Innovative scientific approaches have facilitated significant progress in drug development during recent decades, offering amazing new treatment options to patients across a range of chronic diseases. However, safety and tolerability of drug candidates and newly approved drugs often remain a key concern, leading to labelling restrictions, black box warnings, and withdrawal of otherwise promising innovative medicines.
The TransBioLine project aimed to develop novel safety biomarkers that will reliably indicate injury of the liver, kidneys, pancreas, blood vessels, and central nervous system for drug development purposes. This private-public partnership, funded by the Innovative Health Initiative and EFPIA partners had a project runtime beginning February 2019 and ending January 2025. A legacy of infrastructure and processes to continue and facilitate biomarker research across a comprehensive network of industry, academic institutions, and small and medium-sized enterprises remains, and hopes to continue to provide the scientific community, industry and patients with detailed data across a large spectrum of advanced safety biomarkers.
A large thank you to all patients and volunteers that have consented to donate their time, biological material, and data to the consortium research efforts of improving patient and volunteer safety in drug development, as well as supporting research on mechanisms of injury and the diagnosis and progression thereof. We strive and continue to strive to make the best use of your donation by sharing all our findings publically, and continuing to pursue the development and implementation of tools that will make drugs safer, and help physicians treat patients better.
TransBioLine promises a decisive advance in biomarker discovery, development, validation, regulatory qualification and application, and bring about a fundamental change in the way drug safety is monitored in clinical trials, and toxicities are diagnosed and managed in clinical practice.