PHARMECO is supported by the Innovative Health Initiative Joint Undertaking (IHI JU). The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe. The project's overall objective is to revolutionize pharmaceutical manufacturing towards sustainability by integrating environmentally friendly technologies/processes and harmonized sustainability assessments methods into healthcare industry practices. This encompasses early design phase, operation, and eventual use and disposal. The project's first objective is to enhance the early-stage development of pharmaceutical products by implementing Sustainable-by-Design (SSbD)-driven process-intensified platforms (e.g. continuous manufacturing). This involves designing sustainable processes based on so-called SELECT (Safety, Environment, Legal, Economy, Control and Throughput) criteria and setting up eco-friendly systems for producing small molecules, peptides, oligo-nucleotides, proteins and ribonucleic acid (RNA) with advanced control measures. Next, PHARMECO aims to scale up and demonstrate environmentally-friendly processes for industrial manufacturing and decontamination, which includes creating infrastructure for studying key unit operations with sustainable technology and for SSbD-driven process intensified manufacture at a scale sufficient for clinical testing and a manufacturing process that is easily transferred to a Good Manufacturing Practice (GMP) environment. PHARMECO also aims to steer the development of (bio)manufacturing processes towards sustainable production through digital decision-making tools. This involves creating a modular digital tool for assessing sustainability from multiple perspectives, evaluating practices. Finally, the project seeks to establish a standardized approach for assessing the environmental sustainability of pharmaceuticals, which involves collaboration with various stakeholders to create scientifically robust guidelines, applying consistent Life Cycle Assessment (LCA) methodologies, and facilitate regulatory adoption of standardized LCA practices. By integrating sustainability considerations into every phase of manufacturing, PHARMECO will positively revolutionize pharmaceutical industry.

SYNTHIA is an ambitious collaboration between public and private institutions to facilitate the responsible use of Synthetic Data (SD) in healthcare applications. The project will improve the methodological and technical aspects of SD Generation (SDG) by developing new techniques and advancing established ones for different data modalities, including genomics and imaging, to improve the generation of realistic multimodal and longitudinal data. This project will provide the research community with approaches for transparent benchmarking of alternative SDG methods for specific applications, identify and establish evaluation metrics and methodologies, and contribute to the standardisation of an evaluation assessment framework for SD. Robust evidence of SD applicability in a set of use cases across a broad spectrum of medical conditions will be crucial to demonstrate the potential of SD to accelerate data-driven solutions of equivalent quality to those derived from real patient data. Furthermore, legal and regulatory implications of SD use will be analysed with the aim of delivering an assurance framework to guide secure SD utilization in healthcare. These significant breakthroughs will be implemented through the open SYNTHIA federated platform, facilitating responsible SD use by the health research community. The platform will facilitate users´ long-term access to extensively validated, reusable synthetic datasets, as well as to SDG workflows and SD assessment frameworks. The federated infrastructure will rely on extended open-source frameworks for interoperability with other data-sharing infrastructures in the context of the European Health Data Space. A multidisciplinary collaboration of SDG developers, FAIR data experts, clinical researchers, developers of therapies and data-based tools, legal experts, socio-economic analysts, regulatory, policy advocacy, and communication experts will provide a 360º vision on how to advance healthcare applications through SD use.

Europe generates real world health data (RWD) that has the potential to inform the development and evaluation of medicines and medical devices. However, multiple barriers remain that limit the access, analysis, interpretation, and use of RWD, hampering its use. Additionally, the limited uptake of existing guidelines for the generation and use of real world evidence (RWE) adds complexity in the use of RWD to inform decision making. The GREG consortium will leverage the learnings of previous and ongoing key RWE initiatives to fill these gaps by generating, pilot-testing, and disseminating evidence-based guidance and tools for the use of RWE to inform the development and evaluation of medicines, medical devices, and combinations. To achieve these goals, we will work with key stakeholders to iteratively test and improve our guidance and tools, backed by case studies from previous successful and unsuccessful examples. We will engage with the most relevant European RWE initiatives and access the largest network of RWD partners in Europe, namely the European Health Data and Evidence Network (EHDEN) through our partner, the EHDEN Foundation. Additionally, we will provide multi-stakeholder gatherings (including patient and public representatives) to promote the dissemination, adoption, and implementation of RWE for decision-making in Europe. Our public and private partners will co-create use cases working closely with key regulatory and health technology experts in bespoke fora. These will be used initially to evaluate existing guidelines, and later to pilot-test the GREG guidance and tools. Our outputs will include training for all involved stakeholders on the use of our guidance and tools, and practical templates to facilitate regulatory and health technology/payer submissions. Together, these will accelerate access to better medicines and medical devices for European citizens.

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths. Lung and liver cancers were among the top three leading causes of cancer death in 2020 with 1.8 million and 830.000 deaths, respectively. On the other hand, soft tissue sarcomas are relatively uncommon cancers diagnosed in about 1% of all adults, but much more common in children and young adults, accounting for 7–10% of paediatric malignancies; they are an important cause of death in the 14–29 years age group. Interventional Oncology involves miniaturized instruments (biopsy needles, ablation electrodes, intravascular catheters) and minimally-invasive access, guided by imaging techniques (X-ray, ultrasound, computed tomography, magnetic resonance imaging) – to target cancer with ablative or localized drug delivery strategies. Interventional Oncology can be used as a stand-alone approach, or in combination with the other approaches (‘pillars’) to enhance treatment efficacy. While cancer survival has significantly improved over time through innovations in each individual pillar, our current understanding of cancer now leads us to an intertwining of pillars and multimodal care pathways: Interventional Oncology is uniquely suited to leverage and enhance the effects of the conventional therapy pillars, while reducing the burden on the healthcare system. IMAGIO will leverage Interventional Oncology in the clinical setting to improve the cancer survival outcomes, through minimally invasive, efficient, and affordable care. We will deliver four complete, multimodal care pathways for two of the most aggressive cancers (liver, lung) and one of the most debilitating when treated with current approaches (sarcoma): 1. Multimodal interventional imaging for fast and precise radioembolization therapy of liver cancer; 2. Multimodal ablation therapy of liver cancer; 3. Multimodal diagnosis and therapy in early-stage lung cancer; and 4. Multimodal MR-HIFU-enabled therapy for abdominal sarcoma. IMAGIO will mature the next-generation interventional imaging across the full spectrum, from pre-clinical developments to impact validation in clinical trials. Expertise on Interventional Oncology and immunotherapy will be leveraged from pioneering clinical research centres and leading industry covering the full value chain of oncological care, as well as cancer patient and professional organisations. Such synergetic partnerships will accelerate the impact of the technologies and transform the way healthcare solutions are delivered, providing access to safe, fast, and effective care. By focusing on the local delivery of therapy, IMAGIO will drive the substitution of conventional higher dose systemic alternatives or invasive surgical approaches, thereby accelerating recovery, reducing complication rates and the number of patient visits.

CAREPATH aims to improve chronic disease management and medication persistence by transforming the care ecosystem, ensuring personalised support for better health outcomes, and reducing healthcare costs. We focus on improving medication adherence and persistence for three prevalent chronic conditions: Obesity (BMI ≥ 30 kg/m2), Type 2 Diabetes Mellitus (T2DM), and cardiovascular diseases (CVD), including chronic heart failure (CHF), across six diverse European countries: Germany, Israel, the Netherlands, Poland, Spain, and Sweden. These countries represent various EU healthcare environments and economic statuses, emphasising the need for tailored approaches to patient care. Our strategy involves integrating localised non-digital and digital health solutions to address the unique healthcare delivery challenges in each region. The CAREPATH toolbox collects, combines, and customises existing solutions into adaptable modules for broad application in both primary and secondary care settings. This toolbox will be tested in four studies across two settings in all six countries in both primary and secondary care. Three pilot studies in different regions as well as a proof-of-concept study in Germany will be conducted. This comprehensive evaluation, including HTA, aims to assess the toolbox's implementation and effectiveness, with a strong focus on learning what works for what groups of patients in which setting. Recognizing the significant impact of obesity, particular emphasis is placed on treatment adherence and persistence of medications that facilitate weight loss, such as dual GIP/GLP-1 receptor agonists, but CAREPATH studies also include patients using lipid-lowering drugs, insulin, and SGLT2 inhibitors. Our goal is to empower patients by improving communication and data sharing among patients, healthcare providers, and other stakeholders, thereby supporting the entire ecosystem and alleviating the burden on healthcare systems.