Antiviral Drugs Advisory Committee
Overview of Issues Debra B. Birnkrant, M.D.
[HTML] [PPT] Director, Division of Antiviral Drug Products
(DAVDP)
Sponsor
Presentations
Boehringer Ingelheim
Pharmaceuticals, Inc.
·
Introduction Burkhard
Blank, M.D.
Senior
Vice President Medicine/DRA
·
Tipranavir Development Douglas
Mayers, M.D.
International
Head, Therapeutic Area Virology
·
Efficacy and Drug: Scott McCallister, M.D.
Drug Interactions Global
Medical Team Leader, TPV
·
Safety Christopher
Corsico, M.D.
Head,
Drug Surveillance and Information
·
Resistance Douglas Mayers, M.D.
International Head,
Therapeutic Area Virology
·
Potential Utility of Tipranavir Daniel Kuritzkes, M.D.
In Current Clinical Practice Director of AIDS Research,
[HTML] [PPT] Brigham
and Women’s Hospital,
Division of AIDS,
Associate
Professor of Medicine,
·
Conclusions Burkhard
Blank, M.D.
Senior Vice President Medicine/DRA
· Backup Slides Presented AM
· Backup Slides Presented PM
FDA Presentations
Division of Antiviral Drug Products
·
Efficacy Evaluation Rafia
Bhore, Ph.D.
[HTML] [PPT] Statistical
Reviewer
· Resistance Evaluation Lisa Naeger, Ph.D.
[HTML] [PPT] Senior Microbiology Reviewer
o Backup Slides Presented
· Exposure-Response Data Jenny J. Zheng, Ph.D.
[HTML] [PPT] Pharmacometrics
Reviewer
· Drug Interactions Yuanchao (Derek) Zhang, Ph.D.
[HTML] [PPT] Clinical Pharmacology and Biopharmaceutics
Reviewer
· Safety Profile and Conclusions Andrea James, M.D.
Questions to the Committee