International research project making drug development safer

A new international research project, involving researchers from the University of Liverpool, has been launched to help with the regulation and safety aspects of drug development.

The Innovative Medicines Initiative (IMI) has 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.

In the development of drugs, robust biomarkers are needed to improve diagnosis, monitor drug activity and therapeutic response to help guide the development of safer and targeted therapies for various chronic diseases. While different types of biomarkers have been impactful in the field of drug development, the process of identifying and validating disease novel biomarkers has been challenging. Recent scientific advances have made it possible to accelerate the discovery and development of specific biomarkers for complex chronic diseases.

Preventing and diagnosing harm

The TransBioLine Project is a consortium of 27 partners across pharmaceutical companies, small and medium-sized enterprises, and academic institutions, including the University of Liverpool, 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 £24m and will be active through 2024.

The University of Liverpool researchers working on the project are from the MRC Centre for Drug Safety Science, the Institute of Translational Medicine and the Institute of Integrative Biology.

Professor Kevin Park, University of Liverpool’s lead for the project, said: “We are excited to be a part of this vital research project. Our work aims to improve medicines for all, by creating strategies that can predict, prevent or diagnose harm from medicines during their development.”

Large expert and knowledge network

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.”

Establishing infrastructure

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.

IMI is the world's biggest public-private partnership in the life sciences. It is a partnership between the European Union and the European pharmaceutical industry. The Initiative works to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need.