Kevin Phelan, Ph.D.
Senior Consultant, Regulatory Strategy
Dr. Kevin Phelan is a neuroscientist with 25 years of experience in new drug development, regulatory affairs and compliance. He specializes in the design and execution of regulatory strategies related to new drugs, new formulations, and new therapeutic uses for approved products. His broad experience includes the areas of neuroscience, pain, inflammation, autoimmune diseases and oncology.
Currently Kevin is a consultant, advising companies on investigational new drug programs regulated by the FDA and other international government agencies. This typically includes early IND planning, preparation for Pre-IND/End-of-Phase 2/Pre-NDA FDA Meetings, IND/NDA submissions, Pre-NDA labeling review, and the development of promotional claims.
Over the course of a 20-year career at Pfizer, Kevin was a member of Global R&D, and Worldwide Regulatory Affairs. During this period, he worked extensively in a variety of therapeutic areas, including neuroscience, pain and inflammation. He was responsible for FDA interactions related to agents for the treatment of acute pain, arthritis, chronic pain, neuropathic pain, fibromyalgia, and epilepsy. He also worked extensively in the area of abuse deterrent/tamper-resistant opiate reformulation.
Dr. Phelan received a PhD in Neurobiology from The University of Chicago and conducted postdoctoral research at the Columbia University Medical Center.