FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
AGENDA
October 3, 2001
The Town Center Hotel –Silver Spring, Maryland
NDA 21-356, Viread™ (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., proposed for the treatment of human immunodeficiency virus (HIV) infection.
8:30 a.m. Call to Order/Welcome Roy M. Gulick, M.D., M.P.H.
Chair, AVAC
Introduction of Committee
8:35 a.m. Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AVAC
8:45 a.m. Introduction/Opening Remarks Debra Birnkrant, M.D.
Acting Director
Division of Antiviral Drug Products, FDA
9:00 a.m. Sponsor Presentation Gilead Sciences, Inc.
Overview of Development Program Norbert Bischofberger, Ph.D.
Executive Vice President
Research and Development
Clinical Trial Results Jay Toole, M.D., Ph.D.
Vice President
Clinical Research
Phase IV Plans and Concluding Remarks Norbert Bischofberger, Ph.D.
9:45 a.m. FDA Presentation Kimberly Struble, Pharm.D.
Senior Regulatory Review Officer
Division of Antiviral Drug Products, FDA
James Farrelly, Ph.D.
Pharmacology Supervisor
Division of Antiviral Drug Products, FDA
10:30 a.m. Break
10:45 a.m. Questions to Presenters
12:00 p.m. Lunch
AVAC MEETING
AGENDA
October 3, 2001
1:00 p.m. Open Public Hearing
Yvette Delph, M.D. - Treatment Action Group (TAG)
Brett Grodeck – Santa Monica, California
Ben Cheng – Project Inform
2:00 p.m. Questions to Committee
Committee Discussion
5:00 p.m. Adjourn