NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the expansion of the company’s leadership team with the appointment of R. Heath Coats as Vice President of CMC, Regulatory Compliance and Quality Control. In his new role, Mr. Coats will be the strategic and technical lead for manufacturing design, technology transfer, analytical test development, quality control, drug product formulation development, facility buildout, and CMC regulatory interactions and filings for jCyte’s first-in-class regenerative cell therapy, jCell, for retinitis pigmentosa (RP) and future indications.
Mr. Coats brings to jCyte over 30 years of regulatory compliance, quality, and CMC experience from a number of key roles in government, large contract manufacturing organizations, industry, consulting, and academia, with specific expertise with biologics, vaccines, and cell and gene therapies. He spent the bulk of the last decade at the FDA working in the Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Manufacturing and Product Quality (CBER/OCBQ/DMPQ) where he was responsible for key interim assignments as Acting Branch Chief and Acting Team Lead. While at the FDA, Mr. Coats participated in the review and evaluation of numerous innovative cell and gene therapy INDs and BLA marketing applications, including the first ophthalmology gene therapy product, Luxturna®. His responsibilities also included meeting with manufacturers to review facility designs and leading pre-license and pre-approval inspections supporting Biologics License Application (BLA) submissions and supplements including the identification and review of corrective actions by several multinational pharmaceutical companies. Of note, Mr. Coats participated in the inspections of multiple global manufacturing facilities for the first FDA licensed chimeric antigen receptor (CAR) T-cell therapy product Kymriah®.
Prior to his time at the FDA, Mr. Coats spent nearly a decade at Lonza in their validation group focused on supporting endotoxin detection products, cell culture media, and cell therapy contract manufacturing operations. Mr. Coats and his teams authored, executed, and reviewed validation activities supporting the qualification of facilities, utilities, equipment, packaging, software, and processes utilized in the manufacturing of CBER and CDER regulated products.
Mr. Coats joins jCyte from Parexel International, where he served as a subject matter expert in the evaluation of quality systems and manufacturing facilities for biologics, including cell and gene therapy products and vaccines. During his time at Parexel, Mr. Coats leveraged his extensive FDA experience to conduct inspections of clients’ programs, evaluate all aspects of their manufacturing processes and documentation, and assist in document preparation and reviews related to FDA and EMA submissions and meetings.
Mr. Coats holds a BS in Biology from Mount Saint Mary’s University (Maryland) and earned a MS in Biomedical Science from Hood College. He also served as a fellow and, subsequently, a biologist and senior researcher at the National Cancer Institute Cancer Research and Development Center.
“Heath’s addition to the jCyte team brings us a leader with the perfect blend of expertise in the creation, inspection, and validation of manufacturing facilities, the development and evaluation of quality systems, and the knowledge of how global regulatory bodies think about and control for CMC compliance,” said Dr. Shannon Blalock, Chief Executive Officer. “His three decades of experience, and specifically, his time in the Office of Biologics and Quality at the FDA working with cell and gene therapies, will be invaluable as we finalize the lock-down of our cGMP compliant commercial scale final drug manufacturing process for our transformative jCell platform technology. I am excited to welcome Heath to our growing leadership team to help ensure we deliver jCell to the millions of patients around the world with RP and other retinal degenerative conditions who currently have no treatment options.”
“I am thrilled to join jCyte given the Company’s incredible mission to bring jCell to the many patients with retinal dystrophies, like RP, as quickly as possible,” said Mr. Coats. “In my 30-year career, I have rarely encountered the situation where there is ample time before launch to ensure that an already scaled final drug manufacturing process is fully cGMP compliant. This is the case with jCell, and I look forward to ensuring its global commercial supply so that, upon approval, it can immediately be made available to RP patients around the world.”
jCell is a first-in-class investigational treatment for RP which has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation. In addition to RMAT designation, jCell has received Orphan Drug designation from the FDA and the European Medicines Agency.
About jCyte, Inc.
jCyte, Inc. is a late-stage clinical development biotech company focused on developing its first-in-class regenerative cell therapy, jCell, for RP and other retinal degenerative disorders. The treatment is minimally invasive and given as an intravitreal injection. There are currently no FDA approved therapies for RP. The Company is pioneering a new era of regenerative therapies to address the significant unmet medical needs of patients suffering from a broad set of retinal degenerative diseases. For more information, visit www.jcyte.com.
