Inria and InSilicoTrials partner up on a European project leveraging simulation for cardiac devices and drugs

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Inria Sophia Antipolis Méditerranée is leading SimCardioTest, a new EU project funded with 8 million Euros that will provide  insight into designing new predictive tools in cardiac pathologies. Among the ten partners, the rising startup InSilicoTrials.

The search for new drugs and devices is particularly difficult in the case of cardiovascular disease, which remains the leading cause of death worldwide, with 18 million deaths each year according to World Health Organization estimates. Currently, 15 million people in Europe live with heart failure, and it is one of the few cardiovascular diseases whose prevalence continues to rise. Beyond the risk of death, heart failure has a significant and lasting impact on patients’ health and well-being.

Moreover, despite the massive increase of investment in healthcare, the number of new approved drugs has stayed stable for the last 10 years. The huge increase in R&D costs and the complexity of the regulatory pathways hamper tremendously the commercialisation of new drugs and put many patient populations at risk of not receiving adequate therapy. Additionally, the dramatically increasing attrition rate across all phases of drug and device development pipeline highlights the lack of reliability of both existing preclinical animal models and the current design strategies for clinical trials, urging the need for new predictive tools. Computer modelling and simulation can create scientific evidence based on controlled investigations including satisfying demands for safety, efficacy & improved access.

SimCardioTest project is being funded by the European Commission to develop a standardized and secure cloud-based platform where in-silico trials run seamlessly.

> SimCardioTest is an international consortium of 10 partners organized through the SimCardioTest project is set to design new predictive tools.

> EU funding of 8 million Euros will enable this major collaboration effort.

> The project, coordinated at Inria – the French national research institute for the digital sciences in Sophia Antipolis, France, will kick off on Monday 25th 2021.

The role of the Italian startup InSilicoTrials.

One of the partners that will develop the SimCardioTest project is InSilicoTrials, whose mission is to revolutionize the healthcare sector through a highly innovative cloud-based platform. Today, the long and expensive development, as well as the registration/certification processes for new drugs and medical devices, are becoming unsustainable, especially for small and medium enterprises. Modeling and simulation can reduce these costs up to 50% and greatly accelerate the go-to-market of new products. Thanks to a unified interface, simplified workflows and the cybersecurity of the cloud, InSilicoTrials allows the use of these advanced models not only to large pharmaceutical companies, but also to SMEs and CROs, significantly reducing costs and time frames.

InsilicoTrials is a rising startup, a game-changer whose reputation as a unique and reliable company is growing fast, mainly because of its team of highly qualified professionals, the very strong scientific and regulatory network and its continuos interaction with many renowned players of the healthcare market. The in silico tools created by the SimCardioTest Consortium will be integrated and commercialized through the InSilicoTrials platform, enabling their adoption and diffusion on a global scale.

The Simcardiotest project will use personal data previously collected for medical purposes in the context of routine care. These data will be anonymized. Technical security measures are in place to safeguard the rights and freedoms of the data subjects in order to respect the ethical conduct of research imposed by the European Commission (ethical evaluation procedure H2020), and compliance with the General Data Protection Regulation (GDPR).

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 101016496.

In-silico methods, together with high-performance computing infrastructures, the increasing availability of patient-specific data and big data analysis based on artificial intelligence, has the potential to bring clinical trials to the 21st century, leveraging standardised and trustworthy computational approaches.

Cardiac pathologies case studies

Three cardiac use cases will demonstrate the platform effectiveness, along with the required verification & validation processes and certification support of the medical device or medicine. A unified web platform will enable to test the safety and efficacy of drugs and devices. The project will specifically work on three case-studies:

> modeling for in-silico simulation of catheterization and pacing devices, including catheter navigation, the pacing performance and the mechanical fatigue. It will leverage a physical simulator using 3D printing and soft robotics.

> modeling for in-silico fluid simulations for stroke risk management, including models of thrombus formation and drug treatment, for better patient selection, device setting personalisation and prediction of treatment response

> modeling for drug-ion channel interaction to analyse the effects of drugs at a multi-scale level from cell to organ, in normal and pathological conditions, such as ischemia, heart failure or atrial fibrillation.

An international consortium

Through the SimCardioTest project, an international consortium of 10 partners has now joined forces with the aim to demonstrate feasibility, effectiveness and benefits of in-silico trials for cardiac devices & drugs; with a broad aim to gain the trust of scientists, companies, regulatory bodies, physicians, patients and to promote healthcare innovation in Europe and beyond. The simulations corresponding to actual measurements will be performed, and will be verified, validated, including uncertainty quantification and certification, following international standards.  This project aims also to facilitate and encourage the industrial and commercial exploitation of the results.

The European Union is funding the project with a total of 8 million euros until 2024. Kicking off the project, 40 researchers will meet on line. The SimCardioTest consortium partners are scientific institutions, and non-public partners from France, Belgium, Italy, Norway, Spain, and USA. The Advisory Board is composed of the European Agency for Medicine, Food and Drug Administration in USA, Roche, the University of Lyon, Dassault Systèmes and Auckland Bioengineering Institute in New Zealand.

SimCardioTest, a significant impact on clinical trials, regulatory systems and healthcare innovation

1) it will accelerate the adoption of computer simulations for testing medicines & medical devices, their translation into the clinic and the market, increase the trust of users (healthcare professionals & patients.
2) redesign current clinical trials and create a unique, digitalized, personalized testing environment,
3) contribute to reducing the size and duration of the human clinical trials and contribute to significantly reducing animal testing in clinical trials,
 4) contribute to increased efficacy and patient safety in clinical trials,
5) reduce development costs & shorter time-to-market for new drugs & new medical devices.

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