Rebecca Lipsitz is an Associate Director in Janssen’s Global Regulatory Policy and Intelligence office. She advises and develops policy on a broad range of FDA-related regulatory policy issues. Her portfolio areas include Immunology, Microbiome Therapeutics, Vaccines, Precision Medicine, and Real-World Evidence. She works with product teams, regulatory affairs and cross-functional colleagues, as well as industry colleagues outside of Janssen to identify key policy opportunities. She is responsible for crafting strategies and advocacy efforts to enhance interactions with health authorities and advance medical product development. Prior to joining Janssen in June of 2016, she spent her career in the Federal government working on public health emergency preparedness at HHS and FDA. At FDA, she was the senior advisor in the Office of Counterterrorism and Emerging Threats. In that role, she coordinated public health preparedness activities and provided regulatory input to Federal agency partners. Before joining FDA she served as a policy analyst at the US Department of Health and Human Services (HHS). She oversaw efforts to develop medical countermeasure requirements for public health emergencies, working closely with colleagues throughout the Federal government under the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE). She has experience leading working groups and developing consensus policy recommendations on a wide range of medical and regulatory policy issues. Dr. Lipsitz received her AB from Barnard College and her PhD from the University of California, San Diego. In addition, Dr. Lipsitz completed post-doctoral training at the NIH, where she developed novel spectroscopic methods to study protein-protein interactions during apoptosis.
Tuesday, September 24
1:00 PM – 1:55 PM