Title: First-in-Human Trials of Cellular Therapies
Speaker: John Hyde, M.D., Ph.D,
Medical Officer, Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
Presented April 15, 2013
This presentation was part of the webinar event, "Clinical Trials: Moving Stem Cell based Therapies to the Clinic - Presentations from FDA and Leading Experts" hosted by CIRM and the Regenerative Medicine Consortium. The focus of the webinar is on the lessons learned from IND/Phase I trials including overcoming the challenges, and addressing the regulatory issues, as stem cell based therapies move towards the clinic.
Visit the webinar agenda page, for more details including the speakers' Power Point presentations
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