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.

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.

Cervical cancer (CxCa) is caused by high risk types of the human papillomavirus (a.o. HPV16). Prophylactic HPV vaccination is not the standard of care in all European countries, and where approved it is not sufficiently adopted. Once infected, these vaccines no longer prevent premalignant lesions and CxCa, which can only be treated with surgery or radio-chemotherapy. However, this is not effective in recurrent/advanced CxCa. In underdeveloped countries, CxCa is often detected when it is too late for curative treatment. With an estimated global incidence of 500.000 new cases of CxCa and 274.000 deaths per year, the need for an effective therapy is extremely high. Targeted immunotherapy is an effective approach to induce a tumour-directed immune response. Previously, members of the IMMUNISA consortium have formulated ISA101, a cancer vaccine consisting of overlapping synthetic long peptides covering all epitopes of the HPV16 oncogenic proteins. ISA101 has shown promising Phase 1 clinical trial results in patients with advanced CxCa where it works synergistically with chemotherapy. IMMUNISA now proposes the multi-centre randomised Phase 2 CervISA-2 trial; a careful assessment of the efficacy of the proprietary ISA101b therapeutic vaccine in combination with chemotherapy for the treatment of CxCa, measured by a prolonged progression free survival. A multidisciplinary collaboration between leading clinical EU sites specialised in CxCa, a partner providing strategic and operational regulatory service and a cutting-edge biotech SME will enable the optimal implementation of the CervISA-2 trial, exploitation activities and overall project dissemination. This is pivotal to catapult further development of ISA101b as a commercial vaccine and push it towards clinical implementation as fast as possible. For ISA101b, IMMUNISA will provide, 1) clinical data on the efficacy, 2) a solid exploitation strategy and 3) the regulatory framework for efficient translation to clinical use.

Faecal incontinence (FI) is a common condition affecting ~67 million people in Europe, seriously impairing living and productivity of affected individuals and their families. Women with FI arising from childbirth injury may benefit from regenerative medicine using autologous skeletal muscle derived cells (ASMDC) to restore function of damaged sphincter muscle. However, progress is hindered by sub-optimal manufacturing and delivery techniques contributing to inconsistent results. AMELIE proposes an innovative approach that uses ASMDC attached to implantable microcarriers that will enable delivery of a higher number of viable ASMDC into the damaged sphincter muscle, increasing the likelihood of cell engraftment, regeneration of muscle and improved continence. To achieve this, AMELIE will develop bespoke implantable microcarriers suitable for clinical use; establish robust bioprocessing for manufacture of the cell-microcarrier combination; and for the first time, robustly test, in a randomised clinical trial, the principle that delivery of ASMDC in an anchored, natural state, provides more effective and consistent treatment. AMELIE comprises a highly interdisciplinary, gender balanced, consortium of internationally recognised experts and key-opinion leaders with relevant experience from academia and industry across Europe in the fields of engineering (IST, PS, UCL, NHSBT), biological sciences (NHSBT, UCL, IISFJD), and translational regenerative medicine (QMUL, MUG, AUH, AU, RUH, UHE, IISFJD, CVBF). BCR will lead dissemination activity and stakeholder interaction with patients and the public, healthcare professionals, industry and third party FI charities across Europe to establish reciprocal dialogue with people that will interact with the new technology throughout the lifetime of the AMELIE project. TTOP will lead knowledge management and exploitation to develop a marketing strategy and business plan to facilitate future exploitation of the technology to ensure patient benefit.

Prostate Cancer (PCa) is the second leading cause of cancer, among men in Europe. There are currently major unmet needs in this field, such as insufficient knowledge on risk factors that contribute to PCa and on patient characteristics (including genetic profiles) that could facilitate patient stratification. Finally, there is lack of meaningful engagement of all key stakeholders, while the knowledge currently gained from clinical practice and real life data is not being fed back into PCa patients’ care pathways. There is thus a need for better definition of PCa across all stages, improved patient’s stratification at diagnosis, and standardisation of PCa-related outcomes based on real life data. PIONEER’s unique dual approach is to first identify critical evidence gaps in PCa by respected Key Opinion Leaders, and then embark on a research priority setting exercise that reflects the needs of all key stakeholders in PCa management. To achieve this, PIONEER has brought together comprehensive datasets that consists of the most relevant prostate clinical trials and registries, large epidemiological cohorts, electronic heath records, and real-life data from different European (and non-European) patient populations. These unique data sets will be integrated, standardised, harmonised and analysed using approaches that are built on our experience of similar previous IMI projects i.e EMIF, and eTRIKS, and analysed using a unique set of methodologies and advanced analytics methods (OMOP, eHS). PIONEER has already performed a first PCa research priority setting survey, where major stakeholders were asked to identify the current unmet needs in PCa. The five most important open questions will be used as pilot studies to verify PIONEER’s research framework. As such, PIONEER’s deliverables will be outcome-driven, value-based and patient-centric, and relevant to all key stakeholders, as they would have been meaningfully involved from the inception of the project.