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Antiviral Drugs Advisory Committee 

October 19-20, 2006

Slides

Presentations, discussion, and questions will focus on clinical trial design issues in the development of products for the treatment of chronic hepatitis C infection.  This meeting is being convened in response to the growing number of products in development for this indication. The primary objectives for the committee deliberations are to discuss issues relating to the identification of appropriate control arms, populations for study, endpoints, and long-term follow-up.

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FDA Introductory Remarks Hepatitis C: Perspective on Drug Development Issues, Debra Birnkrant, M.D. Director, Division of Antiviral Products, FDA (PPT) (HTM)

Hepatitis C Epidemiology, Natural History, Impact, and Viral Kinetics, Kenneth E. Sherman, M.D., Ph.D.  Gould Professor of Medicine, Director, Division of Digestive Diseases, University of Cincinnati Medical Center, Cincinnati, Ohio, (PPT) (HTM)

Clinical Experience: Difficulties in Trial Design for Therapeutic Products to Treat Chronic HCV Infection, John M. Vierling, M.D., F.A.C.P. Professor of Medicine and Surgery, Director of Baylor Liver Health, Chief of Hepatology, Baylor College of Medicine, Houston, Texas (PPT) (HTM)

Community perspective, Jules Levin, Executive Director/Founder, National AIDS Treatment Advocacy Project (NATAP) (PPT) (HTM)

Summary of Industry Reposes and Regulatory Perspective, William Tauber, M.D., Medical Officer, Division of Antiviral Products, CDER, FDA (PPT) (HTM)

Open Public Hearing

Janice K. Albrecht, Ph.D., Vice President Hepatology Clinical Research, Schering-Plough Research Institute, Kenilworth, NJ (PPT) (HTM)

Questions (PPT) (HTM)

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