Speaker

Deborah Hursh is a senior investigator and CMC reviewer in the Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies at CBER, FDA. She received a Ph.D. in Molecular, Cellular and Developmental Biology from Indiana University and did postdoctoral work in the Dept. of Cellular and Developmental Biology at Harvard University. At FDA, Dr. Hursh evaluates products derived from stem cells and participates in policy development in the areas of stem cells and assisted reproduction. She was the review chair of the Humanitarian Device Exemption review committee resulting in the approval of the Miltenyi CliniMACS CD34 Reagent System, a Class III device used to select stem cells. In addition to her regulatory activities, she is the Principal Investigator of a research lab studying issues relevant to the safety and effectiveness of cell therapy products.

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