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
Four LOIs accepted by the FDA
The FDA has decided to Accept the DILI Work Package into the Biomarker Qualification Program. We are very happy to have DIVI, DINI, DIKI and DILI already accepted by the FDA Biomarker Qualification Program! Take a look at our 4 FDA-accepted Letters of Intent for the Biomarker Qualification following this [...]
TransBioLine Newsletter Year 2 is online!
We are delighted to announce that the TransBioLine Newsletter Year 2 is online! This Newsletter summarizes the highlights of the scientific progress and the consortium activities during the second year of the project. Don’t want to miss a thing about TransBioLine? Subscribe to our newsletter now! The TransBioLine project has [...]
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.