Dr. Couture’s recognized expertise–established over nearly three decades of work with experimental biologics, heavily focused on cell and gene therapies–includes organizational management, regulatory affairs, business development, process development, GMP manufacturing and clinical development, GMP manufacturing and clinical development. Dr. Couture was a key participant in numerous first-in-man clinical studies, including the first human gene therapy trials, the first direct administration to humans of a genetically engineered virus, and many other cell and gene therapy firsts.
Prior to joining Orbsen Therapeutics, Dr. Couture was the Founding Director and Senior Vice President of the Center for Applied Technology (CAT) at City of Hope where he established and oversaw the offices of IND Development and Regulatory Affairs, Quality Systems, Technology Licensing and COH’s two precedent setting GMP biologics manufacturing facilities, the Center for Biomedicine and Genetics and the Cell Therapy Production Center. Dr. Couture directed the successful production of over 300 lots of clinical grade viral vectors, vaccines, plasmid DNA, monoclonal antibodies, bacterial products and hematopoietic cell-based therapeutics and pluripotent stem cell derived cell products including: cardiomyocytes, retinal pigment epithelia, neural stem and progenitor cells and dopaminergic neurons. Lentivirus vectors produced at the CAT have been used by over a half dozen groups in clinical trials across the country, including those resulting in the first reported successful clinical outcomes in leukemia with CAR-T immunotherapeutics.
At COH, Dr. Couture oversaw a combined staff of approximately 60 scientists and technical staff. He oversaw nearly 50 active INDs and was a member of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee, as well as several FDA working groups. In addition to currently leading two biotechnology companies and consulting with or participating on the advisory boards of a number of additional biotechnology companies, he has been an ad hoc analyst for venture capital firms and has mentored many start-up companies in the Southern California area. He previously founded and/or served as Director or CEO of several biotechnology companies including Cell City, Genbasix, Aliva Biopharmaceuticals, and eMTA Commons, Inc., and held senior scientist and management positions at Genzyme Corporation and Ribozyme Pharmaceuticals.
Current role