Initiatives

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)

UK Launches World’s Largest Genetics Project to Tackle Deadly Diseases
The £200 million Whole Genome Sequencing project, the most ambitious genome sequencing project to date, is set to deliver the whole genome sequencing of all 500,000 UK Biobank participants to improve understanding, diagnosis, treatment and prevention of illnesses including cancer, dementia, diabetes, heart disease, arthritis, and chronic kidney disease. The £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, AstraZeneca, GlaxoSmithKline 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.   (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 Topol Review:  Preparing the healthcare workforce to deliver the digital future

Delivered in 2019, The Topol Review Preparing the healthcare workforce to deliver the digital future was led by cardiologist, geneticist, and digital medicine researcher Dr Eric Topol, the Founder and Director of the Scripps Research Translational Institute. The Review outlined recommendations to ensure the NHS is the world leader in using digital technologies to benefit patients.  This will involve implementing technologies such as genomics, digital medicine, AI and robotics at a faster pace and on a greater scale than anywhere else in the world.  (February 2019)

The NHS Long Term Plan   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.   (gov.uk   December 2, 2018)

The UK Biobank is a research resource following the health of its 500,000 participants who joined the study between 2006-2010. These volunteers have undergone tests and provided blood, urine and saliva samples, and detailed information about themselves. Information provided by participants is made available to approved health scientists in a way that does not identify the individuals concerned. More than 10,000 researchers have registered to use UK Biobank from 68 countries, and 1,000 projects are under way. Around three-quarters of registrations are now from overseas. Academic and industry researchers can use Biobank data to understand why some people develop particular diseases and others do not, with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. If you are a health scientist from anywhere in the world, academia or industry, and wish to use the resource, you can begin your application process here. The Biobank has set out to make the system as easy as possible for you to access data, while protecting the anonymity of its participants. (UK Biobank)

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)

Making a reality of the Accelerated Access Review: improving patient access to breakthrough treatments   The Accelerated Access Review made a series of recommendations to enable the NHS to: improve patient outcomes, use the UK’s strong biosciences research and life sciences industrial base, enhance the international competitiveness of our life sciences industry. The response to this review sets out how government will work with industry and the health system to create an approvals system so that cost-effective breakthrough products can get to NHS patients as fast as possible. Key elements of this response include: an Accelerated Access Collaborative that will develop an accelerated access pathway to bring breakthrough products to market and then to patients as quickly as possible; £86 million government funding to support innovators and the NHS in overcoming barriers to getting new, innovative technologies to patients quickly; and improved NHS England commercial capacity and capability to deliver deals that achieve better value for the NHS and innovators.  (Gov.uk /Depts of Health and BEIS   November 2017)
BELS NOTE: Former GSK CEO Sir Andrew Witty is to lead the Accelerated Access Collaborative charged with selecting and progressing access to five new drugs and devices each year.

Stephen Hawking endorses new £50 million centre Gifts totaling more than £32 million, together with government funds of over £17 million, have enabled the launch of a highly innovative Centre in Cambridge (UK) that is pioneering new approaches to understand and treat neurodegenerative disorders such as Alzheimer’s and Parkinson’s diseases, motor neurone disease and frontotemporal dementia. The Centre for Misfolding Diseases has been established to tackle some of the world’s most devastating diseases. Many of the neurodegenerative diseases are currently incurable and represent a huge burden for an ageing society, potentially crippling healthcare systems with costs that already exceed those associated with cancer and heart conditions combined. … In addition to fundamental science, the new building will house a Chemistry of Health Incubator that will respond to the need for closer integration between the University and industry and aim to increase the rate at which scientific breakthroughs are translated into new therapies. (University of Cambridge – October 27, 2017)

PHE launches campaign to rein in use of antibiotics  Public Health England has launched a major new campaign designed to further rein in inappropriate use of antibiotics, as estimates show that around 5,000 people in England alone die every year because of antimicrobial resistance. As part of the Keep Antibiotics Working campaign, TV adverts featuring antibiotic pills singing “Every time you feel a bit under the weather, don’t always think that we can make you better”, are being broadcast to urge people to stop asking healthcare professionals for antibiotics because taking them when they are not necessary increases the risk of a more severe or longer infection. It will also support pharmacists by providing evidence and resources to support their conversations with patients about the use of antibiotics.  (PharmaTimes – October 23, 2017)

Life-saving medical breakthroughs don’t happen in Britain by accident  (Jeremy Hunt/Health Minister & Greg Clark/ Business Minister) One of the abiding strengths of the UK is its extraordinary capacity for innovation and creativity, and perhaps nowhere more so than in the field of medical science. Few countries can match our roll call of achievement, from the discovery of antibiotics in the 1940s, to life-saving vaccination programmes in the 1950s and 60s, through to pioneering hip and knee replacement surgeries and IVF treatments in the 1970s and 80s. More recently, Britain again is laying the foundations for the new age of personalised medicine, with world-leading programmes like the 100,000 Genome project, helping us to understand the genetic basis of cancers and rare disease – a fitting legacy for a nation that first discovered DNA. …These achievements are not a matter of chance, nor are they solely the product of isolated genius. Rather they reflect the outstanding environment we have built, over many decades, to enable and translate cutting edge research, from conceptual design into clinical practice. Whether it’s through our world-class higher education institutions, or the outstanding infrastructure and scale provided by clinical research teams within our NHS and NIHR, this country is one of the best places in the world to develop and deliver innovative ideas in healthcare and medical technology. And we want to keep it that way. …As a sign of the government’s commitment to the sector, we are announcing the first phase of investment in life sciences with £160m providing investment in projects supporting advanced therapies, medicines and vaccines development, manufacturing and research.  (The Times August 30, 2017)

Early Access to Medicines

Making a reality of the Accelerated Access Review: improving patient access to breakthrough treatments   The Accelerated Access Review made a series of recommendations to enable the NHS to: improve patient outcomes, use the UK’s strong biosciences research and life sciences industrial base, enhance the international competitiveness of our life sciences industry. The response to this review sets out how government will work with industry and the health system to create an approvals system so that cost-effective breakthrough products can get to NHS patients as fast as possible. Key elements of this response include: an Accelerated Access Collaborative that will develop an accelerated access pathway to bring breakthrough products to market and then to patients as quickly as possible; £86 million government funding to support innovators and the NHS in overcoming barriers to getting new, innovative technologies to patients quickly; and improved NHS England commercial capacity and capability to deliver deals that achieve better value for the NHS and innovators.  (Gov.uk /Depts of Health and BEIS   November 2017)
NOTE: Former GSK CEO Sir Andrew Witty is to lead the Accelerated Access Collaborative charged with selecting and progressing access to five new drugs and devices each year.

Recognising that the process to authorize medicines is very long, expensive and challenging, especially for smaller companies with greatly limited funding, the Early Access to Medicines Scheme was introduced in March 2015. The programme aims to give patients with a life threatening or seriously debilitating condition when there is no other treatment available to them access to promising new drugs that have yet to go through the full licensing process.  The Medicines and Healthcare Products Regulatory Agency (MHRA) makes decisions about these medicines using its Promising Innovative Medicine designation which can bestow an early signal that the medicine may be a possible choice for the EAMS scheme. After further investigation, if the MHRA decides that doctors can prescribe the drug, the positive scientific opinion lasts for one year, with the potential to be renewed.

Innovate UK

Innovate UK (formerly the Technology Strategy Board) is the UK’s innovation agency. An executive non-departmental public body sponsored by the Department for Business, Innovation & Skills.  Works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. Work with companies to de-risk, enable and support innovation. Fund the strongest opportunities, connect innovators with the right partners they need to success, help innovators launch, build and grow successful businesses. Innovate UK has established four sector groups, including health and life sciences.

Innovate UK’s Delivery Plan for the year 2016 to 2017 shows how it will invest £561 million, with a more focused approach to innovation support.

Innovate UK has long played a pioneering role in connecting businesses with ‘lead customers’ for their new ventures – for example in the public sector through the Small Business Research Initiative (SBRI) programme – and this will continue.

Innovate UK’s network of Catapult centres has been established to support and encourage innovation and growth across the UK by transforming its capability for innovation in specific areas and helping to drive future economic growth. The three Catapult Centres focused on the life sciences are:

Cell and Gene Therapy Catapult    works to drive the growth of the cell and gene therapy industry by helping cell and gene therapy organisations translate early stage research into commercially viable and investable therapies.

Medicines Discovery Catapult    operates at the earliest stages of medicines development, developing and validating new technologies for testing of potential medicines before human trials and supporting the key UK strength in pharmaceutical, biotechnology and contract research organisations.

The aim of the NHS Innovation Acceleration (NIA) is to deliver on the commitment detailed within the Five Year Forward View – creating the conditions and cultural change necessary for proven innovations to be adopted faster and more systematically through the NHS, and to deliver examples into practice for demonstrable patient and population benefit.  In its first year, the 17 fellows who joined the programme received support to take their high impact innovations to more than 60 NHS organisations, benefited more than three million patients, and helped attract funding of over £8m.  After this successful first year, NIA 2016 will be open for applications from healthcare innovators on Friday 17 June 2016, closing on 1 August 2016. This round of applications will focus on three challenges based on population health needs: prevention, early intervention and long-term condition management, with successful applicants announced in October.

The Clinical Research Network (CRN) is part of the National Institute of Health Research, the research arm of the NHS, and is wholly funded by the Department of Health in the UK.  This unique initiative provides the infrastructure that allows high-quality clinical research to take place in the NHS, so that patients can benefit from new and better treatments. The organisation helps researchers to set up clinical studies quickly and effectively; supports the life sciences industry to deliver their research programmes; provides health professionals with research training; and works with patients to ensure their needs are at the very centre of all research activity.

Record-Breaking Trial Recruitment Now a Reality   A unique, wholly government-funded initiative has made the UK the hot ticket in clinical trial recruitment.  The National Institute of Health Research’s Clinical Research Network, wholly funded by the Department of Health in the UK, is a unique initiative aiming to aid researchers to set up trials quickly and easily, by working closely with pharma, healthcare professionals, and of course, patients.   (April 2016)

Based at the University of Bristol, the Avon Longitudinal Study of Parents and Children, also known as Children of the 90s, is a world-leading birth cohort study that has been charting the health of 14,500 families in the Bristol area in order to improve the health of future generations. Between April 1991 and December 1992 we recruited more than 14,000 pregnant women into the study and these women (some of whom had two pregnancies or multiple births during the recruitment period), the children arising from the pregnancy, and their partners have been followed up intensively over two decades.  ALSPAC is the most detailed study of its kind in the world, providing the international research community with a rich resource for the study of the environmental and genetic factors that affect a person’s health and development. ALSPAC aims to inform policy and practices that will provide a better life for future generations.

UK Biobank is a major national health resource with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank recruited 500,000 people 40-69 years of age in 2006-2010 from across the UK to take part in this project. The recruits have undergone measures, provided blood, urine and saliva samples for future analysis, detailed information about themselves and agreed to have their health followed, including their lifestyle, weight, height, diet, physical activity and cognitive function, as well as genetic data from blood samples. Linkage to a wide range of health records is also under way, including data from general practices. Over many years this will build into a powerful resource to help scientists discover why some people develop particular diseases and others do not.

UK Biobank launches world’s largest imaging project to shed new light on major diseases   It will create the biggest collection of scans of internal organs, and transform the way scientists study a wide range of diseases, including dementia, arthritis, cancer, heart attacks and strokes. The £43m study will involve imaging the brain, heart, bones, carotid arteries and abdominal fat of 100,000 current participants of UK Biobank, a visionary project set up in 2006 by the MRC & Wellcome Trust to create a research resource of half a million people across the UK to improve health.   (Medical Research Council    April 2016)