A new EU-funded project, In Silico World, is aiming to encourage the use of simulation in the development of drugs and medical devices.

In experimental sciences, the term ‘in silico’ refers to an experiment performed on a computer or via a simulation. Funded by the EU’s Horizon 2020 programme and coordinated by the University of Bologna, the In Silico World project will develop 11 solutions for Italian start-up InSilicoTrials.

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InSilicoTrials leverages computational technologies to test the safety and efficacy of medical devices and products, including advanced solutions such as tissue engineering constructs for regenerative medicine. The company says modelling and simulation can reduce clinical trial-associated costs by up to 50% and greatly accelerate the go-to-market of new products.

The solutions developed as part of the In Silico World project will target medical products to treat osteoporosis, tuberculosis, multiple sclerosis, coronary stenosis, cerebral aneurysms, mammary carcinoma and Covid-19 infection, among others.

As these solutions are developed, the consortium will produce data for validation, regulatory pathways and technical standards. It will also produce policy documents and information packages for patients, doctors and senior healthcare industry stakeholders, as well as computational strategies to make such simulations more powerful and efficient.

The consortium will also focus on developing new curricula to educate the workforce on the development and use of InSilicoTrials’ technologies, and a robust business model for the commercial exploitation of these technologies.

In a statement, In Silico World co-ordinator and University of Bologna professor Marco Viceconti said: “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, 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.”

InSilicoTrials: bringing several EU projects together

In Silico World isn’t the only EU-funded project InSilicoTrials is involved with – it’s also part of Brainteaser and SimCardio Test.

Brainteaser is a project aiming to use artificial intelligence (AI) to help patients more effectively manage multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS), as well as to develop models to predict disease progression.

InSilicoTrials’ role in the project will include leading the development of AI simulation and software cloud platform, exploitation activities, quality assurance and risk management, as well as helping to define guidelines for Software as Medical Device certification.

Meanwhile, SimCardio Test is a European Commission-funded project developing new predictive tools in cardiac pathologies, with the aim of creating a standardised and secure cloud-based platform where in silico trials run seamlessly.

The in silico tools created by the SimCardioTest Consortium will be integrated and commercialised through the InSilicoTrials platform, enabling their adoption and diffusion on a global scale.

A simulated future for clinical trials?

While regulatory agencies are encouraging drug and device developers to use modelling in their work, many lack the necessary IT infrastructure. InSilicoTrials aims to solve this problem by collecting the best simulation models from universities and embedding them in a scalable IT cloud-based platform that can be used across a wide range of studies.

InSilicoTrials CEO Luca Emili says: “The models that InSilicoTrials is using to support the development of medical devices and drugs represent an important part of the future of clinical trial activity.

“As digitalisation has significantly changed industries like banking, insurance, entertainment, and tourism, in the same way the use of very powerful models can support the translation from labs and animal testing as well as human trials into something quicker, less expensive, and more efficient. In silico methods could reduce the time and cost of drug and medical device development by up to 50% of actual spending.”

Of course, even the most meticulously simulated laboratory test could have different outcomes when compared to real-world data. But no company is aiming to completely digitise drug and device testing. Rather, companies like InSilicoTrials are seeking to enhance the process, allowing researchers to bypass clinical dead-ends and work as quickly as they can to develop life-saving products.

“When we think about the outcome of modelling we have to think of an element that is managing just a part of the drug’s or device’s development,” Emili says.

“The logic of refinement, reduction, and replacement, often referred to as the 3Rs, represent the trajectory to implement these methods in a way that could guarantee acceptable results, the nearest possible to the real-world outcome. The validation of models represents a fundamental step to guarantee this level of quality. We at InSilicoTrials are highly committed to providing validated models to our customers to let them significantly benefit from modelling and simulation.”