Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

 

Antiviral Drugs Advisory Committee

 

March 11, 2005

 

Hilton

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.

                                                                                                Chair

                        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.

                                                                        Director,

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