REPORTS

UK Health Security Agency Pathogen Genomics Strategy   The UK Health Security Agency (UKHSA), a division of the Department of Health and Social Care responsible for public health in the UK, sets out a strategy to improve UKHSA’s ability to detect and understand the pathogens that pose the greatest risks to the UK population, which will help to ensure that policy and public health decision making are underpinned by the best possible scientific evidence. The programme includes a five-year plan to integrate genomics into every aspect of infectious disease control, giving priority to vaccine-preventable diseases, emerging infections, and antimicrobial resistance.  Overall, the strategy will develop accredited, resilient genomic services that lead to improved clinical care and provide cost-effective and demonstrable public health benefit. (gov.uk January 2024)

A New National Purpose: Innovation Can Power the Future of Britain   A joint report by Tony Blair and William Hague, sets out a plan to re-imagine state and public services, make better use of data, and improve the access of tech companies to skills and financing.  The report calls for the creation of an NHS Data Trust, with a controlling stake owned by the NHS and additional investments from trusted companies, which would allow data to be deployed to fuel “research, public health and patient treatment”, whilst also “strictly preserving privacy and preventing misuse”.  (Tony Blair Institute for Global Change   February 22, 2024)

UK Biotech Financing 2023 ( UK BioIndustry Association January 2024)

Evaluating patient access to rare disease treatments: Insights from the UK and Beyond Based on a series of interviews and focus groups with key stakeholders in the rare disease space, including NHS England, NICE, patient groups, clinicians, and industry, the report calls for the UK to lead greater collaboration between stakeholders in the UK and internationally to improve access to new treatments for rare disease patients. (pwc & UK BioIndustry Association   November 2023)

Academic to Entrepreneur:  Unlocking the Potential of UK Spinouts According to a London business think tank report, university ownership of research-based intellectual property is holding back the growth of British spin-out companies. They state that a radical rethink of how academic research is commercialised is needed. While universities typically own significant equity and IP rights for startups founded by staff, a model of “professor privilege”, in which academic staff retain full ownership of their research, would act as an incentive to commercialise IP developed in their work at universities. (Entrepreneurs Network   July 2023)

MHRA Corporate Plan 2023-26   The MHRA plans to create faster risk-proportionate regulatory pathways that will support innovation in areas such as artificial intelligence, cell therapy and vaccines while focusing on public trust, improved access to safe and effective products and the pursuit of new strategic partnerships.   (MHRA   July 2023)   

Data saves lives: reshaping health and social care with data Government launched a new strategy to drive transformation in health and care by reshaping the way data is used, with focus on seven principles to harness the data driven power and innovation seen during the pandemic: Improving trust in the systems’ use of data; giving professionals data they need to provide the best care; improving data for adult social care; supporting local decision makers with data; empowering researchers with data they need to develop treatments and diagnostics; working with partners; and developing the right technical infrastructure. (gov.uk June 2022)

Genomics Beyond Health This 198-page digest reports on where we are with genomic science and where the technology may take us, exploring how the genome can influence people’s traits and behaviours beyond health and how studying our DNA presents both benefits and challenges to society. (gov.uk January 2022)

NICE signals commitment to greater flexibility in its evaluation of promising new health technologies and making patient access fairer   New changes at the UK’s National Institute for Health and Care Excellence (NICE) feature new evaluations and will give patients earlier access to innovative new treatments by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base. They cover how topics are chosen (topic selection), the steps and stages in each evaluation (processes), and how evidence is collected and considered (methods).   (NICE   January 20, 2022)
NOTE:  BELS Brief Chats podcast episode 11 features 20-year veteran and outgoing CEO of NICE, Gillian Leng

UK Biotech Financing in 2021   2021 was the highest year on record for investments into UK biotech and life sciences companies. £4.5 billion was raised in public and private financings, £1.7 billion (60%) more than in 2020. (BIA & Clarivate  January 2022)

2021 Cell and Gene Therapy GMP manufacturing report and  2021 UK cell and gene therapy skills demand report During 2021 the UK’s cell and gene therapy industry has grown apace, despite the impact of the COVID-19 pandemic, with further job opportunities stimulated by targeted government investment. These reports highlight the continued growth across the UK’s Advanced Therapy Medicinal Product manufacturing capacity and strong demand for highly skilled personnel throughout the C&GT sector. (Cell & Gene Therapy Catapult  November 2021)

Genomics Nation  A summation and benchmarking of the UK’s genomics ecosystem, its size and strengths, and how the UK excels in genomics.  (BIA  July 2021)

Creating value & underpinning resilience:  Making the UK one of the best places to manufacture medicines   New infrastructure and a culture of collaboration are helping the UK become a global hub for the development, production and delivery of cutting-edge therapies This report features recent investment and collaboration in UK medicines manufacturing shows the great progress being made in this crucial area for the sector and the UK’s economy.   (KTN October 2021)

Life Sciences Vision The UK’s research and innovation response to COVID-19 demonstrates how the country can act as a global centre for innovation when Government, the sector and NHS work together. For this reason, our Life Sciences Vision has been co-developed by these same partners to ensure they have shared goals that can be delivered by working and innovating together. (gov.uk July 2021)

Genomics Nation An overview of the genomics sector in the UK which consists of 154 companies that are headquartered in the UK, develop or deliver clinically accredited products and services, and for which genomics is a core of their business. (BIA July 2021)

Genome UK: the future of healthcare Aiming to extend the UK’s leadership in genomic healthcare and research, this Strategy sets out a vision, aspirations and plans to transform genomic healthcare in the UK over the next 10 years. Included is a commitment to improve understanding of the genetic causes of diseases and to use this knowledge to precribe more effective treatments to patients with crucial focus on equity of access, data security, privacy and building public trust.. Plans call for the use of genomic technologies to drive improvements in diagnostics,, personalised medicine, disease prevention, and research. Institutions key to achieving progress include the NHS Genomic Medicine Service, Genomics EnglandAccelerating Detection of Disease challengeUK Biobank, and NIHR BioResource. (gov.uk September 26, 2020)

Genome UK: 2021 to 2022 implementation plan This report builds on the vision laid out in Genome UK, to maintain and extend the UK’s leadership position in enabling provision of world-leading genomic healthcare to patients in the UK and across the world.. This first implementation plan sets out a series of commitments to achieve meaningful progress over the period of 2021 to 2022, and how delivery partners will work together across the healthcare system. (gov.uk May 19, 2021)

12 Things We Know about COVID-19   Using data drawn from the Health Data Research Innovation Gateway,, the12 things we know about COVID-19 report brings into sharp focus our current understanding of the coronavirus pandemic. It features a wealth of detailed information – from how the virus affects the elderly and the obese, to what we know about outbreaks in care homes, to effects of the pandemic on care for other conditions such as cancer and heart disease. Published by Health Data Research UK, the report also demonstrates the necessity for timely, secure access across all aspects of the coronavirus.   (UKRI   September 29, 2020)

Genome UK: the future of healthcare   From seminal discoveries in fundamental science through to translation into clinical practice and improved patient outcomes, the UK has made a vast contribution to the rapidly evolving and exciting fields of genetics and genomics. The Genome UK report sets out a national strategy/plan to cement the UK’s status as a global leader in genomics by enabling the provision of world-leading genomic healthcare to patients in the UK and across the world. The report sets out how the genomics community will work together to harness the latest advances in genetic and genomic science, research, and technology for the benefit of patients. Our vision is to create the most advanced genomic healthcare ecosystem in the world, where government, the NHS, research and technology communities work together to embed the latest advances in patient care. Our goal is that patients in the UK will benefit from world-first advances in genomic healthcare through globally leading collaborations between the government, NHS and researchers, building on already successful programmes such as the 100,000 Genomes Project, delivered by NHS England and Genomics England, and UK Biobank.   (HM Govt  September 26, 2020)

Life Sciences Industrial Strategy Update    In the two years the Life Sciences Industrial Strategy launched, there has been very substantial progress in making the UK a more attractive place for life sciences companies to succeed and grow. These developments are the result of a strong collaboration between all aspects of this diverse industry – pharma, biotech, medtech, digital and diagnostics – the wider research community in the UK, the NHS and government. Together these parties have identified opportunities and acted on them, and have similarly recognised our limitations and worked to overcome them. This coalition has made a significant difference to the sector and has also shown what a clear, well‑targeted strategy can achieve. This report describes the progress made against the targets set in the original Life Sciences Industrial Strategy published in August 2017. A substantial majority of the objectives in the Life Sciences Industrial Strategy have been met and more are being delivered now. … This Strategy creates not only opportunities for economic growth but it also underpins a more efficient and effective health system. Together, it is hard to see where government can better spend its resources and energy.   (gov.uk   January 13, 2020)

Accelerating Detection of Disease   The pioneering Accelerating Detection of Disease initiative will recruit 5 million healthy volunteers into the largest-of-its-kind research study aiming to invent new ways to detect and diagnose chronic disease early in order to prevent the development of disease. The cohort aims to collect biological (blood) samples and health related data on all participants, with plans to collect repeat samples from a subset and to run a range of future studies and/or interventions. The programme is expected to share results with participants, which will involve ethical and practical challenges. A CEO has been hired (April 2020), advisory groups are preparing policies such as consent, communication and engagement, recruitment, ethics, governance and consents, and the use of digital and technology tools. The technology will be developed by a new partnership between government and industry using AI to develop the next generation of treatments. The main study is expected to be launched in 2021. The data created will allow evaluation of new polygenic risk scoring across millions of volunteers to see if and how we can incorporate them into smarter, more targeted clinical trials, research, and screening programmes. It will be made available to researchers from academia and industry, creating the largest and deepest dataset for medical and diagnostic research in the world. (2020)

Artificial Intelligence: How to get it right — Putting policy into practice for safe data-driven innovation in health and care  This report sets out the foundational policy work that has been done in developing the plans for the NHS AI Lab. It also shows why we’re so hopeful about the future of the NHS.   (NHS   October 2019)

UK Launches World’s Largest Genetics Project to Tackle Deadly Diseases
WHOLE GENOME SEQUENCING: Transforming health research   A ground-breaking initiative to sequence the whole genomes of 450,000 UK Biobank participants is set to deliver the whole genome sequencing of 500,000 UK Biobank participants to improve understanding, diagnosis, treatment and prevention of illnesses such as cancer, dementia, heart disease, arthritis, and chronic kidney disease. It is the biggest endeavour of its kind ever undertaken, and will transform the way in which scientists study health.  Funding of £200 million comes from a consortium with £50 million each from the UK Research & Innovation and Wellcome Trust, and £100 million in total from Amgen, AstraZenecaGlaxoSmithKline and Johnson & Johnson. The data will be linked to other detailed clinical and lifestyle data for the anonymised volunteers in UK Biobank. This will combine to give unique insight as to why some people may develop particular diseases and some may not. This project follows completion of Genomics England’s 100,000 Genomes Project, which delivered a massive step in showing the value of genetics in diagnosing and treating rare diseases and cancer.  (Biobank   September 2019)

A new National Artificial Intelligence Lab will use the power of artificial intelligence (AI) to improve the health and lives of patients   The AI Lab, supported by £250 million investment by government, will bring together the industry’s best academics, specialists and technology companies to work on some of the biggest challenges in health and care, including earlier cancer detection, new dementia treatments and more personalised care. The lab will sit within NHSX, the new organisation that will oversee the digitisation of the health and care system, in partnership with the Accelerated Access Collaborative. The investment will support the ambitions in the NHS Long Term Plan, which includes pledges to use AI to help clinicians eliminate variations in care.   (gov.uk   August 8, 2019)

New NICE Evidence Standards   NICE published its Digital Health Evidence Standards, setting out the evidence requirements, including clinical and economic impact, for different types of technology to support companies, commissioners and others, so they better understand what a good level of evidence looks like to speed uptake and adoption. (March 2019)

The NHS Long Term Plan   Announced in January 2019, The NHS Long Term Plan aims to relieve pressure on services and ensure sustainability for future years. Prevention is at the heart of all areas of the plan’s focus, which includes smoking cessation, obesity and type 2 diabetes,  diet and alcohol, antimicrobial resistance and vaccines, cancer—earlier diagnosis and more stratified screening, mental health, air pollution, children and maternity care, and gambling aims to relieve pressure on services and ensure sustainability for future years. There are a multitude of aims and initiatives within the 136 page document.  The Kings Fund has published The NHS Long-Term Plan Explained.  (January 2019)

Tackling antimicrobial resistance 2019–2024:  The UK’s five-year national action plan   This document sets out the UK’s 2019–2024 national action plan to tackle AMR within and beyond our own borders. Developed in consultation with a broad range of stakeholders across different sectors, it builds on the achievements of our last strategy (2013–2018), and is aligned with global plans and frameworks for action. The plan has ultimately been designed to ensure progress towards our 20-year vision on AMR, in which resistance is effectively contained and controlled. It focuses on three key ways of tackling AMR: • reducing need for, and unintentional exposure to, antimicrobials; • optimising use of antimicrobials; and • investing in innovation, supply and access.   (January 2019)

Life Sciences Sector Deal 2  The Government’s second Sector Deal has announced a world-first commitment to sequence one million whole genomes in the UK within five years; an additional £50m investment in the digital pathology programme and £37.5m funding for a network of regional Digital Innovation Hubs.   (HMG   December 2, 2018)

Strategic Prospectus: Building the UKRI Strategy   UK Research & Innovation (UKRI) represents a major reorganization of research funding in the UK which is being led by Mark Walport, immunologist and former leader of the Wellcome Trust and chief scientific advisor to government. UKRI is uniting Innovate UK, Research England, and the seven research councils that support UK science, akin to combining the NIH, National Science Foundation and National Endowment for the Humanities. UKRI aims to provide a cohesive strategy and focused voice for UK science to improve efficiencies, encourage interdisciplinary research, enable innovation and research to flourish, foster excellence and collaboration on the global stage, push the frontiers of human knowledge and understanding, and deliver economic impact across the UK.  (UKRI   May 2018)

BIA members’ guide to the Patent Box February 2018   The Patent Box election provides a reduced rate of corporation tax of 10% for profits attributable to patents. These can be profits that arise on selling patented products and licensing (including milestones and royalties) or selling qualifying IP rights. A company can also claim a benefit if it uses patented technology that it has developed to manufacture products or provide services.  (BIA, FTI Consulting, Confluence Tax, et al   Feb 2018)

Pipeline Progressing: the UK’s global bioscience cluster in 2017   The UK has the strongest pipeline in Europe across all preclinical and clinical stages, with 351 preclinical products, 43 phase I, 70 phase II and 15 phase III.  UK biotech company IPOs raised more than twice as much money in 2017 (£234m) than in 2016 (£105m). UK biotech raised more on the public markets than in venture capital as UK companies matured and progressed through the funding lifecycle with £515m raised in venture capital, £234m raised in IPOs and £452m raised in follow on funding. The London Stock Exchange’s Main Market has seen major indirect investment through vehicles that fund the biopharma sector including Arix Bioscience (£113m) and Biopharma Credit (£606m). And the 2017 IPO listings on Nasdaq (NuCana plc, Nightstar Therapeutics and Verona) show that there is global demand for UK biotech companies.  (BIA and Informa Pharma Intelligence   January 25, 2018) (BIA and Informa Pharma Intelligence   January 25, 2018)

State of the Discovery Nation 2018 and the role of the Medicines Discovery Catapult   This report, developed collaboratively by the Medicines Discovery Catapult, Innovate UK and the UK BioIndustry Association, identifies improvements in technology and processes that SMEs are asking for: humanised models of drug discovery for better predictability in clinical trials, new computational biology and advanced informatics for more informed R&D, access to the best national knowledge and services – not just the closest – and easier access to consented patient data and samples. The government-backed Medicines Discovery Catapult is starting to address these needs.  (Medicines Discovery Catapult and BIA   January 2018)

The rise of Corporate Venture Capital investment in UK biotech   New research published by the Association of the British Pharmaceutical Industry (ABPI) shows that the amount of capital invested alongside CVC into UK companies increased six-fold between 2010 and 2015, marking a fundamental shift in how start-up British biotech is funded. During 2015, financing rounds involving CVC amounted to $647 million of $1033 million invested in unquoted UK life sciences companies (2016: $567m of $965m). UK companies closed 68% of European financing rounds involving CVC in 2016, up from about a fifth a decade ago.   (ABPI   December 2017)

Developing effective ctDNA testing services for lung cancer    A report published by the PHG Foundation (Cambridge UK) argues that limited awareness of validated ctDNA testing technology is restricting access to targeted therapy in a sub-group of patients with non-small cell lung cancer. Lung cancer is an area of unmet clinical need with only 5% of patients surviving more than 10 years post diagnosis. Developing effective ctDNA testing services for lung cancer outlines the most pressing issues affecting the implementation and provision of ctDNA testing and describes examples of good practice from some of the laboratories that have pioneered the introduction of ctDNA testing into the NHS. (PHG Foundation   September 2017)

‘Building something great: UK’s Global bioscience cluster’  This report demonstrates that the UK is in a strong position relative to the leading life science clusters in Boston and the San Francisco Bay area and that it is maintaining its lead in Europe. This is despite a challenging year of financial uncertainty with Brexit and the US election leading to markets cooling across the globe in 2016, meaning UK companies are having to work harder than ever to secure the funding that they need.   (Informa Pharma and BioIndustry Association   May 2017)

Sir John Bell delivers strategy to build UK’s status as world leader in life sciences  The Life Science Industrial Strategy is a report from the life science sector to UK government that offers an ambitious vision and proposals to capitalize on UK strengths to encourage growth and improve patient outcomes. Sir John outlines findings of an independent sector-led review with input from stakeholders across the £64 billion sector, including global companies, SMEs, charities and, importantly, the NHS. The Strategy addresses challenges and opportunities around five key themes:  Science—ensuring continued support for the science base, maintaining its strength and ensuring its internationally competitiveness; Growth—creating an environment that encourages companies to start and grow, builds strengths across the UK and expands manufacturing; NHS—galvanizing NHS-industry collaboration and facilitating better patient outcomes through improved adoption of innovative treatments and technologies; Data—making the best use of data and digital tools to support research and better patient care; Skills—enabling access to a pool of talented people to support the sector’s aims with sufficient skills. The Strategy recommends the establishment of the Healthcare Advanced Research Program (HARP), a programme allowing charities and the NHS to collaborate on ambitious and long-term UK-based projects aimed at transforming healthcare and taking advantage of the latest medical trends of the next 20 years. The report’s recommendations will be considered by government and used to work towards a sector partnership between government and the sector. (gov.uk  August 30, 2017)

Building our Industrial Strategy   This Green Paper* sets out the government’s strategy to address long-term challenges to the UK economy, including billions of pounds worth of investment in life sciences and technology and an education system with new technical qualifications for people who want an alternative to university. (HM Government   January 2017)
BELS Ed:  A green paper is a preliminary report of government proposals that is published in order to provoke discussion.  BELS is providing input on the Life Science Industrial Strategy in collaboration with the American Pharmaceuticals Group for which we interviewed 10 members of the BELS community to solicit their insights and suggestions for improving the UK life science sector.

Antimicrobial resistance: The State of the Nation report on UK R&D    Antimicrobial resistance (AMR) is one of the most important issues facing the global healthcare community. The failure to find a solution threatens the very heart of modern medicine. Without concerted and coordinated international action we could be faced with a situation where common infections are once again fatal. The UK has a real chance to lead the way in combatting AMR. We have a commitment and passion that has already forced the pace of international action. But we will have to do more if we are to make any real impact on this global issue. This report is a snapshot of the current state of the nation of R&D in the UK, focused on tackling the global challenge of antimicrobial resistance.  (PwC’s Strategy&   November 2016)

Accelerated Access Review  This Review recommends to government ways to accelerate access for NHS patients to innovative medicines, medical technologies, diagnostics and digital products.  It aims to take years off the drug development process and to make the UK is the best place in the world to design, develop and deploy these innovations.
Led by an independent chair, Sir Hugh Taylor, and supported by Sir John Bell as Chair of the External Advisory Group    October 2016

The Cell and Gene Therapy Catapult Annual Review 2015/16 highlights statistics on UK industry growth. Investment in 2015 was over £400m at year end compared to £35m in 2012. There were 42 cell and gene therapy developers in the UK and half of those were considered to be rapidly growing their R&D activities. This represents growth of 90 percent in the number of developers since 2012. Employment in the sector more than doubled from 540 in 2012 to over 1000 at the end of 2015 and growing. The number of cell and gene therapy clinical trials in the UK grew 50% from 2013. The size of the highly specialised Good Manufacturing Practice (GMP) standard manufacturing footprint for cell and gene therapies grew 50% from 2013.  (Cell & Gene Therapy Catapult   Sept 21, 2016)

Latest reports on cell and gene therapy clinical trials and preclinical programmes indicate the industry in the UK is progressing   Two newly updated databases provide a snapshot of clinical trials and preclinical research in cell and gene therapies active in the UK in 2016, including 57 cell and gene therapy clinical trials, including 6 in vivo trials of which 5 are commercially sponsored.  (Cell & Gene Therapy Catapult   July 29, 2016)

Progress being made in UK regenerative therapies industry says expert report   One year on from the publication of the Regenerative Medicines Expert Group (RMEG) Report in 2015, a report detailing progress against the recommendations of RMEG, authored by the Chief Executives of key delivery organisations is published.  (Cell & Gene Therapy Catapult   June 10, 2016)

Tackling Drug-Resistant Infections Globally: Final Report & Recommendations   Jim O’Neill’s final report discusses the rising problem of antimicrobial resistance and offers cross-sector recommendations to reduce the overuse of antimicrobials, prevent infections, make better use of current treatments, and increase the supply of new treatments. It also stresses the need for global public awareness.
The Review on Antimicrobial Resistance, chaired by Jim O’Neill. Report commissioned by UK Prime Minister.   May 2016

Strategy for UK Life Sciences      The Government’s strategy report focuses on applying biology in healthcare applications and explains how the UK will become the global hub for life sciences in the future, providing an unrivalled ecosystem that brings together business, researchers, clinicians and patients to translate discovery into clinical use for medical innovation within the NHS. The UK will provide an environment and infrastructure that supports pioneering researchers and clinicians to bring innovation to market earlier and more easily, making the UK the location of choice for investment. Life sciences will continue to be vibrant in the UK and will be a key contributor to sustained economic growth.  (Dept for Business, Innovation & Skills; & Office for Life Sciences   December 5, 2011)

UK Biotech A 10 year horizon     This joint collaboration between the BIA and Evaluate to examine the performance of the UK biotech industry over the past decade. The report provides a detailed view of the industry between 2005 and 2014 and highlights trends in M&A, drug approvals, venture financing and IPOs. The report also exhibits the strength of the UK biotech sector by identifying drugs that were originated in the UK and have been subsequently approved in the US over the last 10 years.   (Evaluate & UK BioIndustry Association /BIA )    July 2015