FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
AGENDA
May 13, 2003
Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD
NDA 21-567 and 21-568, Reyataz™ (atazanavir sulfate) capsules and powder for oral use, Bristol-Myers Squibb Company, proposed for the treatment of HIV infection in combination with other antiretroviral agents
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 Debra B. Birnkrant, M.D. Director
Division of Antiviral Drug Products
FDA
8:30 a.m. Evaluation of QT Interval Joel Morganroth, M.D.
Chief Scientist and Chairman
eResearch Technology, Inc.
Clinical Professor of Medicine
University of Pennsylvania
8:45 a.m. Sponsor Presentation Bristol-Myers Squibb Company
Introduction Elliott Sigal, M.D., Ph.D.
Sr. Vice President, Global Clinical
and Pharmaceutical Development
Clinical Development Program and Steven M. Schnittman, M.D.
Clinical Trial Results Vice President, Global Development
Cardiac Electrophysiology Evaluations John H. Lawrence, M.D.
Executive Director
Clinical Design and Evaluation
Characterization of Hyperbilirubinemia Michael Giordano, M.D.
Group Director
Clinical Design and Evaluation
Characterization of Lipid Profile Michael Giordano, M.D.
Overall Risk/Benefit and Conclusions Elliott Sigal, M.D., Ph.D.
10:00 a.m. Questions from the Committee
10:15 a.m. Break
10:30 a.m. FDA Presentation Kendall Marcus, M.D.
Medical Officer
Division of Antiviral Drug Products
Lisa Naeger, Ph.D.
Microbiology Reviewer
Division of Antiviral Drug Products
Tom Hammerstrom, Ph.D.
Statistical Reviewer
Division of Biometrics III
11:30 a.m. Questions from the Committee
12:15 p.m. Lunch
1:15 p.m. Open Public Hearing
2:15 p.m. Charge to the Committee/Questions for Discussion
5:00 p.m. Adjourn