IMI Prioritises Drug Safety and Regulation

Medical research experts in drug-induced liver injury from the University of Nottingham and NIHR Nottingham Biomedical Research Centre have joined a major new international research initiative to improve the safety and regulation in the development of drugs. As part of the EU’s Innovative Medicines Initiative (IMI), the Translational Safety Biomarker Pipeline (TransBioLine) project will generate data to support the development of novel safety biomarkers for five target organ systems (kidney, liver, pancreas, vascular and central nervous system) for use in drug development.

Robust biomarkers are vital in the creation of new drugs to improve diagnosis, monitor drug activity and therapeutic effect. They help guide the development of safer, more targeted treatments for chronic diseases but up to now the process of identifying new and reliable biomarkers has been difficult. The new ‘pipeline’ has been set up to address this and speed up the discovery and development of specific biomarkers for complex chronic diseases.

The TransBioLine Project is a consortium of 27 partners across pharmaceutical companies, small and medium-sized enterprises along with academic institutions from 10 European countries. It is to be 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.

Professor Guruprasad Aithal, the Deputy Academic Co-ordinator for TransBioLine and the 'Drug-induced liver injury (DILI)' work package lead:, said: “TransBioLine is an enormous opportunity to turn science into clinical practice to improve safe use of medication. It will boost NIHR Nottingham BRC researchers who have led discoveries in DILI field over the past two decades. Drs Jane Grove and Stuart Astbury are contributing to the discovery and evaluation of new tests to identify liver injury early and reduce patient harm and Beth Robinson will be the project coordinator for the DILI work package.”

Shashi Ramaiah, Executive Director, Pfizer Drug Safety Research & Development and TransBioLine Lead Scientist said: “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. 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.