Food & Drug Administration
Center for Biologics Evaluation & Research
Vaccines and Related Biological Products Advisory Committee
November
16-17, 2005
Consultants
DAY 1
James Cook, M.D. *** Robin Robinson, Ph.D. ***
Chief, Section of Infectious Diseases Senior Project Officer for the
Department of Medicine Office of Research and Development
University of Illinois at Chicago Coordination in the Office Emergency
808 S. Wood Street Preparedness, HHS/OPHEP/ORDC
Chicago, IL 60612 200 Independence Avenue, S.W.
Humphrey Bldg., Rm. 638G
Seth Hetherington, M.D. ** Washington, DC 20201
Chief, Medical Officer
VP Clinical Development
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
Philip Minor, Ph.D. ***
Head, Division of Virology
National Institute for Biological Standards
and Control
Blanch Lane, South Mimms, Potters Bar
Hertfordshire EN6 3QG
England
** Acting Industry Representative
*** Temporary Voting Members
Food & Drug Administration
Center for Biologics Evaluation & Research
Vaccines & Related Biological Products Advisory Committee
November
16-17, 2005
Speakers
Day 1
Rino Rappuoli, Ph.D.
Chiron Corporation
Chief Scientific Officer for Chiron
Bell Atlantic Tower
1717 Arch Street, 28th Fl.
Philadelphia, PA 19103
Jeroen Medema
Solvay Pharmaceuticals, Inc.
Senior Scientist, Vaccines
901 Sawyer Road
Marietta, GA 30062
FDA Participants
Philip Krause, M.D. Keith Peden, Ph.D.
Head, Unit of Viral Latency Senior Investigator
Laboratory of DNA Viruses Laboratory of Retrovirus Research
Division of Viral Products Division of Viral Products
OVRR/CBER OVRR/CBER
1401 Rockville Pike, HFM-457 1401 Rockville Pike, HFM-454
Rockville, MD 20852 Rockville, MD 20852
Andrew Lewis, Ph.D.
Chief, Laboratory of DNA Viruses
Head, Unit on Cell Substrates and
Adventitious Agents
Division of Viral Products
OVRR/CBER
1401 Rockville Pike, HFM-457
Rockville, MD 20852
Arifa Khan, Ph.D.
Section Chief
Laboratory of Retrovirus Research
Division of Viral Products
OVRR/CBER
1401 Rockville Pike, HFM454
Rockville, MD 20852
Food & Drug Administration
Center for Biologics Evaluation & Research
Vaccines and Related Biological Products Advisory Committee
November
16-17, 2005
Consultants
DAY 2
Seth Hetherington, M.D. ** Mark Steinhoff, M.D. ***
Chief, Medical Officer Professor
VP Clinical Development International Health and Epidemiology
Inhibitex, Inc. Bloomberg School of Public Health
1165 Sanctuary Pkwy., Suite 400 Johns Hopkins University
Alpharetta, GA 30004 615 N. Wolfe Street
Baltimore, MD 21205
Lisa Jackson, M.D., M.P.H. ***
Senior Science Investigator Melinda Wharton, M.D., M.P.H. ***
Center for Health Studies Acting Deputy Director of the
Group Health Cooperative National Immunization Program
1730 Minor Avenue, Suite 1600 Centers for Disease Control and
Seattle, WA 98101 Prevention
1600 Clifton Road, N.E. (MS E61)
Pamela McInnes, D.D.S. *** Atlanta, GA 30333
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
Steven Piantadosi, M.D., Ph.D. ***
Director of Oncology
Biostatistics
Johns Hopkins Oncology Center
550 North Broadway, Suite 1103
Baltimore, MD 21205
Robin Robinson, Ph.D. ***
Senior Project Officer for the
Office of Research and Development
Coordination in the Office of Public
Health Emergency Preparedness
HHS/OPHEP/ORDC
200 Independence Avenue, S.W.
Humphrey Bldg., Rm. 638G
Washington, DC 20201
** Acting Industry Representative
*** Temporary Voting Members
Food & Drug Administration
Center for Biologics Evaluation & Research
Vaccines & Related Biological Products Advisory Committee
November
16-17, 2005
Speakers
Day 2
Sandra Steiner, Ph.D.
Microbiologist/Immunologist
Respiratory Diseases Branch, Immunology Laboratory
Division of Bacterial and Mycotic Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, NE (MS A-36)
Atlanta, GA 30333
Matthew R. Moore, M.D., M.P.H.
Commander, USPHS
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, GA 30333
Jan Poolman, Ph.D.
Director, Bacterial Vaccine R&D
GlaxoSmithKline, Inc.
2301 Renaissance Blvd.
Bldg. 510, PO Box 6154
King of Prussia, PA 19406
George Siber, M.D.
Executive Vice President and
Chief Executive Officer
Wyeth
401 North Middleton Road
Pearl River, NY 10965
Louis Fries, M.D.
Vice President, Clinical and Medical Affairs
ID Biomedical Corporation
Suite 103
6996 Columbia Gateway Drive
Columbia, MD 21045
FDA Participants
Douglas Pratt, M.D., M.P.H. Marion Gruber, Ph.D.
Chief, Clinical Trials Branch Associate Director for Regulatory
Division of Vaccines and Related Policy
Products Applications OVRR/CBER
OVRR/CBER 1401 Rockville Pike, HFM-481
1401 Rockville Pike, HFM-485 Rockville, MD 20852
Rockville, MD 20852