The UK Life Sciences Ecosystem

Overview – about this project

For the first time the Japanese Life Sciences industry has collaborated to assess the UK ecosystem.

We have done this through a three-stage process between January and April 2020: meeting in person, a series of one to one interviews, and a final validation exercise.

We sought to map where companies are engaging, what the perceived strengths and weaknesses are of the UK system, as seen through the eyes of Japanese life sciences companies, and what improvements would be valued.

We also discussed which are the key competitor countries in different parts of what we consider to be the UK Value Chain.

The COVID crisis hit midway through the project and was not in scope but we provide some high level thoughts on the UK Life Science community’s response.

In the course of the exercise we found that there is low awareness of the Life Sciences Strategy and Sector Deals in the Japanese life sciences R&D community.

We would welcome the opportunity to work with Government in developing ways to enhance communication of the UK’s Life Sciences offer and improve cut through at a global level in the Japanese Life Sciences industry.

Key strengths

  • Unprecedented collaboration by all actors in the system
    • Government support and funding
    • Industry sharing of analyses, altruism over profit
    • Recruitment of all COVID patients into trials
    • UK centres benefitting from international initiatives eg COVID R&D Leaders Network, REMAP-CAP
  • Rapid regulatory approval
    • Expertise and agility of MHRA
    • Local ethics committees dramatic reduction of approval time
  • Improved trial design
    • Home setting and use of digital
  • Genomics England COVID-19 cohorts data set
    • Backed by Government investment of £28 million

Risks/gaps

  • The COVID-19 trials experience is not drawn upon for system redesign

Reinforcing actions

  • Build capability to adopt rapid regulatory approvals long term
  • Leverage digital technology that has been developed to embed home-based patient involvement in trials as standard

Key competitor countries

  • USA

Key findings – the UK as a base for basic research and clinical trials

In basic research, JPG considers the UK to be in the premier league of R&D countries: leading academics, great science, supportive funding institutions, a rich biotech ecosystem and willingness to collaborate.

JPG companies are involved in various research consortia, scout for talent and have significant investments in UK biotech.

Japanese companies see the UK as a world leader in early stage trials with a unique mix of leading clinical pharmacology expertise, high quality facilities and an experienced regulator.

As a result JPG members have international hubs for clinical trials based in the UK and a significant proportion of global early phase trials take place here.

Views are mixed on late stage trials – the UK has a lot going for it and particular strength in rare diseases, but in other areas the view is the UK cannot compete with Eastern Europe and China.


Key findings – digital and data landscape

JPG companies welcome Government and NHS efforts to embrace cutting edge digital technology and the evolving ecosystem it is building around it.

NICE is the only agency in the world that is currently producing guidance in this area and NHS is collaborating well with industry.

However significant barriers to diffusion need to be overcome before the UK can be an important global player.

The UK’s Biobank and 500,000 Genomes projects have been used extensively worldwide and place the UK in the premier league for genomics.

JPG companies are actively seeking to work with these datasets and believe they would benefit from greater genetic and socioeconomic diversity.

The UK is considered to be a global leader in real world data. UK datasets have an excellent reputation and provide a wealth of data for epidemiology across all care settings.


UK Life Sciences’ response to COVID

The way in which the UK Life Sciences community has pulled together in response to the COVID crisis is unprecedented.

Collaboration by all actors in the system, with important support from Government, has enabled implementation of the ACCORD-2 platform trial, a model approach that has long-been aspired to in the scientific community.

Together with a drive to recruit all COVID patients into trials, JPG believes that UK Life Sciences is at the forefront of the global drive for effective treatments  and vaccines.

The experience has provided a springboard for a more agile clinical research architecture in the future, as well as trials that are more patient-centred. JPG believes it is crucial the opportunity to build on the significant UK response is not lost.

We recommend a review of what has worked well through this experience that can be taken forward in a new and innovative approach to clinical trials eg accelerated trial approvals and digital, innovative trial designs.

JPG companies are committed to playing their role in supporting such changes, and in the search for effective treatments for COVID, as well as other diseases, and to continue to collaborate so that progress can be achieved at pace.


Key findings - what actions could improve competitiveness?

The system must keep its foot on the accelerator across the value chain as other countries are continually investing and improving. Stakeholders, including JPG, should be part of a process of ongoing review in order to reflect the most current thinking and to drive improvements.

UK Government needs to be realistic about the shadow cast by EU Exit among Japanese Life Sciences companies. Clarity and transparency on EU exit future is needed to rebuild confidence. This includes the role of MHRA and future research funding.

In digital there is a need to address barriers to adoption in order to speed diffusion of innovation.

Tackling red tape would enable greater agility in industry’s access to genomic and real world data sets. There are further quality dimensions that would enhance the UK offer: such as greater population diversity in 500,000 Genomes and better linkage between primary and secondary care NHS datasets.

Leveraging the investment and experience from the COVID clinical trials approach would enable the UK to become world-leading in this space.

JPG would like to work with the UK Government to maximise the opportunities of its Life Sciences strategies. We recommend more concise version of reports and updates, a supporting narrative on the UK Biobank and 500,000 Genomes opportunities, creating a tailored set of messages for Japanese companies.


JPG view of the Life Sciences Ecosystem in the UK

Overall Project Conclusions

Global leader

Global Leader in Early Stage Trials

Key strengths

  • The UK has a unique mix of leading scientific expertise, high quality facilities and an experienced regulator that means it is one of the best places in the world to run early stage trials*
    • Collective nature of clinical pharmacology expertise in clinical units, academia and MHRA is a key differentiator
    • MHRA accepts innovative study designs & local ethics committees are skilled in assessing pre-clinical data
    • Phase I units have significant expertise in dose escalation, mass balance and proof of concept studies
    • Centres of excellence in some disease areas
  • Agile rapid manufacturing CMO/CROs
  • Small biotech clusters around Golden Triangle are strong drivers of early trials
  • UK Tax Regime is a key enabler for some JPG companies

Risks to global competitiveness

  • Uncertainty about future alignment with EU regulations and research collaborations
  • Complacency - MHRA expertise in phase I studies and early scientific advice must be safeguarded as other markets are improving their offer

Reinforcing actions

  • Clarity and transparency on EU Exit future
  • Building a system post Brexit that means leading investigators wish to remain in the UK.
  • Enable continuity of EU collaborations

Key competitor countries

  • China
*Ranks first in Europe with 147 Phase I and 253 Phase II clinical trials started in 2017. ABPI – Clinical research - How the UK is researching medicines for the future

Global leader in Real World Data

Strengths

  • UK datasets have an excellent reputation and provide a wealth of data for epidemiology across all care settings with an ongoing drive to enhance quality and access
    • CPRD
    • Disease registries
    • HES
    • QoF
    • Rare disease real world data
    • NHS Digitrials
  • CPRD data can support NICE dossiers and appraisals in other settings
  • Commitments in LSIS to improve access and infrastructure

Risks/gaps

  • Inadequate linkage between primary and secondary care
  • Time lag in data availability
  • Industry is over-reliant on third-party vendors

Reinforcing actions

  • Ensure data collection aligns to changes in treatment paradigms.
  • Improve speed and access to data
  • Improve harmonisation of data

Key competitor countries

  • Netherlands and Sweden
  • Can vary according to disease area

Premier league

Premier League for Basic Science

Key strengths

  • Academic excellence
    • Leading universities and university hospitals
    • Fundamental science, disease biology, genomics, medicinal chemistry
    • Attracts top talent from around the world
  • Collaboration sits at the heart of UK science
    • Leadership of many significant EU collaborations,
    • CASE-like research initiatives between academia and pharma sector
    • ‘pay as you go’ approach to some collaborations favoured by pharma
    • Pre-competitive research consortia
    • Biomedical research clusters
    • Translational consortia eg Dementia Platform UK
    • JPG companies are working as part of a UK Dementia Consortium with Alzheimer’s Research UK
  • Readily accessible funding streams from Government, research bodies and charitable institutions
    • The UK Health Research Analysis 2018 published by UKCRC reports that a total of £2.56bn of research was funded by public bodies and charities in 2018, with the largest proportion (44%) coming from the charitable sector.
    • The proactive role of Government incentivising research into antibiotics has seen increases in public and charitable sector funding in this area

Risks to global competitiveness

  • Loss of IMI/Horizon 2020 funding & research collaborations following EU exit
    • Some world class UK research sites are built on EU funding, leadership of EU collaborations which could now be at risk
  • Perceived attitudes to immigration and potential exit of top talent EU nationals

Reinforcing actions

  • Clarity and transparency on EU Exit future to instil confidence in the UK ecosystem
    • Provide certainty for EU nationals already living in the UK
    • Government must set out its long term strategy for research funding for academia and life sciences
  • Learn from the success of the competition
    • A business to business ‘culture’ underpins the US and Singaporean approach in academia and increases success in securing pharma investment. Provide training for UK universities on how to package their offers
  • Enshrine the commitment to invest 2.4% of GDP in law as an Act of Parliament

Competitor countries

  • USA (Boston), Singapore

Premier League in Genomics with World-leading Datasets

Key strengths

  • UK Biobank and 500,000 Genomes have already been used extensively worldwide and UK research expertise has grown
    • Researchers are developing fluency in these datasets
    • Vetting process is rigorous and promotes high quality research
    • Balanced approach to release of derived data encourages private investment and broad scientific utility

Risks/gaps

  • Public concerns over use of data
  • There is relatively low genetic diversity in the dataset
  • Red tape means data applications are burdensome

Reinforcing actions

  • Increase genetic and socioeconomic diversity
  • Improve transparency and agility of the application process
  • Increase accessibility of derived data

Competitor countries

  • Not identified

Behind the curve

Despite a ‘head start’ the UK is behind the curve on late stage trials (JPG views are mixed)

Key strengths

  • UK’s leadership of international collaborations, high proportion of early stage trials and global KOLs gives it a head start in trial placement
    • Robust execution of trials
    • A leading country for rare disease trials
    • Response to COVID has demonstrated high potential
    • Significant public sector investment in translational research system*

Risks/gaps

  • Some JPG companies view the UK as a favoured location for investment in late stage trials but others believe the reality is that the global competition is too strong – others are investing more and recruit faster
    • Absence of research culture in NHS
    • High costs and slow set up times
    • Small patient pool relative to other countries
    • Future of MHRA is casting a shadow
    • Multi-centre leadership shifting away due to Brexit

Remedial actions

  • The system must continue to apply measures to help improve enrolment
    • Address high costs – set up fees and wide variation in site budgets
    • Speed up
  • OLS and the NHS should enable the system to quickly adapt to remote trials in a post COVID world or risk slipping back further
  • Turn the NHS dataset into a competitive opportunity as payers interest in RWE grows

Key competitor countries

  • Russia, China, Eastern Europe
  • UK leads in rare diseases
*NIHR has invested over £1bn per year and announced 5 specialist patient recruitment centres in May 2020

Green shoots but significant barriers to overcome in digital & AI

Strengths

  • Determination in Government to be cutting edge and the system is organising itself accordingly
    • Secretary of State is a champion of digital
    • Evolving digital ecosystem at national level (NHSX, NHS Digital) and of incubation centres and tech transfer enabling commercialisation
    • NICE is the only HTA body undertaking digital appraisals
    • AHSNs are spearheading diffusion in partnership with industry
    • Tech firms like Google are basing European Hubs in UK
    • NHS is investing in skills through Digital Exemplars and wishes to be an early adopter in AI
    • Investment in AI by public and private sectors is growing eg NHS investment in image ased technology in diagnosis and screening

Risks/gaps

  • Diffusion is slow
    • Poor NHS IT infrastructure
    • Landscape is fragmented & CCGs are unwilling to engage
    • Capability gap
  • Data privacy and governance

Remedial actions

  • Identify and learn from best practice
    • Germany has a ‘national wrapper’ that has been effective in overcoming local barriers to adoption
    • Digital is more advanced in some areas of clinical practice
    • Ensure HTA guidance and pathways keep pace and appropriately updated
    • Increase AI based trials beyond imaging into other areas of clinical practice eg treatment optimisation and personalised care

Competitor countries

  • US leads globally
  • Germany has the edge in Europe on digital
  • China co-leads with US on AI