Our Leadership Team
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Andrew E. Mulberg, MD, FAAP, CPI
Head, Global Regulatory Affairs Andrew is currently an Executive pharmaceutical leader leading strategy and operational aspects of drug and biological development for NDA and BLA submissions for pediatric and adult rare diseases, cystic fibrosis, gastroenterology and hepatology. He is currently Senior Vice President, Regulatory Affairs at Neurogene Inc, a company devoted to gene therapy approaches to management of neurodegenerative and neurodevelopmental disorders in children and adults. Formerly, he served Senior Vice President, Global Regulatory Affairs at Amicus Therapeutics from 2016-2020 and responsible for the approval of Galafold (migalastat) for the treatment of Fabry disease in adults. He has been involved in the registration planning for AT-GAA, a novel enzyme replacement therapy for Pompe disease in infants, children and adults. He served as Division Deputy Director of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) since 2010-2016. Before joining FDA, Andrew was Portfolio Leader in Established Products responsible for worldwide leadership of Internal Medicine products in Johnson and Johnson from 2000-2010. Andrew is a graduate of Columbia College of Columbia University and of the Mount Sinai School of Medicine. He completed his residency in Pediatrics at the Children’s Hospital of Philadelphia followed by a Pediatric Gastroenterology Clinical Fellowship and a Post-Doctoral Fellowship in Cellular and Molecular Physiology at New England Medical Center. Andrew is Adjunct Professor of Pediatrics at the University of Maryland School of Medicine and has served as Attending, Pediatric Gastroenterology and Nutrition at Cooper University Hospital in New Jersey caring for children with gastrointestinal diseases. He is Principal Editor of Pediatric Drug Development: Concepts and Applications published in 2011 and 2013. He is a member of Alpha Omega Alpha Honor Medical Society, American Gastroenterological Association and the North American Society for Pediatric Gastroenterology and Nutrition.
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