The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is pleased to present the following lecture:
Perspectives on Rare Diseases and Gene Therapies
Wednesday, April 19, 2016 | 4:30 - 5:30 PM
Stanford University
Li Ka Shing Center Room 101, 291 Campus Drive, Palo Alto, CA 94305
Registration Link: https://www.eventbrite.com/e/fda-lecture-perspectives-on-rare-diseases-and-gene-therapies-tickets-33588485063
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Ilan Irony, MD Deputy Division Director |
Dr. Irony will present an overview of the FDA structure and describe the Office of Tissues and Advanced Therapies within the Center for Biologics Evaluation and Research, then move to a quick overview of the FDA’s regulation of Orphan Products and how we regulate and promote development of gene therapies for rare diseases.
Ilan Irony, MD is an internist and endocrinologist, who joined the FDA Center for Biologics Evaluation and Research (CBER) in September of 2000 as a clinical reviewer after 6 years in group medical practice in the Washington DC area and post-doctoral training at UCSF and NIH. He transferred to the Division of Metabolism and Endocrinology Products in the FDA Center for Drug Evaluation and Research in 2005, and became a clinical team leader in 2009. Since December 2011, he has been back to CBER as the chief of the General Medicine Branch, which is part of the Division of Clinical Evaluation and Pharmacology / Toxicology in the Office of Tissues and Advanced Therapies and more recently as Deputy Division Director. Dr. Irony wrote or contributed to FDA draft and final guidances, and actively participates in scientific and regulatory working groups within and outside FDA. He oversees the clinical aspects of regulatory applications for cellular and gene products intended for treatment of non-oncology diseases and conditions.
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