How Biomarkers Can Improve the Drug Development Process

Dr. Susan McCune of the FDA’s Center for Drug Evaluation and Research discusses some ways that biomarkers are being used to improve drug development. FDA recognizes biomarker development as a high priority area for future research and collaboration among stakeholders and is taking action to better understand biomarkers used in drug development. CDER’s Biomarker Qualification Program strives to make biomarker data publicly available by establishing a biomarker’s value for a particular context of use in drug development and regulatory review.
Learn more about FDA’s biomarker qualification program at www.fda.gov/biomarkerqualifica.... Access the Examples of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities (NMEs) and New Biological Therapeutics (October 2007to December 2015) at www.fda.gov/Drugs/DevelopmentA....