REPORTS

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)
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.

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)

The Economic contribution of the UK Life Sciences industry​ reflects our sector’s key role in contributing to the UK economy. The average productivity of UK Life Sciences employees, expressed as Gross Value Added (GVA), is £104,000 compared to the UK GVA average of £49,000. Other key findings in the report include: UK Life Sciences contributed £30.7bn to the economy in 2015, providing an estimated tax contribution of £8.6bn to the exchequer; each Life Sciences job supports 2.5 jobs elsewhere in the UK economy, meaning the sector supports a total of 482,000 jobs; jobs are distributed throughout the UK, with every region containing a UK head office of a Life Sciences firm; and major clusters of Life Sciences activity can be found in East Anglia, Wales, and the South East of England.  (PwC   March 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)

Accelerated Development and Access to Innovative Medicines for Patients   The Medicines and Healthcare products Regulatory Agency (MHRA) and the UK BioIndustry Association (BIA) brought together experts from across the sector to assess and discuss the performance of various efforts designed to accelerate patient access to innovative products such as targeted cancer drugs, T-cell-based cancer immunotherapies, and cell and gene therapies, and how the NHS might respond to current innovation challenges. While such products embody health benefits and commercial opportunities, they are different from the kind of small molecules that went before, presenting challenges around how they are regulated, assessed and commissioned for use in the NHS. This report summarises the presentations and perspectives of the MHRA, the European Medicines Agency (EMA), the life science industry, National Institute for Health and Care Excellence (NICE), NHS England, academia, research charities, patient organisations and investment firms.
Report on joint MHRA & BIA Conference held in London May 4, 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

Wellcome Trust Monitor Report Wave 3: Tracking public views on science and biomedical research    The Wellcome Trust Monitor examines how the public understands and views medical research. Through interviews with a sample of the UK population every three years since 2009, the Monitor enables the medical and scientific community to understand themes such as public trust in medical information, participation in medical research and levels of knowledge and understanding. The public express high levels of interest in medical research. Around three-quarters of the public say they are interested in medical research, which is a high level of interest, consistent with previous waves. Women, older adults, those with higher educational qualifications, and those who know more about science are more likely to be interested in medical research. The public are particularly interested in the development of new drugs, vaccines and treatments, as well as mental health.  (Ipsos MORI & Wellcome Trust   April 2016)

Transforming UK Life Science Sites—A Toolkit for Action    In considering how the UK can make use of both the sites formerly occupied by Big Pharma and the people they once employed, this report provides a single first source of information and advice for those involved in supporting the growth of life science sites in the UK. It shares best practice from case studies from the UK and around the world; provides key questions and issues to consider; and lists further sources of information and support. It is targeted at an audience of stakeholders, from both the public and private sectors, who are actively involved in creating new life science sites, growing existing ones, and repurposing those undergoing change.  (Office for Life Sciences   March 2016)

The One-Way Mirror: Public attitudes to commercial access to health data    The public need to have confidence in how their patient records are used for research, and this will require both openness and transparency. Research has shown that the public are generally supportive of research using health information, but there is little understanding of what this actually means in practice. The Wellcome Trust commissioned Ipsos MORI to undertake research into public attitudes towards commercial organisations accessing health, medical and genetic data. In understanding more about these attitudes, Wellcome aims to inform the development of good data governance and communications about how data can and cannot be used, to help build a trustworthy system for the use of patient data in research.  (Ipsos MORI report prepared for Wellcome Trust   March 2016)

The State of the UK Healthcare & Life Sciences Sectors—Myths, Realities & Challenges   Facts, data and case studies demonstrate how and where investors have made money from the sector. Includes analysis of the myths, misconceptions and realities of the investment sector; capital market perspectives from the London Stock Exchange; market overview and assessment provided by EY Investor; and insight from Neil Woodford.
Biotech & Money   January 2016

Celebrating UK Bioscience   This report provides snapshots of some exemplar past and present UK bioscience successes to help illuminate where the sector is shaping scientific innovation and delivering benefits to patients, including Humira, Lemtrada, Keytruda, the first PARP inhibitor, StaR® technology, and Oxitec’s genetically engineered mosquitoes. These case studies help to illuminate a wider UK bioscience success story. Large parts of the global innovation in modern drug development are rooted in the UK. The core development of many key blockbuster drugs changing patients’ lives today happened in the UK. Looking forward, the UK is at the heart of the development of a new generation of genetically targeted personalised medicines and cancer immunotherapy, as well as the science tools and platforms underpinning these game-changing therapies.  (UK BioIndustry Association   June 2015)

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)

The UK Biotechnology Industry and the Public Markets, 2015/16:  World class science, world class investment opportunities    The UK is at the cutting edge of a global market [with] a world class science base and has produced blockbuster pharmaceutical products… two of the world’s top three universities for life sciences – taking first and joint second place – and together, UK scientists have been awarded over 80 Nobel Prizes. This strong science and research base underpins a life sciences industry comprising over 4,300 companies and their sites developing, manufacturing and marketing products and services to the UK and global markets. The UK has the largest pipeline of new pharmaceutical product candidates in Europe, developing over 580 product candidates in 2015.
UK BioIndustry Association (BIA)   January 2016

Building the third global cluster:  State of the Nation 2015    2014 was a banner year for UK bioscience, raising £1.2bn in innovation capital, 143% up on 2013, and the best financing year ever in terms of innovation capital – defined as equity capital raised by firms with annual revenues under $500m, ie £304m per annum.  This banner year would not be possible without the fundamental strengths of the overall fiscal ecosystem that, coupled with its science base, make the UK an attractive hub for this innovative sector. This year’s report highlights the important role that the Biomedical Catalyst plays in filling a crucial structural gap in the investment pathway, early in company development where private sector investors will not venture alone.  (Ernst & Young & UK BioIndustry Association   October 2015)

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

Celebrating UK Bioscience: Unravelling the stories behind UK bioscience success    Briefly illustrates a few UK bioscience successes, past or ongoing, helping to illuminate where UK bioscience is shaping scientific innovation and is delivering benefits to humanity.  Examples include Humira, Lemtrada, Keytruda, personalized medicines with background on the first PARP inhibitor, StaR technology, and Oxitec’s genetically engineered mosquitoes.   (UK BioIndustry Association /BIA  June 2015)