Comparative Effectiveness Research and Personalized Medicine: Policy, Science, and Business
Nearly 250 attendees participated in an all-day conference, “Comparative Effectiveness Research and Personalized Medicine: Policy, Science, and Business,” that explored the intersection of comparative effectiveness research and personalized medicine. Co-hosted by the National Pharmaceutical Council and the Personalized Medicine Coalition, the conference examined how comparative effectiveness research (CER) and personalized medicine can work together to deliver quality care that improves patient outcomes, although speakers cautioned that much more work is ahead to ensure alignment of these two important scientific movements.
Overview
Through three panel discussions and keynote speeches by Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality, and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, conference attendees:
- Gained a better understanding of the legislative proposals under consideration in Congress;
- Considered important questions about how CER will be conducted, how much will be invested in that research, what entities will oversee the research, and how the results will be used to drive clinical and reimbursement decisions;
- Listened to speakers debate the impact of CER on patient health outcomes if it does not take into account the molecular makeup of patients, since evidence has shown that patient subgroups may respond differently to therapeutic options based on demographic characteristics, genetic variation, and coexisting medical conditions; and
- Learned about the business implications of CER and personalized medicine on pharmaceutical innovation.
Materials distributed to conference attendees include:
- Issue Brief: "21st Century Science: Comparative Effectiveness Research and Personalized Medicine"
- "Comparative Effectiveness Research and Personalized Medicine: From Contradiction to Synergy," a report by The Lewin Group
Expand for Agenda
o view presentations (in PDF format) from the conference, click on a speaker’s name.
CONFERENCE AGENDA
SETTING THE STAGE
- Cliff Goodman, PhD, Senior Vice President, The Lewin Group
PANEL 1 – PERSONALIZED COMPARATIVE EFFECTIVENESS RESEARCH: POLICY CONSIDERATIONS
- Andrew Dawson, U.S. House Committee on Ways and Means, Subcommittee on Health
- Amy Miller, Personalized Medicine Coalition
- Neera Tanden, U.S. Department of Health and Human Services
- Andrew Wu, U.S. Senate Committee on Finance
- Moderator: Cole Werble, FDC-Windhover, Elsevier Business Intelligence
AFTERNOON KEYNOTES
- Carolyn M. Clancy, MD, Agency for Healthcare Research and Quality
- Janet Woodcock, MD, U.S. Food and Drug Administration
PANEL 2 – OPPORTUNITIES FOR A PERSONALIZED MEDICINE APPROACH TO COMPARATIVE EFFECTIVENESS RESEARCH
- Amy P. Abernethy, MD, Duke Comprehensive Cancer Institute
- Robert S. Epstein, MS, MS, Medco Health Solutions
- Adolph P. Falcon, MPP, National Alliance for Hispanic Health
- Michael Lauer, MD, FACC, FAHA, National Heart, Lung and Blood Institute, National Institutes of Health
- Moderator: Jeffrey Cossman, MD, The Critical Path Institute
PANEL 3 – BUSINESS IMPLICATIONS OF COMPARATIVE EFFECTIVENESS RESEARCH WITH STRATIFIED POPULATIONS
- Pierre Cassigneul, XDx, Inc.
- Robert Honigberg, MD, MBA, MS&T Consulting LLC
- Teresa L. Lee, JD, MPH, AdvaMed
- Newell McElwee, PharmD, MSPH, Merck & Co., Inc.
- Moderator: John Iglehart, Health Affairs
CLOSING REMARKS
- Cliff Goodman, PhD, Senior Vice President, The Lewin Group