Raw & starting materials for cell and gene therapies

Gary C du Moulin, PhD MPH, RAC retired as Vice President, Quality Operations at Genzyme Biosurgery and Senior Director of Quality Aseptic Control for Genzyme (A Sanofi Company) after a 20 year career in the development and execution of quality systems for Genzyme’s products including biologics and the FDA approved cell based therapeutics, Carticel and Epicel. Previously, he served as Vice President, Quality Operations at Cellcor, a pioneering company in the field of somatic cell immunotherapy based upon the infusion of T cells that have been activated ex vivo using a combination of previously generated cytokines and an anti-CD3 monoclonal antibody. Before entering the field of cell therapy he began an academic career on the faculty of Harvard Medical School and has 160 publications in the areas of microbiology, epidemiology, and the regulation and quality control of living cells as a therapeutic modality. Dr du Moulin received his graduate degrees from Northeastern University and Boston University School of Medicine. Dr du Moulin has served on US Pharmacopoeia’s Gene Therapy, Cell Therapy, and Tissue Engineering Expert Committees and chaired the ad hoc advisory panel for fetal bovine serum. He currently serves on the Modern Microbiological Methods Expert Panel. He has served on the editorial board of Regenerative Medicine and is RAC certified and past Chairman of the editorial board of the Regulatory Affairs Professionals Society Magazine, RAPS Focus. Dr du Moulin was appointed to the Grants Review Working Group of the California Institute for Regenerative Medicine (CIRM). He is retired from the US Army Reserve at the rank of Colonel after 38 years of service. He has held academic appointments at Harvard Medical School, Boston University School of Medicine, Northeastern University, and most recently has completed a teaching assignment at the Massachusetts College of Pharmacy and Health Sciences University where he taught graduate pharmacists a course entitled, “Principles of Quality Assurance and Quality Control in a Regulated Environment”. Dr du Moulin continues to consult in the cell and gene therapy sector and helps develop STEM programming for youth-based non-profit organizations.

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