Food and Drug Administration

Center for Drug Evaluation and Research

Dermatologic and Ophthalmic Drugs Advisory Committee

Kennedy Ballroom

Holiday Inn

8777 Georgia Avenue

Silver Spring, Maryland

Agenda May 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
FDA

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

11:15 Break

11:30 Questions from the Committee

12:30 Lunch

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

5:00 Adjourn