Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary (2007)
Chapter: Appendix A Workshop Agenda
A
Workshop Agenda
UNDERSTANDING THE BENEFITS AND RISKS OFPHARMACEUTICALS
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. Foodand Drug Administration |
| Jeffrey Leiden, M.D., Ph.D. President and COO, Abbott Laboratories |
Topic 1 | What general frameworks are used to assess risk/benefit innon-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 inMedicine, University of Michigan |
| Sheila Jasanoff, J.D., Ph.D. Professor, John F. Kennedy School of Government, HarvardUniversity |
9:45 am | Discussion |
10:05 am | Break |
10:20 am | Assessing the effectiveness of risk/benefit algorithms fromother 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, JohnsHopkins 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 |
12:45 pm | What are the challenges in effectively educating peopleabout 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 BehavioralSciences, 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 forpharmaceuticals? (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. Foodand 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 |
| Peter A. Tollman, Ph.D. Senior Vice President and Director, The Boston ConsultingGroup |
| David Slavin, M.D. Executive Director, World Wide Development BusinessInnovations 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 ofpharmaceuticals? (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 |
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 HopkinsUniversity |
| 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 oracademia 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/benefitinformation 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 |
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 caseexample (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 FamilyMedicine, Dartmouth University |
| Kevin A. Schulman, M.D. Professor of Medicine, Duke University |
| Mark Fendrick, M.D. Professor, Department of Internal Medicine, University ofMichigan |
4:00 pm | Discussion |
4:35 pm | Next Steps |
5:30 pm | Adjourn |
