Richard McFarland, PhD, MD is the Chief Regulatory Officer at ARMI | BioFabUSA. Dr. McFarland comes to ARMI from the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career spanning 16 years involved review over an extensive range of products and policy development in numerous areas both inside FDA, across the federal government, and internationally. He spent more than a decade as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies and its predecessor office, the Office of Cellular, Tissue and Gene Therapies. In this position, he was heavily involved in policy development for tissue engineering, regenerative medicine, and alternatives to animal use in regulatory decision making. In addition to development of risk-based regulatory oversight paradigms within FDA, his interests included broader efforts to create an interlocking network of interagency efforts to foster growth of basic and translational science to support maturation of the overlapping fields of tissue engineering and regenerative medicine from primarily discovery science toward a stage of commercial development.
His position at ARMI will allow him to apply the knowledge and experiences gained by over the last decade and half in the field to ARMI’s efforts to establish an industrial common, in the form of a Manufacturing Innovation Institute within the Manufacturing USA network, with the aims to coalesce the field and provide a route for nascent product concepts to reach the marketplace. Bringing these products to the market will benefit critical U.S. public health needs and will provide the economic drivers needed to create new highly-skilled jobs.
Dr. McFarland, Ph.D., M. D. received his B.S., Ph.D., and M.D. from the University of North Carolina at Chapel Hill, and completed his anatomic/clinical pathology residency and immunopathology fellowship training at UT Southwestern in Dallas. Immediately prior to joining the FDA, he was on the faculty of the Pathology Department of the University of Texas Southwestern in Dallas. In addition to FDA policy documents he has co-authored over 25 articles in peer-reviewed articles journals including Nature, the Proceedings of the National Academy of Science (PNAS), and Blood.