In this project, a multinational consortium of high-tech SMEs, academic research institutes, biotech and pharma partners, affiliated patient-centred organisations and professional societies will achieve a multi-faceted diagnostic and prognostic platform and a precision medicine approach. This consortium will together realize a patient empowerment centred decision support system that will enable multiple stakeholders to participate in improved and more rapid diagnosis and prognosis, as well as the potential of precision medicine for accelerated development of new therapies. Citizens and patients will be empowered to contribute to the efficient planning and usage of resources. The project will begin by rapidly delivering a nomogram. Data from the pandemic will be used to validate and further optimise a scalable multifactorial diagnosis/prognosis solution. Existing and new data and sample collection efforts will be used to perform molecular profiling, which - using advanced AI techniques will be shaped into a precision medicine approach. These initial outputs will undergo further enhancement and assessment to evaluate the value they add to the development of a decision support system. The entire effort will be supported by the deployment of a federated machine learning system that will allow for the GDPR compliant use of multinational data resources. The various iterations of the decision support system and the federated machine learning system will be made available to other coronavirus initiatives with the intent to develop a stakeholder community that forms the basis for a highly efficient innovation ecosystem. Our proposed study will be one of the first to develop innovative machine learning, and clinical procedure improvement that will potentially make a huge socio-economic impact for the coronavirus outbreak.

Autism Spectrum Disorder (ASD) is a heterogeneous neurodevelopmental condition affecting over five million people in the European Union. The combination of core symptoms (deficits in social-communication and repetitive and restricted behaviours and interests) and common comorbidities (e.g. epilepsy and depression) significantly reduces the quality of life and life-span of affected individuals. Currently there are no effective drug treatments for the core symptoms. Key factors that have hampered progress include; 1) limited understanding of the underlying pathophysiolog(ies); 2) lack of successful translation from animal models to humans; 3) testing of drugs with specific actions in biologically heterogeneous populations; 4) limited expertise of many European ASD centres in running large-scale clinical trials; and 5) trial designs (e.g. placebo effects). Our vision, therefore, is to apply a precision medicine approach to ASD and improve patient outcomes by tailoring treatments to a patient’s biological profile. Our efforts will build on the achievements of 5 other IMI initiatives, 4 Horizon 2020 networks, and 6 SMEs for the first time to; 1) align global resources to validate and qualify stratification biomarkers from infancy to adulthood; 2) develop objective outcome measures that can be used in trials; 3) create a European-wide clinical trials network that reliably carries out studies able to support filings to the EMA/FDA; 4) carry out better targeted clinical trials linked to other international efforts – including quick wins or “fast fails” of ineffective agents; 5) translate molecular mechanisms and drug effects between preclinical models and particular subtypes of ASD. Together we will bring Europe to the forefront of clinical research in ASD. Also we will provide a sustainable legacy that is accessible by others across the world, attracts industry into ASD, and helps transform healthcare.

The vision of Immune Safety Avatar (imSAVAR) is to develop a platform for integrated nonclinical assessments of immunomodulatory therapy safety and efficacy. Existing nonclinical models do not adequately represent the complexity of the immune system and its interactions in both immunoncology and immunmediated diseases. They also do not accurately reflect the diversity of response to new therapies that is seen in clinical medicine. We will, thus, constantly refine existing and develop new nonclinical models with the final goal of validation aiming at: (i) understanding the value of nonclinical models for predicting efficacy and safety of immunomodulators incorporating cellular high throughput assays, complex organisms models and micro physiological systems, (ii) developing new endpoints and better monitoring approaches for immune function tests, and (iii) designing cellular and molecular biomarkers for early detection of adverse effects. The platform imSAVAR will be based upon case studies for prioritized therapeutic modalities and has been built around institutes of the Fraunhofer-Gesellschaft which has strong track records in applied science and in particular toxicology. The consortium 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. We will share experience on customized models that can be deployed (w.r.t. the 3Rs principles), establish the necessary infrastructure, conduct the analyses and provide wider disease domain expertise. This conjoint effort assures that the platform imSAVAR constantly benefits the field of immune safety evaluation, and will generate opportunities for European businesses. A guiding principle of this consortium is the meaningful engagement of multiple stakeholders including patients and regulators. A multi-stakeholder community will be established.