Kathleen concentrates on coalescing cross-sector and global regulatory policy as Senior Director on the Global Regulatory Policy and Intelligence team for Janssen Research & Development, LLC one of the Pharmaceutical Companies of Johnson & Johnson. Recent areas of concentration include Combination Products, Digital Health in Clinical Trials, and the Microbiome.
Dr. Basmadjian has worked in Regulatory Affairs in both the public (US FDA and NIH) and the private (pharmaceutical MNCs) sectors for 30 years. Prior to a formal move into the policy role, Kathy headed several global and regional therapeutic areas within regulatory affairs in her 15 years with J&J, most recently in the previous Centocor Biotech unit. A large percentage of her regulatory career was spent in the small molecule drug arena, at Novartis, the National Institute on Drug Abuse and the US FDA.
Kathleen conducted her doctoral research on malaria at the National Institute of Allergy and Infectious Diseases, receiving her degree from Catholic University of America, while working at the FDA.