ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

November 14, 2002

Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD

BLA 125061, peginterferon alfa-2a in combination with ribavirin, NDA 21-511, Hoffmann-La Roche, Inc., proposed for treatment of chronic hepatitis C

8:30 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

8:40 a.m. Introduction Karen D. Weiss, M.D.
Director
Division of Clinical Trial Design and
Analysis
FDA

Emanuel F. Petricoin, III, Ph.D.
Division of Therapeutic Proteins
FDA

9:00 a.m. Sponsor Presentation Hoffmann-La Roche, Inc.

Introduction Dr. Candice Teuber
Group Director
Regulatory Affairs

Overview of Pegasys-Copegus Dr. Joseph Hoffman
Development Program V.P. & Group Leader
Virology and Transplantation

Efficacy Dr. Frank Duff
Clinical Leader

Safety Dr. Jonathan Solsky
Director, Drug Safety and
Risk Management

Conclusions Dr. Joseph Hoffman

10:30 a.m. Break

10:45 a.m. FDA Presentation William Tauber, M.D.
Medical Officer
Division of Clinical Trial Design and
Analysis

11:45 a.m. Questions to the Presenters

12:30 p.m. Lunch

1:30 p.m. Open Public Hearing

2:30 p.m. Charge to the Committee/Questions/Discussion

4:00 p.m. Adjourn