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Sunday, June 26
 

8:30am EDT

#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 EDT
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 08: Reg Affairs, Tutorial
 
Monday, June 27
 

8:30am EDT

#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, Ph.D., PMP, is Director, Global Project and Alliance Management at Merck, where she has been a Project Manager for 15 years. She has managed multiple development programs from early to late stage, including several NDA submissions leading to successful product approvals... 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... Read More →
avatar for Susan Uptain

Susan Uptain

Head of Regulatory Affairs Operations, Baxalta
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... 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... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Forum

8:30am EDT

#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, 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

Manager, Clinical Trial Management, Eli Lilly and Company
Carrie is a Manager with Eli Lilly and Company overseeing Clinical Trial Managers on Oncology trials. 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... Read More →
avatar for Bill Hanlon

Bill Hanlon

Chief Development Officer and Head of Global Regulatory Affairs, Covance Inc.
Dr. William Hanlon, PhD, is the chief development officer and head of global regulatory affairs for Covance. He has been with Covance for four and a half years, after spending 25 years in pharma in the discovery and the development side of developing drugs for global commercialization... Read More →


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

10:45am EDT

#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... Read More →

Speakers
avatar for Charu Gautam

Charu Gautam

Senior Medical Director, IQVIA
Charu Gautam is a Physician with over 20 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 and a board certification in Clinical Pharmacology . She is also a lead faculty... Read More →
avatar for Andrew Melli

Andrew Melli

Senior Manager, SOUSEIKAI Global Clinical Research Center
Andrew Melli is the Senior Manager of Global Clinical Development at SOUSEIKAI Global Clinical Research Center, serving as both liaison for international business development and investment, as well as an active member of the clinical trial team. It is his hope to help bridge the... Read More →
avatar for Maria João Queiroz

Maria João Queiroz

Global CEO, 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... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

10:45am EDT

#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
Sara graduated with her PharmD from Butler University and then completed the Purdue University/Eli Lilly and Company Drug Information Residency. She then accepted a role with Global Medical Information (GMI) at Lilly. Sara spent several years supporting numerous products/therapeutic... 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... 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... 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... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

2:00pm EDT

#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... Read More →

Speakers
DL

Dominique Lagrave

Director, Global Regulatory Affairs and Safety Operations, Amgen
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... Read More →
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... Read More →


Tuesday June 28, 2016 2:00pm - 3:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model/Outsourcing, Session

4:00pm EDT

#259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies
Limited Capacity seats available

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

The session provides an overview of outsourcing models for regulatory activities to achieve a scalable, flexible model, while decreasing the complexity of internal regulatory affairs activities and assuring full regulatory compliance. Both industry and consultant company perspectives will be shared.

Learning Objectives

Describe the benefits of outsourcing of regulatory activities to allow focus on core strategic aspects of the company; Recognize different models of outsourcing of regulatory activities and how to best apply them to your own business; Identify the key success factors to ensure cost efficient and compliant outsourcing.

Chair

Andrew S. Verderame

Speaker

Regulatory Outsourcing: Consultant Perspective
Andrew S. Verderame

Regulatory Outsourcing: Industry Perspective
Dietmar Boecker, PhD

Outsourcing Life Cycle Management: A Model of Efficiency
Alistair Davidson



Chair
avatar for Andrew Verderame

Andrew Verderame

President, Pharmalex US Regulatory
Andrew S. Verderame, MBA, RAC leads the PharmaLex US staff in providing FDA-specific regulatory guidance and consulting services. PharmaLex clients benefit from his wealth of experience, including leading well over one hundred meetings with FDA, managing multi-site regulatory teams... Read More →

Speakers
avatar for Dietmar Boecker

Dietmar Boecker

Vice President, Head Regulatory Affairs, Established Products and Intl Dev, Bayer Pharma AG
since 01.01.2016: VP, Head RA Established Products and Int. Development, Bayer Pharma AG 01.12.2012 - 31.12.2015 Director, RA Marketed Products, Bayer Pharma AG 01.09.2007 - 30.11.2012 Deputy Director Global Submission Management & Archiving, Bayer AG 01.08.2001 - 31.08.2007 Associate... Read More →
avatar for Alistair Davidson

Alistair Davidson

Senior Director, Delivery Solutions, Regulatory Affairs, PPD
Alistair is Senior Director, Regulatory Delivery Solutions at PPD, where he is responsible for country regulatory management and strategic development of PPD’s regulatory services globally. He has held senior leadership roles in regulatory affairs in GSK and Quintiles, with a track... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model/Outsourcing, Session

4:00pm EDT

#270: Implementing Knowledge Management: Industry Perspectives
Limited Capacity seats available

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

This session will discuss how knowledge management is a pivotal systematic element of life cycle management. The use of prior knowledge in risk assessments in the design, development, and maintenance of product quality as well as the justification for changes is predicated on robust knowledge management systems that integrate information and data from multiple sources.

Learning Objectives

Discuss the role knowledge management plays in the design, development, and maintenance of product quality.

Chair

Paige Kane

Speaker

Think Big but Start Small: The Evolution of Knowledge Management at a Large Pharmaceutical Company
Jodi Schuttig, MBA

CMC Data Readiness and Future Proofing for IDMP
Kim S. Northam

Why Wonder When You Can Know?
James Roberts, PhD



Chair
avatar for Paige Kane

Paige Kane

Regulatory Science Researcher/ Director KM CoE, Dublin Institute of Technology/ Merck & Co., Inc.
Paige Kane, CPIP, is the Director of Knowledge Management Pfizer Global Supply/ Global Technology Services. Ms. Kane is responsible for developing and implementing the Knowledge Management Strategy for Pfizer Global Supply (PGS) with a strong focus on people, processes and collaboration... Read More →

Speakers
avatar for Kim Northam

Kim Northam

Manager, Regulatory Affairs, Accenture Accelerated R&D Services
Kim has ten years’ experience in CMC and has managed various projects from complex in licencing activities, to compliance and remediation, and also process transformations. Through her tenure at Accenture Kim has helped companies improve their CMC data management ensuring timely... Read More →
avatar for James Roberts

James Roberts

Head, Platform Analysis, GlaxoSmithKline
James Roberts leads a team of scientists, engineers and compliance experts to embed data integrity, data quality and compliance into analytical testing processes in real-time. He founded Allotrope Foundation in 2012 with colleagues from other pharma companies and is using the Allotrope... Read More →
avatar for Jodi Schuttig

Jodi Schuttig

Director, Knowledge Management, Merck & Co., Inc.
Jodi Schuttig, Director of Knowledge Management in the Merck Manufacturing Division, has over 25 years of experience in the phar¬maceutical sector through various roles at Merck. Jodi holds a B.S. in Mechanic Engineering and a M.B.A. in Business Administration. In 2013 Jodi joined... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session

4:00pm EDT

#275: Creating a Competency-Based Onboarding and Learning Program on a Budget
Component Type: Workshop
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

The competitive talent landscape demands effective investment in onboarding and employee development. Workshop participants will design a departmental-level onboarding program and individual learning plan using an industry competency model.

**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

Examine the life sciences industry competency model for organizational adoption and implementation; Identify approaches for development of a department-employee level onboarding program that is a right fit for the organization; Evaluate industry lessons learned in implementing individual employee learning plans-competency models.

Chair

Patterson Shafer

Speaker

Create an Onboarding Curriculum That Fits Your Budget
Liz Wool, BSN



Chair
PS

Patterson Shafer

Specialist Leader, Deloitte Consulting LLP
Pat is a specialist leader in Deloitte Consulting’s Life Sciences group with more than 30 years of consulting experience. During his career, he has led dozens of learning and development initiatives, including curriculum design, competency model development, running train the trainer... Read More →

Speakers
avatar for Liz Wool

Liz Wool

Global Head of Training, Barnett International
Liz Wool CCRA, CID, CMT, is Global Head of Training at Barnett International, an education, training and consulting company. Liz possesses 26 years in the product development industry and 37 years in the healthcare industry. Liz's expertise is in clinical research, operations strategy... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop

4:00pm EDT

#277: PMDA Town Hall
Limited Capacity seats available

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

The progress of the Pharmaceuticals and Medical Devices Agency (PMDA) International Strategic Plan 2015, which was announced after the success of shortening the review period for medicines products, will be presented and will include audience Q&A.

Learning Objectives

Discuss the latest Pharmaceuticals and Medical Devices Agency's (PMDA) activities and direction on Japanese pharmaceutical regulation; Recognize the PMDA’s challenges under the international regulatory environment.

Chair

Toshiyoshi Tominaga

Speaker

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Tomiko Tawaragi

Panelist
Nobumasa Nakashima, PhD



Chair
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →

Speakers
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)
Dr. Nakashima joined Pharmaceutical and Food Safety Bureau of Ministry of Health, Labor, and Welfare in 1992. He spent his career in the international field such as at WHO and OECD, not only in the domestic field. He has been Director of the Office of International Programs, PMDA... Read More →
avatar for Tomiko Tawaragi

Tomiko Tawaragi

Chief Safety Officer, Pharmaceuticals and Medical Devices Agency (PMDA)
Ms.Tomiko Tawaragi is in position of the Chief Safety Officer of PMDA since July 2014. She is responsible for post-marketing safety measures and GMP/QMS for pharmaceuticals and medical devices. She spent most of her careear as a technical officer of Ministry of Health, Labour and... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 18: Global Regulatory, Forum
 
Wednesday, June 29
 

10:30am EDT

#320: Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 0.50; IACET 0.50; RN 0.50

Design thinking is a customer-centric approach designers use to solve complex problems. A design mindset is focused on solutions, starting with the perspective of the end-user-and their needs. This session will provide a brief introduction to design thinking, describe its benefits and potential applications to clinical development, and provide a brief example of how one company applied the methodology. The session will be followed by an Engage and Exchange session where participants will apply design thinking concepts hands on.

Learning Objectives

Recognize the basics of design thinking; Describe the case for applying the design thinking methodology in clinical development; Identify areas in which design thinking could be applied in clinical development to enhance trial success and the participant experience.

Chair

Patricia Leuchten


Chair
avatar for Patricia Leuchten

Patricia Leuchten

Chief Executive Officer and President, The Avoca Group
Patricia Leuchten has more than 25 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing and strategic alliances. In 1999, she founded The Avoca Group, a consulting and research firm specializing in clinical outsourcing, alliance... Read More →

Wednesday June 29, 2016 10:30am - 11:00am EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT-GCP, Session

10:30am EDT

#309: Global Stakeholder Management: Across the Ocean Between East and West
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000188; RN 1.25

In this forum, participants will learn and discuss practical techniques and tips for global stakeholder management, such as identification of key stakeholders. The focus will be on West-East hybrid R&D organizations.

Learning Objectives

Discuss practical advantages/limitations of stakeholder management implementation; Identify key success factors in global stakeholder management in pharmaceutical R&D; Describe ideas for effective implementation of global stakeholder management.

Chair

Atsushi Tsukamoto

Speaker

Panelist
Robert A. Hilke, MA

Panelist
Gareth Julian Monteath



Chair
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Vice President, New Drug Regulatory Affairs, Daiichi Sankyo Co., Ltd.
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →

Speakers
avatar for Robert Hilke

Robert Hilke

Chief Executive Officer, Hilke Communications Corporation
Robert Hilke is the CEO of Hilke Communications Corporation, a firm specializing in providing intercultural communications and TOEIC training for global businesspeople, many of whom work in the pharmaceutical industry. Mr. Hilke's primary research interest is the management of diverse... Read More →
avatar for Gaz Monteath

Gaz Monteath

Executive Director, Link Global Solution Inc.
Dr. Gareth ("Gaz") Monteath is Executive Director at Link Global Solution Inc., an HR and OD consulting firm based in Tokyo. In his position, Gaz is responsible for the overall content and quality of programmes. LGS has long experience of working with pharmaceutical and medical instruments... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj/Port Mgt/Strat Planning, Forum

10:30am EDT

#311: Outsourcing: Assessing CRO Performance and Challenges
Limited Capacity seats available

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

Outsourcing has been a major topic in the pharmaceutical industry over the last decade. As drug development costs increase, trial complexity grows, and work in emerging markets becomes more important, the industry has looked toward outsourcing to help combat these challenges. But what impact has the rising proportion of outsourcing had on operational performance? How is the effect being measured or tracked? This panel will explore the dynamic between CROs and sponsors and their expectations, the operational benefits of outsourcing, as well as the challenges from outsourcing. It will examine performance and the crucial factors that influence internally-conducted trials versus outsourced trials, how these differences are being managed, and what changes have occurred over time.

Learning Objectives

Recognize the operational benefits and challenges of outsourcing clinical trials; Classify the different approaches to outsourcing and the strategic trade-offs.

Chair

Scott R Martin, JD

Speaker

Creating an External Alliances Structure
John F. Kurtz

How Real World Research Challenges Outsourcing Strategies
Michael George Minor

Controlling Study Level Budgets with CROs
Michael Williamson, MSc



Chair
avatar for Scott Martin

Scott Martin

Principal, KMR Group Inc.
Scott Martin is a Principal of KMR Group a firm specializing on biopharmaceutical R&D performance, information and analytics. Among Scott’s areas of expertise are: clinical development performance, resource management, assessing efficiency and productivity in R&D, and implementing... Read More →

Speakers
avatar for John Kurtz

John Kurtz

Senior Director, External Alliances, Janssen R & D, LLC
John is Senior Director, External Alliances for Janssen Pharmaceutical Companies of Johnson & Johnson. His primary focus is to drive value creation and R&D effectiveness by optimizing collaborations with Key R&D Strategic Suppliers. John has over 25 years’ experience building and... Read More →
avatar for Michael Minor

Michael Minor

Senior Vice President, Global Head Operations and Strategic Planning, ICON Peri-Approval and Observational Research
Michael Minor is SVP, Global Head, Peri-Approval & Observational Research at ICON. Mike has >30 years’ experience leading Phase I-IV and non-interventional research, and as outsourcing professional in pharma companies and CROs giving him a balanced perspective of sponsor/provider... Read More →
avatar for Michael Williamson

Michael Williamson

Associate Director Outsourcing and Contracts Management, UCB Biosciences, Inc.
Mike has been with UCB for over seven years serving as a sourcing and procurement professional implementing innovative sourcing models, vendor strategic partnering arrangements, and spending improvement analysis focused on clinical research. Mike is currently Associate Director and... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Session

10:30am EDT

#315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My!
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-549-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum will examine how the international regulatory community is responding to the challenge of pediatric product development (limited access to patients) with alternative strategies to generate meaningful data and enhance program efficiency.

Learning Objectives

Discuss the unique challenges and opportunities associated with development of therapies for pediatric populations; Describe how stakeholders can work together to improve the development of, evaluation of, and application of innovative strategies that will advance pediatric product development; Identify opportunities to translate policy into advances for the field of pediatric drug development.

Chair

Christina Bucci-Rechtweg, MD

Speaker

FDA Perspective
Lynne P. Yao, MD

FDA Perspective
Mary Dianne Murphy, MD

Health Canada Perspective
Ariel E. Arias

Panelist
Jordi Llinares Garcia



Chair
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Pediatric and Maternal Health Policy, Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 16 yrs of experience in Clinical Development and Regulatory Policy... Read More →

Speakers
avatar for Ariel Arias

Ariel Arias

Senior Advisor, Centre for Biologics Evaluation, BGTD, Health Canada
Dr Arias has many years of experience in the assessment of drug products. He has provided expert advice for a number of drug safety regulatory initiatives and represented Health Canada in various international drug regulatory technical committees (e.g., ICH, PAHO). He is an adjunct... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in... Read More →
MM

Mary Murphy

Director, Office of Pediatric Therapeutics, Office of Special Medical Programs, FDA
Dianne Murphy, MD, FAAP, is Director of the Office of Pediatric Therapeutics (OPT) Office of the Commissioner at FDA. Dr. Murphy was a medical officer at Bethesda Naval; Dir. of the virology laboratory at the U. of Tenn., Knoxville & tenured Professor at the U. of Florida, Jacksonville... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

2:00pm EDT

#333: Hearing the Patient Voice in Pharma and What Patients Want You to Know
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-517-L04-P; CME 1.25; IACET 1.25; RN 1.25

Are you considering creating a position for a director of patient engagement but have no idea where to start? Or do you just want to know more about what patients think about your drugs and what they want you to know? Learn how to do it from industry executives who have spent their time learning about patients and putting programs in place to advance advocacy efforts. They will also share real-world examples of pharma programs and experiences involving the patient voice.

Learning Objectives

Explain why it is important to have a director of patient engagement; Describe how to create the position, what the primary responsibilities should be, what the biggest challenges are in creating it, including how to overcome them; Discuss how to determine what patients think of your drug and efforts, what they are saying about it, and what they want you to know.

Chair

Ed Miseta, MBA

Speaker

Panelist
Roslyn F Schneider

Panelist
Beverly L Harrison

Panelist
Eric J. Peacock, MBA



Chair
avatar for Ed Miseta

Ed Miseta

Editor, Life Science Connect
Ed is the chief editor for the website Clinical Leader and a contributing editor to Life Science Leader magazine. He covers the latest trends, challenges, innovations, and best practices in the conduct of clinical trials. He has a BS in Business Economics and an MBA, both from The... Read More →

Speakers
avatar for Beverly Harrison

Beverly Harrison

Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
Leading the Patient Support Group @ Janssen R&D (a J&J Co.), reporting directly to the Chief Medical Officer, Beverly focuses on developing strategies for patients’ needs by working with internal/external stakeholders & engaging patient advocacy organizations. She is a R&D & nonprofit... Read More →
avatar for Eric Peacock

Eric Peacock

Co-founder and Chief Executive Officer, MyHealthTeams
Eric Peacock is the CEO of MyHealthTeams. Eric cofounded MyHealthTeams with the belief that if you are diagnosed with a chronic condition, it should be easy to find the best people around to help you. To date MyHealthTeams has launched social networks in 24 different chronic conditions... Read More →
avatar for Roslyn Schneider

Roslyn Schneider

Global Patient Affairs Lead, Pfizer Inc
Roz leads Global Patient Affairs at Pfizer, a hub of patient centricity, driving integration of patient experiences and perspectives across the company and the product lifecycle. She held roles in Medical Affairs, Medical Strategy and Medicine Development for twelve years at Pfizer... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#336: Effect of International Reference Pricing on Planning for Global New Product Launches
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-597-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000184; RN 1.25

As more countries adopt cost containment strategies, it becomes increasing difficult to plan and execute successful, global launches of new drugs. This session will provide an overview of how to plan a successful launch given these challenges.

Learning Objectives

Identify the variables which influence the price of new drugs; Explain how international reference pricing affects optimal launch sequence; Recognize the other considerations (e.g., country scope, intellectual property, clinical plan) when planning a successful launch.

Chair

Matthew Steven Curin, PharmD

Speaker

What Every Project Manager Should Know about HTA and Pricing
Claire Corry, MS

Mapping the Global Launch Sequence in a Partnership
Nathan J. Murray

Practical Application of Global Launch Best Practices
Matthew Steven Curin, PharmD



Chair
avatar for Matthew Curin

Matthew Curin

Executive Director, Program Management, Epizyme
Matt has been working in the pharmaceutical industry for almost 20 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →

Speakers
avatar for Claire Corry

Claire Corry

Director, Global Project and Alliance Management, Merck & Co., Inc.
Claire Corry currently is a Director in Global Project and Alliance Management at Merck and has been working in project and portfolio management roles for 15 years. Claire has a wealth of knowledge across all phases of drug development, working with both small molecules and biologics... Read More →
avatar for Nathan Murray

Nathan Murray

Global PRA Advisor, Autoimmune, Eli Lilly and Company
Currently lead a cross-functional (and multinational) team in the development of global price, reimbursement and access (PRA) strategy for both pre-launch and commercialized products. Primarily responsible for achieving acceptable access and reimbursement levels for patients and for... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Session

2:00pm EDT

#343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-546-L04-P; CME 1.25; IACET 1.25; RN 1.25

Companies’ global development strategies and the competency of many maturing regulatory authorities are evolving. Which practices and processes will lead to an optimal future regulatory environment that expedite availability of new medicines?

Learning Objectives

Identify current global development and submission strategies for new medicines; Describe potential changes to the global regulatory landscape over the next ten years and realistic scenarios for regulatory review as medicines regulation evolves based on regulatory science; Discuss current and future regulatory barriers to global development and licensing and possible potential solutions.

Chair

Prisha Patel, MSc

Speaker

Industry Perspective
Joseph C. Scheeren, PharmD

WHO Perspective on Medicines Development in the Emerging Markets
Mike Ward



Chair
PP

Prisha Patel

Manager, Global Development Programme, Centre For Innovation In Regulatory Science (CIRS)
Prisha Patel is the Manager for the Global Development programme at the Centre for Innovation in Regulatory Science (CIRS), London, focusing on emerging markets. Her responsibilities include managing the emerging markets industry benchmarking and agency benchmarking projects and working... Read More →

Speakers
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs 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 the DIA Board of Directors... Read More →
avatar for Mike Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO)
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

2:00pm EDT

#352: From Mistakes to Success: Lessons Learned from Organizational Change Management Programs
Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000194; RN 1.25

Challenges facing a project team may include providing enough time to successfully plan and implement a change management strategy. In this forum, we will review lessons learned that will help participants gain insights as to what will contribute to a successful initiative.

Learning Objectives

Improve planning activities to better prepare your organization for change; Apply lessons learned to identify areas for improvement and avoid unnecessary problems; Identify the organizational change management models that best suits your needs.

Chair

Diane Cooney

Speaker

Managing Change for Large-Scale Projects
Elizabeth Rager, MA

Leading Global Change Management
Walter Hinz, MBA



Chair
avatar for Diane Cooney

Diane Cooney

Senior Consultant, Paragon Solutions
Diane Cooney of Paragon Solutions started her career as a writer, before moving into consulting. With communication as her foundation, Diane’s interest evolved into understanding how strategy impacts planning and performance, and how culture influences our perception of our world... Read More →

Speakers
avatar for Walter Hinz

Walter Hinz

Senior Director, Celgene Corporation
Walter Hinz has been in the IT field for over 25 years. He has experience in the IT service industry and the global Life Sciences field. He has had the opportunity to solve difficult business problems, partner with customers to create value and lead change. Walter has a Master’s... Read More →
avatar for Elizabeth Rager

Elizabeth Rager

Corporate Entity Information Officer, Penn Medicine
Elizabeth Rager is the Corporate Entity Information Officer for Penn Medicine and a frequent sponsor of enterprise wide technology initiatives requiring extensive change management. Elizabeth's scope of leadership extends through all business areas including Finance, Marketing, Supply... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Forum

4:00pm EDT

#364: Cell and Gene Therapies: Current Global Landscape
Limited Capacity seats available

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

This session aims to cover the current global regulatory landscape for products belonging to gene therapy, cell therapy, and regenerative medicine, a rapidly emerging class of medicinal products with huge potential for managing many unmet medical needs and contribute substantially to patient care. The complexity of the products and the regulatory development and expectations across different regions, both established and emerging, will be covered.

Learning Objectives

Identify and understand the challenges unique to the regulatory review of global clinical trials with gene therapies; Discuss the development of regenerative medicine after new pharmaceuticals and medical devices law was implemented in Japan; Describe the regulatory development of cell therapy in Taiwan, including comparison of regulatory development of cell therapy among selected Asia countries and future prospects.

Chair

Linda F. Bowen

Speaker

Examining the Global Regulatory Environment and Scientific Landscape for Gene Therapy Clinical Trials
Victoria Rocchi

Regulation of Cell Therapy Products in Asia
Chao-Yi Joyce WANG, MSc

New Approach to Development of Regenerative Medicines in Japan
Noriaki Murao, MS



Chair
avatar for Gopalan Narayanan

Gopalan Narayanan

Biologics and Advanced Therapies Expert, NDA Group
Trained in Internal Medicine. Currently providing strategic support and advice to Biotech/Pharma companies on regulatory science primarily in Biotechnology, Cell and Gene Therapy. Previously Head of Biotechnology Unit, MHRA, UK and Expert Medical Assessor; Member of Committee for... Read More →

Speakers
avatar for Linda Bowen

Linda Bowen

Senior Director, Global Regulatory Science and Policy, Sanofi
Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →
avatar for Noriaki Murao

Noriaki Murao

Representative, NM Consulting
Noriaki received BS and MS degrees in pharmacy from Fukuoka University and Kyushu University. He spent his professional career for new drug development in pharmaceutical industries for four decades. He is currently running an independent regulatory consultancy business. He contributed... Read More →
avatar for Victoria Rocchi

Victoria Rocchi

Senior Regulatory Affairs Specialist, AnGes, Inc.
Victoria Rocchi is a Senior Specialist in Global Regulatory Affairs at AnGes, Inc. Ms. Rocchi has extensive experience in communications, project management and is a certified teacher. She began her career in the pharmaceutical industry at Merck Sharp and Dohme in Regulatory Operations... Read More →
avatar for Chao-Yi Wang

Chao-Yi Wang

Director, Division of Medicinal Products, Ministry of Health and Welfare, TFDA, Chinese Taipei
Ms. Chao-Yi (Joyce) Wang was appointed as the Director of Division of Medicinal Products, TFDA, Chinese Taipei, Ministry of Health and Welfare on January 7, 2016. She is responsible for management of pharmaceutical policies and regulations, including premarket approval of medicinal... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session
 
Thursday, June 30
 

10:45am EDT

#404: Bringing CRO Collaboration into the 21st Century
Limited Capacity seats available

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

With ever increasing rates of outsourcing and new outsourcing models being created, pharmaceutical companies are seeking new ways to collaborate with CROs. Whether its data, documents, team collaboration, etc., sponsors and CROs need easier ways to communicate. We will discuss how to solve these challenges.

Learning Objectives

Discuss how to efficiently collaborate with CROs; Explain how to easily understand study metrics and status for a fully outsourced portfolio; Describe how to utilize a CTMS to collaborate between sponsors and CROs.

Chair

Matthew J. Kiernan, MBA

Speaker

Optimizing Collaboration Between Sponsors and CROs Using CTMS in Today's eClinical Landscape
Lynn Fraser, MS

Outsourcing and the Clinical Data Mess, and Why It Isn’t Acceptable
Matthew J. Kiernan, MBA

Building an Integration Platform for Collaborating with CROs
Jennifer Bush, MS



Chair
MK

Matthew Kiernan

Partner, Pharmica
Matt Kiernan is a Partner at PHARMICA Consulting, a firm which focuses on operational excellence in the life sciences industry. Mr. Kiernan has over fifteen years of industry expertise in operational excellence, project management, portfolio management, resource management, and m... Read More →

Speakers
JB

Jennifer Bush

Director, LIfe Sciences Product Strategy, Oracle Health Sciences
Jennifer Bush is a life sciences professional with over 19 years of industry experience in both business and IT environments. She has worked in large pharma & CRO, working in both business and IT departments managing data transformation, eClinical implementations including implementation... Read More →
avatar for Lynn Fraser

Lynn Fraser

Senior Product Manager, BioClinica, Inc.
Lynn Fraser is a Product Manager at Bioclinica where she manages multiple enterprise clinical trial management technology solutions used by thousands of users and within a global environment. She has 7+ years of experience in Clinical Research technology, and 15+ years in web applications... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA