UK CEiRSI - The UK's Centre of Excellence on In-silico Regulatory Science and Innovation - Pilot Phase

Effective and robust medical technology and pharmaceutical testing and approval processes are critical to public protection, enhanced health and wellbeing. However, existing human and animal trials have high failure rates and can frequently lead to negative consequences for patients. They also add time and cost to the delivery of new treatments and devices (typically eight years and 30% of costs for a pharmaceutical product). A growing body of evidence suggests that ln-silico Technologies {i.e. computational modelling and simulation techniques used across medical product R&D lifecycles) could radically improve medical product testing, trials and assessment processes, providing significantly increased reliability while reducing time and costs. This would directly benefit patients by reducing failure and recall rates for new medical products, and would generate economic growth by stimulating innovation in businesses developing pharmaceuticals and medical technologies. However, the use of evidence from in-silico technologies has not yet been integrated into regulatory processes. Our aim is to address this deadlock by establishing a UK Centre of Excellence on in-silico Regulatory Science and Innovation (UK CEiRSI) to develop tools, standards, and best practices for integrating evidence from computational models into the regulatory process.