In June 2020, the Chancellor first announced that the Autumn Comprehensive Spending Review would prioritise making the UK a “scientific superpower” as we look to set ourselves apart in the post-Brexit world. The great achievements of the life sciences sector during the COVID-19 pandemic have shown the benefits of delivering the Prime Minister’s ambitions for science. But to make this a reality, the Government must focus on the early stage research where the really cutting-edge science is taking place.
One area where the UK can set itself apart is in clinical research. 12% of global trials for cutting-edge cell and gene therapies are already taking place in the UK, and as we have witnessed in the past year, the life sciences sector is trialling, developing and delivering innovative treatments at pace to patients in the UK and beyond. The Government’s new Vision ‘Saving and Improving Lives: The Future of UK Clinical Research Delivery’ details an ambition to support the whole clinical research community to build back stronger from COVID-19 and make the UK a world-leading destination to conduct innovative research. It sets out what we can achieve if policymakers, industry and the public sector work together to capitalise on our existing strengths and use lessons learned during the pandemic to develop new ones.
But, if the Vision is to truly harness the R&D ecosystem’s capabilities and continue to deliver new and potentially life-saving treatments to patients, it must recognise the integral role of early-phase research. In April, Silence Therapeutics, where I am the Head of the Scientific and Advisory Board, and the Foundation for Science and Technology brought together an esteemed group of individuals from across government, industry, academia and patient groups to discuss opportunities to boost clinical research in the UK post-Brexit and how the Vision can deliver them. All agreed that early-phase research in the UK is facing a unique set of challenges which, if overcome, can ensure the UK continues to be an attractive and competitive destination for companies to design, trial and develop novel medicines for common and rare diseases.
The UK continues to be a European leader in early-phase research, but to become a global scientific superpower we must close the gap that sits between us and our biggest competitors in China and the USA. A primary tool the Government must leverage to achieve this is regulation. Crucially, it must use the freedom that our departure from the EU provides us with to reappraise the utility of the extensive and burdensome work required to dose a new molecule in man in the age of precision medicine. A progressive approach would encourage investment by biotech and pharmaceutical companies to conduct their research in the UK and would facilitate UK companies to attract the necessary investment required to design and carry out innovative trials. A modern regulatory approach that accounts for the huge advances we have made in precision medicine will be instrumental in overcoming this barrier without compromising patient safety.
The rapid development of the AstraZeneca-Oxford COVID-19 vaccine has not only been a shining example of the talent and expertise of our scientists but also the adaptability, resilience and global leadership of the MHRA. By reducing red tape and remaining focused on ensuring that innovative, safe and effective treatments reached patients as quickly as possible, it achieved an extraordinary feat to expedite approvals for vaccines and therapeutics that have changed the course of the pandemic around the world.
Through the lessons it has learned during the pandemic, the MHRA is best placed to implement a more permanent risk-based approach to regulation in clinical research, and I am pleased to see it has made a commitment to this in its recent Delivery Plan. From my time chairing the MHRA, I am acutely aware of the way the agency upholds gold standard patient safety standards. By choosing to apply proportionate regulatory requirements depending on the level of risk that a treatment poses to the patient, it can continue to do this while also delivering new and potentially-life saving treatments at home and abroad.
Supporting our unique NHS and thriving life sciences industry with effective regulation will have huge benefits for fast-tracking how these treatments are developed and rolled out. This will be transformative in the area of rare disease, where nearly 7% of the population will be affected in their lifetime and for many there won’t be any available treatment. We must address this huge unmet need and provide these patients with new and advanced solutions. Early-phase research is the steppingstone from which critical research into novel medicines and therapeutics begins, and it is therefore essential for the Government to support and champion its role if it is to maintain and increase its performance as a scientific superpower.
The Government’s Vision for clinical research is encouragingly backed up by £64m in funding over the next year, which will no doubt have wide-reaching benefits for kickstarting research which has been paused over the pandemic and supporting the development of important tools which will improve how we identify and recruit patients for both early and late phase trials in the UK. However, these will all continue to be essential features of a scientific superpower even when the pandemic is behind us, particularly as we prepare for the threat of another in the future. The world of clinical research now looks to the next Comprehensive Spending Review for assurance that the Government will continue to provide the necessary long-term funding required to cement the UK’s place as a world-leading destination to conduct early and late phase clinical trials for decades to come.
I so admire what the life sciences ecosystem has been able to achieve in the past 18 months and am encouraged by its aspirations for the future. We have a unique opportunity to reflect on where we can do better and how quickly we can do it. Early-phase research provides the crucial foundation on which the delivery of innovative and effective treatments is built, and I look forward to seeing what we can achieve through an ambitious Vision that secures both the long-term investment and support required to make the UK the best place in the world to develop, regulate and deliver medicines.
You can find a formal report from the April roundtable on the Foundation for Science and Technology website here. This report provides more information on the Government’s Vision for clinical research and details a set of core recommendations the group made to government to ensure it maximises on the UK’s potential to become a world-leader in clinical research.
Professor Sir Gordon Duff is former Chair of the MHRA and currently heads up the Science and Technology Advisory Board at Silence Therapeutics, an AIM and NASDAQ listed biotech company headquartered in London with research facilities in Berlin, Germany and offices in New Jersey, USA.