MRF’s Critical Role in Biomarker Development

MRF is focused on developing a biomarker that can speed myelin repair treatments to MS patients. We initiated this difficult effort in 2017 after polling senior pharma executives along with distinguished NIH and academic scientists. They expressed the need for a myelin repair biomarker and noted that no effort to develop one was even being contemplated.

We have made great progress and are close to our goal. But people frequently ask, if biomarkers are so useful in drug discovery, drug development, FDA approval and for patient treatment decisions, why don't pharmaceutical companies with their deep pockets typically invest in biomarker development?

Challenges to Biomarker Development

There are many challenges to developing biomarkers. On a foundational level, identifying potential biomarkers requires basic research typically done in academic labs. However, academia doesn’t have the ability to then commercialize these biomarkers. That’s where pharmaceutical companies come in, but currently there isn’t a natural pipeline between academia and pharma. There are many reasons for this gap, but a key one is related to IP. Biomarkers discovered in more "open" academic / consortia settings make them less attractive for exclusive corporate investment.

Beyond this, there are additional obstacles for pharmaceutical companies. Most are reluctant to invest heavily in standalone biomarker development because the process is prohibitively expensive, scientifically risky, and often lacks a clear return on investment (ROI) compared to traditional drug development.

1. High Cost & Resource Intensity: Developing a biomarker alongside a new drug increases the financial and time burden on a sponsor. The "discovery to refinement" pipeline requires massive investments in technical and clinical validation across multiple studies. If their drug development program is not successful (about 90% of programs that make it to clinical trials are not successful) then the associated biomarker development program, even if it had been successful, would have no value.
2. Commercial & Financial Risk: Like drugs, most biomarker candidates fail during validation due to technical issues or flawed scientific hypotheses. Even if they are successful, historically, diagnostics have been "under-appreciated assets.” Companies often find they aren't rewarded for the cost of development through traditional pricing or reimbursement models. And biomarkers (especially predictive ones) segment patient populations. This can lead to smaller "indicated" populations, potentially reducing the total sales volume for the associated drug.
3. Administrative Impediments: Identifying, validating, refining and scaling up assays to provide the biomarker readout is a lengthy journey over multiple years. “Staying the course” for long periods of time is difficult in pharma because surprisingly there are frequent changes in programs within pharma companies. And non-revenue producing investments require unwavering support from the CEO, while the typical tenure of a pharma CEO is 6 to 8 years.

MRF Bridges the Gap in Biomarker Development

MRF took on this difficult and daunting task of developing a biomarker because, for all the reasons above, it would not have been done otherwise. Plus, this risky, complex, collaborative endeavor plays directly to MRF’s unique strengths and expertise. As a neutral non-profit, we can bridge the gap between academic research and commercial pharma. We have demonstrated over the last 22 years that we can mitigate risk and deliver rapid results by selecting stellar scientists, having clear measurable stretch goals and closely managing the team. And we have the credibility and contacts in pharma to move biomarker assays from academic labs to commercial pharma testing and usage.

As an MS patient driven and supported organization, nothing will deter our focus on achieving our goal.