Periodic Reporting for period 4 - TransBioLine (Translational Safety Biomarker Pipeline (TransBioLine): Enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease)
Berichtszeitraum: 2022-02-01 bis 2023-01-31
TransBioLine is organized into five organ system work packages (WP) and six enabling WP that include 6-miRNA (liquid biopsy), 7-biobank and assay development, 8-data management, 10-regulatory interactions, and 11-communication packages. Each organ WP has the objective of collecting pre-clinical and clinical data that will support the utility of candidate biomarkers in the increased sensitive and specific assessment of specific organ injury. Supporting work packages aim at a) assessment of miRNAs and miRNA profiling as biomarkers for each of the five target organ systems b) developing and validating fit-for purpose assays for biomarker quantification, c) establishing and maintaining a centralized biobank, d) collecting, curating, sharing, and analyzing high-quality clinical and biomarker data, e) leading regulatory qualifications, f) effectively managing the project and g) disseminating project activities and ensuring sustainability of TransBioLine-generated assets. Overall, TransBioLine is a project dedicated to increased patient safety and streamlined drug-development processes.
During the project’s 6-year lifetime, TransBioLine will be the leading public-private partnership focusing on the clinical qualification of new safety biomarkers. TransBioLine will open new markets by introducing commercially available diagnostics products through innovative SMEs. MLM, Signatope, and TAmiRNA will substantially benefit from their involvement in the qualification process, including the validation of their assays and proprietary platforms, as an important competitive advantage. ITTM will benefit from the interaction with EFPIA and consortium partners by improving data sharing and harmonization services and technologies. The expected harmonization and improved interoperability of tranSMART with Sample Management and eCRF systems will open new opportunities and further facilitate data integration in preclinical and clinical projects. All SMEs have risen to the challenges, foreseen and unforeseen, that have occurred in TransBioLine due to its complexity and size, gaining valuable experience and advantages over competitors.