Ellen Feigal, M.D., Senior Vice President of Research and Development, CIRM
• 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)
• Eduardo Marbán, M.D., Ph.D., Founder and Chairman of Scientific Advisory Board, Capricor, Inc. and Director, Cedars-Sinai Heart Institute, Mark S. Siegel Family Professor
• Jonathan D. Glass, M.D., Professor, Neurology and Pathology, Emory University School of Medicine
The focus of this 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.
• Presentation by FDA – Considerations for Early Phase Clinical Trial Design in Cellular Therapies- issues the FDA considers in evaluating the risks vs. benefits of early phase trial proposals
• Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients
• Lessons learned from Phase I trial of autologous cardiosphere-derived stem cell product for myocardial infarction and comparison to new allogeneic trial with the same indication
• Questions and Answers
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