Biomarker Assessment in Clinical Phases of Drug Development
Michael D Silva,
Principal Investigator,
BBRC, Syngene International Limited
Incorporation of a robust biomarker strategy during drug discovery and development helps in ensuring that ultimately the right drug is given at the right dose to the right patient, bringing closer the reality of personalized/targeted medicine. During the clinical phase of drug development, clinical biomarkers can help in better understanding of target engagement, pharmacodynamic activity (PD), dose selection, safety/efficacy, enable patient stratification and potentially predict clinical outcome. Multiple technology platforms have been utilized for biomarker assessment.
Since its invention in the late 1960’s, the flow cytometry based technology platform has technically advanced to allow multi-parametric analysis using greater than 13 colors and is now quite frequently used for blood based clinical biomarker analysis. Using biomarker examples for PD, target engagement, safety/efficacy this talk will highlight the approaches used for assay qualification and implementation of flow cytometry based biomarker assays into clinical trials to contribute to the above goal.
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