Dr. Gregory J. MacMichael, Ph.D., has over 40 years of experience in the biopharmaceutical industry. He held pivotal roles in the development and manufacturing of numerous biologics, vaccines, and cell and gene therapies. As the President of CMC Bioservices, he leads a consultancy dedicated to advancing these pharmaceutical platforms. In his senior positions at Novartis, Wyeth, Eli Lilly, Chiron, Centocor, and Cook Pharmica, he led the development of robust, cost-effective processes for producing both drug substance and product processes for numerous monoclonal antibodies, therapeutic proteins, and vaccines, resulting in the successful launch of multiple products. As Global Head of Cell and Gene Therapies at Novartis, he spearheaded the CMC efforts for the acquisition of CART19 (Kymriah) from the University of Pennsylvania, which became the first FDA-approved CAR-T cell therapy.

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As Vice President of Vaccine Development at Wyeth, he was instrumental in the improvement of Prevnar and the development of Prevnar 13, which have generated billions in annual sales and significantly reduced the incidence of pneumococcal disease globally. At Eli Lilly, he led the development and commercialization of Xigris and Forteo for sepsis and osteoporosis, respectively, achieving regulatory approvals and market success. Notably, the Xigris HEK293 suspension process was leveraged in the development of lentiviral suspension processes used by many cell and gene therapy companies today. His work at Chiron involved developing multiple recombinant vaccines in CHO cells and the MF59 adjuvant currently used in many vaccines. His contributions at Centocor led to the development of high yielding, stirred-tank perfusion processes to produce monoclonal antibodies such as Remicade, ReoPro, and Centoxin, which have had a profound impact on the treatment of autoimmune diseases and cardiovascular conditions. Additionally, Greg has held leadership roles in various biotech firms, guiding them through critical phases of clinical development and commercialization. Dr. MacMichael's experience and leadership have significantly advanced the biopharmaceutical industry, driving innovation and successful product development.