MetaHeps GmbH is part of the European IMI - Project Translational Safety Biomarker Pipeline (TransBioLine), which started on April 15, 2019.
The project is 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, vessels and central nervous system) for application in drug development. The Martinsried Startup Company MetaHeps GmbH is part of the TransBioLine-Consortium. MetaHeps was chosen to perform causality assessment of liver injury by drugs with its unique in vitro test using patient derived blood cells.
The TransBioLine Project is a consortium of 27 partners including pharmaceutical companies like Pfizer, Merck Sharp & Dohme, Eli Lilly, Novartis, Roche, Janssen and Sanofi, as well as small and medium-sized enterprises, and academic institutions from 10 European countries. It is coordinated by the University of Zurich with Pfizer as the industry lead. TransBioLine 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,” says Shashi Ramaiah, Executive Director, Pfizer Drug Safety Research & Development and TransBioLine Lead Scientist. Michael Merz, Consortium Coordinator, University of Zurich, adds, “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 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.”
The Martinsried Startup Company MetaHeps GmbH is part of the European IMI - Project TransBioLine. MetaHeps GmbH takes part in Transbioline as Provider of the world first in vitro test to Diagnose and determine causality in drug induced liver injury (DILI).
DILI is a major concern in drug development, since its idiosyncratic form (affecting susceptible individuals rather than dose-dependent toxicity) is a major cause for late stage drug failures, market withdrawals and Marketing restrcitions. The game-changing Technology of MetaHeps GmbH will allow drug-developers to de-risk and accelerate drug-development. The further development of this late-stage drug-rescue tool leads the way to prediction of DILI to further improve drug safety.
About the Innovative Medicines Initiative
The Innovative Medicines Initiative 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.