Descrizione del progetto
Test in silico e certificazione dei prodotti sanitari
La modellizzazione e la simulazione computerizzata sono in grado di incrementare la velocità e ridurre i costi del ciclo di sviluppo della maggior parte dei prodotti. Il progetto SimCardioTest, finanziato dall’UE, si propone di implementare la modellizzazione computerizzata, la simulazione e l’intelligenza artificiale al fine di progettare e collaudare farmaci e dispositivi medici per il cuore. Gli scienziati del progetto realizzeranno una piattaforma per condurre sperimentazioni in silico e ottenere prove scientifiche basate su indagini controllate. La simulazione delle condizioni patologiche e delle caratteristiche di coorte dispone del potenziale per superare i limiti della sperimentazione clinica, quali la sottorappresentazione dei gruppi. Ciò riduce inoltre la dimensione e la durata delle sperimentazioni cliniche sugli esseri umani e della sperimentazione animale, oltre a fornire solide informazioni personalizzate. L’impiego della tecnologia in silico in ambito sanitario accelererà la certificazione di prodotti e farmaci e fornirà ai pazienti la migliore assistenza possibile.
Obiettivo
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.
Campo scientifico
- 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
Parole chiave
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SC1-DTH-2020-1
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
78153 Le Chesnay Cedex
Francia