Dr. William Hanlon has been an active contributor to the development of innovative new medicines for more than 26 years, holding positions of increasing scientific and leadership responsibility. Trained as a biochemist, Dr. Hanlon spent the first half his career in drug discovery identifying novel small molecules effective in targeting molecular mechanisms regulating inflammatory and immunological disease processes. For the last 12 years, Dr. Hanlon has focussed his attention in early and late clinical development as a regulatory affairs expert advising teams of scientists on the many regulatory challenges to develop new medicines for registration globally.

Currently, Dr. Hanlon is Vice President and Head of Global Regulatory Affairs (GRA) at Covance, Inc. in Princeton, NJ where he has led a group of 165 regulatory professionals for the last 2.5 years. GRA provides clients with a broad array of regulatory support for the planning, development, reviewing, publishing and submission of regulatory documents to Health Authorities in support of clinical trials, agency interactions and marketing applications globally. Dr. Hanlon and his group are also responsible for advising clients on global, regional or local regulatory strategy associated with study design, regulatory agency interactions, as well as drug development programs.

Prior to joining Covance, Dr. Hanlon was Vice President and Head of Global Regulatory Affairs at Archimedes Pharma in Bedminster, NJ where he led a team of regulatory professionals in the US and EU providing complete regulatory support for their flagship pain product (Lazanda® /Pecfent®), product lifecycle management, and molecules in their development pipeline. Prior to joining Archimedes Pharma, Dr. Hanlon spent more than 23 years at Merck Research Laboratories in Rahway, NJ. The first 14 years were in discovery research working on novel immunological and inflammatory targets, and the remainder of his time was in World-wide Regulatory Affairs developing regulatory strategy and leading Regulatory Authority interactions globally for internal drug development programs. Dr. Hanlon’s final position at Merck was as the regulatory Therapeutic Area Co-Leader for the Cardiovascular/Atherosclerosis Franchise developing products for treatment of hypercholesterolemia (Tredaptive®), hypertension, atrial fibrillation (Brinavess®), thrombosis (Zontivity®) and heart failure. During his tenure at Merck, Dr. Hanlon also led a late stage CV/Athero drug development team advancing double and triple combination products through the drug development process.

Dr. Hanlon received his PhD in biochemistry and cell biology jointly conferred from the University of Medicine and Dentistry of New Jersey (UMDNJ) and Rutgers Graduate School in Piscataway, NJ. He completed his post doctoral training at Merck Research Laboratories in Rahway, NJ. He is the author of 21 scientific publications, a book chapter on protein profiling and inventor of 2 patents.