ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

February 20, 2002

Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD

Topic: Approaches to the development of antimicrobial agents for the treatment of resistant pathogens

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

8:20 a.m. Antibiotic Resistance: An Update Janice Soreth, M.D.

Director

8:40 a.m. Developing Drugs for Resistant Pathogens: David Ross, M.D., Ph.D.

Problems and Possibilities Medical Team Leader

Division of Anti-Infective

Drug Products, FDA

9:05 a.m. Industry Presentation (PhRMA) David Shlaes, M.D.

Catherine Hardalo, M.D.

Lianng Yuh, Ph.D.

Christy Chuang-Stein, Ph.D.

9:35 a.m. Break

9:55 a.m. Industry Presentation Francis Tally, M.D.

Cubist Pharmaceuticals

10:25 a.m. IDSA Presentation Louis B. Rice, M.D.

George H. Talbot, M.D.

Dennis D. Wallace, Ph.D.

10:55 a.m. Committee Discussion

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

2:00 p.m. Summary and Presentation of Issues Mark Goldberger, M.D., M.P.H.

2:10 p.m. Committee Discussion

4:00 p.m. Adjourn