The members of TransBioLine have established a network of clinical trial centers throughout Europe to enroll volunteers in over a dozen clinical trials spanning pathologies that allowed for the identification of biomarkers as potential markers of injury of five different organs or organ systems (kidney, liver, pancreas, vascular, nervous system). In total, over 40,0000 samples from over 1,800 individuals have been collected from patients and normal healthy volunteers, with a corresponding database housing clinical data collected during each study and biomarker data generated by TransBioLine analysis partners.
During the 6 years of the Project runtime, SYNAPSE has lead Project management, Communication, Dissemination and Sustainability, providing the environment and tools intended promote interactions between experts, in and outside the Project fostering the attainment of the objectives.
“Working at TransBioLine has been a very exciting journey from a management perspective. From day one, we have carefully taken care of the project in order to make it flourish to its best/highest potential – overall, we are proud of what TransBioLine has been able to deliver. Most importantly, along the way, I have had the pleasure of meeting great leaders who I have deeply enjoyed working with and who I will really miss.”
Estefanía Callado - SYNAPSE, TransBioLine Project Manager
In particular to highlight:
And above all, TransBioLine has endeavoured to establish means of making collected biosamples with their corresponding database housing clinical and biomarkers data, available to the broader research community, where consent by patients and volunteers has been explicitly given to do so. With the support of study physicians and patient population, a legacy Biosample Repository and a TransBioLine Database have been created.
Select biosamples and data, where patients and volunteers have consented explicitly to future use in biomedical research, will be made available to researchers for ethically approved studies where possible upon request.
It is foreseen that all Project outputs will support drug-induced biomarkers qualification to be used by pharmaceutical and biotechnology industries during drug safety evaluation throughout phase I-III trials for mitigating safety issues in clinics and drive the broader market access of assays and assay panels for high-value biomarkers that also serve multiple purposes potentially as diagnostic, prognostic and disease response biomarkers.
“Even if I joined the team half-way to the project, I’ve been given the opportunity to bring SYNAPSE expertise in projects communication and sustainability and collaborate with great experts avid to share their knowledge and findings to the broad community. A big thank you and congratulations for the accomplishments”
Nathalie Bofarull - SYNAPSE, TransBioLine Project Manager
Health research and development projects are highly dependent, not only on expertise and resources availability, but also on how they are steered to secure objectives accomplishment. In addition, during TransBioLione, a continued effort towards ensuring the adequate project outcome’s sustainability has been the priority of all partners from the very beginning. All in all, contributing to the progresses and milestones achieved in safety biomarker research and regulatory qualification.
TransBioLine has made a decisive advance in biomarker discovery.
The Translational Safety Biomarker Pipeline (TransBioLine) Project aims to generate exploratory and confirmatory data supporting regulatory qualification and acceptance of novel safety biomarkers for five target organ systems (kidney, liver, pancreas, vascular, and central nervous system) for application in drug development.