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Bioanalytics
Speaker Spotlight

Speaker Spotlight: Optimizing CAR T Cell Trials: Guidance on Developing and Validating Flow Cytometry Assays for Pharmacokinetics in Clinical Trials

Wednesday, October 23, 2024
10:00 AM – 11:00 AM MT
Location:Spotlight Stage A, Aisle 1100, Exhibit Hall

Bioanalytics

While industry guidance for developing and validating flow cytometry assays in CAR T cell clinical trials has made significant strides, some deficiencies remain. These deficiencies revolve around standardization of detection reagents, harmonization of methodologies across different laboratories and flow cytometers, and ensuring robustness and reproducibility of assays. Additionally, there is a need for further clarity on specific parameters to measure such as cell specific CAR T detection, appropriate controls to include, and validation criteria to meet regulatory requirements. Addressing these remaining deficiencies is crucial for ensuring the reliability and comparability of flow cytometry data across the multitude of different clinical trials and ultimately advancing the field of CAR T cell therapies.

Learning Objectives:

  • Detail Best Practices: Provide a comprehensive guide on developing and validating flow cytometry assays tailored for CAR T cell pharmacokinetics, ensuring accuracy and consistency in trial data.
  • Enhance Accuracy: Offer insights into optimizing assay conditions and techniques to improve the precision of pharmacokinetic measurements, crucial for evaluating therapeutic efficacy.
  • Address Challenges: Discuss common challenges and solutions in the assay development process, helping researchers overcome obstacles and refine their methodologies.
  • Ensure Regulatory Compliance: Highlight key considerations for meeting regulatory standards and ensuring the reliability of assay data in clinical trial submissions.