Three weeks ago we introduced the concept of the Biomarker Intelligence Maturity Model where we unveiled the 5 stage, 4 swim-lane model representing how companies improve biomarker intelligence management to win in drug and diagnostic development. This is the second installment of that series where we will cover the Process swim lane. Specifically, we are talking about the process to qualify biomarkers.

We see a general pattern emerging regarding the process of qualifying biomarkers.  At one end of the spectrum small pharmaceutical companies with a small number of drug development programs typically have no formal process management for the management of biomarker intelligence and the subsequent biomarker qualification. Biomarker use is intermittent for single use projects.

At the other end of the spectrum organizations with 50+ drug development programs have some biomarker management process to gauge qualification level of biomarkers in the context of a specific drug program. In addition, these sophisticated organizations benchmark their effective use of biomarkers in drug development relative to their peers in the industry and share their progress throughout the organization. In our Biomarker Intelligence Maturity Model, the bulk of the organizations we engage with generally fall into the stage 2 category moving to stage 3.

Currently there isn’t a “gold standard” process for the qualification and validation of biomarkers.  Two processes from the National Biomarker Development Alliance (NBDA) and the FDA are starting to garner some attention. The NBDA process can be visualized at a high level by the following image.  It has been designed by a respected panel of experts.  We view the NBDA process as a strong candidate for internal management of biomarker pipelines for centralized groups with numerous drug development programs underway.   It can give a quick visual “snapshot” of how ready a specific biomarker panel is for a clinical trial.


Deep information and resources about the National Biomarker Development Alliance can be found at

The FDA has placed the Biomarker Qualification Program within the Drug Development Tools Qualification Programs category to “speed up” the clinical trials process by having qualified biomarkers that can be used in multiple trials as long as the context of use is similar.  A high level graphic from FDA shows the focus on the stages of submitting information to satisfy the regulatory requirements.  Which is certainly worth tracking if the decision is made to follow this path.


Detailed information on the FDA process and examples of submissions can be found here.

Several of our customers use BiomarkerBase to compare their use of biomarkers in clinical trials relative to other companies focused on the same therapeutic areas, disease or drug target. You can find some examples of those landscapesblog posts herehere and here.