Food and Drug Administration
Center for Biologics Evaluation and Research
SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
Meeting # 112: November 14, 2007
Teleconference Meeting
Committee Members FDA Participants
Dr. Ruth Karron, Chair Dr. Norman Baylor
Dr. Lisa Jackson Dr. Sheldon Morris
Dr. Jack Stapleton
Dr. Steven Self
Dr. Seth Hetherington*
Executive Secretary Committee
Management Specialist
Christine Walsh, R.N. Denise Royster
These summary minutes for the November 14, 2007 Meeting of the Vaccines and Related Biological products Advisory Committee were approved on ______11/28/07__________.
I certify that I participated in the November 14, 2007 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.
_______/s/__________________ __________/s/_______________
Christine Walsh, R.N. Ruth Karron, M.D.
Executive Secretary Chair
*Industry Representative
The Chair, Dr. Ruth Karron, called the one hundred and twelfth Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 1:05 p.m. ET on November 14, 2007. The meeting addressed the March 15, 2007 site visit of the intramural research programs of the Laboratory of Method Development, Division of Viral Products and the May 24, 2007 site visit of the Laboratory of Mycobacterial Diseases & Cellular Immunology, Division of Bacterial Parasitic & Allergenic Products, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER).
The meeting was held by telephone conference call. The public was welcome to attend the open
session of the meeting at the Food and Drug Administration, Building 29B,
Conference Room A/B,
An Open Public Hearing was announced. Public comment was offered via an electronic message from B. Sachau. Copies of the comment were provided to committee members, displayed in the public notebook at the meeting, and made part of the official meeting record. Public comment was offered by Dr. Jaya Gosh.
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/cber07.html#VaccinesandRelatedBiological.
Proceedings were adjourned at approximately 3:30 p.m. ET on November 14, 2007.
Open Session
The telephone conference meeting focused on the intramural research programs of the Laboratory of Method Development, Division of Viral Products and the Laboratory of Mycobacterial Diseases & Cellular Immunology, Division of Bacterial Parasitic & Allergenic Products, Office of Vaccines Research and Review (OVRR). The committee heard presentations on the overview of the Laboratory Site Visit process and overview of the Office of Vaccines Research and Review from Dr. Michael Brennan, an overview of the Division of Viral Products from Dr. Jerry Weir and an overview of the Division of Bacterial Parasitic & Allergenic Products from Dr. Milan Blake. The committee also heard presentations to include overviews of each research Laboratory from Dr. Konstantin Chumakov, Laboratory of Method Development and Dr. Sheldon Morris, Laboratory of Mycobacterial Diseases & Cellular Immunology.
Closed Session
The committee discussed the site visit reports from the March 15, 2007, Laboratory of Method Development and the May 24, 2007 Laboratory of Mycobacterial Diseases & Cellular Immunology. The committee approved the site visit reports.