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Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee

April 10-11, 2008


April 10, 2008

Safety of Cell Therapies Derived from Human Embryonic Stem Cells, Steven Bauer, Ph.D., DCGT, OCTGT, FDA (ptt) (htm)

Developing a Safe hESC-Product for Diabetes, Melissa Carpenter, Ph.D., Novocell (ptt) (htm)

Safety Considerations for the Clinical Application of Human Embryonic Stem Cells, Jonathan Dinsmore, Ph.D., Advanced Cell Technology (ptt) (htm)

Human Embryonic Stem Cells: Considerations for Therapeutic Development, Jane Lebkowski, Ph.D., Geron Corp. (ptt) (htm)

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., Harvard Medical School (ptt) (htm)

Tracking Cells After Administration:  Are They Delivered Correctly, Where Do They Go, and What Do They Become, Jeffrey Bulte, Ph.D., The Johns Hopkins University School of Medicine  (pdf)

April 11, 2008

CBER Research Office Site Visit, Carolyn Wilson, Ph.D., CBER, FDA (ptt) (htm)

OCTGT Office Site Visit, Report and Response, Suzanne Epstein, Ph.D., OCTGT, CBER, FDA (ptt) (htm)

Update on the Somatic Cell Therapy Letter, Kimberly Benton, Ph.D., DCGT, CBER, FDA  (ptt) (htm)

Update on OCTGT Guidance Development Program, Richard McFarland, Ph.D., M.D., OCTGT, CBER, FDA  (ptt) .htm)

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Page last updated May 1, 2008 kkhorizonal rule
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