Food and Drug Administration
Center for Biologics Evaluation and Review
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
November 13, 2013
|Committee Members||FDA Participants|
|Dr. Robert Daum, Chair|
Dr. Gillian Air
Dr. Michael Hudgens
Dr. Pedro Piedra
Dr. Ambrose Cheung
Dr. Anna Durbin #
Dr. Gregory Gray
Dr. Gary Schoolnik
Dr. Carol Tacket
Dr. Edgar Marcuse
Dr. Kent Kester +
Dr. Theordore Tsai **+
Dr. Stephanie Christner *
|Dr. Carolyn Wilson|
Dr. Konstantin Chumakov
Dr. Jerry Weir
Dr. Hana Golding
Dr. Carol Weiss
Dr. Ira Berkower
Dr. Marion Gruber
|Designated Federal Official||Committee Management Specialist|
|Donald Jehn, M.S.||Rosanna Harvey|
These summary minutes for the November 13, 2013 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on November 19, 2013.
I certify that I participated in the November 13, 2013 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.
|/// original signed///||/// original signed///|
|Donald Jehn, M.S. |
Designated Federal Official
|Robert Daum, M.D.|
# Chair for Site Visit Review of Laboratory of Retrovirus Research and Laboratory of Immunoregulation
** Industry Representative
+ Did not attend
The Chair, Dr. Robert Daum, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 12:30 p.m. EST on November 13, 2013. The meeting addressed the June 4, 2013 site visit of the intramural research programs of the Laboratory of Retrovirus Research (LRR) and Laboratory of Immunoregulation (LIR), Division of Viral Products (DVP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER).
The meeting was held by telephone conference call and adobe connect. The public was welcome to attend the open session of the meeting at the Food and Drug Administration, Rockwall II Bldg, Conference Room 1033, 5515 Security Lane, Rockville, 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 World Wide Web at the 2013 Vaccines and Related Biological Products Advisory Committee Meetings main page.
Proceedings were adjourned at approximately 3:30 p.m. EST on November 13, 2013.
The telephone conference meeting focused on the intramural research programs of the Laboratory of Retrovirus Research and Laboratory of Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review. The committee heard presentations of an overview of the Research Site Visit Process and OVRR’s research programs from Dr. Carolyn Wilson, an overview of the Division of Viral Products from Dr. Jerry Weir, an overview of the Laboratory of Retrovirus Research from Dr. Hana Golding and an overview of the Laboratory of Immunoregulation from Carol Weiss.
The committee discussed the site visit report of June 4, 2013 with Dr. Durbin giving an overview of the report. The committee approved this report with minor administrative modifications.