FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
April 10 - 11, 2008
Hilton Hotel, Gaithersburg, Maryland
AGENDA
April 10, 2008
OPEN COMMITTEE DISCUSSION
Cellular Therapies Derived from Human Embryonic Stem Cells Scientific Considerations for Pre-Clinical Safety Testing
9:00 a.m. Welcome and Introduction of Members
Walter Urba, M.D., Ph.D., Chair
9:10 Conflict of Interest Statement
Gail Dapolito, Executive Secretary
9:15 FDA Introduction: Scope and Limitations
Steven Bauer, Ph.D.
Chief, Cell and Tissue Therapy Branch
Division of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research, FDA
Guest Presentations
Developing a Safe hESC-Product for Diabetes
9:30 Melissa K. Carpenter, Ph.D.
Vice President of Research and Development
Novocell, Inc.
9:50 Q&A
10:00 Safety Considerations for the Clinical Application of Human Embryonic Stem Cells
Jonathan Dinsmore, Ph.D.
Senior Vice President, Clinical and Regulatory
Advanced Cell Technology and Mytogen, Inc.
10:20 Q&A
10:30 Human Embryonic Stem Cells : Consideration for Therapeutic
Development
Jane S. Lebkowksi, Ph.D.
Senior Vice President of Regenerative Medicine
Geron Corporation
10:50 Q&A
11:00 a.m. Break
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
April 10, 2008
Hilton Hotel, Gaithersburg, Maryland
AGENDA
April 10, 2008
Guest Presentations (Cont’d)
11:15 a.m. Preclinical Evaluation of Human Stem Cells for Safety and Function: Examples from Neuronal Transplantation in Animal Models of
Parkinson’s Disease
Ole Isacson, M.D.
Director, Center for Neuroregeneration Research
McLean Hospital/Harvard Medical School
11:45 Q&A
11:55 Tracking Cells After Administration: Are They Delivered Correctly, Where Do They Go, and What Do They Become? Jeffrey Bulte, Ph.D.
Professor of Radiology, Biomedical Engineering and
Chemical Engineering & Biomolecular Engineering
Johns Hopkins University
12:25 p.m. Q&A
12:35 OPEN PUBLIC HEARING
1:05 Lunch
2:05 Committee Discussion of Questions
4:00 Break
6:00 p.m. Adjourn
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
April 10-11, 2008
Hilton Hotel, Gaithersburg, Maryland
AGENDA
April 11, 2008
RESEARCH and REGULATORY UPDATES
8:00 a.m. Welcome and Introduction of Members
Walter Urba, M.D., Ph.D., Chair
8:05 Conflict of Interest Statement
Gail Dapolito, Executive Secretary
8:10 Recognition of Committee Service
Karen Midthun, M.D.
Deputy Director
Center for Biologics Evaluation and Research, FDA
8:20 Update – Research Program, Office of Cellular, Tissue and Gene Therapies (OCTGT)
Response to September 2005 Review of OCTGT Research Program
Carolyn Wilson, Ph.D.
Acting Associate Director for Research
Center for Biologics Evaluation and Research (CBER)
Suzanne Epstein, Ph.D.
Associate Director for Research
Office of Cellular, Tissue and Gene Therapies, CBER
9:20 Q&A
9:30 Break
9:45 OPEN PUBLIC HEARING
10:15 Update - FDA Somatic Cell Therapy Letter
Kimberly Benton, Ph.D.
Deputy Director, Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies, CBER
10:45 Q&A
10:50 Update - OCTGT Guidance Development Program
Richard McFarland, Ph.D., M.D.
Associate Director for Policy
Office of Cellular, Tissue and Gene Therapies, CBER
11:20 Q&A
11:25 a.m. Adjourn