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Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA

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Felix W Frueh

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA

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Lawrence J Lesko

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA

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Shiew-Mei Huang

† Author for correspondence

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA

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Email the corresponding author at shiewmei.huang@fda.hhs.gov

Published Online:1 Jul 2008https://doi.org/10.2217/17520363.2.3.305

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Abstract

The US FDA encourages the integration of biomarkers in drug development and their appropriate use in clinical practice. It is believed that this approach will help alleviate stagnation and foster innovation in the development of new medical products, and, ultimately, lead to more personalized medicine. To facilitate the use of biomarkers in drug development and clinical practice, the FDA organized workshops, issued guidances, established a voluntary submission process, developed online educational tools and, most importantly, strives to ensure the integration of this information into drug labels, for example, via the update of existing labels, or the inclusion of appropriate language in new drug labels. A pilot process has been set up to qualify novel biomarkers that are not associated with specific drug products, but are of more common use (e.g., biomarkers for drug safety). In addition, the FDA has initiated the creation of various consortia that are working towards the identification and characterization of exploratory biomarkers in order to qualify them for a specific use.

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Published online 1 July 2008

Published in print June 2008

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Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

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