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 aims 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. By the end of the project, the team will have set up an infrastructure and processes to continue biomarker research across a comprehensive network of industry, academic institutions, and small and medium-sized enterprises, providing to the scientific community, industry and patients with detailed data across a large spectrum of advanced safety biomarkers.
Latest News
8th Consortium Meeting, 11th & 12th of April 2024– TransBioLine partners gather in Sitges (Barcelona)
The 8th TransBioLine Consortium meeting took place in Sitges (Barcelona) on the 11th and 12th of April 2024. This 2-days hybrid meeting of the Consortium members included updates on all the organ Work Packages, discussions on project sustainability as well as scientific sessions. The meeting started with a welcome from Sashi Ramaiah (Project [...]
TransBioLine submits its 1st Qualification Plan to the FDA
The TransBioLine consortium has been working for the past five years on discovery, validation and regulatory qualification of a variety of safety biomarkers for drug-induced organ injury. On Friday, February 9, 2024, the first Biomarker Qualification Plan from TransBioLine on Drug Induced Nervous System Injury was submitted to the FDA. [...]
7th Consortium Meeting, 5th – 6th October 2023– TransBioLine partners gather in Basel (Switzerland)
At the beginning of October, more than 40 members of TransBioLine participated in the 7th Consortium Meeting hosted by Roche in Basel (Switzerland). Only 15 months left until the project end, the main focus of this Consortium Meeting was put on team alignment to secure the execution of project objectives. [...]
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.