(13 Oct 2009)
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The mission of the HESI Project Committee on the Development and Application of Biomarkers of Nephrotoxicity is to advance the scientific basis for the development and application of biomarkers of kidney toxicity; to develop a systematic approach for the evaluation of biomarkers that bridge from the pre-clinical to clinical stages of drug development; and to provide a scientific forum for building consensus regarding how to apply biomarkers of toxicity in risk assessment.
Most biomarkers used for pre-clinical and clinical evaluations have been available since the 1950s. While these markers have stood the test of time, there has been little progress in the development of new, more sensitive indicators of cellular and tissue damage over the past 50 years. Furthermore, there exists a dearth of biomarkers that bridge from pre-clinical testing methodologies to clinical evaluations.
The advent of new “-omic” technologies (genomics, proteomics, and metabonomics) promises to provide immense opportunity for the discovery and development of new markers of cellular and tissue integrity. Such biomarkers should be easily measurable at low concentrations in accessible tissues such as blood and urine. In addition, they should be specific and sensitive indicators of target organ toxicity.
With the introduction of these new technologies, interest in developing new biomarkers for the prediction of toxicity has expanded rapidly. The U.S. Food and Drug Administration has established a new initiative to improve the use of biomarkers for the identification of drug-related organopathies. In addition, a full scientific program was dedicated to biomarkers at the 2002 Annual HESI meeting.......
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