18 Jan Enzyvant Therapeutics
Kevin Healy, Senior Vice President, Regulatory Affairs, Pharmacovigilance, and Quality
April 21 | 12:00pm | Gaudi 2 Ballroom
Enzyvant Therapeutics is a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases. The company’s first commercial product is FDA-approved RETHYMIC, a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. Enzyvant has distinctive capabilities in expedited development of regenerative therapies for rare diseases. The company has obtained and leveraged multiple regulatory designations including Regenerative Medicine Advanced Therapy (RMAT), Breakthrough, Fast Track, Rare Pediatric Disease, Orphan Drug, and Advanced Therapies Medicinal Product (ATMP). The Enzyvant team has managed the unique CMC challenges of highly variable human tissue and has a strong track record in working with academia. This includes updating of clinical-stage manufacturing practices to meet commercial GMP requirements and successful operational and commercial interactions in multi-layered institutions. Enzyvant is wholly owned by Sumitovant Biopharma.