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Developing an Effective Training Curriculum for Cell and Gene Therapy Operational Teams

Chris A. Learn*, Tracy D. Stewart, Monica R. Shah

Cell And Gene Therapies (CAGT) have become a market force across a continuum of therapeutic indications. The CAGT market value is expected to reach nearly $7 billion USD by 2027 with a cost-adjusted growth rate of nearly 20% according to leading market research indices. Given their complexity, scope and breadth, it is essential to effectively educate and train resources to perform the required CAGT clinical trial operational delivery functions, as the quality and integrity of this form of therapy directly impacts patient safety. Described herein are empirical data, experiences and best practices for establishing a CAGT training curriculum to help achieve clinical trial operational competencies, protocol compliance and better patient outcomes.