Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

Clin Pharmacol Ther. 2015 Jul;98(1):34-46. doi: 10.1002/cpt.136. Epub 2015 Jun 6.


The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become accepted for use through submission of biomarker data during the drug approval process. Another emerging pathway for acceptance of biomarkers is via the biomarker qualification program developed by the Center for Drug Evaluation and Research (CDER, US Food and Drug Administration). Evidentiary standards are needed to develop and evaluate various types of biomarkers for their intended use and multiple stakeholders, including academia, industry, government, and consortia must work together to help develop this evidence. The article describes various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification. A path forward for coordinating efforts to identify and explore needed biomarkers is proposed for consideration.

Publication types

  • Review

MeSH terms

  • Biomarkers, Pharmacological*
  • Drug Approval* / legislation & jurisprudence
  • Drug Discovery*
  • Drug Industry / legislation & jurisprudence
  • United States
  • United States Food and Drug Administration


  • Biomarkers, Pharmacological