REPORTS

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