Gastrointestinal Drugs Advisory Committee
Food
and Drug Administration
Center
for Drug Evaluation and Research
Holiday Inn, 8777 Georgia Ave.,
Silver Spring, MD
Chemoprevention of Colorectal Cancer
8:00 Call to Order, Introductions: M. Michael Wolfe, M.D., Chair
Meeting Statement: Thomas H. Perez, M.P.H., Executive Secretary
Acting Director, Division of Gastrointestinal and Coagulation Drug
Products
8:15 Epidemiology and Mechanisms of Colorectal Cancer - - Anil K. Rustgi, M.D., T.Grier Miller Associate Professor of Medicine and Genetics; University of Pennsylvania
8:45 Colorectal Cancer Screening and Surveillance - - David A. Lieberman, M.D., Chief, Division of Gastroenterology, Oregon Health Sciences University
9:15 Overview of Chemoprevention Trials -- Bernard Levin, M.D., Vice President for Chemoprevention, Professor of Medicine, UTMD Anderson Cancer Center
9:45 Benefit and Risk Analysis for Chemoprevention of Sporadic Colorectal Cancer -- Mark Avigan, M.D., C.M., Medical Officer, Division of Gastrointestinal and Coagulation Drug Products
10:15 Break
10:30
Questions Regarding Presentations
11:00
Open Public Hearing
12:00
Lunch
1:00 Introduction
to Questions - - Mark Avigan, M.D., C.M.
Medical
Officer, Division of Gastrointestinal & Coagulation Drug Products
1:10 Charge
to the Committee - - Victor F.C. Raczkowski, M.D., M.Sc.
Acting Director, Division of
Gastrointestinal & Coagulation Drug Products
1:20 Discussion
of Questions
3:15 Break
3:30 Discussion
of Questions – continued
5:30 Adjourn
Consultants:
Curt D. Furberg, M.D.
Professor, Department of Public Health Sciences
Wake Forest University School of Medicine
Scott Lippman, M.D.
UT MD Anderson Cancer Center
Guest
Experts:
Bernard Levin, M.D.
Vice President
for Chemoprevention
Professor of Medicine, UTMD Anderson Cancer Center
John A. Baron, M.D.
Professor of Medicine, Community and Family Medicine
Dartmouth Medical School
David F. Ransohoff, M.D.
University of North Carolina at Chapel Hill
Alex Krist M.D.
Dept. of Family Practice
Virginia Commonwealth University
Barnett Kramer, M.D.
Associate Director for Disease Prevention
Office of Disease Prevention, National Institutes of Health
Anil K. Rustgi, M.D.
Chief of
Gastroenterology
University of Pennsylvania
David A. Lieberman, M.D.
Chief, Division
of Gastroenterology
Oregon Health Sciences University
George S. Goldstein, M.D.
Open Public Hearing Participants:
Robert Sandler, M.D.,
Professor of Medicine and Epidemiology
University of North Carolina at Chapel Hill
Sylvia Kleiman