Hélène Hardy, Ph.D, Pharm.D, MPH

Hélène Hardy earned her Ph.D in clinical pharmacology from the University of Lille II, France. She has a Pharm.D from the University of Buffalo School of Pharmacy and an MPH from the University of Massachusetts. Prior to joining the pharmaceutical industry, she worked at the Center for HIV/AIDS Care and Research at Boston University and was an Associate Professor of Pharmacy practice and Director of HIV Specialty Residency Program at Massachusetts College of Pharmacy and Health Sciences. She practiced in the Infectious Diseases clinic at Boston Medical Center and worked as an investigator at the Center for HIV/AIDS Care and Research in Boston, MA. She collaborated on several NIH-sponsored grants, AIDS Clinical Trial Group (ACTG) and Industry-sponsored trials, while focusing her research activities on Adherence to Antiretroviral Therapy. Dr Hardy transitioned from academia to the pharmaceutical industry in 2010 served in a variety of US and global roles in different functions over the past 15 years, including US Medical Brand Lead for Virology (Medical Affairs), Medical Monitor in Immuno-Oncology (R&D), Senior Drug Safety Scientist (Pharmacovigilance), Global Regulatory Lead (Regulatory) at Bristol Myers Squibb, and interim Health of US regulatory at Actelion. While in R&D, she led and coordinated multiple cross-functional project teams with emphasis on new drug applications filings in the area of Immuno-oncology and Infectious Diseases. Dr. Hardy Joined Janssen Infectious Diseases R&D in 2019 as the early clinical development team leader for a Bacteriophage Program. She helped to successfully deliver the first new molecular entity (NME) declaration for this  program. She subsequently joined the Janssen GPH organization in 2021 as the Bedaquiline Compound Development Team Leader (CDTL), and is currently responsible for leading a global cross-functional compound development team addressing a number of new initiatives focused on therapeutic innovation in tuberculosis and Leprosy.  

Conflict of Interest: Has an ownership interest in Johnson & Johnson