The Innovative Medicines Initiative (IMI) today announced the launch of the Translational Safety Biomarker Pipeline (TransBioLine) Project, a five-year program 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.

“One of the major gaps in drug development is the lack of qualified safety biomarkers with acceptable precision and accuracy for safety monitoring during clinical development,” said  Shashi Ramaiah, Executive Director, Pfizer Drug Safety Research & Development and TransBioLine Lead Scientist. “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.”

Michael Merz, Consortium Coordinator, University of Zurich, said, “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. These include indicators of tissue damage like liquid biopsy, biomarkers that could facilitate patient stratification, and standardized tests for detection of these biomarkers. These new markers are ultimately expected to not only improve safety of new and approved drugs, but also to contribute to better diagnosis and management of acute and chronic diseases. It is really exciting to see years of enthusiastic preparation translating into this project going forward now.”

When the project ends in 2024, the consortium will have established 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.