Fellowship training for cellular therapy laboratory directors.

Abstract

The rapidly evolving field of cell and gene therapy (CGT) demands a new generation of leaders capable of managing complex manufacturing processes while navigating stringent regulatory environments. To address this need, Mayo Clinic established a Cellular Therapy Fellowship (CTF) program specifically designed to train future laboratory directors by integrating hands-on manufacturing experience with didactic instruction in laboratory management, quality systems, and regulatory science. The CTF curriculum includes structured rotations through cleanroom manufacturing, quality assurance, and process development groups. Fellows gain expertise in diverse manufacturing platforms, such as CAR-T cells, mesenchymal stromal cells, and other cellular therapies, while overseeing manufacturing for clinical trials and product development. Once competent, fellows transition into an Acting Director role, wherein fellows make real-time decisions under supervision, preparing them for the responsibilities of independent leadership. Since its inception, the program has trained fellows with diverse backgrounds, including PhD- and MD-trained professionals, tailoring their experiences to career goals. Graduates demonstrate competencies in laboratory management, cGMP manufacturing, and translational research through notable deliverables such as publications, conference presentations, and regulatory submissions. This manuscript outlines the development, implementation, and outcomes of the program, providing a roadmap for institutions to establish their own fellowship programs and cultivate the next generation of CGT laboratory leaders.