Vice President, Regulatory Affairs and Quality
Dr. Kevin Healy is a Vice President of Regulatory Affairs and Quality at Enzyvant, a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases. Kevin has over 10 years of Regulatory experience and has had positions of increasing responsibility within large pharma, biotechnology, and at a contract research organization. He has expertise in leveraging expedited regulatory pathways for rare diseases and therapies for unmet medical needs. At Enzyvant, Kevin is leading the development and execution of global regulatory strategies for an investigational tissue-based regenerative therapy that recently received both Breakthrough Therapy and Regenerative Medicines Advanced Therapy Designations. He is also the regulatory lead for an investigational enzyme replacement therapy being developed for the treatment of Farber disease.
Prior to joining Enzyvant, Kevin led the Global Regulatory Affairs department at Roivant Sciences, where he served as the regulatory lead for several products across multiple therapeutic areas. Kevin joined Roivant from Mallinckrodt Pharmaceuticals, where he was a Senior Director leading the Autoimmune and Rare Disease portfolio. At Mallinckrodt, Kevin also led the development of several products in the pain therapeutic area, from Pre-IND activities through successful filings and registration. Kevin began his career at a contract research organization in Research Triangle Park, NC, and spent several years at Gilead Sciences, where he served on global development teams for HBV and HCV treatments. Kevin received his BS in Biological Sciences from Cornell University, completed his PhD in Biochemistry at the University of Wisconsin-Madison, and completed a postdoctoral research fellowship in the Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill. Kevin has completed his Regulatory Affairs Certification and has been an invited speaker at numerous national and international conferences.
Tuesday, September 24
12:15 PM – 12:45 PM
Tuesday, September 24
2:05 PM – 3:00 PM