Hilary M. Malone

Biography

Dr. Malone is an experienced business leader in the pharmaceutical industry with specialist expertise in global regulatory affairs and compliance spanning the development, registration, and marketing of innovative prescription drugs and vaccines. Dr. Malone currently serves as Chief Regulatory Officer and Head of Global Regulatory Affairs for Sanofi, a position she has held since 2013. Prior to joining Sanofi, Dr. Malone was the Chief Regulatory & Compliance Officer for Reata Pharmaceuticals, a small US-based biotech company. Dr. Malone has also held roles as the Senior Vice President and Head of Worldwide Regulatory Strategy for both Pfizer and Wyeth, overseeing all products across the human health businesses (pharmaceuticals and vaccines, consumer health brands, generics, and infant nutritionals). Earlier in her career, Dr. Malone held positions of increasing responsibility at SmithKline Beecham/GlaxoSmithKline and AstraZeneca. Dr. Malone earned her B.Sc.in Physiology and her Ph.D. in Molecular Neuropharmacology from the University of Dundee, Scotland, UK and also spent time in postdoctoral research at the University of California, San Francisco prior to joining the pharmaceutical industry. Dr. Malone was a leader in the development and commercialization of a number of pharmaceutical products including Avandia®, Pristiq®, Sutent®, Toujeo®, Crestor®, Prevnar 13®, Praluent®, and Lemtrada®. Her experience as a pharmaceutical executive and regulatory expert will be invaluable as Inhibikase advances discussions with U.S., European, and other global regulatory authorities regarding the pathway for development, approval, and commercialization of the company’s novel products.

Research Interest

clinical science