Biomarker Assay Development and Validation*

After biomarkers are identified, the development and validation of assays useful for clinical trials are often difficult tasks for pharmaceutical companies to handle without prior diagnostic development experience. This workshop will present the critical requirements and procedures of assay development and validation, sample requirements, stability studies, and assay performance documentation. It will also address quality assurance (e.g. GLP) requirements to ensure the consistency in producing the biomarker assays and enabling the assays to be used for clinical trials and down-stream commercialization. For commercialization, the FDA approval process and requirements will be reviewed.