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

7:45 am

Breakfast

8:15 am

Opening Remarks

 

Workshop Co-Chairs

 

Steven Galson, M.D., M.P.H.

Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

 

Jeffrey Leiden, M.D., Ph.D.

President and COO, Abbott Laboratories



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OCR for page 63
Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary 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 7:45 am Breakfast 8:15 am Opening Remarks   Workshop Co-Chairs   Steven Galson, M.D., M.P.H. Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration   Jeffrey Leiden, M.D., Ph.D. President and COO, Abbott Laboratories

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary Topic 1 What general frameworks are used to assess risk/benefit in non-pharmaceutical industries or organizations? (20 minute presentations) 8:45 am Understanding the psychology of risk/benefit assessment   Discussion Leader: Jeffrey Leiden, M.D., Ph.D.   Paul Slovic, Ph.D. President, Decision Research   Peter Ubel, M.D. Director, Center for Behavioral and Decision Sciences in Medicine, University of Michigan   Sheila Jasanoff, J.D., Ph.D. Professor, John F. Kennedy School of Government, Harvard University 9:45 am Discussion 10:05 am Break 10:20 am Assessing the effectiveness of risk/benefit algorithms from other industries   Discussion Leader: Steven Galson, M.D., M.P.H.   Dennis Paustenbach, Ph.D. President, ChemRisk   Jonathan M. Samet, M.D., M.S. Professor and Chair, Department of Epidemiology, Johns Hopkins University   Joshua T. Cohen, Ph.D. Lecturer, Tufts New England Medical Center   Richard Hall, Ph.D. Vice President, Science and Technology (retired), McCormick & Company, Inc. 11:40 am Discussion 12:00 pm Lunch

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary 12:45 pm What are the challenges in effectively educating people about risk/benefit decisions?   Discussion Leader: Jeffrey Leiden, M.D., Ph.D.   Hal Sox, M.D. Editor, Annals of Internal Medicine   Isaac Lipkus, Ph.D. Associate Research Professor, Psychiatry and Behavioral Sciences, Duke University   Steven Woloshin, M.D., M.S. Professor of Medicine and Community and Family Medicine, Dartmouth University 2:05 pm Discussion Topic 2 How do we currently assess risk/benefit ratios for pharmaceuticals? (20 minute presentations) 2:25 pm Unique challenges for pharmaceuticals   Discussion Leader: Steven Galson, M.D., M.P.H.   Steve Galson, M.D., M.P.H. Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration   Brian Strom, M.D., M.P.H. Chair, Department of Biostatistics and Epidemiology, University of Pennsylvania 3:05 pm Discussion 3:30 pm Break 3:45 pm Advantages and drawbacks of the current system   Discussion Leaders: Tim Franson, M.D., and Sandra Kweder, M.D.   Peter Barton Hutt, LL.B., LL.M. Senior Counsel, Covington & Burling LLP

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary   Peter A. Tollman, Ph.D. Senior Vice President and Director, The Boston Consulting Group   David Slavin, M.D. Executive Director, World Wide Development Business Innovations Unit, Pfizer Inc.   Brian Strom, M.D., M.P.H. Chair, Department of Biostatistics and Epidemiology, University of Pennsylvania 5:05 pm Discussion 5:30 pm Adjourn to Reception Wednesday, May 31, 2006 8:00 am 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? 8:30 am Goals/objectives of future systems   Discussion Leader: Jeffrey Leiden, M.D., Ph.D.   Jeffrey Leiden, M.D., Ph.D. President and COO, Abbott Laboratories   Douglas Throckmorton, M.D. Deputy Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration   Carl Spetzler, Ph.D., M.B.A. Chairman, Strategic Decisions Group 9:30 am Discussion

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary 9:50 am Applicable systems from other industries   Discussion Leader: Steven Galson, M.D., M.P.H.   Lynn Goldman, M.D., M.P.H. Professor, Environmental Health Sciences, Johns Hopkins University   John Graham, Ph.D. Former Administrator, Office of Management and Budget, Office of Information and Regulatory Affairs 10:30 am Discussion 11:00 am Break 11:15 am What specific methodologies from other industries or academia are adaptable to the drug review system?   Discussion Leaders: Jeffrey Leiden, M.D., Ph.D., and Sandra Kweder, M.D.   Alan Garber, M.D., Ph.D. Professor of Medicine, Stanford University   Louis Garrison, Ph.D. Professor of Pharmacy, University of Washington 11:55 am Discussion 12:20 pm Lunch 1:40 pm How should we continuously update risk/benefit information with post-marketing data?   Discussion Leaders: Mark Berger, M.D., and Paul Seligman, M.D., M.P.H.   J. Marc Overhage, M.D., Ph.D. Chief Executive Officer, Indiana Health Information Exchange, Senior Investigator, Regenstrief Institute 2:00 pm Discussion 2:30 pm Break

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary 2:40 pm Presentation of Zometa as a case example   Larry Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics, U.S. Food and Drug Administration 3:00 pm Discuss how new approaches could work with the case example (Zometa) (15 minute presentations)   Discussion Leader: Jeffrey Leiden, M.D., Ph.D.   Lisa Schwartz, M.D., M.S. Associate Professor of Medicine and Community and Family Medicine, Dartmouth University   Kevin A. Schulman, M.D. Professor of Medicine, Duke University   Mark Fendrick, M.D. Professor, Department of Internal Medicine, University of Michigan 4:00 pm Discussion 4:35 pm Next Steps 5:30 pm Adjourn