April 24, 2007
Slides
FDA Introductory Remarks Katie Laessig, M.D. Medical Team Leader, Division of Antiviral Products, FDA (ppt) (htm)
Applicant Presentation
Introduction, Background and Overview of Maraviroc, Michael Dunne, M.D., Therapeutic Area Head, Infectious Diseases, Pfizer (pdf)
Clinical Efficacy, Howard Mayer, M.D., Global Clinical Leader, Pfizer (pdf)
Safety and Toleration, Steve Felstead, M.D., Maraviroc Team Leader, Pfizer (pdf)
In Vitro and In Vivo Tropism and Resistance Evaluation, Mike Westby, Ph.D. Virology Team Leader, Pfizer (pdf)
Medical Need and Place in HIV Armamentarium, Dan Kuritzkes, M.D., Brigham and Women's Hospital, Boston (ppt) (htm)
Conclusions, Mike Dunne, M.D. (pdf)
FDA Presentation
Clinical Safety and efficacy, Scott Proestel, MD, Medical Officer, Division of Antiviral, Products, CDER, FDA (ppt) (htm)
Exposure-Response Modeling, Pravin Jadhav, PhD, Pharmacometrician/Clinical, Pharmacologist, Office of Clinical, Pharmacology, CDER, FDA (ppt) (htm)
Tropism and Resistance, Lisa Naeger, PhD, Clinical Virologist, Division of Antiviral Products, CDER, FDA (ppt) (htm)
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