Food and Drug Administration
Center for Drug Evaluation and Research
Dermatologic and Ophthalmic Drugs Advisory Committee
8777 Georgia Avenue
Silver Spring, Maryland
AgendaMay 23, 2002
8:30 Call to Order and Opening Remarks Lynn Drake, M.D.
Acting Chair, DODAC
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Acting Executive Secretary, DODAC
BLA 125036, alefacept, Biogen, Inc.
- indicated for the treatment of patients with chronic plaque psoriasis who are candidates for phototherapy or systemic therapy.
Introduction Ezio Bonvini, M.D.
Division of Monoclonal Antibodies
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
8:45 Sponsor Presentation Biogen, Inc.
Overview: Burt Adelman, MD
Executive Vice President
Research and Development
Clinical Experience: Akshay K. Vaishnaw, MD, PhD
Director, Medical Research
Clinical Safety: Gloria Vigliani, MD
Vice President, Medical Research
Alefacept Risk Benefit Profile: Mark Lebwohl, MD
Chairman, Professor of Dermatology
Mount Sinai School of Medicine
10:15 FDA Presentation Louis Marzella, M.D., Ph.D.
Division of Clinical Trial Design and Analysis
OTRR, CBER, FDA
11:30 Questions from the Committee
1:30 Open Public Hearing
Gail M. Zimmerman - National Psoriasis Foundation
Diane Lewis - National Psoriasis Foundation
Maryellen Crawford - National Psoriasis Foundation
Sean Morton - National Psoriasis Foundation
Alan Menter, M.D. – Psoriasis Specialists Patient Advocacy Group
2:30 Committee Discussion and Vote