FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
AGENDA
August 6, 2002
Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD
NDA 21-449, adefovir dipivoxil tablets, Gilead Sciences, Inc., proposed for 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
8:10 a.m. Opening Remarks Debra B. Birnkrant, M.D.
Director
Division of Antiviral Drug Products
FDA
8:15 a.m. Sponsor Presentation Gilead Sciences, Inc.
Evaluation of Liver Histology in Zachary D. Goodman, M.D., Ph.D.
Clinical Trials for Chronic Viral Hepatitis Chief, Division of Hepatic Pathology
Armed Forces Institute of Pathology
Introduction Alan Taylor, Ph.D.
Chronic Hepatitis B Vice President, Regulatory Affairs
Pre-Clinical Gilead Sciences
Clinical Pharmacokinetics
Clinical Efficacy and Safety Carol Brosgart, M.D.
Pivotal Studies Vice President, Clinical Research
Supportive Studies Gilead Sciences
Further Studies
9:45 a.m. Break
10:15 a.m. FDA Presentation Rafia Bhore, Ph.D.
Mathematical Statistician
Division of Antiviral Drug Products
Tan T. Nguyen, M.D., Ph.D.
Medical Officer
Division of Antiviral Drug Products
11:15 a.m. Discussion of Presentations
12:00 p.m. Lunch
1:00 p.m. Open Public Hearing
Larry Kramer
Rochelle Yedvarb
Elias Anastasopoulos
Alan P. Brownstein, M.P.H. – American Liver Foundation
2:00 p.m. Charge to the Committee/Questions/Discussion
5:00 p.m. Adjourn