Center for Biologics Evaluation and
Research
Cellular, Tissue and Gene Therapies
Advisory Committee
SUMMARY MINUTES
Teleconference
Meeting #42, November 20, 2006
National Institutes of Health
Building 29, Room 115
COMMITTEE MEMBERS TEMPORARY VOTING MEMBER
James
J. Mulé, Ph.D., Chair David M. Harlan, M.D., Site Visit
Chair
Matthew J. Allen, Vet. M.B.,
Ph.D.
Michéle P. Calos, Ph.D.
Jeffrey S. Chamberlain, Ph.D.
Richard J. Chappell, Ph.D.
Stanton L. Gerson, M.D. FDA PARTICIPANTS
Kurt C. Gunter, M.D. * Kathryn
Carbone, M.D.
Farshid Guilak, Ph.D. Kathleen
Clouse, Ph.D.
Larry W. Kwak, M.D., Ph.D. Steven Kozlowski, M.D.
Doris A. Taylor, Ph.D. Barbara
Rellahan, Ph.D.
Sharon F. Terry, M.S.**+ Amy Rosenberg,
M.D.
William W. Tomford, M.D.* Daniela Verthelyi,
M.D., Ph.D.
Walter Urba, M.D., Ph.D. Keith Webber,
Ph.D.
Savio L.C. Woo, Ph.D. Wendy
Weinberg, Ph.D.
Executive Secretary Committee Management Specialist
Gail Dapolito Rosanna
Harvey
The summary minutes for the
November 20, 2006 meeting of the Cellular, Tissue and Gene Therapies Advisory
Committee were approved on May 7, 2007.
I certify that I attended the
November 20, 2006 meeting of the Cellular, Tissue and Gene Therapies Advisory
Committee and that this report accurately reflects what transpired.
//s// //s//
___________________________ ______________________________
Gail Dapolito, Executive
Secretary James J. Mulé
Ph.D., Chair
+Not Attending
*Industry
Representative
**Consumer
Representative
FDA Cellular, Tissue and Gene Therapies
Advisory Committee
Summary Minutes
Meeting #42, November 20, 2006
The Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met by teleconference on November 20, 2006. Dr. James Mulé, Chair opened the meeting and called the roll. The Executive Secretary read a statement into the public record that it was determined that the Committee discussions on November 20, 2006 presented no potential for a conflict of interest. Time was allotted during the meeting for public comment. No individuals from the public requested time at the meeting to address the Committee on the issue at hand.
Open Session
In open session, the Committee received 1) an overview of the research and regulatory activities in the Divisions of Therapeutic Proteins and Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research and, 2) an overview of individual research programs in the Laboratory of Immunology, Division of Therapeutic Proteins and the Laboratory of Immunobiology, Division of Monoclonal Antibodies. Following the research overviews and the open public hearing, the open session was adjourned.
For more detailed information concerning the open session presentations
and committee discussion summarized above, please refer to the meeting
transcripts available on the FDA website at http://www.fda.gov/ohrms/dockets. Please submit all external requests to the
FDA Freedom of Information Office.