ISW

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 kinds 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.

Reason for applying to HSbooster.eu services

• To approach ISO Technical Committees and to select the right people to talk with
• To identthe ify critical path needed to successfully submit a good standardisation proposal
• To identify people that can guide the process

Main Standardisation Interests

The main objective is to propose a harmonised ISO standard for the use of Insilco trials in the medical device. In particular, within the project, we are identifying the use of ASMS VV-40 as a guideline to create a new standard with specific modifications and add-ons to adapt and enlarge the VV40 to all medical products; to include different types of modelling and simulation framework; to suggest how to do a risk analysis to identify various levels of severity on verification, validation and uncertainty quantification; provide concrete examples, verification, validation and uncertainty quantification for certain types of modelling techniques like ABM modelling framework as a good point from which to start. 

Summarising the objects related to standardisation in our project are:

1. Transitional adoption of VV-40
2. Development of an EU harmonised standard
3. Tailored training and re-training programs
4. Global harmonisation via the International Medical Device Regulators Forum (IMDRF)
5. EU qualification programme for Medical Device Development tools