monday June 27, 2016 8:30am - 9:45am
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Limited Capacity seats available

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-523-L01-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000186; RN 1.25

This forum will provide an overview of traditional small molecule drug development, and highlight special considerations, opportunities, requirements, and risks for specialized programs, such as oncology, vaccines, biologics, or breakthrough therapies.

Learning Objectives

Explain how oncology, vaccine, and biologic drug development are similar to, or different from, a traditional small molecule program; Compare and contrast oncology, vaccine, and biologic drug development with respect to project leadership and project management strategies, approaches, and resource investment decisions; Discuss the impact of breakthrough therapy designation on each of these.

Chair

Eva M. Finney, PhD, PMP

Speaker

Panelist
Susan Uptain, PhD

Panelist
David Robinson, PhD



Chair
avatar for Eva Finney

Eva Finney

Director, Global Project & Alliance Management, Merck & Co., Inc.
Eva M. Finney, PhD, PMP, is Director, Global Project and Alliance Management at Merck & Co., Inc., where she has worked as a Project Manager for 13 years: 4 years in Molecular Profiling, supporting the Oncology and Neuroscience portfolios, & 9 years in GPAM, where she has managed multiple development programs from early to late stage, across a variety of therapeutic areas. Most recently, Eva has managed several NDA submissions leading to... Read More →

Speakers
DR

David Robinson

Principal Consultant, Robinson Vaccines and Biologics LLC
Independent consultant with 25 years experience in global vaccine and biologics product commercialization, process development and CMC regulatory strategy/execution (IND, BLA, PAS). Over 20 years at Merck, chaired the CMC development team that achieved approval of RotaTeq, an oral live virus vaccine, headed the product development teams that entered Merck’s first biosimilars into development and led the CMC regulatory group that achieved... Read More →
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations, Shire
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc. Dr. Uptain has over 14 years’ experience in global drug development in Oncology, Diabetes and Respiratory. She holds a Ph.D. in Molecular and Cellular Biology from... Read More →


Monday June 27, 2016 8:30am - 9:45am
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#105: Maximize the Value of Your Product by Beginning with the End in Mind
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000189; RN 1.25

Less than 1% of compounds make it to market. It is critical for biopharmaceutical developers to evaluate their probability of success. In this interactive forum, experts will share their insights to help you maximize the value of your asset.

Learning Objectives

Describe the elements of a regulatory strategy and why it is needed; Discuss the value of your product as part of your development strategy; Explain why and how to develop a target product profile; Discuss how the TPP guides the drug development process and sets expectations; Describe how to avoid typical reasons for delays and denials of a product marketing application.

Chair

Jayanthi Reddy, MBA, MS, PMP

Speaker

Panelist
Bill Hanlon, PhD

Panelist
Carrie Furin



Chair
JR

Jayanthi Reddy

Director and Cardiovascular Pipeline Leader, Global Project Management, Merck & Co., Inc.
Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.

Speakers
avatar for Carrie Furin

Carrie Furin

Pharmaceutical Project Manager, Eli Lilly and Company
Carrie is a Pharmaceutical Project Manager with Eli Lilly and Company overseeing Oncology drug development projects. She has over 10 years of drug development experience in clinical operations and project management. Carrie has led teams across multiple therapeutic areas and phases, which has provided her insight on the importance of planning, bridging the space between sound science and commercial success, and team communication. Carrie has a BA... Read More →
avatar for Bill Hanlon

Bill Hanlon

VP, Head of Global Regulatory Affairs, Covance Inc.
Dr. Hanlon is Vice President and Head of Global Regulatory Affairs at Covance. His group is responsible for all project related regulatory activities involving strategic drug development planning, medical & regulatory writing, Health Authority meetings and regulatory document submissions. Prior to joining Covance, Dr. Hanlon spent 24 years in the Pharmaceutical Industry, most of that time at Merck Research Laboratories in Rahway, NJ


Monday June 27, 2016 8:30am - 9:45am
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

A recent French clinical trial resulted in one subject dead and five with severe health problems. The panel will examine how to best understand the risks in providing feedback to address participant safety, timelines, and costs.

Learning Objectives

Working with the sponsor, identify IP risks and best understand potential adverse events/serious adverse event (AE/SAE); Formulate a process to best address participant safety; Adapt to clinical information in addressing participant safety and timelines and cost of study.

Chair

William B Smith

Speaker

Panelist
Howard Greenberg, MD

Panelist
Thijs Van Iersel, MD

Panelist
Mary L. Westrick, PhD



Chair
avatar for William Smith

William Smith

President, New Orleans Center for Clinical Research
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical Research and Volunteer Group located within the University of Tennessee Medical Center. Dr. Smith has been involved as a Principal Investigator in over 1800 clinical... Read More →

Speakers
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Pharmaceuticals, Inc.
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering, business, and clinical research. He's been an Investigator of more than 130 early phase clinical trials from ~30 sponsors, and authored 50+ papers, and has been... Read More →
avatar for Thijs Van Iersel

Thijs Van Iersel

Senior Director of Science, Early Development Services, PRA Health Sciences
Dr van Iersel is an MD with > 20 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Resident at Urology, and as Principal Investigator, Medical Director and Manager at Clinical Pharmacology Units of PBR and Xendo. He led the phase 1-2 clinical development of suggamadex at Organon, the Netherlands and... Read More →
avatar for Mary Westrick

Mary Westrick

Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology at the University of Wisconsin-Madison. Dr. Westrick sits on the Dean's Industrial Advisory Board for the College of Pharmacy at Purdue, where she was... Read More →


Monday June 27, 2016 8:30am - 9:45am
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-554-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this session, representatives from large pharmaceutical companies will present and discuss the science, current methodologies and achievements in their advanced clinical programs in the area of immuno-oncology. They will address what makes the difference to standard and targeted therapies, what has been learned by studying the interaction of the tumor and the immune system, and the predictors for patient response.

Part 2 is scheduled for Monday, June 27, 10:45AM-12:00PM.

Learning Objectives

Describe the most recent advances in cancer immunotherapy; Discuss the interaction of the tumor and the immune system; Identify predictors for patient response.

Chair

Holger G. Adelmann

Speaker

Overview of Immuno-Oncology
Ashok K. Gupta

Molecular Predictors of Response to Immuno-Oncology Therapeutics
Brandon Higgs, PhD

Opportunities and Challenges for the Use of Biomarkers in Anti-PD1/PD-L1 Immunotherapy
Ti Cai, PhD



Chair
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association for Clinical Pharmacology & Therapeutics, German Association for Applied Human Pharmacology, a fellow of the Royal Microscopical Society, Oxford, and lecturer at... Read More →

Speakers
TC

Ti Cai

Director, Global Clinical Biomarkers and Companion Diagnostics, EMD Serono
Ti Cai joined EMD Serono in March 2015 as Director, Clinical Biomarkers and Companion Diagnostics. He is currently leading clinical biomarker development for avelumab (anti-PD-L1 antibody) program. Prior to EMD Serno, Ti worked at Celgene, Sanofi and Amgen where he led biomarker research for multiple projects. Ti Cai completed his undergraduate study at Fudan Univeristy in China, obtained his PhD degree at State University of New York and... Read More →
AG

Ashok Gupta

Vice President, Head of Clinical Immuno-Oncology, Medimmune
avatar for Brandon Higgs

Brandon Higgs

Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and Bioinformatics from George Mason University and a Master’s in Bioinformatics from Johns Hopkins University. His current research focuses on translational approaches in... Read More →


Monday June 27, 2016 8:30am - 9:45am
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-526-L01-P; CME 1.25; IACET 1.25; RN 1.25

In vitro diagnostic devices are important tools intended for use in the diagnosis of disease or other conditions, including a determination of the state of health. Based on a diagnosis, it seems reasonable for a company to recommend an appropriate prescription drug treatment. This session reviews the basics of advertising and promotion for devices and prescription drugs in the context of intended use and approved indications. Taking the substantial evidence requirements and recent 1st Amendment challenges into consideration, the panelists will provide a systematic assessment of scenarios when company may or may not co-promote or recommend a prescription treatment based on a diagnostic outcome.

Learning Objectives

Identify valuable insights into the regulatory and legal boundaries of advertising and promotion of a device with a prescription drug when these tactics go beyond the approved intended use/indication, and when this may be viewed as an unapproved new combination device/drug product.

Chair

Kimberly Belsky, MS

Speaker

Panelist
Alan G. Minsk, JD

Panelist
Minnie Baylor-Henry, JD, RPh



Chair
avatar for Kimberly Belsky

Kimberly Belsky

Executive Director, OneSource Regulatory
Kimberly (Kim) Belsky is an Executive Director at OneSource Regulatory (OSR). Prior to OSR, Kim was the Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals. In that role, Kim was responsible for a diverse portfolio that included Rx drug (brand and generic) OTCs/Nutritionals/Cosmetics, and devices. Kim has 25 years of pharma experience, with 15 in regulatory affairs.

Speakers
avatar for Minnie Baylor-Henry

Minnie Baylor-Henry

President, B-Henry & Associates
President of B-Henry & Associates, a consulting firm focused on providing regulatory and compliance strategy services to life sciences companies. Prior to assuming her current role in early 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business. J&J is one of the largest and most diverse medical devices businesses in the world, with 2014 sales of just over $27... Read More →
avatar for Alan Minsk

Alan Minsk

Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP
Alan G. Minsk is a partner in the Food and Drug and Government and Regulatory Practices. Mr. Minsk was recently recognized by Chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers 2013. Mr. Minsk focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic and food companies, on all legal and regulatory matters... Read More →


Monday June 27, 2016 8:30am - 9:45am
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#109: EHR in Clinical Research: Heralding a New Era
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will focus on the work completed by the CDISC EHR-to-CDASH (E2C) team mapping data from EHR into EDC as eSource. Ongoing studies will be profiled. Representatives from a sponsor, academia, and EDC vendor will present.

Learning Objectives

Identify the components of EHR systems; Discuss complexities associated with EHR to EDC data transfer; Describe data standards and proper mapping between systems; Describe regulatory implications; Discuss how this will be able to help clinical research sites.

Chair

Trisha D Simpson

Speaker

EHR to EDC Data Transfer: Experiences and Lessons
Ian Sparks

The eSource Stakeholders Group and Next Steps
Michael A. Ibara, PharmD

EHR-EDC Integration Case Study: The Good, the Bad, and the Beautiful
Sue Dubman, MA



Chair
avatar for Trisha Simpson

Trisha Simpson

Director, Global Biometry Standards, UCB Biosciences, Inc.
Trisha is currently the Director of Global Integrated Standards at UCB. She’s been in the pharma industry for over 20 years. Her work at UCB includes standards governance; overseeing a Metadata Repository (MDR) build; and initiating an Electronic Healthcare Record (EHR) data retrieval pilot project. In addition to her duties at UCB, Trisha is also very active with CDISC and TransCelerate (co-chair of CDASH, member of the CAC, CDISC TLC... Read More →

Speakers
avatar for Sue Dubman

Sue Dubman

Director, IT and Informatics Innovation, University of California San Francisco (UCSF)
20+ yrs. experience. Sr. Dir, IT Innovation, at UCSF. Part of a multi-disciplinary team to innovate changes in care & research. Previously Sue was Sr. Dir, Genzyme, strategy, standards and arch. Before that, served as Dir, NCI Informatics Initiatives & VP/CIO at 2 biopharmas. At NCI, part of the original team that formed caBIG, a very large experiment in global data sharing. CDISC BOD for 6 yrs & Chair of CAC. Very active in Parkinson’s... Read More →
avatar for Michael Ibara

Michael Ibara

Head of Digital Healthcare, CDISC
Dr. Ibara is Head of Digital Healthcare for CDISC where his current work includes overseeing CDISC's participation in the FDA eSource project. He has over 20 years experience at the intersection of technology and healthcare. Previously he lead groups in pharmacovigilance and in business development coordination at Pfizer, where he created and lead the ASTER project was the first time adverse events were retrieved directly from an electronic... Read More →
avatar for Ian Sparks

Ian Sparks

Senior Director, Research Science, Medidata Solutions Worldwide
Ian Sparks is a Senior Director in Medidata Labs, an innovation group focused on evaluating new technologies and data integrations. Ian's recent work has been in integrating wearable sensors and Electronic Health Records with EDC using CDISC and HL7 standards. Ian holds a bachelors degree in Computing and has more than 20 years experience in the eClinical industry.


Monday June 27, 2016 8:30am - 9:45am
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#110: Updates and Pending Issues in the US Biosimilar Environment
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-544-L01-P; CME 1.25; IACET 1.25; RN 1.25

The US biosimilars market is maturing rapidly. In the past year, we’ve seen the first biosimilar launch in the US market, multiple draft guidances on biosimilars and biologics emerge from the FDA, and several biosimilar applications that focus on diverse range of complex reference products. The debate and discussion in the US around biosimilars highlights the importance of the biosimilars market to the US drug industry, and the continued impact of the 2010 Biologics Price Competition and Innovation Act. This panel will discuss recent developments in US biosimilars regulation from a manufacturer’s perspective, lessons learned, and areas that would benefit from further global policy discussion.

Learning Objectives

Discuss recent developments in US biosimilar regulation: Identify areas that would benefit from further global policy discussion.

Chair

Andrew S. Robertson, JD, PhD

Speaker

Panelist
Karen M Hauda

Panelist
Mark McCamish

Panelist
Kimberly Greco



Chair
AR

Andrew Robertson

Director, Global Regulatory Policy, Merck & Co., Inc.
Andrew S. Robertson works in Global Regulatory Affairs at Merck & Co., focusing on regulatory policies concerning vaccines, biologics, biosimilars, in vitro diagnostics, mobile medical apps and software medical devices. He has over 13 years of experience spanning academia, industry and government. Andrew holds a JD from the University of California, Berkeley, and a Ph.D. in structural biology from Cambridge University.

Speakers
KG

Kimberly Greco

Director, Research and Development Policy, Amgen Inc.
avatar for Karen Hauda

Karen Hauda

Senior Director, Regulatory Policy, Novo Nordisk Inc.
Karen Hauda is the Senior Director for Regulatory Policy in the Clinical Development, Medical and Regulatory Affairs Division at Novo Nordisk. In this role, she supervises regulatory advocacy and develops filing strategies to positively influence the regulatory environment in the United States and globally. Karen also teaches in the Department of Global Health at George Washington University, in Washington, D.C. She holds a M.S. in Veterinary... Read More →
avatar for Mark McCamish

Mark McCamish

Global Head Biopharm and Oncology Injectables Development, Sandoz, Inc
Dr. McCamish is a physician scientist with a long history of drug, biologic, and biosimilar development in large and small organizations. He is currently Global Head of Biopharmaceutical Development for Novartis biosimilar development housed in Sandoz International.


Monday June 27, 2016 8:30am - 9:45am
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recently we have seen increased efforts of Asian regulatory harmonization. Hear speakers from Asian agencies and industry and learn how they try to collaborate and harmonize regulations to enable more efficient drug development in this emerging region.

Learning Objectives

Discuss recent changes in drug development regulations in Asia; Describe the Asian regulation trend relating to harmonization with ICH and other global initiatives; Identify how the industry and regulatory agencies collaborate with each other for better and faster drug development by reviewing recent examples of global drug development utilizing multiregional clinical trials including Asia.

Chair

Akio Uemura, PhD

Speaker

Update on Clinical and Regulatory Environment for Drug Development in Korea
Min Soo Park

Rapidly Changing Regulatory Landscape in China
Dan Zhang

Impacts of ICH E17 Guideline in Asian Drug Development
Yoshiaki Uyama, PhD



Chair
avatar for Akio Uemura

Akio Uemura

Senior Director, Head of Development, Japan, Allergan Japan K.K.
1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Japan, 2013: Head of Global Development Japan, Allergan Japan, 2014: present position, PhD in biological engineering from Osaka Univ

Speakers
avatar for Min Soo Park

Min Soo Park

Chair, KCGI
Min Soo Park is a physician, trained specialist and Professor in Pediatrics (Neonatology) and Clinical Pharmacology. He received MSc in Clinical Pharmacology at Univ of Aberdeen, UK, and Ph.D. in Medicine at Ajou University, Korea. He served as VP of KoNECT and is in charge of clinical research infrastructure buidling as Chair of Korea Clinical Trials Global Initiative since 2014. He is Director of CTC at Severance Hospital, Yonsei University... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety measure. He is also a rapporteur of ICH E17 (MRCTs) expert working group.
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational Corp., a member of Quintiles Executive Operation Committee, and was also the Chairman of the Board for Quintiles Medical Development (Shanghai) Company Ltd.


Monday June 27, 2016 8:30am - 9:45am
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#112: The Upcoming European Clinical Trials Regulation
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will give an opportunity to understand the requirements of the new European Clinical Trial Regulation, the IT developments for its implementation, and to discuss the expectations and preparedness for implementation by global sponsors.

Learning Objectives

Recognize the requirements of the new clinical trial regulation; Discuss major information technology developments required for its implementation; Describe the impact of the regulation for the main stakeholders; Identify the expectations and challenges to be faced by global sponsors.

Chair

Anabela Marcal, PharmD

Speaker

The EU Portal and Database: A Pillar of the Clinical Trial Regulation
Anabela Marcal, PharmD

Getting Ready for the Changes: A Sponsor Perspective
Nick Sykes, MS

Transparency in Clinical Trials: A European Update
Marie-Agnes Heine, MA



Chair
avatar for Anabela Marcal

Anabela Marcal

Head of Compliance and Inspections Department, European Medicines Agency, European Union
Anabela joined the EMA in 1999 and was holding various roles, until she was appointed Head of Compliance and Inspections Department in August 2013.

Speakers
avatar for Marie-Agnes Heine

Marie-Agnes Heine

Head of Communication Department, Stakeholders and Communication Division, European Medicines Agency, European Union
Marie-Agnes Heine is Head of Communication Department at the European Medicines Agency, London. She is a senior external relations and communications specialist with 25 years of experience in communications strategy development and implementation, journalism, advocacy and media campaigns. | Marie-Agnes has worked as communications officer and spokeswoman for United Nations Department of Public Information, the International Organization for... Read More →
avatar for Nick Sykes

Nick Sykes

Senior Director, Worldwide Regulatory Strategy, Pfizer Ltd.
Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer for 17 years. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology


Monday June 27, 2016 8:30am - 9:45am
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-604-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are the experts in their disease and its impact, and across the research enterprise, stakeholders are working to identify how to best leverage this expertise to enhance trial design, conduct, and overall relevance to patients. This session will provide patient, regulator, and industry perspectives on how this goal can be achieved. Speakers will review key FDA, Clinical Trials Transformation Initiative, and sponsor initiatives designed to bring the patient into the conversation as trials are designed, implemented, and their results reviewed. Presenters will discuss challenges faced and offer ideas on how these challenges may be proactively addressed.

Learning Objectives

Discuss key FDA initiatives related to patient engagement and how these may better incorporate the patient perspective into all stages of drug development; State a patient perspective on how patients could be better engaged in trial design and recruitment and learn about a project to facilitate patient engagement and recruitment.

Chair

Jonca C. Bull, MD

Speaker

Patient Perspective
Jane Perlmutter

Patient Centric Trial Design: It's More Than Just the Trial
Joseph Kim

FDA Perspective
Elektra Johanna Papadopoulos



Chair
avatar for Jonca Bull

Jonca Bull

Assistant Commissioner for Minority Health, Office of the Commissioner, FDA
Dr. Bull worked at the FDA from 1994 to 2006. She served as Director of clinical regulatory policy at Genentech and as Vice President for US Regulatory Policy at Novartis, returning to FDA in 2012 to serve in the Office of the Commissioner as Assistant Commissioner for Minority Health,

Speakers
avatar for Joseph Kim

Joseph Kim

Senior Advisor, Clinical Innovation, Eli Lilly and Company
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on innovative patient engagement solutions. He has spent over 17 years in the Pharma industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. He holds a BS in Molecular Biology and an MBA. He can be reached at kim_joseph_p@lilly.com and... Read More →
EP

Elektra Papadopoulos

Acting Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Elektra has been a medical officer at the FDA since 2001 and she currently serves as the Acting Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in CDER. The Staff provides internal consultation regarding clinical outcome assessment development and implementation across different therapeutic areas. The Staff also participates in guidance and policy development with regard to use of clinical outcome... Read More →
avatar for Jane Perlmutter

Jane Perlmutter

Founder and President, Gemini Group
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of research questions, design of trial protocols, and encouraging innovation to increase the speed of developing new treatments. She is also involved in health research... Read More →


Monday June 27, 2016 8:30am - 9:45am
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-605-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical relevance has re-emerged within recent discussions in both the quality and regulatory arenas, with specific focus on patient expectations, clinically relevant specifications, residual uncertainty, and benefit-risk based decision making. Translating highly technical information into the pertinent patient-centric frame requires an intricate balance. This session highlights multiple opportunities for collaboration and communication, with the end goal of improving medicines, ensuring their availability, and assuring their use in accordance with patient needs.

Learning Objectives

Share common experiences regarding the establishment of clinically relevant specifications; Identify areas for future discussion with regard to clinical relevance in the quality arena; Discuss specific cases that illustrate establishment and/or challenges establishing clinically relevant specifications.

Chair

Richard T. Lostritto

Speaker

Paving the Road Toward Setting Clinically Relevant Drug Product Specifications: The Relevance of Biopredictive Dissolution Testing
Sandra Suarez Sharp, PhD

Industry Perspective
Ganapathy Mohan, PhD

FDA Perspective
Laurie Graham



Chair
RL

Richard Lostritto

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Richard (Rik) Lostritto currently serves as a Division Director In FDA's ONDQA. Prior to this, he served in the FDA as a Team Leader, and Chemsitry Reviewer.

Speakers
LG

Laurie Graham

Acting Director, DIPAP, OPPQ, OPQ, CDER, FDA
Ms. Graham is the Acting Directorof the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.
GM

Ganapathy Mohan

Head of Global CMC, Merck & Co., Inc.
Ganapathy Mohan is the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials. | | Prior to this he was the head of Global CMC at Merck where he led a team of professionals that support global regulatory filings in the area of pharmaceutical products and Medical Devices. | Mohan has a Ph.D in Analytical... Read More →
SS

Sandra Suarez Sharp

Biopharmaceutics Lead (Acting), DB Branch III, ODNP, OPQ, CDER, FDA
Dr. Sandra Suarez-Sharp joined the Office of Clinical Pharmacology (OCP) at the FDA, in September 1999. Currently, she works at the Office of New Drug Products/Division of Biopharmaceutics (FDA/OPQ/ONDP) as a Master Biopharmaceutics Reviewer/Biopharmaceutics Lead (acting) supporting all therapeutic areas.


Monday June 27, 2016 8:30am - 9:45am
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The session will review the implementation status of the 2010 EU Pharmacovigilance Legislation and its associated Good Pharmacovigilance Practices Guidelines, focusing on the key challenges and uncertainties arising from implementation, as well as some future proposals to measure impact on facilitating the performance of pharmacovigilance in the European Union. Did it do what it originally set out to achieve? Key to the success of implementing a robust pharmacovigilance system is the ability to strengthen the monitoring of benefit risk throughout a products life cycle. The results of the PROTECT work stream that arose as a quantum leap forward in benefit risk evaluation from the Innovative Medicines Initiative in the EU will be explored and how the results have changed industry and regulatory authority standards.

Learning Objectives

Discuss the current status, challenges, and uncertainties arising from the implementation of the EU Good Pharmacovigilance Practices Guidelines associated with the 2010 EU Pharmacovigilance Legislation; Describe future strategies to measure the impact that the legislation and guidelines have had since implementation; Explore how the results of PROTECT have changed industry and regulatory standards.

Chair

Valerie E. Simmons, MD, FFPM

Speaker

Introduction, General Overview of Implementation of the EU GVP Guidelines: Did They Actually Deliver?
Valerie E. Simmons, MD, FFPM

IMI PROTECT: Challenges, Successes, and the Effect on PhV in Europe
Stella C.F. Blackburn

Important Risks Resulting from EU PV Legislation and Guidance: Best Practice to Allow Optimized Patient Safety?
Leonardo Ebeling



Chair
avatar for Valerie Simmons

Valerie Simmons

EU QPPV, Global Patient Safety, Eli Lilly and Company Ltd
Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. | Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Committee, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks... Read More →

Speakers
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Risk Management, Real World & Late Phase Research, Quintiles Inc.
Currently VP and Global Head of risk management at Quintiles, Dr Blackburn worked in pharmacovigilance at the European Medicines Agency for almost 17 years. She developed the EMA's risk management policies and strategy for Europe and was the lead author of the European guidelines. Prior to this she worked in the pharmaceutical industry and hospital medicine. She originally co-developed the course in PhV and PhEPi at LSHTM where she is Hon... Read More →
LE

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions. In 1998, Dr. Ebeling launched his CSO company providing drug safety services in medical science, pharmacovigilance, risk management and regulatory affairs... Read More →


Monday June 27, 2016 8:30am - 9:45am
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will review best practices for quantifying a meaningful change in a patient-reported outcome (PRO) endpoint and establishing a responder definition in the presence of missing score data. Missing data strategies that do not assume absence of a PRO score means “non-responder.”

Learning Objectives

Recognize problems in responder analyses if subjects discontinue study treatment or withdraw from a trial; Compare approaches published by EMA, NAS, and in the ICH E9(R1): Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials; Recognize how to combine multiple missing data approaches to tell the data story.

Chair

Scott Komo, DrPH

Speaker

Panelist
Yeh-Fong Chen, PhD

Panelist
Lisa A Kammerman, PhD, MS



Chair
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining the FDA in 1999. He received a BA in Chemistry from the University of California, Davis and an MS and DrPH in Biostatistics from the University of California... Read More →

Speakers
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Dr. Yeh-Fong Chen is the statistical team leader supporting the Division of Gastroenterology and Inborn Errors Products at the Division of Biometrics III at US Food and Drug Association. She joined FDA in 2000 immediately after graduation with a PhD degree in Statistics from the University of Iowa. She has had years' experience in reviewing drug applications for psychiatry products and has performed reviews for drug products in the cardiovascular... Read More →
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Science Director in the Advanced Analytics Center at AstraZeneca. She consults on complex study designs and statistical innovation projects, and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she led the Office of Biostatistics’ Clinical Outcome Assessments program. In that role, she helped develop policy for the design, analysis, and interpretation of... Read More →


Monday June 27, 2016 8:30am - 9:45am
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#119: Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop will introduce participants to the concept of narrative medicine and the skills and habits of reflective writing and listening in order to better recognize, receive, absorb, interpret, and honor stories of illness in a clinical setting.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Define narrative medicine; Explain how narrative competence is applied to nourish empathic health care professional-to-patient relationships; Apply the skills of close reading and reflective writing in a small group setting.

Chair

Jesus Rivera, MSc

Speaker

Facilitator
Lauralee Leonard



Chair
JR

Jesus Rivera

Senior Learning Manager, Bristol-Myers Squibb Company
Jesús is a seasoned learning and development professional with over 20 years experience diagnosing, planning and implementing training, organizational development and technology solutions that address the learning needs of global financial services and pharmaceutical organizations.

Speakers
LL

Lauralee Leonard

Senior Medical Writer, Bristol-Myers Squibb Company


Monday June 27, 2016 8:30am - 9:45am
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#120: DIA 2016: Student Forum
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: IACET 1.25

DIA offers students and emerging professionals a large number of networking and job hunting opportunities. This session will explore some of these opportunities in industry and in government agencies, and will also explore how DIA student chapter participation has helped students start their careers while participating in chapter events and opportunities.

Learning Objectives

Describe the role of student chapters in career starts; Identify industry career opportunities; Identify government regulatory career opportunities.

Chair

Danny Benau, PhD

Speaker

Government Positions: Opportunities, Considerations, and Processes for Federal Employment
Tammy J. Massie

DIA Student Chapter Membership as Part of a Career Springboard
Philip Masaitis

Opportunities in the Drug Safety Arena
Sameer Thapar, PharmD, RPh



Chair
avatar for Danny Benau

Danny Benau

Director, Biomedical Writing Programs, University of the Sciences
BA, Boston University, 1975; PhD, Boston University, 1984; MSOD, University of Pennsylvania; Wyeth Ayerst Research 1991 - 2001; Principal Scientific Writer; Freelance; Writing Consultant; Currently Associate Professor of Biomedical Writing University of the Sciences in Philadelphia.

Speakers
avatar for Danny Benau

Danny Benau

Director, Biomedical Writing Programs, University of the Sciences
BA, Boston University, 1975; PhD, Boston University, 1984; MSOD, University of Pennsylvania; Wyeth Ayerst Research 1991 - 2001; Principal Scientific Writer; Freelance; Writing Consultant; Currently Associate Professor of Biomedical Writing University of the Sciences in Philadelphia.
avatar for Philip Masaitis

Philip Masaitis

Student, Philadelphia College of Pharmacy, University of the Sciences
Currently pursuing a Doctor of Pharmacy degree at the Philadelphia College of Pharmacy, Phil has interned at GlaxoSmithKline Consumer Healthcare, serves as DIA Chapter President at the University of the Sciences, and was selected as the recipient of the 2016 DIA National Student Leadership Award. His future plans include pursuing a career in the pharmaceutical biotech industry with a focus on integrating innovative digital tools into current... Read More →
avatar for Tammy Massie

Tammy Massie

Mathematical Statistician, Office of Equal Opportunity and Customer Outreach, National Institutes of Health (NIH)
Tammy Massie has worked as a mathematical statistician at various centers in the FDA for the past 13 years. In spring 2016, Tammy moved to NIH to perform statistical work on a variety of demographic subgroups within the Office of Equity, Diversity and Inclusion. Tammy recieved her PhD in Biostatistics from Medical College of Virginia. In 2002 both Tammy and her husband, a fellow MCV graduate were offered and accepted positions as Federal... Read More →
avatar for Sameer Thapar

Sameer Thapar

Director, Global Pharmacovigilance, Oracle; Professor, Rutgers, The State University of New Jersey
Dr. Sameer Thapar is Oracle Health Science Consulting’s Director of Global Pharmacovigilance and concurrently Assistant Professor, Drug safety and Pharmacovigilance, Masters in Clinical Trial Sciences program at Rutgers University. As a subject matter expert in pharmacovigilance operations and compliance, he has built global departments and defended in successful FDA, MHRA, and EMA health authority inspections. He is well versed in a... Read More →


Monday June 27, 2016 8:30am - 9:45am
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#121: Rare Disease Clinical Trials: Coping with Unique Challenges
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-602-L01-P; CME 1.25; IACET 1.25; RN 1.25

This symposium provides a unique opportunity to hear three interconnected but distinct perspectives on rare disease clinical trials. We will have an overview of the rare disease clinical environment in terms of therapy focus, geography and volume along with a compare and contrast of operational metrics with respect to start up and recruitment to set the stage. Next, the challenges related to ensuring robust safety and efficacy outcomes from a statistical perspective in an environment where limited patient sample sizes is a reality will be explored along with creative methods for overcoming these challenges. Finally, a rare disease in-depth case study involving Latin America and pediatric patients will showcase best practices on how to harness the unique cultural and environmental aspects of this region to meet enrollment targets.

Learning Objectives

Recall the most prolific areas in rare disease work and industry trends; Use metrics to validate start-up and enrollment challenges; Identify the operational challenges of rare disease trials in terms of recruitment as well as in conventional statistical analysis approaches; Discuss the unique cultural and environmental aspects of enrolling pediatric patients in a rare disease pediatric trial in Latin America; Share best practices on how enrollment can be met.

Chair

Maureen Smith

Speaker

Rare Disease: Understanding Operational Challenges
Linda Martin, MBA

Orphan Indications and Clinical Trials: Coping with Unique Challenges and Why Rare Diseases Warrant Special Treatment
Stephan de la Motte, DrMed, MD

Solving Enrollment Challenges for Rare Disease Global Clinical Trials in Latin America
Sara G Tylosky, MBA



Chair
avatar for Maureen Smith

Maureen Smith

Patient Advocate / Secretary, Canadian Organization For Rare Disorders (CORD)
Maureen Smith’s M.Ed. (Educational Psychology) interest in patient advocacy stems from a rare disease diagnosis at the age of 8. She is the Secretary of the Canadian Organization for Rare Disorders (CORD), co-chair of the Rare/Orphan Disease program track for the Drug Information Association’s annual meeting (2014-2016), a member of the CIHR-Institute of Genetics’ GELS Priority & Planning Committee and the patient member on Ontario’s... Read More →

Speakers
LM

Linda Martin

President and Founder, KMR Group Inc.
Linda Martin is a founder and President of KMR Group, a firm specializing in biopharmaceutical R&D performance, data and analytics. Her areas of expertise include the measurement and evaluation of R&D productivity and clinical development, including subspecialties of enrollment and site performance. Linda has a Master of Management degree from Northwestern University’s Kellogg Graduate School of Management and an undergraduate degree from the... Read More →
avatar for Stephan de la Motte

Stephan de la Motte

Chief Medical Advisor, Synteracthcr
Dr. Stephan de la Motte serves as Chief Medical Advisor at SynteractHCR. With nearly 30 years of experience, he is renowned for his scientific and medical expertise and clinical trial knowledge of Phase I, II and III studies. Over the course of his career, he has served as coordinating investigator for six clinical trials, as principal investigator for 60 trials and as investigator for 80+ trials. His impressive contributions include delivering... Read More →
avatar for Sara Tylosky

Sara Tylosky

CEO, Farmacon
Sara Tylosky, President & CEO at Farmacon has > 20 years of experience in strategic management & global marketing in the pharmaceutical & biotech industries. Farmacon works with sponsors, from large pharmas to start-up biotechs, from market intelligence to project manage enrollment including training & feedback for Phase 2-4 trials to reach enrollment early and reduce study costs. Sara holds a Masters in Business from Florida Atlantic University... Read More →


Monday June 27, 2016 8:30am - 9:45am
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:30am

Coffee Break
Exhibit Hall

Monday June 27, 2016 9:30am - 10:45am
Exhibit Hall Exhibit Hall

9:30am

Exhibit Hall Open
Monday June 27, 2016 9:30am - 6:00pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:30am

Student Poster Session
Component Type: Poster Presentation




Speakers
avatar for Sarthak Athavle

Sarthak Athavle

Student, Representative and Coordinator, Student Chapter, SPP SPTM, SVKM - NMIMS College
avatar for Magdalena Bujar

Magdalena Bujar

Doctoral Student, University of Hertfordshire
EM

Emel Mashaki Ceyhan

PhD Student, Cardiff University
MC

Mansi Chaturvedi

Student, Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital
avatar for Adam Chin

Adam Chin

Pharmacy Student, President-Elect, SSHP, Touro College of Pharmacy
avatar for Mor Fall

Mor Fall

PhD Student, Service of Clinical Pharmacology, EMET/FMPO, University Cheikh Anta Diop/Université Claude Bernard Lyon1, France
avatar for Tetyana Kolodyezna

Tetyana Kolodyezna

Pharmacy Student, National University of Pharmacy
Master student in Pharmacy. Got Bachelor degree with honors in Pharmacy in 2015. During student years participated at number of conferences and scientific events in Ukraine and Europe. During studying for Master degree work as a senior laboratory assistant at Department of Clinical Pharmacology and Clinical Pharmacy at National University of Pharmacy.
avatar for Reshma Lakhram

Reshma Lakhram

Student, Touro College of Pharmacy
avatar for Hai-Ha Le

Hai-Ha Le

PhD Candidate, Pharmacology, Claude Bernard Lyon 1 University
YP

Yen Ping Lim

National University of Singapore
avatar for Tomoko Matsumoto

Tomoko Matsumoto

Student, Global Regulatory Science, Pharmaceutical Science, Gifu Pharmaceutical University
avatar for Manthan Mehta

Manthan Mehta

Topiwala National Medical College & BYL Nair Charitable Hospital
avatar for Christopher Milan

Christopher Milan

Pharmacy Student, Phi Lambda Sigma Chapter President, Touro College of Pharmacy
avatar for Daichi Mori

Daichi Mori

Student, Global Regulatory Science, Pharmaceutical Science, Gifu Pharmaceutical University
RM

Rebecca Mullen

Northwestern University
avatar for Mehdi Namil

Mehdi Namil

Student, College of Pharmacy, University of North Texas Health Science Center
AP

Anisha Patel

PhD Candidate, Department of Pharmacotherapy and Outcomes Science, Virginia Commonwealth University School of Pharmacy
avatar for Mira Patel

Mira Patel

PhD Student, Pharmaceutical Economics, Policy, and Outcomes, University of Arizona
avatar for Shivani Shah

Shivani Shah

PharmD Candidate, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey
avatar for Shoyo Shibata

Shoyo Shibata

PhD Candidate, Faculty of Pharmacy, Keio University
SY

Seung Yeon Song

PhD candidate, Chung-Ang University College of Pharmacy
JS

Jinuk Suh

Chung-Ang University
avatar for Myungsuk Yang

Myungsuk Yang

Student, Department of Pharmaceutical Industry, Chung-Ang University
avatar for Weixiang Zhang

Weixiang Zhang

Student, Institute of Chinese Medicine, University of Macau


Monday June 27, 2016 9:30am - 6:00pm
TBD Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:00am

Speaker Training Session
If you or a colleague would like to practice and receive some fantastic feedback and speaking advice, please stop by! Look for signs for the Speaker Training Room

Monday June 27, 2016 10:00am - 10:30am
104A 104A

10:00am

#122: DBMS Consulting/Clinical Ink Innovation Theater: Accelerating Clinical Trial Innovation: Technology Case Studies for Improving Data Collection, Monitoring, and Medical Coding Processes
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Standardization supports efficiency but usually with a lack of flexibility. Make the introduction of new technologies less challenging by limiting the scope of change. Learn how one top 5 pharmaceutical company is replacing EDC with eSource by mapping data into their existing processes and clinical database. Learn solutions for expiring dsNavigator support and how a centralized medical coding model can eliminate coding discrepancies by integrating safety systems with RDC, Rave and InForm via Oracle's TMS.

Chair

DBMS Consulting


Chair
Monday June 27, 2016 10:00am - 10:30am
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#142: Why We All Need Mentors (and How to Be a Good Mentor to Others)
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: IACET 1.00

Most who are fortunate enough to take an executive course return to the office filled with enthusiasm, ready to implement their new learnings. Unfortunately, the demands of the day job soon crush that enthusiasm. A mentor makes all the difference.

Learning Objectives

Discuss how having a good mentor can "up your game" continually; Describe what makes a good mentor including how they can help you succeed; Explore some of the tools, techniques and skills successful executive coaches use.

Chair

David B. Stein

Speaker

CRA Retention: Insider’s Perspectives on Interventions to Anchor a Tenured, Talented Workforce
Nadia Bracken



Chair
avatar for David Stein

David Stein

Independent eClinical Consultant, D. Bartley Consulting
David Stein is an eClinical Consultant with over 25 years of leadership and entrepreneurial experience ranging from successful start-ups and mergers and acquisitions to managing clinical technology product portfolios for several large companies. He has specialized in product strategy and developing new products, software packages and methodologies. As a team leader and personal coach, he also has a passion for mentoring, building high... Read More →

Speakers
avatar for Nadia Bracken

Nadia Bracken

Clinical Trials Manager, Gilead Sciences, Inc
Founder and Chief Experience Officer (CXO) at ClinOps Toolkit. Her top-ranked pharma-industry blog has been frequented by visitors from 150+ countries. Nadia, finalist in the 2010 inaugural Pharmatimes US Clinical Researcher of The Year, shares over a decade of Phase I-IV clinical trial management experience. Nadia networks with like-minded ClinOps Professionals and helps them become extraordinarily effective. Nadia is your go-to girl for... Read More →


Monday June 27, 2016 10:45am - 11:45am
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#144: Root Cause Analysis: Getting to ‘Why’ When Something Goes Wrong in Your Trial
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

It is easy to get lost in the terminology around understanding the why of a problem – audit finding, response, CAPA, root cause analysis, fishbone diagram. This practical session will get you working with others on an example issue, using some basic ideas on root cause analysis and trying them out. You will learn the basics of getting to why without worrying about the terminology. Getting to the why when something goes wrong on your trial means you have the best chance of determining ways to stop the same thing impacting your trial (or another one) again. It’s a key part of a learning organization.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Apply root cause analysis techniques to determine probable root causes of an issue (such as from an audit finding); Explain the purpose of root cause analysis.

Chair

Keith John Barber

Speaker

Facilitator
Helen Howitt



Chair
avatar for Keith Barber

Keith Barber

Executive Director, INC Research
Keith Barber has worked in Quality, Process, Training and Clinical management positions for over 20 years. He currently manages INC's Process Quality Management department, which includes CAPA management, controlled document management and internal GXP consultancy. Keith has also performed 'Quality Partnership' roles in CROs and has been responsible for developing and implementing significant process improvement initiatives.

Speakers
avatar for Helen Howitt

Helen Howitt

Director, Process Quality Management, INC Research


Monday June 27, 2016 10:45am - 11:45am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this symposium, the presenters are examining various innovative approaches to and requirements for conducting clinical trials in Japan, India, and Latin America, as well as how their respective regulatory environments have contributed to fostering innovation, product development, and clinical research.

Learning Objectives

Discuss the requirements for conducting clinical trials in Japan, India and Latin America; Share insights into innovative regulatory approaches that could impact clinical studies in these regions; Describe factors one needs to consider when conducting ethno-bridging studies outside the United States.

Chair

Larry A. Blankstein, PhD

Speaker

Issues and Solutions When Conducting Complex Caucasian Clinical Studies in Japan
Andrew Melli

Clinical Trials in India: An Update on Current Status
Charu Gautam, MD

Clinical Research in Latin America: Trends, Challenges and New Opportunities
Maria João Queiroz, MD



Chair
avatar for Larry Blankstein

Larry Blankstein

Consultant, Clinical Development, Blankstein Consulting Group
Dr. Larry Blankstein is an independent Senior Consultant to the Pharmaceutical and Biotechnology industry. He has over twenty-two years experience in drug development strategy, clinical operations and mergers and acquisitions. He received his Ph.D. degree in Biology from Wesleyan University in Middletown, CT. His industry drug development experience was at Quintiles, Seragen and Genzyme.

Speakers
avatar for Charu Gautam

Charu Gautam

Director, Global Clinical Operations, Cliantha Research Ltd
Charu Gautam is a Pharmaceutical Physician with 17 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and Medical teams. Qualified as MBBS, MD followed by a board certification , she is also a lead faculty at various GCP workshops and conferences. Experienced with Phase I and Phase II /III studies in Oncology, Dermatology, GI, Psychiatry and been part of team conducting... Read More →
avatar for Andrew Melli

Andrew Melli

Senior Manager, SOUSEIKAI Global Clinical Research Center
Andrew Melli is the Senior Manager of Scientific Affairs and Foreign Relations at SOUSEIKAI Global Clinical Research Center, serving as both PR liaison for international business development, as well as an active supporting member of the clinical trial team. It is his hope to bridge the information gap for those interested in next-level clinical trials and a mature Japanese market, complimented by a revamped Japanese regulatory structure on par... Read More →
avatar for Maria João Queiroz

Maria João Queiroz

Chief Executive Officer, Eurotrials Scientific Consultants
More than two decades at executive leadership positions in the pharmaceutical industry, Founding Member & CEO at Eurotrials, a CRO in Europe and Latin America. With a Degree in Medicine, specialization in Immunohematology and a post-graduation in Pharmaceutical Medicine. Has active participation in Health Cluster Portugal, CLC Council at DIA, Advisory Council of School of Health Science at University of Minho and in Academic Clinical Research... Read More →


Monday June 27, 2016 10:45am - 12:00pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#124: Risk-Based Monitoring in Clinical Trials
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-518-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will examine the implementation of risk-based monitoring strategies in clinical trials and their impact on site performance, patient safety, data integrity, and study quality.

Learning Objectives

Discuss how risk-based monitoring (RBM) can help investigator sites improve overall site performance, with higher efficiency and improved patient safety; Describe best practices in site/CRO partnering to successfully drive efficiencies and improve oversight of patient safety and data quality; Identify the importance of planning the RBM strategy in order to make it actionable.

Chair

Ellen Kelso

Speaker

How to Successfully Plan and Implement a Risk-Based Monitoring Strategy
Francois Torche, MBA

Risk-Based Monitoring: What Does It Mean for Clinical Study Sites?
Jill Collins

The Impact of Risk-Based Monitoring on Site Performance: Reducing Risks While Improving Patient Safety and Study Quality
Robin Douglas, MA



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance systems.

Speakers
avatar for Jill Collins

Jill Collins

Executive Director, Innovation, INC Research
Jill Collins, Executive Director, Clinical Innovation at INC Research, with 20 years of experience in global operations management, leads the development of transformative approaches to trials with a focus on data-driven process optimization, including INC’s RBM solution: Strategic Data Monitoring. She is an active member of the ACRO-Transcelerate CRO Forum on the Risk-Based Monitoring and the Shared Investigator Platform Working Groups. Jill... Read More →
RD

Robin Douglas

Site Solutions Director, Site and Patient Networks, Quintiles
Robin Douglas has 22 years of clinical research experience, including 16 years as a site manager / administrator. | | Currently Robin serves as Site Solutions Director at Quintiles. Her core responsibility is to ensure an enhanced site experience when working with Quintiles which includes leading our RBM Site Readiness team. Prior to that, she served as Director of Site Management and was responsible for the performance of the Prime and... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 18 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During his ten year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the CluePoints' statistical engine. Francois has served as CluePoints... Read More →


Monday June 27, 2016 10:45am - 12:00pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-520-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patient recruitment is a challenging activity, which becomes even more so in rare diseases where populations are small, patients are geographically dispersed, and eligible subjects may not be physically (or economically) capable of traveling to a trial site. Unfortunately, current recruiting methods (e.g., listing on trial and patient organization websites, relying on key opinion leaders and trial investigators, billboards) may be limited in reach, overly reliant on busy physicians, and too costly or cost-ineffective. It behooves clinical trialists in rare diseases to consider mechanisms beyond these standard approaches. The aim of this session is to catalyze unconventional thinking and to provide a framework to organize innovative recruitment ideas.

Learning Objectives

Discuss the challenges of patient recruitment in rare diseases; Compare conventional and out-of-the-box ideas for patient recruitment; Illustrate a framework for organizing innovative recruitment ideas.

Chair

Badri Rengarajan, MD

Speaker

Leveraging Claims Data for Targeted Recruitment
Donny Chen, MBA

Direct-to-Patient Digital Recruitment: A Targeted Approach to Recruitment Enrollment and Retention Problems
Bethany Bray

Bringing Clinical Trials to Patients: Leveraging Convergent Data Sources to Accelerate Recruitment
Scott Douglas Schliebner, MPH



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes; Director, BD and Market Research, Nodality; Regulatory Team Leader, Genentech; Junior Engagement Manager, McKinsey. Education: A.B., Biology and Public... Read More →

Speakers
avatar for Bethany Bray

Bethany Bray

Chief Executive Officer, Co-Founder, AutoCruitment
Bethany Bray, Oncology and Neuroscience Researcher, Entrepreneur and Technologist, founded AutoCruitment (a technology-enabled digital patient recruitment platform) with a vision to utilize the power of the internet to address recruitment, enrollment and retention problems in clinical trials; by finding the Right patients Faster. She has 10 years of experience in Pharmaceutical Research, Operations and Business Development and holds a BSc in... Read More →
avatar for Donny Chen

Donny Chen

Director, Medical Affairs Research Operations, PPD
Donny Chen, director of medical affairs research operations at PPD, has spent the last 17 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen graduated Phi Beta Kappa from the University of Chicago with concentrations in economics and medicine. He received his MBA from the Chicago Booth School of Business with... Read More →
avatar for Scott Schliebner

Scott Schliebner

Vice President, Scientific Affairs, Rare Diseases - Federal Programs, PRA Health Sciences
Scott Schliebner, VP of Scientific Affairs – Rare Diseases, is a clinical strategist with a 20+ year background in clinical development specializing in rare diseases and orphan drug development. His breadth of experience encompasses all trial phases; a broad variety of study designs; interventional and observational studies; involving small molecules, biologics, gene therapies, and enzyme replacement therapies. His therapeutic expertise focuses... Read More →


Monday June 27, 2016 10:45am - 12:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-596-L04-P; CME 1.25; IACET 1.25; RN 1.25

If studies have 90% power, why don’t 90% of studies have a successful outcome? This workshop will demonstrate how eliciting knowledge from experts and calculating the probability of success of a study or development program can leverage strategic decision-making.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain the statistical concept of Assurance (a.k.a. Probability of Success or PoS) with respect to drug development strategy; Describe the benefits of quantifying current knowledge (prior elicitation) among product and disease experts; Quantify the probability of success of a future clinical trial by participating in a mock exercise to elicit a prior.

Chair

Colleen Russell, MS

Speaker

Facilitator
Sharon Cornell Murray, PhD

Facilitator
David A. Burt



Chair
avatar for Colleen Russell

Colleen Russell

Associate Director, Biostatistics, PAREXEL International
Over 25 years of experience in pharmaceutical, medical and industrial research has fueled my vision for improving efficiency of drug development and clinical trial conduct through innovative technology and statistical methods. I welcome opportunities to collaborate, solve problems and influence through leadership and effective communication.

Speakers
DB

David Burt

Director, Biostatistics, Trevena Inc
David received his PhD in Statistics from Virginia Tech in 2000 and has since been working in the pharmaceutical industry for a number of different companies. Currently he is serving as the Director of Biostatistics at Trevena Inc a biotech company based out of King of Prussia, Pennsylvania.
avatar for Sharon Murray

Sharon Murray

Associate Director, Biostatistics, PAREXEL International
Sharon Murray is Associate Director, Statistics at PAREXEL Ltd. She provides statistical support for the design, analysis and operational aspects of clinical trials as well as for drug development strategy. Sharon holds an MS and PhD in Biostatistics from the University of North Carolina at Chapel Hill. She has over 20 years of experience supporting clinical trials and was previously employed by GlaxoSmithKline.


Monday June 27, 2016 10:45am - 12:00pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#127: Innovative Partnerships: gOVERN - A Research and Early Development’s Outsourcing Vision to Enable Resourcing INovation
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Genentech Research and Early Development (gRED), in partnership with two CROs, has created a novel outsourcing model. This forum will detail the gOVERN model in the areas of partnership, operations, contracting and governance.

Learning Objectives

Discuss the partnership build and structure for the gOVERN model in Genentech Research and Early Development (gRED); Share key structure, learnings and innovation for this novel partnership which promotes transparency, cross-company commitments, and therapeutic-area program-level allocation.

Chair

Hilary Nelson

Speaker

Panelist
Margaret Taylor

Panelist
Jami Norris, MS

Panelist
Kerryn Cress



Chair
avatar for Hilary Nelson

Hilary Nelson

Senior Clinical Program Leader, Genentech, A Member of the Roche Group
Hilary Nelson is Sr. Clinical Program Leader who joined Genentech in 2004. She has held positions on increasing responsibility in Clinical Operations having worked at both the trial and program levels in oncology early clinical development. In addition to her work with CRO alliance partners, she also works in the Immuno-Oncology development space. Hilary is a recipient of the Roche CEO Award for Innovation and Excellence and is a graduate of... Read More →

Speakers
avatar for Kerryn Cress

Kerryn Cress

Senior Director, Technology, Innovation & Performance, PPD
Kerryn has over 12 years of clinical research experience. During her career she has held positions of increasing responsibility in driving transformational change, implementing strategic partnerships, leading cross-functional teams, and developing proposals. Kerryn is a certified Prosci Change Management Practitioner. She earned master’s degrees in Business Administration and Sports Administration from Ohio University, as well as a bachelor’s... Read More →
avatar for Jami Norris

Jami Norris

Vice President, Clinical Development Strategic Partnerships, Quintiles
Jami has more than 22 years of clinical research experience, including 14 years with Quintiles. In her current role, Jami leads the development of Strategic Partnerships. Previously, Jami has worked extensively in overseeing the delivery of key customer portfolios resulting in 5 approved NDA submissions. Jami holds a master’s degree in physiology from the University of South Carolina and bachelor degrees in management and biology from... Read More →
avatar for Margaret Taylor

Margaret Taylor

Associate Director, Oncology Program Group Leader, Clinical Operations, Genentech, A Member of the Roche Group
Peg Taylor is an Associate Director/Program Group Lead at Genentech early development (gRED ) Oncology Clinical Operations. Peg served as the gRED Lead on the gOVERN CRO Strategic Alliance.. Peg has over 25 years of pharma/biotech industry with a deep expertise in early clinical study and program management at both sponsors and CROs. Throughout her career, Peg has had the opportunity to work in various outsourcing models that have contributed... Read More →


Monday June 27, 2016 10:45am - 12:00pm
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#128: Alliance Management Forum
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of the value that can be gained from alliances built between a large global CRO and small or emerging biopharmaceutical companies. Attendees will learn what both the CRO and the biopharmaceutical company must do to build a successful alliance and how to diagnose early on what is needed for a collaborative alliance culture.

Learning Objectives

Identify what large CROs and small biopharmaceutical companies must do to successfully build an alliance with each other; Explain how to build a collaborative alliance culture and what the key questions that must be asked to determine if two companies will have good “chemistry”; Discuss meaningful and effective risk-sharing strategies.

Chair

Solomon Babani, MBA

Speaker

Applying Alliance Management Principles to Help CROs Build Successful Relationships with Small and Emerging BioPharma Companies
Solomon Babani, MBA

New and Emerging Skillsets Needed to Manage Strategic Partnerships
Andrew Townshend

Panelist
Deirdre F BeVard



Chair
SB

Solomon Babani

Vice President, BioPharma Solutions, Covance Inc.
Sol Babani joined Covance in 2013 as Global Vice President, Alliance Management with enterprise-wide responsibilities for several strategic clients. In addition, Solomon is overseeing a corporate-wide initiative aimed at expanding Covance’s relationships with emerging Biopharma. Solomon brings extensive knowledge of the outsourcing and partnering challenges that Biopharma faces when working with CROs from his past experiences at companies, such... Read More →

Speakers
avatar for Deirdre BeVard

Deirdre BeVard

Vice President, Development Operations, Nektar Therapeutics
Deirdre BeVard is Vice President, Development Operations at Nektar Therapeutics. She is responsible for the operational execution of Nektar’s clinical development programs and works with a creative team for clinical trial leadership, data management and contracting & outsourcing. She focuses on an approach where the sponsor and external partners perform as an integrated team with a shared mission of protecting the endpoint and optimizing the... Read More →
AT

Andrew Townshend

Senior Vice President, Alliance Development, INC Research
Vice President of Alliance Development at INC Research. Mr. Townshend has responsibility for developing strategic accounts within the Pharma and biotech industries focused on novel and innovative engagement and alliance models. Prior to this, Mr. Townshend was Vice President Outsourcing at Pfizer .


Monday June 27, 2016 10:45am - 12:00pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#129: Delivering Value Through Medical Information Metrics
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-530-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000193; RN 1.25

As the pharmaceutical environment becomes increasingly demanding, it is essential for companies to have a clear understanding of their customer needs in order to both anticipate and adequately address them. Speakers will illustrate the value of capturing and reporting environmental insights (medical information inquiries) to help identify customer needs. We will examine different insights that can be gained, based on real examples encountered. Speakers will also demonstrate one approach to collating and presenting qualitative functional metrics for medical information to internal leadership. Such reporting and analysis of insights and metrics can demonstrate the value of medical information to the medical affairs function and strategic planning process.

Learning Objectives

Discuss how tracking medical information inquiries can identify environmental insights and trends; Illustrate the value of gathering and communicating qualitative functional medical information metrics to stakeholders; Describe the potential contribution of medical information insights and metrics to strategic and operational planning.


Chair

Sara Doshi, PharmD

Speaker

Delivering Value Through Medical Information Metrics
Dipti Tankala, PharmD, RPh

Effective and Efficient Use of Customer Interactions Data to Anticipate Customer Needs Through Text Analytic Metrics
Edward J. Brauer, PharmD

Tools for Data Insights in Medical Information
Zachary Furqueron, MBA



Chair
avatar for Sara Doshi

Sara Doshi

Director, Medical Information Strategy and Capabilities, GMI, Eli Lilly and Company
Following in June of 2000, she completed the Purdue University/Eli Lilly and Company ASHP accredited Drug Information Residency and then accepted a full time position within Global Medical Information (GMI) at Lilly. Sara spent several years supporting numerous products and therapeutic areas in a traditional medical information role within GMI. Sara is currently in a GMI leadership position focused on MI strategy development/maintenance, business... Read More →

Speakers
avatar for Edward Brauer

Edward Brauer

US ML/RML Strategy and Capabilities Fellow, Lilly USA, LLC
Edward Brauer received his PharmD degree from the University of Southern California in 2015 and received his undergraduate degree in Chemistry from Fresno State in 2010. Currently Edward is a US MSL/RML Strategy and Capabilities Fellow within the US Medical Affairs department at Eli Lilly & Company. He currently has responsibility for Neurodegeneration/Pain and Dermatology MSL teams, where he also supports the teams as an internal liaison to... Read More →
ZF

Zachary Furqueron

Director/Team Leader, Analytics and Reporting Group, External Medical Comm, Pfizer Inc
Zachary has over 20 years of experience at Pfizer, and currently serves as the Director, Team Leader of the Analytics and Reporting group within the company’s Medical Division. In this role he oversees the analytics and reporting activities on behalf of several external-facing functions of the business, such as Medical Information, Publications and Clinical Trial Disclosure, developing innovative and effective data solutions for these... Read More →
avatar for Dipti Tankala

Dipti Tankala

Associate Medical Information Manager, Astellas Pharma Canada Inc.
Dipti received her Bachelors of Science in Pharmacy and Doctor of Pharmacy Degree from the University of Toronto in 2013. She went on to complete a specialty Industrial Pharmacy Residency in Medical Information at Eli Lilly Canada for and won the 2014 Residency Award. Currently, Dipti is work as an Associate Medical Information Manager at Astellas, specializing in oncology.


Monday June 27, 2016 10:45am - 12:00pm
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-535-L04-P; CME 1.25; IACET 1.25; RN 1.25

The ADAPTABLE study, started in 2015, is the largest virtual study ever done in the clinical research industry. Speakers will review the lessons learned from establishing a technology process suited for 20,000 remote patients on this study.

Learning Objectives

Demonstrate a working knowledge of implementing remote consenting; Discuss updates on recent guidance documents and regulatory approvals for virtual data collection.

Chair

Anthony Costello

Speaker

ADAPTABLE: A 20,000 Patient Study Leveraging Health Systems, EHR, and Patients to Transform Clinical Research
Adrian Hernandez

REACHnet’s Recruitment for the ADAPTABLE Virtual Trial Using Technology at the Point-of-Care
Elizabeth Nauman



Chair
AC

Anthony Costello

Chief Executive Officer, Mytrus, Inc.
Anthony Costello: Co-Founder and CEO of Mytrus has co-founded many clinical & hi-tech start-up companies in N. CA. He was selected as PharmaVoice Top 100 Most Inspiring People in Clinical Research, served as Chairman of the Board for the Society for Clinical Data Management, on founding committee for the CDISC CDASH initiative, is a member of the editorial advisory board for Applied Clinical Trials magazine & frequent author & presenter on the... Read More →

Speakers
AH

Adrian Hernandez

Co-Private Investigator, PCORnet Coordinating Center, Professor of Medicine, Duke Clinical Research Institute (DCRI)
Dr. Hernandez is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Faculty Associate Director of the Duke Clinical Research Institute and Director of the Health Services and Outcomes Research Domain. He has led several research grants funded to address issues in clinical care, health policy, quality of care, and outcomes.
avatar for Elizabeth Nauman

Elizabeth Nauman

Research Director, Research Action for Health Network (REACHnet), Louisiana Public Health Institute (LPHI)
As REACHnet's Research Director, Dr. Nauman works with a multi-institutional team to develop and optimize the informatics and technology infrastructures as well as stakeholder engagement to support efficient pragmatic clinical research. She leads the development of the network’s research portfolio in collaboration with local and national research partners. To this role, she brings several years of experience conducting population-based health... Read More →


Monday June 27, 2016 10:45am - 12:00pm
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-540-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum describes the electronic implementation of patient-reported outcomes (PRO)-based endpoint measures developed by the PRO Consortium for irritable bowel syndrome treatment trials. The panel will share lessons learned when pairing technology with clinical measurement.

Learning Objectives

Describe advantages of collecting clinical trial endpoint data electronically, particularly with patterns of data as observed in irritable bowel syndrome treatment trials; Discuss how regulatory agencies view the electronic capture of endpoints in clinical trials; Distinguish between operational and measurement aspects of the electronic implementation of PRO instruments used to assess endpoints in clinical trials.

Chair

Stephen Joel Coons, PhD

Speaker

Pharmaceutical Industry Perspective
David S. Reasner, PhD

ePRO Technology Provider Perspective
Cindy Howry, MS

ePRO Technology Provider Perspective
Adam Butler

FDA Perspective
Sarrit Kovacs



Chair
SC

Stephen Coons

Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute (C-Path). Stephen joined C-Path after a 23-year career in academia. For the past two decades, his primary research focus has been the measurement of patient-reported outcomes.

Speakers
avatar for Adam Butler

Adam Butler

Senior Vice President, Strategic Development and Corporate Marketing, Bracket
Mr. Butler is the Senior Vice President of Strategic Development at Bracket. Bracket offers a unique suite of solutions, with a unique perspective on clinical research development. | Mr. Butler is responsible for Strategic Development for Bracket’s service offerings in Randomization and Trial Supply Management, Electronic Clinical Outcomes Assessments, Rater Training, and Quality Assurance. Mr. Butler has 14 years of experience working in... Read More →
avatar for Cindy Howry

Cindy Howry

Vice President, Product Strategy and Innovation, YPrime Inc
Cindy Howry is nationally recognized thought-leader in the area of eCOA which empowers the patient and engages them to maintain and improve their health, simultaneously enabling clinical teams to have real-time access to better quality clinical data. Ms. Howry has more than 30 years of experience in management and leadership, including 17 years in the eCOA industry. Currently, she is VP of Product Strategy and Innovation for YPrime and... Read More →
avatar for Sarrit Kovacs

Sarrit Kovacs

Clinical Outcomes Assessments Reviewer, COA Staff, OND, CDER, FDA, FDA
Sarrit M. Kovacs is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Center for Drug Evaluation and Research (CDER) at the FDA. She reviews qualitative and quantitative research in numerous disease areas, providing advice and consultation in CDER. Sarrit has over a decade and a half of social science research experience. Sarrit earned her Ph.D. in Developmental Science and a doctoral certificate in measurement from the... Read More →
avatar for David Reasner

David Reasner

President and Founder, Albemarle Scientific Consulting LLC
David is VP, Data Science and Head, Study Endpoints at Ironwood Pharmaceuticals located in Cambridge, Massachusetts. The Data Science group is responsible for development of analytical strategies bridging early phase research through development into the biopharmaceutical product lifecycle. The group integrates quantitative scientists with broadly enabling backgrounds in biostatistics, modeling, psychometrics, and survey methodology with... Read More →


Monday June 27, 2016 10:45am - 12:00pm
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#131: IDMP Update
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

CBER provided critical leadership and technical expertise to the development of IDMP standards and currently continues leading international efforts to delineate a common approach for their implementation and to consider their future application. This session will provide an update on this initiative.

Learning Objectives

Discuss the status of IDMP implementation.

Chair

Vada A. Perkins

Speaker

ISO IDMP: Benefits Beyond Compliance
Niels Gronning, MSc

Interoperability and Standardization Within the Life Sciences: Justification, Mechanisms, and Opportunities
Tom Macfarlane, RAC



Chair
VP

Vada Perkins

Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER, FDA
Capt. Vada A. Perkins, MSc, BSN, RN, is the Deputy Associate Director for Review Management (acting) with the FDA's Center for Biologics Evaluation and Research, Office of the Director. He received his MSc. in Bioscience Regulatory Affairs from The Johns Hopkins University and his BS from the University of Maryland.

Speakers
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more recently the implementation and impact assessment of ISO IDMP.
avatar for Tom Macfarlane

Tom Macfarlane

Director, EU Regulatory Affairs Lead, Accenture
A Neuroscientist by training, Tom has since worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also advises on corporate operating models, technology, and the changes we face as a result of regulatory pressure, squeezed resources, and a rapidly coalescing healthcare system. Tom’s an HL7... Read More →


Monday June 27, 2016 10:45am - 12:00pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Breakthrough Designation (US), PRIME (Europe), and Sakigake (Japan) aim to reduce overall drug development times for certain products. This session shows you how to take advantage of these and other global expedited development programs.

Learning Objectives

Compare and contrast global expedited development pathways; Discuss ways to adapt global development programs to take advantage of all expedited pathways.

Chair

Khyati Roberts, RPh

Speaker

The New Japanese “Sakigake” Strategy for Accelerated Development and Approval: Status, Procedure, and Prospects for Industry
Alberto Grignolo, PhD

Strategies for Using the New European PRIME Pathway
Sharon N. Olmstead



Chair
avatar for Khyati Roberts

Khyati Roberts

Senior Director, Regulatory Policy and Intelligence, AbbVie Inc.
Khyati is currently Senior Director at AbbVie where she coordinates regulatory policy and intelligence activities for the US regulatory environment. She also oversees regulatory policy initiatives in Japan, Asia-Pacific, China, Australia, and Latin America. Khyati also worked at the FDA for 14 years developing and implementing regulatory policies and programs. She has over 24 years of regulatory experience. Khyati attended Rutgers, College of... Read More →

Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, PAREXEL International
Alberto Grignolo, PhD is Corporate VP, Global Strategy at PAREXEL Consulting, where he has worked for 24 years in various regulatory, drug development and management capacities. Most recently he relocated to PAREXEL's Tokyo Office for two years, establishing a new consulting unit there. He is currently engaged in initiatives that address clients' most significant opportunities and challenges in product development and commercialization. He is the... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Development and Regulatory Policy, Novartis Pharmaceuticals Corporation
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation for her future roles working at the FDA for six years in science policy, consumer affairs, and consumer safety. Sharon holds a bachelor’s degree in biology... Read More →


Monday June 27, 2016 10:45am - 12:00pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-562-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, the panelists will give a state-of-the-art overview of the exciting new area of cancer immunotherapies, the current learnings and methodologies, the benefits and challenges, as well as an outlook into the future.

Part 1 is scheduled for Monday, June 27, 2016, 8:30-9:45 AM.

Learning Objectives

Discuss examples of clinical implementation of biomarkers in the development of cancer immunotherapies; Describe what the future looks like for cancer immunotherapies; Explain the role of new technologies for companion diagnostics.

Chair

Holger G. Adelmann

Speaker

Panelist
Arnold B. Gelb

Panelist
Brandon Higgs, PhD

Panelist
Marc Theoret, MD



Chair
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association for Clinical Pharmacology & Therapeutics, German Association for Applied Human Pharmacology, a fellow of the Royal Microscopical Society, Oxford, and lecturer at... Read More →

Speakers
avatar for Arnold Gelb

Arnold Gelb

Senior Director, Clinical Biomarkers and Companion Diagnostics, EMD Serono Research & Development Institute, Inc.
avatar for Brandon Higgs

Brandon Higgs

Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and Bioinformatics from George Mason University and a Master’s in Bioinformatics from Johns Hopkins University. His current research focuses on translational approaches in... Read More →
MT

Marc Theoret

Lead Medical Officer, OHOP, OND, CDER, FDA


Monday June 27, 2016 10:45am - 12:00pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-561-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this session, basic information on regulations of software as a medical device will be provided. Also, the expectation of mobile health devices in terms of quality of life and medical economy and challenges to develop such devices will be discussed.

Learning Objectives

Explain the regulations on software as a medical device including topics discussed in the International Medical Device Regulators Forum Standalone Medical Device Software Harmonization Working Group for the utilization of mobile health for enhancement of quality of life; Discuss the potential of mobile health in terms of reducing medical costs.

Chair

Madoka Murakami, PhD

Speaker

Academic Perspective
Hiroshi Hosoi

Industry Perspective
Nersi Nazari, PhD

FDA Perspective
Bakul Patel



Chair
MM

Madoka Murakami

Unit Chief, Division of Regulatory Cooperation, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)

Speakers
avatar for Hiroshi Hosoi

Hiroshi Hosoi

President, Nara Medical University
Hiroshi Hosoi, M.D., Ph.D. is a president of Nara Medical University in Japan. He is a doctor who specializes in Otorhinolaryngology. In 2004, he found a new sound conduction pathway “cartilage conduction,” which is different from the two previously known sound conduction pathways, i.e., air and bone conductions. This new pathway has been applied to medical equipment, e.g., hearing aids and to non-medical equipment, e.g., cell phones and... Read More →
avatar for Nersi Nazari

Nersi Nazari

Chairman and Chief Executive Officer, Vital Connect, Inc.
Nersi is Chairman & CEO of VitalConnect, a medical device and healthcare solutions company applying advanced biosensor technology and surrounding data management systems to deliver an innovative platform that enables clinical-grade continuous monitoring of vital signs. He is a veteran technology entrepreneur with more than 25 years of experience in technical innovation, corporate management, and venture funding. He has a doctorate in electrical... Read More →
avatar for Bakul Patel

Bakul Patel

Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical device software. He is the FDA liaison between the FCC and the ONC and chairs the International Medical Device Regulators Forum (IMDRF) "software as a medical... Read More →


Monday June 27, 2016 10:45am - 12:00pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#136: Clinical Data Disclosure and Transparency: ClinicalTrials.gov Final Rule, EU Requirements, and Other Key Updates
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will involve a panel and analyze the ClinicalTrials.gov Final Rule, discuss how companies are navigating the US and EU disclosure/transparency mandates, and discuss data sharing expectations.

Learning Objectives

Identify the requirements of the Final Rule expanding the ClinicalTrials.gov database; Describe how industry is navigating US and EU disclosure mandates; Discuss how companies are approaching data sharing expectations

Chair

Robert Paarlberg, MS

Speaker

Panelist
Rebecca J. Williams

Panelist
Marla Jo Brickman, PhD



Chair
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in global clinical trial disclosure strategy and operations, regulatory policy and regulatory intelligence. Bob has more than 35 years of industry experience in US and international regulatory affairs. Bob has been actively involved with clinical trial disclosure since 2005. Bob is Chair of DIA’s Clinical Trial Disclosure Community. He received a M.S. in... Read More →

Speakers
avatar for Marla Jo Brickman

Marla Jo Brickman

Senior Director/Team Leader, Clinical Trial Disclosure Group, Pfizer Inc
Marla Jo Brickman, PhD, is the Senior Director/Team Leader for the Clinical Trial Disclosure Group at Pfizer and serves as the global disclosure policy lead for all clinical trial registration and results disclosures, as well as, providing oversight of Pfizer’s implementation of the PhRMA/EFPIA principles. Marla received her PhD and completed her post-doctoral training in Immunology from Duke University, in Durham, NC.
avatar for Rebecca Williams

Rebecca Williams

Assistant Director, ClinicalTrials.gov, NCBI, National Library of Medicine, NIH
As the Assistant Director of ClinicalTrials.gov, Dr.Williams is responsible for the results submission process, outreach and education, policy and regulation development, and research related to evaluating and improving reporting of clinical research.


Monday June 27, 2016 10:45am - 12:00pm
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#137: Using Technology to Make Trials Accessible to More Clinical Trial Participants
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

As clinical care moves toward increasingly patient-centric models, research must also account for the participant’s perspective in order to maximize clinical trial recruitment, enrollment, adherence, and completion. Quality indicators that capture information about participant preferences and challenges can be used to inform clinical trial feasibility. Leveraging mobile technologies, in particular, can potentially empower a participant population, while emphasizing participant understanding of the commitment involved and, simultaneously, easing burdens on sites and study staff. This session will explore mobile applications, including eConsent, and at-home clinical trials, as potential tools—even providing the capacity to conduct remote trials—to spur participation through increased participant engagement, convenience, and satisfaction.

Learning Objectives

Identify emerging technologies and methods for both achieving efficiencies and optimizing effectiveness in clinical trial design; Evaluate quality metrics related to participant satisfaction and challenges associated with study implementation; Assess technologies and methods for their impact on clinical trial feasibility from a participant-focused perspective; Describe how to create an integrated plan, leveraging available technologies and methods, to improve the success of clinical trials.

Chair

Linda M Coleman, Esq, JD

Speaker

Mobile Clinical Trial Technologies: Use Cases and GCP Compliance Considerations
Philip J. Coran, Esq

Mobile Technology in Research: A Compliance and Ethics Review Perspective
Linda M Coleman, Esq, JD

Mobile Health Applications and eConsent: A Sponsor’s Perspective
Kevin Hudziak, MS



Chair
LC

Linda Coleman

Director, Human Research Protection Program, Yale University
Ms. Coleman is the Director of the Human Research Protection Program at Yale University. Prior to joining Yale, she was the Vice President of Regulatory and Legal Affairs at Quorum Review and an attorney at Bennett Bigelow & Leedom. Ms. Coleman has experience in research ethics, regulatory compliance, Medicare and Medicaid reimbursement, litigation, behavioral health, employment, and health law.

Speakers
avatar for Philip Coran

Philip Coran

Senior Director of Quality and Regulatory Affairs, Medidata Solutions Worldwide
Phil Coran is a Sr. Director of Quality & Regulatory Affairs at Medidata. Prior to joining Medidata, Phil was at Pfizer for 12 years in the Medical Quality Assurance and Internal Audit groups. From 1999-2001, Phil was an IT Risk Consultant at Deloitte & Touche & Arthur Andersen accounting firms. Phil is a Certified Information Systems Auditor (CISA) & Privacy | Professional (CIPP/US), a Juris Doctor of Fordham Law School, and a U. of... Read More →
avatar for Kevin Hudziak

Kevin Hudziak

Consultant, Innovation Lead, Eli Lilly and Company
Kevin works in the Clinical Innovation group at Lilly as an Innovation Lead focused on implementing eConsent and other technologies across the Lilly portfolio. Kevin participated in the CTTI Informed Consent project and is currently a member of the TransCelerate eConsent project. He also is certified as a Lean Six Sigma Black Belt.


Monday June 27, 2016 10:45am - 12:00pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-599-L04-P; CME 1.25; IACET 1.25; RN 1.25

The adoption of quality by design principles and subsequent incorporation of enhanced approaches in regulatory submissions introduced several challenges for industry as well as regulators. This session will discuss how the principles described in ICH Q9 are applied, specifically how quality risks are assessed, managed, and communicated by industry and evaluated by regulators and how results from risk assessments are used to determine quality criteria for demonstrating control and developing and maintaining a robust control strategy for a product.

Learning Objectives

Describe how quality risks are assessed, managed, and communicated by industry; Discuss how quality risks are evaluated by regulators.

Chair

Kristin Murray, MS

Speaker

Benefit-Risk Considerations and Strategies for Investigation and Control of Impurities
David White

Risk Management: A Team Sport
Wendy Wilson-Lee, BSN, PhD

Applications of Risk Management Tools to Quality by Design and Control Strategy Creation in Rare Disease
Joseph Kauten



Chair
KM

Kristin Murray

Director, Global CMC Regulatory Affairs, Shire Pharmaceuticals
Kristin Murray, MS, BS - Ms. Murray is a director in the Global Regulatory Affairs CMC department and oversees a team who manage global regulatory CMC submissions for both investigational and commercial products at Shire Pharmaceuticals, Lexington, MA. Before her tenure in regulatory affairs, Ms. Murray was a manager of a bioanalytical laboratory at Wyeth Pharmaceuticals, overseeing clinical, nonclinical, and impurity analytical method... Read More →

Speakers
JK

Joseph Kauten

Biologics CMC Control Strategy Leader, Shire Pharmaceuticals
Dynamic Technical Leader with a proven track record of value driven innovation, robust process development, and cross-functional influence. Extensive experience in facility and process design from greenfield/brownfield through to successful technology/process transfer, process performance qualification and commercialization of bulk API therapeutics. Established history of developing and leading high performance teams.
avatar for David White

David White

Principal Scientist, AstraZeneca
I joined pharmaceutical development in 2003 as line manager in analytical science working primarily in late phase projects. After secondments to formulated product development and then post approval regulatory, I returned to drug substance in 2014 as a principle scientist responsible for promoting control strategy and measurement science. My current focus is the development of tools to help project teams visualise control strategies earlier... Read More →
avatar for Wendy Wilson-Lee

Wendy Wilson-Lee

Acting Branch Chief, Office of New Drug Products, OPQ, CDER, FDA
Wendy is an acting Branch Chief in the Office of New Drug Products, bringing 10 years of review experience to the position. She has a B.S. in Chemical Engineering as well as a B.S. in Chemistry from North Carolina A&T State University. She earned her Ph.D. in Pharmaceutical Science under Dr. Larry Augsburger at University of Maryland – Baltimore. Wendy is a wife and a mother and shares her love of S.T.E.M. and leadership development through... Read More →


Monday June 27, 2016 10:45am - 12:00pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-568-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interdisciplinary session will explain how, with increased patient engagement, both regulatory and health technology assessment agencies need to be able to assess and report on how patient input is being utilized and how it is informing the decision process.

Learning Objectives

Discuss how health technology assessment agencies and regulators engage with patients so that the assessment and decision making is utilizing patients’ viewpoints; Identify the challenges that agencies face to ensure that the patient’s viewpoints are embedded into their decision processes; Assess the types of parameters agencies are using to measure the impact patient engagement is having on their processes and decision making.

Chair

Neil McAuslane, PhD, MSc

Speaker

FDA Perspective
Theresa M. Mullin, PhD

Empowering Patients as Organizational Change Agents
Durhane Wong-Rieger, PhD, MA

HTA Perspective
Victoria Thomas, MSc



Chair
avatar for Neil McAuslane

Neil McAuslane

Director, Centre For Innovation In Regulatory Science (CIRS)
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (previously CMR International) and works in the area of regulatory strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology from the University of Edinburgh.

Speakers
avatar for Theresa Mullin

Theresa Mullin

Director, Office of Strategic Programs, CDER, FDA
She leads a number of CDERs strategic initiatives including human drugs international program, data standardization, business informatics, lean management, development of benefit-risk and other decision support tools, program analysis and major user fee negotiations. Currently serving as FDAs lead negotiator for PDUFA 2017 reauthorization and the lead negotiator for the BsUFA 2017 reauthorization. She leads the FDA Patient Focused Drug... Read More →
avatar for Victoria Thomas

Victoria Thomas

Head of Public Involvement, Public Involvement Programme, National Institute For Health and Care Excellence (NICE)
Victoria Thomas has run the Public Involvement Programme at NICE since 2009, and has been with the Programme since 2001. Following a degree in Art History, Victoria has worked exclusively in the public and voluntary sector, specialising in healthcare quality improvement activities and in patient and public involvement. Victoria’s MSc, in Science and Society, concentrated on issues of science communication and science and the public. Victoria... Read More →
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board, DIA International; Advisory Board, Canadian Institutes of Health Research Institute of Genetics. Durhane has a PhD in psychology from McGill and was professor at... Read More →


Monday June 27, 2016 10:45am - 12:00pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-576-L05-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how to understand, develop, and implement the review/reporting process for events considered anticipated based upon the disease under study which is an important new procedure within clinical development. Attendees will also learn through the examination of case studies clarifying issues leading to uninformative safety reporting.

Learning Objectives

Describe barriers to implementation of the FDA Rule; Clarify the FDA Rule and guidance in order to reduce the number of uninformative safety reports; Recognize the end to end process of the aggregate review and reporting of Anticipated Events; Convert the knowledge of the process into a tangible approach for adoption; Identify how to guide an organization to develop and implement a process; Identify opportunities for improving the quality and efficiency of IND safety reporting processes.

Chair

Robert (Mac) Gordon, MS

Speaker

Using Case Studies to Facilitate Implementation of the FDA Rule for IND Safety Reporting
Marsha Millikan

FDA Perspective
Jonathan P. Jarow, PhD

One Company's Approach to Developing and Implementing an Anticipated Events Review Process
Robert (Mac) Gordon, MS



Chair
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Biostatistician, Janssen Pharmaceutical Companies of Johnson & Johnson
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career. Currently he is a clinical trial and clinical safety statistician at J&J. His clinical focus has been immunology for the past 10 years.

Speakers
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor to the Center Director, CDER, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology Products. Prior to joining the FDA he was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University.
avatar for Marsha Millikan

Marsha Millikan

Advisor, Expedited Reporting Global Patient Safety, Eli Lilly and Company
18 years of pharmaceutical drug safety experience. Currently oversees global PV expedited reporting business processes. She supported multiple projects including the FDA IND rule changes, database updates, creation of an investigator line listing report, & EU GVP process updates. Previously she worked in PV surveillance, case management, quality, & call center AE reporting. Before pharma, she worked as a hospital clinical pharmacist consulting on... Read More →


Monday June 27, 2016 10:45am - 12:00pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#141: Transforming Health Care Data for Clinical Research: Strategy and Experiences from the PCORnet Common Data Model
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will define the strategic importance of the PCORnet Common Data Model in the use of electronic health records(EHR) and health plan data for research, its key role in the ADAPTABLE pragmatic trial, and how these experiences are generalizable to other stakeholders.

Learning Objectives

Assess the opportunities and challenges of using electronic health data for clinical research, including data management processes, coordinating center practices, and data quality; Describe the strategic role and development of a common data model for a national distributed research network; Evaluate the application of a common data model in the design of a pragmatic clinical trial.

Chair

Shelley Rusincovitch

Speaker

Leveraging a Common Data Model for a Pragmatic Clinical Trial in a Distributed Research Network: The PCORnet ADAPTABLE Study
Lesley H. Curtis, PhD

A Common Data Model and Diversity of Stakeholder Beliefs: How Do You Know What You Actually Know, Collectively?
Aaron Sorensen, MA

Applying the PCORnet Common Data Model to the EHR Ancillary Study of the HARMONY Trial: Strategy and Design Considerations
Carol E Koro, PhD



Chair
avatar for Shelley Rusincovitch

Shelley Rusincovitch

Project Leader in Applied Informatics and Architecture, Duke Translational Research Institute
Shelley Rusincovitch is a Project Leader in Applied Informatics & Architecture with the Duke Translational Research Institute (DTRI), with highly-technical experience in database programming, clinical trials, outcomes registries, and health system data warehousing. Her responsibilities include serving as manager for the DTRI Applied Informatics team, data strategist for the PCORnet Distributed Research Network Operations Center (DRN OC), and... Read More →

Speakers
avatar for Lesley Curtis

Lesley Curtis

Professor of Medicine; Director, Center for Pragmatic Health Systems Research, Duke Clinical Research Institute (DCRI)
A health services researcher by training, Dr. Curtis oversees a portfolio of projects that use observational data to address questions related to clinical and comparative effectiveness, pharmacoepidemiology, health care delivery, and epidemiological trends. Dr. Curtis has considerable experience analyzing Medicare claims data, large clinical registries, and prescription drug data, and has led the linkage of large clinical registries with... Read More →
avatar for Carol Koro

Carol Koro

Senior Director, Worldwide Epidemiology, GlaxoSmithKline
Carol Koro currently works for GSK, focusing on metabolic and cardiovascular epidemiologic research. Dr. Koro has a PhD in Pharmaceutical Health Services Research from the University of Maryland and is a PA licensed pharmacist. She has done extensive research on the safety of diabetes medications and has over 40 peer-reviewed publications. Dr. Koro is interested in leveraging real-world data, using innovative approaches and sources, to... Read More →
avatar for Aaron Sorensen

Aaron Sorensen

Senior Bibliometrics Consultant, Digital Science


Monday June 27, 2016 10:45am - 12:00pm
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#143: Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Over the past decade, several policy strategies have emerged that promise to promote drug development in areas of unmet need, such as exclusivity previsions and advanced market commitments. Recently, one of these policy strategies, the priority review voucher (PRV), has garnered new attention and has re-emerged as a possible driver in R&D for rare pediatric diseases, neglected tropical diseases, and public health emergencies. The PRV program is a regulatory incentive administered by the FDA to promote drug development for certain underserved patient populations. Under the original PRV program, signed into law in 2007, FDA awards a voucher to sponsors for the regulatory approval of a novel drug targeting a particular neglected tropical disease; sponsors that redeem a PRV are subsequently allowed to designate any one NDA/BLA, regardless of indication, as priority review, reducing the target regulatory review period by four months. Since 2007, nine vouchers have been issued by the FDA, and reported sales of the voucher have continued to increase to as much as $350 million. This panel takes a closer look at the value of the PRV as an incentive, focusing on past experiences related to the PRV program, current use, legislative trends, potential value, and its role in encouraging much needed R&D for rare pediatric and neglected tropical diseases.

Learning Objectives

Explain the history and mechanics of the FDA priority review voucher (PRV) program; Describe current policy initiatives regarding the PRV program and industry response to the PRV incentive; Assess the value of the PRV as an incentive for rare and neglected diseases.

Chair

Andrew S. Robertson, JD, PhD

Speaker

Priority Review Vouchers: A New Paradigm for Funding Research?
Patricia R Anderson, RAC

The Priority Review Voucher: The Value, the Pipeline, and the Opportunities for R&D
Andrew S. Robertson, JD, PhD

Priority Review Vouchers: Legislation and History - What You Need to Know
Alexander Varond, JD



Chair
AR

Andrew Robertson

Director, Global Regulatory Policy, Merck & Co., Inc.
Andrew S. Robertson works in Global Regulatory Affairs at Merck & Co., focusing on regulatory policies concerning vaccines, biologics, biosimilars, in vitro diagnostics, mobile medical apps and software medical devices. He has over 13 years of experience spanning academia, industry and government. Andrew holds a JD from the University of California, Berkeley, and a Ph.D. in structural biology from Cambridge University.

Speakers
avatar for Patricia Anderson

Patricia Anderson

Vice President, Regulatory Services, Mapi
Ms. Anderson has covered many aspects of drug development during over 30 years in the pharmaceutical and biotechnology industry. Ms. Anderson has held several positions which have included the areas of regulatory affairs, drug development, and due diligence for licensing. She has arranged and been involved in meetings with many global agencies including the FDA, and the EMA, including a successful CHMP arbitration. In 2015 she was awarded the... Read More →
avatar for Alexander Varond

Alexander Varond

Associate, Hyman, Phelps & McNamara, PC
Alexander J. Varond works on medical device and drug development, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity issues. Mr. Varond also supports ongoing litigation efforts and performs due diligence for corporate transactions.


Monday June 27, 2016 10:45am - 12:00pm
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

11:45am

Luncheon
Discuss what you’ve learned and meet with exhibitors at our daily luncheon in the Exhibit Hall

Monday June 27, 2016 11:45am - 2:30pm
Exhibit Hall Exhibit Hall

12:15pm

#146: Tata Consultancy Services Innovation Theater: Data Transparency Initiative: An Innovative Solution
Limited Capacity seats available

Component Type: Session
Level: Intermediate

With a growing commitment in the pharma world to data transparency, we require an innovative technology-driven solution using newly developed digital tools to make data and document sharing solutions achievable, scalable, and cost-effective. Metadata analytical algorithms will be used for de-identification and anonymization of data. This will ensure a greater control of the quality and reduction in overall process time.

* Presented by: Helle-Mai Gawrylewski, Sr. Director Regulatory Medical Writing, Janssen R&D. Titusville, NJ, USA
* Supported by: Arghya Chattopadhyay, Vice President, Biostatistics and Statistical Programming, Tata Consultancy Services

Chair

Tata Consultancy Services


Chair
Monday June 27, 2016 12:15pm - 12:45pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:15pm

#147: Interpreting Meaningful Change on PRO Instruments: Methods in Action
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

One aspect of patient-reported outcome (PRO) instrument development that continues to perplex the field is the interpretation of change scores. How much change must be observed on a PRO instrument to be able to say that a patient has experienced a treatment benefit? This session will provide a brief background on commonly-used and novel methods for assigning meaning to PRO score changes, and then attendees will participate in one of three activities where these methods are demonstrated. The goal of the methods demonstrated in each of these three activities is to identify a threshold at which changes on the PRO instrument are deemed meaningful. The first activity will be a mock exit interview where a participant is probed about their experience during a clinical trial and the meaning behind their observed PRO scores. The second activity will be a mock bookmarking exercise where a participant rates hypothetical vignettes as better, worse, or the same as their own condition using items from a PRO instrument. The third activity will be a group exercise on synthesizing results from multiple methods into one responder definition (i.e., the triangulation process). The session attendees will reconvene at the end of these exercises to discuss the value and challenges of each method.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Recognize the value of and challenges with different methods for informing the interpretation of change on PRO instruments by engaging in mock exercises demonstrating these methods in practice.

Chair

Cheryl D. Coon, PhD

Speaker

Facilitator
Scott Komo, DrPH



Chair
avatar for Cheryl Coon

Cheryl Coon

Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument development and has supported stakeholder communication across a broad range of therapeutic areas. Dr. Coon received her PhD in Quantitative Psychology at the... Read More →

Speakers
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining the FDA in 1999. He received a BA in Chemistry from the University of California, Davis and an MS and DrPH in Biostatistics from the University of California... Read More →


Monday June 27, 2016 12:15pm - 1:15pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:15pm

#145: Student Poster Session and Oral Presentations 1A
Limited Capacity seats available

Component Type: Poster Presentation

Join us in the Exhibit Hall Poster Area (Hall A Entrance) for a series of 3 minute presentations delivered by this year's Student Poster Presenters.


Monday June 27, 2016 12:15pm - 2:15pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:00pm

#148: PAREXEL Innovation Theater: Balancing Rapid Approval with Demonstration of Value
Limited Capacity filling up

Component Type: Session
Level: Intermediate

Global options for rapid approval and access present significant opportunity in the US, Europe, and now Japan. Yet postapproval demands for value demonstration, along with the diversity of payer and regulatory requirements in these regions, have generated unanticipated challenges. PAREXEL will present unique solutions that leverage the benefits of development acceleration, strategically balanced with clinical evidence and real-world innovations that support reimbursement.

Chair

PAREXEL International


Chair
Monday June 27, 2016 1:00pm - 1:30pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:30pm

#149: EMA's Publication Policy 0070: Best Practices for Implementation
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

In this session, we will share experiences and discuss best practices and solutions to challenges that sponsors are facing with EMA Policy 0070. EMA has provided general guidance but has not been prescriptive. They have also emphasized that this will be a learning process for both EMA and industry with an opportunity to provide feedback along the way. In this session, there will be a brief overview, followed by break-out discussions in small groups. Questions to be discussed include:

• What steps are sponsors taking to ensure that their approach and rationale are consistent from document to document? How may this feedback be shared with EMA to ensure consistency in what is accepted?

• How are companies approaching the anonymization of case narratives?

• How can organizations best write documents bearing in mind downstream CCI and patient de-identifying redaction (without using expensive vendors)? How are organizations managing their internal governance?

• How are companies handling the review of Informed Consent Forms for ‘older’ CSRs that are in scope of Policy 0070?

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe steps sponsors are taking to ensure their approach and rationale are consistent from document to document; Identify approaches sponsors are using to anonymize case narratives; Discuss how companies are handing the review of Informed Consent Forms for legacy clinical trials.

Chair

Robert Paarlberg, MS

Speaker

Facilitator
Helle M Gawrylewski, MA



Chair
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in global clinical trial disclosure strategy and operations, regulatory policy and regulatory intelligence. Bob has more than 35 years of industry experience in US and international regulatory affairs. Bob has been actively involved with clinical trial disclosure since 2005. Bob is Chair of DIA’s Clinical Trial Disclosure Community. He received a M.S. in... Read More →

Speakers
avatar for Helle Gawrylewski

Helle Gawrylewski

Senior Director, Medical Writing and Alliance Management, Janssen Research & Development, LLC
Head Med Affairs Writing/ MW Alliances, previously director of Early Development and multiple therapeutic area writing at J&J for 17yrs. 2-term MW SIAC Chair, and CDISC Protocol Rep/Glossary Group from 2001. Held positions of increasing responsibility in MW and management for 40+ years.


Monday June 27, 2016 1:30pm - 2:15pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:45pm

#150: Quintiles Innovation Theater: Evidence Optimization: Fueling Smarter Clinical Development and Value Generation
Limited Capacity filling up

Component Type: Session
Level: Intermediate

Drug development challenges drive the need to translate scientific and therapeutic advances to better outcomes. Maximizing real-world and clinical evidence can shorten cycle times from pipeline to patient. This presentation highlights innovative approaches by integrating evidence alongside scientific expertise, technology and global delivery to:
Design and deliver smarter trials
Accelerate study start-up
Make earlier, more informed decisions
Execute with efficiency
Generate better value from evidence.

Chair

Quintiles Transnational


Chair
avatar for Quintiles Transnational

Quintiles Transnational

Quintiles Transnational

Monday June 27, 2016 1:45pm - 2:15pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:30pm

#151: Plenary Session and Keynote Address
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Join us for the DIA 2016 Keynote Address.

Chair

Sandra A. Milligan, JD, MD

Speaker

Welcome Remarks
Barbara Lopez Kunz, MSc

Welcome Remarks
Tatsuo Kurokawa, PhD

Opening Remarks
Hans-Georg Eichler

Opening Remarks
Gigi Hirsch, MD

Keynote Address: Bad Bugs, Good People, and Big, Bold Ideas
Larry Brilliant



Chair
avatar for Sandra Milligan

Sandra Milligan

Senior Vice President, Head of Regulatory Affairs and Safety, Merck Research Laboratories
Sandra Milligan, MD, JD, is Vice President, Global Regulatory, Immunology, Infectious Diseases and Ophthalmology for Genentech/Roche, developing and directing global strategic regulatory plans to facilitate and optimize product development, regulatory approval, and commercialization. Sandra is the President-Elect for the DIA Board of Directors.

Speakers
avatar for Larry Brilliant

Larry Brilliant

Chairman, Skoll Global Threats Fund
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of... Read More →
avatar for Gigi Hirsch

Gigi Hirsch

Executive Director, Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
Her current efforts are leading the New Drug Development Paradigms initiative (NEWDIGS), a “think and do tank” that is re-engineering pharmaceutical innovation to deliver new, better, affordable therapeutics to the right patients, faster. Within the broad strategic framework of “Adaptive Biomedical Innovation,” NEWDIGS’ flagship project focused on aligning stakeholders around more adaptive, patient-centered approaches to the... Read More →
avatar for Tatsuo Kurokawa

Tatsuo Kurokawa

President, Japan Self-Medication Industry
Dr. Tatsuo Kurokawa started his career as a staff of Japan’s Ministry of Health, Labour and Welfare (MHLW). It includes NDA review, pharmacovigilance and drug safety measures, WHO activities, ICH and international collaboration. After retirement from Government official, he became a professor of Drug Development and Regulatory Sciences, Faculty of Pharmacy, Keio University. He is a member of the DIA Board of Directors since 2009 and Chair of... Read More →


Monday June 27, 2016 2:30pm - 4:00pm
Ballroom AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

Opening Reception
Network with 7000+ attendees and 450+ exhibitors at the Opening Reception in the Exhibit Hall.

Monday June 27, 2016 4:00pm - 6:00pm
Exhibit Hall Exhibit Hall

4:15pm

#152: Student Poster Session and Oral Presentations 1B
Limited Capacity seats available

Component Type: Poster Presentation

Join us in the Exhibit Hall Poster Area (Hall A Entrance) for a series of 3 minute presentations delivered by this year's Student Poster Presenters.


Monday June 27, 2016 4:15pm - 5:30pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:30pm

#153: BBK Innovation Theater: Reimagining the Patient Experience Through mHealth Technologies
Limited Capacity filling up

Component Type: Session
Level: Intermediate

mHealth remains one of the most talked about trends in clinical R&D. Yet despite many successes across life sciences and health care, industry-wide adoption lags. Patient-centric strategies are critical to any study’s success, and few efforts are more patient-centric than providing tools to improve patient engagement and enable efficient data collection and sharing. This presentation will offer advice on mHealth engagement strategies and share insights gleaned from real use cases.

Chair

BBK Worldwide


Chair
BW

BBK Worldwide

BBK Worldwide

Monday June 27, 2016 4:30pm - 5:00pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

5:15pm

#154: ConvergeHealth by Deloitte Innovation Theater
Limited Capacity seats available

Component Type: Session
Level: Intermediate



Chair

ConvergeHEALTH by Deloitte


Chair
Monday June 27, 2016 5:15pm - 5:45pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  • Audience Intermediate
  • format json
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

5:30pm

Student Poster Awards Ceremony
DIA Booth #1425. Join us as we present the awards to the Student PosterPresentation winners.  

Monday June 27, 2016 5:30pm - 5:45pm
Exhibit Hall Exhibit Hall
 
Tuesday, June 28
 

7:00am

Coffee and Light Refreshments
Tuesday June 28, 2016 7:00am - 8:00am
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

7:00am

Attendee, Speaker, and Exhibitor Registration Open
Tuesday June 28, 2016 7:00am - 5:00pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

#202: Changing Cultures to Advance Patient Engagement
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-614-L04-P; CME 1.50; IACET 1.50; RN 1.50

The importance of engaging patients in medical product development is a message that has reached the industry. Acting on that message to adopt and sustain meaningful practice requires organizational cultures that value and place high priority on patient focus. In this session, sponsor companies and patient organizations will share their experiences with building internal cultures that encourage the collective group and individuals to incorporate patient engagement into their everyday work. A diverse panel will discuss reframing the challenges of cultural change to achieve the best outcomes for patients in the health care process.

Learning Objectives

Explain the role of organizational culture in enabling meaningful patient engagement practices; Assess key motivators for organizations to adopt a patient-focused culture; Describe effective approaches to incorporating patient focus throughout the organization; Discuss ways to meet challenges that may prevent a fully patient-focused culture.

Chair

Kim McCleary

Speaker

Panelist
Lode Dewulf

Panelist
Andrea Stern Ferris

Panelist
Andrew J. Garvey

Panelist
Mary Stober Murray, MBA

Panelist
Durhane Wong-Rieger, PhD, MA



Chair
avatar for Kim McCleary

Kim McCleary

Managing Director, Fastercures
Kim McCleary is Managing Director of FasterCures, a center of the Milken Institute. She leads a new FasterCures program to advance the science of patient input and expand patient engagement in FDA’s assessment of benefits and risks for medical products. She has participated in every opportunity organized by the FDA to shape its Patient-Focused Drug Development Initiative (PFDDI) and has worked with several patient organizations to prepare for... Read More →

Speakers
avatar for Lode Dewulf

Lode Dewulf

Vice President and Chief Patient Affairs Officer, UCB
Lode Dewulf has a passion for patient perspectives and understanding. As medical practitioner he deeply realized that good health education was at least as important as good medicines. in 1989 he joined the pharmaceutical industry, to provide good education on diseases and new treatments. In 1999 he took a 1y sabbatical to co-found PlanetMedica, Europe’s first Healthcare internet portal. With now >25y of global pharmaceutical experience he... Read More →
avatar for Andrea Ferris

Andrea Ferris

President and Chairman, LUNGevity Foundation
Andrea is the President and Chairman of LUNGevity. In her role as President of LUNGevity, Andrea is responsible for setting and executing the strategic direction of the organization and its science programs. Prior to LUNGevity, Andrea had a variety of management experiences. She worked at Decision Lens, a software company she helped launch, Johnson& Johnson, Lehman Brothers and Coopers & Lybrand. Andrea received her MBA from Wharton with... Read More →
avatar for Andrew Garvey

Andrew Garvey

Global Patient Advocacy Lead, GlaxoSmithKline
Andrew leads GSK’s global work with patient organizations (excluding the US). He is responsible for leading the work to develop collaborations with patient organizations to bring patient insight into GSK, improve the management of diseases and to strengthen the capabilities of patient organizations. Andrew has worked at GSK for 20 years in sales and marketing, public affairs and communications roles before leading on first GSK’s patient... Read More →
avatar for Mary Murray

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company
Mary Stober Murray is responsible for supporting global clinical development efforts by building relationships with advocacy organizations and diverse patient and provider communities to keep them informed, educated and prepared to support clinical development of BMS compounds.
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board, DIA International; Advisory Board, Canadian Institutes of Health Research Institute of Genetics. Durhane has a PhD in psychology from McGill and was professor at... Read More →


Tuesday June 28, 2016 8:00am - 9:30am
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

#203: Next Generation Collaborations: Transforming the Industry
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-609-L04-P; CME 1.50; IACET 1.50; RN 1.50

“Alone we can do so little; together we can do so much.” Harnessing the power of collaboration truly has the ability to alter the healthcare landscape as we know it today. What is the next generation of collaborations and what will be unique about them? What will change in our organizations in the future, and how will they be different from today? Is collaborative R&D going to become a reality for our industry? What roles will FDA and other stakeholders play? This forum will bring together a diverse panel representing some of the industry’s most influential and powerful organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health. Submit your questions in advance for the panelists to annualmeetingprogram@diaglobal.org; subject line: Next Gen Collaborations.

Learning Objectives

Review the role of collaborations to date in better aligning biopharmaceutical R&D with needs and constraints of an evolving health ecosystem; Discuss the impact of coming landscape changes on the industry of tomorrow and needs that new collaborations must address; Describe the stakeholders and innovative elements of the new and transformational collaborations that are emerging.

Chair

Dalvir Gill, PhD

Speaker

Panelist
Margaret A. Anderson, MA

Panelist
Christopher P. Austin, MD

Panelist
Jonathan P. Jarow, PhD

Panelist
C. David Nicholson, PhD

Panelist
Drew Schiller



Chair
avatar for Dalvir Gill

Dalvir Gill

Chief Executive Officer, TransCelerate BioPharma Inc.
Dalvir Gill, PhD, has been CEO of TransCelerate since January 2013. Formerly President of Phase II-IV Drug Development at PharmaNet-i3, Dr. Gill has more than twenty-five years of drug development experience. He holds a BSc from the University of Hertfordshire, a PhD from the Royal Free Hospital School of Medicine in London, and an executive program diploma in the health economics of pharmaceuticals from the Stockholm School of Economics. He is a... Read More →

Speakers
avatar for Margaret Anderson

Margaret Anderson

Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration, cultivating a culture of innovation and engaging patients as partners. She is also acting president and CEO of the Melanoma Research Alliance, the largest private... Read More →
avatar for Christopher Austin

Christopher Austin

Director, National Center for Advancing Translational Sciences, National Institutes of Health (NIH)
Christopher P. Austin, M.D., is director of the National Center for Advancing Translational Sciences (NCATS) at the U.S. National Institutes of Health (NIH). Austin leads the Center’s work to improve the translation of observations in the laboratory, clinic and community into interventions that reach and benefit patients—from diagnostics and therapeutics to medical procedures and behavioral changes.
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor to the Center Director, CDER, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology Products. Prior to joining the FDA he was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University.
avatar for C. David Nicholson

C. David Nicholson

Executive Vice President, Brand R&D, Allergan
Dr. Nicholson joined Actavis as SVP, Global Brands R&D in August 2014. Previously, he served as Chief Technology Officer and EVP, R&D for Bayer CropScience from March 2012 to August 2014; VP of Licensing and Knowledge Management at Merck from 2009 to December 2011; and SVP, responsible for Global Project Management and Drug Safety at Schering-Plough from 2007 to 2009. From 1988 to 2007, Dr. Nicholson held various leadership positions at... Read More →
avatar for Drew Schiller

Drew Schiller

Co-Founder and Chief Technology Officer, Validic
Drew Schiller co-founded Validic and serves as the CTO. At Validic, Drew leads the product and technology strategy, drives key initiatives, and works closely with senior executives at partner organizations to stay ahead of the technology curve. Drew sits on the Consumer Electronics Association (CEA) Health & Fitness Technology Board and contributes to CEA Health & Fitness subcommittees on Interoperability, Privacy and Security, and Standards... Read More →


Tuesday June 28, 2016 8:00am - 9:30am
Ballroom A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

#201: International Regulatory Convergence, Collaboration, and Cooperation
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.75; IACET 1.75; RN 1.75

Join senior leadership from international regulatory authorities to hear the latest on multi- and bilateral initiatives that avoid duplication and increase mutual reliance, their strategic governance, and their impact on industry.

Part 1 of this session will see the heads of three regulatory agencies provide updates on the challenges facing them as global regulators, both domestic and within the framework of international cooperative initiatives.

In Part 2, the panel will be joined by additional heads of regulatory authorities with leading roles in the International Coalition of Medicines Regulatory Authorities (ICMRA) and will provide an overview of the developing role of ICMRA and initiatives aimed at facilitating interactions, coordination, and convergence. It will also address ICMRA's current status of strategic collaboration in areas such as pharmacovigilance, crisis management and supply chain integrity (GMP and traceability).

The combined panel will look at existing initiatives to avoid duplication and increase mutual reliance between regulators, the need for strategic governance of these initiatives and their impact on industry and other stakeholder.

Learning Objectives

Identify the current framework of bilateral and multilateral international cooperation initiatives; Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

Chair

Emer Cooke, MBA

Speaker

Panelist
Emer Cooke, MBA

Panelist
Robert M. Califf, MD

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Anil Arora

Panelist
Lorraine Nolan, PhD

Panelist
Jonathan Mogford

Panelist
John Skerritt, PhD

Panelist
Jarbas Barbosa, MD, PhD



Chair
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation Sector. She currently is the Head of International Affairs (formerly International Cooperation Sector)

Speakers
avatar for Anil Arora

Anil Arora

Chair of the ICMRA; Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Mr. Arora has a breadth of experience in the private and public sectors. He has worked internationally-bilaterally, as well as with the UN and the OECD, including leading a multi-year program with the National Bureau of Statistics in the modernization of China’s statistical system and infrastructure. Mr. Arora has completed the Canada School of Public Service’s Living Leadership and Advanced Leadership Program, the Public Sector Management... Read More →
avatar for Jarbas Barbosa

Jarbas Barbosa

ICMRA Project Lead; Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems. In July 2015, he was nominated Director President of the Brazilian Health Regulatory Agency – Anvisa.
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is the Chief Executive of Pharmaceuticals and Medical Devices Agency since 2008. Before taking the current position, he spent most of his career as a neurosurgeon after he graduated from the University of Tokyo in 1968. He also has wide-ranging experience overseas, such as at Max-Planck Institute in Germany and at China-Japan Friendship Hospital in Beijing.
JM

Jonathan Mogford

Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),
avatar for Lorraine Nolan

Lorraine Nolan

Vice-Chair of the ICMRA; Chief Executive, Health Products Regulatory Authority (HPRA)
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines... Read More →
avatar for John Skerritt

John Skerritt

ICMRA Project Lead; Deputy Secretary for Health Products Regulation, Department of Health
Dr John Skerritt joined the Commonwealth Department of Health in May 2012 and is currently a Deputy Secretary. He was formerly the National Manager, TGA, until his role was expanded and that position was absorbed into his current role. He also has responsibility for the Department’s Office of Drug Control which is responsible for developing the new medicinal cannabis regulatory scheme.


Tuesday June 28, 2016 8:00am - 9:45am
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

Exhibit Hall Open
Tuesday June 28, 2016 9:00am - 5:00pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

Professional Poster Session 1
Component Type: Poster Presentation




Speakers
HA

Heba Abdullah

Global Safety Medical Director, Amgen Inc.
JA

Joshua Ainsley

Data Scientist, Fino Consulting
HA

Hyun-Kyung An

Korea Institute of Drug Safety & Risk Management
TA

Takashi Ando

Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
avatar for Alexandra Atkins

Alexandra Atkins

Senior Scientific Director, NeuroCog Trials
ED

E. Dennis Bashaw

Director, Division of Clinical Pharmacology III, OTS, CDER, FDA
JC

Jessica Chou

Section Chief, TCDE
EC

Eunhee Chung

Director, Global Clinical Development, SOUSEIKAI Global Clinical Research Center
avatar for Shaun Comfort

Shaun Comfort

Associate Director and Senior Safety Science Leader IIDO, Genentech, A Member of the Roche Group
Dr. Comfort is Associate Director for Risk Management and Sr. Safety Science Leader for Roche-GNE Late Stage Ophthalmology/Hematology Products. He is a Board Certified Neurologist with 13 years combined industry experience including roles as former Medical Reviewer at the US FDA and VP of Clinical Research at Anesiva. Most recently, he has been involved in evaluating Artificial Intelligence solutions in Pharmacovigilance.
AC

Alisha Couto

Post Doc Fellow, Bayer HealthCare, Rutgers, The State University of New Jersey
MC

Mabel Crescioni

Director, ePRO Consortium, Critical Path Institute
avatar for Irene Darras

Irene Darras

Global Regulatory Affairs Fellow, Rutgers, The State University of New Jersey
avatar for Colleen Davenport

Colleen Davenport

Director- Global Regulatory Sciences - Oncology, Bristol-Myers Squibb
Over 17 years of experience in the pharmaceutical industry with more than 14 years in regulatory affairs working across multiple therapeutic areas. Colleen has held Regulatory Affairs positions at Sanofi-Aventis, GlaxoSmithKline, and Accenture and is currently the Executive Director of Regulatory Affairs and Pharmacovigilance at AnGes, Inc. a small biotechnology company focused on a Phase 3 gene therapy product for Critical Limb Ischemia. Colleen... Read More →
DD

Dominique Demolle

CEO, Tools4patient
avatar for Elena Dubcenco

Elena Dubcenco

Associate Medical Director, Robarts Clinical Trials Inc./ University of Western Ontario
Her wide-ranging experience is underscored by numerous scientific publications, including academic and peer-reviewed journal articles; video, oral, and poster presentations; awards and grants including Cook Medical Don Wilson Award by the American Society for Gastrointestinal Endoscopy and NOSCAR® Olympus Medical Systems Research Award by the American Society for Gastrointestinal Endoscopy (ASGE) and Society of American Gastrointestinal... Read More →
avatar for Joseph Fiore

Joseph Fiore

Senior Clinical Scientist, Merck & Co., Inc.
Joe Fiore is Sr. Clinical Scientist at Merck & Co., Inc. in Upper Gwynedd, PA within the Clinical Sciences & Study Management group. He supports oncology clinical trials across phase I-III for the anti-PD1 drug pembrolizumab for patients with non-small cell lung cancer and advanced melanoma. Joe earned his PharmD from the University of Pittsburgh and is a registered pharmacist in the state of New Jersey. He completed his fellowship training at... Read More →
BG

Beverly Gow

Director of Pharmacovigilance Support Services, PrimeVigilance
KH

Kristin Hanson

Scientific Consultant, UBC: An Express Scripts Company
avatar for Nick Hargaden

Nick Hargaden

President, US Operations, Algorics
US operations lead and co-founder at Algorics, a data analytics software and solutions company in the clinical trials space. Nick has been working in the application of software technology in clinical trials since 1998. He has previously held leadership positions with global responsibilities in operations, business development, and quality management functions._x000D_ | _x000D_ | Nick holds a Ph.D. in Cognitive Science from the University of... Read More →
avatar for Rick Hart

Rick Hart

Director of Global Technology Solutions, BioStorage Technologies
Rick has 25 years experience in global technology solutions. Rick leads the effort in the development of ISIDOR®, a transformational and scalable informatics platform which integrates research and sample data to advance bioscience discoveries._x000D_ | _x000D_ | Rick received his BS degree from Purdue University. He has dedicated his career to the development of software solutions for various industries including manufacturing, life science... Read More →
MH

Michelle Hoiseth

Vice President, PAREXEL Access, PAREXEL
avatar for Kristen Hollingsworth

Kristen Hollingsworth

Global Business Leader, Diagnostics-Oncology, Johnson & Johnson
Seasoned pharmaceutical and diagnostics executive with experience leading cross-functional teams focused on drug development, clinical operations, business development and commercialization. Known for combining strong general management expertise, effective strategic thinking skills and thorough market assessment capabilities to produce highly differentiated products with strong customer appeal.
avatar for Elisa Holzbaur

Elisa Holzbaur

Manager, ePRO Services, Almac Group
Elisa Holzbaur is Manager, ePRO Services for Almac Clinical Technologies. In this role, she is responsible for creating and maintaining operational procedures to support the delivery of Almac’s ePRO solutions. Working with functional teams across the organization, Elisa provides expert counsel on the most efficient electronic patient reported outcome trial designs and works to improve Almac’s ePRO service offering.
RH

Rebecca Hummel

Quality Manager, CNS Healthcare
GK

Gaeun Kang

Fellow, Division of Clinical Pharmacology, Chonnam National University Hospital
avatar for Wasif Khan

Wasif Khan

Scientist, icddr,b
I was trained from Johns Hopkins Bloomberg School of Public Health with 26 years of experience in Clinical Trials. My vision is to build the bridge between global CROs and the Key opinion leaders (KOI) so that Bangladesh becomes a potential game changer for international clinical trials and global CROs to explore in this newly emerged clinical research country.
LK

Laura Khurana

Scientific Advisor, ERT
CL

Camilla Lau

Sr. Clinical Trial Manager, Gilead Sciences
avatar for Lawrence Liberti

Lawrence Liberti

Executive Director, Centre For Innovation In Regulatory Science (CIRS)
For the past 36 years, Mr Liberti has worked in the fields of regulatory affairs and clinical R&D. Since 2009 he has served as the Executive Director of CIRS (formerly the CMR International Institute for Regulatory Science), an independent, division of Thomson Reuters. He is pursuing his Doctorate through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation at Utrecht University, researching expedited regulatory pathways with... Read More →
avatar for Xiu Wei Lim

Xiu Wei Lim

Regional Clinical Innovation and Operational Excellence Head, Quintiles
Xiu Wei is the Head of Innovation in Quintiles APAC. She leads the idealization, development & execution of mobile initiatives focusing on leveraging mobile technology to increase productivity & quality in Clinical Operations across APAC. Her team also collaborates with Quintiles mobile COE to ensure quality delivery. Her breath of knowledge across Clinical Operations in her past experience as a CRA allows her to identify key focus areas across... Read More →
RM

Richard Macaulay

Senior Consultant, PAREXEL Access Consulting
RM

Ramya Mathew

Post-Doctoral Fellow, Medical Affairs, Rutgers, The State University of New Jersey
DM

Dan McDonald

Director, Business Development, Imperial
EM

Eric Morrie

Director, Product Operations, ClinCapture
MN

Masahide Nakajima

Manager, Pharmacovigilance Cordination & Administration Department. Ikuyaku., Mitsubishi Tanabe Pharma Corporation
avatar for Samarth Parikh

Samarth Parikh

Postdoctoral Fellow, Janssen Pharmaceutical Companies of Johnson & Johnson
Samarth Parikh is the Post-Doctoral Fellow at Janssen Pharmaceutical Companies of Johnson & Johnson in Global Medical Safety. He is responsible for project managing and preparing safety surveillance reports/responses to internal and external safety queries. In addition, he is also a preceptor for PharmD rotation students. He earned his PharmD from the Philadelphia College of Pharmacy and is a registered pharmacist in the State of Pennsylvania and... Read More →
avatar for Matthew Pazdernik

Matthew Pazdernik

Director, Regulatory Submission Planning and Portfolio Management, Merck & Co., Inc.
Matt Pazdernik is the Submission Planning & Portfolio Management Lead for Merck Regulatory Affairs, responsible for the global enterprise system to manage Regulatory Submission Plans, an enterprise-level Portfolio Planning & Project Management capability integrating the process and tools for Submissions Planning and Portfolio Management, delivery of an authoritative source for submission milestone tracking and management to align and drive... Read More →
avatar for Jennifer Ross

Jennifer Ross

Lead Biostatistician, Almac Clinical Technologies
Jennifer Ross is Lead Biostatistician at Almac, where she provides statistical consultancy on randomization methodology, IXRS® implementation and ePRO implementation. She is a member of C-Path’s ePRO Consortium where she is co-Chair of the Publications and Presentations Subcommittee. Jennifer has a Master of Science in Statistics and a Master of Philosophy in Education in Psychometrics from University of Pennsylvania, where she has taught... Read More →
MS

Mikhail Samsonov

Chief Medical Officer, R-Pharm
avatar for Earl Seltzer

Earl Seltzer

Associate Therapeutic Strategy Director, Therapeutic Science and Strategy, Quintiles
I have 10 years of industry experience, starting as a clinical research coordinator and moving to site management and business development oversight for a large mutlispecialty research site in Raleigh, NC that focused on adult and pediatric phase Ib-IV clinical trials. For the past 2 years, I have worked at Quintiles in the global feasibility department with a focus on pediatrics, cardiovascular medicine, and general medicine in close... Read More →
JS

Jui Shah

Health Scientist Administrator, NIAID, Clinical Research Resources Branch, National Institutes of Health (NIH)
CS

Carrie Shults

Development Group Leader, Research Scientist, Lyophilization Technology, Inc.
TW

Tai Wai Shun

Medical Reviewer, TCDE
FS

Fenan Solomon

Regulatory Affairs, Rutgers University
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Senior Project Manager, Tufts Center for the Study of Drug Development
Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade... Read More →
avatar for Michelle Thompson

Michelle Thompson

Vice President, FDA Quality and Regulatory Consultants, LLC
Mrs. (Holbrook) Thompson is a well respected business leader and Quality Assurance (QA) professional. She has been working in QA for over ten years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She has been a Registered Quality Assurance Professional in good clinical practices (RQAP-GCP) since 2007 and an active member in the Society of Quality Assurance (SQA) and the North Carolina SQA chapter. She has two dogs and is an... Read More →
LV

Lucie Vu

Postdoctoral Fellow, MCPHS University
avatar for Chris Watson

Chris Watson

Director of Product Strategy, Exco InTouch
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 17 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 8 years, Chris have been translating his commercial experience into the clinical technology industry. With an extensive knowledge of product and software development processes he is responsible for... Read More →
DW

Diane Webb

President, BizInt Solutions, Inc.
KY

Kun Yang

Post-Doctoral Fellow, Biogen, MCPHS University
JZ

Joshua Zhang

Senior Medical Director, Celldex
RZ

Rafal Ziecina

Medical Director, Quintiles


Tuesday June 28, 2016 9:00am - 5:00pm
TBD Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:30am

Coffee Break
Exhibit Hall

Tuesday June 28, 2016 9:30am - 10:30am
Exhibit Hall Exhibit Hall

9:40am

#204: Professional Poster Session and Oral Presentions 1A
Limited Capacity seats available

Component Type: Poster Presentation

Join us in the Exhibit Hall Poster Area (Hall A Entrance) for a series of 5 minute presentations delivered by this year's Professional Poster Presenters.


Tuesday June 28, 2016 9:40am - 10:20am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:40am

#205: It’s Not You; It’s Me: Dealing with Team Challenges, Critique, and Criticism
Limited Capacity seats available

Component Type: Workshop
Level: Basic

The life science industry is dominated by teams. High-functioning teams create a dynamic where innovation and productivity flourish; however, even the most motivated teams can have challenging team members or be derailed by uninformative feedback, critique, and criticism. Obtaining team buy-in and actionable feedback can be challenging, especially while endeavoring not to appear defensive or strident. Initially, this session will outline specific team member personalities that can disrupt a project or process. Small groups will focus on strategies for keeping cool, obtaining information, and maintaining team rapport. Attendees will be encouraged to share their examples and solutions within their small group. This will be an interactive session for attendees at all levels.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the challenges of critique and criticism; Detail strategies for handling challenging team members; Strategize how to create a better rapport.

Chair

Robin Whitsell


Chair
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc.
Robin Whitsell is the president and founder of Whitsell Innovations, Inc.(WI). WI is a full-service medical and scientific writing firm established in 2006 and headquartered in Chapel Hill, NC, focusing on the needs of pharmaceutical, device, and biotech clients. Prior to founding WI, she was the assistant director of preclinical and clinical programs at a start-up pharmaceutical company and led one program from pre-IND through NDA. She has 18... Read More →

Tuesday June 28, 2016 9:40am - 10:25am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:45am

Speaker Training Session
If you or a colleague would like to practice and receive some fantastic feedback and speaking advice, please stop by! Look for signs for the Speaker Training Room

Tuesday June 28, 2016 9:45am - 10:15am
104A 104A

9:45am

#206: Covance Innovation Theater: Leveraging Patient Data and Historical Investigator Performance Data to Realize Faster Patient Recruitment
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Patient recruitment and enrollment is one of the most critical opportunities to improve the clinical trial execution process. Twenty to 60 percent of the total clinical development timeline is spent on identifying and recruiting the right patients. Through Covance’s proprietary Xcellerate® knowledgebase with over 175,000 individual investigators and our LabCorp patient database with over 70 million de-identified patients, we are able to leverage the two databases to significantly increase our site optimization towards faster patient enrollment.

Chair

Covance Inc.


Chair
CI

Covance Inc.

Covance Inc.

Tuesday June 28, 2016 9:45am - 10:15am
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#207: Advancing the Appropriate Use of Mobile Clinical Trials: The Clinical Trials Transformation Initiative
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-513-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session, we will present preliminary findings and future project plans for the Clinical Trials Transformation Initiative's Mobile Clinical Trials Program, comprised of three project areas: legal and regulatory issues, scientific and technological issues, and stakeholder perceptions.

Learning Objectives

Describe objectives, methods and preliminary findings of the Clinical Trials Transformation Initiative's Mobile Clinical Trials Program; Identify barriers, real and perceived, that inhibit widespread adoption of mobile technology in clinical trials; Consider opportunities to mitigate identified barriers to adoption.

Chair

Kristen Miller

Speaker

Clinical Trials in the 21st Century : If They Could Put a Man on the Moon…
Robert A. DiCicco, PharmD

Patient Perspective
Cynthia Geoghegan



Chair
avatar for Kristen Miller

Kristen Miller

Health Scientist Policy Analyst, Office of Medical Policy, CDER, FDA
Kristen Miller helps to lead FDA’s activities with Clinical Trials Transformation Initiative (CTTI), a public private partnership between FDA and Duke University that identifies and promotes practices to increase the quality and efficiency of clinical trials. She joined the FDA in 2002, and prior to her work with CTTI through the Office of Medical Policy, she worked on postmarketing safety activities under FDAAA and FDASIA, specifically Risk... Read More →

Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Pharmacology Sciences and Operations, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over 25 years of experience in clinical development. His area of expertise includes clinical pharmacology and experimental medicine, clinical trial design, project... Read More →
avatar for Cynthia Geoghegan

Cynthia Geoghegan

Patient Representative, Patients and Partners LLC
A patient advocate and cancer survivor with decades of health policy, communications and capacity-building experience, Cindy Geoghegan founded Patient & Partners to ensure that the patient perspective is strategically integrated into industry, academic, government and non-profit efforts focused on patient outcomes and clinical benefit. She has founded, transformed and grown several patient-led non-profit organizations, and represents the... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#213: FDA Enforcement Update: Advertising and Promotion
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-527-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA enforcement actions and policy guidances need to be understood by every company because they reflect FDA's priorities and concerns in regulating advertising and promotion. In this forum, FDA representatives will examine the latest agency enforcement actions and policies and what they mean.

Learning Objectives

Describe the latest FDA enforcement actions and policy initiatives in the area of advertising and promotion; Explain what the enforcement actions reflect about FDA policies and priorities.

Chair

Philomena McArthur, JD

Speaker

CDER Perspective
Thomas W. Abrams

CBER Perspective
Lisa L. Stockbridge, PhD



Chair
avatar for Philomena McArthur

Philomena McArthur

Vice President Global Policies, Procedures & Training, Healthcare Compliance & P, Johnson & Johnson International
Philomena McArthur's diversified experience spans 25 yrs. She currently oversees the Regulatory Advertising & Promotion Dept. in Health Care Compliance supporting the Janssen Pharmaceutical companies of Johnson & Johnson, for whom she has worked for 10 yrs. Philomena has held a variety of roles at other companies including BMS and Pfizer, and has worked as a litigation attorney in New Jersey. She has a BA in biology from Bucknell Univ. & a JD cum... Read More →

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (OPDP), Food and Drug Administration. Before becoming Director of OPDP, Mr. Abrams was Director of the Division of Drug Marketing, Advertising, and Communications.
avatar for Lisa Stockbridge

Lisa Stockbridge

Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA
Dr. Stockbridge is chief of the Advertising and Promotional Labeling Branch in CBER’s Office of Compliance and Biologics Quality. Her team reviews promotional labeling and advertising, proprietary names, and product labeling. With over 15 years of experience in both CDER’s DDMAC and CBER’s APLB, she continues to serve on taskforces and special projects. Dr. Stockbridge holds a B.A. in Biology and Psychology from Manhattanville College and a... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#215: Exploring the Use of Virtual Technologies and Virtual Teams Within Medical Affairs Organizations
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-603-L04-P; CME 1.00; IACET 1.00; RN 1.00

Medical affairs teams are involved in a wealth of communication methods across the pharmaceutical/device, and biotechnology industries. Communication is at the core of each job unit. However, with the evolving reliance on technology, typical communication methods are being disrupted. One of the greatest issues facing medical affairs teams in recent years has been how to assess and incorporate these new technologies, especially virtual technologies, and expand the impact of their organization. With iPads, notebooks, wearable devices, and other advances in the electronic space, medical affairs team members, both internal facing and external facing, need to become proficient with these new technologies. Additionally, organizations need to establish rules regarding the use of the technologies. This session will address some of the issues and benefits of implementing these new, disruptive technologies within both established and emerging medical affairs teams.

Learning Objectives

Discuss the issues and benefits of implementing new, disruptive technologies for use with medical affairs teams.

Chair

J. Lynn Bass

Speaker

Experience of Leveraging External Virtual Teams to Expand the Capabilities of a Newly Formed Medical Affairs Organization
Rachel Couchenour

Meeting Thought Leader Needs with Technology
Craig J. Klinger, RPh



Chair
avatar for J. Lynn Bass

J. Lynn Bass

Director, Medical Affairs, Jazz Pharmaceuticals
Lynn has 16+ years of experience in the Medical Science Liaison (MSL) profession with tenures at Baxter BioScience, Lilly, Amgen, and most recently Jazz Pharmaceuticals. She has been an active member of the MSL community for over 14 years and has co-authored numerous MSL surveys. Currently, Lynn serves as the Chair, DIA Medical Science Liaison Community.

Speakers
avatar for Rachel Couchenour

Rachel Couchenour

Senior Director, Medical Affairs, Mateon Therapeutics
Rachel Couchenour, PharmD, MBA is a recognized leader with 15 years experience in the pharmaceutical industry. She currently serves as Sr. Director, Medical Affairs at Mateon Therapeutics, accountable for building and executing the medical affairs strategy for this clinical stage oncology biopharmaceutical company. Prior to joining the industry she was in academia with clinical practice in ambulatory care. BS in Pharmacy, UNC-Chapel Hill... Read More →
avatar for Craig Klinger

Craig Klinger

Consultant, Field Medical Liaison Strategy and Capabilities - Trainer, Lilly USA, LLC
Craig has been an employee of Eli Lilly and Company for the past 25 years. Craig was a Senior Medical Liaison Consultant in the New York City Metropolitan area for over 13 years. He currently is the USMD Operations Consultant - Trainer for all on boarding MLs at Lilly.


Tuesday June 28, 2016 10:30am - 11:30am
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Innovative tools/methods acceptable to drug developers and regulators require focused development strategies for necessary evidence. This session presents case studies illustrating what has been learned to achieve success based on real examples.

Learning Objectives

Discuss the importance of consortia in advancing biomarkers, modeling, and simulation tools that inform drug development; Describe through a lessons learned approach on reaching consensus on the science (e.g. data sharing, governance procedures); Identify and help scientists understand the competencies and expectations involved in development of novel tools and methodologies.

Chair

Martha Ann Brumfield, PhD

Speaker

FDA Perspective
ShaAvhree Y. Buckman-Garner, MD, PhD



Chair
avatar for Martha Brumfield

Martha Brumfield

President and Chief Executive Officer, Critical Path Institute
Martha A. Brumfield, PhD, heads the Arizona-based non-profit in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science. She has 20 years’ experience at Pfizer most recently as senior vice president of worldwide regulatory affairs and quality assurance. She chairs the Board of Directors for the RAPS and has served on Institute of Medicine consensus committees focusing on global... Read More →

Speakers
avatar for ShaAvhree Buckman-Garner

ShaAvhree Buckman-Garner

Director, Office of Translational Sciences, CDER, FDA
ShaAvhrée Buckman-Garner, MD, PhD, FAAP is the Director of the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), at the FDA. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the Division of Pediatric Drug Development, Office of Counter Terrorism and Pediatric Drug Development, CDER. Dr. Buckman-Garner received her MD and PhD degrees with an... Read More →
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation Sector. She currently is the Head of International Affairs (formerly International Cooperation Sector)


Tuesday June 28, 2016 10:30am - 11:30am
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#220: Regulatory Changes in China and the Impact to Global Drug Development Planning
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

In August 2015, the Chinese Food and Drug Administration (CFDA) issued extensive changes to drug reviews and approvals. It has effectively redefined the definition of a new drug and the approval process for any new drug development as well as generics. While China is becoming the second largest pharmaceutical market, it would benefit all firms to carefully review and digest the impact of such a change to their global drug development planning; in turn, this allows them to take advantage of this change and properly adapt. This session will highlight the changes that have a direct impact on the clinical development strategy and share case studies with the audience to illustrate the best approach in handling these regulatory changes.

Learning Objectives

Recognize changes made by the Chinese Food and Drug Administration to drug reviews and approvals; Identify how to best leverage these changes for your new drug developments and generics.

Chair

Dan Zhang

Speaker

Innovative Biopharmaceutical Drug Development in China: Trends and Transformations
Helena Zhang

Regulatory Changes in China
Feng Yi

Outline of Reforming IND/NDA Practice in China
Fudong An



Chair
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational Corp., a member of Quintiles Executive Operation Committee, and was also the Chairman of the Board for Quintiles Medical Development (Shanghai) Company Ltd.

Speakers
avatar for Feng  Yi

Feng Yi

Former Assistant to the Director-General, CFDA; SVP, Medical and Reg Affairs, Fountain (Beijing) Medical Technology Development Co., Ltd.
avatar for Helena Zhang

Helena Zhang

Senior Director and Chief Medical Officer, Quintiles
Dr. Helena Zhang, MD. MBA is Senior Director and Chief Medical Officer for Quintiles in the Greater China region. In this role she provides medical and ethical leadership of projects conducted by Quintiles in China. She enhances the strategic partnerships with top hospitals, Key Opinion Leaders and medical associations in China. Dr. Zhang joined the industry in 1994 where she worked with several leading medical device companies and... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#222: Valuing the Clinical Trial Patient
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-566-L01-P; CME 1.00; IACET 1.00; RN 1.00

Increasingly, during clinical research development, decisions are made on how to make trials more patient centric, increase patient engagement, and how/when patients will receive their individual research results. In this session, a patient advocate will share perspectives on each of these elements of research design and execution and a bioethicist will share the bioethical considerations for providing individual clinical trial test results to patients. Finally, participants will also hear about a pharmaceutical company's challenges and lessons learned when they decided to thank their clinical trial patients in a national television advertisement.

Learning Objectives

Recognize an increased awareness of clinical trial patients desired benefits from participating in a research study; Describe bioethical considerations when determining whether to provide clinical trial patients with their individual trial test results; Discuss a sponsor company’s experience with thanking clinical trial patients in a television advertisement.

Chair

Jane Perlmutter

Speaker

Bioethical Considerations with the Return of Individual Research Results and Incidental Findings to Clinical Trial Research Participants
Sandra Prucka, MS

Panelist
Deborah Howe



Chair
avatar for Jane Perlmutter

Jane Perlmutter

Founder and President, Gemini Group
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of research questions, design of trial protocols, and encouraging innovation to increase the speed of developing new treatments. She is also involved in health research... Read More →

Speakers
avatar for Deborah Howe

Deborah Howe

Associate Director, Vendor Alliance Lead, Bristol-Myers Squibb Company
Deborah Howe is an Associate Director in Vendor Alliance Management in Global Clinical Operations at Bristol-Myers Squibb. Deborah joined Bristol-Myers Squibb in 2005 and has held positions of increasing responsibility in the area of clinical trial recruitment and retention. Deborah graduated from Quinnipiac College with a BS degree in Marketing/Public Relations and completed an accelerated program in Respiratory Therapy.
avatar for Sandra Prucka

Sandra Prucka

Innovation Lead, Eli Lilly and Company
Before coming to Eli Lilly and Company in 2009 I was a clinical genetic counselor and Director of Genetic Counseling Services at the University of Alabama at Birmingham. I have been in the Tailored Therapeutics group at Lilly for 7 years. During this time I completed an internship in our Bioethics group focusing on the ethics of individual results return (IRR). I currently co-chair The Harvard Multiregional Clinical Trials working group to... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-569-L01-P; CME 1.00; IACET 1.00; RN 1.00

The inclusion of valid, reliable patient-centered outcomes is increasingly important for observational studies. Yet, identifying such outcomes is challenging. This session will discuss resources for identifying and developing outcome measures.

Learning Objectives

Describe the need for standardized or harmonized outcome measures for use in observational clinical research studies; Identify challenges to identifying valid, reliable, standardized outcome measures for use in new studies; Discuss examples of disparate outcome measure definitions; Summarize resources that can assist researchers in selecting appropriate outcome measures.

Chair

Richard Gliklich, MD

Speaker

Panelist
Elise Berliner, PhD



Speakers
EB

Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Elise Berliner, Ph.D., is the Director of the Technology Assessment Program at AHRQ which provides technology assessments to Medicare to inform coverage decisions and other policy issues. Prior to joining AHRQ, Dr. Berliner worked as a consultant on cost-effectiveness and outcomes research and in research and development at medical technology companies. She was a Congressional Fellow at the Office of Technology Assessment. Dr. Berliner received... Read More →
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, Better Outcomes
Dr. Richard Gliklich is the CEO of Better Outcomes Corporation. He was founder and CEO of Outcome Sciences, a health information and services company. He led the company from inception through its acquisition by Quintiles. A graduate of Yale University and Harvard Medical School and a former Charles A. Dana Scholar at the University of Pennsylvania, Dr. Gliklich is currently an XIR at General Catalyst, a surgeon at Mass Eye and Ear Infirmary, and... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-590-L01-P; CME 1.00; IACET 1.00; RN 1.00

Early consideration of the issues unique to rare disease development allows sponsors to proactively and adequately identify/address them during development and to have productive interactions with Health Authorities (HA). Unique program elements will be compared and contrasted, focusing on regulatory aspects of rare/orphan development and early HA consult to create successful programs that address the particular challenges. We will also discuss how to strategically take advantage of the various US and EU incentives such as market exclusivity, tax reduction, and expedited review process, as well as grants to facilitate the development of orphan drugs, to enhance orphan drug development.

Learning Objectives

Discuss the regulatory requirements unique to the global development of rare disease and orphan drugs, including the regulatory implications; Explain the regulatory considerations to create efficient, feasible, and sufficient rare disease and orphan drug programs; Summarize regulations regarding orphan drug designations in the US and EU; Discuss and demonstrate how drug developers can take advantage of the regulators' incentives to optimize their investment in orphan drug development.

Chair

Maureen Smith

Speaker

Maximizing the Advantages of US and EU Orphan Drug Designation Incentives
Irene Pan

Global Regulatory Considerations in Rare Disease and Orphan Drug Development: When Patients Are Waiting and Everyday Counts
Lauren Peterson Tornetta



Chair
avatar for Maureen Smith

Maureen Smith

Patient Advocate / Secretary, Canadian Organization For Rare Disorders (CORD)
Maureen Smith’s M.Ed. (Educational Psychology) interest in patient advocacy stems from a rare disease diagnosis at the age of 8. She is the Secretary of the Canadian Organization for Rare Disorders (CORD), co-chair of the Rare/Orphan Disease program track for the Drug Information Association’s annual meeting (2014-2016), a member of the CIHR-Institute of Genetics’ GELS Priority & Planning Committee and the patient member on Ontario’s... Read More →

Speakers
IP

Irene Pan

Senior Research Scientist, UBC: An Express Scripts Company
Irene Pan, MSc, is a Senior Research Scientist with UBC: An Express Scripts Company. With over 12 years of clinical research experience, Ms. Pan has conducted numerous studies in a wide range of therapeutic indications including ophthalmology, neurology, cardiology, oncology and respiratory medicine. She has hands-on experience in designing and managing clinical trials, as well as extensive experience in non-interventional research, including... Read More →
avatar for Lauren Tornetta

Lauren Tornetta

Director, Global Regulatory Affairs, Pfizer Inc
15 years of experience across public and government (FDA) sectors with an MBA in biotechnology and an MS in biochemistry. Global experience leading reg strategy with drugs (NCE, line extensions, drug: drug codev, biologic products, and combination products [drug: device]), in all dev phases including filings, and multiple Advisory Committee Meetings. Experience in multiple TAs including Neuroscience, Pain, Inflam/Immunology, CV and Renal, GI, and... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#208: Measuring Return on Engagement: An Interim Report on the DIA-Tufts CSDD Metrics Study
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The patient centricity movement has generated substantial activity within both the public and private sectors, but to date no quantitative data have been gathered on the adoption and impact of specific patient-centric initiatives implemented by pharmaceutical and biotechnology companies to support processes within the medical product life cycle. Similarly, no effort has been made to harmonize the patient centricity principles and draft guidance recommendations developed by public and public-private consortia with industry drug development practice and policy. DIA, in collaboration with Tufts Center for the Study of Drug Development (CSDD), have undertaken a comprehensive study to address these critical needs. In this forum, the Tufts CSDD-DIA team, along with industry representatives participating in the study, will describe the study objectives and approach as well as work to date. In addition, they will share interim observations and insights from preliminary data that have been gathered and analyzed.

Learning Objectives

Discuss current outcomes and effectiveness of patient engagement in the medical product life cycle; Identify the benefits of standard metrics to advance the practice of meaningful patient engagement in medical product development and approval processes; Describe the objectives and approach of the DIA-Tufts CSDD study; Discuss observations of the study based on data collected to date, including patient engagement practice, metrics in use, and barriers to robust patient engagement programs.

Chair

Mary Jo Lamberti
Elizabeth Lincoln, MA

Speaker

Panelist
Kathleen A. Foley, PhD

Panelist
John Manganaro

Panelist
Jeffrey W. Sherman, MD, FACP

Panelist
Ellen Coleman



Chair
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Senior Research Fellow, Tufts University
Mary Jo Lamberti manages multi-sponsored and grant funded research projects at the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. She has extensive experience conducting research on biopharmaceutical industry practices and trends within CROs and sites.
avatar for Elizabeth Lincoln

Elizabeth Lincoln

Global Director of Engagement, DIA
Prior to DIA, Elizabeth spent 12 years in Human Capital consulting at Accenture and five years at Career Concepts, Inc. She has worked across industries and for Fortune 100 as well as small, family-owned businesses in human resources and organization development. Since joining DIA, she has become deeply involved in DIA's patient engagement initiatives.

Speakers
avatar for Ellen Coleman

Ellen Coleman

Senior Vice President, Mark Krueger and Associates, Inc.
Ellen Coleman is senior vice president at Mark Krueger & Associates, Inc. She brings considerable experience working with patients with chronic and life-threatening illnesses. Prior to joining MK&A, Ellen was the executive vice president of EmergingMed, overseeing advocacy relations and patient-facing services for individuals with cancer searching for clinical trials. Ellen has received numerous awards including the Ronald & Patti Rosenfeld... Read More →
avatar for Kathleen Foley

Kathleen Foley

Senior Director, Pfizer Inc.
Kathleen A. Foley is a senior director and the Patient Centered Metrics Lead in the Global Health and Value Innovation Center at Pfizer, where she is responsible for the development of metrics contributing to the science of patient input. Dr. Foley has a master’s degree from the School of Public Health at the University of Michigan and a PhD in sociology and demography at the University of Pennsylvania.
JM

John Manganaro

Deputy Director, Regulatory Policy and Intelligence, Bayer HealthCare Pharmaceuticals
John has over 20 years in the pharmaceutical industry in Medical and Regulatory Affairs. He has extensive experience with various topics ranging from medical information, safety, compliance, product quality, intelligence research and regulatory issues. John is currently Deputy Director, Regulatory Policy and Intelligence at Bayer for the US, Latin America and Canada. | John holds a Pharm.D. from the University of Nebraska and M.S. in... Read More →
avatar for Jeffrey Sherman

Jeffrey Sherman

Chief Medical Officer and Executive Vice President, Research and Development, Horizon Pharma, Inc.
Jeff has more than 20 years of experience in the pharmaceutical industry. He is President of the Drug Information Association (DIA) and a member of the Board of Directors. He also served as chairperson of the DIA 2008 Annual Meeting and received an Outstanding Service Award in 2001.


Tuesday June 28, 2016 10:30am - 11:45am
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#209: The Promotable Project Manager: Leadership Behaviors Critical to Success in the Life Sciences
Component Type: Workshop
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000187; RN 1.25

This workshop will facilitate the participants' examination of their own leadership behaviors and provide unique insight on how participants might develop new skills to expand their influence and impact.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe the results of new research on the leadership skills that lead to professional advancement of project and program managers; Explain how project and program managers can expand their influence and deepen their leadership impact when leading or managing life science projects.

Chair

Richard J Heaslip, PhD


Chair
avatar for Richard Heaslip

Richard Heaslip

Founder, Programmatic Sciences LLC
Rick Heaslip is the Founder of Programmatic Sciences LLC, a consultancy specializing in the development of highly effective project and program leaders. Rick often advises life science companies seeking to improve their abilities to lead and manage projects. | | Rick is also a faculty member at the Univ. of Penn, where he teaches program management & leadership. He was formerly VP of Project & Portfolio Management at Wyeth and is author of... Read More →

Tuesday June 28, 2016 10:30am - 11:45am
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000190; RN 1.25

This session will familiarize the audience with the Project Management Office (PMO), with a focus on the value added opportunities that a PMO can provide to your organization. Utilizing best practices and real-world examples, we will identify those PMO processes and tools that assist companies with achieving their project goals along with their overall portfolio strategies. This session will dovetail information regarding value added portfolio management, the effective utilization of processes and tools within a PMO, and the challenges of building a culture of innovation in project portfolio life cycle.

Learning Objectives

Define the role of a Project Management Office (PMO) and how it can bring value to an organization; Describe what a structured PMO can do in partnership with their functions; Discuss how to introduce incremental and radical innovation to drive the project portfolio and gain a competitive edge and accelerate growth.


Chair

Karen M. Marks

Speaker

What Value Can a Project Management Office Bring to Your Organization?
Kristin Fitzgerald, MBA, PMP

Best Practices for a PMO: Developing a PMO with Effective Processes
Karen M. Marks

Driving Innovation by Expanding the Role of Integrated Project Portfolio: Challenges and Best Practices
Dinesh Singh, MBA



Chair
avatar for Karen Marks

Karen Marks

Vice President, Global Program Management Office, Baxter International, Inc.
Karen Marks is the Vice President of the Global PMO for Baxter. Prior to joining Baxter, she has held positions in ConvaTec and Merck & Co and AT&T. Karen’s educational background includes a BS from Muhlenberg College in Human Resources Management, Master's Certification in Project Management from Steven's Institute of Technology and a Six Sigma Black Belt.

Speakers
avatar for Kristin Fitzgerald

Kristin Fitzgerald

Director, Global Project Management, Project Management Office, Merck & Co., Inc.
Kristin Fitzgerald has been in the pharmaceutical industry for over 16 years and has worked in many different areas including, IT, Data Management, and Operations. In her current role, she manages support and leadership to Project Managers, Finance, and IT with respect to project scheduling infrastructure and all associated reports, tools and references used for portfolio management. Kristin received an MBA from Monmouth University and a BS... Read More →
avatar for Dinesh Singh

Dinesh Singh

Client Partner, Life Sciences, Cognizant
He is a seasoned advisor with 13 years of experience in business strategy, complex program management and large transformation/integration initiatives in life sciences industry. He has worked with leading pharmaceuticals clients to help them address key business problems and align their strategies. He has worked on R&D IT strategy and roadmap, managing large business/IS transformation programmes in clinical data management, and business process... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#211: Collaboration with a Purpose
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

While there is much to do in addressing many areas in need of attention within our industry, TransCelerate BioPharma, Inc., the Association of Contract Research Organizations, and the Society for Clinical Trials have been actively working towards a collaboration with a purpose. With ample opportunities to focus their attention, these three collaborators have chosen areas that will yield a significant impact on site sustainability and thereby bring efficiencies and increased quality to the overall industry. Topics to be discussed will include site best practices, Common Language Evaluation and Reconciliation (CLEAR), site score card, and Site Advocacy Groups (SAGs).

Learning Objectives

Discuss how collaboration with a purpose can impact site sustainability and increase quality; Identify initiatives to support a collaboration with a purpose.

Chair

Christine Pierre, RN

Speaker

Panelist
Rehbar H. Tayyabkhan

Panelist
Douglas J. Peddicord, PhD



Chair
avatar for Christine Pierre

Christine Pierre

President, Society for Clinical Research Sites
Christine is an internationally recognized expert on the site landscape, trends and site management. She has conducted and contributed to research on site-related topics leading to meaningful change and stronger site partnerships and sustainability. She was the founder of RxTrials and is currently the President of the Society for Clinical Research Sites, a global trade organization representing over 2,800 sites in 42 countries and remains... Read More →

Speakers
avatar for Douglas Peddicord

Douglas Peddicord

Executive Director, Association of Clinical Research Organizations (ACRO)
AAAS Congressional Fellow 1994-1995. Member, Board of Directors, CDISC. With policy expertise in the conduct and regulatory oversight of clinical trials, Dr. Peddicord serves as Executive Director of the Association of Clinical Research Organizations (ACRO).
avatar for Rehbar Tayyabkhan

Rehbar Tayyabkhan

Executive Director, Global Clinical Operations, Bristol-Myers Squibb Company
Reb Tayyabkhan is the Head of Central Clinical Services at Bristol Myers Squibb. He is responsible for Vendor and Outsourcing Management, R&D Contracts and Transparency across as phases of development. | | He is a member of TransCelerate as the sponsor for the risk based monitoring initiative as well as the liaison to the CRO Forum. Prior to joining BMS, Reb worked at PwC and Merck. | | Reb has a BA (Chemistry) and MBA from NYU and a... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#212: Special Populations in Clinical Pharmacology Studies
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-524-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium examines the complex challenges encountered in special population study design. Appropriate management of specialty populations with comorbidities on multiple medications creates challenges in protocol design and enrollment to ensure patient safety and accurate and quality data.

Learning Objectives

Discuss strategies to adapt to industry trends and changing demands of special population studies; Identify options in protocol design and the process for screening patients with comorbidities and concomitant medications; Evaluate the impact of subject population on subject safety data and on assessment of drug safety.

Chair

William B Smith

Speaker

Special Populations in Clinical Pharmacology Studies: Evolving Challenges
William B Smith

Investigational Product and Drug-Drug Interactions in Specialty Populations with Comorbidities: Options in Addressing Safety, Data, Timelines, and Costs
Harry W Alcorn, JR, PharmD

Fast to Patient: Shifting from Healthy Volunteer to Patient Population
Richard Scheyer, MD

QTcF in Special Populations
Robert Kleiman



Chair
avatar for William Smith

William Smith

President, New Orleans Center for Clinical Research
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical Research and Volunteer Group located within the University of Tennessee Medical Center. Dr. Smith has been involved as a Principal Investigator in over 1800 clinical... Read More →

Speakers
avatar for Harry Alcorn

Harry Alcorn

Chief Scientific Officer, DaVita Clinical Research
Chief Scientific Officer for DaVita Clinical Research a CRO, located in Minneapolis Minnesota and Lakewood Colorado. He has served as PI on over 100 protocols and Sub Investigator on over 250 protocols which have included Renal (Full and Adaptive), Hepatic and Pulmonary, along with Normal volunteer's studies. Clinical Faculty appointments at Uni of Minnesota, Creighton Uni, Uni of Nebraska Medical Center, Uni of Colorado, and Virginia Common... Read More →
RK

Robert Kleiman

Chief Medical Officer and Vice President, Global Cardiology, ERT
Dr. Kleiman is a cardiac electrophysiologist who has performed research in both basic and clinical electrophysiology and practiced clinical electrophysiology for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer, and works with pharmaceutical clients to develop cardiac safety strategies for their clinical development programs, including the design of cardiac safety trials, the analysis of cardiac safety... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical Affairs, Medpace
Dr. Richard Scheyer is VP Medical Affairs at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY Upstate, and completed residency and fellowship at Yale before joining the Neurology faculty. He served on the FNIH Biomarkers Consortium and the Board of... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#214: Product Management Strategies: Maximizing Content Re-Use to Meet Diverse Customer Information Needs
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Much interest exists in the pharmaceutical industry to develop new technologies to facilitate re-use of content and information across drug development. While structured authoring approaches are being implemented by the industry, it is equally important if not more so to understand the customer’s needs for content and information. Thus, devising strategies to manage content sooner in the drug development process will enable pharmaceutical companies to be better positioned to provide that information in an efficient, timely way while reducing costs. This session will present diverse approaches to content and product information management, while providing useful tips that the audience participants will be able to utilize in their day-to-day workplace.

Learning Objectives

Discuss the importance of content re-use strategies while providing proven tips for medical writers and medical communications professionals to use in their workplace; Recognize pertinent information for how content management and content re-use streamlines document creation and document life cycle for global applications; Identify adaptability to digital media when developing content re-use strategies.

Chair

Frank Hubbard, PhD

Speaker

An Overview of Content Re-use and Product Information Management Strategies: What’s In It for Me?
Frank Hubbard, PhD

Content Management and Re-use: Efficient Streamlining of Product Information Content and Life Cycle
Susan Bairnsfather, MSc

Developing a Strategy for Content Transformation
Cecil Lee, RPh



Chair
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions, Inc.
Following a 14-year career in the Medical Communications Science group at AstraZeneca, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my previous Medical Writing and DIA experience, I was named in 2015 the Medical Writing co-chair for the DIA Annual Conference, Track 6. My academic training is in Cancer... Read More →

Speakers
avatar for Susan Bairnsfather

Susan Bairnsfather

CEO, Regulatory Writer, Regulatory Affairs Professional and Statistical Analyst, EPharmaTech LLC
Susan Bairnsfather is CEO of EPharmaTech, LLC which offers clinical development and regulatory submission consulting to the pharmaceutical and biotech industry. With >20 years’ experience, she is a cross-trained individual in the functional roles of regulatory writer, regulatory affairs professional, and statistical programmer. Susan has led workshops for topics on regulatory submission processes, drug development, and statistics at the... Read More →
avatar for Cecil Lee

Cecil Lee

Knowledge Management Consultant, Global Medical Information, Eli Lilly and Company
I have been in Global Medical Information function at Eli Lilly for 10 years and 15 with the company. Previous roles include Technical Lead in technology, process and people capabilities, Emerging Markets Technical Lead as well as Manager for our Diabetes business unit. The Knowledge Management Content Strategist role has a mission to develop and execute a content strategy which continuously drive innovation and enhance efficiency on content... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#217: Electronic Submissions Gateway: Next Generation
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Electronic Submissions Gateway (ESG) is an FDA solution for accepting electronic regulatory submissions. It has been in production since 2006. This session will provide an update and Q&A on its status and the technology and process enhancements.

Learning Objectives

Discuss the Electronic Submissions Gateway (ESG) process and solutions for submission of regulatory; Describe the technology and process enhancements planned for ESG._x000D_


Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA eCTD v4.0 Two-Way Communication
Mark A. Gray

Panelist
Virginia Hussong

Panelist
La Misha Fields



Chair
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Advisor, Office of Strategic Programs, CDER, FDA
Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at Daiichi Medical Research, and Exec Dir, Biostatistics and Data Management at Purdue Pharma L.P. Ron was elected President of the DIA 07-09. Ron received a PhD in... Read More →

Speakers
avatar for La Misha Fields

La Misha Fields

IT Program Manager, Electronic Submissions Gateway, OIMT, OC, FDA
La Misha Fields is the Program Manager of the FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 6 years of FDA experience, including 5+ years in the Center for Drugs. Ms. Fields completed her bachelor’s degree in Computer Networking and her master’s degree in Business Administration at Strayer University.
avatar for Mark Gray

Mark Gray

Senior Project Manager, BSS, CBER, FDA
Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities include representing CBER in the development of international electronic submission standards, with a focus on the ICH electronic Common Technical Document... Read More →
avatar for Virginia Hussong

Virginia Hussong

Director, Div. of Data Management Services & Solutions, OBI, OSP, CDER, FDA
Ginny Hussong has over 20 years of experience in the pharmaceutical industry, of which the past 10 have been in CDER. As Acting Director of the Division of Data Management Services and Solutions, she supports the receipt, processing and archive of electronic regulatory submissions, provides training for reviewers on CDER's primary review tools, develops guidance and specifications to support data standards implementation and development, and... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

During this session, the value of metadata repositories will be discussed, and the audience will be provided with real-world practical experience regarding the traps to avoid, and the process to follow, to enable a successful metadata repository implementation.

Learning Objectives

Describe the complexities associated with defining metadata repository requirements; Discuss how to develop a methodology for implementing a successful metadata repository.

Chair

David Handelsman

Speaker

Semantic Metadata Repository at the Core of E2E eClinical Solutions
Isabelle M de Zegher

Implementing a Metadata Repository Based on Value and Not Technology
David Handelsman

Metadata Repositories: From the Outside In
Wayne R. Kubick, MBA



Chair
avatar for David Handelsman

David Handelsman

Senior Director, Industry Strategy, d-Wise
Dave Handelsman is a life sciences expert with 25 years of industry, software and management experience. As Senior Director of Strategy and Product Development at d-Wise, Dave is responsible for d-Wise’s growth and evolution, and for further establishing d-Wise as the go-to partner for healthcare and life sciences organizations. Prior to joining d-Wise in 2014, Dave held leadership roles at SAS, ClinTrials Research and PRA. He is currently the... Read More →

Speakers
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International (CIO), and a 12 year ride as a senior executive at Lincoln Technologies, Phase Forward, and Oracle Health Sciences. Mr. Kubick holds a B.A. from the University of... Read More →
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher, MD, MsC, is Vice President, Integrated Solutions at PAREXEL INFORMATICS. She has 12 years experience in pharma through PAREXEL, Novartis, UCB and Cap Gemini, and 10 years in Health Care IT. She served on the CDISC Board of Directors for 3 years.


Tuesday June 28, 2016 10:30am - 11:45am
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-552-L01-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on specific aspects of the regulatory development of novel combination biologics, as well as bifunctionals. Specific considerations for each of these modalities for different clinical stages and therapy areas will also be addressed, and a comparison/contrast of development requirements for each will be provided.

Learning Objectives

Describe the regulatory requirements for development of combinations of novel biologicals and bifunctional biologics.

Chair

Owen Fields, PhD

Speaker

Unique Challenges in the Regulation of Bispecific Antibodies
Raj G Nair, MD

Unique Preclinical and Clinical Aspects of Bifunctional Development
Rakesh Dixit, PhD

Q and A Panel
Badrul Chowdhury, MD, PhD



Chair
avatar for Owen Fields

Owen Fields

Vice President, Inflammatory and Immunology, WW Safety and Regulatory, Pfizer Inc
I received my Ph.D. in molecular and cellular biology from Berkeley. Following this I worked in food biotechnology regulation at the US FDA. I then moved to regulatory strategy at Wyeth where I worked in autoimmune disease, tissue repair, and other areas. After the merger with Pfizer I was responsible for regulatory strategy for Pfizer R&D. I am currently VP of regulatory strategy for Inflammation and Immunology at Pfizer R and D. I have 25 years... Read More →

Speakers
avatar for Badrul Chowdhury

Badrul Chowdhury

Director, Division of Pulmonary, Allergy, and Rheumatology Products, OND, CDER, FDA
Dr. Badrul A. Chowdhury is the Director of the Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, US Food and Drug Administration. Dr. Chowdhury is trained and board certified in Internal Medicine, and in Allergy and Immunology, and he also has a PhD in Immunology.
avatar for Rakesh Dixit

Rakesh Dixit

Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune
RN

Raj Nair

Medical Officer, DPARP, OND, CDER, FDA
I am a medical officer within the Division of Pulmonary Allergy, and Rheumatology since 2013. I was previously an assistant professor in Rheumatology at Georgetown University with an interest in use of musculoskeletal ultrasound in diagnosis and management of patients with rheumatic disease. I completed a clinical fellowship at the University of North Carolina-Chapel Hill and have an interest in potential regulatory paths forward for bispecific... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-555-L04-P; CME 1.25; IACET 1.25; RN 1.25

The complexity of the regulatory environment is growing rapidly in light of new technologies for disease surveillance, diagnostics, and medication. This session will focus on future knowledge and predictions in intelligence with an impact on the regulatory world.

Learning Objectives

Recognize the complexity of the future regulatory environment in light of new technologies; Identify challenges and opportunities in the field of digital data for disease surveillance, personalized medicines and individual stakeholder engagement through innovative tools; Evaluate future knowledge against new technologies.

Chair

Joseph C. Scheeren, PharmD

Speaker

Current Status of Big Data Use in the Health Care Sector: View from the Market
Luke D. Dunlap, MSc

Big Data Being Part of FDA eHealth Policy: Viewpoint of the Regulator
Robert M. Califf, MD

Challenges of Big Data in the Regulatory Environment from the Legal Point of View
Denise Esposito, JD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer Consumer Care AG
Joseph Scheeren, Pharm.D. is Senior Vice President, Head Regulatory Affairs for Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of CIRS, PhRMA and DIA. He is a member of Advisory Boards for CIRS, SAFE-BioPharma, Yale Regulatory Affairs Track, and CoRE Singapore. He is an elected corresponding Member of the Academie Nationale de... Read More →

Speakers
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.
LD

Luke Dunlap

Senior Principal, Real World Evidence Solutions, IMS Health
avatar for Denise Esposito

Denise Esposito

Partner, Covington & Burling LLP


Tuesday June 28, 2016 10:30am - 11:45am
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#223: Global Harmonization: Current ICH Quality Initiatives
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-567-L04-P; CME 1.25; IACET 1.25; RN 1.25

The concepts described in ICH Q8, Q9, Q10, and Q11 provide opportunities for a more science- and risk-based approach for developing medicinal products. It is important to have a harmonized implementation approach of these guidelines within and outside ICH regions. In addition, it is critical to focus on the commercial phase of product life cycle to be able to realize the full benefits of these guidelines. This session will discuss current ICH activities including ICH Q12 and ICH Q11 IWG. Industry speakers will share their perspectives on these initiatives and propose ways to address current technical and regulatory challenges.

Learning Objectives

Discuss current ICH activities; Examine different ways to approach technical and regulatory challenges; Recognize the importance of the guidelines within and outside of the ICH regions.

Chair

Moheb M. Nasr, PhD, MS

Speaker

A Holistic Approach for Global Management of Manufacturing Changes
Romuald Braun, MSc

ICH Q11 IWG Update
Timothy J.N. Watson, PhD

What Is Needed to Make ICH Q12 a True Transformational Guideline?
Roger Nosal



Chair
avatar for Moheb Nasr

Moheb Nasr

Vice President, CMC Regulatory Strategy, GlaxoSmithKline
Dr. Nasr joined GlaxoSmithKline (GSK) in September 2011 as Vice President for Global CMC Strategy. Prior to joining GSK, Dr. Nasr served as the Director of the Office of New Drug Quality Assessment (ONDQA), CDER, FDA. Dr. Nasr established and led ONDQA for 8 years. Dr. Nasr represented FDA at ICH and was instrumental in the development of QbD concept and key quality regulatory guidelines. Dr. Nasr obtained his Ph.D. degree in Chemistry at the... Read More →

Speakers
avatar for Romuald Braun

Romuald Braun

Managing Director, uanotau gmbh
Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in Life Sciences industry. He played roles on client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server and in cloud environments, in Europe and in US. Romuald is holding the degree of Master of Drug Regulatory Affairs in addition to diploma in Data Technology.
avatar for Roger Nosal

Roger Nosal

Vice President and Head, Global CMC, Pfizer Inc
He is accountable for development, preparation, prosecution and defense of investigational, commercial and post approval regulatory CMC submissions globally for new chemical, biological, vaccine & device candidates as well as generic and consumer health products. Roger was instrumental in establishing Pfizer’s and industry’s adoption of Quality by Design and has been an advocate for global regulatory harmonization.
avatar for Timothy Watson

Timothy Watson

Research Fellow, GCMC Advisory Office, Pfizer Inc
Tim was one of the PhRMA expert working group (EWG) members on the ICHQ11 regulatory guidance document for drug substance, and the current Rapporteur for the ICHQ11 Starting Material IWG. He is also served on the ICHQ7 IWG Q&A team, ICHQ3C EWG, and supporting many other ICH efforts (such as Q12). Tim’s primary responsibility at Pfizer is to collaborate with Regulatory CMC team leaders, Co-Development teams (technical teams), and Pfizer Global... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#226: The Global Conundrum: Herding Cats - Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi-Country Pharmacovigilance Activities
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

As pharmaceutical companies seek ways to centralize and better coordinate with affiliates, some pharmacovigilance activities, such as interfacing with health care professional and patients, must be managed locally. Dealing with these activities across multiple countries can be extremely complicated, and companies must find ways to simplify and improve their processes. In this forum, we will explore the Pharmacovigilance (PV) Affiliate Network from both corporate and local perspectives and review case studies of issues faced by companies of all sizes, from start-up to multi-national. In addition, we will present an approach to clarifying the current affiliate situation using an affiliate’s survey tool as well as available in-house data sources. We will also demonstrate a risk-assessment approach that can be applied to generate a clear view of systemic risk (exposure across all or many affiliates) and unique risks (exposure specific to one particular or a few local affiliates). Finally we will highlight methods to streamline PV affiliate processes and the benefits this approach provides to the enterprise. A panel discussion following the presentations offers attendees the opportunity to ask questions and to discuss ideas about global PV affiliate management with the speakers.

Learning Objectives

Assess similarities and differences between regions including recognizing peculiarities in present day international pharmacovigilance scenarios; Describe a methodology for identifying and assessing systemic and unique risks across the affiliate network; Identify the potential benefits from implementation of an affiliate risk-reduction and simplification exercise on portfolio management; Evaluate the company needs and formulate high-impact solutions to minimize risk and improve processes.

Chair

Hershell William Thompson

Speaker

Managing a PV Affiliates Network: The Challenges and Considerations in Maintaining Oversight and In-Country Connections
Lesia Tontisakis, BSN

A Global Conundrum: Seeking Simplicity in Multi-Country Pharmacovigilance Activities
Marco Anelli



Chair
avatar for Hershell Thompson

Hershell Thompson

Managing Consultant, Navitas Life Sciences, Inc.
Hershell is a Managing Consultant with Navitas Life Sciences and has with over 25 years of medicines development and change management experience. He has extensive operational experience in phase I-IV clinical trials, health outcomes, pharmacovigilance and medical devices. He was formerly Director of Strategy and Change Management at GSK and has successfully led a number of global change initiatives. His most recent work has focused on assessment... Read More →

Speakers
avatar for Marco Anelli

Marco Anelli

Head of Pharmacovigilance and Medical Affairs Advisory Services, Productlife Group
Marco Anelli is Head of Pharmacovigilance and Medical Affairs Advisory Services at ProductLife Group . In the past 25 years he has worked in Phase I-IV and PV. In addition, Marco is also QPPV and has prepared and signed over 200 non-clinical and clinical overviews and summaries. | Before PLG, Marco was R&D Director at Keypharma and Medical Affairs Director at Eurand. He has an MD from Milan University and a master’s degree in... Read More →
avatar for Lesia Tontisakis

Lesia Tontisakis

Director, Pharmacovigilance, Global Patient Safety and Epidemiology, Allergan
Lesia Tontisakis joined Allergan in 2011 leading key Safety Operations functions ensuring global quality & compliance targets are met. Key responsibilities include QMS oversight, compliance, Inspection Readiness, PVA Management, Training and Vendor Oversight (ICSR management and Affiliate PV activities). Past PV roles include Boehringer-Ingelheim-US and Pfizer-US, Greece. She has a BSN from Widener University, Chester PA. She practiced as a... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-600-L04-P; CME 1.25; IACET 1.25; RN 1.25

The requirement to properly plan, track, and manage signals from all sources has never been greater, and we are seeing an increasing focus of inspectors on companies' signaling strategies. This session describes cutting edge research from a local and a global perspective and will aid companies in designing a fit-for-purpose signal detection and management strategy for their product portfolios. This sesion will utilize real life examples in the presentation.

Learning Objectives

Describe signal management regulatory requirements in the EU, US, and other regions; Discuss how the basic principles of modern signal detection and management systems can be adapted to fit various-sized portfolios while ensuring quality is optimized; Recall developments in advanced signaling informatics.

Chair

Deirdre McCarthy, MS

Speaker

What Is the Utility of GIS Technology in the Postmarket Setting?
Henry "Skip" Francis

Practical Tools for Signal Management: How Do You Overcome Challenges and Meet the Regulatory Needs of Pharmacovigilance?
Shelley Gandhi, MS

Global Signal Detection with Regional Relevance: Development and Field Testing of Surveillance Strategies for the Emerging Indian Market
Ola Caster, PhD



Chair
avatar for Deirdre McCarthy

Deirdre McCarthy

Senior Benefit Risk Management Director, Quintiles Inc.
Over 15 years in PV, spanning CRO, regulatory authority and company. Areas of special interest are EU post-marketing safety systems & product benefit-risk management. Adjunct Lecturer in international PV at Tufts University School of Public Health and Community Medicine in Boston. Member of the ISoP Executive Committee for two terms and co-chair ISoP global training programme (ETP). Regular speaker and trainer at industry meetings and conferences... Read More →

Speakers
avatar for Ola Caster

Ola Caster

Senior Researcher, Uppsala Monitoring Centre
Ola Caster is Senior Researcher at the Uppsala Monitoring Centre and affiliated with the Department of Computer and Systems Sciences, Stockholm University. He has nearly ten years’ experience from research and development in global pharmacovigilance, with formal qualifications PhD in Computer and Systems Sciences and MSc in Pharmacy and Mathematical Statistics. His primary research interests are methods to support post-marketing signal... Read More →
HF

Henry Francis

Director for Data Mining and Informatics Evaluation and Research, OTS, CDER, FDA
Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating the efficient use of scientific methods to evaluate complex data information in order to make regulatory decisions for drug approval and drug safety.
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley Gandhi brings a wealth of experience in the pharmacovigilance arena after being with the MHRA (UK Regulatory Authority) for 19 years and 2 years with the NDA group working with industry. She has extensive knowledge of all European regulatory processes related to monitoring the safety of licensed medicinal products and ancillary devices and has investigated possible risks and has taken appropriate actions to minimise risk to public heath... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#228: Increase Value of Clinical Trials Through Impactful Branding
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

This session will offer participants an exciting opportunity to participate in an agency-style strategic brainstorm session designed to help clinical teams improve the value of their study brands by developing a stronger and more purposeful connection to the brand, key study objectives, and various stakeholders.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Demonstrate strategic tools that can lead to more meaningful communications for internal and external stakeholders.

Chair

Neil Weisman

Speaker

Facilitator
Robert Klein

Facilitator
Marie Eckerd



Chair
avatar for Neil Weisman

Neil Weisman

Executive Vice President and General Manager, Continuum Clinical
Neil Weisman, EVP and General Manager of Continuum Clinical, helps pharmaceutical and biotech companies bring new therapies to market faster and more efficiently by solving critical communication challenges that impact the clinical development process. With more than 15 years of experience, Neil leads the strategic direction for Continuum Clinical clients and oversees a global team of dedicated healthcare marketers, clinical trial experts, and... Read More →

Speakers
avatar for Marie Eckerd

Marie Eckerd

Global Feasibility and Recruitment Partner, AstraZeneca
Marie Eckerd is currently a Feasibility and Recruitment Partner at Astra Zeneca. She has lead large global programs through submission across various therapy areas. Previous to AstraZeneca, Marie held leadership positions in Project Management and Data Management with the former Wyeth-Ayerst and IBEX Technologies. Recently, she presented at various conferences to highlight work streams that bridged feasibility, data analytics and patient-centered... Read More →
avatar for Robert Klein

Robert Klein

Chief Strategy Officer, Continuum Clinical
Bob Klein, Chief Strategy Officer of Blue Chip Marketing Worldwide and Continuum Clinical, is dedicated to helping pharmaceutical and biotech companies unearth insights that accelerate clinical trail enrollment and retention. With more than 30 years of experience, Bob is responsible for leveraging the agency’s proprietary D3 strategic planning process and full-service primary research capabilities to the maximum benefit of our clients.


Tuesday June 28, 2016 10:45am - 11:45am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

11:30am

Luncheon
Discuss what you’ve learned and meet with exhibitors at our daily luncheon in the Exhibit Hall

Tuesday June 28, 2016 11:30am - 2:00pm
Exhibit Hall Exhibit Hall

12:00pm

#230: Quintiles Innovation Theater: Transforming Patient Recruitment Through Site and Patient Engagement
Limited Capacity filling up

Component Type: Session
Level: Intermediate

Transforming patient recruitment requires operating with patients in mind from start to finish for better outcomes. Generating awareness and trust is an imperative first step. Then getting patients involved in program and protocol design pre-recruitment also effects study execution. It is also imperative to support sites through proper tools, training, and support. Learn how we’re using innovative solutions and partnerships to transform the way patients impact study success.

Chair

Quintiles Transnational


Chair
avatar for Quintiles Transnational

Quintiles Transnational

Quintiles Transnational

Tuesday June 28, 2016 12:00pm - 12:30pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:00pm

#231: Introduction to Structured Content
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Typically content is created and managed and delivered as large static documents. Content is created multiple times by multiple authors and content is siloed between content creators and product lines. Multiple inconsistent versions of content exist.

Submission-related standards such as eCTD and SPL require structured content; however, these standards only provide the capability to submit content, they do not support the need to more effectively create and manage content. Structured content is today’s best practice for the creation, management, and delivery of content for clinical, labeling, and promotional materials. We will introduce you to the concepts of structured content in a fun, interactive way, then take you through real-world examples so you can understand the inner workings of structure. You will leave with 10 Steps to Structure guidelines.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the concepts and benefits of structured content.

Chair

Ann Rockley, MLIS


Chair
avatar for Ann Rockley

Ann Rockley

Chief Executive Officer, The Rockley Group Inc.
Ann Rockley has helped pharmaceutical, medical devices, and healthcare providers create intelligent content strategies and adopt structured content management for more than 15 years. She has helped clinical, labeling, and marketing content teams meet the increasing demands of regulatory requirements, complexities of globalization, and growing reliance on mobile devices. Ann is the author of "Managing Enterprise Content: A Unified Content... Read More →

Tuesday June 28, 2016 12:00pm - 1:00pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:00pm

Innovation Row Tour
New to DIA 2016, Innovation Row will showcase entrepreneurial work in Life Sciences Product Development.  Key leaders in the clinical and product development space will have the opportunity to showcase their work being done in the field to advance global health care product development.  Innovation Row will feature nine brief presentations, each with a 30-second video and a three-minute overview.  The presentations will be followed by a panel discussion of professors, business development professionals, and investors. This session will provide a great opportunity for audiences – made up of students, health care leaders, and more – to participate in an engaging discussion around the innovation of products and compelling new ideas to deliver effective products to patients. 

Then, companies that have investor arms and the venture capitalist community are invited to a closed-door meeting where they can have conversations with the exhibitors or presenters on potential funding opportunities.

Innovation Row Presenters Include:


Schedule of Events

12:00PM     Innovation Row Presentations to Panel of Professors, Business Development Professionals and potential investors 

1:15PM      Tours of the Innovation Row area

 

Tuesday June 28, 2016 12:00pm - 1:45pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:00pm

#229: Professional Poster Session and Oral Presentions 1B
Limited Capacity seats available

Component Type: Poster Presentation

Join us in the Exhibit Hall Poster Area (Hall A Entrance) for a series of 5 minute presentations delivered by this year's Professional Poster Presenters.


Tuesday June 28, 2016 12:00pm - 1:45pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:40pm

#232: PRA Innovation Theater: Transforming EMR to EDC
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Disparate EMR systems and lack of CFR 21-11 compliance have hamstrung efforts streamlining data entry for research. PRA's Predictivv platform reduces the duplicate data entry by transforming EMR to EDC in real time.

"Predictivv is the foundation of PRA and our drive towards evidence driven healthcare and research."

Jane Quigley, Vice President of Medical Informatics

Chair

PRA Health Sciences


Chair
Tuesday June 28, 2016 12:40pm - 1:10pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:20pm

#233: Veeva Innovation Theater: The Great RIM Throwdown! How Are You Managing Regulatory Events?
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Regulatory professionals were asked to share what their organization does well, and what they do poorly when managing regulatory events like manufacturing changes or health authority requests. We’ve taken their top challenges and tested Veeva Vault RIM to see how it stands up. Can it address standardization, tracking, data quality and lack of metrics? Can it deliver local market visibility in three clicks or less? Come see for yourself.

Chair

Veeva Systems


Chair
Tuesday June 28, 2016 1:20pm - 1:50pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

1:30pm

Exhibit Guest Passes
Visit the Onsite Exhibitor Registration Desk and present a business card to gain access to the Exhibit Hall.

Tuesday June 28, 2016 1:30pm - 3:30pm
TBA Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#235: Global Clinical Supply Logistics Study
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.00; IACET 1.00; RN 1.00

The Tufts Center for the Study of Drug Development has recently conducted a study gathering metrics on the impact of clinical supply logistics on global studies among 14 biopharmaceutical, CRO, and provider companies. A comprehensive survey was conducted and study data on logistics were gathered.

Learning Objectives

Describe the top strategies that companies use to optimize distribution networks; List some insights gained into shipping practices and approaches to investigational drugs and supplies; Identify performance indicators for successful distribution strategies.

Chair

Mary Jo Lamberti

Speaker

Distribution Networks and Strategies
Eric A. Valentine, MBA

Cycle Time Metrics and Impact on Study Conduct
Cheryl D. Mahon, PharmD



Chair
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Senior Research Fellow, Tufts University
Mary Jo Lamberti manages multi-sponsored and grant funded research projects at the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. She has extensive experience conducting research on biopharmaceutical industry practices and trends within CROs and sites.

Speakers
avatar for Cheryl Mahon

Cheryl Mahon

Director, Clinical Pharmacy, Astellas Pharma US, Inc.
Cheryl Mahon is a Director at Astellas Pharma US, Inc, responsible for the North American Clinical Supply Coordination team since 2007. This group is part of a global function responsible for forecasting, planning, packaging/labeling, distribution and return of clinical materials for studies Phase I-IV. Prior to Astellas, Cheryl has managed clinical supplies at another company for seven years and also has experience in CMC Regulatory and... Read More →
avatar for Eric Valentine

Eric Valentine

Global Director, Clinical Distribution Services, Catalent Pharma Solutions
Eric Valentine is the Global Director of Distribution Services for Catalent Pharma Solutions, responsible for developing the facilities network and logistics strategies in support of Catalent's Clinical Supply Services business. He has a background of 20 years' experience serving in leadership positions in the CRO and drug development services industries. Mr. Valentine holds an MBA in Finance from Seton Hall University and a B.A. in Business... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#237: Acquisitions and Mergers: When Companies’ Regulatory Operations Systems and Processes Converge
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; PDU 1.00 PMI 2166-000192; RN 1.00

This session will explore key aspects necessary for success when integrating regulatory operations teams as a result of mergers and acquisitions.

Learning Objectives

Discuss the necessary elements for successfully integrating regulatory operations departments during a merger or acquisition; Identify risks related to migrating information between systems; Respond to questions from others in the organization on best practices for integrating regulatory solutions.

Chair

Sarah Powell, RAC

Speaker

Challenges and Business Impact Associated with Mergers and Acquisitions
Meredith K Sewell

Building a Regulatory Information Management Capability for the Next Decade: People, Process, and Technology - Case Study
Dominique E. Lagrave



Chair
avatar for Sarah Powell

Sarah Powell

President, Powell Regulatory Services
Sarah has over 29 years of experience in pharmaceutical and related regulated industries. Most recently, Sarah has worked on assisting clients with projects related to process improvements, standards development, defining filing strategies and writing and review of submission content. Prior to that, Sarah worked on projects related to implementation of regulatory solutions and has contributed to defining product strategies for industry leading... Read More →

Speakers
DL

Dominique Lagrave

Director GRAAS Operations, Global Regulatory Writing, Amgen Inc.
Dominique has over 20 years of International Regulatory Affairs experience with the last 15 years spent in Global Regulatory Operations management. | Since 2015, Dominique is a Director at Amgen where he is leading the Global Regulatory Operations organization with responsibility for RIM, Publishing and submission management. | Dominique holds a Pharm D and a Master in Regulatory Affairs from the University of Paris.
MS

Meredith Sewell

Director, Global Regulatory Publishing, Allergan
Meredith Sewell is Allergan’s Director of Global Regulatory Affairs Operations and leads the Publishing, RIM and Archiving functions. Meredith joined the company in Irvine, CA in 2006 and in 2015, after Allergan merged with Actavis, Forest, Watson & Warner-Chilcott, she now leads a united team of 27 people in Allergan offices in the US, England, Australia, Brazil and Singapore.


Tuesday June 28, 2016 2:00pm - 3:00pm
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#252: Capturing Real-World Data in Rare Diseases
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-591-L01-P; CME 1.00; IACET 1.00; RN 1.00

Although much can be learned from interventional-type clinical trials, a fuller picture of disease course and experiential journey can only be understood by observing patients longitudinally in real-world settings where co-morbid conditions, medication noncompliance, economic considerations, and a host of other factors come into play. However, capturing real-world data in rare diseases poses distinctive demands: fewer patients, patient inability to report on disease experience due to youth or infirmity, and need for longitudinal tracking. This panel seeks to present conventional and novel approaches to capturing real-world data in rare diseases.

Learning Objectives

Discuss the benefit of real-world data; Summarize the distinctive demands for real-world data and data collection in rare diseases; Describe ways to address real-world data demands in rare diseases.

Chair

Badri Rengarajan, MD

Speaker

Unique Paradigms to Rare Diseases Research
Donny Chen, MBA

Real-World Evidence and Rare Diseases
Derenda Nichols



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes; Director, BD and Market Research, Nodality; Regulatory Team Leader, Genentech; Junior Engagement Manager, McKinsey. Education: A.B., Biology and Public... Read More →

Speakers
avatar for Donny Chen

Donny Chen

Director, Medical Affairs Research Operations, PPD
Donny Chen, director of medical affairs research operations at PPD, has spent the last 17 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen graduated Phi Beta Kappa from the University of Chicago with concentrations in economics and medicine. He received his MBA from the Chicago Booth School of Business with... Read More →
avatar for Derenda Nichols

Derenda Nichols

Senior Director, Clinical Trial Management, Medpace
Derenda Nichols has more than 25 years experience in the CRO industry. Her diverse background includes monitoring and site management, regulatory affairs, medical writing, global project management, operations and most recently, executive management. She has successfully participated in planning and executing large, multi-country projects a variety of therapeutics including orphan/rare diseases. She is currently a Sr. Director, Clinical Trial... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#253: Update from Health Canada
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-613-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide attendees the opportunity to speak directly to regulators about the current and future state of regulation of biological drugs at Health Canada. The forum will focus on biotherapeutic products (monoclonal antibodies, hormones and enzymes, and cytokines) and will have both clinical and chemistry and manufacturing representation. Specific topics to be discussed will include: changes to the Guidance Document for Subsequent Entry Biologics (SEB), the SEB Scientific Advice Meeting Pilot, risk management considerations for biotherapeutic products, international harmonization, and Health Canada as a flat, flexible, and forward looking organization.

Learning Objectives

Summarize key issues discussed by Health Canada; Identify regulatory hot topics.

Chair

Jeffrey Skene, MSc

Speaker

Panelist
Jeffrey Skene, MSc



Chair
avatar for Agnes Klein

Agnes Klein

Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products, Health Canada
Agnes V. Klein MD is currently the Director, CERB in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in drug development and medical bioethics. SHe represents Canada at ICH and is member of several medical international orgnaizations

Speakers
JS

Jeffrey Skene

Division Chief, Monoclonal Antibodies, Health Canada
Jeffrey Skene has been with Health Canada since 2003. He began his career at Health Canada in Regulatory Affairs and later joined the group responsible for the review of monoclonal antibodies as a CMC reviewer. Today, Mr. Skene is the Chief of the Monoclonal Antibodies Division that is responsible for CMC review of monoclonal antibody submissions, laboratory testing and On-Site Evaluations (OSE). He holds a M.Sc. in Biochemistry with a... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#255A: DIA Innovation Theater: Special Session for Exhibitors: Global Trends in Drug Development and Opportunities with DIA Worldwide
Limited Capacity seats available

Component Type: Session
Level: Basic

An exclusive opportunity for DIA Exhibitors! This special session will kick off with a presentation on market insights into global trends in drug development. This informative session will also include an opportunity to meet DIA’s Senior Vice President and Managing Directors from Greater China, Europe, ASEAN, Japan and Americas who will provide upcoming opportunities within their region for 2016 -2017. This is an excellent opportunity to learn about upcoming opportunities where your Company can expand its brand awareness and engage with local stakeholders in your products and services.

AGENDA

2:00 pm Welcome & Opening Remarks
Jonathan Commons
Senior Vice President, Marketing, DIA

2:00 – 2:20pm Global Trends in Drug Development
Michael Kleinrock
Director Research Development
IMS Institute for Healthcare Informatics

2:20 – 2:30pm What’s Happening in China
Carol Zhu
Senior Vice President & Managing Director, DIA Greater China

2:30 – 2:40pm What’s Happening in Japan
Ko Sekiguchi, MBA
Senior Vice President & Managing Director, DIA Japan

2:40 -2:50pm What’s Happening in Europe
Holger Adelmann, MD, PhD
Senior Vice President & Managing Director, DIA EMA

2:50 -3:00pm What’s Happening in Americas
Julie Ho
Associate Director, Business & Market Development, DIA

3:00pm Q/A & Final Remarks
Jonathan Commons
Senior Vice President, Marketing, DIA

Chair

Jonathan Commons

Speaker

Panelist
Michael Kleinrock, MA

Panelist
Carol Zhu, MBA

Panelist
Ko Sekiguchi, MBA

Panelist
Holger G. Adelmann

Panelist
Julie Ho



Chair
avatar for Jonathan Commons

Jonathan Commons

Senior Vice President, Marketing, DIA
Prior to joining DIA, Mr. Commons worked for more than a decade in the Pharmaceutical industry. He most recently served in global roles as the Senior Director of Digital and Patient Engagement at Chimerix and Vice President of Investigator Education and Patient Engagement at Quintiles. At GlaxoSmithKline (GSK) he worked on the commercialization of pharmaceutical products across a range of therapeutic areas including Oncology, Cardiovascular... Read More →

Speakers
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association for Clinical Pharmacology & Therapeutics, German Association for Applied Human Pharmacology, a fellow of the Royal Microscopical Society, Oxford, and lecturer at... Read More →
avatar for Julie Ho

Julie Ho

Associate Director, Business and Market Development, DIA
avatar for Michael Kleinrock

Michael Kleinrock

Director, IMS Institute For Health Informatics, Research Development, IMS Health
Michael serves as Research Director for the IMS Institute. He writes and speaks regularly on key  health care topics related to the current and future place of biopharmaceuticals in healthcare.  He brings a deep understanding of complex data sources and analytics from IMS and elsewhere, as well as the historic drivers of performance in key market segments.
avatar for Ko Sekiguchi

Ko Sekiguchi

Senior Vice President and Managing Director, DIA Japan
avatar for Carol Zhu

Carol Zhu

Senior Vice President and Managing Director, DIA China


Tuesday June 28, 2016 2:00pm - 3:00pm
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#255B: Lost in Translation: The Importance of Data Presentation
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Participants will “learn by doing” how poorly conceived and executed tables and graphs can actually prevent understanding of the science. In contrast, when data presentations are well-designed, they can communicate the key messages of even very large and complex data sets. After a short presentation on the fundamentals of good data presentation, participants will be divided into smaller working groups where they will be challenged with complex and difficult to understand examples of figures and datasets and asked to consider what are the key messages and the best method for communicating them. These real-life data examples are guaranteed to open eyes and enlighten. After each exercise, the groups will come back together to discuss, share, and analyze the messages and their presentations, and conclude with a summary of lessons learned.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Demonstrate how to change uninformative tables and graphs into data presentations that communicate clearly.

Chair

Barry Drees, PhD


Chair
BD

Barry Drees

Senior Partner, Trilogy Writing & Consulting GmbH

Tuesday June 28, 2016 2:00pm - 3:00pm
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#234: TransCelerate's Risk-Based Monitoring: Sharing What We Are Learning
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

TransCelerate members will share successful risk-based monitoring (RBM) implementation lessons learned during this interactive session. Regulators, sponsors, CROs and clinical research site personnel will gain practical insight for an RBM implementation strategy.

Learning Objectives

Discuss successful practices and lessons learned through an evaluation of TransCelerate company risk-based monitoring (RBM) studies and recent publications; Describe key change considerations needed to successfully implement an RBM strategy both from a site and sponsor perspective; Summarize what this unique collaboration of 20+ sponsors is doing to assist vendors in understanding the technology gaps with respect to existing tools and systems that support RBM methods.

Chair

Brett Wilson

Speaker

TransCelerate RBM Successful Practices and Lessons Learned
Joanne Benedict, MSc

TransCelerate's Approach to Understanding and Managing Site and Other Stakeholder Expectations, Wants, and Needs
Kate Owen

Site Representative
Allison Camacho

Searching for a Technology Solution to Support Risk-Based Monitoring
Mary Cusack



Chair
avatar for Brett Wilson

Brett Wilson

Head, Monitoring Excellence, Bristol-Myers Squibb Company
Brett Wilson, BSP, is Head of Monitoring Excellence at Bristol-Myers Squibb and leads both Risk Based Monitoring and eSource initiatives with TransCelerate BioPharma. Within BMS, Brett is responsible for ensuring an accountable and sustainable adaptive monitoring model focused on the support of people and process, tools and technology and monitoring effectiveness.

Speakers
avatar for Joanne Benedict

Joanne Benedict

Senior Advisor, Genentech, A Member of the Roche Group
Joanne Benedict is a Senior Advisor in Roche Genentech's Process, Training, and Systems group. She develops business strategies, processes, and systems which support continuous improvement and innovation in clinical trials. Specializing in operations, technology, and process optimization, she is also experienced with change management including training programs which maximize embedding of new business processes.
AC

Allison Camacho

Research Manager, Dallas Diabetes and Endocrine Center
Allison Camacho joined Dr. Julio Rosenstock as his Research Manager of the Dallas Diabetes and Endocrine Center in 2002. Currently, Allison’s responsibilities include managing eight coordinators, five supporting staff, and manages the budgets and contracts for the site, ensuring the overall conduct of more than 45 trials in phases Ib–IV, . | | With expertise in feasibility and conduct of diabetes trials, Allison has served on many advisory... Read More →
avatar for Mary Cusack

Mary Cusack

Associate Director, Global Clinical Operations, Bristol-Myers Squibb Company
Mary has over 17 years of pharmaceutical experience of which over half have been spent at Bristol-Myers Squibb in Global Clinical Operations. Mary serves as the Business Integration Lead. In this capacity, she has responsibility to manage technical implementations within clinical business operations. Mary has a BS in Chemical Engineering from the University of Pennsylvania, a MBA from The Wharton School, and a MS in Business Administration from... Read More →
avatar for Kate Owen

Kate Owen

Vice President, Clinical Trial Management, Novo Nordisk Inc.
Kate is the Vice President of Clinical Trial Management at Novo Nordisk (Princeton, NJ) with 22 years’ experience within the biotech, pharmaceutical and CRO space. Her leadership has led to improved productivity, cost-effectiveness, quality and staff morale. She sponsors the Novo Nordisk RBM project endorsed late in 2015 & is now responsible for the implementation, adaptation & change management across the organization globally.


Tuesday June 28, 2016 2:00pm - 3:15pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-522-L04-P; CME 1.25; IACET 1.25; RN 1.25

The legislative and regulatory landscapes for expanded access to investigational therapies are evolving due in part to public attention. This session will examine strategies proposed by stakeholders to address ethical, regulatory, and policy considerations.

Learning Objectives

Recognize FDA requirements for expanded access and the current regulatory, political, and social environment; Identify challenges faced by stakeholders from ethical, regulatory, and policy perspectives; Describe industry best practices for managing expanded access programs.

Chair

Kim M. Quaintance-Lunn

Speaker

Is There a Better Way? An Industry Perspective
Sandra A. Morris, PhD, PMP

The Ethics of Compassionate Use
Alison Bateman-House



Chair
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Head, US Regulatory Policy, Bayer
Kim Quaintance-Lunn serves as the Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the development of regulatory strategies. Kim previously served as Senior Director, Global Regulatory Policy and Intelligence, Eisai Inc, and Associate Director for Regulatory Affairs, Office of New... Read More →

Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, New York University Langone Medical Center
Alison Bateman-House holds PhD and Masters of Public Health degrees from Columbia University and a Masters of Bioethics from the University of Virginia. She has advanced training in both social science and bioethics, and she has worked in the fields of bioethics and public health ethics at several universities, including the New York University Langone Medical Center. At NYU, she part of the Division of Medical Ethics, and she is Deputy... Read More →
avatar for Sandra Morris

Sandra Morris

Vice President, Strategy Realization, Johnson & Johnson
Dr. Morris is currently VP, Strategy Realization for the J&J CMO. Prior to joining J&J, Dr. Morris spent 18 years at Merck where she was VP, Global Project Management. Dr. Morris received her PhD in Organic Chemistry and completed postdoctoral research in biochemistry.


Tuesday June 28, 2016 2:00pm - 3:15pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#238: Prescription Drug Marketing Regulatory Primer
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-528-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will provide a basic introduction to the regulation of prescription drug advertising and promotion. It will cover such important information as fair balance, required claim support, comparative claims, preapproval activities, and medical conventions.

Learning Objectives

Discuss important environmental forces and agencies impacting the regulation of prescription drug promotion; Apply advertising and promotional regulations to advertising/marketing materials; Explain the importance of reviewing FDA regulatory letters as they apply to these regulatory decisions.

Chair

Lucy Rose, MBA

Speaker

FDA Perspective
Thomas W. Abrams



Chair
avatar for Lucy Rose

Lucy Rose

President, Lucy Rose and Associates, LLC

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (OPDP), Food and Drug Administration. Before becoming Director of OPDP, Mr. Abrams was Director of the Division of Drug Marketing, Advertising, and Communications.


Tuesday June 28, 2016 2:00pm - 3:15pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

This CFAST session will focus on some of the innovative approaches being used to move towards E2E concept-based standards development and show the value these enhanced standards can bring for all stakeholders involved. Analysis elements (ADaM) and therapeutic area user guides (TAUGs) will also be discussed as well the therapeutic area (TA) Specification project which seeks to include TA metadata into the FDA standards catalogue.

Learning Objectives

Recognize the CFAST Initiative and the potential benefit of implementing these standards; Discuss some of the innovative approaches employed to move closer to E2E concept based data standards; Recall the FDA Therapeutic Area User Guide Specification project.

Chair

Rhonda Facile, MS

Speaker

CFAST Program Participation and the FDA Specification Project
Ron D. Fitzmartin, PhD, MBA

ADaM and Therapeutic Area User Guides: Current Thinking
Susan J. Kenny, PhD

Biomedical Concepts and End-to-End Metadata Development
Diane E. Wold, PhD



Chair
avatar for Rhonda Facile

Rhonda Facile

Vice President, Standards and Development, CDISC
Rhonda Facile has +25 yrs of clin research experience including monitoring, project management, outsourcing, planning and regulatory affairs. At CDISC she is CFAST Program Manager, a project that seeks to develop Therapeutic Area data standards.

Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Advisor, Office of Strategic Programs, CDER, FDA
Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at Daiichi Medical Research, and Exec Dir, Biostatistics and Data Management at Purdue Pharma L.P. Ron was elected President of the DIA 07-09. Ron received a PhD in... Read More →
avatar for Susan Kenny

Susan Kenny

President, Maximum Likelihood, Inc.
Susan is a biostatistician with 20 years of experience in research for public health and for the pharmaceutical industry. She has been active in CDISC since 2000 and is a senior team member of ADaM. Her areas of interest included CDISC implmentation strategies and graphical methods for statistics.
avatar for Diane Wold

Diane Wold

Director, Concept Modeling, CDISC
Diane Wold received her PhD in Statistics from UNC-Chapel Hill. She joined Burroughs Wellcome in 1984 as a project statistician held a variety of positions, leading to her current role in Data Standards at GSK. Since 2002, she has been active in CDISC, and currently provides consultation to the CDISC Therapeutic Area Standards program.


Tuesday June 28, 2016 2:00pm - 3:15pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

We will share practical experience and tips for addressing the compliance challenges for clinical solutions using cloud technology and auditing vendors of IaaS, PaaS, and SaaS services. Benefits, challenges, and possible remediation are discussed.

Learning Objectives

Identify infrastructure issues related to data integrity and system security for SaaS, IaaS, and PaaS services; Discuss audit compliance issues related to cloud based software solutions; Identify how to check for critical quality evidence based on 50+ audits of IT suppliers.

Chair

Teri Stokes, PhD, MS, MT

Speaker

Software as a Service (SaaS) and Cloud Provider Qualification: An Auditor's Perspective
Calvin H Kim, MS

Maintaining the Validation Status of Software as a Service (SaaS) in a Regulated Environment
Anu Virkar

Are You Cloud Compliant? Practical Considerations for Managing Clinical Data in the Cloud
Srinivas Karri, MSc



Chair
avatar for Teri Stokes

Teri Stokes

Director, Quality Assurance Compliance, Cytel Inc.
Dr. Stokes worked 11 years as a Medical Technologist in hospital, research, and central medical laboratories. Then 16 years at Digital Equipment Corporatin (DEC) first in the Large Computer Group, second in the Laboratory Data Products Group, and finally at DEC in Basel, Switzerland doing Computer Validation consulting across Europe. Since 1996 she has had her own computer validation consultancy GXP International. Author of 3 books and many... Read More →

Speakers
SK

Srinivas Karri

Director, Clinical Warehousing Cloud Strategy, Oracle Corporation
As an industry strategy lead for clinical data cloud based applications, I help identify, define and create new services to support management of clinical data using cloud based technologies and capabilities. I have over 20 years experience with developing, implementing, selling and supporting clinical data applications for a diverse set of life sciences companies.
avatar for Calvin Kim

Calvin Kim

Senior GxP IT Auditor, Bayer HealthCare Pharmaceuticals
Calvin is a seasoned IT auditor with over 20 years of experience in various sectors of GxP regulated industries. As a core member of a global QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technologies used in pharmaceutical, consumer health, animal health, and medical device sectors across a global organization, he has completed more than 100 evaluations and audits of IT... Read More →
avatar for Anu Virkar

Anu Virkar

Vice President, Quality and Compliance, Merge, eClinical An IBM Company
Anu Virkar, MS, MA, PMP is the VP of Q&C at Merge eClinical. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and med device industry for over 12 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She has obtained ISO9000 certification. Anu is well versed in regulatory guidelines that govern pharma &med device & has exceptional track record of... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.

Chair

Karin Van Baelen, PharmD

Speaker

FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc



Chair
avatar for Karin Van Baelen

Karin Van Baelen

Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those guidelines. In addition, she oversees the development of regulatory strategy for products from all therapeutic areas. Karin engages in policy development at national... Read More →

Speakers
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of... Read More →
avatar for Sean Tunis

Sean Tunis

Founder and Chief Executive Officer, Center For Medical Technology Policy (CMPT)
Sean Tunis, MD, MSc is the Founder, President, and Chief Executive Officer of the Center for Medical Technology Policy. CMTP’s main objective is to improve the quality and relevance of clinical research by providing a neutral forum for collaboration among experts, stakeholders and decision makers. He advises a wide range of domestic and international public and private health care organizations on issues of comparative effectiveness, evidence... Read More →
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist and cardiologist. Prior to coming to CDER in 2003, previous positions included director of a translational angiogenesis program at NHLBI, NIH; and Medical Officer... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-556-L04-P; CME 1.25; IACET 1.25; RN 1.25

Digital technology is being integrated with drugs, biologics, and devices in an effort to improve treatment monitoring and management. This session will examine regulatory challenges of these combinations from the perspective of industry and FDA.

Learning Objectives

Recognize FDA requirements for approval of combination products involving digital technology; Identify challenges faced by industry in developing these products and by FDA during their review; Describe how industry and FDA are addressing these challenges.

Chair

Todd Paporello

Speaker

Determining the Regulatory Classification of Software Used in Tandem with Pharmaceuticals
Bradley Merrill Thompson

Tool to Product: An Interactive Case Study in the Evolution of a Pharma App from Clinic to Commercial
Anthony D. Watson, MBA, MS

CDRH Perspective
Bakul Patel

Office of Combination Products Perspective
John Barlow Weiner, JD

CDER Perspective
Ashley Boam



Chair
avatar for Todd Paporello

Todd Paporello

Vice President and Head of North American Regulatory Affairs, Bayer HealthCare Pharmaceuticals
Todd Paporello is Vice President and Head of North American Regulatory Affairs Pharmaceuticals and Consumer Health. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche / Genentech and Merck / Schering-Plough. Todd holds pharmacy (PharmD) and business (MBA) degrees from Rutgers University and Fairleigh Dickinson University.

Speakers
avatar for Ashley Boam

Ashley Boam

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Ashley serves as acting Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including application review & inspection. Prior to joining CDER, Ashley spent nearly 20 years in the Center for Devices and Radiological Health. She holds bachelor's and... Read More →
avatar for Bakul Patel

Bakul Patel

Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical device software. He is the FDA liaison between the FCC and the ONC and chairs the International Medical Device Regulators Forum (IMDRF) "software as a medical... Read More →
avatar for Bradley Thompson

Bradley Thompson

General Counsel, Combination Products Coalition, Epstein, Becker and Green P.C.
BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Mr. Thompson also advises such companies on the unique aspects of combination product development and manufacturing.
avatar for Anthony Watson

Anthony Watson

Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in the Center for Devices and Radiological Health of the FDA He has a BS in Engineering from United States Naval Academy and a MBA and MS in Management Information... Read More →
avatar for John Weiner

John Weiner

Associate Director, Policy and Product Classification Officer, OCP, OC, FDA


Tuesday June 28, 2016 2:00pm - 3:15pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#243: Patient Involvement Today and Tomorrow: What’s in It for Patients?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-563-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patient engagement (PE) is the latest catch phrase in health care. But how can stakeholders apply it in a meaningful way? This forum will draw a picture of the PE landscape and trends and articulate a path forward to high value patient outcomes.

Learning Objectives

Identify the current patient engagement landscape by providing an overview of initiatives underway that are focused on meaningful patient involvement; Discuss general trends in patient engagement with respect to patient involvement through the research to care continuum, highlighting predictions for how this may impact future efforts; Examine the current and future impact of patient engagement efforts on patients’ life goals, quality of life, and desired clinical outcomes.

Chair

Marc M. Boutin, JD

Speaker

Panelist
Lode Dewulf

Panelist
Anton Hoos

Panelist
Graeme Johnston, CPA

Panelist
Isabelle Moulon, MD

Panelist
Theresa M. Mullin, PhD

Panelist
Bettina Ryll



Chair
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Chief Executive Officer of the National Health Council, an organization that brings together all segments of the health care community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers.

Speakers
avatar for Lode Dewulf

Lode Dewulf

Vice President and Chief Patient Affairs Officer, UCB
Lode Dewulf has a passion for patient perspectives and understanding. As medical practitioner he deeply realized that good health education was at least as important as good medicines. in 1989 he joined the pharmaceutical industry, to provide good education on diseases and new treatments. In 1999 he took a 1y sabbatical to co-found PlanetMedica, Europe’s first Healthcare internet portal. With now >25y of global pharmaceutical experience he... Read More →
avatar for Anton Hoos

Anton Hoos

Head of Medical Affairs, Amgen GmbH
Tony Hoos currently serves as the Chief of Medical for Amgen in Europe, which includes all therapeutic areas as well as all medical departments in Europe. Tony has been passionate about patient involvement in the development and life cycle of medicines for many years. He has worked extensively with stakeholders to involve patients in the benefit-risk assessment of medicines and he is one of the founders of ‘Patient Focused Medicines... Read More →
avatar for Graeme Johnston

Graeme Johnston

Patient and Member of the Advisory Board of PFMD
Graeme (63) is a retired partner of PWC in London, UK. He had cancer in 2001 and was diagnosed with Rheumatoid Arthritis in 2006. He retired in 2009. Since then he has been active in health and patient advocacy initiatives at a local and national level in the UK. When the PFMD initiative began Graeme was asked to join as an articulate patient from a different background. He is married with three sons aged from 28 to 15.
avatar for Isabelle Moulon

Isabelle Moulon

Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of Patients and Healthcare Professionals Department in December 2013. She is co-chair of the EMA patients’ and healthcare professionals working parties.
avatar for Theresa Mullin

Theresa Mullin

Director, Office of Strategic Programs, CDER, FDA
She leads a number of CDERs strategic initiatives including human drugs international program, data standardization, business informatics, lean management, development of benefit-risk and other decision support tools, program analysis and major user fee negotiations. Currently serving as FDAs lead negotiator for PDUFA 2017 reauthorization and the lead negotiator for the BsUFA 2017 reauthorization. She leads the FDA Patient Focused Drug... Read More →
avatar for Bettina Ryll

Bettina Ryll

Founder, Melanoma Patient Network Europe
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered risk/ benefit assessment tools. She lectures and advises on patient-centric drug development, member of ASCO and ISPOR and current chair of the ESMO Patient... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#244: Transforming Clinical Development Through Enterprise Quality Management
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Quality oversight throughout the clinical development life cycle is complex, crosses many functions, and can pose changes in seamlessly communicating and managing quality risks identified along the way. This session will discuss the role of executive leadership in driving and ensuring transparent communication about quality throughout an organization. Additionally, presenters will describe how their organizations have developed and implemented a enterprise quality management approach tailored to their particular context.

Learning Objectives

Identify the benefits of implementing a holistic, clinical-focused quality management system; Discuss how enterprise quality management can be tailored to an organization’s operating context; Recognize how executive leadership can drive a quality-focused culture and timely execution.

Chair

Ann Meeker-O'Connell, MS

Speaker

Executive Leadership Position on Quality
John Hubbard, PhD

Establishing a Quality Management System During Accelerated Growth of a Lean Operation
Coleen Glessner, MBA

Research and Development QA Integrated Quality Strategy: An Approach to Ensuring Quality and Managing Quality Risks Across the Drug Life Cycle
Kevin Grebner



Speakers
avatar for Coleen Glessner

Coleen Glessner

Vice President, R&D Quality and Compliance, Alexion
As Vice President, Head of Research and Development Quality and Compliance at Alexion, Coleen leads the establishment of a quality management system for R&D to assure the highest standards of Quality in ultra-rare diseases. Most recently, she has been focused on implementing sustainable processes and controls for Alexion’s accelerated growth while developing a culture of quality. She has a BS from the University of Pittsburgh and an MBA from... Read More →
avatar for Kevin Grebner

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie Inc.
Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has held various positions in a variety of organizations including Clinical Development, Clinical Outsourcing, and Drug Discovery. Kevin has a B.S. in Chemistry from... Read More →
avatar for John Hubbard

John Hubbard

President and Chief Executive Officer, BioClinica
Dr. Hubbard has held positions of increasing responsibility in the Pharmaceutical, SMO and CRO industries. In his current position as Global President of the Clinical Research Division for ICON plc, he has oversight of more than 4,400 employees conducting 360 projects in 55 offices and 32 countries


Tuesday June 28, 2016 2:00pm - 3:15pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#245: Risk-Based Inspections
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Inspections are a critical component for assuring product quality. The adoption of a risk-based approach to inspections has enabled the integration of product review with traditional inspection criteria and focuses efforts on inspection issues rather than simply on assurance of compliance. This session will highlight ongoing efforts and initiatives geared towards the continuing implementation of risk-based inspections.

Learning Objectives

Discuss related procedural and/or policy challenges and present specific case studies related to risk-based inspections; Identify best practices and ideas for future discussion with regard to risk-based inspections; Identify potential areas for further collaboration on risk-based inspections.

Chair

Mahesh R. Ramanadham, PharmD, MBA

Speaker

Quality Agreements: Defining the Business of Pharmaceutical Quality
Karen Bossert

Integrated Quality Assessment of the Manufacturing Process and Facilities
Robert Iser, MS



Chair
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Division Director (Acting), Div. of Inspectional Assessment, OPF, OPQ, CDER, FDA
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD from the University of Maryland and his MBA from the University of Baltimore. Prior to FDA, he had experience in the generic pharmaceuticals industry. He continues... Read More →

Speakers
KB

Karen Bossert

Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. | Karen has authored and presented numerous papers and courses in freeze drying. She currently teaches a course on Validation of Lyophilization at the PDA-TRI.
avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA, Bob spent 7 years in the pharmaceutical industry with experience related to management of quality systems, method development, and support of manufacturing process... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#246: Valuing the Signal and the Noise in Health Care Horizon Scanning
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

Horizon scanning is a method for identifying and monitoring interventions and innovations that have potential to impact clinical care, patient outcomes and the broader health care system. Dedicated horizon scanning programs focused on American and international markets function as publicly available tools useful for setting research agendas; planning regulatory and coverage/payment decisions; and providing early alerts to patients, clinicians, and health technology assessors. In this forum, representatives from American- and European-based horizon scanning efforts will demonstrate how both hits (early captured innovations with major impacts) and misses (e.g., non-identified interventions, non-impactful interventions), and the broader horizon scanning system methodology can provide a useful view of emerging technologies and the future health care landscape.

Learning Objectives

Identify horizon scanning resources and findings; Describe uses for horizon scanning findings by research funders, technology assessment organizations and coverage/payer groups; Describe the use of horizon scanning for understanding the larger landscape of innovation in a variety of clinical areas.

Chair

Christian Cuevas, PhD

Speaker

Horizon Scanning Systems: Comparison of US and International Systems
Diane Robertson

Panelist
Elise Berliner, PhD

Panelist
Christian Cuevas, PhD



Chair
avatar for Christian Cuevas

Christian Cuevas

Senior Clinical Analyst, Health Technology Assessment Group, ECRI Institute
Clinical Analyst at ECRI Institute | I worked on the Horizon Scanning program following the clinical development of close to 200 emerging oncology interventions and determining their potential to have an impact on the healthcare system. | Postdoctoral Fellow at University Pennsylvania | Studied immune responses against Arenaviruses in cell culture and mouse models. | PhD. in Molecular Biology, Princeton University | B.S. in Biology, National... Read More →

Speakers
EB

Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Elise Berliner, Ph.D., is the Director of the Technology Assessment Program at AHRQ which provides technology assessments to Medicare to inform coverage decisions and other policy issues. Prior to joining AHRQ, Dr. Berliner worked as a consultant on cost-effectiveness and outcomes research and in research and development at medical technology companies. She was a Congressional Fellow at the Office of Technology Assessment. Dr. Berliner received... Read More →
avatar for Diane Robertson

Diane Robertson

Director, Health Technology Assessment, ECRI Institute
Served as ECRI Institute's project manager for the AHRQ Healthcare Horizon Scanning Program for 5 years. More than 30 years (including 22 with ECRI Institute’s Health Technology Assessment program) leading projects, health technology research and analysis, writing, and publishing health technology information for healthcare professionals and consumers, including health technology forecasting, horizon scanning, and technology assessment.


Tuesday June 28, 2016 2:00pm - 3:15pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#247: Fit for Purpose and Modern Validity Theory in PROs
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-575-L01-P; CME 1.25; IACET 1.25; RN 1.25

Fit for purpose is an important consideration in patient-reported outcomes (PROs). This session will provide an overview of current validity theory and the thinking on the idea of fit for purpose, and situate the concept of fit for purpose within the broader topic of validity.

Learning Objectives

Articulate key concepts in modern psychometric validity theory; Describe the notion of fit for purpose as it relates to patient/clinician reported outcomes.

Chair

R.J. Wirth, PhD

Speaker

Current Thinking in Validity Theory
Jonathan D Rubright, PhD, MSc

Validity: US Regulatory Considerations
Ashley F. Slagle

How Does Fit for Purpose Fit in Validity Theory?
Michael Edwards, PhD, MA



Chair
avatar for R.J. Wirth

R.J. Wirth

President, Vector Psychometric Group, LLC
R.J. Wirth is President and managing partner at VPG. He trained in the L. L. Thurstone Psychometric Lab, receiving his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research focuses on modern psychometrics with an emphasis on measurement invariance in longitudinal models. He has published numerous book chapters and journal articles appearing in outlets such as Health Psychology, Medical Care... Read More →

Speakers
ME

Michael Edwards

Managing Partner, Vector Psychometric Group, LLC
Michael C. Edwards is a managing partner at VPG. He earned his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research is generally focused on modern psychometrics with specific emphases on item response theory, factor analysis, and computerized adaptive testing. Dr. Edwards is also an Associate Professor in the quantitative area of the Department of Psychology at The Ohio State University.
avatar for Jonathan Rubright

Jonathan Rubright

Psychometrician, National Board of Medical Examiners
As psychometrician at the National Board of Medical Examiners, Jonathan shoulders operational responsibility for high-stakes medical exams and leads exam-related research. Prior to NBME, he worked at AICPA and also evaluated tests to support research on human subjects with impaired cognition. His unique background in medicine, measurement, and certification/licensure allows him to manage tensions between methodological rigor, practical... Read More →
avatar for Ashley Slagle

Ashley Slagle

Scientific and Regulatory Consultant, Aspen Consulting, LLC
Dr. Slagle is a consultant who provides scientific and regulatory advice to drug product developers on patient centered drug development. Formerly with the US FDA Clinical Outcome Assessment (COA) Staff, her experience includes over 15 years of policy analysis and outcomes research, including COA development, implementation, and analysis to evaluate treatment benefit for regulatory purposes. She received her PhD in Pharmaceutical Health... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#248: Mind the Gaps: The Science of Designing, Implementing, and Evaluating Benefit-Risk Communication for Medicinal Products
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-580-L04-P; CME 1.25; IACET 1.25; RN 1.25

Effective benefit-risk communication is central to ensuring safe and appropriate use of medicinal drug products. Additionally, regulatory authorities across the globe are now demanding evidence of the effectiveness of risk communication measures included as part of formal risk management programs. Currently, however, the design, dissemination and application of best practices in benefit-risk communication have been limited. This forum seeks to highlight the main gaps in the design, implementation, and evaluation of benefit-risk communication for medicinal products, to identify best practices in those areas, and to explore ways to reduce those gaps moving forward.

Learning Objectives

Identify the main facilitators and barriers in the design of current benefit-risk communications; Describe the key gaps in the translation and implementation of benefit-risk communication best practices into real-world practices (e.g., at the community level, and across cultures, health care systems and regulatory authority jurisdictions); Discuss the major gaps in the evaluation of risk communication, and how these gaps can be effectively addressed.

Chair

Meredith Y. Smith

Speaker

Communicating Risk Information to Patients: Gaps in Current Approaches and How Health Literacy and Information Orientation Measures Can Improve Effectiveness
Kristina Birnbrauer, PhD

Gaps and Best Practices in Designing Risk Minimization Communication Campaigns
Elaine H Morrato, DrPH, MPH

Evaluating Effectiveness of Benefit-Risk Communication
Gerald J. Dal Pan, MD



Chair
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Dr. Meredith Smith is Global Risk Management Officer in the Global Patient Safety department at Amgen. She is a social and behavioral scientist by training and has worked in the industry for approximately 15 years. She served on the CIOMS IX Working Group on Risk Minimization Toolkit and is currently the Risk Communication Co-Chair of the Benefit-Risk Assessment, Communication and Evaluation (BRACE) SIG of the International Society for... Read More →

Speakers
avatar for Kristina Birnbrauer

Kristina Birnbrauer

Sr. Research Consultant, MSP Analytics
Kristina Birnbrauer is a health communication and research professional with expertise in patient and healthcare provider education and health behavior interventions. Kristina found her niche after a life-threatening mosquito borne virus in 2010. She is experienced in study and survey design, analysis and interpretation. Her background in professional and interpersonal communication informs the health behavior and patient-centered research she... Read More →
avatar for Elaine Morrato

Elaine Morrato

Associate Dean for Public Health Practice, Colorado School of Public Health
Elaine Morrato, DrPH MPH is the Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into clinical practice. Dr. Morrato has contributed her expertise in numerous FDA advisory committee meetings on issues of drug safety and risk management. She also directs the Pragmatic Trials and Dissemination and Implementation Science program in the Colorado... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins. He trained in Internal Medicine at the Hospital of the Univ of Pennsylvania, and in Neurology at Johns Hopkins. He is board certified in Internal Medicine and Neurology.


Tuesday June 28, 2016 2:00pm - 3:15pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#249: Current Topics for Pharmacovigilance in Japan
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Did you know that Japan has a relief system for adverse reactions which makes payments to patients who have suffered adverse reactions during use of drugs for their approved indications? Are you aware of the many actions taken recently in Japan for under-reporting or missed reporting of adverse reactions by domestic and foreign-headquartered pharmaceutical companies? Do you struggle to understand the requests of your Japanese partners and colleagues related to managing pharmacovigilance and adverse reaction report exchange in that country? Have you ever been overwhelmed by solicited cases from Japanese observational studies or had trouble interpreting the results of all-case surveillance studies from that country? This session aims to give a full background on the postmarketing surveillance system in Japan including the re-examination and re-evaluation systems, the role of observational studies and the current practices in risk management. The session will also examine recent cases of non- or under-reporting of ICSRs and the possible connection between complexity of PV regulation, the multitude of ways in which safety information can reach pharmaceutical companies and unintentional noncompliance with reporting regulations. Finally, since 1980 Japan has had a Fund for Relief Services for Adverse Drug Reactions. The details of the system and how it serves as a safety net will be described.

Learning Objectives

Discuss how the complexity of pharmacovigilance regulation can be a factor in non- or under-reporting of ICSRs; Describe the regulatory and legal context for pharmaovigilance in Japan; Recognize the different varieties of Japanese postmarketing observational studies and how they are performed; Interpret Japanese pharmacovigilance regulations and expectations; Explain the Relief System for Adverse Reactions in Japan, how it operates and is funded, and its practical effects on patients.

Chair

Stewart Geary, MD

Speaker

Observational Studies in Japan and Asia
Stewart Geary, MD

Relief Services in Occurrence of Serious Adverse Drug Reactions
Naohiro Otaki

Root Cause Analysis of and Solutions for Under Reporting Safety Information of ICSRs in Clinical Research and Sales Activities
Teiki Iwaoka, PhD, MS



Chair
avatar for Stewart Geary

Stewart Geary

Senior Vice President, Chief Medical Officer, Eisai Co., Ltd.
Stewart Geary has worked at Eisai since 1996 in PV, clinical safety and regulatory science. He was a member of the CIOMS VII, VIII and IX Working Groups, and currently serves on the Executive Committee of JAPhMed and the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical Medicine. He is also the content editor for Safety and Pharmacovigilance for the DIA Global Forum.

Speakers
avatar for Teiki Iwaoka

Teiki Iwaoka

Executive Consultant, Director of Drug Safety Outsourcing Planning, CAC Croit Corporation
Drug Safety & Pharmacovigilance expert. EWG for ICH E2B, and Rapporter for ICH E2D. Lecturer of many educational seminars worldwide more than 20 years. Executive Consultant, and Auditors for Global Pharmacovigilance Compliance.
avatar for Naohiro Otaki

Naohiro Otaki

Technical Officer, Application Review Division I, Office of Relief Funds, Pharmaceuticals and Medical Devices Agency (PMDA)
Technical officer of PMDA since Feb.2010 and technical officer of Office of Relief Funds of PMDA since Jan. 2014.


Tuesday June 28, 2016 2:00pm - 3:15pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, we will discuss open-label, delayed-start studies and open-label extension studies that are conducted to evaluate safety and efficacy. A statistician will describe delayed-start study designs and an epidemiologist will discuss when such studies are needed, and the interpretation of study findings. An ethicist will identify the ethical aspects of these study designs and their conduct.

Learning Objectives

Explain the objectives of open-label, long-term extension studies; Describe the role and design of delayed-start studies and single-arm extension studies in the evaluation of efficacy and safety; Discuss ethical considerations when designing and conducting open-label, long-term extension studies.

Chair

Lisa A Kammerman, PhD, MS

Speaker

Delayed-Start Study Design and Analyses for Demonstrating Disease Modification
Scott Andersen, MS

Bioethics of Open-Label Extension Studies
Robert M Nelson

When, if Ever, Open-Label Extension Studies Are Needed and Appropriate (and What Are the Alternatives)?
Jesse Aaron Berlin, DrSc



Chair
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Science Director in the Advanced Analytics Center at AstraZeneca. She consults on complex study designs and statistical innovation projects, and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she led the Office of Biostatistics’ Clinical Outcome Assessments program. In that role, she helped develop policy for the design, analysis, and interpretation of... Read More →

Speakers
SA

Scott Andersen

Principal Research Scientist, Eli Lilly and Company
Scott has been a statistician designing and analyzing neuroscience clinical trials for nearly 20 years. While most of his research has focused on depression and schizophrenia disease states, Scott has spent the last five years working on Alzheimer's Disease. In 2015, Scott co-authored two Delayed Start manuscripts with Hong Liu-Seifert.
avatar for Jesse Berlin

Jesse Berlin

Vice President and Global Head of Epidemiology, Johnson & Johnson
Jesse Berlin is Vice President of Epidemiology at Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He joined J&J over 11 years ago after spending 15 years at University of Pennsylvania, where he was a Professor of Biostatistics. He has authored or coauthored over 250 peer-reviewed publications in a wide variety of clinical and methodological areas, including papers on the study of meta-analytic methods as... Read More →
avatar for Robert Nelson

Robert Nelson

Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric Therapeutics, OC, FDA
Robert “Skip” Nelson, M.D., M.Div., Ph.D. is currently the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. Prior to joining FDA full-time in 2009, he was Professor of Anesthesiology, Critical Care and Pediatrics at The Children’s Hospital of Philadelphia and University of Pennsylvania School of Medicine.


Tuesday June 28, 2016 2:00pm - 3:15pm
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#251: Embracing Virtual Training Solutions in 2016: Focus on Performance!
Component Type: Workshop
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

In today’s global clinical research framework, delivering face-to-face training, is not always an option. This workshop explores the solutions that webinars and virtual classrooms provide for the stated learning objectives as well as the desired stakeholder performance outcomes after the training.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Differentiate between webinar and virtual classroom training delivery methods for investigator meetings, employee training and development; Discuss best practices, challenges and successes with webinar and virtual classroom instructional design, methods, and tools; Identify three attributes of webinars and virtual classrooms that promote employee engagement and learning, as well as the associated activities that support organizational performance goals.

Chair

Liz Wool, BSN