Roundtable: Accelerating CAR T Development from Preclinical to Clinical Utilizing Key Biomarker Insights

From revealing phenotypic and functional characterization of CAR T-cell products, along with mechanistic markers of efficacy and predictive markers of safety and response, biomarkers of all types play a central role in delivering critical insights that support informed decisions at every step of therapeutic development. As is the case with adoptive cell therapies, the probability of successful progression from discovery to first-in-human (FIH) to registrational trials and beyond depends more heavily on a holistic approach to therapeutic development. In this roundtable, expert speakers focus on the design and approach for preclinical efficacy studies, understanding how these studies fit into the larger safety and toxicology package to bridge into the clinic and inform the implementation of successful biomarker strategies to accelerate development of a therapeutic.