The Synapse team is delighted to announce the launch of a new Innovative Medicines Initiative project, the Translational Safety Biomarker Pipeline (TransBioLine) Project, aims to generate exploratory and confirmatory data supporting regulatory qualification and acceptance of novel safety biomarkers for five target organ systems (kidney, liver, pancreas, vascular, and central nervous system) for application in drug development.
The TransBioLine Project is a consortium of 27 partners across pharmaceutical companies, small and medium-sized enterprises, and academic institutions from 10 European countries, and is coordinated by the University of Zurich with Pfizer Inc. as the industry lead. It is funded by the IMI Joint Undertaking as a public-private partnership, with a budget of 28M€ and will be active through 2024.
This is one of the largest public-private partnerships of European and American scientists that focuses on the development and regulatory qualification of new safety biomarkers. The TransBioLine Project provides a unique opportunity to access a large expert and knowledge network, including data and samples from clinical trials, to enable the global safety qualification of identified novel biomarkers. Implementing qualified safety biomarkers in early clinical trials will mitigate safety attrition of promising drug candidates and advance projects to clinics through higher-quality and better-informed decision making.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821283. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA companies.”