FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

 

DRAFT 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 FDA Consultant

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.

Group Director

Clinical Design and Evaluation

 

Overall Risk/Benefit and Conclusions Elliott Sigal, M.D., Ph.D.

 

 

 

 

 

9:45 a.m. Questions from the Committee

 

10:00 a.m. Break

10:15 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

 

 

11:15 a.m. Questions from the Committee

 

12:00 p.m. Lunch

 

1:00 p.m. Open Public Hearing

2:00 p.m. Charge to the Committee/Questions for Discussion Debra B. Birnkrant, M.D.

5:00 p.m. Adjourn