Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Antiviral Drugs Advisory Committee
Hilton
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).
Chair
Introduction of Committee
Conflict of
Interest Statement Anuja
Patel, M.P.H.
Executive
Secretary, FDA
Director, Division of Antiviral Drug Products (DAVDP)
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
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