Top considerations for developing a biomarker solution and CDx strategy

When it comes to designing clinical trials with expedience and efficiency, many drug developers are choosing biomarker-driven strategies for their investigational precision medicines. As key features of developing new therapies and diagnostics, biomarkers define the disease biology, provide potential targets for new therapies and provide strong potential for market differentiation. When considered together with companion diagnostic (CDx) development, biomarkers also offer relevant clinical information that may bring deeper insights, enabling breakthroughs in various precision medicines. At the 2022 Japan Symposia, Mark Roberts, senior director of diagnostic development services, weighed in on ways drug developers can examine their biomarker and CDx strategies and enhance outcomes for their programs.

Key biomarker applications in clinical development

As with most strategic planning, asking the right questions at the right time enables preparation for the best possible outcome. In biomarker strategies, this means understanding the current landscape and beginning with the end goal in mind. According to Roberts, the primary question to address is whether there is a clinically relevant biomarker for your drug development program. “If the molecular drivers of the disease are well established, it may be possible to move immediately within your clinical trial to the intent-to-treat population, enrolling only those patients that exhibit or have an absence of the correct biomarker,” Roberts added. If not, early clinical trials will be designed to prove the hypothesis of a biomarker’s clinical relevance.  

Other key questions to consider include:

• Do you have a clinically relevant test for your drug development program?
• Will you use a test to change/modify treatment in your clinical trial?
• Will you use a test to determine patient inclusion/exclusion criteria in your clinical trial?
• Will you use a test to assign patients to a specific arm of your clinical trial?

Once you have selected the best biomarkers for your therapeutic area of interest, it’s important to take a holistic approach to your strategy by anticipating other components of the clinical trial design. Building for flexibility and adaptability will help you stay ahead as unexpected circumstances arise. Proactively planning for the parallel development and commercialization of your CDx is also crucial in proving the value of your treatment’s efficacy with targeted biomarkers.

Why co-develop a drug and its CDx strategy?

Developing a drug and its CDx typically involves two separate trials and a three-way partnership among the drug developer, the in vitro device manufacturer and the testing laboratory. Due to the added complexity, strong project management and excellent communication is essential to provide greater oversight of projects and clearly define expectations and deliverables. To facilitate development and streamline processes, drug developers may wish to consider the multiple benefits of a co-development model.

First, a co-developed strategy improves trial design by identifying target patients quickly, enrolling only those who would most likely benefit from the investigational therapy. Furthermore, it provides balance across treatment arms and helps to enhance the safety profile of a prospective new drug. Secondly, it reduces the development time and medical prescription and diagnosis costs associated with the development, while also illustrating comparative effectiveness.However, it is worth mentioning a couple of challenges associated with the co-developed strategy. First, developers are likely to encounter recruitment competition for the low number of patients within a patient population. Second, there may be overlapping regulatory considerations that must be accounted for, particularly in regard to the varying regulatory requirements in the U.S. versus Europe versus the Asia-Pacific region. The decision-making process in developing an optimal biomarker and CDx strategy for an investigational precision medicine can be complex. When your therapeutic needs a CDx, rely on an experienced partner for guidance. As your laboratory partner, we can develop and validate your tests, help you navigate regulatory hurdles and accelerate your products’ journey to market. Explore our biomarker and CDx capabilities, contact us.