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Preconference Tutorial [clear filter]
Sunday, June 26
 

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

Executive Director, Regulatory Consulting and Submissions, INC Research
Elaine B. Taylor is Global Head of Regulatory Consulting and Submissions at INC Research responsible for leading a global team of regulatory professionals providing consultation, development, and management of regulatory interactions and submissions for sponsors. With over 25 years... 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... 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... Read More →
avatar for Daniel Liu

Daniel Liu

Chief Science Officer, Beijing Clinical Service Center
Daniel Liu, PhD, has served for more than two decades in global clinical research departments, in both management and operations, for such multinational drug companies as Novartis, Pfizer, Sanofi, Schering-Plough, Johnson & Johnson, and Medidata. Dr. Liu has served as Core Expert... 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... 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... 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 has been in the pharmaceutical industry working in drug safety for over 30 years. He started his career at Genentech and led the drug safety departments at a number of subsequent companies, Gilead Sciences, Tularik and Nuvelo, before serving as the head of the medical... 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... Read More →


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

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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... 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... 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... Read More →


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... Read More →
avatar for Saad Shakir

Saad Shakir

Director, Drug Safety Research Unit
Saad Shakir is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines. He has worked and... Read More →


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... Read More →
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... Read More →
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... 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... Read More →


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
avatar for Ronald Bartek

Ronald Bartek

Co-Founder/Founding President, 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... Read More →
avatar for Linda Deal

Linda Deal

Head of Patient-Centered Outcomes Measurement, Pfizer Inc.
Linda currently serves as PCOA Lead working across Pfizer’s therapeutic categories addressing efforts to develop, validate and use COAs as endpoints for providing evidence of medical treatment benefit differentiation, labeling and value. Linda has served patients and the pharmaceutical... Read More →
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... Read More →
avatar for Jonathan Goldsmith

Jonathan Goldsmith

Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Dr. Goldsmith is Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to federal service, he was a tenured professor in academia and focused on clinical drug development in regulated industry, at NHLBI/NIH and at orphan disease foundations. He earned his... Read More →
avatar for David Schubert

David Schubert

Vice President of Regulatory and Quality, Stealth BioTherapeutics
David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of experience... Read More →


Sunday June 26, 2016 9:00am - 5:00pm
112AB 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
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →


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... Read More →
avatar for Lisa Peluso

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group
Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals... 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 40 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... Read More →


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... Read More →
avatar for Catherine Sigler

Catherine Sigler

Executive Director, Safety, Epidemiology, Registries, and Risk Management (SERRM, 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... Read More →
avatar for Annette Stemhagen

Annette Stemhagen

SVP & Chief Scientific Officer, UBC
Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management within... Read More →


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... Read More →


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... Read More →
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... Read More →


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