“In Silico World: Lowering barriers to ubiquitous adoption of In Silico Trials” is a collaborative project funded by the European Commission (EC) in the frame of the Horizon 2020 programme. It aims at accelerating the uptake of modelling and simulation technologies used for the development and regulatory assessment of medicines and medical devices by lowering seven identified barriers: development, validation, accreditation, optimisation, exploitation, information, and training.
The project started in January 2021, and in this time, we accumulated many individuals and institutions following our work with interest as they see its potential to impact the future of In Silico Trials.
Here are some of our more interesting achievements.
In ISW, we are further developing eleven in silico trial solutions for the development of drugs, medical devices, or Advanced Therapeutic Medicinal Products (ATMPs) targeting different medical specialities, such as orthopaedics, cardiology, neurology and oncology. BBCT-Hip, UISS-TB, InSole and UISS-MS, the most mature solutions at the start of the project, are or will soon be available through commercial partners as pre-regulatory tools.
We are working to produce seven publicly available validation data collections: HipValid, StentValid and TBValid are already available on Zenodo and we expect all planned collections to be ready before June 2024.
Technical standards and regulatory barriers
The project underwent an in-depth analysis of the ethical and legal aspects of in silico trials. We published a second report summarising the main legal challenges surrounding in silico EU trials. There, we summarised how data protection barriers impact data sharing healthcare, the standardization shortcomings in the regulatory system for medical devices and medical technologies, and the future challenges that artificial intelligence regulation could entail for scientific research.
A considerable effort has been spent exploring the regulatory barriers and finding ways to lower them. We completed the first Qualification Advice with EMA for BBCT-Hip, and plan to complete the second for UISS-TB before the end of 2023. The “Towards Good Simulation Practice” consensus report has now been finalised, and we expect it to be published by Nature-Springer as an open-access book in early 2024. Thanks to our activities, the IEC-ISO has started a new workgroup to develop a technical standard on the credibility assessment of predictive models to develop medical products, consistent with the ASME VV-40:2018, but that will allow the harmonisation of the EU regulatory system for medical devices and medical technologies.
Responsible Research & Innovation
We aim to boost the outreach of In Silico World’s outcomes and to conduct collective, anticipatory governance of in silico trial technologies, referred to as Responsible Research & Innovation (RRI).
The strategy adopted within the communication activities identifies those project outputs that are particularly suitable for the outreach towards key stakeholders as well as relevant external events and media that can be used to further enhance the project’s dissemination. We produced more than 180 communication activities including papers, conferences, scientific events, workshops, press releases, and over 700 communication items (including various cross-dissemination activities with other EU-funded projects).
As for the engagement with stakeholder communities, we organised 3 focus groups around Europe (Belgium, Italy, Hungary) to monitor the perception of in silico trials among senior management of medical industries, clinicians, and policy experts, and to promote citizens and patients’ trust in in silico technologies. We held an RRI Workshop among our experts on governance solutions for the barriers to in silico medicine where we discussed the possible ethical, legal, and societal barriers throughout the innovation process and reflected on existing and potential governance solutions but also on the connection between society and research to better grasp the current understanding of different stakeholders.
We also started the Associate Partner Programme, open to universities, research hospitals, biomedical companies, software vendors, contract research organisations, notified bodies and regulatory agencies, etc. The goal is to maximise the impact of our work on the Community of Practice that is developing around in silico medicine.
Re-training and education
An important task in the project is to educate the future workforce in this innovative domain. This refers to educating new graduate students and retraining employees who are already active in the field of innovation in clinical care, pharmaceutics, or medical devices. We have identified the learning needs of several stakeholder categories, such as engineering and medical students, or professionals active in relevant fields either with a medical, engineering or even legal background. Learning material is now being developed with a focus on offering it in an on-site way. Test material will be evaluated first in small groups of course takers, and then expanded to more elaborated courses towards the end of the project.
Specific activities have been dedicated to exploring exploitation opportunities for the computational results obtained within ISW, to defining viable business models (such as internal R&D tools, consultancy services, software-as-a-service, on-premises software…), and plan of the post-project commercialization through the marketplace InSilicoTrials.com. In the past two years, periodic monitoring was established for each solution, together with the developer partners, to track progress and collect valuable information regarding the product area of application, envisioned context-of-use, expected target users and market sector, and intellectual property management. This analysis produced a “List of viable business models” at the end of 2022 and will finally be collected in a detailed “Exploitation Plan” at the end of 2023.
Access the full report here
Check our Repository on Zenodo