The University of Manchester is bringing together some of the UK's brightest minds from across academia, industry and regulatory affairs to make medical product testing and approval processes faster, safer, and more cost-effective.
A £1m funding award from the Medical Research Council in collaboration with UKRI Innovate UK will accompany £1.2 million of in-kind support from 85 partners to fund the pilot phase of the UK Centre of Excellence on In-Silico Regulatory Science and Innovation (UK CEiRSI). This Centre will collaborate globally to address some of the sector's most pressing challenges and target unmet patient outcomes and safety needs.
The consortium will work with computational modelling and simulation and AI techniques-all of which are poised to revolutionise the healthcare landscape. The UK CEiRSI will contribute to making the UK the best milieu for delivering medical innovations using in silico evidence and regulatory science.
The Centre will consist of leading universities from the UK's four nations, world-class companies, and health systems and regulatory bodies, including the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE) and the Health Research Authority (HRA) but will also collaborate with colleagues in the Food and Drug Administration (FDA) in the US, and the European Medicines Agency (EMA) in mainland Europe.
Professor Alex Frangi, Bicentennial Turing Chair in Computational Medicine at The University of Manchester, will direct the Centre.
He said: "Human and animal trials often face high failure rates resulting in delays, increased costs, and potential risks to patients.
"On average, pharmaceutical products take 12 years to develop, with testing consuming up to 30% of costs.
"However, we will seek to address these critical inefficiencies by developing in-silico technologies that produce digital evidence for the digital age. Our aim is to reflect engineering practices in other sectors where physical testing is complemented by virtual testing and product optimisation. This will result in improved medical products (drugs or devices), faster and more affordable lifesaving therapies for patients, and innovative regulatory approval processes."
He added: "These cutting-edge tools can greatly enhance reliability in testing, while substantially reducing development time and costs, as well as improving the diversity of testing conditions, leading to more equitable care."
"And that will benefit patients through reduced failure rates and recalls, while fostering economic growth by driving innovation in pharmaceuticals and medical technologies."
However, despite their transformative potential, a regulatory deadlock for in-silico technologies means the technologies face barriers to adoption. Regulators lack frameworks to assess in-silico evidence, while developers hesitate to invest without clear pathways to approval.
The UK CEiRSI aims to break the deadlock and position in-silico technology and virtual trials as a mainstream approach to eliminate risk from future medical and pharmaceutical innovation developments. To tackle this impasse, the Pilot phase will implement an In Silico Airlock Initiative where actors from industry, academia and regulatory bodies will explore 10 industry-led pre-commercial regulatory pilots and assess the opportunities and limitations of current credibility frameworks.
Building on the success of a six-month discovery phase, UK CEiRSI will bring together industry leaders, regulators, Health Technology Assessment (HTA) and standardisation bodies, academics, and patient representatives - to test and refine frameworks for assessing in-silico evidence.
Reports from the project will address key issues such as regulatory frameworks, legal and ethical implications, and patient risk reduction, paving the way for in-silico technologies to make a real impact on our lives.
- "in silico" is a term used to describe experiments or studies that are performed using computer simulations or software.
