Food & Drug Administration

Center for Biologics Evaluation & Research

Vaccines and Related Biological Products Advisory Committee

December 14-15, 2005

Consultants

DAY 1

Bruce Gellin, M.D., M.P.H. ***

Director

National Vaccine Program Office (NVPO)

Hubert Humphrey Building, Rm. 725H

200 Independence Ave., SW

Washington, DC 20201

Samuel Maldonado, M.D., M.P.H. **

Senior Director

Global Regulatory Affairs

Chairman, Pediatric Drug Development Committee

Johnson & Johnson Pharmaceutical Research and

Development L.L.C.

920 Route 202 South

Raritan, NJ 08869

Pamela McInnes, D.D.S. ***

National Institute of Allergy and Infectious

Diseases (NIAID)

Deputy Director, Division of Microbiology

and Infectious Diseases (DMID)

National Institutes of Health

6610 Rockledge Drive, Room 6113

Bethesda, MD 20892

** Acting Industry Representative

*** Temporary Voting Members

Food & Drug Administration

Center for Biologics Evaluation & Research

Vaccines & Related Biological Products Advisory Committee

December 14-15, 2005

Speakers

Day 1

Mark Bagarazzi, M.D.

Director, World Wide Regulatory Affairs

Vaccines/Biologics

Merck Research Laboratories

P.O. Box 4, BLB-22

West Point, PA 19486

Penny Heaton, M.D., M.P.H.

Director, Department of Biologics Clinical Research

Merck Research Laboratories

P.O. Box 4, BLB-22

West Point, PA 19486

FDA Participant

Rosemary Tiernan, M.D., M.P.H.

Medical Officer

Division of Vaccines and Related

Product Applications

OVRR/CBER

1401 Rockville Pike, HFM-485

Rockville, MD 20852

Hector Izurieta, M.D., M.P.H.

Epidemiologist

Division of Epidemiology

OVRR/CBER

1401 Rockville Pike, HFM-222

Rockville, MD 20852

Food & Drug Administration

Center for Biologics Evaluation & Research

Vaccines and Related Biological Products Advisory Committee

December 14-15, 2005

Consultants

DAY 2

Bruce Gellin, M.D., M.P.H. *** Michael Rowbotham, M.D. ***

Director Professor of Clinical Neurology and

National Vaccine Program Office (NVPO) Anesthesia

Hubert Humphrey Building, Rm. 725H Director, UCSF Pain Clinical Research

200 Independence Ave., SW Center

Washington, DC 20201 1701 Divisadero Street, Suite 480

University of California San Francisco

Thomas Fleming, Ph.D. *** San Francisco, CA 94115

Professor and Chairman

Department of Biostatstics, SC-32 Daniel Scharfstein, Sc.D. ***

University of Washington Associate Professor

Seattle, WA 98195 Department of Biostatistics

Johns Hopkins Bloomberg School of

Seth Hetherington, M.D. ** Public Health

Chief, Medical Officer 615 North Wolfe Street

VP Clinical Development Baltimore, MD 21205

Inhibitex, Inc.

1165 Sanctuary Pkwy., Suite 400

Alpharetta, GA 30004

Pamela McInnes, D.D.S. ***

National Institute of Allergy and Infectious

Diseases (NIAID)

Deputy Director Division of Microbiology

and Infectious Diseases (DMID)

National Institutes of Health

6610 Rockledge Drive, Room 6113

Bethesda, MD 20892

** Acting Industry Representative

*** Temporary Voting Members

Food & Drug Administration

Center for Biologics Evaluation & Research

Vaccines & Related Biological Products Advisory Committee

December 14-15, 2005

Speakers

Day 2

David Gutsch, M.D.

Director, Regulatory Affairs

Merck Research Laboratories

P.O. Box 4, BLB-22

West Point, PA 19486

Jeffrey Silber, M.D.

Senior Director, Clinical Research

Merck Research Laboratories

P.O. Box 4, BLB-22

West Point, PA 19486

FDA Participant

Patricia Rohan, M.D.

Medical Officer

Division of Vaccines and Related

Product Applications

OVRR/CBER

1401 Rockville Pike, HFM-485

Rockville, MD 20852