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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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