1. § Independent scientific and analytical verification of the
biomarker – this process involves verification of the analytical
performance characteristics and clinical correlation of a
biomarker with a biological process or clinical outcome
* Linking a biomarker to a clinical endpoint - Qualification is a
process applied to a particular biomarker to support its use as a
surrogate endpoint in drug discovery, development or post
approval and, where appropriate, in regulatory decision making
¶ Assessing all technical aspects of the biomarker assay
The Biomarker Pipeline
Provided by: Ali Mobasheri, BSc ARCS, MSc, DPhilProvided by: Ali Mobasheri, BSc ARCS, MSc, DPhilProvided by: Ali Mobasheri, BSc ARCS, MSc, DPhilProvided by: Ali Mobasheri, BSc ARCS, MSc, DPhil