In the Zone: biomarker assays
Reliable diagnostic, prognostic, predictive, pharmacodynamic and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing and monitoring. Being able to identify the most effective biomarkers and then utilize them to stratify patients and evaluate therapeutic benefit can reduce both drug development time, clinical trial sizes and facilitate more rapid regulatory approvals and time to market. As such, in the early stages of drug development, a drug developer should begin to evaluate biomarkers for potential diagnostic application in parallel with the development of the therapeutic drug itself.
Early research will focus on identifying potential biomarkers based on knowledge of the drug’s mechanism of action. The goal is to identify measurable analytes that accurately correlate to an early biological effect; i.e., a measurable change in normal biology. The quality of the biomarker assay need only fulfil the requirements necessary for internal decision-making. How a biomarker assay is further applied to a drug’s development, e.g., as a clinical endpoint (primary, secondary or exploratory) in a clinical protocol, will determine when an assay should evolve from research quality to a clinical diagnostic test or even a Companion Diagnostic (CDx).
Infographic: biomarker assays – In this infographic the following key topics are addressed: how do you determine what level of validation is required to measure a biomarker?; recommendations for assay validation of a biomarker method supporting an exploratory endpoint; recommendations for assay validation of a biomarker method supporting a pharmacodynamic endpoint; and recommendations for assay validation of a biomarker method supporting patient selection, decision or safety endpoints.
Biomarker assays – bioanalytical meets CLIA – How a biomarker assay is being applied to a drug’s development will determine when an assay should evolve from research quality to a clinical diagnostic test. The requirements for a lab developed test with regard to assay performance, validation requirements and when the assay is used for patient selection and risk determination within a clinical study is presented in this webinar.