The overall aim is the establishment of a platform that consists of processes for developing nonclinical assessment strategies as well as models that represent the complexity of diseases and predict the immune related adverse events.
In addition, the generation of integrated nonclinical overviews for Investigational New Drug and clinical trial applications will be based upon the imSAVAR standard, making the process much more efficient. The platform will continue after the funding period driven by a stakeholder community for developing new assessment strategies and supporting the implementation of existing ones.
Objective 1: ID MoAs
Identification of immunomodulatory modes of action (MoAs) that have insufficient methods for predicting human toxicities so that resources can be focused where they are most likely to lead to real differences in predicting immunosafety.
Objective 2: Refine & Build Models
Refine existing models, develop new models, and identify biomarkers for preclinical assessment of efficacy and safety for immuno-oncology and immuno-inflammatory therapeutics so that development of unsafe immunomodulatory therapies can be stopped early in the development process.
Objective 3: Create a Platform
Establish a platform that combines models with a network of biosample resource providers that can carry out immune safety assessment strategies in an efficient manner and continually to progress the field.
Objective 4: Outreach beyond Funding Period
Creation of immune safety stakeholder community and business models that can maintain and extend the vision of imSAVAR beyond the funding period.