In the age of personalized medicine, biomarkers are emerging as important tools in drug development. 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.
Today, PhRMA released a new video explaining what biomarkers and surrogate endpoints are. 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.
Biomarkers have many uses in the drug development process, including providing the ability to diagnose disease and track disease progression. For disease areas where there is a significant unmet need or the condition is serious or life-threatening, like cancer, the U.S. Food and Drug Administration (FDA) may allow for the use of a biomarker in a clinical trial as a way to measure the effect of a medicine; this is known as a surrogate endpoint. In these instances, a biomarker is expected to predict clinical benefit. The surrogate endpoint can thus be substituted for a clinical outcome, which otherwise might take years to assess in a clinical trial.
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.
Read more about proactive policy solutions to modernize the FDA and deliver innovative treatments to patients here.
Andrew Powaleny Andrew Powaleny is Director of Public Affairs at PhRMA. Before joining PhRMA in 2015, he worked at the House Energy and Commerce Committee and later as a communications consultant. Andrew came to Washington, D.C. via Connecticut and proudly sings with the Gay Men’s Chorus of Washington, runs with the DC Front Runners and serves on the Alumni Council for The Fund for American Studies. He is also a member of the National Lesbian Gay Journalists Association.