Appendix A

Workshop Agenda

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: An Institute of Medicine Workshop

September 20-21, 2011

National Academy of Sciences
Keck Building, Room 100
500 Fifth Street, N.W.
Washington, DC 20001

Background:

The Food and Drug Administration (FDA) has defined regulatory science as the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products (FDA, 2010). The FDA Science Board, in Science and Mission at Risk (FDA Science Board, 2007), described regulatory science as a science-based decision-making process needed to fulfill the responsibilities of a public health agency: “FDA must have the scientific staff and resources to undertake the regulatory research that will provide a basis to: (1) improve capacity for safety and efficacy evaluations and monitoring of candidate and licensed products; (2) modernize current regulatory pathways; and (3) develop new regulatory pathways where there are currently none.” According to the report, this capacity is important because “decisions made in regulation development, pre-market approvals, legal actions and



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Appendix A Workshop Agenda Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: An Institute of Medicine Workshop September 20-21, 2011 National Academy of Sciences Keck Building, Room 100 500 Fifth Street, N.W. Washington, DC 20001 Background: The Food and Drug Administration (FDA) has defined regulatory sci- ence as the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products (FDA, 2010). The FDA Science Board, in Science and Mission at Risk (FDA Science Board, 2007), described regulatory science as a science- based decision-making process needed to fulfill the responsibilities of a public health agency: “FDA must have the scientific staff and resources to undertake the regulatory research that will provide a basis to: (1) improve capacity for safety and efficacy evaluations and monitoring of candidate and licensed products; (2) modernize current regulatory pathways; and (3) develop new regulatory pathways where there are currently none.” According to the report, this capacity is important because “decisions made in regulation development, pre-market approvals, legal actions and 67

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68 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE related public health emergencies must be based on understanding of contemporary and emerging science within the context of the risk analy - sis paradigm.” A number of gaps in the regulatory science discipline and infrastructure have been identified. They include workforce and resource constraints; cultural differences and systemic barriers to collaboration and exchange among the agency, academia, and industry; and deficien - cies in the network and infrastructure necessary to forge the collaboration and communication needed to advance regulatory science. There has been recognition that collaborative approaches are necessary to advance regulatory science. In early 2010, FDA and NIH announced a unique col- laboration, with establishment of a joint FDA-NIH leadership council to enable cross-agency efforts to improve regulatory science. This workshop will explore issues related to strengthening a work- force for innovative regulatory science in therapeutics development. The workshop will (1) consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics devel - opment through an interdisciplinary regulatory science workforce and (2) examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA. Meeting Objectives: • Define and discuss the current regulatory science workforce, with particular attention to discussion of the disciplines involved and professional training opportunities. — Identify gaps between the essential components of a workforce that will produce innovation in regulatory science and the cur- rent reality. • Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development. • Examine application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening of a robust national regulatory science workforce. — Identify and discuss specific opportunities for enhancing col- laboration and coordination—among relevant federal pro- grams and between FDA and the extramural community—to strengthen a regulatory science workforce supporting innova- tion in therapeutics development. — Identify barriers to implementation of collaborative models, and discuss potential solutions to address those identified barriers. • Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies, but also throughout

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69 APPENDIX A the extramural sector, to build the discipline and establish career paths in the area of regulatory science innovation for therapeutics development. SEPTEMBER 20, 2011 8:30 a.m. Welcome and Introductions Barry Coller, Workshop Co-Chair Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University elaine Gallin, Workshop Co-Chair Principal QE Philanthropic Advisors Session I: Defining a Discipline of Regulatory Science Session Objectives: • Discuss the promise of and role for innovative regulatory science in therapeutics development. • Define the discipline of regulatory science in therapeutics development. 8:40 a.m. Keynote Address, Food and Drug Administration ViCki Seyfert-MarGoliS Senior Advisor for Science Innovation and Policy Office of the Commissioner Food and Drug Administration 9:00 a.m. Keynote Address, National Institutes of Health Story landiS Director National Institute of Neurological Disorders and Stroke National Institutes of Health

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70 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE 9:20 a.m. Keynote Address, Industry andrew dahleM Vice President & Chief Operating Officer, Lilly Research Laboratories Eli Lilly & Co. 9:40 a.m. Keynote Address, Academia ralph SnyderMan Chancellor Emeritus Duke University 10:00 a.m. Panel Discussion with Keynote Speakers: Components of a Robust Academic Discipline of Regulatory Science Objectives: • efine “innovation” in regulatory science. What are the D benchmarks and metrics of success in a discipline of regulatory science? • ropose and discuss the essential, core components of P a robust discipline of innovative regulatory science in therapeutics development. • ist key skills, techniques, and areas of expertise needed L by a regulatory science workforce. ellen SiGal, Panel Moderator Chair and Founder Friends of Cancer Research Panelists: • eynote speakers (FDA, NIH, Industry, and Academia K represented above)

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71 APPENDIX A Session II: Core Competencies of an Innovative Regulatory Science Workforce Session Objectives: • Consider the core components of an innovative regulatory science discipline and essential competencies of a regulatory science workforce. • Through case studies, provide examples of the practice of regulatory science and the needed skill set of the workforce involved. SteVen GalSon, Session Chair Vice President for Global Regulatory Affairs Amgen Inc. Case Studies: Components and Application of Innovative Regulatory Science 10:30 a.m. Therapeutics Development Mary dwiGht Vice President for Government Affairs Cystic Fibrosis Foundation 10:50 a.m. Drug Safety Munir pirMohaMed Deputy Director MRC Centre for Drug Safety Science, University of Liverpool 11:10 a.m. Components of Regulatory Science Through the Lens of Translational Science Barry Coller Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University roB Califf Director, Duke Translational Medicine Institute Professor of Medicine Vice Chancellor for Clinical and Translational Research Duke University Medical Center

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72 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE 11:45 a.m. Panel Discussion: Perspectives on Core Competencies for a Regulatory Science Workforce Session Speakers and Additional Discussants: SteVen GalSon, Panel Moderator Vice President for Global Regulatory Affairs Amgen Inc. Mary dwiGht Vice President for Government Affairs Cystic Fibrosis Foundation Clifford lane Deputy Director for Clinical Research and Special Projects National Institute of Allergy and Infectious Diseases National Institutes of Health Munir pirMohaMed Deputy Director MRC Centre for Drug Safety Science, University of Liverpool Melinda wharton Deputy Director, National Center for Immunization and Respiratory Diseases Centers for Disease Control 12:40 p.m. LUNCH Session III: Education and Training of a Regulatory Science Workforce Session Objectives: • Discuss education and training opportunities needed to develop a robust workforce in regulatory science in therapeutics development. Identify gaps between those needed components and the current reality. • Identify and discuss specific opportunities, including collaborative approaches, to strengthen education and training opportunities for a regulatory science workforce. • Examine barriers to implementation of those strategies and discuss potential solutions to those identified barriers.

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73 APPENDIX A alaStair wood, Session Chair Partner & Managing Director Symphony Capital LLC 1:40 p.m. Overview of Existing Training Programs in Regulatory Science Carl peCk Professor, Pharmacology and Medicine University of California, San Francisco 2:00 p.m. Education and Training: What Is Needed and How Do We Get There? 2:00 p.m. eMMa MeaGher Director, Translational Research Education Institute of Translational Medicine and Therapeutics University of Pennsylvania Perelman School of Medicine 2:15 p.m. annette Mollet European Center of Pharmaceutical Medicine University of Basel, Switzerland 2:30 p.m. Panel Discussion with Speakers alaStair wood, Panel Moderator Partner & Managing Director Symphony Capital LLC 3:00 p.m. BREAK Session IV: Regulatory Science Career Development and Advancement: Career Paths Within and Outside Academia Session Objectives: • Discuss career and career development opportunities that currently are available, or that would need to be available, to strengthen and support research and practice of regulatory science in therapeutics development. • Discuss regulatory science careers outside academia, including industry, FDA, and other federal agencies. Focus on career tracks in innovative regulatory science (as distinguished from regulatory affairs and compliance).

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74 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE • Identify and discuss specific opportunities, including collaborative approaches, to encourage the career development for a workforce in regulatory science in therapeutics development. Examine barriers to implementation of those strategies and discuss potential solutions to those identified barriers. 3:20 p.m. Session Overview and Introductory Remarks Carl peCk, Session Chair Professor, Pharmacology and Medicine University of California, San Francisco Regulatory Science Career Paths in Academia Panel 1: 3:25 p.m. williaM Chin Executive Dean for Research Harvard Medical School 3:35 p.m. daVid deMetS Professor, Department of Biostatistics & Medical Informatics University of Wisconsin-Madison 3:45 p.m. kathy GiaCoMini Professor and Co-Chair, Department of Bioengineering and Therapeutic Sciences University of California, San Francisco Regulatory Science Career Paths Outside Academia Panel 2: 4:00 p.m. leSlie wheeloCk Office of the Chief Scientist Food and Drug Administration 4:10 p.m. Jonathan wieSt Director for Training and Education, Center for Cancer Research Office of Training and Education, National Cancer Institute National Institutes of Health 4:20 p.m. henrietta ukwu Senior Vice President for Global Regulatory Affairs PPD, Inc.

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75 APPENDIX A 4:30 p.m. Panel Discussion with Speakers: Career Development Pathways: What Is Needed and How Do We Get There? Carl peCk, Panel Moderator Professor, Pharmacology and Medicine University of California, San Francisco 5:30 p.m. ADJOURN SEPTEMBER 21, 2011 8:30 a.m. Welcome and Introductions Workshop Co-Chairs Barry Coller Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University elaine Gallin Principal QE Philanthropic Advisors Session V: International Applications elaine Gallin, Session Chair Principal QE Philanthropic Advisors 8:35 a.m. Regulatory Science Workforce Needs to Maintain a Robust Global Therapeutics Pipeline XaVier luria Head, Safety and Efficacy of Medicines Human Medicines & Evaluation European Medicines Authority

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76 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE 8:55 a.m. Regulatory Science Workforce Needs to Support Therapeutics Development for Global Neglected Diseases MiChael Brennan Senior Advisor for Global Affairs Aeras Global TB Vaccine Foundation Session VI: Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice Session Objectives: • Discuss funding opportunities that would need to be available to strengthen and support research and practice of regulatory science in therapeutics development. What institutions, public or private, could offer research funding and other support to create an infrastructure and habitat for innovative regulatory science? Outline a sustainable funding model. • Identify and discuss specific opportunities for enhancing collaboration and coordination to strengthen a regulatory science workforce supporting innovation in therapeutics development. • Identify barriers to implementation of funding strategies and collaborative models, and discuss potential solutions to address those identified barriers. Barry Coller, Session Chair Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University 9:15 a.m. GiGi hirSCh Program Director, NEWDIGS Executive Director, Center for Biomedical Innovation Massachusetts Institute of Technology 9:30 a.m. williaM Greenlee President & CEO The Hamner Institutes 9:45 a.m. theodore reiSS Research Professor of Medicine Vanderbilt University School of Medicine

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77 APPENDIX A 10:00 a.m. Panel Discussion Led by Workshop Co-Chairs: Fellowship/Exchange Programs FDA CTP Regulatory Science Fellowship (pilot) lawrenCe deyton Director Center for Tobacco Products Food and Drug Administration FDA Commissioner’s Fellows Program uroS dJekiC Commissioner’s Fellow (2008-2010) Senior Regulatory Reviewer/Policy Analyst Center for Biologics Evaluation and Research Food and Drug Administration CBER Regulatory Science Activities Carolyn wilSon Associate Director for Research Center for Biologics Evaluation and Research Food and Drug Administration Visiting Lecturer/Expert Programs at FDA kate ahlport Executive Director Health Research Alliance FDA Rotation for Clinical Research Fellows at the NIH Clinical Center Juan lertora Director Clinical Pharmacology Program NIH Clinical Center 10:45 a.m. Q&A with Panelists

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78 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE Session VII: Setting the Agenda Session Objectives: • Explore resources and stakeholder engagement needed to build the discipline and establish career paths in the area of regulatory science innovation for therapeutics development. • Discuss specific next steps for stakeholders to strengthen a workforce for innovative regulatory science in therapeutics development. 11:00 a.m. Discussion with Panelists and Workshop Attendees Led by Workshop Co-Chairs Barry Coller, Workshop Co-Chair Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University elaine Gallin, Workshop Co-Chair Principal QE Philanthropic Advisors SteVen GalSon Vice President for Global Regulatory Affairs Amgen Inc. alaStair wood Partner & Managing Director Symphony Capital LLC Carl peCk Professor, Pharmacology and Medicine University of California, San Francisco GiGi hirSCh Program Director, NEWDIGS Executive Director, Center for Biomedical Innovation Massachusetts Institute of Technology williaM Greenlee President & CEO The Hamner Institutes

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79 APPENDIX A theodore reiSS Research Professor of Medicine Vanderbilt University School of Medicine 12:00 p.m. ADJOURN

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