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.

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, New Jersey, United States
  • Novartis Pharma AG, Basel, Switzerland
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, 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, Munich, Germany
  • Servicio Andaluz De Salud, Sevilla, Spain
  • The Critical Path Institute (C-Path) Non Profit Corporation, Tucson Az, 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, Zürich, 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, Oberwil, Switzerland
  • Information Technology For Translational Medicine (Ittm) SA, Esch-sur-Alzette, Luxembourg
  • Metaheps GMBH, Munich, Germany
  • Mlm Medical Labs GMBH, Moenchengladbach, Germany
  • Signatope GMBH, Reutlingen, Germany
  • Synapse Research Management Partners SL, Barcelona, Spain
  • Tamirna GMBH, Vienna, Austria
Patient organisations
  • Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau Fundacion, Barcelona, Spain

Participants
NameIHI funding in €
Abx Cro Advanced Pharmaceutical Services Forschungsgesellschaft Mbh1 294 360
Assistance Publique Hopitaux De Paris81 400
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 Muenchen443 450
Metaheps GMBH284 000
Mlm Medical Labs GMBH604 800
Servicio Andaluz De Salud188 946
Signatope GMBH1 990 000
Synapse Research Management Partners SL900 000
Tamirna GMBH1 231 000
The University Of Liverpool940 250
The University Of Nottingham832 700
Universidad De Malaga246 452
Universidad De Salamanca69 500
Universitaet Bern80 040
Universitat Zurich2 389 381
Universiteit Leiden34 000
University Of Newcastle Upon Tyne109 475
Total Cost13 999 998