It’s just over a year since the government published their strategy for UK Life Sciences. Yesterday David Cameron visited Cancer Research UK’s Cambridge Research Institute to publish an update on progress they’ve made over the past year and announce a new initiative – to make the UK a leader in genomics and bioinformatics. They’ve also published an update on progress implementing David Nicholson’s plan to improve the uptake of innovations to improve healthcare across the NHS which was published at the same time – Creating change: Innovation, health and wealth one year on.
The overall conclusion is lots of good progress has been made so far but there is further to go – see below for a summary of the key achievements so far – many involving medical research charities – and next steps in what is a long-term, ten year strategy.
On 5 December 2011, the government published a Strategy for UK Life Sciences: Building a life sciences ecosystem.
This brought together the initiatives that were already underway to support life sciences and announced some new ones including:
- Appointing two new Life Sciences Champions – Chris Brinsmead and John Bell – and an independent Life Sciences Advisory Board
- £180 million Biomedical Catalyst Fund – available to universities and small or medium enterprises to support the development of promising early-stage drugs into new treatments.
- An agreement between MRC and AstraZeneca giving academia access to 22 compounds developed by AstraZeneca for further research. In October MRC awarded £7 million funding for 15 successful research projects through this collaboration.
- An Early access scheme – involving the Medicines and Healthcare products Regulatory Agency (MHRA) working with industry and charities to identify where new treatments could potentially be given conditional authorisation, their assessment could be accelerated or they could even be licensed early.
- The creation of the Health Research Authority (HRA) to combine and streamline regulation, making the process more straightforward and easier to navigate. The HRA is now up and running and the draft Care and Support Bill includes clauses to establish it as non-departmental public body.
- The use of patient data for research – The government confirmed their plan to establish a secure Clinical Practice Research Datalink (CPRD) and also to hold a public consultation on the use of patient records for research.
- Investment in stratified medicine and emerging technologies, e.g. synthetic biology, informatics and regenerative medicine
Alongside the Life Sciences Strategy the government published a strategy to support innovation across the NHS – Innovation Health and Wealth. This included:
- plans to establish a number of Academic Health Science Networks across the country. These are now getting up and running.
What does today’s one year progress update say?
There’s a foreword from David Cameron saying he is pleased with progress over the past year. And a nice number:
Thanks in large part to this work, the UK has received over £1bn of new private life science investment over the last year,
The number 10 press release contains a little more detail on where this £1bn comes from – it includes investment by charities:
£500 m from GSK to build its first new manufacturing plant in almost 40 years at Ulverston in Cumbria and invest more in its two sites at Montrose and Irvine in Scotland as a direct response to the introduction of the Patent Box;
£25 m leveraged in from the private sector to bridge the ‘Valley of Death’ adding to a government commitment of £49m to 64 projects through the Biomedical Catalyst; and
£294 m through the UK Research Partnership Investment Fund (UK RPIF) from businesses and charities.
There is a lot of emphasis on the life sciences strategy being a long-term process – this is referred to as a 10-year strategy. As the life sciences champions – Sir John Bell and Chris Brinsmead put it:
This is a long-term Strategy and the government departments involved still have much to do, but the outcomes to date show early promise and we anticipate an acceleration of the programme as it moves into its second year
Pages 50-54 includes a neat summary of progress on the objectives set out in last year’s strategy. Big things in this include:
- The Biomedical catalyst fund which is co-funded by MRC and the Technology Strategy Board to the tune of £180 million has so far this year committed £49m to 64 projects led by universities and SMEs, which will leverage at least £25m of private sector funding.
- To support regenerative medicine, the Research Councils have established a £25m UK Regenerative Medicine Platform – the funding to be invested over 5 years. Last week’s autumn statement also earmarked £20 million of a £600 million capital investment to further support this platform with imaging and cell manufacture technologies as well as a clean room. See some more background on support for regenerative medicine here.
- The Clinical Practice Research Datalink is up and running providing secure access to anonymised patient data for research.
- An MRC investment of £10.6m in three large-scale collaborative awards under its Stratified Medicine Initiative. These will tackle diseases which have a huge impact on patient’s lives – rheumatoid arthritis, hepatitis C and a rare condition called Gaucher disease
- A roadmap has been published and a council established to lead the development of synthetic biology in the UK. They’re just getting up and running with their first meeting this month.
- The Cell Therapy Catapult is up and running
- The UK Clinical Trials Gateway was launched in April to pull together information about clinical trials.
- A consultation is currently open on changes to the NHS Constitution to clarify how patient data is handled by the NHS – we’ll be responding to this before the deadline on 28 January. The report also mentions the Fiona Caldicott review looking at the handling of patient data to ensure we have got the balance between confidentiality and sharing for patient benefit right – we gave evidence to the inquiry not long ago.
- The Medicines and Healthcare Regulatory Authority (MHRA) has consulted on the possibility of allowing early access to some new treatments and are reviewing responses at the moment. We responded here.
- A group of experts has met twice so far to discuss improvements in healthcare regulation including more adaptive approaches to licensing – they continue to meet quarterly.
And there are updates on progress in specific areas:
Clinical Trials Regulation – mentions the ongoing update to EU law and that the UK is pushing for risk proportionate approach to clinical trial approvals and a mechanism for harmonising applications for multi-state clinical trials. AMRC has signed a joint statement on the proposed EU Regulation currently being debated in Brussels, which has lots of useful info on the plans.
Use of animals in research – recognising that carefully regulated use of animals plays an essential role in scientific research and that the government and the police are committed to working closely with the life sciences community to manage any risk from the activities of animal rights campaigners. Earlier this year surface routes moving animals in and out of the UK for research were closed in response to animal rights activity.
Today’s big announcement
Chapter 5 (page 41) focuses on today’s big new announcement – “Making the UK a world leader in genomics and bioinformatics”.
By combining NHS clinical information with new genomic sequences there is real opportunity to capitalise on past investments in the NHS and medical research.
It announces two actions the government will take:
- Develop the capability to undertake whole genome sequencing at scale for the benefit of patients in the NHS
- Develop the genomic platforms to make the UK the destination of choice for life sciences
To help achieve this the Department of Health has committed £100 million to begin the sequencing of the genomes of 100,000 individuals with cancer, rare diseases and infectious diseases. This will take time to get up and running. David Nicholson – Chief Executive of the NHS – will lead the process with initial service design in place by June 2013. The first few contracts will be in place by April 2014 and the 100,000 genomes will be sequenced over the next three to five years. This money will support not just the sequencing, but the upskilling of staff and development of bioinformatics career paths, plus an increase in bioinformatics capacity which is needed to be able to use the genomic data gathered.
MRC are also working with other funders to explore plans for a £10 million genome analysis of a subset of UK Biobank participants.
Genomic data is hugely personal and there is recognition of the need to handle this safely and securely, protecting patient confidentiality. All of the 100,000 individuals involved in this initiative must understand and give their consent for their data to be handled and this will be monitored by the Department of Health Chief Medical Officer, Sally Davies. And there is a plan for public communication and engagement to shape how the this data is collected and handled as this goes forward:
We will begin a dialogue with patients and partners to establish the correct approach within the NHS to capitalise on the creation of a health care system able to generate and use large amounts of genetic data to improve the health of patients.
This announcement was broadly welcomed including by Cancer Research UK who also qualified the time it will take for this research to lead to benefits for patients:
But, it will be some time before everyone with the disease will be able to have treatment based on the genetic make-up of their cancer.
and by Genetic Alliance UK who represent individuals with genetic conditions:
this marks a significant step change towards realising the potential recent progress in genomics has revealed.
As outlined in this strategy, this is a long-term process. A lot of work is still ongoing and there is more to be done. This ongoing government focus on life sciences is really welcome. The long-term nature of the strategy – now stretching over ten years – is really important to encourage investors looking to support science in the UK. Funders need to make long-term decisions about their research strategies and this is much easier when there is a clear long-term UK strategy for them to work within. This supports collaborations and partnerships.
This clear framework gives valuable underpinning to enable medical research charities to work in partnership with other funders to support medical research, and work together to ensure that the whole system delivers benefits to patients in the UK and worldwide.