Universiteit Van Amsterdam (Netherlands) - Technische Universiteit Eindhoven (Netherlands) - Virtual Physiological Human Institute for Integrative Biomedical Research Vzw (Belgium)- SANO Centrum Zindywidualizowanej Medycyny Obliczeniowej Miedzynarodowa Fundacja Badawcza (Poland) - Katholieke Universiteit Leuven (Belgium) - Insilicotrials Technologies S.P.A. (Italy) - Universite de Liege (Belgium) - Erasmus Universitair Medisch Centrum Rotterdam (Netherlands) - Budapesti Muszaki Es Gazdasagtudomanyi Egyetem (Hungary) - DIN Deutsches Institut Fuer Normung E.V. (Germany) - MIMESIS SRL (Italy) - RSSCAN International NV (Belgium)
Paving the way to universal replacement of in vitro and in vivo with in silico
Computer models informed by experimental data enable us to test hypotheses and make predictions, significantly streamlining the research and development cycle relative to trial and error. When it comes to medicine, experimentation relies on biological samples ranging from cultured cells to whole animals, so increased reliance on modelling has additional benefits. Harnessing Big Data and tremendous advances in computing power could pave the way to minimising and eventually eliminating the need for anything other than in silico 'experimentation' in medical research and development. The EU-funded ISW project will bring together a large European consortium and a multi-stakeholder advisory board to lay the groundwork to achieve this goal with attention to the models, regulation, standardisation and more.
The overall aim of the In Silico World project is to accelerate the uptake of modelling and simulation technologies for the development and regulatory assessment of all kind of medical products. This will be achieved by supporting the trajectory of a number of In Silico Trials solutions through development, validation, regulatory approval, optimisation, and commercial exploitation. These solutions, already developed to different stages, target different medical specialities (endocrinology, orthopaedics, infectiology, neurology, oncology, cardiology), different diseases (osteoporosis, dynapenia-sarcopenia, tuberculosis, multiple sclerosis, mammary carcinoma, arterial stenosis, etc.), and different types of medical products (medicinal products, medical devices, and Advanced Therapeutic Medicinal Products). In parallel the consortium will work with a large multi-stakeholder advisory board to form a community of Practice around In Silico Trials, where academics, industry experts, regulators, clinicians, and patients can develop consensus around Good modelling Practices. As the solutions under development move toward their commercial exploitation, the ISW consortium will make available to the Community of Practice a number of resources (technologies, validation data, first in kind regulatory decisions, technical standardisation plans, good modelling practices, scalability and efficiency-improving solutions, exploitation business models, etc.) that will permanently lower barriers to adoption for any future development.