Regenerative Medicine and its location and potential impact in the UK healthcare system
by Andrew Webster and John Gardner
Regenerative medicine (RM) has developed over the past 30 years via early work on stem cells and tissue engineering. The past decade has seen a rapid growth in clinical research and commercial investment because of the ability to manipulate and create different types of cells for therapy. While this work promises a new approach to handling both rare and more common conditions, transforming the way healthcare is organised and delivered in the clinic, it will thereby introduce and confront a range of challenges.
The existence of a national health system, which includes research-intensive hospitals with close links to world-leading academic institutions, means that the UK is potentially very well-suited to conducting clinical studies of promising regenerative medicines. Several of the NIHR Biomedical Research Centres, for example, are specialising in regenerative medicines, and as of July 2017 there were over 60 RM clinical trials underway, or soon to commence, within the UK. Developments within the UK are targeting a range of disease areas, but main areas include blood cancers; bone and cartilage defects; the eye, and neurological disease. There are, currently, 41 RM companies active in the UK, with growing investment in the gene therapy area.
Over the past three years there have been some significant policy initiatives. The UK government has provided £55m to develop the Cell and Gene Therapy Catapult in Stevenage whose aim is to support UK and overseas firms’ investment and product development. As an ‘advanced therapy’, proposals for regenerative medicine and its scale up have been made (MMIP, 2016), and the House of Commons recent report (HoC, 2017) recommended an NHS ‘fast track’ appraisal system for the field, arguing too that the UK’s Personalised Medicine strategy should explicitly include regenerative medicine and cell therapies. Innovate UK will provide £30m over the next four years for the establishment of new Advanced Therapy Treatment Centres across the NHS.
Fostering innovation in the UK NHS is a challenge recognised by the Department of Health. We see an increasing centralisation of planning which makes ‘cost-reducing’ innovation more attractive than ‘value for money’ innovation – where the benefit of RM lies - because of very tight budgets which mean there is very little headspace for new innovation.
The key developments noted above show how new clinical and policy networks are trying to create an ‘innovation space’ for RM. Accelerating innovation through ‘fast tracks’ however runs up against organisational and budgetary inertia. The proposed Centres will moreover face considerable demands including working with new manufacturing micro-factories close to clinics that will provide cell lines to quality and quantity levels. Scenarios need to be developed for the likely size and profiles of clinical populations treatable through different cell line supply chains that will support national and regional planning in the NHS.