MHRA set to receive nearly £1m from BEIS’ Regulator’s Pioneer Fund

The Medicines and Healthcare products Regulatory Agency (MHRA) has received a total of £970,688 from the Department for Business, Energy and Industrial Strategy’s (BEIS) Regulators’ Pioneer Fund.

The funding will support three projects that aim to harness regulatory innovation in digital, data and scientific areas, in order to accelerate benefits for patients, the healthcare sector and clinical research.

The three programmes are focused on improving patient access to life-changing therapies in clinical trials, establishing a way to safely introduce complex artificial intelligence (AI) into front line clinical settings and marking the UK as the place to launch advanced microbiome products that can assist in the development of tailored medicine.

One of the MHRA’s central aims is to focus on unlocking scientific and digital innovation that works in tandem with the evolving needs of patients, to ensure the delivery of research innovation that promotes the protection and improvement of patient health.

A sum of £750,387 has been given to the first project to tackle the challenges of finding control groups for clinical trials, through the development of alternative synthetic datasets.

Dr Puja Myles, director of the Clinical Practice Research Datalink at the MHRA, said: “This funding could revolutionise how clinical trials are conducted, giving patients access to potentially life-changing treatments, saving money that could be better spent on more advanced research while providing highly reliable results for the clinical researchers.”

The second project has been awarded £167,863 to deliver a workable methodology that can help to provide clinicians with an understanding of which factors the algorithm considered and the weight it assigned them.

Speaking on the second project, Professor Johan Ordish, head of software and AI at the MHRA, said: “Patient safety is at the heart of everything we do, and we’re determined to be well prepared to get AI technology to the bedside safely, effectively and with confidence in this assurance.”

The third project has been awarded £52,438 to explore the development of guidelines surrounding the regulation of microbiome therapeutics and diagnostics.

Dr Nicola Rose, deputy director, R&D at the MHRA, said: “The study of microbes associated with the human body has the potential to greatly advance our understanding of human health and disease, providing new solutions for public health and allowing us to move towards a new era of personalised medicines.

“However, the absence of specific guidelines can delay the approval process for companies looking to bring their expertise and their pioneering treatments to the UK.

“We want to change that and make the UK the home for innovation in microbiome therapeutics and diagnostics, and will work with our extended network of scientists, clinicians, companies and regulators, both nationally and internationally, to capture the requirements needed for effective guidance.”