Keith M. Wonnacott｜前美国 FDA 官员 诺华制药法规事务总监

Keith M. Wonnacott, Ph.D.
Director of Regulatory Affairs，Novartis Pharmaceuticals，Cell and Gene Therapies Unit

Keith Wonnacott 博士在细胞和基因治疗法规事务领域拥有 14 年的从业经验。2015 年 1 月，他加入了诺华制药细胞和基因治疗部门，任法规事务总监。期间，他负责细胞和基因治疗发展的法规战略和政策。来诺华公司之前，Wonnacott 博士任职于美国 FDA 生物制品评估和研究中心，领导细胞治疗部门，负责细胞治疗包括干细胞、异体胰岛 CMC 审核、免疫疗法、癌症疫苗、异种器官移植和组织工程产品。Wonnacott 博士已发表许多关于细胞治疗监管的文章和书籍。

Dr. Keith Wonnacott has 14 years of regulatory experience in the field of cell and gene therapies.  He joined Novartis Pharmaceuticals as a director of regulatory affairs in the Cell and Gene Therapy Unit in January 2015.  In this role he advises on regulatory strategy and policy for cell and gene therapies.  Prior to Novartis, Dr. Wonnacott was the Chief of the Cellular Therapies Branch at the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA).  His branch was responsible for the CMC review for all cellular therapies including stem cells, allogeneic pancreatic islets, immunotherapies, cancer vaccines, xenotransplantation products, and tissue engineered products.  Dr. Wonnacott has published several articles and book chapters on the regulation of cellular therapies.

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