ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

February 19, 2002

Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD

Topic: Proposed approach for selection of delta in non-inferiority (equivalence) clinical trials

8:00 a.m. Call to Order and Introductions L. Barth Reller, M.D.

8:05 a.m. Conflict of Interest Statement Tara P. Turner, Pharm.D.

Executive Secretary, AIDAC

8:10 a.m. Opening Comments Mark Goldberger, M.D., M.P.H.

Acting Director

Office of Drug Evaluation IV,

FDA

8:15 a.m. Historical Perspective, Selection and Renata Albrecht, M.D.

Implications of Delta Acting Director

Division of Special Pathogen and

Immunologic Drug Products,

FDA

8:35 a.m. Active Control Non-Inferiority Studies: Robert Temple, M.D.

Theory, Assay Sensitivity, Choice of Margin Associate Director for

Medical Policy

Center for Drug Evaluation and

Research, FDA

8:55 a.m. Statistical Issues in Specification of Delta Daphne Lin, Ph.D.

Statistical Team Leader, FDA

9:35 a.m. Break

9:50 a.m. Medical Perspective: Bacterial Meningitis George H. McCracken, Jr., M.D.

University of Texas Southwestern

Medical Center at Dallas

10:15 a.m. Industry Presentation (PhRMA) David Shlaes, M.D.

Catherine Hardalo, M.D.

Lianng Yuh, Ph.D.

Christy Chuang-Stein, Ph.D.

10:45 a.m. Industry Presentation Francis Tally, M.D.

Cubist Pharmaceuticals

11:15 a.m. IDSA Presentation Vincent T. Andriole, M.D.

George H. Talbot, M.D.

Dennis D. Wallace, Ph.D.

John E. Edwards, Jr., M.D.

11:45 a.m. Issues Regarding Choice of the Margin Thomas R. Fleming, Ph.D.

in Non-Inferiority Trials University of Washington

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

Kem Phillips, Ph.D. – Advanced Biologics, LLC

(Statement for the Record)

1:30 p.m. Medical Perspective: John Powers, M.D.

Hospital Acquired Pneumonia/Meningitis Medical Officer

Division of Special Pathogen and Immunologic Drug Products,

FDA

1:55 p.m. Medical Perspective: Susan Thompson, M.D.

Acute Exacerbation of Chronic Bronchitis Medical Officer

Division of Anti-Infective

Drug Products, FDA

2:20 p.m. Break

2:35 p.m. Summary and Charge to Committee Mark Goldberger, M.D., M.P.H.

2:50 p.m. Committee Discussion

5:30 p.m. Adjourn