Enzyvant receives FDA approval for RETHYMIC®️ (allogeneic processed thymus tissue-agdc) Learn More
Chief Executive Officer
Rachelle Jacques joined Enzyvant as CEO in 2019 to prepare for the next phase of the company, focusing investments and capabilities on the development of transformative regenerative therapies for rare diseases. Under her leadership, Enzyvant received FDA approval for its lead asset, a one-time tissue based regenerative therapy. It is one of the first three FDA-approved products with the Regenerative Medicine Advanced Therapy (RMAT) designation.
Rachelle brings to Enzyvant strong global and U.S. background in strategic, cross-functional leadership roles spanning finance, business operations, manufacturing, and commercial, including the successful launches of several novel therapies for rare diseases. She served as the Senior Vice President and Global Complement Franchise Head at Alexion, where she was responsible for global franchise strategy development and execution across the therapeutic areas of hematology, nephrology, and neurology. She was Vice President of U.S. Hematology Marketing at Shire, which acquired Baxalta in 2016, and served as Vice President of Business Operations at Baxalta after its spinoff from Baxter. Rachelle held multiple leadership positions at Baxter, including Vice President of Finance, U.S. BioScience Business. Earlier in her career, she served in various roles at Dow Corning Corporation, including operational management positions in the U.S., Europe, and China.
Rachelle currently serves on the Board of Directors of Corbus Pharmaceuticals and uniQure. She is co-chair of the Alliance for Regenerative Medicine (ARM) Tissue Engineering & Biomaterials Committee and is a founding member of the ARM Action for Equality Task Force.
Rachelle received her B.A. degree in business administration from Alma College.
Chief Operating Officer
Jeb Ledell is Enzyvant’s Chief Operating Officer, responsible for operationalizing company strategy toward short and long-term goals and leading key business functions, including Finance, HR, Legal and IT.
In this role, Jeb draws from more than two decades of experience leading high performing teams at tech and biotech companies to drive operational excellence, strategy and product development. Prior to Enzyvant, Jeb was COO at Compass Therapeutics, a developer of targeted antibody therapies, and Horizon Discovery Group, a developer of research and clinical gene-editing applications. He led operations at both organizations through several changes in scale. Additionally, Jeb worked in multiple technology, operational, and development roles at Zalicus, a development-stage pain and inflammation therapeutics company.
Jeb has a BS degree in Chemical Engineering from Worcester Polytechnic Institute.
Senior Vice President, Head of Late-Stage Development and Commercialization
As Senior Vice President, Head of Late-Stage Development and Commercialization at Enzyvant, Andrea Ashford-Hicks leads strategy, new product planning and has accountability for the company’s lead FDA-approved product, including medical affairs, supply, clinical, patient services and commercial activities.
Andrea has extensive experience leading commercial strategy and execution in both emerging and established biopharmaceutical companies. She headed up late-stage asset strategy and commercial activities at Agenus and was Vice President of US Oncology Marketing at EMD Serono. She also led new business development for North America Immunology and Oncology at Johnson & Johnson and worked in marketing and sales roles at Pfizer, Allos Therapeutics, and Schering-Plough.
Andrea received a BA in Biology from the University of Pennsylvania and a BS in Finance from the Wharton School of Business.
Jim Luterman, PhD
Senior Vice President, Head of Early-Stage Development and Partnering
In his role as Senior Vice President, Head of Early-Stage Development and Partnering, Jim Luterman leads expansion of Enzyvant’ s regenerative medicine pipeline, including preclinical and process development activities, as well as assessment of new potential assets.
Jim brings to Enzyvant more than 20 years of experience in product development and commercial strategy for emerging and global biotech companies. He led integrated R&D for an autologous cell-based therapy at OvaScience, early development at Shire for rare diseases, and program strategy for the flagship product at CombinatoRx. He also worked on new product commercialization at Biogen.
Jim received his PhD in Neuroscience from Rutgers and was a postdoctoral fellow at Mount Sinai School of Medicine in New York City. He has an undergraduate degree in Biology/Psychology from Bucknell University.
Kevin Healy, PhD, RAC
Vice President, Regulatory Affairs and Quality
Kevin Healy is Enzyvant’s Vice President for Regulatory Affairs, Pharmacovigilance, and Quality. In this role, Kevin leads Enzyvant regulatory strategy and execution, including guiding the company’s lead asset, designated as a Regenerative Medicine Advanced Therapy (RMAT), to an FDA approval in 2021. He also is responsible for oversight of pharmacovigilance and quality systems at Enzyvant and partner organizations.
Kevin brings more than a dozen years of biotech and pharmaceutical regulatory affairs experience to his role at Enzyvant. He was the head of Global Regulatory Affairs at Roivant Sciences and led development and successful filings for several therapies in the autoimmune and rare disease portfolio at Mallinckrodt Pharmaceuticals. He also served on global development teams for hepatitis B and C virus treatments at Gilead Sciences.
Kevin received his BS in Biological Sciences from Cornell University, his PhD in Biochemistry from 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.