Kimberley Cummings, Ph.D., RAC is a regulatory affairs executive with more than two decades of experience leading global regulatory strategy across pharmaceutical and medical device development, with a particular focus on rare diseases and combination products. Dr. Cummings most recently served as Senior Vice President of Regulatory Affairs & Clinical Development at Neurogastrx, where she advanced programs targeting gastrointestinal disorders. Prior to that, she was Vice President of Regulatory Affairs at Levo Therapeutics, overseeing late-stage development for a rare neuroendocrine condition.
Earlier in her career, Dr. Cummings held senior consulting roles at global CROs, where she led cross-functional teams and regulatory submissions spanning all phases of development. She is recognized for her expertise in FDA interactions, orphan drug designations, and strategic alignment across regulatory, clinical, and quality functions. Dr. Cummings earned her Ph.D. in biomedical sciences with a specialization in pathology from the Medical College of Ohio (now part of the University of Toledo) and holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.