1. ¹Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
2. ²Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA
3. ³Translational Sciences, Novartis Institutes for BioMedical Research, Novartis Pharma AG, Basel, Switzerland
4. ⁴Laboratory Sciences and Investigative Toxicology, Safety Assessment, Merck, West Point, Pennsylvania, USA
5. ⁵PDL, Roche, Basel, Switzerland

Correspondence: FM Goodsaid, (Federico.Goodsaid@fda.hhs.gov)

Received 2 May 2009; Accepted 3 June 2009; Published online 26 August 2009.

Abstract

Novel biomarkers of kidney toxicity are powerful tools not only with respect to their clinical applications but also because of their impact on drug development. These biomarkers can influence the assessment of efficacy of new drugs for kidney diseases as well as the risk management for new drugs. The science behind these novel biomarkers reflects the evolution over the past decade of genomic and proteomic platforms that have transformed the discovery and development of new biomarkers for preclinical and clinical applications in drug development. Several of these biomarkers are in use as transcriptomic biomarkers in animal models as well as translational proteomic biomarkers in animal models and in humans. Their ability to detect kidney damage earlier than is possible with currently accessible biomarkers is being given qualification through regulatory biomarker-qualification programs, which will help establish consensus for their widespread use.