imSAVAR - Immune safety avatar: nonclinical mimicking of the immune system effects of immunomodulatory therapies

The vision of Immune Safety Avatar (imSAVAR) is to develop a platform for integrated nonclinical assessments of immunomodulatory therapy safety and efficacy.The imSAVAR is an Innovative Medicines Initiative funded project that aims to develop a standard for integrated nonclinical safety overviews for immune-modulatory investigational new drugs (IND) and clinical trial applications (CTA).Our imSAVAR platform will improve the prediction of the transferability of safety and efficacy of immunomodulators from pre-clinical models to first-in-human studies in collaboration with the private sector, pharma, regulators and technology providers. This joint effort not only benefits the field of immune safety evaluation, but will also generate various opportunities for European businesses as well as foster the meaningful engagement of multiple stakeholders including patients and regulators.