“…17 In another White Paper, Mody and collaborators from the International Consortium for Innovation and Quality in Pharmaceutical Development present an industry perspective on best clinical pharmacology practices for the development of CAR-T and T cell receptor T cell therapies, including clinical study design and modeling and simulation strategies, underscoring the unique and critical role of clinical pharmacology. 18 This is further exemplified in the study by Masilamani et al, 19 who compare bioanalytical methods for characterization of CAR-T cellular kinetics. Unlike proteins or antibodies, CAR-T are "living cell" therapies whose pharmacokinetics (PKs) are characterized by expansion, distribution, contraction, and persistence.…”