Lesley R. Maloney, Pharm.D., is Global Regulatory Policy Lead for Digital Health at Genentech/Roche. She is responsible for shaping the external regulatory environment on digital health topics and integrated solutions, including use of digital health technologies in drug development, SaMD, and AI/ML. She was previously Head of US Regulatory Policy for Roche Diagnostics. Prior to joining Roche, Dr. Maloney worked for the U.S. Food and Drug Administration in the Office of the Commissioner, where she served in various roles, including Senior Policy Advisor and Deputy Chief of Staff. Dr. Maloney holds a doctor of pharmacy degree from the University of Oklahoma and did an Executive Residency in Association Leadership and Management at ASHP.