NOW ENROLLING PHASE III sunRIZE TRIAL In the study of congenital hyperinsulinism

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Susan Stewart, JD, LL.M

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Susan Stewart, J.D. has more than 30 years of experience in biopharmaceutical regulatory affairs and quality assurance, overseeing and developing innovative regulatory strategies and leading interactions with global health authorities for drugs and biologics aimed at addressing unmet medical needs. In addition to being an independent regulatory consultant for several years, she is chief regulatory officer for Candel Therapeutics and previously was CRO at Frequency Therapeutics and Kaleido Biosciences. Prior to that, she was senior vice president of regulatory affairs, quality and compliance at Tokai Pharmaceuticals and vice president, regulatory affairs at Transmolecular Therapeutics. She also spent 13 years at Genzyme Corporation (Sanofi) in regulatory and compliance roles, including serving as vice president, regulatory affairs, after beginning her career with Abbott Laboratories in regulatory and quality positions. She is the regulatory advisor for The Termeer Foundation.

Susan received her J.D. from Concord Law School at Purdue University Global, her LL.M from the Maurice A. Deane School of Law, Hofstra University, and her B.A. from the University of Massachusetts. Sue is a Fellow of the Regulatory Affairs Professionals Society and holds both US and EU RAC certifications.