Innovation and strength in
the UK biotech sector
Itâs number one in Europe and is second only to the US on the world stage. The UK biotech sector has established a leading, innovative, international role in stem-cell research, tissue and cell therapy, gene therapy and pharmacogenetics. And with great progress being made in bioprocessing and biosecurity, too, the UK bioscience industry is an attractive proposition for investment.
Aisling Burnand, Chief Executive of the BioIndustry Association
The UK bioscience industry is recognised as one of the most advanced in the world. It is the leading player in Europe with approximately one third of all bioscience companies and is second globally only to the US. There are currently more than 450 UK companies of which 16 were profitable last year. These companies employ some 22,500 people and in 2003 (the latest year for which verified data is available) the sector generated £3.6 billion of revenue, raised £392 million of equity investment and 36 new companies were formed. With 42 marketed drugs and 224 drugs in clinical development or awaiting regulatory approval, this is undoubtedly a major success story and a testament to the UK?s innovative science base.
However, innovation alone is not enough to enable the industry to succeed in commercial terms. A secure business and regulatory environment with the right support mechanisms, financial conditions and government policies needs to be in place for this sector to really fl ourish.
While the opportunity for UKbased bioscience companies to really contribute to increasing national health and wealth remains large, recent years have been tough as companies struggle to secure the right finance to forge ahead with innovative programmes in a highly competitive market. However, the good news is that there are a growing number of innovative companies with strong technologies, some of which already boast marketed products and revenue streams, which is beginning to change the complexion of the sector. For the public companies, proposed changes to company law and the review of pre-emption guidelines should make capital raising easier.
In 2003 the strategy and framework for the successful development of the industry was given a major boost thanks to the biggest-ever policy review of the sector ? the Bioscience Innovation and Growth Team (BIGT) led by the BIA, DTI and the Department of Health and chaired by Sir David Cooksey. The focus of its report to government (Bioscience 2015 - Improving National Health, Improving National Wealth) was to ensure that the UK retains its world leadership in bioscience.
The Bioscience Leadership Council, chaired by Sir Richard Sykes, was also set up to oversee the implementation of the recommendations. Already there are encouraging signs of change, particularly from government. Significant funding has been earmarked to strengthen clinical research and the establishment of the UK Clinical Research Collaboration, which brings together the NHS, research funders, industry, regulatory bodies, Royal Colleges, patient groups and academia to support NHS provision of an environment that facilitates and promotes high-quality clinical research for the benefit of patients.
Some of the key areas where the UK has established a leading, innovative, international role include stem-cell research, tissue and cell therapy, gene therapy and pharmacogenetics. UK companies are also making great progress in bioprocessing and another area worthy of mention is biosecurity, where several major international contracts have been awarded to UK bioscience companies.
The UK is undoubtedly a world leader in stem-cell research and this has come about largely because it has one of the most forwardthinking regulatory environments for stem-cell research anywhere in the world. This legislative infrastructure is designed to ensure the highest quality research and development, and safeguard against unethical research practices. For example, research is strictly regulated under licence from the Human Fertilisation and Embryology Authority and only permitted on embryos up to 14 days old. Researchers in this field must have approval by an independent Ethics Committee and there must be no financial inducement.
A forward-thinking regulatory environment means the UK is a world leader in stem cell research
In May 2004, five of the UK?s research councils announced £16.5 million in new research grants to help speed fundamental stem-cell research and the development of stem cell-based therapies in the UK. The 57 multidisciplinary grants will be used to fund a wide range of stemcell research, from investigations into how widely adult stem cells can differentiate, to the development of treatments for spinal cord injuries. Some of the investment is also being used to fund the Human Embryonic Stem Cell Resource Centre at the University of Sheffield.
May 2004 also saw the opening of the UK Stem Cell Bank, a unique government-backed resource that will store, characterise and supply ethically approved, quality-controlled stem-cell lines for research and, potentially, for treatment. This is the first resource of its kind worldwide and will be a repository for adult, foetal and embryonic stem cells. The first two human embryonic stem-cell lines deposited at the bank were developed separately by researchers at King?s College, London and the Centre of Life in Newcastle.
The leading stem-cell research organisations in the UK such as ReNeuron, the Roslin Institute, Stem Cell Sciences, Intercytex and CXR Biosciences to name but a few, are pioneering the development of regenerative therapies using human stem cells. The goal is to produce new cell-based treatments for major diseases such as stroke, Parkinson?s disease and diabetes.
|The key ways of diffusing the threat of bioterrorism are the development of safe and potent vaccines|
In order to make these treatments a reality, leading UK scientists and entrepreneurs have been calling for the creation of a charitable foundation to promote and fund stem-cell research in the UK. The group believes that a fund of £100m is necessary to anchor the UK?s leading position and to fund ?translational? research in order to get potential stem-cell therapies into clinical testing in order to prove their benefits.
Pharmacogenetics combines the fields of pharmacology and genetics, in order to identify the genetic basis of drug response. This allows greater insight into the reasons for variable patient responses to pharmacological agents, thereby allowing improvements in both drug development and patient care. In the future it should help doctors identify the most appropriate treatment and dosage for individual patients. The field of modern pharmacogenetics has evolved from observations during the 1950s that some ethnic groups were more likely to be slow or fast metabolisers of specific families of drug compounds, an observation we now know is due to genetic variations in metabolising enzyme genes.
Pharmacogenetic research is already being used to identify patients at risk of rare or serious side effects from drugs already on the market, for example, GSK is carrying out a unique study to identify genetic variations associated with hypersensitivity to the HIV drug Abacavir. Another UK company, DxS, is developing genotyping tests for use on DNA extracted from any relevant sample, both during human trials of new drug candidates, and subsequently in parallel with the marketed drug.
Bioprocessing involves taking living cells and turning them into manufacturing units. These various technologies can be used to generate a broad range of biopharmaceutical healthcare products. Bioprocessing is a high-value manufacturing sector and the fastest-growing sector of the global pharmaceutical industry, accounting for 10% of total pharmaceutical sales and over 30% of drugs in development.
In January 2005 the DTI announced the £3 million funding of a National Bioprocessing Knowledge Transfer Network as part of its Technology Programme. The KTN (bioProcessUK) will cover the biopharmaceutical bioprocessing sector, including regenerative medicines, proteins and vaccines. This is a real boost for UK bioscience and will help capture significant value for the UK from this rapidly expanding sector. The UK?s leading companies in this field include Avecia, Cambridge Antibody Technology, Cobra Biomanufacturing and Lonza Biologics.
Biosecurity has become a high priority for governments and the UK biotechnology industry is well-positioned to play a leading role in strengthening international biodefences. The key ways of diffusing the threat of bioterrorism are the development of safe and potent vaccines that can be deployed on a large scale, effective treatments for people who do become infected, diagnostics that will enable rapid identification of a pathogen and detection systems that can monitor for potential attacks.
The most widely studied agents in terms of biological warfare are anthrax, botulism, bubonic plague and smallpox. Spurred by the threat of bioterrorism, modern drug discovery techniques are being applied to find therapies to combat these potentially deadly pathogens.
The UK has many smaller and mid-size companies and organisations excelling in vaccinology that have established leading positions in vaccine development and manufacture. Acambis is developing a second-generation smallpox vaccine and is manufacturing emergencyuse stockpiles of this investigational vaccine for the US government. Avecia has been awarded a $50 million contract for the development of a recombinant plague vaccine by the US National Institute of Allergy and Infectious Diseases (NIAID).
Cambridge Biostability, a new stable vaccine technology developer, is a major partner in a $5.4 million grant awarded to DynPort Vaccine Company for the development of a new vaccine against botulism. UK leaders include the Health Protection Agency (HPA), which is the sole manufacturer of licensed anthrax vaccines in the UK, The Defence Science and Technology Laboratory - currently working on a new dual pneumonic and bubonic plague vaccine - and an anthrax vaccine, as is Microscience.
The UK has always had the innovative science base and it is now poised to make a major contribution to the knowledge economy, whose development is a common goal among European leaders and sights are firmly set on making this a reality. The recent government 10-year science strategy is welcome and will undoubtedly be a boost for the UK sector, allowing more innovative science to meet its commercial potential. While funding at all stages and in all areas will inevitably always be an issue and financing windows remain few and far between, if these hurdles are addressed then UK bioscience can really deliver the commercial, patient and national economic benefits it undoubtedly has to offer.
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