Mary Ann Smith is Regulatory Policy Director, Digital Medicine & Devices, with Novartis since 2009 focused on software as a medical device, technology applications and enabled clinical trials, combination products and regulatory strategy. Ms. Smith has regulatory experience at Nektar, Abbott and Hitachi and positions at Stanford Research Institute and Brand Institute. Ms. Smith holds a BS pharmacy, MS technology management, lectures for UCSF-Stanford CERSI and as a HBA mentor.