Carla Fiankan is Adverum’s senior vice president of regulatory affairs. In her role, Ms. Fiankan develops and manages the regulatory strategies for Adverum’s suite of gene therapy products and oversees all facets of Adverum’s global regulatory affairs, including filings and interactions with the major regulatory authorities around the world. Throughout her 27-year career, Ms. Fiankan has led global regulatory strategies for the development, licensure, and life-cycle management of biologics, pharmaceuticals, medical devices, and gene therapy products and has successfully developed, managed and executed strategies to meet board-led targets and corporate objectives.
Previously, Ms. Fiankan was vice president of regulatory affairs at InterMune, Inc. (acquired by Roche), where she led the successful registration of Esbriet® and managed other development-stage programs. Prior to that, as associate director of regulatory affairs at Gilead Sciences, Inc., Ms. Fiankan developed and executed regulatory strategies for marketed and investigational drugs across the antiviral, cardiovascular and respiratory franchises; she also successfully completed the registrations of Emtriva®, Truvada®, and Atripla® in the U.S., E.U., Canada, Australia, and in over 100 developing countries. Based on her successful registrations in the developing world, Ms. Fiankan co-authored a White Paper on the Gilead Access Program model which is used as a Case Study at Harvard Business School. Prior to Gilead, Ms. Fiankan held positions with increasing responsibilities at Amgen Inc., where she led the registration of Aranesp® in the U.S. E.U., and Canada. Earlier in her career, Ms. Fiankan also held positions at InSite Vision, Inc., and Syntex (acquired by Roche).
Ms. Fiankan earned her bachelor of science degree in biology from Notre Dame de Namur University and her master of science in microbiology from San Jose State University.