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Tuesday, May 30, 2006
7:45am: Breakfast
8:15am: Opening Remarks
Workshop co-chairs
- Steven Galson, MD, MPH
Director, CDER, FDA
- Jeff Leiden, MD, PhD
Former President and COO, Abbott Laboratories
Topic 1: What general frameworks are used to assess risk/benefit in non-pharmaceutical industries or organizations? (20 minute presentations)
8:45am: Understanding the psychology of risk/benefit assessment
Discussion Leader: Jeff Leiden, MD, PhD
- Paul Slovic, PhD
President, Decision Research
- Peter Ubel, MD
Director of the Center for Behavioral and Decision Sciences in Medicine, University of Michigan
- Sheila Jasanoff, JD, PhD
Professor, John F. Kennedy School of Government, Harvard
9:45am: Discussion
10:05am: Break
10:20am: Assessing the effectiveness of risk/benefit algorithms from other industries
Discussion Leader: Steven Galson, MD, MPH
- Dennis Paustenbach, PhD
President, Chemrisk
- Jonathan M. Samet, MD, MS
Professor and Chair, Department of Epidemiology, Johns Hopkins University
- Joshua T. Cohen, PhD
Lecturer, Tufts New England Medical Center
- Richard Hall, PhD
Vice President, Science and Technology (retired), McCormick & Co., Inc.
11:40am: Discussion
12:00pm: Lunch
12:45pm: What are the challenges in effectively educating people about risk/benefit decisions?
Discussion Leader: Jeff Leiden, MD, PhD
- Hal Sox, MD
Editor, Annals of Internal Medicine
- Isaac Lipkus, PhD
Associate Research Professor, Psychiatry and Behavioral Sciences, Duke
- Steven Woloshin, MD, MS
Professor of Medicine and Community and Family Medicine, Dartmouth
2:05pm: Discussion
Topic 2: How do we currently assess risk/benefit ratios for pharmaceuticals? (20 minute presentations)
2:25pm: Unique challenges for pharmaceuticals
Discussion Leader: Steven Galson, MD, MPH
- Steven Galson, MD, MPH
Director, CDER, FDA
- Brian Strom, MD, MPH
Chair, Department of Biostatistics and Epidemiology, University of Pennsylvania
3:05pm: Discussion
3:30pm: Break
3:45pm: Advantages and drawbacks of the current system
Discussion Leaders: Tim Franson, MD and Sandra Kweder, MD
- Peter Barton Hutt, LLB, LLM
Senior Counsel, Covington & Burling
- Peter A. Tollman, PhD
Senior Vice President and Director, The Boston Consulting Group
- David Slavin, MD
Executive Director, World Wide Development Business Innovations Unit, Pfizer
- Brian Strom, MD, MPH
Chair, Department of Biostatistics and Epidemiology, University of Pennsylvania
5:05pm: Discussion
Wednesday, May 31, 2006
8:00am: Breakfast
Topic 3: How should we evaluate the risks and benefits of pharmaceuticals? (20 minute presentations)
Charge to the panel: What are the steps to adopt these new approaches for the drug review system? What are the areas of agreement? What additional work needs to be done?
8:30am: Goals/objectives of future systems
Discussion Leader: Jeff Leiden, MD, PhD
9:30am: Discussion
9:50am: Applicable systems from other industries
Discussion Leader: Steven Galson, MD, MPH
- Lynn Goldman, MD, MPH
Professor, Environmental Health Sciences, Johns Hopkins University
- John Graham, PhD
Former Administrator OMB, Office of Information and Regulatory Affairs
10:30am: Discussion
11:00am: Break
11:15am: What specific methodologies from other industries or academia are adaptable to the drug review system?
Discussion LeaderS: Jeff Leiden, MD, PhD and Sandra Kweder, MD
- Alan Garber, MD, PhD
Professor of Medicine, Stanford
- Louis Garrison, PhD
Professor of Pharmacy, University of Washington
11:55am: Discussion
12:20pm: Lunch
1:40pm: How should we continuously update risk/benefit information with post-marketing data?
Discussion LeaderS: Mark Berger, MD and Paul Seligman, MD, MPH
- J. Marc Overhage, MD, PhD
Chief Executive Officer, Indiana Health Information Exchange, Senior Investigator, Regenstrief
2:00pm: Discussion
2:30pm: Break
2:40pm: Presentation of Zometa as a case example
- Larry Lesko, Ph.D.
Director, Office of Clinical Pharmacology and Biopharmaceutics, FDA
3:00pm: Discuss how new approaches could work with the case example (Zometa) (15 minute presentations)
Discussion Leader: Jeff Leiden, MD, PhD
- Lisa Schwartz, MD, MS
Associate Professor of Medicine and Community and Family Medicine, Dartmouth
- Kevin A. Schulman, MD
Professor of Medicine, Duke
- Mark Fendrick, MD
Professor, Department of Internal Medicine, University of Michigan
4:00pm: Discussion
4:35pm: Next Steps
5:30pm: Adjourn
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