Project description
In silico testing and certification of healthcare products
Computer modelling and simulation have the power to increase speed and reduce costs in most product development pipelines. The EU-funded SimCardioTest project aims to implement computer modelling, simulation and artificial intelligence to design and test cardiac drugs and medical devices. Scientists will establish a platform for running in silico trials and obtaining scientific evidence based on controlled investigations. The simulation of disease conditions and cohort characteristics has the potential to overcome clinical trial limitations, such as under-representation of groups. It also reduces the size and duration of human clinical trials as well as animal testing, and offers robust, personalised information. Leveraging in silico technology in healthcare will expedite product and drug certification and offer patients the best possible care.
Objective
Despite massive investment in healthcare, huge R&D cost increase and regulatory pathway complexity hamper tremendously commercialisation of new devices & medicines, putting patient populations at risk of not receiving adequate therapy. At the same time, outside healthcare, computer modelling and simulation (CM&S) is precisely recognised to increase speed & agility while reducing costs of development. CM&S can create scientific evidence based on controlled investigations including variability, uncertainty quantification, and satisfying demands for safety, efficacy & improved access.
Cardiac modelling has dramatically gained maturity over the last decades, with personalisation to clinical data enabling validation. We selected a number of cardiac devices and medicines where CM&S is mature enough and that represent the most common cardiac pathologies, to demonstrate a standardised and rigorous approach for in-silico clinical trials.
SimCardioTest will bring a disruptive innovation by creating an integrated and secure platform standardising & bridging model simulations, in-silico trials, and certification support. This environment will go beyond the state-of-the-art in computational multi-physics & multi-scale personalised cardiac models. Diseased conditions and gender/age differences will be considered to overcome clinical trials limitations such as under-representation of groups (e.g. women, children, low socio-economic status). Advanced big data, visual analytics & artificial intelligence tools will extract the most relevant information.
It is critical that Europe demonstrates its capacity to leverage in-silico technology in order to be competitive in healthcare innovation. SimCardioTest exploitation aims at delivering a major economic impact on the European pharmaceutical and cardiac devices industry. It will accelerate development, certification and commercialisation, and will produce a strong societal impact contributing to personalised healthcare.
Fields of science
- natural sciencescomputer and information sciencesartificial intelligence
- natural sciencescomputer and information sciencesdata sciencebig data
- medical and health sciencesbasic medicinepathology
- natural sciencescomputer and information sciencescomputational sciencemultiphysics
- medical and health sciencesmedical biotechnologyimplants
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
78153 Le Chesnay Cedex
France