Eric Franca

Director of Conformity Assessment Program, FDA

Eric Franca received his PhD in Biomedical Engineering from the University of Florida where he investigated novel carbon nanomaterials for developing more effective neural electrodes. He began his professional career as a lead reviewer of medical devices at the Food and Drug Administration. He subsequently moved into a policy analyst position managing the content and publication of guidances, orders, and regulations related to medical device review and CDRH policies. He currently serves as Director of the Conformity Assessment Program in his role as an Assistant Director in CDRH’s Division of Standards and Conformity Assessment. Concurrent with his work as a regulator within the FDA, Dr. Franca has participated in standards development, serving in leadership positions within the US National Committee to the IEC and as an US technical expert on several standard development committees.

: ericfranca

Dara Wambach, MA

Executive Director of Regulatory Affairs, Mirum Pharmaceuticals

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.

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