Food and Drug Administration

Center for Drug Evaluation and Research (CDER)


Antiviral Drugs Advisory Committee


March 11, 2005



620 Perry Parkway

Gaithersburg, Maryland



The Antiviral Drugs Advisory Committee will discuss new drug applications (NDAs) 21-797 and 21-798, entecavir tablets and entecavir oral solution, respectively, Bristol-Myers Squibb Company, proposed for the treatment of patients with chronic hepatitis B infection (HBV).


8:00 Call to Order and Opening Remarks Janet Englund, M.D.


Introduction of Committee


Conflict of Interest Statement Anuja Patel, M.P.H.

Executive Secretary, FDA



8:10 Overview of Issues Debra B. Birnkrant, M.D.

Director, Division of Antiviral Drug Products (DAVDP)


8:15 Sponsor Presentations

Bristol-Myers Squibb Company

        Introduction Elliott Sigal, M.D., Ph.D.

Chief Scientific Officer & President,

Pharmaceutical Research Institute

        Background Richard Wilber, M.D.

Vice President,

Global Development

        Nonclinical Safety Lois Lehman-McKeeman, Ph.D.

Distinguished Research Fellow,

Discovery Toxicology

        Clinical/Efficacy and Safety Helena Brett-Smith, M.D.


Infectious Diseases Clinical Research

        Resistance Richard Colonno, Ph.D.

Vice President,

Infectious Diseases Drug Discovery

        Benefit vs. Risk Assessment Donna Morgan Murray, Ph.D.

Executive Director,

Global Regulatory Sciences

9:30 Questions from the Committee


9:45 Break


10:00 FDA Presentations

Division of Antiviral Drug Products


        Carcinogenicity Issues James G. Farrelly, Ph.D.

Pharmacology Team Leader, DAVDP

        Clinical Issues Linda L. Lewis, M.D.

Lead Medical Officer, DAVDP

11:00 Discussion


Noon Lunch


1:00 Open Public Hearing


2:00 Continue Discussion and Questions to the Committee


5:00 Adjourn