- COMMENT
eTRANSAFE: data science to empower translational safety assessment
- Ferran Sanz0,
- François Pognan1,
- Thomas Steger-Hartmann2,
- Carlos Díaz3,
- Shoji Asakura4,
- Alexander Amberg5,
- Nathalie Bécourt-Lhote6,
- Niklas Blomberg7,
- Nicolas Bosc8,
- Katharine Briggs9,
- Frank Bringezu10,
- Claire Brulle-Wohlhueter11,
- Søren Brunak12,
- Ruud Bueters13,
- Giulia Callegaro14,
- Salvador Capella-Gutierrez15,
- Emilio Centeno16,
- Javier Corvi17,
- Mark T. D. Cronin18,
- Philip Drew19,
- Guillemette Duchateau-Nguyen20,
- Gerhard F. Ecker21,
- Sylvia Escher22,
- Eloy Felix23,
- Miguel Ferreiro24,
- Markus Frericks25,
- Laura I. Furlong26,
- Robert Geiger27,
- Catherine George28,
- Melanie Grandits29,
- Dragomir Ivanov-Draganov30,
- Jean Kilgour-Christie31,
- Tevfik Kiziloren32,
- Jan A. Kors33,
- Naoki Koyama34,
- Annika Kreuchwig35,
- Andrew R. Leach36,
- Miguel-Angel Mayer37,
- Peter Monecke38,
- Wolfgang Muster39,
- Chihiro Miyamoto Nakazawa40,
- Gavin Nicholson41,
- Rowan Parry42,
- Manuel Pastor43,
- Janet Piñero44,
- Nils Oberhauser45,
- Juan Manuel Ramírez-Anguita46,
- Adrián Rodrigo47,
- Aljosa Smajic48,
- Markus Schaefer49,
- Sebastian Schieferdecker50,
- Inari Soininen51,
- Emma Terricabras52,
- Panuwat Trairatphisan53,
- Sean C. Turner54,
- Alfonso Valencia55,
- Bob van de Water56,
- Johan L. van der Lei57,
- Erik M. van Mulligen58,
- Esther Vock59 &
- …
- David Wilkinson60
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Ferran Sanz
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain.
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François Pognan
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Novartis Pharma, Basel, Switzerland.
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Thomas Steger-Hartmann
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Bayer, Berlin, Germany.
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Carlos Díaz
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Synapse Research Management Partners, Madrid, Spain.
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Shoji Asakura
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Eisai, Tsukuba, Ibaraki, Japan.
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Alexander Amberg
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Preclinical Safety, Sanofi, Frankfurt am Main, Germany.
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Nathalie Bécourt-Lhote
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Non-Clinical Drug Safety, Translational Medicine, Servier, Suresnes, France.
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Niklas Blomberg
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ELIXIR, Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.
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Nicolas Bosc
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European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.
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Katharine Briggs
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Lhasa Limited, Leeds, UK.
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Frank Bringezu
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Chemical and Preclinical Safety, Merck Healthcare KGaA, Darmstadt, Germany.
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Claire Brulle-Wohlhueter
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Translational and Genomic Medicine Safety, Sanofi, 91380 Chilly-Mazarin, France.
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Søren Brunak
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Technical University of Denmark (DTU), Lyngby, Denmark; Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain. Present address: Novo Nordisk Foundation Center for Protein Research, University of Copenhagen, Copenhagen, Denmark.
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Ruud Bueters
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Janssen Research & Development, Janssen Pharmaceutica, Beerse, Belgium.
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Giulia Callegaro
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Leiden Academic Centre for Drug Research (LACDR), Leiden University, Leiden, The Netherlands.
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Salvador Capella-Gutierrez
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Barcelona Supercomputing Center (BSC), Barcelona, Spain.
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Emilio Centeno
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain.
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Javier Corvi
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Barcelona Supercomputing Center (BSC), Barcelona, Spain.
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Mark T. D. Cronin
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Liverpool John Moores University, Liverpool, UK.
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Philip Drew
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PDS Consultants, Leicester, UK.
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Guillemette Duchateau-Nguyen
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Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
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Gerhard F. Ecker
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Universität Wien, Vienna, Austria.
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Sylvia Escher
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Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany.
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Eloy Felix
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European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.
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Miguel Ferreiro
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GMV, Tres Cantos, Madrid, Spain.
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Markus Frericks
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BASF, Ludwigshafen, Germany.
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Laura I. Furlong
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain; MedBioinformatics Solutions, Barcelona, Spain.
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Robert Geiger
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BASF, Ludwigshafen, Germany.
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Catherine George
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Ipsen Innovation, Les Ulis, France.
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Melanie Grandits
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Universität Wien, Vienna, Austria.
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Dragomir Ivanov-Draganov
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Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
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Jean Kilgour-Christie
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Novartis Pharma, Basel, Switzerland.
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Tevfik Kiziloren
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European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.
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Jan A. Kors
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Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
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Naoki Koyama
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Eisai, Tsukuba, Ibaraki, Japan.
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Annika Kreuchwig
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Bayer, Berlin, Germany.
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Andrew R. Leach
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European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.
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Miguel-Angel Mayer
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain.
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Peter Monecke
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Preclinical Safety, Sanofi, Frankfurt am Main, Germany.
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Wolfgang Muster
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Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
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Chihiro Miyamoto Nakazawa
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Eisai, Tsukuba, Ibaraki, Japan.
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Gavin Nicholson
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Optibrium Ltd., Cambridge Innovation Park, Cambridge, UK.
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Rowan Parry
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Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
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Manuel Pastor
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain.
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Janet Piñero
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain; MedBioinformatics Solutions, Barcelona, Spain.
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Nils Oberhauser
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Novartis Pharma, Basel, Switzerland.
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Juan Manuel Ramírez-Anguita
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain.
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Adrián Rodrigo
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GMV, Tres Cantos, Madrid, Spain.
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Aljosa Smajic
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Universität Wien, Vienna, Austria.
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Markus Schaefer
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Preclinical Safety, Sanofi, Frankfurt am Main, Germany.
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Sebastian Schieferdecker
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Boehringer Ingelheim Pharma, Biberach an der Riss, Germany.
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Inari Soininen
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Synapse Research Management Partners, Madrid, Spain.
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Emma Terricabras
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Hospital del Mar Research Institute (IMIM), Universitat Pompeu Fabra, Barcelona, Spain.
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Panuwat Trairatphisan
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AbbVie Germany, Ludwigshafen am Rhein, Germany.
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Sean C. Turner
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AbbVie Germany, Ludwigshafen am Rhein, Germany.
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Alfonso Valencia
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Barcelona Supercomputing Center (BSC), Barcelona, Spain; Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain.
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Bob van de Water
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Leiden Academic Centre for Drug Research (LACDR), Leiden University, Leiden, The Netherlands.
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Johan L. van der Lei
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Synapse Research Management Partners, Madrid, Spain; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
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Erik M. van Mulligen
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Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
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Esther Vock
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Boehringer Ingelheim Pharma, Biberach an der Riss, Germany.
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David Wilkinson
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Lhasa Limited, Leeds, UK.
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Nature Reviews Drug Discovery 22, 605-606 (2023)
doi: https://doi.org/10.1038/d41573-023-00099-5
References
Pognan, F. et al. The eTRANSAFE project on translational safety assessment through integrative knowledge management: achievements and perspectives. Pharmaceuticals (Basel). 14, 237 (2021).
Piñero, J. et al. Genomic and proteomic biomarker landscape in clinical trials. Comput. Struct. Biotechnol. J. 21, 2110–2118 (2023).
Callegaro, G. et al. The human hepatocyte TXG-MAPr: gene co-expression network modules to support mechanism-based risk assessment. Arch. Toxicol. 95, 3745–3775 (2021).
Pastor, M., Gómez-Tamayo, J. C. & Sanz, F. Flame: an open-source framework for model development, hosting, and usage in production environments. J. Cheminform. 13, 31 (2021).
Steger-Hartmann, T. et al. Perspectives of data science in preclinical safety assessment. Drug Discov. Today 28, 103642 (2023).
Clark, M. & Steger-Hartmann, T. A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans. Regul. Toxicol. Pharmacol. 96, 94–105 (2018).
Steger-Hartmann, T. et al. Introducing the concept of virtual control groups into preclinical toxicology testing. ALTEX 37, 343–349 (2020).
Competing Interests
Some authors are employed in the pharmaceutical industry or in small-and-medium sized enterprises, as indicated in their affiliations. The other authors declare no competing interests.
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