Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary (2007)
Chapter: Appendix A Workshop Agenda
A
Workshop Agenda
UNDERSTANDING THE BENEFITS AND RISKS OF PHARMACEUTICALS
May 30–31, 2006
NAS Keck Center
Room 100
500 Fifth Street NW
Washington, DC 20001
Tuesday, May 30, 2006
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7:45 am |
Breakfast |
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8:15 am |
Opening Remarks |
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Workshop Co-Chairs |
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Steven Galson, M.D., M.P.H. Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
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Jeffrey Leiden, M.D., Ph.D. President and COO, Abbott Laboratories |
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Topic 1 |
What general frameworks are used to assess risk/benefit in non-pharmaceutical industries or organizations? (20 minute presentations) |
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8:45 am |
Understanding the psychology of risk/benefit assessment |
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Discussion Leader: Jeffrey Leiden, M.D., Ph.D. |
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Paul Slovic, Ph.D. President, Decision Research |
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Peter Ubel, M.D. Director, Center for Behavioral and Decision Sciences in Medicine, University of Michigan |
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Sheila Jasanoff, J.D., Ph.D. Professor, John F. Kennedy School of Government, Harvard University |
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9:45 am |
Discussion |
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10:05 am |
Break |
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10:20 am |
Assessing the effectiveness of risk/benefit algorithms from other industries |
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Discussion Leader: Steven Galson, M.D., M.P.H. |
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Dennis Paustenbach, Ph.D. President, ChemRisk |
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Jonathan M. Samet, M.D., M.S. Professor and Chair, Department of Epidemiology, Johns Hopkins University |
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Joshua T. Cohen, Ph.D. Lecturer, Tufts New England Medical Center |
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Richard Hall, Ph.D. Vice President, Science and Technology (retired), McCormick & Company, Inc. |
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11:40 am |
Discussion |
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12:00 pm |
Lunch |
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12:45 pm |
What are the challenges in effectively educating people about risk/benefit decisions? |
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Discussion Leader: Jeffrey Leiden, M.D., Ph.D. |
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Hal Sox, M.D. Editor, Annals of Internal Medicine |
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Isaac Lipkus, Ph.D. Associate Research Professor, Psychiatry and Behavioral Sciences, Duke University |
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Steven Woloshin, M.D., M.S. Professor of Medicine and Community and Family Medicine, Dartmouth University |
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2:05 pm |
Discussion |
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Topic 2 |
How do we currently assess risk/benefit ratios for pharmaceuticals? (20 minute presentations) |
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2:25 pm |
Unique challenges for pharmaceuticals |
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Discussion Leader: Steven Galson, M.D., M.P.H. |
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Steve Galson, M.D., M.P.H. Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
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Brian Strom, M.D., M.P.H. Chair, Department of Biostatistics and Epidemiology, University of Pennsylvania |
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3:05 pm |
Discussion |
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3:30 pm |
Break |
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3:45 pm |
Advantages and drawbacks of the current system |
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Discussion Leaders: Tim Franson, M.D., and Sandra Kweder, M.D. |
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Peter Barton Hutt, LL.B., LL.M. Senior Counsel, Covington & Burling LLP |
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Peter A. Tollman, Ph.D. Senior Vice President and Director, The Boston Consulting Group |
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David Slavin, M.D. Executive Director, World Wide Development Business Innovations Unit, Pfizer Inc. |
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Brian Strom, M.D., M.P.H. Chair, Department of Biostatistics and Epidemiology, University of Pennsylvania |
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5:05 pm |
Discussion |
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5:30 pm |
Adjourn to Reception |
Wednesday, May 31, 2006
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8:00 am |
Breakfast |
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Topic 3 |
How should we evaluate the risks and benefits of pharmaceuticals? (20 minute presentations) |
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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? |
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8:30 am |
Goals/objectives of future systems |
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Discussion Leader: Jeffrey Leiden, M.D., Ph.D. |
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Jeffrey Leiden, M.D., Ph.D. President and COO, Abbott Laboratories |
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Douglas Throckmorton, M.D. Deputy Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
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Carl Spetzler, Ph.D., M.B.A. Chairman, Strategic Decisions Group |
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9:30 am |
Discussion |
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9:50 am |
Applicable systems from other industries |
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Discussion Leader: Steven Galson, M.D., M.P.H. |
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Lynn Goldman, M.D., M.P.H. Professor, Environmental Health Sciences, Johns Hopkins University |
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John Graham, Ph.D. Former Administrator, Office of Management and Budget, Office of Information and Regulatory Affairs |
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10:30 am |
Discussion |
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11:00 am |
Break |
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11:15 am |
What specific methodologies from other industries or academia are adaptable to the drug review system? |
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Discussion Leaders: Jeffrey Leiden, M.D., Ph.D., and Sandra Kweder, M.D. |
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Alan Garber, M.D., Ph.D. Professor of Medicine, Stanford University |
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Louis Garrison, Ph.D. Professor of Pharmacy, University of Washington |
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11:55 am |
Discussion |
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12:20 pm |
Lunch |
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1:40 pm |
How should we continuously update risk/benefit information with post-marketing data? |
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Discussion Leaders: Mark Berger, M.D., and Paul Seligman, M.D., M.P.H. |
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J. Marc Overhage, M.D., Ph.D. Chief Executive Officer, Indiana Health Information Exchange, Senior Investigator, Regenstrief Institute |
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2:00 pm |
Discussion |
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2:30 pm |
Break |
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2:40 pm |
Presentation of Zometa as a case example |
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Larry Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics, U.S. Food and Drug Administration |
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3:00 pm |
Discuss how new approaches could work with the case example (Zometa) (15 minute presentations) |
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Discussion Leader: Jeffrey Leiden, M.D., Ph.D. |
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Lisa Schwartz, M.D., M.S. Associate Professor of Medicine and Community and Family Medicine, Dartmouth University |
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Kevin A. Schulman, M.D. Professor of Medicine, Duke University |
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Mark Fendrick, M.D. Professor, Department of Internal Medicine, University of Michigan |
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4:00 pm |
Discussion |
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4:35 pm |
Next Steps |
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5:30 pm |
Adjourn |
