The University of Strathclyde has launched a £1 million research initiative aimed at modernising medicines regulation through AI and digital technologies.
The Centre of Excellence in Regulatory Science and Innovation (CERSI) project will work to ensure that data and new technologies, including AI, can be used to produce sustainable medicines safely and effectively, supporting ‘Quality by Digital Design’.
Researchers at Strathclyde plan to unite global expertise with the help of delivery partners, including the Cambridge Crystallographic Data Centre, AstraZeneca UK, Bristol-Myers Squibb, Pfizer and Siemens, to place the UK at the forefront of modern medicines regulation.
The pharmaceutical industry is one of the most heavily regulated sectors worldwide, with compliance vital to ensuring safety and public trust, however by enabling faster, digitally driven approvals of life-saving treatments, both patients and industry partners stand to benefit.
“This project highlights the vital role of science and innovation in shaping the future of medicines regulation,” said Professor Daniel Markl, CERSI Project Lead at the University of Strathclyde.
“The CERSI will establish a framework that ensures the accuracy, robustness, and quality of digital tools, giving regulators and industry confidence in their adoption.
“Through UK and international collaboration, we aim to position regulation as an enabler of innovation, delivering safe and sustainable medicines to patients faster.”
Strathclyde University’s CERSI project forms one strand of a £6.2 million programme from Innovate UK which has invested in seven Centres around the country, including at the University of Liverpool, which is leading a project to explore the potential of pharmacogenomics, and at the Brunel University of London, which is attempting to revolutionise regulation and bring more AI-powered healthcare products to the UK.
The overarching aim of the CERSI initiative is to foster collaboration between industry, academia, and regulatory bodies to drive consensus on digital regulatory approaches, while demonstrating their real-world applications, but also provides tailored training to equip those in the sector with the technical expertise required for digital adoption.
Innovate UK said that each CERSI will play a vital role in shaping the future of regulatory science, and over the coming year, the Centres will develop tools, frameworks and guidance to shape the development and approval of medical innovations.
The hope is that this network of centres will improve healthcare in the UK by accelerating the delivery of pioneering treatments and simplify how these are moved from lab bench to patient bedside.
“New technologies are transforming our economy at rapid pace. Our system of regulation must keep up with that, so that we can quickly and safely seize the economic and social benefits that new innovations could unlock,” said Patrick Vallance, minister for science, research and innovation.
“That is why we are launching CERSIs. They will make a valuable contribution to regulatory innovation – and will complement wider efforts to make the UK’s regulation fit for the future, such as that of our Regulatory Innovation Office.”
The new project follows another research initiative being led by Strathclyde, which is studying how AI could be used to speed up vaccine and medicine development.
That project, led by Redcar-based drug manufacturer Micropore Technologies, aims to fast-track development processes in genomic medicine – which analyses DNA to understand an individual’s genetic makeup – with the hope of treating complex conditions, such as cancer or rare diseases, or even producing new vaccines.