Food and Drug Administration

Center for Drug Evaluation and Research

Arthritis Advisory Committee

Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD

Agenda

August 16, 2001

BLA STN 103950 KineretÔ , (anakinra), Amgen, Inc.

8:00 Call to Order and Introductions: E. Nigel Harris, M.D., Acting Chair

Meeting Statement: Kathleen Reedy, Executive Secretary

Welcome and Introduction: William Schwieterman, M.D. , Branch Chief

Division of Clinical Trial Design and Analysis

Office of Therapeutics Research and Review, CBER

8:15 Amgen Inc. Presentation:

Overview: Roger Perlmutter, MD, PhD, Amgen,

Executive Vice President, Research and Development

Clinical Experience: Moraye Bear, MA, MS, Amgen, Director, Clinical Research

Pirow Bekker, MD, PhD, Amgen, Senior Director, Clinical Research

Concluding Statements: Stanley B. Cohen, MD

Medical Director, Radiant Research, Dallas, Texas

Associate Director, St. Paul Medical Center, Dallas, Texas

President, ACR Research and Education Foundation

9:45 Break

10:00 FDA, CBER Presentation

Overview and Introduction: Raymond P. Donnelly, Ph.D., Senior Investigator

Division of Therapeutic Proteins

Efficacy and Safety: Jeffrey N. Siegel, M.D., Medical Reviewer

Division of Clinical Trial Design and Analysis

Office of Therapeutics Research and Review

11:00 Open Public Hearing

 

11:30 Lunch

12:30 Discussion and Questions

Break

4:30 Summary

5:00 Adjourn