Food and Drug Administration
Center for Biologics
Evaluation and Research
SUMMARY MINUTES
VACCINES AND RELATED
BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
Meeting # 92: November 18, 2002
Committee
Members
Dr.
Robert Daum, Chair
Dr.
Walter Faggett
*Ms.
Barbara Loe Fisher
Dr.
Judith Goldberg
Dr.
Audrey Manley
Dr.
Diane Griffin
Dr.
Sam Katz
Dr.
David Markovitz
Dr.
Gary Overturf
Dr.
Peter Palese
Dr.
Julie Parsonnet
Dr.
David Stephens
Dr.
Rich Whitley
Dr.
Pamela Diaz
Dr.
Richard Walker
Dr.
Dennis Kopecko
Dr.
Scott Stibitz
Dr.
Philip Boucher
Dr.
Neil Goldman
Consultants
Dr.
Estuardo Aguilar-Cordova
Executive
Secretary
Dr.
Jody Sachs
These summary minutes for the November 18, 2002 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on ______________________ .
I
certify that I participated in the November 18, 2002 Meeting of the Vaccines
and Related Biological Products Advisory Committee and that these minutes
accurately reflect what transpired.
_____________________________
______________________________
Jody
Sachs, D.P.M. Robert S. Daum, M.D.
Executive
Secretary Chair
The
Chair, Dr. Robert Daum, called the 92nd Meeting of the Vaccines and Related
Biological Products Advisory Committee to order at 1:00 p.m. EST on November
18, 2002. The meeting addressed the
review of intramural research programs of the Laboratory of Enteric and Sexually
Transmitted Diseases (LESTD), Office of Vaccines Research and Review (OVRR).
An Open Public Hearing session was announced. No public comment was offered.
This
meeting was held by a telephone conference call. The public was welcome to
attend the open portion of the meeting at the Food and Drug Administration,
Bldg 29B, Conference Room C, 29 Lincoln Drive, Bethesda, MD., for public
participation. A speakerphone was provided at the specified location.
Following is a summary of the discussion. Additional information and specific details may be obtained from the transcript of the meeting. The transcript may be viewed on the World Wide Web at: http://www.fda.gov/ohrms/dockets/ac/02acsdocs.htm. A copy of the agenda is attached.
Proceedings
were adjourned at approximately 2:40 p.m. EST on November 18, 2002.
Open Session
Brief Overview of the CBER Laboratories that
underwent a Site Visit:
Dr. Richard Walker, Director
of the Division of Bacterial, Parasitic & Allergenic Products presented an
overview of the Division of Bacterial, Parasitic & Allergenic Products. Dr. Neil Goldman, Assoc. Director for Research in
the Office of the Center Director, and Dr. Karen Midthun, Director, Office of
Vaccines Research and Review responded to questions regarding the site visit
process.
Dr.
Dennis Kopecko, Chief of the Laboratory Enteric and Sexually Transmitted
Diseases, (LESTD),
presented an overview of all research and accomplishments from LESTD
Laboratory.
Dr.
Scott Stibitz and Dr. Philip Boucher then presented their laboratory research
activities to the committee, followed by discussion.
The
Closed Session followed.