Legacy data sharing to improve drug safety assessment: the eTOX project

Ferran Sanz; François Pognan; Thomas Steger-Hartmann; Carlos Díaz; eTOX; Montserrat Cases; Manuel Pastor; Philippe Marc; Joerg Wichard; Katharine Briggs; David K Watson; Thomas Kleinöder; Chihae Yang; Alexander Amberg; Maria Beaumont; Anthony J Brookes; Søren Brunak; Mark T D Cronin; Gerhard F Ecker; Sylvia Escher; Nigel Greene; Antonio Guzmán; Anne Hersey; Pascale Jacques; Lieve Lammens; Jordi Mestres; Wolfgang Muster; Helle Northeved; Marc Pinches; Javier Saiz; Nicolas Sajot; Alfonso Valencia; Johan van der Lei; Nico P E Vermeulen; Esther Vock; Gerhard Wolber; Ismael Zamora

doi:10.1038/nrd.2017.177

Legacy data sharing to improve drug safety assessment: the eTOX project

Nat Rev Drug Discov. 2017 Dec;16(12):811-812. doi: 10.1038/nrd.2017.177. Epub 2017 Oct 13.

Authors

Ferran Sanz¹, François Pognan², Thomas Steger-Hartmann³, Carlos Díaz⁴; eTOX; Montserrat Cases⁴, Manuel Pastor¹, Philippe Marc², Joerg Wichard³, Katharine Briggs⁵, David K Watson⁵, Thomas Kleinöder⁶, Chihae Yang⁶, Alexander Amberg⁷, Maria Beaumont⁸, Anthony J Brookes⁹, Søren Brunak¹⁰, Mark T D Cronin¹¹, Gerhard F Ecker¹², Sylvia Escher¹³, Nigel Greene¹⁴, Antonio Guzmán¹⁵, Anne Hersey¹⁶, Pascale Jacques¹⁷, Lieve Lammens¹⁸, Jordi Mestres¹⁹, Wolfgang Muster²⁰, Helle Northeved²¹, Marc Pinches²², Javier Saiz²³, Nicolas Sajot²⁴, Alfonso Valencia²⁵, Johan van der Lei²⁶, Nico P E Vermeulen²⁷, Esther Vock²⁸, Gerhard Wolber²⁹, Ismael Zamora³⁰

Affiliations

¹ Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Pompeu Fabra, 08003 Barcelona, Spain.
² Novartis Institute for Biomedical Research, Basel, CH-4002, Switzerland.
³ Bayer AG, 13353 Berlin, Germany.
⁴ Synapse Research Management Partners, 08007 Barcelona, Spain.
⁵ Lhasa Ltd, Leeds LS11 5PS, UK.
⁶ Molecular Networks GmbH, 90411 Nürnberg, Germany.
⁷ Sanofi, 65926 Frankfurt am Main, Germany.
⁸ GlaxoSmithKline Research and Development Ltd, Stevenage SG1 2NY, UK.
⁹ University of Leicester, Leicester LE1 7RH, UK.
¹⁰ Technical University of Denmark (DTU), 2800 Lyngby, Denmark.
¹¹ Liverpool John Moores University, Liverpool L3 3AF, UK.
¹² Universität Wien, 1090 Vienna, Austria.
¹³ Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625 Hannover, Germany.
¹⁴ Pfizer Ltd, Groton, Connecticut 06340, USA. Current affiliation: AstraZeneca, Waltham, Massachusettts 02451, USA.
¹⁵ ESTEVE, 08041 Barcelona, Spain.
¹⁶ European Bioinformatics Institute, European Molecular Biology Laboratory, Wellcome Genome Campus, Hinxton, Cambridge CB10 1SD, UK.
¹⁷ UCB Pharma SA, 1070 Brussels, Belgium.
¹⁸ Janssen Pharmaceutica NV, 2340 Beerse, Belgium.
¹⁹ Chemotargets SL, 08003 Barcelona, Spain.
²⁰ F. Hoffmann-La Roche AG, CH-4070 Basel, Switzerland.
²¹ H. Lundbeck A/S, 2500 Copenhagen, Denmark.
²² AstraZeneca AB, SK10 2NA Cheshire, UK. Current affiliation: Lhasa Ltd, Leeds LS11 5PS, UK.
²³ Universitat Politècnica de València, 46022 València, Spain.
²⁴ Servier, 45000 Orléans, France.
²⁵ ICREA, 08010 Barcelona, Spain & Barcelona Supercomputing Center (BSC), 08034 Barcelona, Spain.
²⁶ Erasmus Universitair Medisch Centrum, 3015 CE Rotterdam, The Netherlands.
²⁷ Vrije Universiteit Amsterdam, 1081 Amsterdam, The Netherlands.
²⁸ Boehringer Ingelheim International GmbH, 88379 Biberach an der Riss, Germany.
²⁹ Inte:Ligand GmbH, 1070 Vienna, Austria.
³⁰ Lead Molecular Design S.L., 08172 Sant Cugat del Vallès, Spain.

PMID: 29026211
DOI: 10.1038/nrd.2017.177

Abstract

The sharing of legacy preclinical safety data among pharmaceutical companies and its integration with other information sources offers unprecedented opportunities to improve the early assessment of drug safety. Here, we discuss the experience of the eTOX project, which was established through the Innovative Medicines Initiative to explore this possibility.

MeSH terms

Drug Evaluation, Preclinical / methods*
Drug Industry / methods*
Drug-Related Side Effects and Adverse Reactions*
Humans
Information Dissemination*
Risk Assessment / methods