Biomarkers are more important and prevalent than ever in the drug development process, largely due to their ability to support timely assessments of disease states and therapeutic candidates. As drug development tools (DDTs), biomarkers can serve multiple functions, used for clinical trial enrichment or in clinical outcome assessments (COAs) to evaluate clinical benefit. That is why the proper validation of biomarker assay performance is integral to most drug development plans.

That said, biomarkers are endogenous molecules with much individual variability, and there is still not yet one clear and concise guidance for biomarker validation – so there are still questions around what it takes to sufficiently validate the performance characteristics of a biomarker assay to ensure it can properly establish the value of the target biomarker as a qualified DDT.

In my upcoming webinar, “Exploratory Biomarker Testing: to Qualify or Validate the Assay?” I will seek to address these questions in the context of the latest scientific and regulatory considerations for biomarker validation and explore industry best practices. Topics we’ll touch on will include:

Distinctions Between Assay Qualification & Assay Validation

In the world of biomarker testing, the terms “assay qualification” and “assay validation” are not strictly defined – and most often used interchangeably. Generally, qualification is considered a less extensive form of validation. The depth and robustness of the parameters evaluated and the number of replicates performed for each parameter, is, therefore, generally less in a qualified assay versus a validated one. In the webinar, I will provide examples of cases where a qualified assay can be used to generate sufficient data on a biomarker’s potential usefulness, and cases where more thorough analytical validation would be required.

Considering the Context of Use (COU) in Assay Design

One of the most important steps to determining the level of assay rigor required is defining the biomarker’s context of use (COU), or how it will be used to make decisions during the drug development process. This will help ensure the assay is fit-for-purpose (FFP): set up from the start to generate data that is sensitive, specific, and selective enough to accurately evaluate the biomarker for its intended use. During the webinar, I will discuss these concepts in greater detail, providing insight into core performance expectations to qualify and/or validate an assay and how they guide the setting of minimally acceptable performance criteria.

Join the BioAgilytix Webinar to Learn More

Do you also find yourself questioning, ‘should we qualify or validate an exploratory biomarker assay before sample testing?’ I welcome you to join me, Dr. Afshin Safavi, as I consider the answer during my upcoming webinar: Exploratory Biomarker Testing—to Qualify or Validate the Assay? Co-hosted with Bioanalysis Zone, you can attend this Bioanalysis webinar on Thursday, September 5, 2019 at 15:00 BST / 10:00 AM EDT / 7:00 AM PDT. Register here to save your spot.