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

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

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.

Coordinator

UNIVERSITAT ZURICH

Address

Ramistrasse 71
8006 Zurich

Switzerland

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 2 424 271

Participants (26)

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UNIVERSIDAD DE MALAGA

Spain

EU Contribution

€ 246 452

INFORMATION TECHNOLOGY FOR TRANSLATIONAL MEDICINE (ITTM) SA

Luxembourg

EU Contribution

€ 624 125

LANDSPITALI UNIVERSITY HOSPITAL

Iceland

EU Contribution

€ 87 325

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN

Germany

EU Contribution

€ 443 450

THE UNIVERSITY OF NOTTINGHAM

United Kingdom

EU Contribution

€ 832 700

UNIVERSIDAD DE SALAMANCA

Spain

EU Contribution

€ 69 500

FUNDACIO PRIVADA INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU

Spain

EU Contribution

€ 182 600

TAMIRNA GMBH

Austria

EU Contribution

€ 1 231 000

SIGNATOPE GMBH

Germany

EU Contribution

€ 1 990 000

ABX CRO ADVANCED PHARMACEUTICAL SERVICES FORSCHUNGSGESELLSCHAFT MBH

Germany

EU Contribution

€ 1 294 360

METAHEPS GMBH

Germany

EU Contribution

€ 284 000

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 81 400

SYNAPSE RESEARCH MANAGEMENT PARTNERS SL

Spain

EU Contribution

€ 900 000

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany

EU Contribution

€ 1 386 193,75

UNIVERSITY OF NEWCASTLE UPON TYNE

United Kingdom

EU Contribution

€ 109 475

THE UNIVERSITY OF LIVERPOOL

United Kingdom

EU Contribution

€ 940 250

MLM MEDICAL LABS GMBH

Germany

EU Contribution

€ 604 800

UNIVERSITEIT LEIDEN

Netherlands

EU Contribution

€ 79 150

SERVICIO ANDALUZ DE SALUD

Spain

EU Contribution

€ 188 946

PFIZER LIMITED

United Kingdom

MERCK SHARP & DOHME CORP

United States

Eli Lilly and Company Limited

United Kingdom

NOVARTIS PHARMA AG

Switzerland

F. HOFFMANN-LA ROCHE AG

Switzerland

JANSSEN PHARMACEUTICA NV

Belgium

SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

France

Project information

Grant agreement ID: 821283

Status

Ongoing project

  • Start date

    1 February 2019

  • End date

    31 January 2024

Funded under:

H2020-EU.3.1.7.

  • Overall budget:

    € 27 906 491,50

  • EU contribution

    € 13 999 997,75

Coordinated by:

UNIVERSITAT ZURICH

Switzerland