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

Agenda for March 19, 2002

  8:00      Call to Order, Introductions:         M. Michael Wolfe, M.D., Chair

                Meeting Statement:                      Thomas H. Perez, M.P.H., Executive Secretary

                Opening Comments:                     Victor F.C. Raczkowski, M.D., M.Sc.
                                                                       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,0                     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

Nancy A. Roach, Patient Representative

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

Industry Representative:

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