University College London (UCL) – Written evidence (LSI0058)

Executive Summary

1.      Life sciences in the context of the wider industrial strategy: The UK life sciences sector is world-leading and generates valuable advances in scientific knowledge and healthcare innovations, alongside significant economic and societal benefits for the UK. Consideration of the life sciences strategy is integral to consideration of wider industrial strategy for the UK (and vice versa). Getting the essential underpinning components and broad framework right for the life sciences will also enhance the UK’s industrial strategy more broadly.
 

2.      Sustaining the UK’s research base: The success of the life sciences sector is underpinned by the strength of the UK research base.  Maintaining a world-class research base across a broad spectrum of disciplines, including our strengths in life sciences and in both basic and applied research, is fundamental to the success of the UK’s overall industrial strategy, and to the strength of the life sciences sector. Maintaining public investment in the research base, via a balanced funding model, to sustain our strengths and help to leverage private R&D funding, will be vital. It is also crucial that the UK is able to continue to attract global talent and participate in EU research consortia, following Brexit.
 

3.      Innovation: The UK research base underpins the innovation pipeline and the UK’s strength in translational research. Ensuring the right framework to deliver continued innovation from research is crucial for both the life sciences and the broader industrial strategy. This requires both sustained investment in the research pipeline across a wide spectrum of disciplines, support for industry-experienced developers of novel therapies embedded within the academic base and fast, effective pathways to market to harness the potential of technology and software to develop healthcare innovations.

4.      Role of universities: Universities play a crucial role in delivering the research, innovation and skills necessary to support the life sciences sector and the broader industrial strategy. This includes supporting basic research, undertaking translational research, fostering partnerships between the commercial sector and public bodies such as the NHS, and delivering high-level skills. They are anchor partners in their regional economies. The life sciences strategy should seek to make the most of and invest in universities as key institutions to support innovation, in particular through collaboration with hospitals and industry. This will also help to deliver the wider industrial strategy.

5.      Skills: The life sciences and broader industrial strategy depends on a strong skills base to both generate scientific advances and translate these into applications for societal benefit. The UK needs to invest in a long-term pipeline of training to build up a strong high-level skills base for the life sciences sector for the future. It is also important to support mobility of staff between universities and the NHS, as well as universities and industry, to improve collaboration and the sharing of expertise.

6.      Regulation: The Government should take a number of actions, post-Brexit, to improve UK regulation to support life sciences innovation, including revising UK regulation to facilitate and streamline clinical trials, working with NHS England to ensure there are strong regulatory frameworks to support the use of NHS data for research and healthcare and ensuring that the UK retains access to the EMA and other European regulatory agencies. In addition Government should revise VAT rules to support co-location of universities and business.

A. Introduction

1. UCL is pleased to make a submission to the House of Lords Science and Technology Committee in response to its call for evidence on life sciences and the industrial strategy. UCL is London's leading multi-faculty university, with more than 11,000 staff and 38,000 students from 150 different countries. At UCL, world-class basic science is complemented by translational excellence, reflected in a range of competitive awards: UCL is a partner in three NIHR-funded Biomedical Research Centres, it has led the London Centre of the Farr Institute of Health Informatics Research (one of the four original centres), and it was recently selected as the hub for the £250m UK Dementia Research Institute.

2. The UK life sciences sector is world leading.[1],[2] In part this position has been achieved through the excellent interaction between UK academic research based in universities and industry (examples include the development of the first commercially available confocal microscope and production of therapeutic monoclonal antibodies).

3. Universities also play a central role in enabling partnerships between the commercial sector and public bodies such as the NHS. For example, the NIHR-funded Biomedical Research Centres (the home of many university-hospital collaborations) are vital hubs for translating laboratory-based research into new diagnostic tools and life-saving treatments. Universities also train and provide expertise to their researchers on how to commercialise their research outputs.

4. The life sciences industrial strategy should seek to make the most of and invest in universities as key institutions to support innovation. This is also crucial for the wider industrial strategy. In particular, given the implications of Brexit, it will be crucial to support life sciences to continue to thrive, by seeking to minimise the potential risks of Brexit and exploit potential opportunities.

B. Science and innovation

Q1. How can investors be encouraged to invest in turning basic life science research into new innovations in treatment?

5. Sustaining a strong, broad research base is vital to making the UK attractive to global investors (see Q2), in particular given that investing in translating basic research into new innovations remains highly risky. The cost of creating and bringing a drug to market has been cited as costing up to US$2.6 Billion[3] and often takes 10–15 years. Drugs are very likely to fail at each stage of testing, risking a significant financial cost. This discourages investment in translation.
    
6. Investment by private individuals, entrepreneurs and others can be encouraged through appropriate fiscal measures (such as Entrepreneurs’ Relief). Developing actions that recognise the need for long-term, patient capital investment from entrepreneurs would be particularly helpful in the life sciences, recognising the long life cycle of translation from discovery to treatment. Investment by private bodies (such as pension funds and family wealth funds) should be encouraged: the Patient Capital Review is likely to address this. In addition, development of public funding models to reduce risks associated with investment in very early stage companies and pre-companies, that encourage ‘crowding-in’ of private funding (such as is undertaken by the Rainbow Seed Fund[4],[5]), are desirable.

7. We also note the important role of public investment in leveraging private funding, in particular funding schemes that support pre-clinical development and early clinical testing (e.g. the MRC Confidence in Concept scheme) as these subsequently encourage private investment. Finally, it is also important for funders and universities to continue investing in important research and development to tackle rare diseases, which might otherwise not be successful in attracting investment.

Q2. Why has the UK underperformed in turning basic research in the life sciences into intellectual property? What needs to be done to address this historic weakness in the UK and grow new companies to commercialise new research and related technologies in the life sciences?

8. Promoting innovation and attracting global funding depend on maintaining a world-class research base across a broad spectrum of disciplines. Interdisciplinary research between life sciences and other fields provide new insights that drive innovation (e.g. at the interface of life sciences and technology, see Q10), while the growing trend of emerging life sciences disciplines (such as biomedical engineering or clinical data science) provides important advances for the field. In addition, insights from other areas, such as the social sciences, can support the development of ethical frameworks that ensure research is socially appropriate and supports innovation.[6] The broad UK research base and research at multidisciplinary universities underpin the life sciences innovation pipeline, and make the UK attractive to global investors, supporting the translation of research findings into innovations. In addition, the Industrial Strategy Challenge Fund will provide an important stimulus for industry-focussed life sciences research and investment in skills (see Q3).
    
9. It is important to develop a culture that supports academics to commercialise their findings, enabling basic research to drive innovation. For example, there is a clear tension between the academic incentives to publish findings (including publication requirements from funders to support open science[7]) and the requirement to keep findings confidential to enable patenting. There is often a lack of understanding of what IP is and how it works, which means that academics can publish findings without realising that this prevents the ability to patent the invention, hindering the development of IP. It is important to improve awareness among researchers of the framework for translating research and IP, so that they know what is needed to protect the ability to patent their invention. Integrating education about IP into research students’ and early career researcher training should be a high priority, to support the creation of IP while complementing broader commitments to open science. For example, training in IP is offered to research students and academics at UCL.
    
10. Supporting commercialisation also depends on having the necessary links between academia and industry. Many academic research groups are seeking to further their engagement with industry and joint training (see Q3) and the promotion of greater collaboration (see Q7) will help to support the creation of further links.

11. Experienced industrial drug developers can provide valuable input to support innovation in academia. They help to identify new translational projects, advise academics on IP as well as the appropriate critical pathway, and support funding streams to develop their therapy/innovation. Universities also have a critical institutional role to play in providing expert advice to academics interested in commercialising their findings, and to support them to engage with industry. For example, UCL’s Translational Research Office (TRO - an academic embedded industry experienced group) provides integrated support for translational research, industrial partnerships and drug discovery, and has developed a managed translational portfolio of more than 80 projects attracting a cumulative value of £97m in investment. This portfolio of projects has been advanced by UCL Business, which has supported the creation of 20 life sciences UCL spin-off companies since 2011[8] (such as Autolus, which received £30m in investment from healthcare investment company Syncona to commercialise a new generation of engineered T-cell therapies for cancer).
     
12. Funds to support academics to commercialise their research have an important role. For example, the Apollo Therapeutics Fund – a partnership between UCL, Imperial College and Cambridge University and AstraZeneca, GlaxoSmithKline and Johnson & Johnson Innovation – funds translation of university research into new medicines and provides drug discovery expertise to support academics to translate their findings.

Q3. What can be done to ensure the UK has the necessary skills and manpower to build a world class life sciences sector, both within the research base and the NHS?

13. Building a strong skills base to support the world-leading UK life sciences industry, and industrial strategy more broadly, depends on investing in a long-term pipeline of training. This begins with doctoral training programmes delivered in universities, which provide research students with an important grounding in research and technical skills for their careers.[9] UCL provides the UK’s largest MRC DTP, with Birkbeck College; leads the UK’s largest multi-institutional BBSRC DTP; leads one of the largest ESRC DTPs; and delivers 16 EPSRC CDTs. We welcome the recent increase in PhD studentships allocated under the National Productivity Investment Fund, 10 of which have been awarded to UCL for this academic year. The ability to fill a large number of PhD studentships in a short period of time illustrates the high demand for such training and the availability of high-quality students.
     
14. It is vital to develop skills that cross the boundaries between universities, hospitals and industry. Training clinical academics is a valuable way to promote research that has impact on healthcare. UCL has invested in clinical academic training: through the Academic Careers Office, we have built the UK’s largest cohort of NIHR Academic Clinical Fellows (95) and Clinical Lecturers (53). Industrial CASE Studentships and UCL ‘IMPACT’ Studentships (studentships supervised and funded by both academic and industrial partners) also help to develop industry-focused research skills. Ensuring mobility of the workforce between academia and both the NHS (see Q12), and industry, is also important to share expertise and skills, and support closer collaboration.

15. If the industrial strategy is to be a success, the UK must retain the ability to attract talented individuals from across the EU and globally, to support research-driven innovation across disciplines. If this ability is adversely affected, we risk losing ground to our international competitors as they continue to attract the brightest and best researchers and innovators. To mitigate this will require sending a clear message of continued commitment to recruiting the most talented researchers and innovators (as asserted in the recent Government position paper on Brexit and science and innovation[10]), ensuring a simple, light-touch visa scheme for researchers and introducing dedicated funding schemes to support international recruitment. With regard to the latter, we welcome the £100m Rutherford Fund to provide UK fellowships for highly skilled researchers from around the world.

Q4. How does the UK compare to other countries in this sector, for example Germany and the United States?

16. Compared to other countries, in particular the US and Germany, the UK has a relatively compact pharmaceutical industry. Only about half as many people are employed in the pharmaceutical industry in the UK (61,500 people) as in Germany (114,069),[11] while the US industry (over 854,000)[12] is approximately eight times the size of that in Germany. In light of this, providing a regulatory framework supportive of pharmaceutical research and development (see Q17) will be an important way to ensure the UK is seen as a country welcoming such activities.
     
17. Associations between pharmaceutical companies and university scientists have been key to success in other countries. Such associations have long existed in Germany and Switzerland, supporting their cutting edge, innovative approach to the formulation of new compounds, for which they are now well known. These countries, as well as the US, have also seen significant flow of personnel between universities and the pharmaceutical industry in both directions. By contrast the UK has not had such longstanding associations nor as much flow of personnel, which may have reduced opportunities for innovation. However, a number of associations between industry and universities have been developed in the more recent past (see Q7). It will be crucial to continue supporting such collaborations (for example through translational research funding and collaborative research centres) to ensure that the UK’s industrial strategy allows it to compete on an international scale post-Brexit.

C. Industrial Strategy

Q5. What can be learnt from the impact of the 2011 UK Life Sciences Strategy? What evidence is there that a strategy will work for the life sciences sector?

18. The 2011 Life Sciences Strategy provided an important goal: to capitalise on the expertise in universities and the wider sector to develop a pipeline of treatments. A number of its goals were achieved, illustrating the value of taking a strategic approach to support advances in life sciences. For example, it led to the MHRA Innovation Office being set up in 2012, which provides expert regulatory information and advice that helps organisations to develop innovative products. Continued investment in strategic activities to support the translation of life sciences research is essential if the UK is to be a world leader in life sciences.
     
19. Aside from advances in scientific knowledge and healthcare, strategic investment in the life sciences sector generates economic benefits for the UK: for every pound of public investment in biomedical and health research, private sector R&D output rises by 20p per year in perpetuity[13]. This represents a significant contribution to UK productivity.
     
20. The Biomedical Catalyst,[14] funded by Innovate UK and the MRC, was established as part of the 2011 Life Sciences Strategy. This scheme has been one of the most effective funding schemes established to support innovation in the biomedical field. In addition, it has enabled a renaissance in UK biotech companies, as acknowledged by the BioIndustry Association.[15]

Q6. Does the strategy contain the right recommendations? What should it contain/what is missing? How will the life sciences strategy interact with the wider industrial strategy, including regional and devolved administration strategies? How will the strategies be coordinated so that they don’t operate in ‘silos’?

21. We welcome the recently published Life Sciences Industrial Strategy report[16] led by Sir John Bell. In particular, we value its recognition of the central role of universities in partnering with the NHS and commercial bodies, contributing fundamental research, and building a pipeline to commercialisation. The report acknowledges the importance of maintaining a consistent stream of funding to university research, and recommends that the Government should increase funding for basic science and that UKRI should foster interdisciplinary research. We welcome these recommendations, given the importance of investing in discovery research and interdisciplinary research to drive the pipeline to innovation and commercialisation. We note that maintaining investment in basic research, sustaining and enhancing the UK’s capacity for clinical and translational research to drive innovation, and investment in research skills are vital for the wider industrial strategy.
     
22. Maintaining a strong research base across the breadth of disciplines benefits the life sciences and the broader industrial strategy, with advancements in knowledge in one area having the potential to catalyse innovation in another. For example, researchers at the UCL Institute of Neurology pioneered brain scanning approaches that are now used by neurosurgeons throughout Europe to inform decisions about whether to perform surgery on epilepsy patients and improve the safety of the operation[17]. This illustrates the importance of interdisciplinary research to deliver scientific and healthcare advances.
     
23. UCL also supports the report’s emphasis on the importance of pools of patient capital for investment, and the need for mechanisms to build long-term capital pools through tax relief, to allow the life sciences companies of the future to grow. As described under Q17, there is also a need to review VAT rules affecting university and business co-location, to harness the potential of incubators (whose value is acknowledged in the life sciences industrial strategy report led by Sir John Bell) to support university collaboration with SMEs.

24. It will be important to ensure that the life sciences industrial strategy aligns with and is supported by the wider industrial strategy. For example, Sir John Bell’s report recommends that UKRI fosters interdisciplinary research in the life sciences with other areas; it will be important for cross-cutting aims such as this to feature across the strategies of each sector as well as in the overarching strategy, to ensure that the strategies are joined up.

Q7. What opportunities for small and medium sized enterprises (SMEs) are there/should there be in the strategy? How can they be involved in its development and implementation?

25. SMEs have a valuable role to play in translating academic knowledge into applied outputs with social and economic benefits. UCL collaborates with a large number of SMEs: in 2015/16, for example, UCL had 96 research contracts with SMEs, and 14 SMEs used facilities and equipment-related services. UCL’s partnerships with SMEs have stimulated the development of new therapies. For instance, UCL has partnered with the company SoftV,[18] which provides strong games development expertise to academic research projects. By connecting academics and games designers, this collaboration has led to the creation of new types of therapy. It is important to support partnerships between academia and SMEs (e.g. through reviewing VAT rules, see Q17) in order to support commercialisation.

26. Further funding is needed to support SME creation. The UCL Technology Fund provides funding for innovations through the development journey from initial proof of concept to practical commercial application, and investment in commercialisation of research at UCL has led to the creation of several SMEs (see Q2). Further early stage translational funding, such as proof-of-concept funding and technology transfer grants, as well as pools of patient capital, are needed to support the creation and incubation of new SMEs.

D. NHS procurement and collaboration

Q10. How can public procurement, in particular by the NHS, be an effective stimulus for innovation in the Life Sciences Sector?

27. NHS procurement is often too slow and inflexible to provide an effective stimulus for innovation in the life sciences sector. The drivers in NHS procurement are typically aimed at cost reduction and standardisation of a product across the NHS. By contrast, life sciences research can sometimes require the use of innovative and novel niche products, often requiring the use of niche suppliers because they supply a product that is innovative. Since the procurement processes in the NHS and in research are different, the drivers for procurement in the NHS do not always translate into drivers for innovation in research, and such a model is unlikely to be fully effective in delivering innovation.

28. NHS evaluation (e.g. NICE) and procurement strategies are oriented towards drug treatments. With the rapid move towards development of digital therapies and devices, there is an urgent need to ensure that NHS procurement processes effectively accelerate evaluation and (where appropriate) widespread adoption of new technologies. This process needs to be rapid and flexible, reflecting the typically shorter time-to-market of such newer approaches, while respecting the need for high-quality evidence of efficacy and cost-effectiveness. An example is MRC-funded research at the UCL-UCLH Biomedical Research Centre, which has used ‘big data’ (information from patients in 11 hospitals) to identify patients at risk of acute kidney injury (AKI). UCL academics are working with Google DeepMind and the Royal Free Hospital NHS Trust on an app to alert clinicians to possible cases of AKI, allowing preventative measures to be taken.

Q12. How can collaboration between researchers and the NHS be improved, particularly in light of increased fiscal pressures in the NHS?

29. The dual support model of research funding, which ensures balanced funding streams, gives universities flexibility in their strategic activities, including supporting joint clinical appointments, strengthening collaboration with the NHS, enabling long-term research activities and emerging research areas, and supplementing grant funding. All of these activities are vital for promoting research-driven innovation. Additionally, the Charity Research Support Fund (provided through QR funding) enables medical research charities to invest in research to develop life-saving treatments, and in many cases also leverages funding from industry partners. Charity funding to the university sector has seen a (welcome) significant increase recently and consideration will be needed of how CRSF and QR funds continue to sustainably leverage charity investment in life sciences and enable the flexible support required.
     
30. NIHR funding has supported collaboration between the NHS and research through the Biomedical Research Centres (BRCs). For example, an initiative at the UCL-UCLH BRC, UCL BioResource, set up in 2012, created a group of 7000 volunteers to take part in research cohorts. It has been integrated with the NIHR BioResource, a group of eight centres, which allows individuals to be contacted for clinical studies depending on their genotype or other characteristics. Continued collaboration will be essential to promote further cohort research.

31. However, NHS staffing pressures have increasingly constrained the ability of medical staff to work in research and the flexibility of trainee doctors to move between NHS and university employers as they train in clinical academic careers. To improve collaboration between the NHS and research, it will be important to protect the flexible movement of doctors, nurses and allied health professionals between NHS and research institutions, allowing staff to take time out of the NHS to do research and then return to work in the NHS. (Permeability between research institutions and industry is equally important.) Expanding the role of Biomedical Research Centres, and the promotion of flexibility, will support joint working between the NHS and academic research.

E. Responsibility and accountability

Q15. Does the Government have the right structures in place to support the life science sector? Is the Office of Life Sciences effective? Should the Government appoint a dedicated Life Sciences Minister?

32. Within Government, coordination is required to support the life sciences sector as it spans multiple ministerial offices. The current arrangements are not optimal. Life sciences requires substantial focus in Government because of its complexity, with many partners involved, and its great potential to generate health-related and economic benefits for the UK. Coordination could be achieved through the appointment of a single life sciences minister (as had been achieved until recently), or via a working group of appropriate seniority and influence, such as the Board suggested in Sir John Bell’s report, which mediates between the different branches of Government.

F. Brexit

Q16. 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?

33. It will be crucial to mitigate the major risk that Brexit will lead to a reduction in the UK’s ability to attract skilled researchers internationally (see Q3).

34. EU funding and consortia have been key to advancing research, and continued access to and involvement in these will be vital to support the UK life sciences sector and wider industrial strategy. EU grants have been successful in bringing together academics and industry. For example, IMI initiatives such as StemBANCC have produced a wide resource of patient-derived cell models that are required for drug discovery. This kind of research is only possible in academic laboratories, but feeds directly into the drug discovery pipeline. The StemBANCC project has allowed UCL academics to engage directly with the pharmaceutical company Eisai in a project to develop novel therapeutics for Parkinson’s disease. In Brexit negotiations, the Government should seek to ensure that resources developed by such EU initiatives remain available to UK researchers post-Brexit.

35. The European Research Council (ERC) has been particularly important for nurturing early career researchers in the life sciences particular through their Starting Grants. Since the Starting Grants were introduced in 2007, the UK has gained the highest number of awards in eight of the 10 call years,[19] including in the latest 2017 round (79 out of a total of 406 awarded)[20]. In 2017 UK awardees also included the highest number from outside the host country, emphasising again the attractiveness of the UK as a global destination for the best and brightest early career researchers.

36. EU consortia provide a framework for international collaboration that the UK cannot replicate on its own. For example, the FORECEE project (Female Cancer Prediction Using Cervical Omics to Individualise Screening and Prevention)[21] is led by Professor Martin Widschwendter at UCL and involves a large team of researchers across universities and hospitals in Sweden, the Czech Republic, Norway, Italy, Germany, the Netherlands, Austria and the UK. GATC Biotech, a sequencing company, and the Oncotyrol Center for Personalized Cancer Medicine in Austria, a public-private partnership of academic and industrial partners, are also involved. The project will investigate the factors that may predict a woman’s risk of developing breast, ovarian, womb and cervical cancer (the 4Cs) and develop Women’s cancer risk IDentification tests, or (WID) tests, and work with key decision makers across Europe to discuss how the tests could be rolled out. The EU framework is crucial to supporting large international collaborations such as this, and securing the UK’s involvement in EU consortia going forward must be a priority for the Government.

Q17. How should the regulatory framework be changed or improved after Brexit to support the sector?

37. There are a number of areas where UK regulation has the potential to improve support for the life sciences sector:

a.       Regulatory frameworks are currently onerous for clinical trials. Post-Brexit the Government should facilitate a quicker and more streamlined setup process for clinical trials, while retaining compliance with global standards to support continued collaboration in international trials. This would set the UK up as a platform for clinical trials, advancing the UK’s capability in life sciences industry.

b.       The regulatory framework needs to keep pace with fast moving sectors such as digital health. The Government should work with NHS England to ensure there are strong regulatory frameworks to make the most of the significant opportunities for use of NHS data for research and healthcare. Translational grants within UCL are rapidly moving towards software and devices rather than traditional therapies. This likely indicates a shift towards greater technology use in healthcare, and there is a need to provide regulatory frameworks to support these.

c.       VAT rules significant discourage research collaborations, both within the university sector and between universities and business. At present, newly constructed charitable buildings can lose their charitable status for VAT purposes if commercial activity surpasses 5% in the first ten years following their creation. This provides a strong disincentive to collaboration with industry. The Government should amend these VAT rules to reduce the detrimental effects on research collaboration.

38. It is important to support the development and adoption of technology in the NHS, yet at present the UK lacks a clear pathway to market for such technologies. Harnessing the potential of technology and software to develop healthcare innovations will require the establishment of fast, effective pathways to market; it will be important for the MHRA to consider this going forward. In autumn 2017, UCL will be holding a workshop with the Academy of Medical Sciences, MHRA, the Centre for the Advancement of Sustainable Medical Innovation (CASMI) and others to consider this issue and how to address it.

Q18. To what extent should the UK remain involved with and contribute to agencies such as the EMA post Brexit?

39. The UK’s involvement with the EMA and other regulatory agencies (such as EURATOM) provides an important part of the infrastructure to support UK life sciences. Replacing these with a UK agency in a reasonable time frame is unrealistic. It should be a priority for the Government to ensure that the UK retains access to these agencies in order to remain competitive in drug development, ensuring that the UK life sciences sector continues to lead the way globally. It will be important to retain the UK’s influence over European regulations, both through the significant role of the MHRA in developing European medical regulations, and the work of leading UK academics as advisors to the EMA.

Acknowledgements

This document is based on contributions from the following members of the UCL community: Tony Langford (Division of Biosciences); Dr Celia Caulcott (Innovation and Enterprise); Dr Ricardo Henriques, Dr Robin Ketteler, Professor Mark Marsh (Laboratory for Molecular Cell Biology); Dr Matt Fisher (Faculty of Laws); Professor Geraint Rees (Faculty of Life Sciences); Sarah Chaytor (Office of the Vice-Provost (Research)); Dr Jane Kinghorn (Translational Research Office). Kasia Olszewska (Department of Science and Technology Studies) carried out research to inform the submission.

15 September 2017