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Towards consensus practices to qualify safety biomarkers for use in early drug development

Nature Biotechnology volume 28, pages 446–454 (2010)Cite this article

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Abstract

Application of any new biomarker to support safety-related decisions during regulated phases of drug development requires provision of a substantial data set that critically assesses analytical and biological performance of that biomarker. Such an approach enables stakeholders from industry and regulatory bodies to objectively evaluate whether superior standards of performance have been met and whether specific claims of fit-for-purpose use are supported. It is therefore important during the biomarker evaluation process that stakeholders seek agreement on which critical experiments are needed to test that a biomarker meets specific performance claims, how new biomarker and traditional comparators will be measured and how the resulting data will be merged, analyzed and interpreted.

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Figure 1: Urinary Kim-1 levels after cisplatin treatment16.

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Authors and Affiliations

  1. Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA

    Frank D Sistare, Sean Troth, Daniel J Holder, David Gerhold & Yan Yu

  2. Novartis Pharma AG, Basel, Switzerland

    Frank Dieterle, Kevin Carl, David Laurie & Gérard Maurer

  3. Amgen, Inc., Thousand Oaks, California, USA

    Dina Andrews-Cleavenger

  4. ClinXus, and Van Andel Research Institute, Grand Rapids, Michigan, USA

    William Baer, Alita Hassan, Matthew J Schipper & Craig Webb

  5. AstraZeneca Pharmaceuticals, Cheshire, England

    Graham Betton & Mark Pinches

  6. Bristol-Myers Squibb, Princeton, New Jersey, USA

    Denise Bounous

  7. Schering-Plough Research Institute, Summit, New Jersey, USA

    Nathaniel Collins & Yi-Zhong Gu

  8. US Food and Drug Administration, Silver Spring, Maryland, USA

    Peter Goering, Federico Goodsaid, David Jacobson-Kram & Karol L Thompson

  9. Sanofi-aventis, Malvern, Pennsylvania, USA

    Valerie Guilpin & Ernie Harpur

  10. European Medicines Agency, London, UK

    Peter Kasper, Romaldas Maciulaitis, Marisa Papaluca-Amati, Spiros Vamvakas & Jean-Marc Vidal

  11. iMED.UL, Lisbon University, Portugal

    Beatriz Silva Lima

  12. Critical Path Institute, Tucson, Arizona, USA

    William Mattes & Elizabeth Walker

  13. Pfizer Inc., Groton, Connecticut, USA

    Leslie Ann Obert & Josef Ozer

  14. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA

    Jonathan A Phillips

  15. Hoffman La Roche, Basel, Switzerland

    Jacky Vonderscher

Authors
  1. Frank D Sistare
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  2. Frank Dieterle
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  28. Jonathan A Phillips
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  30. Matthew J Schipper
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  35. Elizabeth Walker
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  36. Craig Webb
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  37. Yan Yu
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Corresponding author

Correspondence to Frank D Sistare.

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The authors declare no competing financial interests.

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Sistare, F., Dieterle, F., Troth, S. et al. Towards consensus practices to qualify safety biomarkers for use in early drug development. Nat Biotechnol 28, 446–454 (2010). https://doi.org/10.1038/nbt.1634

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