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December 15, 2009: Vaccines & Related Biological Products Advisory Committee Meeting Summary Minutes

Food and Drug Administration
Center for Biologics Evaluation and Research

SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

December 15, 2009
Teleconference Meeting

Committee Members

Dr. John Modlin, Chair
Dr. Lisa Jackson
Dr. Jack Stapleton
Dr. Jose Romero
Dr. Pablo Sanchez
Dr. Frank DeStefano
Dr. Peter Gilbert
Dr. Vicky DeBold
Dr. Margaret Rennels *
 

FDA Participants

Dr. Carolyn Wilson
Dr. Konstantin Chumakov
Dr. Jerry Weir
Dr. Ira Berkower
Dr. Hana Golding
Dr. Norman Baylor
 

Designated Federal Official
Christine Walsh, R.N.
Committee Management Specialist
Denise Royster

These summary minutes for the December 15, 2009 Meeting of the Vaccines and Related Biological products Advisory Committee were approved on  February 5, 2010.

I certify that I participated in the December 15, 2009 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.

________/s/_____________________________/s/_________________
Christine Walsh, R.N.
Designated Federal Official
 
John Modlin, M.D.
Chair

*Industry Representative – attended Open Session Only

The Chair, Dr. John Modlin, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 1:30 p.m. ET on December 15, 2009.  The meeting addressed the June 11-12, 2009 site visit of the intramural research programs of the Laboratory of Retroviruses, Laboratory of Immunoregulation, and Laboratory of Respiratory Viruses, Division of Viral 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 29, Conference Room 121, Bethesda, MD.  A speakerphone was provided at the specified location for public participation.

An Open Public Hearing was announced.  No public comment was offered.

 
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 2009 Meeting Materials page of the Vaccines and Related Biological Products Advisory Committee. Proceedings were adjourned at approximately 4:20 p.m. ET on December 15, 2009.

Open Session

The telephone conference meeting focused on the intramural research programs of the Laboratory of Retroviruses, Laboratory of Immunoregulation, and Laboratory of Respiratory Viruses, Division of Viral Products, Office of Vaccines Research and Review (OVRR).  The committee heard presentations on the overview of the Laboratory Site Visit process from Dr. Carolyn Wilson, an overview of the Office of Vaccines Research and Review from Dr. Konstantin Chumakov, and overview of the Division of Viral Products from Dr. Jerry Weir. The committee also heard presentations to include overviews of each research Laboratory from Dr. Jerry Weir, Laboratory of Respiratory Viruses; Dr. Ira Berkower, Laboratory of Immunoregulation; and Dr. Hana Golding, Laboratory of Retroviruses.

Closed Session

The committee discussed the site visit report from the June 11-12, 2009 Site Visit.  The committee approved the site visit report without modification.