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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.

Call for proposal

H2020-JTI-IMI2-2017-13-two-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action

Coordinator

UNIVERSITAT ZURICH
Address
Ramistrasse 71
8006 Zurich
Switzerland
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 424 271

Participants (26)

UNIVERSIDAD DE MALAGA
Spain
EU contribution
€ 246 452
Address
Avda Cervantes, Num. 2
29016 Malaga
Activity type
Higher or Secondary Education Establishments
INFORMATION TECHNOLOGY FOR TRANSLATIONAL MEDICINE (ITTM) SA
Luxembourg
EU contribution
€ 624 125
Address
9 Avenue Des Hauts-forneaux
4362 Esch-sur-alzette
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
LANDSPITALI UNIVERSITY HOSPITAL
Iceland
EU contribution
€ 87 325
Address
Eiriksgata 5
101 Reykjavik
Activity type
Higher or Secondary Education Establishments
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Germany
EU contribution
€ 443 450
Address
Geschwister Scholl Platz 1
80539 Muenchen
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF NOTTINGHAM
United Kingdom
EU contribution
€ 832 700
Address
University Park
NG7 2RD Nottingham
Activity type
Higher or Secondary Education Establishments
UNIVERSIDAD DE SALAMANCA
Spain
EU contribution
€ 69 500
Address
Calle Patio De Escuelas 1
37008 Salamanca
Activity type
Higher or Secondary Education Establishments
FUNDACIO PRIVADA INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU
Spain
EU contribution
€ 182 600
Address
Calle Sant Antoni M Claret 167
08025 Barcelona
Activity type
Research Organisations
TAMIRNA GMBH
Austria
EU contribution
€ 1 231 000
Address
Leberstrasse 20/8
1110 Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SIGNATOPE GMBH
Germany
EU contribution
€ 1 990 000
Address
Markwiesenstr. 55
72770 Reutlingen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ABX CRO ADVANCED PHARMACEUTICAL SERVICES FORSCHUNGSGESELLSCHAFT MBH
Germany
EU contribution
€ 1 294 360
Address
Blasewitzer Str 78-80
01307 Dresden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
METAHEPS GMBH
Germany
EU contribution
€ 284 000
Address
Am Klopferspitz 19
82152 Planegg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 81 400
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
SYNAPSE RESEARCH MANAGEMENT PARTNERS SL
Spain
EU contribution
€ 900 000
Address
Calle Velazquez 94 Planta 1
28006 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 1 386 193,75
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
UNIVERSITY OF NEWCASTLE UPON TYNE
United Kingdom
EU contribution
€ 109 475
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 940 250
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
MLM MEDICAL LABS GMBH
Germany
EU contribution
€ 604 800
Address
Dohrweg 63
41066 Monchengladbach
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITEIT LEIDEN
Netherlands
EU contribution
€ 79 150
Address
Rapenburg 70
2311 EZ Leiden
Activity type
Higher or Secondary Education Establishments
SERVICIO ANDALUZ DE SALUD
Spain
EU contribution
€ 188 946
Address
Avenida De La Constitucion 18
41071 Sevilla
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
PFIZER LIMITED
United Kingdom
EU contribution
€ 0
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MERCK SHARP & DOHME CORP
United States
EU contribution
€ 0
Address
One Merck Drive
08889 Whitehouse Station Nj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Eli Lilly and Company Limited
United Kingdom
EU contribution
€ 0
Address
Lilly House, Priestley Road
RG24 9NL Basingstoke
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NOVARTIS PHARMA AG
Switzerland
EU contribution
€ 0
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
F. HOFFMANN-LA ROCHE AG
Switzerland
EU contribution
€ 0
Address
Grenzacherstrasse 124
4070 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
JANSSEN PHARMACEUTICA NV
Belgium
EU contribution
€ 0
Address
Turnhoutseweg 30
2340 Beerse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
EU contribution
€ 0
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)