The Mayo Clinic Cellular Therapy Fellowship: Training the Next Generation of Cellular Therapy Leaders

Background & Aim The field of cellular therapy is rapidly evolving with promising clinical outcomes and multiple potential therapeutic targets. This rapid expansion, while exciting, has quickly led to a deficit of qualified directors for burgeoning human cellular therapy laboratories. Unlike conventional drug therapies, cellular based therapies require an added layer of expertise in policy, good manufacturing practices (cGMP) and regulatory elements. Academic medical centers, both nationally and internationally, are in desperate need of well-trained, experienced leaders capable of directing the labs which both oversee and produce these therapeutic agents. To meet this need, we have established the Mayo Clinic School of Graduate Medical Education (MSGME) Cellular Therapy Fellowship; an intensive one-year program for M.D. and Ph.D. candidates consisting of didactic, experiential, and project-driven training with an emphasis on laboratory management and graduated responsibility. Mayo Clinic is a multidisciplinary academic medical and research institution, which houses a lab that directly supports the bone marrow transplant service in addition to a multifaceted immune and progenitor cell program focusing on investigational cell therapies such as mesenchymal stem cells, dendritic cells, and CAR T cells. The program is robust performing more than 500 clinical stem cell transplants annually and encompassing more than 25 active investigator-initiated trials in addition to greater than 30 external manufacturing protocols. Our aim is to produce scientific and clinical leaders fluent in cGMP regulations, quality control and regulatory components, clinical laboratory management, current methodologies in cell therapy manufacturing, IND preparation and clinical trial oversight. Methods, Results & Conclusion Our curriculum mirrors this aim with rotations in the BMT and progenitor cell laboratories, our commercial processing unit, CAR-T manufacturing, quality, apheresis and infusions and leadership and management each with varying levels of graduated responsibility and on-call duties. The fellows actively participate in director level conversations and decisions, which, in combination with the aforementioned experiences and their research projects, provides a thorough and comprehensive training experience for the next generation of cell therapy leaders.