Project description
Novel safety biomarkers for drug development
Testing the safety of drugs is the most important aspect in the drug development pipeline. Although various safety biomarkers have been proposed, substantial sample sizes are required for their validation. The EU-funded TransBioLine project will capitalise on existing data, resources and international collaborations to establish robust biomarkers for use in drug development. Researchers will also develop and validate assays for new safety biomarkers and implement circulating miRNAs as tissue- and mechanism-specific diagnostic tools. Ultimately, the aim is to obtain approval of safety biomarkers as qualified drug development tools by key regulatory authorities such as the EMA and FDA.
Objective
Qualified biomarkers help to optimize drug development and patient safety, yet for the regulatory acceptance of safety biomarkers substantial sample sizes are needed to ensure adequate case and control numbers, and robust evidence sufficient for qualification. To address this challenge, a consortium of leading European research institutions and SMEs has been established. The consortium will generate exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development; establish robust datasets on the DILI, DIKI, DIPI, DIVI and DINI biomarkers to enhance diagnosis of disease; develop and validate assays for new safety biomarkers; implement profiles of circulating miRNAs as tissue and mechanism specific diagnostic tool; have key safety biomarkers accepted as qualified drug development tools by EMA, FDA, and PMDA.
Given the significant expertise available across the consortium, the group will be able to tackle the key challenges related to successful biomarker qualification. A key driving principle of the consortium is cross-linking via existing networks of top profile research institutions, as well as capitalizing on existing data and resources. The Consortium is embedded into a network of international research collaborations such as the Pro-Euro-DILI-registry, TransQST, eTRANSAFE, the i2b2 tranSMART Foundation, the CIOMS DILI working group, EPoS, LITMUS, and BBMRI. To optimize regulatory interaction, we intend to continue our successful collaboration with non-European consortia such as PSTC, the FNIH Biomarkers Consortium, and US DILIN. A key expected result of the consortium will be a “Safety Biomarker Factory”, regularly qualifying new markers, with an associated “Safety Biomarker Warehouse”, providing to the scientific community, industry, and patients detailed data and information, and knowledge across a large spectrum of advanced safety biomarkers.
Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
MAIN PROGRAMME
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H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2)
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
RIA - Research and Innovation action
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-JTI-IMI2-2017-13-two-stage
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
8006 Zurich
Switzerland
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Participants (29)
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29016 Malaga
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4354 ESCH SUR ALZETTE
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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101 Reykjavik
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80539 MUNCHEN
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NG7 2RD Nottingham
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37008 Salamanca
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08041 BARCELONA
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1110 WIEN
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
72770 Reutlingen
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
01067 DRESDEN
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Participation ended
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82152 Planegg
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
75012 Paris
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28006 MADRID
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
10117 Berlin
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NE1 7RU Newcastle Upon Tyne
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L69 7ZX LIVERPOOL
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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.
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L9 7AL Liverpool
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41066 Monchengladbach
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
2311 EZ Leiden
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41071 SEVILLA
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CT13 9NJ Sandwich
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08889 Whitehouse Station Nj
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
RG21 4FA Basingstoke
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4056 Basel
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4070 Basel
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
2340 Beerse
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94250 Gentilly
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85718 Tucson
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3012 Bern
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