Project Description

Lisa Jenkins VanLuvanee, Ph.D., is the Vice President of Research and Development at Facet Life Sciences (formerly Virtual Regulatory Solutions, Inc.).  Dr. VanLuvanee has nearly 20 years of experience in the life sciences industry, and her background includes product development planning, global regulatory submission strategy, dossier preparation and submission, and post-approval life-cycle management.  She specializes in eCTD submissions management, PET radiopharmaceuticals, endpoint selection, and product labeling.  She has provided strategic program guidance, tactical support and content review for over 80 products, including 15 orphan drugs, 2 fast track products, 2 breakthrough therapies, and 3 drug-device combination products.  Her therapeutic area experience spans cardiovascular, CNS (neurology and psychiatry), dermatology, GI, inflammation, infectious disease, ophthalmology, pulmonary, oncology, pain, urology (reproductive), and women’s health.

Prior to her position at Facet, Dr. VanLuvanee served as an Assistant Professor at the University of North Carolina-Wilmington as a research psychologist studying normal and diseased aging.  In 2001, she joined Wyeth Pharmaceuticals a Principal Statistician and then transitioned to Senior Manager of Regulatory Affairs.  Dr. VanLuvanee gained much of her regulatory strategy experience at Wyeth working on venlafaxine, desvenlafaxine, and methylnaltrexone, and received the Wyeth Team of the Year Award twice and the “Above and Beyond Award” four times in a six year stretch.  In 2007, she joined Kendle International, Inc., a clinical trial organization (CRO) headquartered in the Midwest.  In the roles of Associate Director and Regulatory Group Leader at Kendle, Dr. VanLuvanee led numerous New Drug Application (NDA) and Biologic License Application (BLA) teams which resulted in successful U.S. filings and subsequent approvals.  Dr. VanLuvanee also led regulatory affairs, biometrics, and medical writing teams as the Director of Strategic Regulatory Services at ISI (a regulatory submissions company acquired by CSC, Inc., in 2010).

Dr. VanLuvanee received her Bachelor’s Degree from Juniata College, her Ph.D. from Syracuse University, and completed a 3-year post-doctoral fellowship at Washington University in St. Louis.  She served as Deputy Editor of DIA’s Therapeutic Innovation and Regulatory Science journal from 2015-2017.  She has published in a multitude of peer-reviewed industry journals, including Global ForumNeurologyJournal of NeurologyPsychology and Aging, has presented at numerous industry conferences (RAPS and DIA Annual Meetings), and was involved in a series of DIA webinars devoted to understanding the impact of FDASIA.  She and her team at Facet (then Virtual Regulatory Solutions, Inc.) were nominated and shortlisted for the TOPRA Awards for Regulatory Excellence (Support category) in 2014, and she was awarded by PharmaVoice as one of the 100 most inspiring people in 2015 (Regulatory category).