Influenza is a major public health problem. In a conservative estimate, influenza infects annually 60 of the 500 million inhabitants of the EU. Vaccines are the cornerstone for preventing influenza and its consequences. Current influenza vaccines have a moderate variable effect, given the mismatch between vaccine and circulating strains, waning immunity and interference from previous vaccination, among others. The single most important challenge in achieving VE studies for the various influenza vaccines put every year on the European market is the ability of the different stakeholders to work in collaboration. To enable a sustainable network of influenza vaccine VE studies, the Development of Robust and Innovative Vaccines Effectiveness (DRIVE) main goal will be the development of a governance model between public and private entities. This model will ensure scientific independence in the studies and full transparency, allowing different stakeholders to fulfill their needs taking into account their respective obligations and statutes. A second challenge will be to reach the capacity to perform vaccine brand- specific effectiveness studies, which is agile enough to deliver the needed outputs in timely manner, and robust enough to provide results by different age and risk groups and flexible enough to utilize novel tools while at the same time aims to be sustainable. Combining these outputs, DRIVE will establish a sustainable platform for joint influenza vaccine effectiveness evaluation which will have a positive impact on European citizens public health.

Issues of data subjects’ privacy and data security represent a crucial challenge in the biomedical sector more than in other industries. The current IT landscape in this field shows a myriad of isolated, locally hosted patient data repositories, managed by clinical centres and other organisations, which are subject to frequent and massive data breaches. Patients are disenfranchised in this process, and are not able to have a clear understanding of who uses their personal information and for what purposes. This makes it the ideal field to build and test new models of privacy and data protection, and the technologies that encode them. MyHealthMyData (MHMD) aims at changing the existing scenario by introducing a distributed, peer-to-peer architecture, based on Blockchain and Personal Data Accounts. This approach will determine new mechanisms of trust and of direct, value-based relationships between people, hospitals, research centres and businesses, in what will be the first open biomedical information network centred on the connection between organisations and the individual. The system will develop a comprehensive methodology to guide the implementation of data and identity protection systems, specifically defining approaches and tools to profile and classify sensitive data based on their informational and economic value, to assess the most suitable and robust de-identification and encryption technologies needed to secure different types of information, to allow advanced analytics, and to evaluate the overall reliability of a generic multi modular architecture. MHMD will also analyse users’ behavioural patterns alongside ethical and cultural orientations, to identify hidden dynamics in the interactions between humans and complex information services, to improve the design of data-driven platforms and to foster the development of a true information marketplace, in which individuals will be able to exercise full control on their personal data and leverage their value.

In the EU alone, according to the Orphanet DB (https://pubmed.ncbi.nlm.nih.gov/31527858/), 30 million persons, 3,5-6% of the general population, are affected by one of the 6,172 different rare diseases (RDs) of which 72% are genetic and 70% affect children. The path to diagnosis for people suffering from a RD is burdensome, often severely delayed by a diagnostic odyssey. Lack of timely diagnosis affects disease management, family planning, identification of potential beneficial treatments and / or clinical trials. This unacceptable situation does not meet the concept of equity for EU citizens, and requires rapid, structured, and cost-effective corrective actions. The Screen4Care (S4C) consortium will leverage the genomic and digital advent to develop and pilot genetic NBS and AI-guided symptom recognition algorithms, while accounting for all relevant legal, regulatory and ethical considerations. S4C aims to harmonize the results of existing efforts in a horizon scan, by looking at the totality of the available data resources, diagnostic algorithms, and other initiatives with similar ultimate goals. The genetic NBS will interrogate 1) currently treatable RDs (TREAT-map gene panel), 2) actionable RDs (ACT-map gene panel) in 18.000 new-borns in 3 EU countries (D, It, and Cz). Further, S4C will offer whole genome sequencing (WGS) to early symptomatic babies, tested negatively during panel-based NBS to identify known NBS-escaped RDs and novel genes/phenotypes. S4C will also provide two digital diagnosis support systems for RD on the basis of features and symptom complexes: 1) federated ML- and literature-evidence-based algorithm for continuous and automated screening of EHR and 2) meta symptom checker with virtual clinics for patients and HCP offering the possibility of increased accuracy of diagnosis and ongoing supports. Our ambitious goal is to evaluate the validity of our multi-pronged approach to shorten the time to diagnosis for all patients affect by RDs, improve value-based healthcare resource utilization, and hopefully reduce the suffering of millions of European citizens.

CAPSTONE (Controlling Antigen ProceSsing in auTOimmune diseases and caNcEr - Excellence Training Network) is a consortium coordinated by Pr Deprez-Poulain, from the University of Lille, aiming at applying to MSCA-ITN (ETN) call. This transnational network of academic and industrial partners and patient associations providing multidisciplinary and multisectorial training to 15 Early-Stage Researchers in the field of antigen processing and presentation and in the development of novel pharmacological tools for the treatment of cancer and autoimmune diseases and their industrial applications. Cutting-edge research during the last few years has identified the biochemical pathway of intracellular antigen processing as a promising target for modulating the human immune response. Recent results by the consortium, suggest that pharmacological modulation of the activity of a group of intracellular aminopeptidases that generate antigenic peptides has important applications in cancer immunotherapy and in the control of inflammatory disease and autoimmunity. This project fits in an extended network of high-technology companies and leading academic research institutes which will study this specific biochemical pathway and will design and characterize new compounds for treatment. CAPSTONE brings together a multidisciplinary group of world-class researchers coming from 11 different countries in medicinal chemistry, biochemistry, X-Ray crystallography, screening technologies, cellular biology, oncology, autoimmunity, metabolism, bioanalysis, mass spectrometry imaging, formulation, systems biology, that will work together to expose ESRs to key R&D stages, from basic research to pre-clinical development. This project has already been submitted to MSCA-ITN-2017 with a very encouraging score. The ANR-MRSEI grant will allow this transnational consortium to consolidate and fine-tune its proposal to fully succeed in a coming MSCA-ITN call.