Denis Boyle
Education
Ph.D., chemical pathology (medical biochemistry), University of the Witwatersrand, South Africa; M.S., biochemistry, University of Louisville
Summary of Experience
Dr. Boyle has over 30 years of experience in the biopharmaceutical industry, with a particular interest in commercialization, technology transfer, regulatory strategy, good manufacturing practice (GMP), recombinant protein biochemistry, and monoclonal antibodies. At CMC BioPharma, he advises biopharmaceutical clients across all stages of the biologics drug development cycle, including process development, scale-up, manufacturing, late-stage pre-commercialization studies, contract development and manufacturing organization (CDMO) management, and regulatory strategy. Dr. Boyle has served as an expert witness, opining on biotech drug manufacturing in a breach of contract litigation matter and on the scientific value of trade secret information in an arbitration between two biopharmaceutical companies. Prior to joining CMC, he was a consultant at BDO/BPTC and held process development positions at several biotech companies, including Promega, Zoetis, and Pfizer. Earlier in his career, Dr. Boyle worked as a research biochemist at Brown and Williamson Tobacco, as a medical scientist at the South African Institute for Medical Research, and as a technical supervisor at the J.G. Brown Cancer Center. He holds seven patents or applications related to biologics processes.