Early and reliable detection and monitoring of adverse events is essential for improving of patient safety, reducing late attrition of drug candidates, and enhancing understanding of toxic mechanisms. The Translational Safety Biomarker Pipeline (TransBioLine) project will focus on development of biomarkers of injury for liver, kidney, pancreas, vasculature, central nervous system (CNS) and the development of non-invasive microRNA biomarkers using liquid biopsies. The project is coordinated by the University of Zurich with Pfizer as industry lead, and involves 27 partners (pharmaceutical companies, small and medium-sized enterprises, and academic institutions) from ten European countries and the United States of America. With a total budget of € 28 million, the EU and the pharmaceutical companies involved are financing the project.
In addition to two other labs, MLM Medical Labs from Mönchengladbach, Germany, and SIGNATOPE GmbH from Reutlingen, Germany, TAmiRNA is responsible for analyzing several new biomarkers in clinical samples from all over Europe.
TAmiRNA will be responsible for the following tasks within the TransBioLine consortium:
- Leading the work package on microRNA biomarker discovery, validation and qualification
- implementing and validating an NGS platform for absolute quantification in serum and plasma,
- application of this platform for comprehensive characterization of the human circulating miRNome in normal healthy volunteers, and
- development of sensitive and specific organ injury miRNA signatures for kidney, liver, pancreas, vascular and CNS under compliance with regulatory requirements.
For more information visit the TransBioLine homepage or get in touch with TAmiRNA. TAmiRNA GmbH Muthgasse 18 FN 406620x, HG Wien 1190 Vienna, Austria www.tamirna.com
TAmiRNA specializes in technologies for profiling levels of blood-circulating microRNAs and developing multi-parametric classification algorithms ("signatures"). TAmiRNA uses these technologies to develop minimal-invasive diagnostic tests for drug development, early diagnosis and prognosis of disease, and as companion diagnostic tests to support treatment decisions.
Innovative Medicines Initiative (IMI) is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is working to improve health by speeding up the development of the next generation of medicines, particularly in areas where there is an unmet medical or social need.