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 Dr. Stewart Craig as Chief Technology Officer. In his new role, Dr. Craig will be the strategic and technical lead for all drug product development activities, including manufacturing process development, GMP facility design, build-out and scale-up, technology transfer, analytical test method development, quality control, drug product formulation development, and CMC regulatory interactions and filings.
An accomplished biotechnology executive and scientist, Dr. Craig brings to jCyte over three decades of experience in the implementation of technical operations, quality systems, and regulatory affairs for complex biologics, including hematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), neural stem cells (NSCs), activated T cells, gene-modified T cells and gene-modified HSC products, as well as recombinant proteins, monoclonal antibodies, adeno-associated virus (AAV), gamma-retroviral (gRV), and lentiviral (LV) vector products. Stewart holds a B.Sc. in Biochemistry and a Ph.D. in Physical Biochemistry from Newcastle University (U.K.) and has authored more than 100 papers and abstracts many of which are in the cell and gene therapy space.
Prior to joining jCyte, Dr. Craig served as Chief Technical Officer for Erytech Pharma supporting the development of their innovative red blood cell-based therapeutic platform for severe forms of cancer and orphan diseases. Additionally, he has held executive level positions designing, implementing, and operating the CMC and GMP manufacturing infrastructure for various pioneering cell and gene therapy companies. These positions include Chief Manufacturing Officer of Orchard Therapeutics, SVP Technical Operations of Sangamo, EVP Manufacturing and Regulatory of Stemcells Inc., Chief Technology Officer of PCT Cell Therapy Services, and Chief Operating Officer of Xcyte Therapies. Dr. Craig also has extensive experience in the successful leadership of regulatory affairs for cell and gene therapy submissions in the U.S., Canada, and Europe.
“Stewart’s addition to the team brings to jCyte a highly qualified industry executive 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 and operate,” said Dr. Shannon Blalock, Chief Executive Officer. “His more than three decades of experience, and specifically, his deep experience with the late-stage development and commercial manufacture of cell therapies, will be invaluable as we successfully transition our manufacturing process for our transformative jCell platform technology from a clinical to a commercial stage. I am excited to welcome Stewart to our growing leadership team to help us ensure we bring jCell to the millions of patients around the world with RP and other retinal degenerative conditions who currently have no treatment options.”
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 (EMA).
About jCyte, Inc.
jCyte, Inc. is a clinical-stage biotech company focused on developing its first-in-class regenerative cell therapy, jCell, for retinitis pigmentosa (RP) and other retinal degenerative diseases. 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 conditions. For more information, visit www.jcyte.com.