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Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
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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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

 

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×

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

Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×
Page 63
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×
Page 64
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×
Page 65
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×
Page 66
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×
Page 67
Suggested Citation:"Appendix A Workshop Agenda." Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11910.
×
Page 68
Next: Appendix B Discussion Leader and Speaker Biographies »
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All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them.

To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

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