The SC CTSI Regulatory Knowledge and Support (RKS) team in collaboration with the USC + CHLA Alpha Clinic has launched a new self-paced training module, “Cell and Gene Therapy Trials.” This course focuses on implementing quality practices for clinical trials involving these types of regenerative medicine therapies and serves as the inaugural offering in the series, “Special Considerations for Emerging Technologies.”

This project was led by RKS Director, Chair and Associate Professor, Eunjoo Pacifici, PharmD, PhD, and RKS Associate Director Nancy Pire-Smerkanich, DRSc, MS. Additional contributors include RKS Associate Director Tony Succar, PhD, MScMed(OphthSc), along with administrators Annie Ly, MS, Karen Manrique, MS, who oversaw development, and Gordon Wimpress, BSc, BA, who oversaw production. The content draws from various sources, such as the FDA, the National Institutes of Health, clinical research organizations, and the expertise and experiences of key stakeholders within the USC + CHLA Alpha Clinic.

The module is freely available, and open to the entire clinical research workforce, as well as anyone interested in learning more about ensuring quality in cell and gene therapy trials. It includes four chapters that introduce fundamental concepts in CGTs, examine opportunities and challenges inherent in CGT clinical trials, and provide practical case studies along with actionable resources such as templates and checklists. Upon completion of the module, users receive a digital badge and a certificate of completion, which can be added to resumes, CVs, and LinkedIn profiles.

To access this new module, please visit the Cell and Gene Therapy Trials course catalog listing, click the Enroll button, and Login or Create an Account.