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
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
8006 Zurich
Switzerland
See on map
Participants (28)
29016 Malaga
See on map
4354 ESCH SUR ALZETTE
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
101 Reykjavik
See on map
80539 MUNCHEN
See on map
NG7 2RD Nottingham
See on map
37008 Salamanca
See on map
08041 Barcelona
See on map
1110 Wien
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
72770 Reutlingen
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
01307 Dresden
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participation ended
82152 Planegg
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
75012 Paris
See on map
28006 Madrid
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
10117 Berlin
See on map
NE1 7RU Newcastle Upon Tyne
See on map
L69 7ZX Liverpool
See on map
41066 Monchengladbach
See on map
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
2311 EZ Leiden
See on map
41071 Sevilla
See on map
CT13 9NJ Sandwich
See on map
08889 Whitehouse Station Nj
See on map
RG21 4FA Basingstoke
See on map
4056 Basel
See on map
4070 Basel
See on map
2340 Beerse
See on map
94250 GENTILLY
See on map
85718 TUCSON AZ
See on map
3012 Bern
See on map