“In Silico World”: a brave new world of in silico trials kicks off across Europe
The In Silico World project, coordinated by the Alma Mater Studiorum – Università di 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 involving all 14 partner institutions that constitute the international consortium.
“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 of the kick-off. 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 Alma Mater Studiorum, in collaboration with the Rizzoli Orthopedic Institute, presented two of the 11 solutions: BoneStrength, a technology to test in silico new treatments to reduce the risk of bone fractures in patients with osteoporosis, and ForceLoss, a solution to test new pharmaceutical treatments in silico to slow down sarcopenia, the loss of muscle mass that can cause severe complications, especially in the elderly. In addition to Prof Viceconti, who coordinates the project, Prof Gastone Castellani, expert in medical applications of artificial intelligence methods, and on the Rizzoli side Prof Maria Grazia Benedetti, head of physical and rehabilitative medicine, and two orthopedic head physicians, the Prof Cesare Faldini and Prof Francesco Traina will take part in the project.
The last session of the afternoon dealt with horizontal activities that involve the whole consortium, such as ethics requirement, innovation and risk management and dissemination.
The In Silico World consortium sees the participation of 17 legal entities from six different European member states (Italy, Belgium, The Netherlands, Germany, Poland, and Hungary). The consortium includes seven universities (Alma Mater Studiorum – Università di Bologna; Universiteit van Amsterdam; Eindhoven University of Technology; Università degli Studi di Catania; Katholieke Universiteit Leuven; University of Liège; Budapest University of Technology and Economics), three companies (In Silico Trials Technologies S.p.A.; Mimesis srl; RS Print NV), four research hospitals (Istituto Ortopedico Rizzoli Bologna; Garibaldi Hospital, Catania; National Institute of Clinical Neurosciences Budapest; Erasmus Medical Centre), an International research centre (Sano Foundation), a non-governmental organisation (VPH Institute), and one standardisation body (DIN, Deutsches Institut für Normung e.V.)
The project was funded by the EC under the H2020 Call SC1- DTH – 06 -2020. The topic of this call is focused on accelerating the uptake of computer simulations for testing medicines and medical devices, to which the EC dedicated a budget of € 6-8 M for proposal.
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