EP PerMed is a new European Partnership dedicated to Personalised Medicine (PM). It supports PM-related R&I, but also facilitates and accelerates all steps so that PM achievements successfully pass through the full value continuum to be implemented in sustainable health systems for the benefit of people and societies. The partnership will foster demonstration projects and promote successes and lessons learned to demonstrate evidence of PM implementation. EP PerMed activities cover overarching aspects, like patient involvement, exchange with medical societies, infrastructures and international and regional collaboration. The project portfolios of EP PerMed and ERA PerMed (ERA-Net co-fund on PM) and others are supported to become successful innovations in healthcare practice. EP PerMed will be the global PM-platform for scientific and strategic dialogue and alignment, resulting in public documents and publications. Accordingly, it will inform the public, patients, healthcare providers or payers about the latest PM options and engage them. The Strategic Research and Innovation Agenda for Personalised Medicine (SRIA for PM, 2023), developed by EP PerMed partners, is the basis for the partnership's structure and a wide range of its activities. All steps of the SRIA development were strongly support by numerous PM-experts, stakeholders and the European Commission (EC). Thus, the EP PerMed annual Joint Transnational Calls (JTCs) and other funding and activities, events and tools will be in line with the SRIA and outputs will feed into a SRIA update in the coming years. The partnership builds on several developments, initiatives and projects such as ERA PerMed, ICPerMed and its supporting projects (“ICPerMed Family”) funded by the EC. In parallel, it reaches out to the 1+Million Genomes Initiative, other European Partnerships in the Health Cluster and infrastructures like the European Strategy Forum on Research Infrastructures (ESFRI).

The aim of the “European network staff eXchange for integrAting precision health in the health Care sysTems (ExACT)” is to train a new generation of professionals that can contribute to the future of health and healthcare (HC), by providing high-quality, multidisciplinary knowledge in precision health. The greater personalisation of HC is a driver of innovation for research, and for the healthcare system and industry. Still policy makers, HC professionals, citizens, and private companies need to take some steps to realize its potential. In order to harness this challenging landscape, the ExACT consortium provides a cohesive framework for training staff across 7 EU Countries, 1 AC and 2 TCs. During 4 years, the staff involved will be trained on research topics not available at the home institutions thanks to 74 secondments. They will attend courses, workshops, seminars, conferences, and will participate in organizing outreach activities, thus acquiring new skills. Research topics include: Integration of Big Data and digital solutions into the HC systems; Designing and promoting innovative citizen engagement models; Education of healthcare professionals and leadership; Health Technology Assessment in precision health; Ethical-legal, social, organisational and policy issues surrounding precision health. ExACT is embedded in existing cooperation structures, such as the RISE-PRECeDI project, IC PerMed, and CSA TO-REACH. The consortium consists of 14 beneficiaries and 2 partners, of which 10 are academic institutions including Stanford University where a precision health program has been launched, and 7 non academics including 2 SMEs. The participants will produce key reports, policy recommendations, scientific publications, and information materials for citizens, thus fostering public-private interactions. In the long run, ExACT will foster the integration of precision health in the EU HC systems, thus contributing to better health for Europeans citizens.

Context and background of the project:For a rational use of healthcare technologies, their potential value and impact need to be explored. Health Technology Assessment (HTA) provides a systematic evaluation of the properties and (in)direct effects of healthcare technologies to inform decision making. Currently, HTA involves the assessment of safety, clinical effectiveness and cost-effectiveness, and sometimes ethical, legal, organisational and social issues associated with healthcare technologies. These issues are addressed separately from each other as distinct and potentially relevant aspects that need to be taken into account in determining the value of healthcare technology. A limitation of this approach is that it draws a sharp distinction between empirical inquiry on the one hand, and normative inquiry on the other. Such distinction cannot, however, be sustained. The relevance of empirical inquiry into different aspects of healthcare technologies, such as its safety and effectiveness, is derived from a commitment to certain values (e.g. avoiding harm). At the same time, normative inquiry, for instance asking whether a particular treatment respects a patient’s autonomy, necessarily draws on acquaintance with relevant facts. Hence, a new approach towards HTA is needed, one that allows for integration of empirical analysis and normative inquiry. This approach should help the new generation of HTA practitioners to explain to a wider audience how normative commitments give rise to specific empirical inquiry. By explicitly placing empirical inquiry in the context of normative commitments, the VALIDATE approach also offers a means to involve all relevant stakeholders in HTA in a more structural and effective way, i.e. from the start. For students of HTA, it means that they need to familiarize themselves more deeply with concepts and methods that have been developed in the fields of policy sciences and ethicsThe objectives of the VALIDATE project were to develop a new approach towards HTA which allows for the integration of empirical analysis and normative inquiry, developing associated teaching materials and providing opportunities for internships to apply the approach in HTA practice. To this end, a consensus statement was developed, defining the sort of knowledge and skills that are required to conduct this novel type of integrative HTA. Based on the consensus statement, an e-learning course and handbook were developed to educate HTA practitioners in conducting an integrative HTA. Students who successfully completed the e-learning course were offered the opportunity to practice their newly obtained knowledge and skills in internships. Experiences and learning achievements of students were captured in order to further improve the format and content of the teaching materials.Number and profile of participants:Master students, PhD candidates and young professionals in HTA participated by testing and completing the e-learning course, providing feedback on the handbook, and conducting internship projects offered by the partner institutes. In total, 60 participants from 12 different European countries were enrolled in the e-learning course. Twelve participants, from 4 different European countries, completed an internship project. During workshops and panel sessions at the annual meeting of HTAi, over 500 experts from the HTA community (e.g. students, policy makers, HTA researchers, clinicians, industry and patient representatives) were introduced to VALIDATE.Results and impact:All project objectives have been achieved. A consensus statement was developed and published on the project website. Based on this statement, a completely new e-learning course on integrative HTA has been developed, containing text, videos, intermediate assignments, a discussion board, and a final assignment. The e-learning course is freely available on the project website, and has been reviewed and accredited by HTA international (HTAi), the global professional society of HTA. In addition, a handbook containing eight chapters, addressing different aspects of an integrative approach towards HTA has been written and published on the project website. In total, four scientific papers on the VALIDATE project have been submitted to peer-reviewed journals. Finally, the VALIDATE project has been presented at various international meetings.Longer-term benefits:The project results will remain freely available at the project website. Ultimately, these outputs should result in a shift in people’s thinking about the added value of HTA. This would mean a shift from a strong focus on clinical effectiveness and health economics towards an inquiry that brings more clearly the underlying values into view and that admits for a more constructive role for stakeholders in the process. Clearly, for such a shift to take place, more time and sustained efforts are needed. The VALIDATE consortium is committed to continue making those efforts.

Health and care systems in Europe are facing core common challenges, which require harmonised and coordinated solutions. The European Partnership on Transforming Health and Care Systems (THCS) represents a unique strategic opportunity to bring together stakeholders, create synergies, coordinate Research and Innovation actions, facilitate the digitization of health and care services and support the transformation of health and care systems with innovative solutions driven by knowledge and evidence. The general objective of THCS is to contribute to the transition towards more sustainable, efficient, resilient, inclusive, innovative and high-quality people-centred health and care systems equally accessible to all people. For this purpose, THCS aims not only to create new knowledge and scientific evidence but to co-design new solutions and support their transfer and scale-up across countries and regions while also fostering capacity building. The approach for a successful and smooth implementation of THCS will focus on three main work streams: 1) Filling the knowledge gaps with research actions aiming at providing the necessary evidence, 2) Implementation and transfer aiming at supporting actions focusing on the testing of existing solutions and adaptability in different national and regional contexts, and 3) Boosting health and care systems through dedicated activities (capacity building and trainings, study visits, technical assistance, twinning, networking) involving different health and care stakeholders. To address these three work streams, THCS is built around four pillars that group different types of activities addressing different types of stakeholders of the health and care system. The activities are organised in ten Work Packages working closely together to achieve the objectives of the Partnership and clustered in the four Pillars.

Society and clinical practice pose a growing demand on novel biomaterials, ICT, micro and nanotechnologies for innovative medical devices and in vitro diagnostics (Medical Technologies-MTs). In addition to the challenge of time, the new technologies are subjected to other pressing factors such as qualification, regulation, cost, biocompatibility and the need to be applicable worldwide. In the most recent years it is obvious that nano-enabled MTs can be applied in nearly every medical area, with a major presence and increased importance in cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopaedics, and dentistry. On the other hand, any innovation in the Health sector has to be carefully assessed in terms of risk/benefit ratio. Nano-enabled MTs particularly require careful assessment, since they are complex products group and their technological assessments are still under development. This assessment will be a key pillar for the here proposed Open Innovation Test Bed (OITB) To address all the aforementioned challenges, the SAFE-N-MEDTECH consortium aims to bring a strong and competitive cooperation to compete in the market for a coordinated OITB for nano-enabled MTs. SAFE-N-MEDTECH will build an innovative open access platform to offer to companies and reference laboratories, the capabilities, knowhow, networks and services required for the development, testing, assessment, upscaling and market exploitation of nanotechnology-based Medical and Diagnosis Devices. This across the whole Life Cycle. This OITB will offer a multidisciplinary and market oriented innovation approach to SME´s, Healthcare providers and Industries for the translation to the market of MTs, based on a deep understanding and knowledge of the material-nanoproperties, their advance use and applications in MTs and other aspects involved in MTs safety (electric compatibility, electromagnetic properties, etc).