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
3rd Consortium Meeting (Online)
TransBioLine 3rd Consortium Meeting took place in an online format on 8-9th September 2020. Up to 90 people joined the virtual TransBioLine 3rd consortium meeting, having the representation of all consortium partners. Project progress was shared and next steps were agreed to push the project in the good direction. The [...]
The first TransBioLine Newsletter is online!
We are delighted to announce that the first Newsletter of the TransBioLine project is online! This Newsletter summarizes the highlights of the scientific progress and the consortium activities during the first year of the project. Don’t want to miss a thing about TransBioLine? Subscribe to our newsletter now!
WP4 LOI accepted by the FDA!
The TransBioLine WP4 (Biomarkers of vascular injury) Letter of Intent was accepted by the FDA on February 2020 and the team is in preparation to discuss the FDA recommendations to support the next stage, the Qualification Package, during the second quarter of 2020. Press here [...]
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.