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Committee on the Assessment of the US Drug Safety System
Workshop: Advancing the Methods and Application of Risk-Benefit Assessment of Medicines
January 17th, 2006
Location: Keck Center, Room 100
500 Fifth Street, NW
Washington, DC 20001
Purpose of Workshop:
- Identify methodological approaches for performing integrated and explicit assessments of risk-benefit of pharmaceuticals throughout a product’s life-cycle, including identifying the type of information that would be most useful to decision-makers.
- Obtain expert input on the use of new methodological approaches in pre and post-market risk assessment.
- Identify opportunities and barriers in advancing a public health approach to balancing risks and benefits of pharmaceuticals for drug regulation and risk management.
AGENDA
Speakers and times are subject to change
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8:15 a.m.
Opening Remarks
Audio File for Session One
8:30 a.m. - 10:30 a.m.
Overview of Pharmacoepidemiology: What is the Evidence-Base?
Session 1: Assessing a product’s risk-benefit balance throughout its life-cycle involves the use of a variety of epidemiological resources and methods, including the use of ad hoc data sources, automated data systems, and randomized trials. The choice of specific assessment methods involves a consideration of many factors, including how well it informs decision-making intended to optimize a drug’s balance between benefits and risks.
Assessing Risks and Benefits of Pharmaceuticals: Methods and Approaches
Brian Strom, MD, MPH
Chair and Professor
Department of Biostatistics and Epidemiology
University of Pennsylvania
View PowerPoint Presentation
Pre-Market Assessment of Drug Safety at the FDA
Judith Racoosin, MD, MPH
Safety Team Leader
Division of Neurology Products
Division of Psychiatry Products
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
View PowerPoint Presentation
FDA Post-Approval Risk Assessment
Anne Trontell, MD, MPH
Senior Advisor on Pharmaceutical Outcomes
Center for Outcomes and Evidence
Agency for Healthcare Policy and Research
View PowerPoint Presentation
Risk-Benefit Frameworks: Perspectives from the Field of Environmental Health
Jonathan Samet, MD, MS
Professor and Chair
Department of Epidemiology
Johns Hopkins School of Public Health
View PowerPoint Presentation
9:45 a.m.
Discussion: Q & A with IOM Committee Members & Audience
10:30 a.m.
Break
11:00 a.m. - 12:30 p.m.
Case Studies Involving Risk-Benefit Uncertainties
Audio File Session Two (Part 1)
Session 2. This session involves the consideration of two case studies of contemporary drug safety issues, each case involving a different risk-benefit dilemma. The case studies are intended to focus the discussion on the type of information that would be most useful to decision-makers, with the case studies selected to address both the pre-approval and the post-approval period. The intent is to model not what is or is not actually done at the FDA and by the Industry sponsors, but what could or should be done. The proposed format is that speakers for each case study will briefly present the case study, followed by questions of clarification of fact from the IOM Committee and audience. Following lunch, there will be comments from an invited panel and discussion/questions to be posed by the IOM Committee.
Presentation of Case Study 1 - Salmeterol
Scott T. Weiss, MD
Professor of Medicine
Harvard Medical School
View PowerPoint Presentation
Presentation of Case Study 2 – Muraglitazar
Steve Nissen, MD
Medical Director, Cardiovascular Coordinating Center
Cleveland Clinic
View PowerPoint Presentation
Questions of Clarification of Fact
12:30 p.m.
Lunch
1:30 p.m.
Reconvene: Panel Discussions
Audio File Session Two (Part 2)
Suggested Discussion Points for the Panelists: Having heard the case studies, what tool or tools (existing or to be developed) would have narrowed the uncertainty about the benefit-risk profile for the drugs? At what point during evidence development should this tool have been brought into play? What would have remained uncertain? How long would it have taken and at what effort would it have taken to reduce that uncertainty? How were the risks and benefits identified, evaluated, and weighted? Where were the flaws in this process? What could have/should have been differently and why? What resources are needed for your approach? How would this approach improve the current risk:benefit evaluation?
Panel:
Judith K. Jones, MD, PhD
President, The Degge Group, Ltd
Wayne Ray, Ph.D.
Professor, Department of Preventive Medicine
Director, Pharmacoepidemiology
Vanderbilt University
View PowerPoint Presentation
Michael P. Stern, MD
Professor, Department of Medicine
Chief, Division of Clinical Epidemiology
University of Texas, San Antonio
Robert B. Wallace, MD, MS
Professor of Epidemiology, College of Public Health
University of Iowa
Noel Weiss, MD, PhD
Professor of Epidemiology
School of Public Health and Community Medicine
University of Washington
Discussion: Q & A with IOM Committee Members and Audience
3:00 p.m.
Break
3:15 p.m. - 5:00 p.m.
Establishing a framework for risk-benefit methods to reduce uncertainties during a pharmaceutical product’s life-cycle
Audio File Session Three
Session 3. This session is designed to session to reflect on what we learned from the case Studies and panel discussion and to articulate a framework needed to improve the timing, rigor, transparency of risk/benefit assessments.
Janice K. Bush, MD
VP, Quality, Education & Business Support, Benefit Risk Management
Curt Furberg, MD, PhD
Professor, Wake Forest University
Louis Garrison, PhD
Professor of Pharmacy, University of Washington
View PowerPoint Presentation
Joanna Haas, MD, MS
Vice President, Pharmacovigilance, Genzyme Corporation
Jeff Leiden, MD, PhD
President and Chief Operating Officer, Pharmaceutical Products Group, Abbott Laboratories
View PowerPoint Presentation
Alastair J.J. Wood, MD
Professor, Vanderbilt University Medical Center
Discussion - All
5:00 p.m.
Adjourn
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