Biomarkers of Nephrotoxicity Committee

 

Biomarkers of Nephrotoxicity Committee

Mission Statement

The mission of the Biomarkers of Nephrotoxicity Technical Committee is to advance the scientific basis for the development and application of biomarkers of target organ 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.

Specifically, the objectives of the HESI Biomarkers of Nephrotoxicity Technical Committee are to:

  • Engage in a broad-based, multinational collaborative research program to advance the development and application of biomarkers of target organ toxicity (cardiac and renal);

    • Support the collaborative design and execution of biomarker qualification studies.

    • Identify accessible biomarkers with the potential to bridge from the pre-clinical to the clinical stages of drug development;

  • Evaluate the potential utility of newly identified markers of tissue injury for preclinical safety studies; and

  • Build consensus across industrial, academic, and regulatory sectors regarding how to apply newly identified biomarkers of toxicity in risk assessment.

Committee Contacts

HESI Staff

Connie Chen, PhD
cchen@hesiglobal.org

Alexandra Feitel
afeitel@hesiglobal.org

Leadership Team

Jean-Charles Gautier, PhD
Sanofi

Ernie Harpur, PhD
Newcastle University

Members and Fact Sheet

Committee Events

Filter

Events From 2030-12-31—2015-01-01

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Committee Publications

All Publications

Comparison Between Male and Female Sprague-Dawley Rats in the Response of Urinary Biomarkers to Injury Induced by Gentamicin

Differences were examined between male and female Sprague-Dawley rats in the response of 16 urinary biomarkers (measured using several assay platforms) to renal injury produced by gentamicin administered subcutaneously for 10 days at a dosage of 75 mg/kg.

Read more

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    [compat_fields:WP_Query:private] => Array
        (
            [0] => query_vars_hash
            [1] => query_vars_changed
        )

    [compat_methods:WP_Query:private] => Array
        (
            [0] => init_query_flags
            [1] => parse_tax_query
        )

)