A generic operational strategy to qualify translational safety biomarkers

Katja Matheis; David Laurie; Christiane Andriamandroso; Nadir Arber; Lina Badimon; Xavier Benain; Kaïdre Bendjama; Isabelle Clavier; Peter Colman; Hüseyin Firat; Jens Goepfert; Steve Hall; Thomas Joos; Sarah Kraus; Axel Kretschmer; Michael Merz; Teresa Padro; Hannes Planatscher; Annamaria Rossi; Nicole Schneiderhan-Marra; Ina Schuppe-Koistinen; Peter Thomann; Jean Marc Vidal; Béatrice Molac

doi:10.1016/j.drudis.2011.04.011

A generic operational strategy to qualify translational safety biomarkers

Katja Matheis, David Laurie, Christiane Andriamandroso, Nadir Arber, Lina Badimon, Xavier Benain, Kaïdre Bendjama, Isabelle Clavier, Peter Colman, Hüseyin Firat, Jens Goepfert, Steve Hall, Thomas Joos, Sarah Kraus, Axel Kretschmer, Michael Merz, Teresa Padro, Hannes Planatscher, Annamaria Rossi, Nicole Schneiderhan-MarraIna Schuppe-Koistinen, Peter Thomann, Jean Marc Vidal, Béatrice Molac^*

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

65 Scopus citations

Abstract

The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D.

Original language	English
Pages (from-to)	600-608
Number of pages	9
Journal	Drug Discovery Today
Volume	16
Issue number	13-14
DOIs	https://doi.org/10.1016/j.drudis.2011.04.011
State	Published - Jul 2011
Externally published	Yes

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Matheis, K., Laurie, D., Andriamandroso, C., Arber, N., Badimon, L., Benain, X., Bendjama, K., Clavier, I., Colman, P., Firat, H., Goepfert, J., Hall, S., Joos, T., Kraus, S., Kretschmer, A., Merz, M., Padro, T., Planatscher, H., Rossi, A., ... Molac, B. (2011). A generic operational strategy to qualify translational safety biomarkers. Drug Discovery Today, 16(13-14), 600-608. https://doi.org/10.1016/j.drudis.2011.04.011

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abstract = "The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D.",

author = "Katja Matheis and David Laurie and Christiane Andriamandroso and Nadir Arber and Lina Badimon and Xavier Benain and Ka{\"i}dre Bendjama and Isabelle Clavier and Peter Colman and H{\"u}seyin Firat and Jens Goepfert and Steve Hall and Thomas Joos and Sarah Kraus and Axel Kretschmer and Michael Merz and Teresa Padro and Hannes Planatscher and Annamaria Rossi and Nicole Schneiderhan-Marra and Ina Schuppe-Koistinen and Peter Thomann and Vidal, {Jean Marc} and B{\'e}atrice Molac",

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Matheis, K, Laurie, D, Andriamandroso, C, Arber, N, Badimon, L, Benain, X, Bendjama, K, Clavier, I, Colman, P, Firat, H, Goepfert, J, Hall, S, Joos, T, Kraus, S, Kretschmer, A, Merz, M, Padro, T, Planatscher, H, Rossi, A, Schneiderhan-Marra, N, Schuppe-Koistinen, I, Thomann, P, Vidal, JM & Molac, B 2011, 'A generic operational strategy to qualify translational safety biomarkers', Drug Discovery Today, vol. 16, no. 13-14, pp. 600-608. https://doi.org/10.1016/j.drudis.2011.04.011

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AU - Andriamandroso, Christiane

AU - Arber, Nadir

AU - Badimon, Lina

AU - Benain, Xavier

AU - Bendjama, Kaïdre

AU - Clavier, Isabelle

AU - Colman, Peter

AU - Firat, Hüseyin

AU - Goepfert, Jens

AU - Hall, Steve

AU - Joos, Thomas

AU - Kraus, Sarah

AU - Kretschmer, Axel

AU - Merz, Michael

AU - Padro, Teresa

AU - Planatscher, Hannes

AU - Rossi, Annamaria

AU - Schneiderhan-Marra, Nicole

AU - Schuppe-Koistinen, Ina

AU - Thomann, Peter

AU - Vidal, Jean Marc

AU - Molac, Béatrice

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A generic operational strategy to qualify translational safety biomarkers

Abstract

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