InnoScot Health hails ‘fantastic’ funding for MHRA projects

InnoScot Health believes that fresh government funding of £1m for cutting-edge projects aiming to accelerate regulatory innovation represents an important, progressive step.

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

It is expected that these projects will help to drive real-world benefits for patients, the healthcare sector, and clinical research.

The MHRA – which regulates medicines, medical devices, and blood components for transfusion in the UK – says the trio of projects can:

• Improve how patients access life-changing treatments in clinical trials
• Find a way to introduce complex artificial intelligence (AI) safely into front-line clinical settings
• Make the UK a destination of choice for the launching of advanced microbiome products that can support the development of personalised medicine.

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell said: “This £1m funding injection really is fantastic news. Not only does it mean vital regulatory innovation being accelerated, but it also supports one of the MHRA’s core principles – unlocking scientific and digital innovation that keeps pace with the changing needs of patients, ensuring it delivers world-leading research innovation that focuses on protecting and improving patient health.

“The funding has also been granted to key projects, helping to get better healthcare delivery into patients’ hands safely and effectively while enhancing knowledge of important new areas of advancement. We applaud the foresight of BEIS and look forward to seeing positive developments arising from its support of MHRA.

“InnoScot Health shares the MHRA’s aim of patients always receiving the best possible care.”

The bulk of the funding (£750,387) has been awarded to a project that will look to tackle the challenges of finding control groups for clinical trials through the development of alternative synthetic datasets, helping to change the way clinical trials are performed in common and rare diseases, lower their cost, and improve how new treatments are tested.

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 MHRA has recently made great strides in creating ‘artificial patients’, with similar health information to real patients, which could both boost the numbers for small trials and better reflect groups in society that are less well represented in clinical trials, such as different age groups and ethnicities.

The second project, awarded £167,863, aims to address the issue of how to safely introduce complex ‘black-box’ AI products into clinical settings, so that clinicians can be confident that the decision from the AI device is appropriate and suitable in that specific context.

The third project, awarded £52,438, will explore the development of guidelines around regulating microbiome therapeutics and diagnostics – a rapidly emerging field that poses a challenge for regulators and companies due to its novel and complex nature. 

InnoScot Health closely monitors developments in medical device regulation. A skilled team of regulatory experts offers advice to NHS innovators and those working with NHS. The organisation also operates an ISO 13485:2016 quality management system harmonised with the Medical Device Directive.

We ensure awareness and compliance with legal responsibilities and support the design and development of products under an accredited regulatory framework.