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Translational quantitative systems toxicology to improve the understanding of the safety of medicines - Sofia: 116030

Translational quantitative systems toxicology to improve the understanding of the safety of medicines - Sofia: 116030

Objective

TransQST will develop a Quantitative Systems Toxicology (QST) approach, employing pre-existing data where possible, in order to yield new mechanistic insight into drug-induced toxicity. A central tenet of our programme will be to ensure the human physiological and pharmacological relevance of any test system that has been (or will be) used for generating the input data for modelling. By adopting this approach, we will be able to accurately interpret what happens when test systems are perturbed by drug exposure, and ensure translatability of modelling tools. Mechanistic translational biomarkers are a core aspect of our approach and will be applied in parallel with evidence for understanding how to develop, model and apply such biomarkers in a QST setting. The project is structured in 8 work packages to provide the following outcomes: curate the best available experimental data suitable for modelling adverse drug reactions; provide fit-for-purpose QST models that will address key toxicity measures for liver, kidney, heart and GI-tract; provide quantitative risk assessment for off-target toxicity in man based on in vitro and in vivo models; provide a quantitative mechanistic read-across from species (in vivo and in vitro) currently used for the toxicological evaluation of a new drug; provide definition and applicability of the human physiological relevance of preclinical test systems; provide a battery of translational biomarkers that can be used for quantitative read-across from in vitro systems to man and which relate to intracellular pathways (and systems) relevant to drug toxicity. Led by the University of Liverpool, TransQST brings together 14 partners, characterized by their scientific rigour and proven track record. Collectively they will enable achievement of the goals of the call, thanks to their complementarity, proven ability to work together (and with EFPIA partners), and their understanding of how to ensure the relevance of QST to human biology.
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Coordinator

THE UNIVERSITY OF LIVERPOOL

Address

Brownlow Hill 765 Foundation Building
L69 7zx Liverpool

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 620 350

Participants (22)

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UNIVERSITEIT LEIDEN

Netherlands

EU Contribution

€ 1 060 725

FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM

Spain

EU Contribution

€ 900 525

SYNAPSE RESEARCH MANAGEMENT PARTNERS SL

Spain

EU Contribution

€ 341 450

UNIVERSITEIT MAASTRICHT

Netherlands

EU Contribution

€ 675 300

EUROPEAN MOLECULAR BIOLOGY LABORATORY

Germany

EU Contribution

€ 1 026 750

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

United Kingdom

EU Contribution

€ 325 000

CERTARA UK LIMITED

United Kingdom

EU Contribution

€ 450 900

UNIVERSITAT WIEN

Austria

EU Contribution

€ 350 250

UNIVERSITAETSKLINIKUM AACHEN

Germany

EU Contribution

€ 132 435

FORSCHUNGSGESELLSCHAFT FUR ARBEITSPHYSIOLOGIE UND ARBEITSSCHUTZ E.V.

Germany

EU Contribution

€ 350 250

OCELLO BV

Netherlands

EU Contribution

€ 275 775

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 220 500

ABBVIE DEUTSCHLAND GMBH & CO KG

Germany

Eli Lilly and Company Limited

United Kingdom

SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

France

ASTRAZENECA AB

Sweden

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.

United Kingdom

INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

France

JANSSEN PHARMACEUTICA NV

Belgium

ORION OYJ

Finland

BOEHRINGER INGELHEIM INTERNATIONALGMBH

Germany

Heidelberg University Medical School

Germany

EU Contribution

€ 269 790

Project information

Grant agreement ID: 116030

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.

  • Overall budget:

    € 17 327 874

  • EU contribution

    € 8 000 000

Coordinated by:

THE UNIVERSITY OF LIVERPOOL

United Kingdom