Ken VanLuvanee

Ken VanLuvanee is a serial entrepreneur with over 25 years of pharmaceutical and technology expertise. Throughout his career, Mr. VanLuvanee has enjoyed great success in the regulatory process and technology sector of the life sciences industry.

Mr. VanLuvanee is currently the President/CEO of Facet Life Sciences. Prior to creating this organization, Mr. VanLuvanee was the founder of Apyx, a life sciences regulatory consultancy which was acquired by Image Solutions (ISI), which was subsequently acquired by Computer Sciences Corporation (CSC). He held leadership roles in newly formed organizations and was responsible for both strategic and operational performance. Prior to creating Apyx, Mr. VanLuvanee held consulting roles for Barnett International and Accenture, where he gained a practical understanding of regulatory processes and emerging enabling technologies being used across the life sciences industry.

Mr. VanLuvanee was a key participant in the development of the DIA EDM Reference Model, a cross-industry effort to apply standards to the organization and structure of R&D documentation. He was instrumental in both executing on the vision of the reference model and assisting sponsors in the implementation of the model within their technology landscape.

Mr. VanLuvanee received a Bachelors in Business Administration from Saint Bonaventure University in 1988.

Lisa Jenkins VanLuvanee, Ph.D.

Lisa Jenkins VanLuvanee, Ph.D., is the Chief Operating Officer & 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 Forum, Neurology, Journal of Neurology, Psychology 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).

Tobias Massa, Ph.D.

Tobias Massa is a Senior Executive with 38 years of success in pharmaceuticals, biotech, life sciences, and technology. During his career, Tobias assisted in gaining approvals for 27 commercial products and more than 300 investigational products and has coached and mentored over 300 regulatory professionals.

From 2014 to 2016, Dr. Massa served as VP and Head of Global Regulatory Operations at Sanofi where he spearheaded multiple organizational change projects, including the creation of an outsourcing program for non-strategic regulatory activity; strategic planning for the establishment of a regulatory outsourcing center and three regional hubs; the consolidation of regulatory processes and tools across seven business units; and the development of a foundation for the transition of traditional services to a multi-tenant cloud-based SaaS system. Prior to Sanofi, Tobias was tenured with Bristol-Myers Squibb from 2004 to 2014 and also held roles of increasing responsibility at Eli Lilly & Co. and Schering-Plough Research Institute.

Dr. Massa currently sits on the Dean’s Advisory Committee at the State University of New York at Buffalo, College of Arts & Scientists and is an Advisor to the McKinsey Regulatory Advisory Board. A prolific speaker and author of numerous regulatory technical white papers, he has also given more than 50 invited speaking presentations all over the world. Dr. Massa is a Fellow of the American Association of Pharmaceutical Scientists and was the recipient of the BMS Galaxy Awards for Product Development & Management in 2007 and 2008 and the Lilly Research Laboratories President’s Recognition Award in 2001.

Graduating from the City University of New York in 1979 with a Ph.D. in Biomedical Science, Dr. Massa attained his BA (cum laude) in Chemistry from the State University of New York at Buffalo in 1972. He was a Diplomat of the American Board of Toxicology from 1983 to 2003.