University of Manchester – Written evidence (LSI0078)
Introduction
We welcome this opportunity to offer evidence on these important issues. Translational research at the University of Manchester (UoM) encompasses a wide range of activities stemming from discoveries in the fundamental sciences and progressing through a pipeline that includes hypothesis testing and elucidation of disease mechanisms, preclinical research in animal models, through to clinical trials in humans of new drugs, devices and diagnostic procedures and ultimately delivery and adoption within the NHS and 3rd sector organisations. We recently undertook a major restructure of our life sciences and medical faculties to ensure an effective continuum from basic biological research to translation and application in the economy and society. UoM has a strong track record of commercialisation of technology through spin-outs and licensing via our commercialisation subsidiary UMI3 and have very extensive collaborative activities with companies in the health and life sciences sector.
UoM sits in the largest concentration of excellence in health research nationally outside South East England. Key facilities in support of cutting-edge research and innovation are set in the context of a large and stable population exhibiting significant health challenges. Health devolution to GM (£6bn p.a.) has created the unprecedented opportunity for a concerted push towards innovation for both health and economic benefit via a place-based platform, Health Innovation Manchester. The greater Manchester and Cheshire East Science and Innovation Audit highlighted the priority we give to health innovation ad the opportunities for developing a vibrant life sciences sector in the city region. Against this background we set out our responses to selected questions below.
Science and innovation
How can investors be encouraged to invest in turning basic life science research into new innovations in treatment?
We believe that ‘translational managers’ teamed with biologists are needed to identify and actively push forward a route map for translation of the life sciences in to innovative solutions. Investors being able to engage directly with translational managers who ‘speak the same language’ would aid this. Such individuals would need a skills/profile to ‘sell’ the technology to investors.
Further fiscal incentives such as additional tax breaks with matching investment from government and charitable grant sources and pharma/biotech industry would also be beneficial, as we see in the US.
Why has investment been lacking in this sector?
Life scientists are usually cell or molecular biologists, fundamental and basic scientists who feel they are far from the translational face of their research potential. Training of Early Career Researchers in innovation certainly helps but translation needs to driven forward by life science ‘knowledgeable’ people who have the skills and mindset to recognize and take forward opportunities.
Products can be a very long time to market, with a high project attrition rate and a low weight of capital available in relation to the requirement (substantial follow-on capital needed for several rounds). Moreover, early unproven and risky concepts imply that investors are reluctant to invest at the very top of the innovation process. In addition, it is often difficult for incoming investors to undertake appropriate or effective due diligence on these types of investment opportunities if they are non-specialist or to know how best to add value (there appears to be a small/restricted pool of such people in the UK). There is a lack of biotech/life sciences start-up CEO of suitable calibre available, especially outside key clusters.
There are also weaknesses in the broader innovation system (e.g. commercialisation incentives for researchers, lack of access to capital for SMEs, weaknesses of UK large companies, and short-term/inconsistent government policies), see for example the most recent report of the Industrial Strategy Commission (http://industrialstrategycommission.org.uk/wp-content/uploads/2017/07/Laying-the-Foundations-the-Industrial-Strategy-Commission.pdf).
The complexities of managing the NHS suggest that opportunities are missed to use the huge purchasing power of the NHS in demand-driven strategies. There is a public role in addressing market gaps and using convening powers to leverage public and private resources for life sciences commercialisation, but capabilities and institutions to accomplish this are lacking or weak. Third-sector foundations are to some extent able to develop key targets, although this can mean that other less fashionable needs are overlooked. Use of procurement as an instrument for innovation is one of the key objectives of Health Innovation Manchester. We believe that the devolved budget has the right balance of scale and focus for this to be effective.
Does the research base have the necessary infrastructure to be world-leading?
On the whole we believe the UK has a good quality infrastructure but this needs to be continually updated to stay ahead of the competition. It is critical with infrastructure to not only consider estates and equipment but also personnel with the expertise to manage and run it. Investment into data analysis / bioinformatics is an example where support is needed to gain maximum potential from the large data sets able to be generated using techniques such as spectroscopy and microarray.
The clinical translation process needs to accelerate in order to reduce hurdles to gain relevant clinical samples for further translation. This has proven numerous times to both deter industry from engaging with academia in the life sciences and for researchers to actually initiate new projects.
The flow of new inventions is frequently greater than available patent budgets and it can be challenging distinguish where best to apply the limited budget, especially beyond the initial filing phase. The common misconception that TTO’s say ‘no’ far too often to academics hampers life scientists coming forward with their inventions.
Why has the UK underperformed in turning basic research in the life sciences into intellectual property?
It is not clear that the UK has underperformed? We have a creditable number of spin-outs, licenses and some of the most innovative life science research in the world. There are though challenges and of course the situation could be improved. For example many life scientists do not have regular contact with industry and so are unaware how their work could translate, or are not aware of the process of translation. The drive for most basic researchers in the Life Sciences is fundamental discovery and not a commercial focus. While it is not reasonable to expect all researchers to make this their focus it is important to bring more into this activity and to ensure that the discoveries of others are effectively screened and taken forward. In part this is a matter of career incentives such as promotions and rewards but a deeper cultural change is needed to provide underpinning.
The provision of a funding ladder to continue the follow on pathway, including supporting associated patent costs along with the grants, and significantly more proof-of-concept funding is critical. Increased support for relevant clusters to create larger ecosystems, with assistance for creating critical mass outside of the South East is imperative. For example, the Northern Powerhouse Partnership is one route to generate original Life Science research, encouraging innovative thinking, encouraging policy change, which will improve not only the North but also the UK’s quality of life and economy.
Retaining our high quality undergraduate and postgraduate students in research is an important first step. A major issue is the lack of career structure, job insecurity and low salary levels for those beginning a research career, particularly in Universities - we lose expertise and knowledge due to staff moving on to more lucrative jobs in quick succession. We need to invest much more in younger talent, at PhD and in subsequent years – long-term careers for good researchers who do not necessarily want to become group leaders; a career pyramid with a broader base at more levels lower down.
We should also improve links between NHS, universities and industry – this is essential for the Life Sciences base. The NIHR funded BRCs attempt to address this but it takes considerable time to effect change.
In the US, there are arguably more capabilities, as well as more resources available, for emerging life sciences companies to access venture capital and to scale up, and there can be fewer constraints in support for gaining IP protection. Compared with Germany, the UK is probably more flexible, especially in the attractiveness (to date) of its labour market for skilled researchers. The UK fares less well than Germany in terms of consistency of industrial policy, although in other areas such as regulatory openness to innovative approaches and to address complex bioethical issues, the UK is well-placed compared with both the US and Germany.
Industrial strategy
8. Where should the funding come from to support the implementation of the strategy?
One potential stakeholder/funder of Life Sciences technology is corporate private health insurance - large companies that invest in insurance for their staff in 10-year blocks. It is in their interest to keep the staff healthy so they do not claim, so they may invest in preventative healthcare and mental health strategies or cheaper / more effective therapies.
9. How do the devolved administrations and city regions fit into the strategy? Scotland has its own life sciences strategy, how will the two interact?
There should be a seamless link between devolved regions and the strategy but control and fiscal management has to be kept local as in the Greater Manchester devolution arrangement.
NHS procurement and collaboration
10. How can public procurement, in particular by the NHS, be an effective stimulus for innovation in the Life Sciences Sector? Can it help support emerging businesses in the Life Sciences sector?
There is no central mechanism available to ensure that the NHS only procures one type of product. outside of those products/drugs etc that fall within the remit of ’specialised commissioning’ (https://www.england.nhs.uk/commissioning/spec-services/). Whilst recommendations can be made for other changes, anything procured/commissioned through local Clinical Commissioning Groups (CCGs) is a matter of local discretion as a recent NHS England statement clarified (https://www.hsj.co.uk/commissioning/nhs-england-rebuff-girft-surgery-recommendations/7020311.article.
Change would require legal change to the constitution of CCGs and other healthcare organisations (e.g. Foundation Trusts) for public procurement to be more consistent across the NHS. However, the NHS system is set up to allow local procurement of the projects of emerging businesses but without any mechanism for national spread. Consistency of procurement is a key recommendation of many reviews (http://gettingitrightfirsttime.co.uk/wp-content/uploads/2017/08/GIRFT-GeneralSurgeryExecSummary-Aug17v1.pdf Recommendation 7)
11. How can the recommendations of the Accelerated Access Review be taken forward alongside the strategy? Will the recent changes to the NHS England approval process for drugs have a positive or negative effect on the availability of new and innovative treatments in the NHS? How can quick access to new treatments and the need to provide value for money be reconciled?
If the issue is access to new and innovative treatments across the whole of the NHS, then there are organisational changes and possibly new incentives required to make this happen. Attempts to develop more consistent provision of care, through various NHS England programmes, including the Getting It Right First Time (GIRFT) programme, are admirable but lack ‘levers’ to ensure implementation across the NHS. Quick access to treatment and the need to provide value for money cannot be easily reconciled especially when savings resulting are not experienced by the same organisation, or within a single financial year (given the in-year accounting rules in operation in the public sector). This point well supported by research carried out at Manchester https://www.journalslibrary.nihr.ac.uk/hsdr/hsdr02230/#/abstract
12. How can collaboration between researchers and the NHS be improved, particularly in light of increased fiscal pressures in the NHS? Will the NHS England research plan help in this regard? How can the ability of the NHS to contribute to the development of and adopting new technology be improved?
How can collaboration between researchers and the NHS be improved, particularly in light of increased fiscal pressures in the NHS?
Collaboration between the NHS and Researchers has improved since the introduction of CLRN whereby recruitment to portfolio studies equates to some benefit to the Trust. However, those studies are costed equally and take no account of intensity - this leads to Trusts rejecting complex portfolio studies and accepting simple ones, this should definitely be addressed.
NHS departments could be better aligned to ‘feel’ the benefit of step changes in healthcare. For example, a new treatment that may cost more upfront will have to be paid for by (e.g.) GP surgery but savings may come from reduced physiotherapy or rehabitilitation treatment. A joined up process of finance across the full healthcare treatment spectrum to allow flexibility and benefit transfer would help translation of new approaches.
Doing both clinical work and research is very tough and could be more fully recognised and rewarded to encourage the drive for collaboration with researchers; the NHS are currently primarily judged by their care of patients and therefore this is not foremost in their minds. More adaptable career structures could encourage and support those wanting to link research to clinical work. Closer links between discovery science and NHS so that some life science research is led by the needs in the NHS.
Reducing the bureaucracy surrounding the governance and approvals process would help enormously – currently, there seems to be a lot of duplication in the system. The HRA process was supposed to streamline the system but has also generated new requirements for administration.
In recent years the extreme difficulty in accessing routinely collected healthcare records for research, has impacted collaboration - even when appropriate consent has been obtained from patients (for example UK Biobank has needed to enter into arrangements with the three major GP IT providers to access healthcare records from their participants, despite the participants having explicitly consented for their record to be used for research). Much more work needs to be done to convince NHS patients, and their GP’s, of the benefits of data sharing – there was a signal failure to do this when “care.data” was proposed some years ago. Once the population are convinced of the benefits, substantial change to the regulatory apparatus such that the default position is to share unless there are strong reasons not to do so will be required.
NIHR is attempting to address the need for improved collaboration through its funding of Collaborations for Leadership in Applied Health Research and Care (CLAHRCs). NIHR are currently considering the form of future funding (from 2019) for this type of infrastructure. NIHR must be much more closely linked with NHS England and its plans, whilst not being driven only by the relatively short-term priorities.
Will the NHS England research plan help in this regard?
The NHS England research plan https://www.england.nhs.uk/wp-content/uploads/2017/04/nhse-research-plan.pdf appears to be unconnected with NIHR and other research funders at present, although it plans to work in partnership with them. Effective achievement of this aspiration will be key if the NHS England research plan is to help in this regard. NHS ability to contribute to development and adoption will only be improved through additional funding for staff time to do so. This is not currently provided and there is a lack of ‘head space’ for staff to do this. CLAHRC have much informal evidence of the increasing pressure on NHS staff time at all levels, and it is difficult to conclude that anything substantive can be achieved without additional funding.
How can the ability of the NHS to contribute to the development of and adopting new technology be improved?
Researchers need to understand better the challenges of implementing change within the NHS. There is often support at ground level and high-level management but the middle managers require education about how research involvement improves delivery. Better communication with CCGs to encourage implementation of changes that have been shown to be beneficial (before the NICE approval process has been undertaken) would accelerate adoption of improved practice and technologies.
Brexit
16. What impact will Brexit have on the Life Sciences sector? Will the strategy help the sector to mitigate the risks and take advantage of the opportunities of Brexit?
We cannot yet quantify the impact of Brexit on the Life Sciences but there are many risks of disruption depending upon the outcome of negotiations. Concerns include Life Science regulation, medicines approval, trade and single market access, pan-EU research, job market access and importantly IP. Reduced opportunities for EU collaboration and funding are a significant cause for concern. Recruiting good EU scientists at all levels is going to be very challenging. It will be very difficult for the UK to be world-leading in life sciences if we are not leading/ participating in the top level EU and other multi-national projects; science is a collaborative pursuit and anything that stands in the way of allowing open collaborations across countries is limiting. To the extent that the strategy strengthens the UK sector, it will offer some mitigation by increasing the possibility of attracting international investment and offsetting potential loss of EU support.
17. How should the regulatory framework be changed or improved after Brexit to support the sector?
There is an opportunity for the UK to reduce bureaucracy of regulatory approval in the UK – this will aid translation of products to market. This needs to still align with EU CE and FDA so that it is a complementary rather than additional process.
18. To what extent should the UK remain involved with and contribute to agencies such as the EMA post Brexit?
We should continue to be as involved and engaged as much as possible with Europeans agencies concerned with Life Sciences, Medicine and Health; it is vital that we contribute to EMA in order to be competitive in the post-Brexit EU market.
15 September 2017