What Evidence is Essential for New Medical Products?
Implications for Patients and Health Policy

June 13, 2014
AAAS Headquarters
Washington

Conference AAAS Article
Conference Health Affairs Blog Entry
Bibliography of Key Articles
Speaker Biographies
Sponsoring Organizations

Conference Agenda

8:00 am                   Registration

8:30 am                   Welcome
Remarks:               Mark S. Frankel
American Association for the Advancement of Science

8:40 am                   Keynote Addresses
Introductions:       Diana Zuckerman
National Center for Health Research

8:45 am                   Remarks:               Congresswoman Rosa L. DeLauro (D-CT)

9:05 am                   Remarks:               Margaret R. Hamburg (via live video)
Food & Drug Administration

9:15 am                   Panel I. Evidence-Based Policy: Opportunities and Challenges
Moderator:            Susan F. Wood
George Washington University

Speakers:              Aaron S. Kesselheim
Brigham and Women’s Hospital/Harvard Medical
School
Robert Yarchoan
National Cancer Institute

Gregory D. Curfman
New England Journal of Medicine
Rita F. Redberg
JAMA Internal Medicine

10:45 am                 Panel II. Speed vs. Safety: Implications for Public Health of Changing
Standards for Getting Products to Market

Moderator:            Kim Witczak
Patient Safety Advocate
Speakers:              Bernard Lo
Greenwall Foundation
Lisa M. Schwartz & Steven Woloshin
Dartmouth Medical School
Michael Rosenblatt
Merck

12:00 pm                 Lunch

1:00 pm                   Panel III. Biomarkers, Surrogate Endpoints and Other Shortcuts that
May or May Not Predict Health Outcomes

Moderator:            Thomas J. Moore
Institute for Safe Medication Practices
Speakers:              Jerry Avorn
Brigham and Women’s Hospital/Harvard Medical
School
Joseph S. Ross
Yale School of Medicine
Diana Zuckerman
National Center for Health Research
Ann de Velasco
WomenHeart of Miami

2:30 pm                   Panel IV. Post-Market Surveillance and Comparative Effectiveness
Research

Moderator:            Tianjing Li
Johns Hopkins University
Speakers:              Robert Ball
Food & Drug Administration
Sebastian Schneeweiss
Brigham and Women’s Hospital/Harvard Medical
School
Patrick Ryan
Janssen Research and Development

3:45 pm                   Break

4:00 pm                   Panel V. What Kinds of Data are Needed/Used? A Policy Roundtable
Moderator:            Curt D. Furberg
Wake Forest University
Speakers:              C. Bernie Good
VA Pittsburgh Healthcare System
Louis Jacques
Georgetown University School of Medicine
Peter Lurie
Food & Drug Administration
Joseph V. Selby
Patient-Centered Outcomes Research Institute
Anne E. Trontell
Agency for Healthcare Research & Quality

5:20 pm                   Wrap-Up and Adjourn
Remarks:               Aaron S. Kesselheim
Brigham and Women’s Hospital/Harvard Medical
School


Outside funding for the conference is provided by a Robert Wood Johnson Investigator Award in Health Policy Research (Dr. Kesselheim), by the Greenwall Foundation Faculty Scholars Program (Dr. Kesselheim), and the Patient-Centered Outcomes Research Institute (PCORI) through the Eugene Washington PCORI Engagement Awards Program.