Catherine Lee, DrPH is currently Associate Director, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy work on Real-World Evidence, Pediatrics and Immunology Therapeutic Area, at Johnson & Johnson. Before joining Johnson & Johnson in March 2022, Cathy was Health Scientist in the Office Pediatric Therapeutics at the U.S. Food and Drug Administration (FDA) for more than 13 years. She was responsible for developing and implementing global pediatric initiatives for both internal and external stakeholders to meet obligations related to the FDA’s pediatric international programs, specifically collaborative programs with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). During her time at FDA, she was also a Mike Mansfield Fellow in Tokyo, Japan. She spent her fellowship at PMDA, Ministry of Health, Labour and Welfare (MHLW), Japan Pharmaceutical Manufacturers Association (JPMA), and Takeda Pharmaceuticals. She was also involved in evaluating and providing advice on ethical, scientific, and regulatory issues in global pediatric clinical trials. She has a Doctor of Public Health (DrPH) from Columbia University and has a dual BA/MA degree from Boston University.