A Systematic Approach to Providing Safe Quality Care for Patients Receiving Engineered, Non-Stem Cell Therapies

Introduction: Non-stem cell therapies including cellular vaccines and chimeric antigen receptor (CAR) T cells are experiencing explosive growth in research development and clinical applications. Demand is growing, with several CAR products heading for imminent FDA approval. The variety of products poses a challenge to even experienced cancer centers. Our goal was to create clinical and operational infrastructure to deliver these therapies efficiently and safely. We leveraged existing workflows and care models spanning inpatient and outpatient settings and disease groups previously unfamiliar with cell therapies.