Seizing the day: addressing the urgent need for standards development in regenerative medicine

David McCall, Editor, Cell & Gene Therapy Insights, speaks to Richard McFarland, President of the Standards Coordinating Body for Regenerative Medicine (SCB), Chief Regulatory Officer of the Advanced Regenerative Manufacturing Institute (ARMI), and Principal Consultant of BioFabConsulting

Dr Richard McFarland is the President and Chairman of the Board of the Standards Coordinating Body for Regenerative Medicine. He is also serves as Chief Regulatory Officer at the Advanced Regenerative Manufacturing Institute (ARMI) where he oversees regulatory affairs for ARMI and its BioFabUSA program. Prior to joining ARMI in 2017, Dr McFarland served at the FDA’s Center for Biologics Evaluation and Research since 2000 in various positions. He was Associate Director for Policy of the Office of Tissues and Advanced Therapies (and its predecessor office) at the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) for eleven years after six years a reviewer. In addition, during his time at FDA he served on the several interagency standing committees including the Interagency Coordinating Committee for the Evaluation of Alternative Methods to animal use (ICCVAM) and, the Multi-agency Tissue Engineering Sciences group (MATES) for fifteen years, including five years as its Chair. MATES coordinated regenerative medicine efforts across the government.

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