Case Study: Bristol Myers Squibb clarifies liso-cel kinetics with Certara modeling

Using Modeling to Demonstrate the Kinetics of Liso-Cel Transgene

Bristol Myers Squibb sought to understand the high variability in patient response to their CAR-T cell therapy, lisocabtagene maraleucel (liso-cel), and to determine if specific patient characteristics required dose adjustments. They partnered with Certara to employ modeling and simulation services to analyze the cellular kinetics of the therapy.

Certara's pharmacometricians developed a population cellular kinetic model using nonlinear mixed-effects modeling. The analysis determined that the tested patient covariates had a smaller impact than the natural variability between subjects and were not considered meaningful. As a result, Certara's work demonstrated that no dose adjustments were needed for specific populations, providing clear and actionable regulatory guidance for the client.

Bristol Myers Squibb