David Sealey, PhD, specializes in Regulatory Affairs at the Janssen Pharmaceutical Companies of Johnson & Johnson. Through his research and professional experience, David has guided drug development programs at various stages including basic and translational research, early clinical development (IND filing), application for marketing authorization (new drug submission), post-approval lifecycle management, and observational research (real-world evidence). He has contributed to the development and execution of brand strategies, and covered multiple therapeutic areas including oncology, immunology, infectious diseases, cardiovascular/metabolism, neuroscience and rare disease. David trained as a cancer biologist at the Campbell Family Institute for Breast Cancer Research. He holds a Ph.D. (Medical Biophysics) and Hon.B.Sc. (Pharmacology) from the University of Toronto. A long-time mentor, David is currently an Adjunct Professor, Graduate Professional Development in the Department of Molecular Genetics, University of Toronto.