The In Silico World project officially started on January 28th, 2021, with an online kick-off meeting involving all 14 partner institutions that form the international consortium. The project is coordinated by the University of Bologna and funded within the Horizon 2020 research and innovation programme by the European Union.
“The goal of the In Silico World project is to accelerate the adoption of in silico modelling and simulation technologies for the development and regulatory qualification of drugs and medical devices," explains Marco Viceconti (Professor at the Alma Mater Studiorum University of Bologna, Director of the Medical Technology Laboratory at the Rizzoli Orthopaedic Institute and coordinator of the project), "with a long-term impact on reducing the cost and duration of the development and certification processes for new medical products, maintaining or improving the level of patient safety provided by conventional approaches”.
The project will promote the development of 11 in silico simulation solutions designed to assess the safety and/or efficacy of medical devices, drugs and medicines for advanced therapies such as tissue engineering constructs for regenerative medicine.
The 11 solutions target medical products for the treatment of osteoporosis, multiple sclerosis, coronary artery stenosis, brain aneurysms, breast cancer, tuberculosis and SARS-CoV-2 infection (COVID-19).
As these solutions are developed, the consortium will produce data collections for their validation; regulatory pathways and technical standards; regulatory documents and information packs for patients, physicians, corporate executives and so forth; computational strategies to make simulations more powerful and efficient; new curricula to train the workforce in the development and use of technologies for in silico trials; and robust business models for the commercial exploitation of these technologies. All with particular attention to the various legal and ethical implications of such innovative technologies.
The enthusiasm for the start of this new project was widely shared by project partners and guests in the morning session of the meeting. Several participants emphasised the importance of communication in accelerating the adoption of in silico trials, increasing confidence in these innovative technologies, changing the design of clinical trials to include in silico technologies, and consolidating 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 presented two of the 11 solutions in collaboration with the Rizzoli Orthopaedics Institute: BoneStrength, a technology to test in silico new treatments to reduce the risk of bone fractures in patients suffering from osteoporosis, and ForceLoss, a solution to test in silico new pharmaceutical treatments to slow down sarcopenia (i.e. a loss of muscle mass that can cause serious complications, especially in the elderly). In addition to Prof. Viceconti, who is coordinating the project, Prof. Gastone Castellani from the University of Bologna, an expert in medical applications of artificial intelligence methods, and Prof. Maria Grazia Benedetti, director of Functional Recovery and Rehabilitation, and two orthopedic head doctors from the Rizzoli Institute, Prof. Cesare Faldini and Prof. Francesco Traina, will also take part.
The afternoon session concerned cross-cutting activities involving the whole consortium, such as ethical requirements, innovation, and risk management.
Further news on the project development will soon be available on the website at www.insilico.world and on the Twitter account @InSilicoWorld.
ISW Consortium
The In Silico World consortium involves 17 legal entities from six different European member states (Italy, Belgium, The Netherlands, Germany, Poland and Hungary). The consortium comprises seven universities (Alma Mater Studiorum - University of Bologna; Universiteit van Amsterdam; Eindhoven University of Technology; University of Catania; Katholieke Universiteit Leuven; University of Liège; Budapest University of Technology and Economics), three companies (In Silico Trials Technologies SpA; Mimesis srl; RS Print NV), four research hospitals (Rizzoli Orthopaedics Institute; Garibaldi Hospital, Catania; National Institute of Clinical Neurosciences, Budapest; Erasmus Medical Center), one international research centre (Sano Foundation), one non-governmental organisation (VPH Institute) and one standardisation body (DIN, Deutsches Institut für Normung eV).
The project has been funded by the European Union within the framework of the H2020 Call SC1- DTH - 06-2020. The topic of this call is focused on accelerating the adoption of computer simulations for testing drugs and medical devices, to which the EU has dedicated a budget of €6-8 million for the proposal.
