In Silico clinical trials to design and safely test new drugs and medical devices in virtual patients - SILICOFCM and InSilc projects

1. Nenad Filipović, Univerzitet u Kragujevcu (FIN, PMF, FMN), Serbia

Computer simulations are used to design and safely test new products in virtual patients. In silico clinical trial represents a new paradigm for development of new drug and medical device.
Familial cardiomyopathies (FCM) are most commonly diagnosed, or progress of the disease is monitored, through in vivo imaging, with either echocardiography or, increasingly, cardiac magnetic resonance imaging (MRI). The treatment of symptoms of FCM by established therapies could only in part improve the outcome, but novel therapies need to be developed to affect the disease process and time course more fundamentally. In SILICOFCM project we are doing in silico multiscale modeling of FCMs that would take into consideration comprehensive list of patient specific features (genetic, biological, pharmacologic, clinical, imaging and patient specific cellular aspects) capable of optimizing and testing medical treatment strategy with the purpose of maximizing positive therapeutic outcome, avoiding adverse effects, avoiding drug interactions, preventing sudden cardiac death, shortening time between the drug treatment commencement and the desired result.
SILICOFCM platform is a cloud based ICT platform that combines detailed heart reconstructed and computable geometries with state-of-the-art multiphysics solvers (MUSICO, BIOINFORMATICS, DATA ANALYTICS, ALYA and PAK) to directly simulate the heart function and performance of complex biomedical products.
In InSilc project we are developed in silico mechanical stent testing within ISO 25539 standards. The following standard tests are simulated: Dimensional verification, Profile/diameter test, Simulated use – Pushability, Torquability, Trackability, Recoil, Crush resistance Flex/kink, Force to deploy, Longitudinal tensile strength, Crush resistance with parallel plates, Local Compression, Radial Force, Foreshortening, Dog Boning, Three-point bending, Stent-free Surface Area. Risk of fatigue failure is calculated using multiaxial criteria specific for polymers (PLLA) or metals (magnesium).
We believe that with SILICOFCM and InSilc projects we will connect basic experimental research with clinical study and bioinformatics, data mining and image processing tools using very advanced computer models drug, stent and patient database and regulative in order to reduce animal and clinical studies.

Tematska oblast: SIMPOZIJUM B - Biomaterijali i nanomedicina

Datum: 10.07.2019.

Contemporary Materials 2019 - Savremeni Materijali

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