Nicole currently works as a Director, Regulatory CMC, for Sarepta Therapeutics. In her career, she has contributed to drug product and process development, various approved NDA, sNDA and BLA programs, from a technical or regulatory role. Nicole's prior experience also includes working at FDA. She is currently enrolled in the doctorate program at Temple University for RA/QA. Her research project, with Dr. David Lebo and Dr. Lawrence Liberti, focuses on regulatory flexibility in the context of the COVID pandemic and the development and approval of orphan drugs, which are frequently associated with facilitated regulatory pathways.