De-risking the Manufacturing of Cell Therapies through Virus-Inactivated Products

Robert Margolin, Vice President of Global Sales, Akron Biotech

Robert Margolin brings 14 years of business leadership and sales experience in the cell and gene therapy market, with a focus on business development and corporate strategy and execution. His experience ranges across cell therapy drug product and ancillary material manufacturing. Robert’s deep knowledge of clinical and commercial operations has driven process development, scale-up, and design and configuration of electronic systems and logistics platforms for each stage of development. Robert has worked closely with the field’s leading companies and industry organizations throughout the U.S. and Europe. Additionally, Robert played an instrumental role in the formation and growth of the Alliance for Regenerative Medicine, serving as its Vice President of Communications, along with launching several of the field’s preeminent conferences and events. Robert’s network spans the entire industry encompassing KOLs from business, science, medicine, regulatory, policy and advocacy.

Richard McFarland, PhD, President, Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) & Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI)

Dr. Richard McFarland came 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 of an extensive range of products, and policy development in numerous areas 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 (OTAT) and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).

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. In his position at ARMI, he applies his knowledge and experiences to ARMI’s creation of a Manufacturing Innovation Institute within the Manufacturing USA network, to coalesce the field and get tissue-engineered and ancillary products the marketplace. In addition to FDA policy documents, he has co-authored over 25 articles in peer-reviewed articles journals including Nature, Proceedings of the National Academy of Science (PNAS), Science-Translational Medicine, and Blood.