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Translational Safety Biomarker Pipeline (TransBioLine): Enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease

Project description

DEENESFRITPL

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.

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Call for proposal

H2020-JTI-IMI2-2017-13-two-stage

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Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITAT ZURICH
Net EU contribution
€ 2 579 577,31
Address
Ramistrasse 71
8006 Zurich
Switzerland

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Region
Schweiz/Suisse/Svizzera Zürich Zürich
Activity type
Higher or Secondary Education Establishments
Links
Other funding
€ 38 000,00

Participants (28)

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EC signature date 8 April 2019
Last update: 30 June 2023

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Permalink: https://cordis.europa.eu/project/id/821283

European Union, 2023