This talk explores the expanding role of flow cytometry in CAR-T and cellular therapy bioanalysis—from its origins supporting the earliest autologous CAR-T clinical trials to its expanding role in next-generation in vivo CAR therapies. We will trace how flow cytometry methods have matured alongside the CAR landscape, becoming a primary platform for measuring cellular expansion, persistence, and pharmacodynamic response. If you are working on cell therapy development, bioanalytical strategy, or in immunology translational research, you won’t want to miss this discussion.
The CAR therapy space is no longer limited to ex vivo manufactured autologous products. The field continues to mature, with allogeneic, CAR-NK, CAR-M, CAR-Treg, and now in vivo CAR approaches rapidly advancing into the clinic. This shift to in vivo CAR therapies —where functional CAR cells are generated directly inside the patient using viral vectors or lipid nanoparticles—is fundamentally changing the bioanalytical question. The focus shifts from characterizing a known cell product to real time detection, tracking and functional phenotyping of emerging CAR populations.
Learning Objectives:
Attendees will gain practical insight into how advances in multiparametric flow cytometry are enabling deeper characterization of these novel modalities—including assessment of transduction efficiency, expansion kinetics, phenotypic fitness, memory and exhaustion profiling, target cell depletion, and off-target immune effects. We will also discuss how fit-for-purpose bioanalytical methods must evolve to meet the unique regulatory and scientific demands of in vivo CAR programs.
Whether you are supporting a traditional CAR-T program or developing next-generation in vivo cell therapy platforms, this session will equip you with a forward-looking perspective on where flow cytometry is headed—and why it remains indispensable as a core technology for CAR therapy bioanalysis.
About the Expert Speakers:
Brian Wile, PhD – Brian Wile serves as General Manager of Global Flow Cytometry at KCAS Bio, a leading contract research organization specializing in bioanalytical services for drug development. With deep expertise in flow cytometry and its application across complex biologics programs, Brian has been at the forefront of building and scaling fit-for-purpose bioanalytical capabilities to meet the evolving demands of cell and gene therapy development. At KCAS Bio, he oversees a global flow cytometry practice that has supported some of the most innovative CAR-T and cellular therapy programs advancing through the clinic today. Brian’s work spans the full translational arc—from early autologous CAR-T trials to the emerging frontier of in vivo CAR approaches—making him uniquely positioned to speak to how flow cytometry methods must evolve alongside the rapidly shifting CAR therapy landscape. In this session, he brings a practitioner’s perspective on the scientific and regulatory challenges of characterizing next-generation cell therapies in real time.
David Ambrose, MBA, SCYM(ASCP) – David Ambrose is Associate Director of Flow Cytometry Services at KCAS Bio, where he leads development and validation of fit-for-purpose flow cytometry programs supporting global clinical trials. With 18+ years in flow cytometry, his career includes foundational work at the University of Pennsylvania’s Center for Cellular Immunotherapy, where he supported landmark CAR-T cell therapy trials and co-authored publications in Nature, Nature Medicine, and Science Translational Medicine. David is a co-founder of the MidAtlantic Flow Cytometry Association and a certified Specialist in Cytometry (ASCP).
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