TransBioLine

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

Summary

Predicting which potential medicines could be harmful to major organ systems is a major challenge during drug development. The TransBioLine project aims to develop biological markers (biomarkers) that will reliably indicate injury of the liver, kidneys, pancreas, blood vessels, and central nervous system. The biomarkers, which the project hopes to get through regulatory qualification, include indicators of tissue damage, biomarkers to aid patient stratification, and standardised tests for the detection of the biomarkers. By the end of the project, the team will have set up an infrastructure and processes to continue biomarker research across a comprehensive network of industry, academic institutions, and small and medium-sized enterprises, and it will be able to provide the scientific community, industry and patients with detailed data and information across a large spectrum of advanced safety biomarkers. Ultimately, the new markers will not only improve the safety of new drugs, but will contribute to the better diagnosis and management of diseases.

Achievements & News

Participants

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EFPIA companies
  • Eli Lilly And Company LTD, Basingstoke, United Kingdom
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Merck Sharp & Dohme Corp, Whitehouse Station Nj, United States
  • Novartis Pharma AG, Basel, Switzerland
  • Pfizer Limited, Sandwich, United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Gentilly, France
Universities, research organisations, public bodies, non-profit groups
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Charite - Universitaetsmedizin Berlin, Berlin, Germany
  • Landspitali University Hospital, Reykjavik, Iceland
  • Ludwig-Maximilians-Universitaet Muenchen, Munchen, Germany
  • Servicio Andaluz De La Salud, Sevilla, Spain
  • The Critical Path Institute (C-Path) Non Profit Corporation, Tucson, United States
  • The University Of Liverpool, Liverpool, United Kingdom
  • The University Of Nottingham, Nottingham, United Kingdom
  • Universidad De Malaga, Malaga, Spain
  • Universidad De Salamanca, Salamanca, Spain
  • Universitaet Bern, Bern, Switzerland
  • Universitat Zurich, Zurich, Switzerland
  • Universiteit Leiden, Leiden, Netherlands
  • University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Abx Cro Advanced Pharmaceutical Services Forschungsgesellschaft Mbh, Dresden, Germany
  • Information Technology For Translational Medicine (Ittm) SA, Esch-Uelzecht, Luxembourg
  • Mlm Medical Labs GMBH, Monchengladbach, Germany
  • Signatope GMBH, Reutlingen, Germany
  • Synapse Research Management Partners SL, Madrid, Spain
  • Tamirna GMBH, Wien, Austria
Patient organisations
  • Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau Fundacion, Barcelona, Spain
Third parties
  • Aintree University Hospital Nhs Foundation Trust, Liverpool, United Kingdom

Participants
NameEU funding in €
Abx Cro Advanced Pharmaceutical Services Forschungsgesellschaft Mbh1 294 360
Assistance Publique Hopitaux De Paris34 000
Charite - Universitaetsmedizin Berlin1 386 194
Information Technology For Translational Medicine (Ittm) SA624 125
Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau Fundacion182 600
Landspitali University Hospital87 325
Ludwig-Maximilians-Universitaet Muenchen400 000
Metaheps GMBH (left the project)124 804
Mlm Medical Labs GMBH604 800
Servicio Andaluz De La Salud188 946
Signatope GMBH2 254 000
Synapse Research Management Partners SL900 000
Tamirna GMBH1 337 973
The University Of Liverpool788 875
The University Of Nottingham1 018 028
Universidad De Malaga246 452
Universidad De Salamanca69 500
Universitaet Bern45 204
Universitat Zurich2 187 562
Universiteit Leiden3 000
University Of Newcastle Upon Tyne68 000
 
Third parties
NameFunding in €
Aintree University Hospital Nhs Foundation Trust154 250
 
Total Cost13 999 998