Holiday Inn
8120 Wisconsin Avenue
Bethesda, Maryland

Agenda November 4-5, 2002

8:30 Call to Order and Opening Remarks Robert S. Stern, M.D.
Chair, DODAC

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Acting Executive Secretary, DODAC

8:45 Open Public Hearing (Industry)
Joanne M. Fraser, Ph.D., A.C. Stiefel Research Institute, Inc.

9:15 Introduction
Jonathan Wilkin, M.D., Director, Division of Dermatologic and Dental Drug Products, FDA

9:20 Overview of Current Approach to Acne Therapy
Wilma Bergfeld, M.D., Cleveland Clinic

9:35 Evidence of Effectiveness of Acne Products
Jonathan Wilkin, M.D., Director, Division of Dermatologic and Dental Drug Products, FDA

10:00 FDA Perspective on Global Evaluation
Brenda Carr, M.D., Medical Officer, DDDDP, FDA

10:15 Questions to the Speakers (Wilkin, Bergfeld and Carr)

10:45 Break

11:00 The American Academy of Dermatology Consensus Conference Report on Acne Classification
Peter Pochi, M.D., Boston University

11:20 Physicians' Global Severity Scale: What Constitutes Success and the Utility of an Inflammatory Only Scale
James Leyden, M.D., University of Pennsylvania

11:35 Considerations on Success Criteria in Acne Trials
Alan Shalita, M.D., State University of New York, Brooklyn

11:50 Problems with Lesion Counts and Why They are Still Useful
Albert Kligman, M.D., University of Pennsylvania

12:10 Questions to the Speakers (Pochi, Leyden, Shalita and Kligman)

12:30 Lunch

1:30 Statistical Analyses of Acne Clinical Trial Data
Mohamed Alosh, Ph.D., Biostatistics Team Leader, Division of Biometrics III, FDA

2:30 Questions (Alosh)

2:45 Combination Topical Products for the Treatment of Acne Vulgaris
Markham C. Luke, M.D., Ph.D., Dermatology Clinical Team Leader, Dermatology, DDDDP, FDA

3:00 Labeling for Efficacy: The Clinical Study Section
Joseph Porres, M.D., Ph.D., Medical Officer, DDDDP, FDA

3:15 Break

3:30 Questions to the Speakers (Luke and Porres)

4:00 Acne Therapy: A Methodologic Review
Harold Lehmann, M.D., Ph.D., Johns Hopkins Medical Center

4:20 Questions (Lehmann)

4:30 Committee Discussion

5:30 Tentative Adjournment for the Day

8:00 Call to Order and Opening Remarks Robert S. Stern, M.D.
Chair, DODAC

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Acting Executive Secretary, DODAC

8:15 Open Public Hearing (Industry)
Donald A. Berry, Ph.D., Berry Consultants, LLC

8:45 Questions to Committee

Discussion

9:30 Break

10:00 Questions and Discussion

11:00 Adjourn