The launch of a novel drug to the market is preceded by clinical testing and validation both on animal in vitro and in vivo models. Animal models used in drug development have known methodological drawbacks leading to the failure of drugs. Further, animal tests are associated with ethical issues. Moreover, a strong bias in in-human testing still overlooks major population groups e.g. children, women, different ethical groups. It is estimated that 197,000 deaths per year in the EU are caused by Adverse Drug Reactions (ADRs) and the total cost to society of ADRs is €79 billion. The emerging Organ-on-Chip (OOC) field, an alternative to animal test, brings great potential for safe testing and validation: An OOC-systems consists of a 3D-microstructured channel network embedded on a small plastic device that simulates the mechanics and physiological response of an entire organ or organs. Project UNLOOC will develop, optimize, and validate a multitude of ECS-based tools to build OOC-models to replace animal and in-human testing. UNLOOC aims to combine three important characteristics for routine use of OOC models, i.e platforms that combine ECS-based technologies with established biological material, capitalize on AI, parallelized test set-ups allowing efficient high-throughput demands, and standardized procedures enabling reliable results. UNLOOC will develop ECS-based hardware and software tools and validate them in five Use Cases (UCs) performed in 10 European countries. The applications developed and validated will be used by academia and pharma industry to drive drug development, create cosmetics without animal test, personalized medicine and gain new insights into disease. Given the large OOC market, these solutions have great economic value, on average it would result in cost reduction of up to $169M and $706M per new drug reaching the market and will put Europe at the forefront of this booming research field (see impact section for details).

Patients with cancer often have to make complex decisions about treatment, with the options varying in risk profiles and effects on survival and quality of life. Data-driven decision-support tools (DSTs) have the potential to empower patients, support personalized care, improve health outcomes, and promote health equity (optimal decisions also for underserved groups). However, DSTs currently seldom consider quality of life or individual preferences, and their use in clinical practice remains limited. To address these challenges, the 4D PICTURE consortium will further develop a promising methodology, MetroMapping, to redesign care paths that include novel DSTs. We will better predict treatment outcomes by developing innovative algorithms and incorporating patient experiences, values and preferences, using AI-based models. In co-creation with patients and other stakeholders, we will develop data-driven DSTs for patients with breast cancer, prostate cancer and melanoma. We will evaluate these DSTs as part of MetroMapping as well as stand-alone, to ensure their sustainability as well as addressing social and ethical issues. We will explore the generalizability of MetroMapping and the DSTs to other types of cancer and across other EU member states. Improved care paths integrating comprehensive DSTs will empower patients, their significant others and health care providers in decision making, and strengthen care at the system level by improving resilience and efficiency. Whereas the 4D PICTURE consortium includes leaders in modelling, AI, decision making, citizen science, service design, ethics, risk communication, and policy making, this project will impact clinical practice and science across Europe and beyond.

VASTO Proof of Concept aims to develop and test an innovative microfluidic-based platform, which allows to evaluate the efficacy of different cell immunotherapy strategies against solid tumours. For this aim, we propose to microfabricate 3D solid tumour organoids with an aberrant microvascular network provided from the explant of human vessels. Although there are other different vessel-on-a-chip and/or microvascular network formation approaches that use in vitro cell monolayers, we are not aware of any solution covering human ex vivo blood vessel platform as it is proposed here. Therefore, we aim to recreate the existent mechano-chemical barriers characteristics of the tumour microenvironment in solid tumours with this novel ex vivo platform. With this technology, we can define a method to evaluate the efficacy of different immunotherapy-based strategies. Specifically, we focus on studying the effectivity of different Chimeric Antigen Receptor (CAR)-T cell therapies in solid tumours. Hence, the development of VASTO harbours the interest of CAR-T manufacturers to test these cell therapies against solid tumours. We will be able to asses CAR-T cell vascular extravasation, penetration into solid tumours and the CAR-T efficiency for tumour elimination. In addition to its applicability to liver cancer, the acquired knowledge in VASTO also could be extrapolated to any other kind tumours, but also in the development of an ex vivo platform for research in regenerative processes, by incorporating organoids from healthy donors, instead of malignant cells, and promoting functional vasculature, instead of aberrant one. Therefore, this human ex vivo platform will launch a new product to the market very attractive for clinical labs and companies, reducing animal experiments and providing a more reliable alternative for testing different therapies against tumours and approaching a more personalized patient-like model.

Compared to the pace of innovation in electronic consumer products, the pace of innovation for medical devices is lagging behind. It is the overarching objective of Moore4Medical to accelerate innovation in electronic medical devices. Moore4Medical emerging medical applications that offer significant new opportunities for the ECS industry including: active implantable devices (bioelectronic medicines), organ-on-chip, drug adherence monitoring, smart ultrasound, radiation free interventions and continuous monitoring. The new technologies will help fighting the increasing cost of healthcare by: reducing the need for hospitalization, helping the development of personalized therapies, and realizing intelligent point-of-care diagnostic tools. Moore4Medical will bring together 68 specialists from 12 countries who will develop open technology platforms for these emerging fields to help them bridge “the Valley of Death” in shorter time and at lower cost. Open technology platforms used by multiple users for multiple applications with the prospect of medium to high volume markets are an attractive proposition for the European ECS industry. The combination of typical MedTech applications with an ECS style platform approach will enhance the competitiveness for the emerging medical domains addressed in Moore4Medical. With value and IP moving from the technology level towards applications and solutions, defragmentation and open technology platforms will be key in acquiring and maintaining a premier position for Europe in the forefront of affordable healthcare

BACKGROUNDSurgery is indicated to cure or palliate numerous physical ailments; however, it represents a major stress that often leads to adverse effects unrelated to treatment objectives that have profound negative impacts on the capacity to perform activities of daily living, subsequently impairing quality of life. In addition, the longer the hospitalization time of the patient, the greater the cost to the health system. Besides, the increasing demand for major surgery in high risk patients requires new improvements that must include a specific evidence-based approach per procedure.Multimodal surgical rehabilitation, also known as Enhanced Recovery After Surgery (ERAS), entails the application of a series of perioperative procedure measures and strategies aimed at patients who are going to undergo a surgical procedure with the objective of reducing secondary stress caused by the surgical intervention and thus achieve enhanced recovery of the patient and decrease complications and mortality. ERAS protocols are care programs based on scientific evidence, encompassing all aspects of patient care and requiring multidisciplinary management, with the participation of diverse specialists. Starting at the diagnosis, their aim is to recognise patients’ individual needs to optimise their treatment before, during and after surgery. The close collaboration of all specialists participating in the process, as well as of the actual patients and their relatives has proved to be essential.Despite general consensus and clinical evidences supporting ERAS, their full implementation is difficult because peri-operative management is still strongly linked to conventional practices with various groups of professionals.OBJECTIVESThe goal of the EUPEMEN project is to bring together the expertise and experience of national clinical champions who have previously helped to deliver major change programmes in their countries and to use them to spread these ERAS protocols in Europe. This main goal will be achieved with the next specifics objectives:-Preparation of an educational project.-Implementation in a significant number of European hospitals the evidence-based ERAS protocols in a homogeneous and standardised way. -Collection data about hospital stay, morbidity and mortality of European Surgical patients to better know the surgical risk of an individual patient, hence to prevent perioperative complications.PARTICIPANTSIn order to implement the ERAS at hospitals in Europe, 5 partners with health and university profile of 4 different EU countries have created the EUPEMEN project. The 5 partners are leading organisation in development of ERAS protocols.The target groups involved include not just the health professionals who are directly in charge of the care of surgical patients (surgeons, anaesthetists, and nurses), but also all those professionals who, in some way or another, are related to the interdisciplinary treatment of these patients, such as nutritionists, stoma-therapists, physiotherapists, rehabilitators, digestologists, radiotherapists, oncologists and pathologists. As effectiveness (reduction of hospital stays and optimisation of the use of other resources) is one of the advantages of these programmes, health centres administrator, clinical managers and quality coordinators will also benefit from the project. Finally, due to the characteristics of ERAS, primary care physicians and patients play a very active role too.ACTIVITIES & METHODOLOGY1-Preparation of an ERAS manual with the protocols of 6 different modules (Multimodal Rehabilitation Bariatric Surgery, Oesophageal Surgery, Gastric Cancer Surgery, Colon Surgery, Urgent abdominal surgery, Hepatobiliary Surgery) to be followed by all the target group.2-Learning teaching training to teach the future teachers the different protocols to be able to teach them in the different hospitals 3-Development of the EUPEMEN online platform: to host the e-learning training course and a collaborative area to improve and to participate in the ERAS protocols.4-Dissemination of the results in 5 Multiplier events.5-4 transnational meetings.RESULTS & IMPACTS-Development of ERAS Protocols Training Programme for health professionals.-Training to multidisciplinary professionals (200): all the direct target groups involved in perioperative procedure.-Implementation of the Enhanced Recovery Programmes in, at least, 5 hospitals in Europe.-Creation of a professional net with capacity to train stakeholders in hospitals, and to audit the trainers in order to guarantee the correct implementation of the programme.Long-term effect:-Decrease the secondary effects after surgery for patients, consequently, with a faster patient recovery.-Reduce morbidity and mortality caused after surgeries.-Reduce the length of stay (LOS) in the hospital and, consequently, saving money for the public health system and to have more free beds for other new requested patients.