Lawrence Starke

Dr. Starke is currently the global head of Regulatory CMC Policy and Intelligence for cell and gene therapy products at Novartis and is responsible for the development of harmonized CMC regulatory strategies that streamline the development and approval of these products across the Novartis portfolio. He has overseen CMC teams responsible for all phases of CGT development and lifecycle management including global submissions and approvals of three cell and gene therapy products. In addition to his role as the Novartis representative on multiple trade organizations (e.g. ARM, EFPIA, Friends of Cancer Research, BIO, PhRMA), Dr. Starke co-leads the manufacturing subteam of the BeSpoke Gene Therapy Consortium (BGTC) comprised of participants from the National Institutes of Health, FDA, industry, and non-profit organizations. The goal of BGTC is to develop a CMC strategy to streamline and expedite availability of gene therapies for rare- and ultra-rare diseases for which there is no current commercial interest. Dr. Starke also represents PhRMA on the ICH Discussion Group for Cell and Gene Therapies. Prior to joining Novartis, Dr. Starke held management positions of increasing responsibility at Eli Lilly, Merck and Co., and Schering Plough and holds a Ph.D. in cell and molecular biology from Duke University.

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