In the first five years of operations, EATRIS has shown strong proof of concept of the value of the services portfolio, with users ranging from academia, SMEs, large pharma, to biotech and research funding organisations. The overarching aim of EATRIS-Plus is to support the long-term sustainability (LTS) of EATRIS by delivering innovative scientific tools to the research community, strengthening the infrastructure’s financial model and reinforcing EATRIS leadership in the European Research Area (ERA), particularly in the field of Personalised Medicine (PM) research and development. Specific objectives are: (i) To consolidate EATRIS capacities in the field of PM to better serve academia and industry and augment the number of EATRIS Innovation Hubs with large pharma; (ii) To further strengthen the LTS of EATRIS financial model; (iii) To drive patient empowerment through active involvement in the infrastructure’s operations; (iv) To expand strategic partnerships with Research Infrastructures and other relevant stakeholders. The proposal relies on a scientific and technological programme combined with capacity-building activities across 16 EU countries, with the support of two umbrella organisations representing patient organisations and SMEs. EATRIS-Plus will help pooling and exploiting the translational academic capacities of the infrastructure in omic technologies to enable researchers to better address the scientific and societal challenge of PM. Additionally, the coordination office and 13 existing national nodes of the infrastructure will participate in implementing joint outreach, training, industry engagement and international collaboration activities to further build national capacity, increase users’ trust and strengthen EATRIS and the ERA global scientific leadership.

BackgroundTranslational research and medicines development refers to the translation of basic scientific discoveries into clinical applications such as new therapeutic, diagnostic or preventive products. Translational research and medicines development thus lays at the foundation of any improvement of human health and quality of life, and is a motor for growth and innovation. In order to be successful in this field, professionals need to be aware of all stages and research disciplines and also understand the various roles played by academia, industry and regulatory authorities. The multidisciplinary, multi-sectorial and transnational nature of translational medicines underlines the need for a defined set of skills and qualifications which learners and professionals can rely on to move freely between different labour markets and countries. ObjectivesThe objective of C-COMEND is to bring together players from different sectors and disciplines in order to develop curricula and provide a course aimed at PhD students and early Post-Docs, teaching the skills and competencies required to successfully contribute to translational research and medicines development. To ensure that the course indeed teaches the right skills and is relevant for the labour market, be it in academia, industry or the regulatory field, the course curriculum will be based on a competency profile developed during the project. The course will be delivered as a blended course, where the face-to-face course is preceded by e-learning to bring learners to the same level of understanding, thus allowing more in-depth discussion during the face-to-face course. The project aims at delivering the courses to a broad target group. The face-to-face course will therefore be offered twice during the project lifetime with 15 participants for each course from project partners and 15 from participants outside the consortium. The e-learning module will be made accessible to all biomedical students and professionals in Europe and worldwide.Participants: The consortium consists of 5 partners: 2 higher education institutes, 1 research institute, 1 research infrastructure and 1 e-learning provider and developer.ActivitiesThe methodology to develop the courses is the ADDIE principle. ADDIE stands for the steps needed to prepare an effective learning session and which will be implemented in this project accordingly: 1) During the Analysis phase, the project will develop a competency profile for students and professionals in translational research and medicines development. Competency provides a shared ‘currency’ applicable to learning of all types and at all career stages. The profile will include not only the scientific competencies but also competencies in transversal skills and entrepreneurship. The profile will be complemented by a competency portfolio where participants can document the new competencies plus the competencies they already acquired during previous formal, informal and non-formal learning, to support the recognition of their competencies. 2) During the Design Phase, the consortium will design and document the curricula for courses based on the competency profile. The curriculum will apply multi-competency training wherever possible. This will include student presentations of their projects, which will teach the latest scientific developments but also improve their presentation skills. 3) During the Development Phase, the course content will be designed including learning methods which promote the transfer of course content into observable competencies and cater for different learning styles. 4) The Implantation Phase will consist of the implementation of the e-learning module and the face-to-face courses. 5) The feedback of the Evaluation Phase will be used to optimise the 2nd delivery of the e-learning and face-to-face course.In addition to the curricula, courses, the competency profile and a scientific publication, the project will deliver a Business Plan describing how the face-to-face and e-learning courses can be maintained in a way that enables a broad participation and reduces the costs for participants. The envisaged impacts are• Enhanced quality and increasing labour market relevance of learning provision via the developed curricula based on a competency profile• Improving career opportunities of course participants• Fostering the interaction between research, education and innovation • Services available to a broad audience • Support of mobility (between countries and public & private sector)Longer term benefits• Delivery of competencies ensuring the European competitiveness of Medicines Development;• Sustainable contribution to strategic planning of professional development via a publically available competency profile• Increased number of scientific ideas turned into innovative products bringing growth and jobs to the European economy.• Improvements in public health due to better trained professionals

The European Rare Diseases Research Alliance (ERDERA) aims to improve the health and well-being of the 30 million people living with a rare disease in Europe, by making Europe a world leader in Rare Disease (RD) research and innovation, to support concrete health benefits to rare disease patients, through better prevention, diagnosis and treatment. This Partnership will deliver a RD ecosystem that builds on the successes of previous programmes by supporting robust patient need-led research, developing new diagnostic methods and pathways, spearheading the digital transformational change connecting the dots between care, patient data and research, while ensuring strong alignment of strategies in RD research across countries and regions. Structuring goal-oriented public-private collaborations targeted at interventions all along the R&D value chain will ensure that the journey from knowledge to patient impact is expedited, thereby optimising EU innovation potential in RD. To support its ambition and missions ERDERA has been designed as a comprehensive and integrated ecosystem of which structure can be compared to an institute encompassing three main parts: (i) funding, (ii) internal (in house) Clinical Research Network that implements research activities targeting clinical trial readiness of RDs and accelerating diagnosis and translation of research discovery into improved patient care, and (iii) related supporting services (Data, Expertise, Education and Training) as well as an acceleration hub that serve external and internal RD community, all supported by all-embracing coordination and strategy and foundational (inter)national alignment.

canSERVs mission is to make cutting-edge and customised research services available to the cancer research community EU wide, enable innovative R&D projects and foster precision medicine for patients benefit across Europe. By connecting, coordinating, and aligning existing oncology and complimentary research infrastructures (RIs) and providing services in a synergistic way transnationally, canSERV will capitalise on the critical mass of experts and cutting-edge services offered by canSERVs RIs and their extended network. canSERV brings together world-class European life science RIs (BBMRI, EURO-BIOIMAGING, ELIXIR, EU-IBISBA, EuroPDX, EU-OPENSCREEN, INSTRUCT, EATRIS, INFRAFRONTIER, EMBRC, ECRIN, EATRIS, MIRRI, ARIE, CCE, EORTC and IARC) that collectively not only covers all aspects along the development pipeline for oncology, but is also capable of interconnecting these technologies providing users a guidance for navigating them through the entire translational value chain. A patient organisation or resp. governance board members wil bring the patients perspective, while the two SMEs, ARTTIC and ttopstart, will provide valuable input regarding stakeholder engagement, and project management activities. A common access management system (CAMS) will be developed based on mature solutions from INSTRUCT and BBMRI. The CAMS will provide a method for selection of services, construction and submission of research proposals, multi-step review of research proposals, and tracking of the access process from approval through delivery to conclusion. Through a united user-intuitive transnational access where a united catalogue of oncology services will be offered, our users will have access to a comprehensive service portfolio. As our ambition is to scale up canSERV to a pan-European collaboration of RIs for accelerating the development and implementation of solutions for the cancer patient community, the sustainability of this network beyond the end of the project will also be addressed.

EU-PEARL has the ambition of transforming the current approach of conducting single-compound clinical trials into the use of cross-company Integrated Research Platforms (IRPs), taking into consideration both patients’ interests and the opportunities from novel molecules for addressing medical needs. Patient-centric data and knowledge sharing have the potential to accelerate the development of new treatments and reduce the operational costs of clinical trials. EU-PEARL will improve clinical effectiveness, patients’ satisfaction and societal access to timely and affordable medicines and it will shape the clinical trials of the future. This will change the industry paradigm from competition to cooperation in four disease areas and provide the framework for designing IRPs in other disease areas. The main objectives of EU-PEARL are: (1) To create a reusable, accessible and sustainable modular IRP for the design and execution of patient-centric, cross- company IRP in any disease area with unmet needs; (2) To set up the open, dynamic, patient inclusive IRP governance structure that will manage the appropriate regulatory, ethical, legal, statistical and data utilisation requirements of the IRP; (3) To disseminate and exploit the EU-PEARL paradigm through the provision of the necessary common tools, procedures, expertise and operational skills working to the highest scientific, regulatory and ethical standards and best practices, developed jointly by public and industry partners in a consensus-based approach; and (4) To create trial-ready IRP networks in the four disease areas of Major Depressive Disorder (MDD), Tuberculosis (TB), Non-Alcoholic Steatohepatitis (NASH) and Neurofibromatosis (NF).