Michael J. Daley, PhD
President & Founder
Dr. Daley’s 27-year career in the biopharmaceutical and medical device industries has included working in small emerging to large biopharmaceutical companies. After receiving graduate degrees in experimental pathology and medical sciences specializing in tumor biology and immunology, he did a postdoctoral fellowship in biochemical and molecular immunology, and then served two years on the faculty in the Department of Biology at MIT. Dr. Daley began his industrial career in drug discovery at American Cyanamid, and was the Group Leader of Immunology and Microbiology, heading a R&D effort in the use of recombinant cytokines to potentiate vaccines and adjunct treat for infectious disease; as well as mapping agonist/antagonist activities of targeted hormone receptors and ligands.
Dr. Daley joined a joint venture of DuPont and ConAgra, DCV Biologics LLC, as Director of Clinical, Regulatory and Quality Affairs. He helped advance numerous products into clinical development, established an internal QA/QC program, successfully filed two GRAS affirmations, and served as the primary regulatory liaison with FDA. At SRA Life Sciences, an emerging CRO, he was Director of Program Development, helping to establish internal processes and support to expand their marketed services. Dr. Daley joined the Medical Affairs department at Sanofi Pharmaceuticals Inc (sanofi), where he served 8 years as Medical Director of Internal Medicine Products. He had primary responsibility for Hyalgan, an i.a. injection for osteoarthritis knee pain (medical device), which was sold into orthopedic and rheumatology specialty markets. Dr. Daley was responsible for post-marketing support, strategic clinical development, technology assessment, medical education, and publication planning for marketed products. While heading the medical affairs program, he was able to implement a medical marketing strategy that successfully differentiated the brand from the market leader; he also grew the brand’s market share from 20% to market parity in three years. He joined TiGenix Inc, to head up their US Clinical, Regulatory and Medical Affairs efforts. TiGenix is a late-stage biopharmaceutical company focused on the development of innovative local cell-based regenerative medicine and medical device therapies for musculoskeletal disorders.
Dr. Daley founded Cognate Consultants in 2009 as LLC and OrthogenRx, Inc.
OrthogenRx is a late-stage development company focused on the development of generic Class III medical devices. The business model is to identify products being sold formerly US that are identical to currently marketed US products and license them for commercialization in the US. Several suppliers of targeted products have been identified and licensing/supply agreements have been executed. Testing of the substantial equivalence of licensed products, the commercial US products is under way and its novel accelerated regulatory strategies are being executed. With 3 product approvals anticipated by the second quarter of 2014, sales exceeding $100MM are achievable within 5 years. Additional pipeline products are also being developed to expand the orthopedic franchise.