Public Funding for Nafems

A UK Centre of Excellence in in-silico Regulatory Science and Innovation (UK CEiRSI) will scale up activities of the InSilicoUK Pro-Innovation Regulations Network, in pioneering advanced computational modelling and simulation methods (CM&S), aka in-silico methods, to develop and regulate Life and Health Sciences products. Traditional testing for medical and veterinary products is exhaustive and costly to meet stringent safety regulations for both human and animal applications. This usually entails progression from bench testing or cell cultures to animal testing, and human clinical trials. In contrast, sectors like aircraft engineering derive substantial safety and efficacy data from sophisticated computer simulations. Translating this in-silico paradigm to healthcare could revolutionise medical product development by accelerating timelines, curbing expenses, and reducing reliance on animal and human testing. In-silico testing harnesses computational models to simulate the behaviour and efficacy of life/health sciences products throughout their lifecycle. This approach employs digital twins---virtual replicas of medical products, biological systems, or manufacturing processes---and virtual patients (populations) for in-silico testing/trials. These models enable researchers to predict optimal designs and clinical outcomes, enhancing product safety and effectiveness. Digital twins in life/health sciences represent complex simulations of individual patient anatomy and physiology, allowing for personalised medicine and treatment optimisation. Virtual animals, patients, and populations are simulated constructs used in in-silico trials to evaluate the performance of medical interventions without the constraints of traditional clinical trials, offering insights into efficacy and safety across diverse patient groups. Established in March 2022, InSilicoUK (www.insilicouk.org) is a community of over 2,000 stakeholders from academia, industry, and regulatory bodies. The network is dedicated to integrating in-silico evidence into regulatory science, thus improving patient safety, and speeding up the development of medical products. By advocating for computational modelling and simulation, we will advance public health, enhance the healthcare system, stimulate the life/health sciences sector growth, and contribute to the UK's economic prosperity. The UK is set to lead the global shift towards in-silico science and its regulatory acceptance. UK CEiRSI seeks to cultivate a community that supports innovative regulation and establishes a national framework for widely adopting in-silico methods, reinforcing the UK's global influence in life/health sciences. Adopting in-silico testing places the UK at the vanguard of medical product evaluation, solidifying its status as a beacon in life and health sciences innovation. This forward-thinking approach is set to overhaul the evaluation of medical products by streamlining processes, cutting costs, enhancing precision, and upholding patient safety.