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Enhacing TRANslational SAFEty Assessment through Integrative Knowledge Management

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.

Coordinator

FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM
Net EU contribution
€ 1 997 259,00
Address
Doctor Aiguader 88
08003 Barcelona
Spain
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (31)

SYNAPSE RESEARCH MANAGEMENT PARTNERS SL
Spain
Net EU contribution
€ 2 853 375,00
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Address
Calle Velazquez 94 Planta 1
28006 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
LHASA LIMITED
United Kingdom
Net EU contribution
€ 2 930 750,00
Address
Granary Wharf House, 2 Canal Wharf
LS11 5PS Leeds
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Region
Yorkshire and the Humber West Yorkshire Leeds
EUROPEAN MOLECULAR BIOLOGY LABORATORY
Germany
Net EU contribution
€ 840 032,00
Address
Meyerhofstrasse 1
69117 Heidelberg
Activity type
Research Organisations
Non-EU contribution
€ 0,50
Region
Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

BARCELONA SUPERCOMPUTING CENTER-CENTRO NACIONAL DE SUPERCOMPUTACION
Spain
Net EU contribution
€ 489 952,00
Address
Calle Jordi Girona 31
08034 Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

DANMARKS TEKNISKE UNIVERSITET
Denmark
Net EU contribution
€ 642 391,00
Address
Anker Engelundsvej 1 Bygning 101 A
2800 Kgs Lyngby
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
Net EU contribution
€ 1 544 750,00
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITEIT LEIDEN
Netherlands
Net EU contribution
€ 1 535 325,00
Address
Rapenburg 70
2311 EZ Leiden
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
UNIVERSITAT WIEN
Austria
Net EU contribution
€ 878 000,00
Address
Universitatsring 1
1010 Wien
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CERTARA UK LIMITED
United Kingdom
Net EU contribution
€ 260 937,50
Address
One London Wall 6Th Floor
EC2Y 5EB London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Region
London Inner London — West Camden and City of London
MOLECULAR NETWORKS GMBH COMPUTERCHEMIE
Germany
Net EU contribution
€ 954 125,00
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Address
Neumeyerstr 28-34
90411 Nurnberg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Region
Bayern Mittelfranken Nürnberg, Kreisfreie Stadt
OPTIBRIUM LIMITED
United Kingdom
Net EU contribution
€ 531 500,00
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Address
F5-6 Blenheim House Cambridge Innovation Park Denn
CB25 9PB Cambridge
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Region
East of England East Anglia Cambridgeshire CC
LIVERPOOL JOHN MOORES UNIVERSITY
United Kingdom
Net EU contribution
€ 528 875,00
Address
Rodney Street 2 Egerton Court
L3 5UX Liverpool
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
Germany
Net EU contribution
€ 451 000,00
Address
Hansastrasse 27C
80686 Munchen
Activity type
Research Organisations
Non-EU contribution
€ 0,00
PDS COMPUTER SOFTWARE LIMITED
United Kingdom
Net EU contribution
€ 613 375,00
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Address
9 Knighton Grange Road
LE2 2LF Leicester
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 36 572,25
Region
East Midlands (England) Leicestershire, Rutland and Northamptonshire Leicestershire CC and Rutland
 
UNIVERSIDAD POMPEU FABRA
Spain
Net EU contribution
€ 1 754 500,00
Address
Placa De La Merce, 10-12
08002 Barcelona
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
NOVARTIS PHARMA AG
Switzerland
Net EU contribution
€ 0,00
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 7 230 753,00
Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
BAYER AKTIENGESELLSCHAFT
Germany
Net EU contribution
€ 0,00
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 4 393 427,75
Region
Nordrhein-Westfalen Köln Leverkusen, Kreisfreie Stadt
SANOFI-AVENTIS DEUTSCHLAND GMBH
Germany
Net EU contribution
€ 0,00
Address
Bruningstrasse 50
65929 Frankfurt Am Main
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 130 000,00
Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
F. HOFFMANN-LA ROCHE AG
Switzerland
Net EU contribution
€ 0,00
Address
Grenzacherstrasse 124
4070 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 400 000,00
Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt
MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN
Germany
Net EU contribution
€ 0,00
Address
Frankfurter Strasse 250
64293 Darmstadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 682 000,00
JANSSEN PHARMACEUTICA NV
Belgium
Net EU contribution
€ 0,00
Address
Turnhoutseweg 30
2340 Beerse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 625 000,00
INSTITUT DE RECHERCHES INTERNATIONALES SERVIER IRIS
France
Net EU contribution
€ 0,00
Address
Rue Carnot 50
92284 Courbevoie
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 527 453,00
ABBVIE INC
United States
Net EU contribution
€ 0,00
Address
North Waukegan Road 1
60064 North Chicago Il
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 554 000,00
ASTRAZENECA AB
Sweden
Net EU contribution
€ 0,00
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 120 100,00
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
Net EU contribution
€ 0,00
Address
Binger Strasse
55218 Ingelheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 165 000,00
Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
CLARIVATE ANALYTICS (UK) LIMITED

Participation ended

United Kingdom
Net EU contribution
€ 0,00
Address
Friars House, 160 Blackfrias Road
EC1N 8JS London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 20 000,00
Region
London Inner London — West Camden and City of London
 
IPSEN INNOVATION SAS
France
Net EU contribution
€ 0,00
Address
Avenue Du Canada - Zone Industrielle De Courtaboeuf 5
91940 Les Ulis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 610 543,00
EISAI CO LTD
Japan
Net EU contribution
€ 0,00
Address
Koishikawa 6-10 Chome 4
112 88 Bunkyo Ku Tokyo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
GMV SOLUCIONES GLOBALES INTERNET SAU
Spain
Net EU contribution
€ 803 853,50
Address
Calle Isaac Newton 11 Parque Tecnologico De Madrid
28760 Tres Cantos Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Region
Madrid Comunidad de Madrid
 
MEDBIOINFORMATICS SOLUTIONS SL
Spain
Net EU contribution
€ 390 000,00
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Address
Almogavers 165
08018 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
BASF SE
Germany
Net EU contribution
€ 0,00
Address
Carl Bosch Strasse 38
67063 Ludwigshafen Am Rhein
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 887 500,00
Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis