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Validation of Analytic Methods for Biomarkers Used in Drug Development

Authors' Affiliations: ¹ Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland and ² Institute for Pharmaco-genomics and Individualized Therapy, University of North Carolina, Chapel Hill, North Carolina

Requests for reprints: Howard McLeod, Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Campus Box 7360, 3203 Kerr Hall, Chapel Hill, NC 27599-7360. Phone: 919-966-0512; E-mail: hmcleod{at}unc.edu or William D. Figg, Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Building 10/Room 5A01, 9000 Rockville Pike, Bethesda, MD 20892. Phone: 301-402-3623; Fax: 301-402-8606; E-mail: wdfigg{at}helix.nih.gov.

Abstract

The role of biomarkers in drug discovery and development has gained precedence over the years. As biomarkers become integrated into drug development and clinical trials, quality assurance and, in particular, assay validation become essential with the need to establish standardized guidelines for analytic methods used in biomarker measurements. New biomarkers can revolutionize both the development and use of therapeutics but are contingent on the establishment of a concrete validation process that addresses technology integration and method validation as well as regulatory pathways for efficient biomarker development. This perspective focuses on the general principles of the biomarker validation process with an emphasis on assay validation and the collaborative efforts undertaken by various sectors to promote the standardization of this procedure for efficient biomarker development.

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