Megan M. (Suhoski) Davis, Ph.D
Director, Product Development Laboratory (PDL)
I am a cellular immunologist with over 15 years of relevant experience and an avid interest in translating pre-clinical research into clinical application within the field of cell and gene therapy. I earned my Ph.D. in Immunology under the direction of Dr. Carl June from UPenn, developing an artificial antigen presenting cell (aAPC) system that has since been used in the clinic for cell-based therapies (US Patent 7,754,482). I pioneered the first internship at the Penn Center for Innovation, which has since become a successful postgraduate fellowship program in intellectual property management and commercialization. A postdoctoral fellowship at Stanford University with Dr. Edgar Engleman allowed me to study the biology of natural APCs to develop immunotherapy vaccination strategies. Having returned to the Translational Research Program at UPenn as the Associate Director of the Clinical Cell and Vaccine Production Facility (CVPF), I assisted the CVPF Director with the overall planning, resource management, and continued regulatory compliance under good manufacturing practice (GMP) to support more than 30 cell therapy clinical trials (many first-in-human), 20 FDA Investigational New Drug Applications (INDs), and 3 Biologics Master Files (BMFs). My expertise and experience has prepared me to consult on pre-clinical process validation study designs, development of Chemistry, Manufacturing, and Controls (CMC) sections of INDs, and protocol review for more than 10 new cellular therapy clinical trials. I spent 4 years as Director of Scientific Affairs for CVPF, leading the scientific research operations to improve clinical cell manufacturing and quality control testing. I have reviewed and approved the batch records for over 300 manufactured autologous cell therapy products to treat more than 150 clinical trial subjects. As the UPenn Tech Transfer workstream lead, I helped facilitate the successful transfer of the T cell manufacturing process from UPenn to industry collaborators, leading to FDA approval of the first CAR-T cell therapy, Kymriah® for pediatric leukemia and diffuse large B cell lymphoma. Currently, I oversee the Product Development Laboratory (PDL) at UPenn, a team of expert scientists who design strategies to enhance potency and increase overall manufacturing success rates, execute IND-enabling studies to scale up novel pre-clinical research projects into defined clinical manufacturing processes, and evaluate new and emerging technologies that will revolutionize cell therapies, including employing optimal starting material for input.