Last week a new strategy for regenerative medicine – growing new tissue to repair or replace damaged tissue – was published. This is intended to be a route map to guide investment in regenerative medicine over the next five years. It was developed jointly by four research councils – MRC, EPSRC, BBSRC and ESRC – and the Technology Strategy Board.
The UK is a leader in regenerative medicine and the strategy lays out 8 objectives that the UK needs to address to make the most of this position and translate this knowledge into treatments for patients, with the economic benefits this will also bring. Part of the strategy is £25 million invested in a new cross-Council UK Regenerative Medicine Platform (UKRMP) which will offer funding for interdisciplinary research groups who can address some of the challenges that need to be overcome to translate regenerative medicine into treatments.
Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects. Lots of medical conditions are the result of damaged tissues and organs which the body can’t heal itself, so as we get better at it, regenerative medicine offers huge potential to treat people with these conditions.
The UK government published a stocktake of regenerative medicine in the UK in July 2011. This identified ten actions for the UK government to support regenerative medicine, which will be taken forward by the office for life sciences.
The tenth action indicated a plan to develop an ongoing national strategy for regenerative medicine in the UK
In recognition of its potential as a driver for the UK economy and future healthcare, the Government will work towards an integrated, national strategy for regenerative medicine that builds on the strengths of the country’s science, industry and healthcare sectors.
The four research councils – Medical Research Council (MRC), Engineering and Physical Sciences Research Council (EPSRC), Biotechnology and Biological Sciences Research Council (BBSRC) and the Economic and Social Research Council (ESRC) - and the Technology Strategy Board (TSB) got together to undertake a joint strategic review. And this strategy and route map is the result.
What does the strategy say?
The strategy gives an overview of the research and development of regenerative medicine underway in the UK at the moment (Chapter 2). It breaks down where funding for this is coming from and how it is targeted (Chapter 3). Chapter 4 identifies eight areas which need to be addressed to support regenerative medicine:
- underpinning research
- therapeutic options
- product development
- clinical delivery and evaluation
- innovation and value systems
- interdisciplinary collaboration
outlining how the research councils and technology strategy board will take action to address them. Chapter 5 has a nice map summing these actions up, showing who will be responsible for what.
Chapter 3 is interesting as it breaks down where funding is currently going. Using the UKCRC Health Research Classification System which divides research up into 8 categories – underpinning, aetiology, prevention, detection and diagnosis, treatment development, treatment evaluation, disease management, health services – they have broken down how much funding is going into different therapy areas. This shows a relatively high proportion of funding going towards late stage musculoskeletal research reflecting the investment and success in this area. There is also a lot of investment in earlier preclinical eye research – there has been lots of coverage of some of this work. You might have seen earlier this year high profile work underway at Moorfields eye hospital Human stem cells can ‘help blind rats’
So what are they going to do?
Chapter 4 outlines the action that the research councils and technology strategy board will take to support regenerative medicine.
1) Underpinning research – we need to find out more about how cells work – reprogramming, differentiation and ageing, how they react to disease and repair, genetics etc.
Action to support this includes response-mode funding, supporting cross-disciplinary research and with an eye to how this basic research might be translated – although with an awareness that we can’t anticipate all the insights basic research might reveal. An international meeting to discuss collaborative opportunities will be set up.
2) Therapeutic options - treatments including cell transplantation, the stimulation of the body’s own repair system and the use of non-cell based products.
The MRC/TSB biomedical catalyst fund – £180 million which was announced as part of the Strategy for UK Life Sciences to support the development of promising early-stage drugs into new treatments - will support this alongside EPSRC response mode funding.
3) Product development - alongside developing therapies, we need to develop our capacity to manufacture, transport and deliver these new treatments. This includes the right diagnostics and screening technologies to identify those that can benefit.
£25 million to establish a cross-Council UK Regenerative Medicine Platform (UKRMP) which will offer funding for interdisciplinary research groups who can address some of these challenges. The new Cell Therapy Catapult Centre, which is due to be up and running by late summer 2012, will help support links between research and business to tackle some of these challenges.
The British Heart Foundation is raising money to establish one or two centres for Cardiovascular Regenerative Medicine in autumn 2013 with funding for four years. Their awards will complement the UK Regenerative Medicine Platform funding:
Our awards will be made in the context of, and in addition to, the concurrent MRC-led UK Regenerative Medicine Platform (UKRMP) programme of funding, which makes £20 million available for four-year awards in the first phase
4) Clinical Delivery and Evaluation - the UK has good infrastructure in the NHS to support clinical research and trials of new treatments but trials of regenerative medicine technologies are relatively new and bring with them new challenges; trials may need to be designed differently as a result.
MRC and ESRC will support workshops with researchers and the regulator of clinical trials – MHRA – to explore how trials may need to be designed to suit new regenerative medicine products. They will aim to improve trial design and regulatory transparency. The UK Stem Cell Bank is aiming to generate clinical grade embyro stem cell lines for use in potential clinical studies.
5) Innovation and Value Systems - developing sustainable business models so companies can invest and expect to get some returns from their investments. It’s important to ensure that we are ready to take up new therapies when they are developed.
Some work has been done to examine different value systems and business models that could attract investment into developing regenerative medicine products. This may include new regulatory systems, open innovation, patenting etc. ESRC funding can support social science projects in this area.
6) International - The UK is a world leader in regenerative medicine, as Taking Stock of Regenerative Medicine in the UK found. But we need to take action to maintain and build on our success and work collaboratively on an international scale.
ESRC will hold a workshop on international developments and future global challenges and the research councils will support international collaborations through their existing funding streams.
7) Focus - by working towards a common goal, UK research could reach a critical mass of expertise to drive work forward.
The new regenerative medicine platform will help to bring activity together and will have a second, disease-focused phase which will try and build partnerships with other funders including disease-focused research charities and international funders.
8) Interdisciplinary collaboration - regenerative medicine is broad and crosses a lot of disciplines so to be successful it needs to bring disciplines together to work towards shared goals.
The research councils and technology strategy board will establish a network bringing together academic and commercial researchers and funders at all stages. They will develop the network activity in line with the needs of these people.
This is intended to be a route map to guide investment in regenerative medicine over the next five years. The research councils and technology strategy board will be working to deliver the objectives outlined above over the next five years.