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April 17, 2013 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 # 58, April 17, 2013
National Institutes of Health, Building 29B, Conference Room C
Bethesda, MD

COMMITTEE MEMBERS FDA PARTICIPANTS
Evan Y. Snyder, M.D., Ph.D. Chair
Tabassum Ahsan, Ph.D.
Michael R. Bishop, M.D., FACP+
Scott Bruder, M.D., Ph.D.*
William Bugbee, M.D.+
Larry A. Couture, Ph.D.
Timothy P. Cripe, M.D., Ph.D.
Linda A. Dahlgren, D.V.M., Ph.D., DACVS
Leisha A. Emens, M.D., Ph.D.
John D. Gearhart, Ph.D.
Steven A. Goldman, M.D., Ph.D.
Patrick Hwu, M.D.+
Mei-Ling Ting Lee, Ph.D.
Stephen M. Rose, Ph.D.**
* - Industry Representative
** - Consumer Representative
+ - Not Attending
Serge Beaucage, Ph.D.
Jacek Cieslak, Ph.D.
Kula Jha, Ph.D.
Gibbes Johnson, Ph.D.
Steven Kozlowski, M.D.
Edward Max, M.D., Ph.D.
Amy Rosenberg, M.D.

The summary minutes for the April 17, 2013 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee were approved on April 27, 2013.

I certify that I attended the April 17, 2013 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 April 17, 2013.  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 April 17 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 Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), FDA
  • Overview of research and regulatory activities in the Division of Therapeutic Proteins,  OBP, CDER FDA
  • Summary of individual research programs in the Laboratory of Chemistry, DTP, CDER, 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 at the 2013 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee page.

Please submit all external requests to the FDA Freedom of Information Office.