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Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

Abstract

The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortium's (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have been qualified for limited use in nonclinical and clinical drug development to help guide safety assessments. This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.

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Figure 1: Flow charts explaining the proposed limited clinical translational use of the new renal biomarkers.

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Authors and Affiliations

Authors

Contributions

Members of the PSTC Nephrotoxicity Working Group compiling the submission for biomarker qualification: F.D., F.S., J.S.O., C.P.W., W.B., A.S., M.J.S., J.V., S.S., D.L.G., J.A.P., G.M., K.C., D.L., E.H., M.S., D.E., D.H., D.A.-C., Y.-Z.G., K.L.T., P.L.G., J.-M.V., S.T., D.B., D.R.-G., G.B., M.A.D., J.A., J.E.MD., L.S.-D., L.O., M.G., M. Papaluca, S.J., E.A.B., S.A.B., V.G.B., N.C., J.W., D.H., S.S., J.L., P.R., E.W. and W.M.; members of the FDA Biomarker Qualification Review Team, reviewing the submission for biomarker qualification: F.G., D.J.-K., A.F.D., E.A.H., M.B., A.T., P.H., D.T., S.X., W.T. and N.X.; members of the EMEA Biomarker Qualification Review Team, reviewing the submission for biomarker qualification: M. Papaluca, J.-M.V., E.A., R.M., S.V., B.F., B.S.L., P.K., M. Pasanen and K.P.

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Correspondence to Frank Dieterle.

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Competing interests

F.D., G.M., K.C. and D.L. are employees of Novartis; F.S., D.H., S.T., Y.-Z.G., N.C. and D.L.G. are employees of Merck; W.B., A.S., M.J.S. and S.S. are employees of ClinXus; C.P.W. is an employee of Van Andel Research Institute; W.B. is an employee of Grand Valley Medical Specialists; A.S. is an employee of Spectrum Health; M.J.S. is an employee of Innovative Analytics; J.V. and L.S. are employees of Hoffman-La Roche; J.A.P. and S.J. are employees of Boehringer Ingelheim; E.H., M.G. and V.G.B. are employees of Sanofi-Aventis; M.S., J.E.M. and S.S. are employees of Johnson & Johnson; D.E. is an employee of GlaxoSmithKline; D.A.-C. is an employee of Amgen; D.B. is an employee of Bristol-Myers Squibb; D.R.-G., L.O. and S.A.B. are employees of Pfizer; G.B. and M.P. are employees of AstraZeneca; J.A. is an employee of Eli Lilly; E.A.B., J.W., D.H. and J.L. are employees of Abbott; J.S.O. was an employee of Merck.

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Dieterle, F., Sistare, F., Goodsaid, F. et al. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat Biotechnol 28, 455–462 (2010). https://doi.org/10.1038/nbt.1625

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