grit Scientific Data Management Platform serves as the central data management system for the ERA4TB project and ensures storage of both pre-clinical and clinical data in a structured and FAIR format.
ERA4TB aims to accelerate the development of a new, more efficient treatment regimen that will help the world to meet the UN goal of ending the tubelculosis epidemic by 2030.
The main objective of ERA4TB (European Accelerator of Tuberculosis Regime) is to create a European open platform to accelerate the development of new regimens for the treatment of tuberculosis.
ERA4TB is part of the AMR Accelerator, an IMI programme that comprises 9 projects with the shared goal of progressing the development of new medicines to treat or prevent resistant bacterial infections.
The total funding of 207.963.891 € is provided by EU, EFPIA and associated partners. The project runs from 2020-2026.
The project consortium integrates 31 organisations: 7 academic institutions, 4 non-profit organisations, 9 public research organisations, and 5 small-medium enterprises (including grit42), together with 3 EFPIA members, and 3 IMI2 Associated Partners.
Due to the growing issues with microbial resistance where some drugs simply lose effect, it is common to use combination therapy (mixing drugs) in the AMR field.
However, this poses a bit of a challenge in the classic biopharma data systems as all “compounds” being tested need to be registered. And in this case it’s not new compounds but a mixture of other compounds already in the system.
By request from ERA4TB we have together with C-Path extended the grit Scientific Data Management Platform in a way where we can now – not only – handle combinations of compounds but also combination of the batch and the actual vials used to create a new “combination batch/vial”.
Following the virulence studies "compound testing" experiments are being performed. All the animal level data - from both kinds of in vivo studies - including the study design information are being uploaded to grit.
In the IMI ERA4TB project data from both pre-clinical and clinical research are collected and need to be stored in the grit42 platform in order to enable cross study analysis in both areas.
But equally important this ensures the ability to perform data analysis across pre-clinical and clinical data and hence translation from animal studies to the human clinical trials.