Flow cytometry is a powerful technology and under-utilized in drug development. As the therapy for most of the diseases (primarily cancer) are focusing on immune system, Flow cytometry can be a valuable tool to understand the pharmacokinetics (PK) and pharmacodynamic (PD) of the treatment. Flow cytometry technology offers solutions throughout the drug development process, preclinical (R&D, and target identification) to clinical trial and beyond (safety and monitoring).  During clinical trials, Flow cytometry could be utilized for safety assessment with TBNK assay to more complex immunophenotyping assays.

Advantages in utilizing Flow cytometry in drug development are shorter turn-around-time to get the data and relatively high amount of data with small amount of matrix (blood or bone marrow aspirate). Some of the challenges in Flow cytometry are need for trained expertise and sample stability (relatively short time to process the sample).   

Various aspects of assay development to assay implementation, and advantages and challenges in implementing an assay for global clinical trials will be discussed in this presentation.