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eTRANSAFE SIGNED

Enhacing TRANslational SAFEty Assessment through Integrative Knowledge Management

Total Cost €

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EC-Contrib. €

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Partnership

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Project "eTRANSAFE" data sheet

The following table provides information about the project.

Coordinator
FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM 

Organization address
address: Doctor Aiguader 88
city: BARCELONA
postcode: 8003
website: www.imim.es

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Spain [ES]
 Project website http://etransafe.eu/
 Total cost 39˙490˙899 €
 EC max contribution 20˙000˙000 € (51%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2016-09-two-stage
 Funding Scheme IMI2-RIA
 Starting year 2017
 Duration (year-month-day) from 2017-09-01   to  2022-08-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM ES (BARCELONA) coordinator 2˙667˙675.00
2    SYNAPSE RESEARCH MANAGEMENT PARTNERS SL ES (MADRID) participant 2˙953˙375.00
3    LHASA LIMITED UK (LEEDS) participant 2˙930˙750.00
4    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM NL (ROTTERDAM) participant 2˙169˙750.00
5    EUROPEAN MOLECULAR BIOLOGY LABORATORY DE (HEIDELBERG) participant 1˙972˙375.00
6    UNIVERSIDAD POMPEU FABRA ES (BARCELONA) participant 1˙504˙500.00
7    UNIVERSITEIT LEIDEN NL (LEIDEN) participant 1˙382˙825.00
8    MOLECULAR NETWORKS GMBH COMPUTERCHEMIE DE (NURNBERG) participant 954˙125.00
9    UNIVERSITAT WIEN AT (WIEN) participant 878˙000.00
10    PDS COMPUTER SOFTWARE LIMITED UK (LEICESTER) participant 553˙375.00
11    OPTIBRIUM LIMITED UK (Cambridge) participant 531˙500.00
12    LIVERPOOL JOHN MOORES UNIVERSITY UK (LIVERPOOL) participant 528˙875.00
13    CERTARA UK LIMITED UK (LONDON) participant 521˙875.00
14    FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. DE (MUNCHEN) participant 451˙000.00
15    ABBVIE INC US (NORTH CHICAGO IL) participant 0.00
16    ASTRAZENECA AB SE (SODERTAELJE) participant 0.00
17    BAYER AKTIENGESELLSCHAFT DE (Leverkusen) participant 0.00
18    BOEHRINGER INGELHEIM INTERNATIONALGMBH DE (INGELHEIM) participant 0.00
19    CLARIVATE ANALYTICS (UK) LIMITED UK (LONDON) participant 0.00
20    EISAI CO LTD JP (BUNKYO KU TOKYO) participant 0.00
21    F. HOFFMANN-LA ROCHE AG CH (BASEL) participant 0.00
22    INSTITUT DE RECHERCHES INTERNATIONALES SERVIER FR (SURESNES) participant 0.00
23    IPSEN INNOVATION SAS FR (LES ULIS) participant 0.00
24    JANSSEN PHARMACEUTICA NV BE (BEERSE) participant 0.00
25    MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN DE (DARMSTADT) participant 0.00
26    NOVARTIS PHARMA AG CH (BASEL) participant 0.00
27    SANOFI-AVENTIS DEUTSCHLAND GMBH DE (FRANKFURT AM MAIN) participant 0.00

Map

 Project objective

Drug safety assessment is a knowledge-intensive process that demands advancement in data handling methods and tools for facilitating data sharing, mining, analysis and predictive modelling. This need is not restricted to any specific type of data and real advancement requires integrating information of different types and from different sources (e.g. publicly available biomedical knowledge, proprietary preclinical and clinical data, evidence from post-marketing studies) for addressing drug safety assessment from a holistic perspective.

The eTRANSAFE project will address these needs by developing a powerful data integration infrastructure (Knowledge Hub) and a collection of computational tools (exploitation modules) for making optimal use of these data. The proposed system will be a flexible and expandable framework, built on previous experience and applying state-of-the-art methods and technologies for providing the most advanced solutions for data sharing, interoperability and exploitation. An experienced honest broker will guarantee the confidentiality of any proprietary data. The project will develop in silico tools for data mining, visualisation, and prediction of potential toxicity, with specific attention to the assessment of the preclinical to clinical predictivity and the discovery of safety biomarkers. The CDISC-SEND format will be supported, facilitating the preparation of regulatory-compliant documentation. This infrastructure will be underpinned by development of open standards and guidelines recognised by regulatory agencies and international organisations.

The eTRANSAFE consortium brings together 13 organizations that mobilize an unprecedented capacity and resources, uniquely placed to leverage the experience of eTOX and other EU projects and initiatives. The project partners are six prestigious academic institutions, six highly skilled small-medium enterprises (SME) and one European infrastructure (ELIXIR), bringing in this way a perfect balance.

 Deliverables

List of deliverables.
Computational read-across workflows- first version Documents, reports 2020-04-14 16:17:18
Machine-learning models - first version Documents, reports 2020-04-14 16:17:19
Advanced data mining module - first version Documents, reports 2020-04-14 16:17:18
Predictive models repository - first version Documents, reports 2020-04-14 16:17:18
Safety assessment tools - first version Documents, reports 2020-04-14 16:17:18
Report on quantitative weight of evidence methods and software specifications - first version Documents, reports 2020-04-14 16:17:19
Report on knowledge gathering by analysing preclinical data – final version Documents, reports 2020-04-14 16:17:18
Methodology, analysis of existing related initiatives, and tools for implementation Documents, reports 2020-04-14 16:17:18
Data export and reporting module - first version Documents, reports 2020-04-14 16:17:18
Report on release of integrated textual data, identifier and semantic integration services, integrated ontologies, and ontology management and access services to consortium Documents, reports 2020-04-14 16:17:18
First version of knowledge gathering services Documents, reports 2020-04-14 16:17:18
Visualisation module - first version Documents, reports 2020-04-14 16:17:18
Report on consortium needs, available assets and documented knowledge hub (WP9) interfaces Documents, reports 2020-04-14 16:17:18
Knowledge Hub and API specifications - first version Documents, reports 2020-04-14 16:17:18
Report on SEND data sharing exercise – first version Documents, reports 2020-04-14 16:17:18
Initial Data and Knowledge Management Plan Documents, reports 2020-04-14 16:17:18
Project communication plan and initial tool set Documents, reports 2020-04-14 16:17:18
Report on user requirements and system specifications of database(s) Documents, reports 2020-04-14 16:17:18
Deployment of a data infrastructure for consortium partner access Documents, reports 2020-04-14 16:17:18
Report on the procedures for the data donation, extraction, curation and normalisation, ontology mapping, and access to pertinent datasets Documents, reports 2020-04-14 16:17:18
Report on knowledge gathering by analysing preclinical data Documents, reports 2020-04-14 16:17:18
Report on SEND data sharing exercise – third version Documents, reports 2020-04-09 20:50:54
Report on data gathering, processing and database – second version Documents, reports 2020-04-09 20:50:45

Take a look to the deliverables list in detail:  detailed list of eTRANSAFE deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Gopal Pawar, Judith C. Madden, David Ebbrell, James W. Firman, Mark T. D. Cronin
In Silico Toxicology Data Resources to Support Read-Across and (Q)SAR
published pages: , ISSN: 1663-9812, DOI: 10.3389/fphar.2019.00561
Frontiers in Pharmacology 10 2020-04-14
2018 Thomas Steger-Hartmann, Francois Pognan
Improving the Safety Assessment of Chemicals and Drug Candidates by the Integration of Bioinformatics and Chemoinformatics Data
published pages: 29-36, ISSN: 1742-7835, DOI: 10.1111/bcpt.12956
Basic & Clinical Pharmacology & Toxicology 123 2020-04-14
2018 Janet Piñero, Laura I Furlong, Ferran Sanz
In silico models in drug development: where we are
published pages: 111-121, ISSN: 1471-4892, DOI: 10.1016/j.coph.2018.08.007
Current Opinion in Pharmacology 42 2020-04-14
2019 Mark D. Pinches, Robert Thomas, Rosemary Porter, Lucinda Camidge, Katharine Briggs
Curation and analysis of clinical pathology parameters and histopathologic findings from eTOXsys, a large database project (eTOX) for toxicologic studies
published pages: 104396, ISSN: 0273-2300, DOI: 10.1016/j.yrtph.2019.05.021
Regulatory Toxicology and Pharmacology 107 2020-04-14
2017 Ferran Sanz, François Pognan, Thomas Steger-Hartmann, Carlos Díaz, 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
Legacy data sharing to improve drug safety assessment: the eTOX project
published pages: 811-812, ISSN: 1474-1776, DOI: 10.1038/nrd.2017.177
Nature Reviews Drug Discovery 16/12 2020-04-14
2018 Janet Piñero, Abel Gonzalez-Perez, Emre Guney, Joaquim Aguirre-Plans, Ferran Sanz, Baldo Oliva, Laura I. Furlong
Network, Transcriptomic and Genomic Features Differentiate Genes Relevant for Drug Response
published pages: , ISSN: 1664-8021, DOI: 10.3389/fgene.2018.00412
Frontiers in Genetics 9 2020-04-14
2018 Manuel Pastor, Jordi Quintana, Ferran Sanz
Development of an Infrastructure for the Prediction of Biological Endpoints in Industrial Environments. Lessons Learned at the eTOX Project
published pages: , ISSN: 1663-9812, DOI: 10.3389/fphar.2018.01147
Frontiers in Pharmacology 9 2020-04-14
2017 Oriol López-Massaguer, Kevin Pinto-Gil, Ferran Sanz, Alexander Amberg, Lennart T Anger, Manuela Stolte, Carlo Ravagli, Philippe Marc, Manuel Pastor
Generating Modeling Data From Repeat-Dose Toxicity Reports
published pages: 287-300, ISSN: 1096-6080, DOI: 10.1093/toxsci/kfx254
Toxicological Sciences 162/1 2020-04-14

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