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.

Immune cells that are empowered by gene-engineering to seek and destroy cancer cells (engineered T cell therapy) constitute a transformative novel treatment that has the potential to cure cancer. Multiple new versions of this therapy are being developed for distinct types of cancer but their introduction into clinical practice is hampered by a lack of standardized and validated models to predict safety and efficacy, customized manufacturing and monitoring to scale up production and clinical use to industry standard, and strategies for optimal patient conditioning. The T2EVOLVE consortium unites scientists and physicians, regulators and policy makers, SMEs, and patient stakeholders to tackle these challenges in an orchestrated multi-disciplinary multi-stakeholder approach. A core feature of this approach will be the embedding of patient stakeholders as contributing members of the team across all levels of the R&D process. The overall aim is the development of an innovation ecosystem that will accelerate the process of developing engineered T cell therapy in the EU. The project will deliver novel tools for education and for improving the communication between healthcare providers and patients, optimized laboratory models that can help determine how safe and effective new therapies with engineered T cells are, standardized methods in which these therapies are produced and monitored during treatment. The consortium members are innovators and pioneers in this field that are dedicated to bringing the EU to the forefront of the global engineered T cell therapy movement. This effort will ensure that EU citizens will continue to have access to the most innovative and best-available medical care, provide guidance on how to implement this novel treatment into the EU health care system in a sustainable way, and secure a leading role for Europe in this emerging field in medicine and science, the economy and society.