A biomarker is a measure or physical sign that can be used to determine how the body is functioning. This can help researchers develop more individualized treatments, provide an early warning sign for certain health risks and accelerate the availability of new medicines for patients.
As more of these tools are identified and utilized, they have the potential to enhance the research and development process of new medicines by providing new ways to measure disease activity and the impact of the medicines being studied.
In order to take advantage of the promise biomarkers hold in drug research, there is a need to establish a clearly defined biomarker qualification pathway at the FDA. A well-defined regulatory pathway for biomarker qualification can help improve drug development, accelerate patient access to promising therapies, open new avenues for research and yield a more competitive and sustainable biopharmaceutical ecosystem.