Biomarkers are powerful tools which are used by medical professionals in many ways, including in the diagnosis of disease, monitoring how a disease is progressing and, if a treatment is given, how the body is responding. Biomarkers may also help biopharmaceutical researchers determine which medicines may be most effective in certain patients. In a new series of videos Dr. Bernie Zeiher, president of development at Astellas Pharma, discusses how scientists are using biomarkers to create more precise, personalized treatment approaches for patients.
“Biomarkers are used in clinical studies to select patients eligible to be treated in that study,” explains Zeiher. “In the case of oncology, if you’re targeting a tumor that has a particular mutation, you’d run the test before they’re enrolled and see if they have that mutation, and if they are, they’re eligible for treatment.”
The latest iteration of the Prescription Drug User Fee Act enhances the FDA’s biomarker qualification pathway and establishes a dedicated process to improve the use of biomarkers as surrogate endpoints in drug development.
To hear more from Dr. Zeiher on how biomarkers are advancing personalized medicines and helping improve outcomes for patients, explore the video series below.
The Role of Biomarkers in Clinical Trials:
Using Biomarkers to Determine Medicines’ Effectiveness:
Using Biomarkers to Select Clinical Trial Participants:
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.