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

TransBioLine submits its 1st Qualification Plan to the FDA

March 6th, 2024|Latest News|

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. [...]

Clinical studies status (June 2023)

September 1st, 2023|Clinical Studies|

During year 4, huge progress has been done in the enrolment of patients in the clinical studies within the TransBioLine project to move forward in the identification of novel biomarkers that reliably indicate specific organ injury during drug development. To highlight, recruitment for the pancreatic injury working group has finally [...]

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.

Funding period: 01/02/2019 to 31/01/2024. Years: 5 (2019-24)
EFPIA companies: 7. Academic & commercial partners: 22
Total Budget: EUR 28 Million
IMI contribution: EUR 14 Million (in cash).  EFPIA contribution: EUR 14 Million (in kind)
Project Coordinator: University of Zurich. Project Leader: Pfizer LTD
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