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TransBioLine SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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TransBioLine project word cloud

Explore the words cloud of the TransBioLine project. It provides you a very rough idea of what is the project "TransBioLine" about.

substantial group regulatory disease diagnostic fnih qualification accepted community scientific dipi biomarkers networks diagnosis epos optimize qualifying tissue foundation sufficient safety dini fda patient validate interaction generate transqst profile network etransafe dilin tool sizes linking assays markers continue successful mechanism datasets tackle registry confirmatory international pro litmus biomarker smes exploratory tools intend cross warehouse profiles pmda i2b2 spectrum data transmart divi bbmri acceptance diki circulating driving dili ema patients capitalizing industry cioms collaborations qualified pstc expertise factory drug mirnas

Project "TransBioLine" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITAT ZURICH Organization address address: RAMISTRASSE 71 city: ZURICH postcode: 8006 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Switzerland [CH]
Total cost	27˙906˙491 €
EC max contribution	13˙999˙997 € (50%)
Programme	1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
Code Call	H2020-JTI-IMI2-2017-13-two-stage
Funding Scheme	IMI2-RIA
Starting year	2019
Duration (year-month-day)	from 2019-02-01 to 2024-01-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITAT ZURICH UNIVERSITAT ZURICH Organization address address: RAMISTRASSE 71 city: ZURICH postcode: 8006 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (ZURICH)	coordinator	2˙424˙271.00
2	SIGNATOPE GMBH SIGNATOPE GMBH Organization address address: MARKWIESENSTR. 55 city: REUTLINGEN postcode: 72770 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (REUTLINGEN)	participant	1˙990˙000.00
3	CHARITE - UNIVERSITAETSMEDIZIN BERLIN CHARITE - UNIVERSITAETSMEDIZIN BERLIN Organization address address: Chariteplatz 1 city: BERLIN postcode: 10117 website: www.charite.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BERLIN)	participant	1˙386˙193.00
4	ABX CRO ADVANCED PHARMACEUTICAL SERVICES FORSCHUNGSGESELLSCHAFT MBH ABX CRO ADVANCED PHARMACEUTICAL SERVICES FORSCHUNGSGESELLSCHAFT MBH Organization address address: BLASEWITZER STR 78-80 city: DRESDEN postcode: 1307 website: www.abx-cro.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (DRESDEN)	participant	1˙294˙360.00
5	TAMIRNA GMBH TAMIRNA GMBH Organization address address: LEBERSTRASSE 20/8 city: WIEN postcode: 1110 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (WIEN)	participant	1˙231˙000.00
6	THE UNIVERSITY OF LIVERPOOL THE UNIVERSITY OF LIVERPOOL Organization address address: BROWNLOW HILL 765 FOUNDATION BUILDING city: LIVERPOOL postcode: L69 7ZX website: www.liverpool.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LIVERPOOL)	participant	940˙250.00
7	SYNAPSE RESEARCH MANAGEMENT PARTNERS SL SYNAPSE RESEARCH MANAGEMENT PARTNERS SL Organization address address: CALLE VELAZQUEZ 94 PLANTA 1 city: MADRID postcode: 28006 website: www.synapse-managers.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (MADRID)	participant	900˙000.00
8	THE UNIVERSITY OF NOTTINGHAM THE UNIVERSITY OF NOTTINGHAM Organization address address: University Park city: NOTTINGHAM postcode: NG7 2RD website: www.nottingham.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NOTTINGHAM)	participant	832˙700.00
9	INFORMATION TECHNOLOGY FOR TRANSLATIONAL MEDICINE (ITTM) SA INFORMATION TECHNOLOGY FOR TRANSLATIONAL MEDICINE (ITTM) SA Organization address address: 9 AVENUE DES HAUTS-FORNEAUX city: Esch-sur-Alzette postcode: 4362 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	LU (Esch-sur-Alzette)	participant	624˙125.00
10	MLM MEDICAL LABS GMBH MLM MEDICAL LABS GMBH Organization address address: DOHRWEG 63 city: MONCHENGLADBACH postcode: 41066 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (MONCHENGLADBACH)	participant	604˙800.00
11	LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN Organization address address: GESCHWISTER SCHOLL PLATZ 1 city: MUENCHEN postcode: 80539 website: www.uni-muenchen.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (MUENCHEN)	participant	443˙450.00
12	METAHEPS GMBH METAHEPS GMBH Organization address address: AM KLOPFERSPITZ 19 city: PLANEGG postcode: 82152 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (PLANEGG)	participant	284˙000.00
13	UNIVERSIDAD DE MALAGA UNIVERSIDAD DE MALAGA Organization address address: AVDA CERVANTES, NUM. 2 city: MALAGA postcode: 29016 website: www.uma.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (MALAGA)	participant	246˙452.00
14	SERVICIO ANDALUZ DE SALUD SERVICIO ANDALUZ DE SALUD Organization address address: AVENIDA DE LA CONSTITUCION 18 city: SEVILLA postcode: 41071 website: http://www.sas.junta-andalucia.es/principal/default.asp contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (SEVILLA)	participant	188˙946.00
15	FUNDACIO PRIVADA INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU FUNDACIO PRIVADA INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU Organization address address: CALLE SANT ANTONI M CLARET 167 city: BARCELONA postcode: 8025 website: www.santpau.cat contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (BARCELONA)	participant	182˙600.00
16	UNIVERSITY OF NEWCASTLE UPON TYNE UNIVERSITY OF NEWCASTLE UPON TYNE Organization address address: KINGS GATE city: NEWCASTLE UPON TYNE postcode: NE1 7RU website: http://www.ncl.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NEWCASTLE UPON TYNE)	participant	109˙475.00
17	LANDSPITALI UNIVERSITY HOSPITAL LANDSPITALI UNIVERSITY HOSPITAL Organization address address: Eiriksgata 5 city: REYKJAVIK postcode: 101 website: www.landspitali.is contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IS (REYKJAVIK)	participant	87˙325.00
18	ASSISTANCE PUBLIQUE HOPITAUX DE PARIS ASSISTANCE PUBLIQUE HOPITAUX DE PARIS Organization address address: 3 AVENUE VICTORIA city: PARIS postcode: 75000 website: http://www.aphp.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	81˙400.00
19	UNIVERSITEIT LEIDEN UNIVERSITEIT LEIDEN Organization address address: RAPENBURG 70 city: LEIDEN postcode: 2311 EZ website: www.universiteitleiden.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (LEIDEN)	participant	79˙150.00
20	UNIVERSIDAD DE SALAMANCA UNIVERSIDAD DE SALAMANCA Organization address address: CALLE PATIO DE ESCUELAS 1 city: SALAMANCA postcode: 37008 website: www.usal.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (SALAMANCA)	participant	69˙500.00
21	Eli Lilly and Company Limited Eli Lilly and Company Limited Organization address address: Lilly House, Priestley Road city: Basingstoke postcode: RG24 9NL website: www.lilly.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (Basingstoke)	participant	0.00
22	F. HOFFMANN-LA ROCHE AG F. HOFFMANN-LA ROCHE AG Organization address address: GRENZACHERSTRASSE 124 city: BASEL postcode: 4070 website: www.roche.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BASEL)	participant	0.00
23	JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV Organization address address: TURNHOUTSEWEG 30 city: BEERSE postcode: 2340 website: www.janssenpharmaceutica.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BEERSE)	participant	0.00
24	MERCK SHARP & DOHME CORP MERCK SHARP & DOHME CORP Organization address address: ONE MERCK DRIVE city: WHITEHOUSE STATION NJ postcode: 8889 website: www.merck.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	US (WHITEHOUSE STATION NJ)	participant	0.00
25	NOVARTIS PHARMA AG NOVARTIS PHARMA AG Organization address address: LICHTSTRASSE 35 city: BASEL postcode: 4056 website: www.novartis.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BASEL)	participant	0.00
26	PFIZER LIMITED PFIZER LIMITED Organization address address: RAMSGATE ROAD city: SANDWICH postcode: CT13 9NJ website: www.pfizer.co.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (SANDWICH)	participant	0.00
27	SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT Organization address address: Pierre Brossolette 1 city: Chilly Mazarin postcode: 91380 website: www.sanofi-aventis.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (Chilly Mazarin)	participant	0.00

Map

Project 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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