The MOPEAD consortium has proposed a programme of work carefully aligned to the objectives of IMI2 Call to deliver a step-change in AD-related patient engagement (PE) strategies and a paradigm shift in early stage care. It aims to improve patient engagement in three categories: 1) Pre-clinical AD (the most important for prevention trials; 2) Prodromal AD (i.e. MCI with positive amyloid biomarkers); and 3) Very Mild AD. MOPEAD offers four different and complementary strategies, namely AD Citizen-Science, Open House Initiative (OHI), Primary Care Campaign (PCC), and Type 2 Diabetes (T2DM). It seeks subjects eligible for CT scan in all three mentioned categories. The central concept is to test and evaluate the four Patient Engagement models (Runs) to help identify patients at risk of AD in a five-country, multi-centre setting. It builds upon an already successful model, the Open House Initiative pioneered by the coordinator (FACE). Five countries (ES, DE, NL, SE and SL) have been selected to implement these models based upon relevant expertise; the consortium brings together partners for their potential to become long-term assets to European efforts to tackle AD challenges. The methodology involves enhanced pre-screening protocols to select individuals for conventional screening associated to an RCT. Eligible subjects will be invited to formal evaluation using a protocol consensus with EPFIA. MOPEAD possesses confident baseline metrics from which to measure progress and determine the efficacy of PE strategies compared to primary care. Although baseline data exists for only three of the four proposed models, the new model AD Citizen Science approach will add significantly to the holistic approach of the project. The proposal addresses the specific cross-border challenge of improving health care and reducing the economic burden related to AD by means of identifying those patients at risk of developing AD. This will cover a significant gap in the healthcare system.

ConcePTION partners have united around a shared vision that we have a societal obligation to radically and rapidly reduce uncertainty about the safety of medication use in pregnancy and lactation. What do we deliver? ConcePTION aims to create a paradigm shift in how we study medication safety in pregnancy. We will establish (1) a successful, sustainable open-science based EU non-proprietary ecosystem of public and private stakeholders, pregnant women and researchers to generate and disseminate timely and reliable evidence on drugs across maternal, neonatal and long term outcomes of medication exposure in pregnancy and breastfeeding (2) a catalogue with fully characterized data sources for rapid selection of suitable data sources; 3) operational, business, network, information and data governance models, (4) quality assured and tested methodological approaches, analytical tools and data platforms allowing for distributed analyses, (5) procedures and tools for collection of digital data and samples directly from pregnant women, (6) In vitro, in silico and in vivo models for prediction of drug transfer in human milk, (7) a biobank and analytical network for quantification of drug in human milk, (8) best practice documents endorsed by regulators and health authorities and (9) a web-based drug information knowledge bank. How do we deliver? (1) Experienced leaders, able to manage challenging networks and public-public or public-private partnerships. (2) Defragmentation by connecting all key stakeholders and EU networks in this area. (3) Re-use of data, tools and foreground from prior European commission funded projects. (4) Connecting to leaders of similar initiatives in the USA, Canada, Asia and other parts of the world. (5) Systematic consensus & endorsement building. (6) Quality throughout as a precondition to trust the results and information by all users.

GoNano has as its main objective to improve the responsiveness of research & innovation processes to public values and concerns. The project builds on previous projects in public engagement and new technologies to develop a pilot project in each of the nanotechnology research areas ‘Health’, ‘Energy’ and ‘Food’. The pilot projects will engage citizens with researchers, professional users, civil society organisations, industry, and policy makers in a continuous process of deliberative workshops and online consultations to co-create concrete suggestions for future nanotechnologies. GoNano will build a broad community of ‘change agents’ for integrating an ‘RRI way’ of working on research and innovation, and it will develop and disseminate an RRI business case to align public values, needs and concerns with industry’ for profit ambition. GoNano builds on the basic assumption that several types of knowledge are needed to define sustainability, acceptability, and desirability of nanotechnologies, as well as the belief that online and offline engagement activities must be combined with a creative approach to dissemination and communication to ensure continued interest and engagement in the debate on nanotechnologies future application. GoNano believes that its interactive and open approach to: developing the nanotechnology product suggestion; writing policy recommendation and building an RRI business case; informing and educating about nanotechnology as well as the value of co-creation will build trust and mutual understanding among all the stakeholders, including public and private stakeholders and citizens.

HPV-FASTER-Implement aims to improve cervical cancer (CC) prevention. Although human papillomavirus (HPV) vaccination and CC screening programmes have significantly reduced mortality, they have reached a plateau because they remain largely inaccessible and underused by vulnerable populations, creating inequalities in the European healthcare system. This adds to the difficulties already faced by vulnerable populations in their efforts to maintain their mental and physical health. HPV-FASTER-Implement will create a Europe-wide knowledge framework on vulnerabilities and the health challenges they pose, as well as the tools to monitor their evolution. HPV-FASTER-Implement will work with stakeholder representatives, primarily from vulnerable populations, to identify context-specific strategies to deliver combined HPV vaccines and HPV-based CC screening to eligible vulnerable populations, thereby reducing the burden of CC in Europe. HPV-FASTER-Implement will develop health education interventions, communication activities and other services to meet the need of vulnerable population with high risk of CC and inadequate access to health services. Through stakeholder engagement, health literacy promotion, mathematical modelling, implementation research, and vulnerability mapping, we will collect, analyse and share knowledge on gaps and opportunities to improve CC prevention in Europe, and progress FASTER towards CC elimination. We will work to ensure that the data we produce are translated into policy recommendations aimed at strengthening national prevention programmes with interventions tailored to vulnerable populations. In this way, we can leverage limited resources to rapidly reduce CC mortality. We aim to reduce health inequalities by offering an innovative prevention intervention to women at risk, with the hope that 50% of those offered the intervention will take it. HPV-FASTER-Implement will make the necessary improvements to European CC prevention policies.

Polycystic Ovary Syndrome (PCOS) is the most prevalent, chronic endocrine-metabolic disorder of adolescents and young women (AYAs), affecting 5-10% of AYAs worldwide. It is the most frequent cause of anovulatory subfertility. There is no approved therapy for PCOS. Standard off-label treatment with oral contraceptives reverts neither the underlying pathophysiology nor the associated co-morbidities Pilot studies have generated new insights into the pathophysiology of PCOS, and have thus led to the development of a new approach wherein the PCOS phenotype is reverted without side effects. The novel medication is a fixed, low-dose combination of two insulin sensitisers [Pioglitazone (Pio), Metformin (Met)] and one mixed anti-androgen and anti-mineralocorticoid (Spironolactone (Spi)] within a single tablet: SPIOMET SPIOMET4HEALTH will test, in a multicentre Phase II trial, the additive effects of each SPIOMET component, on top of lifestyle measures in AYAs with PCOS. SPIOMET aims at normalising the ovulation rate and endocrine-metabolic status via the reduction of hepato-visceral fat excess, in an early phase of the disorder. This approach is expected to reduce the risk of morbidity (including subsequent anovulatory subfertility), to improve the quality of life, and to lower the economic burden on European healthcare systems. The consortium clusters the experts from key research groups working on PCOS in AYAs, across Europe. The design of SPIOMET4HEALTH foresees that the patients themselves will be engaged over the entire timespan of the project, and will also contribute to the ultimate study evaluation. The update and validation of PCOS-specific Patient Reported Outcome Measures (PROM) will provide the first large-scale evidence on the psychosocial benefits of the tested treatments. The collective evidence from SPIOMET4HEALTH, once completed with economic modelling, will lead to conclusions that inform sound decision-making about PCOS across European healthcare systems.