Medicines Discovery Catapult – Written evidence (LSI0116)

 

The Medicines Discovery Catapult has recently been established as a National Facility for Collaborative Medicines Discovery. It brings together a fragmented UK sector of industry, academia, charities, technologists, services and finance companies who can turn good science into new, high value medicines. Its scope stretches from disease target association to clinical proof of concept and incorporates Precision Medicines, diagnostics and biomarkers.

 

Headquartered in the North West it is collecting a broad range of rare scientific, informatics and industry skills; and providing expert access to scarce new technologies that the sector really needs today. These capabilities help the sector strategically address the unsustainable costs of discovering new medicines by working more effectively together. It is are also enabling research charities though a new, joined up consortia that we call Discovery Syndicates that will engage patient groups with industrialists and academics in bringing the highest value, targeted treatments to a successful proof of principal in clinical trials. This will all bring long term wealth to a vital economic sector for the UK, health for UK patients and retain our position as a global leader in the industry through a time of radical change.

 

The Catapult is an independent company, limited by guarantee with core funding from Innovate UK, an agency of the Department of BEIS.

 

Founded in 2016 the Catapult has hired an exceptional board, chaired by Professor Graham Boulnois and comprised of internationally recognised entrepreneurs, clinical experts, research charity leaders and lay professionals. It has brought together an executive team of industry experts, across therapeutic, diagnostic and informatics fields and is currently expanding its workforce and facilities in Alderley Park, Cheshire. Its facility for innovation at antimicrobial drug resistance, based at the University of Warwick, was opened by the Lord Warner in March 2017.

 

Medicines Discovery Catapult supports a mature community but has a significant job to do in preparing that community for a future with a greatly change pharmaceutical company behaviour. This change is existential, with changes similar to those seen in traditional UK manufacturing industries. In order to survive and thrive in this new environment the new sector of smaller, interacting, specialist players will need to;

 

 

The Catapult has undertaken significant sector engagement and has a unique position at the nexus of industry, academia and government.

 

Amongst its roles are the de-risking of new, enabling technologies, collaborative applied R&D to address system sector issues and; to prepare the sector for a time of industry change through the development of new processes and services.

 

One of these roles – support of the sector in the translation of promising scientific ideas into fundable, industry compatible new medicines - was reflected in the 2017 Life Sciences Industrial Strategy. The Catapult was named as a delivery vehicle for a proposed Translational Fund. This Fund, and the Catapult’s unique capabilities, will enable leading academics and SMEs to combine industry rigour with academic endeavour, and progress more great science into new prototype medicines that can be privately funded or licensed as products that benefit the UK economy and patients.

 

Although the Catapult is new, its sector experience is broad and deep, offering a vision of today’s issues and the potential for new UK solutions based upon solid sector principals.

 

Science and innovation

 

1. How can investors be encouraged to invest in turning basic life science research into new innovations in treatment? Why has investment been lacking in this sector? Does the research base have the necessary infrastructure to be world-leading?

 

  1. Medicines R&D is a high-risk activity that has traditionally been invested in by large multinational pharmaceutical companies and specialist venture investors, whose teams understand the risks involved. The process of discovery, prototyping and clinical development is highly regulated, multidisciplinary and each phase carries significant attrition that even the largest companies cannot fully mitigate. Failure rates in the clinical development remain high, contributing to a high proportion of the cost of new medicines. R&D costs are becoming less sustainable for even large companies. The cost of developing a new drug ranges from $648M[1] to $2.6bn[2].

 

  1. The regulated nature of the clinical development and manufacturing processes have made the sector surprisingly slow to innovate, and many inefficiencies remain unaddressed.

 

  1. Many large pharmaceutical companies have come under financial strain in recent years: their patents have expired and they have failed to develop new medicines to fill the gap. Investment has been focussed on ‘later stage’ developments, thereby reducing investment into the early-stage research that stimulates biotechnology SMEs. Furthermore, merger, acquisition and licensing of others’ assets offers a lower return on investment than in-house derived assets. This reduction in ‘bottom up’ investment has starved the sector of valuable investment in novelty and process improvement.

 

  1. SMEs are a vital component of the UK life sciences sector. The relative success of SMEs is also reflected in the growth of their workforces – over the past five years, 70% of UK SMEs in pharmaceutical R&D have increased their number of employees, compared to only 30% of large companies.[3] Moreover, many large pharmaceutical companies are increasingly outsourcing their innovation activity to SMEs, further emphasising their critical importance, but they lack the flows of capital to resource them at the rate of the large companies.

 

  1. The financial crisis of 2008 had a global impact on high risk investing in SMEs. Whilst this has largely recovered in the risk-savvy environment of the USA, the UK public markets remain skittish for early-stage private life sciences investments and starve fledgling companies of the funds required. Rather, companies receive a breadcrumb trail of small funding rounds that can stifle vital ‘serendipity based’ discovery.

 

  1. Private investors appear wary of companies offering innovative new discoveries that are at too early a stage for clinical testing. Even for those companies progressing completely new medicines, the time spent in multiple rounds of grant, venture capital or public market funding reduces the speed and agility of these innovative firms. It also wears down management teams and encourages the expatriation of companies and assets to the USA and, increasingly, China.

 

  1. There are encouraging ‘pump-priming’ schemes able to back early-stage companies and projects. These include Innovate UK competitions for early stage translation and the 100M pound Biomedical Catalyst fund for later stage translation. These are strongly supported by the sector. However, these funding competitions are oversubscribed with high quality projects, demonstrating the wealth of British ideas worthy of backing. Costs of taking a medicine from an idea to a proof-of-concept range between £3-5M. Currently the Biomedical Catalyst fund provides only 35-45% of such costs. Moreover, the recent 2017 competition provided only £12M across all successful projects nationally. Innovate UK competitions and the Biomedical Catalyst, if sufficiently expanded or leveraged with private money, could increase the number of viable projects. This would nourish and help grown SMEs in the UK. (see also Sections 2.2 & 6.1)

 

  1. Money is not the only important resource. Access to key skills and industry experience that are vital for SMEs to be successful. Thanks to the breadth and depth of its staff’s know-how, the Catapult is able to help inexperienced SME teams to prove and progress their ideas and use valuable money efficiently.

 

  1. Investors need encouragement to back innovators, particularly to back those who come from outside life sciences but with experience of novel technologies. Innovators from information-driven sectors, for example, could help revolutionise the life sciences sector. Supporting them could be achieved through leveraged funds similar to the Dementia Fund: a disease focussed fund seeded by government, leveraged by private investment and managed by experienced venture capitalists, SV Life Sciences.

 

  1. The Translational Fund, outlined in the Life Sciences Strategy, is a clear example of a fund set up for the express purpose of placing significant (up to £5M) resources behind potential new medicines. This gives enough ‘runway’ for these projects to reach a high value without staggered funding. It can build a pipeline that will generate economic value and, through the experience, train a cohort of future sector leaders.

 

  1. The Catapult’s “Discovery Syndicate” concept also opens up radical new ways of funding the sector. Syndicates will be long-term discovery consortia – anchored by disease-specific medical charities - that will contain biopharma SMEs, technologists and larger companies with a focus on that disease. These consortia will be the source of portfolios of collaborative projects and the means through which the results may be disseminated. Charities bring to the Syndicates a greater visibility of clinical realities and real unmet patient; the industrial players provide a clear view on the areas where collaborative R&D will overcome technology and process barriers; the Catapult will manage the process and provides the facility for the R&D to occur.

 

  1. Working with the existing (SEIS/EIS) tax code and modern crowdfunding platform Syndicates can use the venture philanthropy approach to attract new investors, with an interest in the disease to create a parallel fund containing long term, tax efficient money by which to fund their drug R&D activities. Investors could be drawn from high net worth individuals, and institutions who have interest in a disease, without the wish to donate purely to charity, and with the wish for long term return, along with social funding. These funds could open up significant new sums of money for the sector and be the beginning of an innovative new ‘market’ for life sciences investment. Returns could flow to investors in long term revenue share or royalty sales and there could be additional financial return to the charity, as a Syndicate member. (See Section 2.2)

 

  1. The research-base in the UK remains strong. However, there remains a vital need for dedicated infrastructure to drive economic growth in life sciences. For example, academics need a national centre where they can ‘try and test’ their innovation, in order to make it suitable for industry and privately fundable. This is where the Catapult plays a unique and important role, helping to translate academic endeavour and supporting young companies.

 

2. 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?

 

  1. The UK is not fundamentally weak at its ability to perform translation, but it is relatively poor at IP capture, but and is very strong at publication. These elements contribute to the UK’s global positions as only the 17th strongest nation in innovation[4]. The academic drive (and its financial incentives) to publish great science quickly can conflict with the national need to anchor IP in the UK. Whilst this is a Gordian knot, the UK could benefit economically from a privileged national IP review prior to publication, sponsored by the new UKRI. Allowing national Translational Funds early access to the national spring of science could ensure that valuable assets are prepared for funding and development prior to being released for global consumption. The monitoring of the citation of UK funded patents (as NIH does) could be an important new metric to incentivise this behaviour.

 

  1. The approach taken by the US Defence research agency, DARPA, is one from which the UK could benefit. DARPA takes large long-term bets in key technology areas and funds a deep trench of innovation in them. Their successes include the development of GPS and areas of the internet, enabling US companies a privileged feast of innovative IP upon which to build businesses. The formation of a Translational Fund with an investment of £3-5M per project will represent a style of funding akin to that seen in the USA and enable full and fast development of potential assets and the ability to perform ancillary experimentation to deliver serendipitous new discoveries.

 

  1. Engaging medical research charities is vitally important. Medical charities bring the voice and needs of the patient to the beginning of medicines discovery and, by involving them in projects, provides an engaged group of patients willing to volunteer for clinical evaluation. Both of these factors help to deliver patient-centred, high value products. The UK has a thriving research charity sector which invests up to £1bn per year in basic research[5]. Beneficiaries of charities – patients – are increasingly asking their charities to invest in more directly translating this basic biology into new medicines. In the USA, this has been seen recently in the $3.3bn licensing of the drug ‘Orkambi’ funded through discovery by the Cystic Fibrosis Foundation to the pharmaceutical company Vertex.  In the UK, in cancer, this has been successfully undertaken by Cancer Research UK and Institute of Cancer Research with Aberaterone and MRC-T (now LifeArc) with Keytruda. There is equal pressure in many other disease areas and this requires charities to take new levels of risk and to access industrial skills. The Medicines Discovery Catapult believes strongly in practically assisting charities to do this.

 

  1. Grant applications that are successful are put in the public domain, which means that companies in other countries can benefit from their results. This is clearly unhelpful to UK Plc. In addition, grant applications that just miss the mark receive no help. They remain an ‘unknown unknown’ source of ideas and potential value for the UK economy. The number of unfunded projects and grants may represent a valuable stratum of unexploited value for UK Plc. Creating a mechanism to pass these for ‘translational’ review could create more opportunity for the nation and the Medicines Discovery Catapult would be keen to explore how it could do this.

 

3. 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?

 

1.       The lack of growth in the sector in the last 10 years has created a lost generation of biotech management. This has left investors with a dwindling number of experienced biotech leaders and a large number of untested former-pharmaceutical employees with little experience of the very different skills needed to raise and run a small company.

 

2.       The Medicines Discovery market for the talent that does exist is global and very competitive. The UK has a heritage of expertise in the sector and can benefit more from the skills it has, and develop those skills it needs. This mentoring, retooling and retraining needs a national effort.

 

3.       The Catapult has a concept of a Drug Discovery Academy that will harness the best drug hunters from across the UK. Drawn from across the ‘tribes’ of former pharmaceutical companies and unlocking the regional siloes of expertise, this curated group can be put to work to advise early stage companies on the best ways to get appropriate financing and commercial licenses. This team can also mentor the next generation of leaders in the industry.

 

4.       Catapult and other leading executives should be encouraged to take lectureships in Masters degrees for biotech entrepreneurs. Tax policy should ensure that senior people are incentivised to use their time in this way, companies are incentivised to take on staff from these courses and investors are incentivised to invest in less experienced management teams, overseen by industry mentors.

 

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

 

1.       The Life Sciences Industrial Strategy provides detailed evidence of the UK’s strength in basic life sciences, where the UK has a strong international reputation. The report also notes that - despite lower overall investment in R&D in life sciences than Germany or the US - the research community in the UK is twice as productive as in the US and almost three times greater than in Germany. This productivity lead is however not converted into potential new medicines. For example, the UK grows fewer clinical stage companies than the comparable the US. To reach equivalence, it is estimated that the UK would need to build - and provide credible management teams for - 125 additional clinical-stage companies[6].

 

2.       OECD Study on ‘Impact of Public R&D Expenditures on Business R&D Spending’ showed that 1997 and 2012, more than half of the intellectual property related to the world’s new medicines was invented in America. While, in the 2000s, US biopharmaceutical companies introduced more new chemical entities than companies from the next five nations combined. Switzerland was second to the United States in the number of new chemical entities invented between 2001 and 2010.

 

3.       NIH patents averaged 5.14 forward citations, meaning America’s NIH is an integral part of the knowledge chain, with an additional $105.9 million in downstream R&D for every $100 million in taxpayer funding. These downstream connections represent other research organisations, in both the private and public sector, leveraging NIH discoveries into follow-on R&D spending. This implication on IP capture is important to note

 

4.       In the US, venture capital is much more abundant than in UK or Germany and it invests more significant sums in early-stage companies, giving them a significant ‘runway’ to try and test their ideas. This ability to move at pace creates rapid prototypes that are then able to enter the supply chain and recycle money into the sector. They also produce companies with assets that can be picked up by growth capital and developed into billion-dollar biotech’s capable of R&D and commercialisation. In Germany, regional and federal ‘soft’ money supports biotech companies to later stages of development and offsets the early-stage risk for venture investors. In the UK, companies often depend on scarce venture capital at a very early stage, forcing the launch of immature companies and providing venture capital companies with poorly advanced assets and management teams; this further encourages them to invest abroad. This vicious cycle creates further barriers to adopting new models and a perception that the UK is worse at translation than it is – or could be.

 

5.       The European attitude to risk remains significantly more hawkish than that in the US. This reflects national cultures. The UK should work within these norms and recognise the role of government to support assets to a later stage of development, lowering the risk for follow-on venture funding and thereby supporting an environment for leveraged (often inward) investment. However, it is critical that these support funds should be accompanied by independent industrial capability so that money is used well, creating potential new medicines that the industry (and patients) really need.

 

Industrial Strategy

 

5. 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? How can its success be measured against its stated objectives?

 

  1. The 2011 Strategy came at a winnowing time for UK biotech. The success of the Biomedical Catalyst was critical in helping the UK recover from a dearth of funding and a US market that had drawn resources away from the UK. The rise of the services sector for life sciences was also a success of the Strategy; the UK’s expertise was channelled into high-value specialist companies who added value to the economy (albeit by developing many high-value assets for global companies). The growth of the UK’s service sector for life sciences helped address the problems outsourcing work to the US or lower cost countries.

 

6. 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’?

 

  1. The Strategy proposed a Translational Fund, which could transform the UK’s pipeline of potential new medicines via significant (£3-5M) backing of the best projects. It is essential that such a Translational Fund has sufficient funding to help UK SMEs be successful at pace. This level of investment begins at the ceiling of the Biomedical Catalyst and offers a US style approach to backing an ‘asset’. Importantly, this risk is offset by coupling the Catapult’s industrial expertise and capability to manage these programmes, with the experience of the Medical Research Council and National Institutes for Healthcare Research. Led by the Medicines Discovery Catapult so as to support SMEs, the combined capabilities of these three organisations would ensure the success of the Translational Fund. The result would be new, high value companies – and innovative medicines – for the UK.

 

  1. The Strategy supports the idea growing larger-scale companies. Much of the UK biotech stable, constrained financially or perhaps by expectation, fails to grow to significant ‘standalone’ size. Recent significant fundraising by companies such as Immunocore is very encouraging. However, the UK needs more companies with drug candidate assets able to be funded to such a level, along with a diversity of companies such that (likely) failure of some of them does not extinguish the entire sector. The Translational Fund has a key role to play in preparing assets, management teams and the UK market for this. Success will breed further inward investment and momentum.

 

  1. The Strategy recognises the importance of secure, consented access to patient samples and their data. This is critical for the development of new diagnostics, which will help stratify and target relevant patient groups for new medicine testing and for treatment.

 

  1. The importance of best use of data is crystallised in the Strategy, with the aim of developing world-leading expertise and IP in the handling of data that links outcomes to biomolecular information, forming a virtuous circle of clinical learning and industry application.

 

  1. The Strategy recognises the pivotal role that charities can play as conduits for real patient needs, and for trusted access to patients.

 

  1. The Strategy proposes engaging the NHS as a research engine, with the potential to dwarf the development capability of any large pharmaceutical company. If this capability is well harnessed to a Medicines Discovery function as described by the Catapult, the Syndicates and partners in a Translational Fund, then a pipeline of high growth companies can be built.

 

  1. The Catapult supports the development of a number of priority areas of emerging data technologies in a way that their application and value can be realised. This includes the development of new business processes and business models.

 

7. 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?

 

  1. The Strategy reflects the importance of nurturing the SME community of UK innovators, wherever they are in the nation.

 

  1. A recent mapping of the UK biopharma sector by the Office for Life Sciences notes that ‘there is a diverse size range of core biopharma companies with a lot of micro companies: 42% have less than 5 employees and just over 10% have over 250 people.’[7] Thus, many of the companies in the sector have limited people and few strategic resources. In general, they are focused and funded for the short term, often with a single therapeutic asset, and have neither the ability nor the resources to provide innovation for the community.

 

  1. To support SMEs, the Catapult will provide access to skills and scientific assets that today’s SMEs themselves cannot secure. For example, the Catapult’s recent investment in solid-state NMR will provide technology previously unavailable to SMEs in the UK. This technology and expert staff will enable biotech companies, contract research organisations and others to develop complex assays and monitor molecules, drug targets and proteins in unique detail.

 

  1. The Catapult will also work with medical charities, regulators, Research Councils and technologists, so as to support future SMEs in a changing environment.

 

  1. As pharmaceutical companies continue to change their R&D behaviour steadily but not rapidly, a new group of specialist companies must be nurtured. These companies need much more diverse business models, public-private partnerships, Discovery Syndicates and people with skills from outside the sector. These new specialist companies, with disruptive technologies - often in the data field - have found it challenging to work with larger pharmaceutical companies wedded to old approaches. The Catapult has a clear role to play in supporting, applying and proving these new approaches, building consortia of complementary companies, skills and assets for a better future economy. This will be enabled by the closer working of Research Councils and Innovate UK under UKRI and by better coupling NHS research resources to the Medicines Discovery pipeline through NIHR, MRC and the Translational Fund.

 

8. Where should the funding come from to support the implementation of the strategy?

 

  1. We recognise that a mixture of both public and private financial sources will be required to deliver different segments of the strategy. We agree to an extent with Lord David Willetts who said this year in a speech at SCI (the Society of Chemical Industry)  that Government should be prepared to bear the risk of applied research rather than depending on businesses to fund their own research. “The fundamental responsibility of government is to bear risk, to take science from the laboratory to the market place. It is not the role of companies.” We would caveat that whilst government (UKRI/Catapults) can, like NIH, prime the pipeline with higher risk, longer term investments to try and test prototypes, industry is best placed to take those early prototypes to market. Rather than deal with assets on a case-by-case basis, which can be slow and inefficient, industry should be able to drink from a pool of such assets.

 

  1. Creating one leveraged Fund for all types of assets can be complex, as not all of the Life Sciences industry is interested in all types of assets. We support the creation of a generalised Translational Fund and public sector investment in the incentives for the NHS to engage as an impressive research resource for moving early ideas to prototypes and proto-companies. We then believe that disease specific Funds, such as those we propose under the Syndicate model, may for the basis of a managed ‘market’ for industry to enter and support. This approach, similar in nature to how Lloyds of London Syndicates match funds to risk, would be a novel and disruptive approach to this problem.

 

  1. Using the lessons learned over centuries at Lloyds we can see a longer term marketplace where a range of investors may match their investment to diseases-based risk and outcomes. We also believe that the social funding element of the Lloyds market has resonance with the Life Sciences approach and will be a beacon for the UK as a global leader in this sector.

 

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?

 

  1. Although the Medicines Discovery Catapult is headquartered in Alderley Park, near Manchester, it operates as a national centre. The Catapult’s location allows it to benefit from an exceptional industrial heritage left by Astra Zeneca and access to both University of Manchester and CRUK major centre facilities. However, the Catapult is also able to benefit from Greater Manchester’s control of its £6bn health and social care budget, with the potential for more highly coordinated health research. Greater Manchester, uniquely, offers unparalleled knowledge sharing between primary and secondary care and into patient-led research at the new Biomedical Research Centre funded by NIHR. The Catapult enables the nation as a whole to benefit from this resource, but acting as a facilitator for SMEs from across the UK.

 

NHS procurement and collaboration

N/A

 

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?

N/A

 

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?

N/A

 

  1. 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? Responsibility and accountability?

 

1.       The evidence suggests that there is scope for increased support. Applications to the Innovate UK competitions for support under the Biomedical Catalyst are regularly over-subscribed, with only a proportion of high-quality applications receiving funding. The projects supported by the Biomedical Catalyst have been highly successful (see response to Q1). However, funding constraints means that not all applications judged to be of high quality can be funded. This suggests there would be scope to increase the number of awards without reducing the quality of projects funded by the Biomedical Catalyst scheme. This would benefit UK Plc by helping SMEs.

 

2.       There is further scope for more seamless coordination between funding agencies. The establishment of UKRI will solve some of these issues, but clearer processes for co-funding of applications involving the NIHR and Innovate UK would enable greater commercial involvement in the development of new therapies and treatments and the unveiling of potential medicines that the UK could prove in the clinical setting.

 

3.       It is essential for the recommendations of the Accelerated Access Review (AAR) to be appropriately resourced and its delivery monitored. This is because the life sciences industry was energised by AAR and therefore had raised expectations. AAR gained a particularly high level of industry engagement, with contributions from many companies. Consequently, should AAR fail to deliver on its promise, the Government would lose considerable credibility with industry. In short, the Government must resource and deliver the AAR’s recommendations. Failure to do so would harm the UK’s credibility at a time when companies are making investment decisions because of Brexit.

 

13. Who should take responsibility for the implementation of the Life Sciences Industrial Strategy and to whom should they be accountable? What should the UK Government’s role be? What should the role of the academic, charitable and business sectors be?

 

  1. The implementation of the Strategy is a national effort that will depend upon effective coordination and delegation. The Office of Life Sciences, which spans DH and BEIS, has clear strategic oversight and helps bind the two major engines of delivery: UKRI and the NIHR/NHS. Under the Office for Life Sciences, elements of the strategy must be delegated to those groups with the expertise and accountability for delivery. For example, the Translational Fund should be delegated to the Medicines Discovery Catapult, working in partnership with the MRC and NIHR.

 

14. What is the role of companies within the sector, particularly the large pharmaceutical companies, in the implementation of the strategy? How are they accountable for its success?

 

  1. The multinational pharmaceutical industry is changing rapidly. It is changing from an innovator to a recipient of innovation, new prototypes and products. By being increasingly clear and consistent over the long term in needs for new products, and by leveraging funds like the Translational Fund, the industry can help develop a more diverse, robust supply line for its own future.

 

  1. Whilst SMEs have a naturally short horizon, it is important that large pharmaceutical companies have a strategic interest in ensuring their supply chain is supported. However, these are global businesses and the UK must therefore provide a supportive supply chain to attract and retain these companies’ supply chains here in the UK.

 

  1. The rise of pharmaceutical companies focussed on small numbers of specific diseases will provide room for more players and enable more stable long-term chains of supply.

 

  1. Companies are responsible to their owners. SMEs in particular have a necessary focus on the short term. It is the natural role of government, through agencies like Innovate UK and especially through sector-centred facilities in the Catapult Network, to provide the support for a changing environment so that cycles of companies can thrive during and after these changes occur.

 

15. 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? If so, should that Minister have UK-wide or England-only responsibilities?

 

  1. The Catapult supports the many calls in support of a Minister for Life Sciences. This ministerial portfolio supports a £64bn pillar of the UK economy. It spans policy and delivery across industry, science, health, tax, inward investment and education. A minister working full time across government Departments can bring the focus, co-ordination and domain knowledge to bear on the many multidisciplinary issue faced by the sector at a time a dramatic change.

 

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?

 

  1. The UK has a long-tradition of working in a collaborative manner with many European countries and has actively participated in a number of important pan-European support mechanisms including Horizon 2020 and EuroStars. Devising mechanisms that allow such collaboration to continue after EU-exit would benefit the life science sector in the UK. This would also support the more rapid development of new patient therapies, diagnostics and medical technologies.

 

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

 

  1. The regulatory sector has pivotal roles to play in enabling better Medicines Discovery before and after Brexit.

 

  1. The MHRA – like the FDA - can engage with new technology developers and the Catapult to actively investigate new disruptive technologies, showing a regional leadership position in understanding and embracing new sets of data, future-facing experimental models and techniques.

 

  1. The regulatory authorities can also engage on strategic goals such as the stratification of patients for early stage clinical trials; the remodelling of early-stage clinical development systems to enable first-time-in-man trials in patients - which is already the norm for cancer – and the development of more ‘diagnostic-dependant drugs’.

 

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

The sector is global and the UK will require to have influential links with all major regulatory authorities. The UK’s legacy of influence with EMA is based upon scientific and healthcare credibility which is unaffected by Brexit. Its ability to show leadership in emerging areas of medicines discovery, technology understanding and safe, faster-to-patient clinical development routes will continue to influence regulators and industry alike. The industry in particular will cross borders to access robust and smart innovation.

 

28 September 2017

 

 

[1] JAMA Internal Med September 2017: Research and Development Spending to Bring a single cancer drug to Market

[2] Tufts Centre for the Study of Drug Development 2014 Report

[3] TBR’s Economic Research Team and CBSL. 2016. The Changing UK Drug Discovery Landscape. Newcastle: Association of the British Pharmaceutical Industry.

[4] Bloomberg Innovation Index 2017

[5] Association of Medical Research Charities “Research Funding Stats: Charities unique contribution to medical research 2014

[6] UK Bioindustry Association: Vision for the Life Sciences Sector 2025 (2015)

[7] Office for Life Sciences & UK Trade and Investment. July 2015. Strength and Opportunity 2015: The landscape of the medical technology and biopharma sectors in the UK. www.gov.uk/government/uploads/system/uploads/attachment_data/file/525102/bis-16-237-strength-and-opportunity-2015-UK-medical-and-biopharmaceutical-landscape.pdf. Accessed 14 November 2016.