Speakers
Session 1: Standards, Testing and Quality Evidence Supporting Regulatory Decision-Making
Speakers from Intertek, UL and TUV
Hosted by: Dara Wambach, RAPS SF
Dara Wambach, MA, is Executive Director of Regulatory Affairs at Mirum Pharmaceuticals and a regulatory and R&D leader with more than 20 years of experience advancing therapies from early development through commercialization. Her experience includes regulatory leadership roles across small and mid-sized Bay Area biotechnology companies, including more than a decade at Gilead where she led the U.S. regulatory submission and FDA review for the first HIV pre-exposure prophylaxis (PrEP) indication for Truvada.
Dara has contributed to pediatric development programs in HIV, sickle cell disease, and narcolepsy, as well as programs addressing pulmonary and liver diseases. At Janssen Global Public Health R&D, she developed and led Johnson & Johnson’s two-year R&D Fellowship Program with the Institute of Tropical Medicine Antwerp for scientist-physicians from Africa. She is also a member of the RAPS San Francisco Bay Area Chapter Leadership Team and serves as Chair of the Sponsorship Committee.