Area of Expertise:
Lauren is a clinical development and regulatory affairs professional, providing regulatory and technical support in healthcare product development. She specializes in regulatory project management for Investigational New Drug Applications (INDs) and New Drug Applications (NDAs) for filing to the U.S. Food and Drug Administration (FDA). Lauren has experience in various therapeutic areas including infectious disease (e.g., COVID-19), ophthalmology, cardiovascular and oncology diseases. She has managed and authored clinical and regulatory sections of INDs and NDAs for submission, as well as Standard Operating Procedures (SOPs), clinical trial documentation (e.g., protocols), and accelerated pathway designation requests (e.g., Fast Track, Orphan Drug Designation Requests). She also has experience in the management and publishing of electronic and paper submissions for filing to the FDA. Prior to joining SciLucent, Lauren worked in a clinical testing laboratory performing ELISA assays and reviewing regulated documents and raw data in support of vaccine clinical trials. Lauren has a B.S. in Biotechnology from James Madison University.