Part 1 of our webinar series on evolving and improving bioanalytical and biomarker analysis to support clinical trials
The development and validation of biomarker assays in general and cell-based flow cytometry assays in particular is driven by the ‘fit for purpose’ approach. We describe a modular, fit for purpose set of flow cytometry immunophenotyping panels, with wide applications in clinical research, that benefit from reduced development time, thereby reducing cost and accelerating projects. The core assays are designed as a base set of tests that can be run as-is for exploratory end points, further validated for higher importance readouts, or readily modified to include additional markers for customized studies.
What will you learn?
- The benefits of a modular approach to assembling immunophenotyping assays
- Fit for purpose flow cytometry assay validation
- Effective transfer of assays to additional analytical sites
Who may this interest?
- Translational scientists
- Biomarker scientists
- Procurement managers
- Assay development scientists
David Lanham, is Principal Scientific Director at Eurofins Pharma Bioanalysis group, Oxford, UK. He has worked in a wide range of areas within the pharmaceutical CRO industry in the UK for over 25 years, including roles in cell-based assay modelling, pre-clinical toxicology assessment and clinical trial bioanalysis. During this time he has developed an interest and expertise around immune function assessment and biomarker analysis. His current role in Oxford focuses on the application of flow cytometry and ligand binding techniques as investigative tools in bioanalysis during pharmaceutical drug development and is a member of the AAPS Flow Cytometry Action Program Committee.