President and Chief Executive Officer
Ken Mills is the founding President and Chief Executive Officer of REGENXBIO. Prior to REGENXBIO, Mr. Mills was the Chief Financial Officer and Vice President of Business Development at Meso Scale Diagnostics, a privately held life sciences company. There, he served as a member of the founding management team, and worked to establish the company's operations and ongoing business strategy. In this position, Mr. Mills supervised all company activities, including direct management of corporate and business development, strategic planning, finance and accounting activities. Prior to Meso Scale Diagnostics, he was Director of Business Development for IGEN International, a medical diagnostics company. Mr. Mills received an S.B. in chemistry from the Massachusetts Institute of Technology.
Olivier Danos, Ph.D.
Chief Scientific Officer
Dr. Olivier Danos is the Chief Scientific Officer for REGENXBIO. Prior to joining REGENXBIO, Dr. Danos was Senior Vice President, Cell and Gene Therapy at Biogen Inc. At Biogen, Dr. Danos led company efforts dedicated to identifying and developing new technologies for gene transfer and genome engineering. Dr. Danos also co-founded and is an executive member of the board of directors of Lysogene, a NAV Technology Licensee focused on the development of gene therapy product candidates for the treatment of Mucopolysaccharidosis Type IIIA.
Prior to Biogen, Dr. Danos served as Senior Vice President, Molecular Medicine, Synthetic Biology and Gene Regulation at Kadmon Pharmaceuticals. Earlier in his career, Dr. Danos was Director of the Gene Therapy Consortium of the University College of London, Scientific Director at Genethon and Senior Director of Research at Somatix Therapy Corporation. Dr. Danos has directed research focused on gene therapy at the Necker - Enfants Malades Hospital in Paris, the French National Centre for Scientific Research and the Pasteur Institute in Paris.
Chief Medical Officer
Dr. Stephen Yoo is Chief Medical Officer at REGENXBIO. Prior to joining REGENXBIO, Dr. Yoo was Medical Science Director of Clinical Development at AstraZeneca and Group Director of Clinical Development at MedImmune, AstraZeneca's global biologics research and development arm. In these roles, he led the late-phase clinical project teams while providing strategic and operational leadership to physicians and scientists. In previous roles at MedImmune, he provided strategic clinical leadership for early phase programs. Earlier in his career, Dr. Yoo served as Associate Director of Clinical Development at Abbott Laboratories. Dr. Yoo holds an M.D. from the University of California, Los Angeles School of Medicine and a B.A. in molecular and cell biology from the University of California, Berkeley.
Chief Financial Officer
Vit Vasista is the Chief Financial Officer at REGENXBIO. Prior to joining REGENXBIO, Mr. Vasista served as Principal at PRTM Management Consultants, where he developed operational strategies for both private and public organizations, including the development of market entry strategies, innovative business models and operational improvements. Earlier in his career, Mr. Vasista served as Director, Business Development at Meso Scale Diagnostics, a privately held life sciences company. Mr. Vasista received an MBA from the Wharton School at the University of Pennsylvania, an M.S. in mechanical engineering from Stanford University and an S.B. in mechanical engineering from the Massachusetts Institute of Technology.
Senior Vice President, General Counsel
Patrick J. Christmas II is Senior Vice President, General Counsel at REGENXBIO. He has over 15 years of life sciences leadership and public market experience.
Mr. Christmas has managed the legal, compliance, government affairs and business development functions at several biotech and pharmaceutical companies during times of significant growth and business success. Before joining REGENXBIO, he was Vice President, General Counsel and Secretary at Lumara Health (formerly KV Pharmaceutical Company - NYSE: KV.A) through its acquisition by AMAG Pharmaceuticals and Perrigo. Prior to Lumara Health, he was General Counsel and Secretary at the Wellstat Group of Companies and General Counsel at BioVeris Corporation (formerly NASDAQ: BIOV) until its acquisition by Roche. Prior to his extensive life sciences experience, Mr. Christmas was an Associate at Akin, Gump, a leading international law firm.
Mr. Christmas received his J.D. degree with honors from the University of Notre Dame and a B.A. in Economics from Boston College.
Senior Vice President, Intellectual Property
Laura A. Coruzzi is the Senior Vice President of Intellectual Property at REGENXBIO. Prior to joining REGENXBIO, Ms. Coruzzi was a partner at Jones Day, preceded by Pennie & Edmonds, LLP where she counseled clients on patent strategies for biotech and pharmaceutical therapeutics and diagnostics. Her practice encompassed all aspects of patent law, including prosecution, litigation and appeals, in a variety of disciplines in the life sciences, including genetic engineering, molecular biology, virology, vaccines, immunology, therapeutic antibodies, other biologic and small molecule therapeutics, diagnostics, drug discovery, and drug delivery.
Earlier in her career, Ms. Coruzzi was one of the first members of Pennie & Edmonds’ biotechnology group founded by S. Leslie Misrock, affectionately known as the "father of biotechnology patent law.” Most recently, she was a member of the team representing Myriad in Association for Molecular Pathology v. Myriad Genetics (U.S. Supreme Court 2013).
Ms. Coruzzi received her J.D. from Fordham University School of Law, her Ph.D., M.S. and B.S. in Biology from Fordham University, and completed a post-doctoral fellowship at the Mount Sinai School of Medicine before entering the practice of law.
Senior Vice President, Human Resources
Shiva G. Fritsch is the Senior Vice President of Human Resources at REGENXBIO. Ms. Fritsch brings over two decades of experience in research, development and human resources in the biopharmaceutical industry to REGENXBIO. For the past decade, Ms. Fritsch has been a leader in different organizations where she focused on Leadership and Organization Development.
Prior to joining REGENXBIO, Ms. Fritsch was the Senior Director of Talent Management with Novavax, Inc. Before Novavax, Ms. Fritsch held senior human resources roles with Howard Hughes Medical Institute and Human Genome Sciences, Inc. In her prior roles, Ms. Fritsch served as a member of HR Leadership teams, where she directed activities related to Talent Acquisition, Organization and Leadership Development, and implemented HR Business Partner models.
Ms. Fritsch holds an MBA from the Robert H. Smith School of Business at the University of Maryland, College Park, as well as a BA in Biology and Neurobiology from Bryn Mawr College.
Senior Vice President, Technical Operations
Curran M. Simpson is the Senior Vice President of Technical Operations at REGENXBIO. Prior to joining REGENXBIO, Mr. Simpson was the Head of North American Supply Chain and Interim Chief Operating Officer and Integration Lead at GlaxoSmithKline and the Human Genome Sciences division of GlaxoSmithKline. Mr. Simpson earlier served as Senior Vice President of Operations and Vice President of Manufacturing Operations at Human Genome Sciences.
Prior to Human Genome Sciences, Mr. Simpson was Director of Manufacturing Sciences at Biogen and Director of Engineering at Covance Biotechnology Services. Earlier in his career, Mr. Simpson served as Recovery Technology Coordinator, Worldwide and Pilot Plant Manager of the North America Division at Novo-Nordisk Biochem; Senior Research Engineer at Genentech; Senior Scientist, Development at Genencor; and Senior Chemist at Nalco Chemical Co.
Mr. Simpson has an M.S. in surface and colloid science from Clarkson University and a B.S. in chemical engineering and chemistry from the Clarkson College of Technology.
Vice President, Law and Policy
Sara Garon Berl is the Vice President, Law and Policy at REGENXBIO. Prior to joining REGENXBIO, she was a Principal at FOXKISER LLP where she focused on developing strategies in a variety of legal and regulatory areas for FDA-regulated products. She previously served as an associate at Covington & Burling, where she focused on commercial litigation and arbitration in the areas of health law, intellectual property, securities and deceptive trade practices. Ms. Berl received a J.D. from Stanford University and an S.B. in mathematics from the Massachusetts Institute of Technology.
Vice President, Manufacturing
Niall Carolan, Ph.D. is the Vice President of Manufacturing and Supply Chain at REGENXBIO. Prior to joining REGENXBIO, Mr. Carolan was the Director of Biopharmaceutical Technology at GlaxoSmithKline (GSK), leading a product technical oversight function and a process development lab function for GSK programs and as a CMO service provider. Before GSK, Mr. Carolan was Director of Manufacturing Sciences at Human Genome Sciences, with earlier roles in tech transfer, project management and supply chain. Earlier in his career, Mr. Carolan held roles in manufacturing management and global technology coordination at Novozymes, and in process engineering at Novo Nordisk in Denmark. Mr. Carolan holds a Ph.D. in bioprocessing and a B.Eng. in chemical engineering from the Queen's University, Belfast, Northern Ireland.
Vice President, Information Technology
Jerome W. Jackson is the Vice President of Information Technology at REGENXBIO. Prior to joining REGENXBIO, Mr. Jackson served as the Director of Information Systems at Meso Scale Diagnostics, a privately held life sciences company where he was a member of the founding team and worked to establish and scale operations. Mr. Jackson holds an MBA and an M.S. in finance from the University of Maryland, Robert H. Smith School of Business and a B.S. in biochemistry from the University of Maryland, College Park.
Louis Licamele, Ph.D.
Vice President, Biometrics
Dr. Louis Licamele is the Vice President of Biometrics at REGENXBIO. Prior to joining REGENXBIO, Dr. Licamele was Vice President, Informatics at Vanda Pharmaceuticals Inc. overseeing the Biostatistics and Data Management functions and served as a member of the executive team. Dr. Licamele was responsible for setting up, optimizing and overseeing a wide range of functional units within Vanda spanning both clinical and commercial informatics while providing strategic and operational leadership relating to drug development for rare, orphan disorders. He helped setup the core informatics services when Vanda was founded in 2003.
Dr. Licamele holds a Ph.D. in Computer Science from the University of Maryland where his doctoral thesis was on computational methods for drug discovery. He also has a B.S. in both Biology and Computer Science from Georgetown University and a M.S. in Computer Science from the University of Maryland.
Vice President, Regulatory Affairs
Lynne Fahey McGrath, Ph.D., is the Vice President of Regulatory Affairs at REGENXBIO. Prior to joining REGENXBIO, Ms. McGrath was Global Head of Regulatory Affairs at Novartis Consumer Heath where she led a team of 250 regulatory and CMC associates in 50 countries, managing more than 10,000 product licenses. She played a key R&D role in the creation of the Novartis - GlaxoSmithKline joint venture. Previously, Ms. McGrath spent 10 years at Novartis Oncology managing global strategy for multiple development teams and as U.S. Head of Regulatory Affairs, where she directed the strategy for accelerated approval of multiple drugs including those for rare diseases worldwide.
Prior to Novartis, Ms. McGrath worked at Pharmacia as global regulatory lead in oncology, most notably successfully registering Celebrex in the EU for a rare genetic disease. In addition, she worked at Schering Plough for seven years, both in regulatory affairs and in toxicology, and at Hoechst for eight years, managing product safety and risk assessment.
Ms. McGrath holds a Ph.D. and an M.P.H. in public health from the University of Medicine and Dentistry of NJ - Robert Wood Johnson Medical School and a B.S. in biology and chemistry from the University of Connecticut.
Vice President, Clinical Research & Development
Rickey Reinhardt is the Vice President of Clinical Research & Development at REGENXBIO. Prior to joining REGENXBIO, Dr. Reinhardt worked for GlaxoSmithKline (GSK) in the Rare Disease Unit as Vice President, Translational Medicine and Clinical Development. Prior to GSK, he worked for Covance as Vice President of Global Molecule Development, Novo Nordisk as Executive Director of Clinical Pharmacology, Clinical Research and Medical Affairs (Metabolic Diseases), and Merck as Associate Director of Clinical Pharmacology. His experience has included preclinical, clinical, regulatory, and medico-marketing strategy and hands on experience with all aspects of the clinical trial process for clinical pharmacology, registration, and post-marketing trials.
Dr. Reinhardt obtained his Bachelor’s Degree in Biochemistry from the University of California (UCLA), and Ph.D. and M.D. from Louisiana State University.
Vice President, Commercial & Portfolio Planning
Réka Shinkle is the Vice President of Commercial and Portfolio Planning at REGENXBIO. Prior to joining REGENXBIO, she served as Head, Early Cardiovascular and Metabolic Disease in AstraZeneca's Global Product and Portfolio Strategies group. Previously, Ms. Shinkle held roles of increasing responsibility in new product planning, global strategy marketing and portfolio planning at MedImmune, the fully integrated biologics subsidiary of AstraZenenca. These roles spanned therapeutic areas, and involved partnering with research and development colleagues to progress the biologics pipeline as well as building capabilities. Ms. Shinkle also held sales and marketing positions at Eli Lilly & Company, including global-launch planning, market research and brand strategy. Ms. Shinkle received an MBA from the University of Michigan and a B.S. in chemistry from Yale University.
Vice President, Clinical Operations
Vice President, Quality
Sherri Van Everen, Pharm.D.
Vice President, Medical Affairs
Sherri Van Everen is the Vice President of Medical Affairs at REGENXBIO. Prior to joining REGENXBIO, Dr. Van Everen worked for Avalanche Biotechnologies as Executive Director of Scientific Collaborations, Translational Medicine, leading all Medical Affairs activities. Prior to that, she worked for Genentech and Eli Lilly and Company. Her experience has included medical affairs roles in outcomes research, health economics, field medical affairs, publications and congress strategy. Her therapeutic experience includes cell and gene therapy, Retina, Ophthalmology and Critical Care.
Dr. Van Everen obtained her Bachelor’s Degree in Biomedical Science from Texas A&M University and Pharm.D. from the University of Texas at Austin.
Vice President, Corporate Development