FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC)
IMMUNOSUPPRESSIVE DRUGS SUBCOMMITTEE MEETING
AGENDA
January 24, 2002
Gaithersburg Holiday Inn
Two Montgomery Village Avenue
Gaithersburg, MD 20879
NDA 21-083 Rapamune® (sirolimus) Oral Solution – Cyclosporine Withdrawal Maintenance Regimen
8:30 a.m. Call to Order and Opening Remarks Janet A. Englund, M.D.
Subcommittee Chair
Introduction of Subcommittee
Conflict of Interest Statement Tara P. Turner, Pharm. D.
Executive Secretary, AVAC
8:40 a.m. FDA Introductory Remarks Renata Albrecht, M.D.
Acting Director
Division of Special Pathogen
and Immunologic Drug Products, FDA
8:45 a.m. Sponsor Presentation Wyeth-Ayerst Research
Introduction Randall B. Brenner, M.S.
Senior Manager
Worldwide Regulatory Affairs
Overview John F. Neylan, M.D.
Design of Clinical Studies Vice President
Efficacy Review Transplantation Immunology,
Safety Review Clinical Research and Development
Pharmacokinetics James Zimmerman, Ph.D.
Concentration-Controlled Trials Senior Director
Therapeutic Drug Monitoring Clinical Pharmacokinetics,
Clinical Research and Development
Concluding Remarks John F. Neylan, M.D.
10:45 a.m. Break
11:00 a.m. FDA Presentation Rosemary Tiernan, M.D., M.P.H.
Medical Officer
Division of Special Pathogen
and Immunologic Drug Products, FDA
12:00 p.m. Lunch
1:00 p.m. Open Public Hearing
Alan Wilkinson, M.D., F.R.C.P.
Director, Kidney and Pancreas Transplantation
Professor of Medicine
UCLA
2:00 p.m. Charge to the Subcommittee Renata Albrecht, M.D.
2:10 p.m. Subcommittee Discussion and Vote
5:00 p.m. Adjourn