Imein Bousnina, Pharm.D, is a Program Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Dr. Bousnina trained as a pharmacist and holds an MSc in International Regulatory Affairs. Over her 8 years at Roche-Genentech, she has specialized in FDA's regulation of New Alternative Methods, digital health (including Software as a Medical Device and Digital Health Technologies used in drug development), rare disease drug development, and companion diagnostics. She actively engages in several external groups including BIO, PhRMA, EveryLife Foundation for Rare Diseases, NORD, DiMe, and PMC among others, and serves in leadership roles on some of their taskforces.