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U.S. Department of Health and Human Services

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May 31, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Minutes

SUMMARY MINUTES
Meeting # 51, May 31, 2011
National Institutes of Health, Building 29B, Conference Room A/B
Bethesda, MD

COMMITTEE MEMBERSTEMPORARY VOTING MEMBER
Steven Dubinett, M.D., Chair
Tabassum Ahsan, Ph.D.
Larry A. Couture, Ph.D.
Linda A. Dahlgren, D.V.M., Ph.D., DACVS
Evanthia Galanis, M.D.
Steven A. Goldman, M.D., Ph.D.
Mary Horowitz, M.D., M.S.    
Mei-Ling Ting Lee, Ph.D.
Mahendra S. Rao, M.D., Ph.D.*+
Peter L. Saltonstall**+
Evan Y. Snyder, M.D., Ph.D.

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

Matthew Allen, Vet., M.B., Ph.D.
 FDA PARTICIPANTS

 


 

Kurt Brorson, Ph.D.
Kathleen Clouse, Ph.D.
David Frucht, M.D.
Dianne Hirsch, Ph.D.
Steven Kozlowski, M.D.
Edward Max, Ph.D.
Ashutosh Rao, Ph.D.
Amy Rosenberg, M.D.
Emily Shacter, Ph.D.
Tzanko Stantchev, M.D.   
Patrick Swann, Ph.D.
Mate Tolnay, Ph.D.
Wendy Weinberg, Ph.D.
Wen Jin Wu, M.D., Ph.D.
Baolin Zhang, Ph.D.

Designated Federal OfficerCommittee Management Specialists
Gail DapolitoJoanne Lipkind, M.S.
Sheryl Clark, M.B.A.

The summary minutes for the May 31, 2011 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee were approved on  August 4, 2011.

I certify that I attended the May 31, 2011 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and that this report accurately reflects what transpired.

            //s//                
Steven Dubinett, M.D.
 

             //s//                         
Gail Dapolito

The Cellular, Tissue and Gene Therapies Advisory Committee met by teleconference on May 31, 2011.  Dr. Steven Dubinett, 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 May 31 presented no potential for a conflict of interest. FDA participants were introduced and 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 activities in the Division of Therapeutic Proteins (DTP) and Laboratory of Biochemistry, DTP, OBP, CDER, FDA
  • Overview of research activities in the Division of Monoclonal Antibodies (DMA) and the Laboratory of Cell Biology, Laboratory of Molecular and Developmental Immunology and the Laboratory of Molecular Immunology, DMA, OBP, CDER

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.