The In Silico World project, coordinated by the University of Bologna and funded by the European Union’s Horizon 2020 research and innovation programme, officially started on the 28th January 2021 with an online kick-off meeting that saw the participation of all 14 partner institutions, including the VPHi.
“The aim of the In Silico World project is to accelerate the uptake of modelling and simulation technologies for the development and regulatory assessment of medicines and medical devices – explains Marco Viceconti, Professor at Alma Mater Studiorum University of Bologna and coordinator of the project – with a long-term impact of reduction of the cost and duration of the development and regulatory assessment of new medical products, while maintaining or improving the level of safety provided by conventional approaches”.
The project will further the development of 11 solutions for in silico trials, designed to test the safety and/or the efficacy of medical devices, medicinal products, and even advanced therapy medicinal products such as tissue engineering constructs for regenerative medicine. The 11 solutions will target medical products to treat osteoporosis, tuberculosis, multiple sclerosis, coronary stenosis, cerebral aneurysms, mammary carcinoma, and covid-19 infection, among the others. As these solutions are further developed, the consortium will produce data collections for validation, regulatory pathways and technical standards; policy documents and information packages for patients, doctors, senior management in companies, etc.; computational strategies to make such simulations more powerful and efficient; new curricula to educate the workforce on the development and use of in silico trials technologies; and robust business models for the commercial exploitation of these technologies. All with focused attention to all legal and ethical implications of such disruptive technologies.
The enthusiasm for the beginning of this new project was generally shared by all partners and guests in the morning session. Various speakers highlighted the importance of communication in accelerating the adoption of in silico trials, by increasing the trust in these innovative technologies, changing the design of regulatory trials to include in silico technologies, and consolidating the regulatory pathways based on in silico trials.
After the lunch break, a more technical session introduced the role and work trajectory of each partner. The VPHi presented the activities it will be responsible of that mainly focus around dissemination, communication, and Responsible Research & Innovation (RRI). RRI, in the specific, aims to identify and address social and ethical barriers throughout the innovation process, so as to enhance the societal embeddedness and responsiveness of innovations.
Last afternoon session dealt with horizontal activities that involve the whole consortium, such as the ethics requirement, innovation and risk management and dissemination.
More news on the project development will be soon make available on the project website, which will be published at www.insilico.world and on the Twitter account @InSilicoWorld [https://twitter.com/InSilicoWorld]