Bennett Levitan, MD, PhD is Senior Director, Benefit-risk Assessment, Department of Epidemiology at Janssen R&D, Pharmaceutical Companies of Johnson & Johnson. He introduced state of the art patient-focused benefit-risk assessment to Johnson & Johnson and his group has led numerous clinical teams in preparation of benefit-risk assessments and patient preference studies for regulatory submissions and health authority advisory meetings. He has co-led cross-disciplinary teams to implement processes to support growing regulatory requirements for patient-focused benefit-risk assessment both during development and post-approval. Bennett has published widely on both theoretical and pragmatic aspects in benefit-risk and patient preference studies and is a frequent speaker on these topics in national and international conferences. He co-led development of the PhRMA Benefit Risk Action Team (BRAT) Framework for drug benefit-risk assessment and the Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Framework. Bennett serves on several committees that inform policy on benefit-risk methods including the IMI PREFER project on patient preference studies, the ISPE Benefit-Risk Assessment, Communication and Evaluation (BRACE) team, the CTTI Patient Groups & Clinical Trials work stream, the PCORI Advisory Panel on Patient Engagement and the PhRMA Patient-Focused Drug Development Work Group. Bennett received his BSc (Electrical Engineering) from Columbia University in New York and his MD-PhD. (Bioengineering) from the University of Pennsylvania and was a postdoctoral fellow at the Santa Fe Institute.