FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

AGENDA

August 7, 2002

Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD

Topic: Clinical trial design issues in the development of products for the treatment of chronic hepatitis B infection

 

8:00 a.m. Call to Order Roy M. Gulick, M.D., M.P.H.
Chair, AVAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AVAC

8:15 a.m. Opening Remarks Jeffrey Murray, M.D., M.P.H.
Deputy Director
Division of Antiviral Drug Products
FDA

8:30 a.m. Natural History and Clinical Virology of Jay H. Hoofnagle, M.D.
Hepatitis B NIDDK/NIH

9:15 a.m. Treatment of Chronic Hepatitis B Anna S. F. Lok, M.D.
University of Michigan
Medical Center

10:00 a.m. Break

10:30 a.m. Pharmaceutic Development Issues for Nathaniel A. Brown, M.D.
Hepatitis B Senior Vice President
Hepatitis Clinical Research
Idenix Pharmaceuticals

11:00 a.m. Surrogate Endpoints for Hepatitis B Trials Greg Soon, Ph.D.
Statistical Team Leader
Division of Antiviral Drug Products
FDA

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

Lee Crooks Hepatitis B Foundation
Gilead Sciences, Inc.

2:00 p.m. Charge to the Committee/Questions/Discussion

5:00 p.m. Adjourn