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Click on a speaker's name to see their slides. Please note that not all speakers had slides.
8:00 am Welcome
- Gail Cassell, Symposium Chair and Moderator (no slides)
Eli Lilly and Company
Co-Chair, IOM Forum on Drug Discovery, Development, and Translation
8:10 am Session 1: Preserving the Public Trust: Ensuring Drug Safety, Efficacy,
and Availability
- Tommy Thompson (no slides)
Coalition for a Stronger FDA
Former Secretary, Department of Health and Human Services
- Jane Henney (no slides)
University of Cincinnati Academic Health Center
Former Commissioner of the U.S. Food and Drug Administration
- Ellen Sigal
Friends of Cancer Research
- Steve Galson
U.S. Food and Drug Administration
8:50 am Q&A
9:05 am Session 2: Integration of Pre and Post Market Review
- Alta Charo, Panel Moderator
Member, IOM Drug Safety Committee
- Hugh Tilson
UNC School of Public Health
- Garret Fitzgerald
University of Pennsylvania School of Medicine
- Bob Temple (slides coming soon)
U.S. Food and Drug Administration
- Ellis Unger
U.S. Food and Drug Administration
- Tim Franson
Lilly Research Laboratories, Eli Lilly and Company
10:05 am Q&A
10:25 am Break
10:40 am Session 3: Enhancing Post Market Safety Monitoring
- Andy Stergachis, Panel Moderator
University of Washington
Member, IOM Drug Safety Committee
- Gerald Dal Pan
U.S. Food and Drug Administration
- Mark McClellan
AEI Brookings Joint Center for Regulatory Studies
Former Commissioner of the U.S. Food and Drug Administration
- Richard Platt
Harvard Medical School and Harvard Pilgrim Health Care
- Barbara Alving
National Institute of Health
- Alec Walker
i3 Drug Safety, Ingenix
- Ron Krall
Senior Vice President and Chief Medical Officer
GlaxoSmithKline
12:00 pm Q&A
12:30 pm Lunch: Open Roundtable Discussion
1:30 pm Session 4: Conducting Confirmatory Drug Safety and Efficacy Studies
- Andy Stergachis, Panel Moderator (for slides, see session 3)
University of Washington
Member, IOM Drug Safety Committee
- Janet Woodcock
U.S. Food and Drug Administration
- Rob Califf
Duke University Medical Center
- Deborah Zarin
National Library of Medicine
- Gretchen Dieck
Pfizer
2:20 pm Q&A
2:50 pm Break
3:05 pm Session 5: Enhancing Post Market Regulation and Enforcement
- Alta Charo, Panel Moderator (for slides, see session 2)
University of Wisconsin
Member, IOM Drug Safety Committee
- Chris Schroeder
Duke University School of Law
Member, IOM Drug Safety Committee
- Peter Barton Hutt (no slides)
Covington & Burling LLP
- Eve E. Slater
Vertex Pharmaceuticals and Theravance, Inc.
Former Assistant Secretary for Health, U.S. Department of Health and Human Services
- Mary Pendergast (no slides)
Pendergast Consulting
- Marlene Haffner
Amgen, Inc.
4:05 pm Q&A
4:30 pm Session 6: Drug Safety Regulation: Looking to the Future
- Myrl Weinberg (no slides)
National Health Council
- Mark McClellan
AEI Brookings Joint Center for Regulatory Studies
Former Commissioner of the U.S. Food and Drug Administration
5:10 pm Q&A
5:20 pm Closing Remarks
- Gail Cassell, Symposium Chair and Moderator (no slides)
Eli Lilly and Company
Co-Chair, IOM Forum on Drug Discovery, Development, and Translation
5:30 pm Adjourn
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