Digital twins for in silico clinical trials using modelling and simulation

Human-based methodologies are at the central stage, as shown by the FDA Modernization Act 2.0, and ‘Advancing alternative methods’ (https://www.fda.gov/science-research/advancing-alternative-methods-fda/about-alternative-methods). This includes in silico techniques, such as machine learning and modelling and simulation, which are needed to analyse, integrate and augment preclinical and clinical data, to improve the understanding of phenotypic variability of human patho-physiology, and to accelerate therapy development. In this presentation, I will describe our work contributing to two key and complementary visions with powerful traction in medicine, and specifically in cardiology: Digital Twins for precision medicine (Corral-Acero et al, 2020) and In Silico Trials for therapy evaluation using virtual patient populations (Viceconti et al, 2020). I will describe how this work is powered by intersectoral collaborations, and specifically by extensive and diverse collaborations with pharma, biotech and devices industry.