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November 29, 2012: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Summary Minutes

Food and Drug Administration
Center for Biologics Evaluation and Research
Cellular, Tissue and Gene Therapies Advisory Committee

SUMMARY MINUTES
Meeting # 56, November 29, 2012
National Institutes of Health, Building 29B, Conference Room A/B
Bethesda, MD

 

COMMITTEE MEMBERSFDA PARTICIPANTS
Evan Y. Snyder, M.D., Ph.D.. ChairAndrew Byrnes, Ph.D.
Tabassum Ahsan, Ph.D.Suzanne Epstein, Ph.D.
Michael R. Bishop, M.D., FACP+Wu Ou, M.D.
Scott Bruder, M.D., Ph.D.*Graeme Price, Ph.D.
Larry A. Couture, Ph.D.Raj Puri, M.D., Ph.D.
Timothy P. Cripe, M.D., Ph.D.Jakob Reiser, Ph.D.
Linda A. Dahlgren, D.V.M., Ph.D., DACVSStephanie Simek, Ph.D.          
Leisha A. Emens, M.D., Ph.D.Cheng-Hong Wei, Ph.D.
John D. Gearhart, Ph.D.Carolyn Wilson, Ph.D.
Steven A. Goldman, M.D., Ph.D.+.Celia Witten, Ph.D., M.D.
Francis Hornicek, Ph.D., M.D. 
Patrick Hwu, M.D.+ 
Mei-Ling Ting Lee, Ph.D. 
Stephen M. Rose, Ph.D.** 

* - Industry Representative
** - Consumer Representative
+ - Not Attending  

 

The summary minutes for the November 29, 2012 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee were approved on January 21, 2013.

I certify that I attended the November 29, 2012 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and that this report accurately reflects what transpired.

 

//s////s//
Evan Snyder, M.D., Ph.D., Chair
Cellular, Tissue and Gene Therapies
Advisory Committee, FDA
Gail Dapolito, Designated Federal Officer
Cellular, Tissue and Gene Therapies
Advisory Committee, FDA

 

The Cellular, Tissue and Gene Therapies Advisory Committee met by teleconference on November 29, 2012.  Dr. Evan Snyder, Chair, opened the meeting.  The Designated Federal Officer called the roll and read a statement into the public record that it was determined that the Committee discussion on November 29 presented no potential for a conflict of interest. The Committee Members and FDA participants were introduced.   Time was allotted during the meeting for public comment. No individuals from the public requested time at the meeting to address the Committee.

 

Open Session
In open session, the Committee heard presentations on the following:

  • Overview of research and regulatory activities in the Center for Biologics Evaluation and Research (CBER) and the Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER, FDA
  • Overview of research and regulatory activities in the Division of Cellular and Gene Therapies (DCGT), OCTGT, CBER, FDA
  • Summary of individual research programs in the Gene Transfer and Immunogenicity Branch, DCGT, OCTGT, CBER, FDA.

Following the presentations and the open public hearing the open session was adjourned.

For more detailed information concerning the open session presentations and committee discussions summarized above, please refer to the meeting transcripts available on the FDA website.  Please submit all external requests to the FDA Freedom of Information Office.