The idea of this project is to create a platform that will enable a coordinated effort of determining which MoAs should be evaluated with non-clinical immune safety model evaluation. The impact of such an effort will be maximised if all those engaged in this effort are operating under a set of standards both with regards to the models used and the preanalytical handling of samples. Such alignment will markedly increase the efficiency of the effort and maximise the usability of available resources such as human samples.
imSAVAR aims to achieve the following impact-outcomes:
- Provision of new tools and models to enable a better understanding of the inherent safety risks of immunomodulatory therapeutics.
- Improvement of drug development processes and regulatory assessments for immunomodulatory therapeutics through the characterisation of innovative immunobiology models and biomarkers.
- Better definitions of limitations in the translatability of non-clinical test systems to patients which will enable the most appropriate and efficient combinations of test systems to be used in future safety assessment and contributing to 3Rs.