Claude Nicaise M.D. Head, Strategic Orphan Regulatory Affairs Claude Nicaise, M.D., is head, strategic orphan regulatory affairs at Ovid Therapeutics. He is a respected executive with over 20 years of significant product development experience, particularly in orphan diseases. Prior to joining Ovid, Claude was an executive vice president of clinical development and regulatory affairs at Formula Pharmaceuticals, Inc. Before that, he was senior vice president, strategic product development and global regulatory affairs at Alexion Pharmaceuticals, where he managed all regulatory activities and co-managed development programs with the head of R&D and designed, interpreted and filed all programs supporting development in rare diseases. Prior to joining Alexion, Claude served in various positions of increasing responsibility at Bristol-Myers Squibb for 24 years. Claude holds an M.D. from the Université libre de Bruxelles in Belgium. Claude is the author of more than 60 research articles published in peer-reviewed journals and is a member of several professional medical associations, including the American Society of Clinical Oncology; the European Society for Medical Oncology; the American Society for Microbiology; and the American Society of Hematology.

clinical development and regulatory affairs