Meeting Agenda

Agenda: Streamlining the Clinical Research Enterprise.

9:00 am Goals for the Morning Session

Enriqueta Bond, Ph.D.
President, Burroughs-Wellcome Fund
Chair, Clinical Research Roundtable

9:10 am Regulations and Responsibilities That Impact Clinical Research
(10 minute presentation and 10 minute discussion)

David Lepay, M.D., Ph.D.,
Senior Advisor for Clinical Science and Director,
Office for Good Clinical Practice
Food and Drug Administration

Bernard Schwetz, DVM, Ph.D.
Senior Advisor for Science
Food and Drug Administration

Irene Stith-Coleman, Ph.D.
Director, Division of Policy, Planning and Special Projects
Office of Human Research Protections
Department of Health and Human Services

10:10 am Conducting Clinical Research – Suggestions for Improvement
(10 minute presentation and 10 minute discussion)

John Gallin, MD
Director, Clinical Center
National Institutes of Health

Larry Meinert, M.D.
Sr. Vice President Clinical Services
Covance Inc.

Adrian Dobs, M.D.
Professor of Medicine
Director, Clinical Research Unit
Johns Hopkins University
School of Medicine

11:30 am Break

11:45 am Clinical Research Roundtable Discussion – Identification of Next Steps

12:30 pm Lunch

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