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By identifying a novel approach to treat allergy and autoimmune disease the University of Bristol has created a new field of research into antigen-specific peptide immunotherapy. Initial work carried out by Professor David Wraith at the University has since 2008 led to the creation of new businesses, (including the spinout company Apitope), generated 100s of millions of pounds of investment and underpinned both the adoption of new technology and the development of new products by the pharmaceutical industry. The commercial impact of this research into antigen specific immunotherapy is on-going and expanding.
Researchers at the Dunn School of Pathology at the University of Oxford have played a major role in the development of an effective and innovative treatment for the chronic debilitating disease multiple sclerosis (MS). Research arising from the work of immunologists in Oxford, and partner neuroscientists in Cambridge University, has shown that low dose treatment with the lymphocyte depleting antibody alemtuzumab can break the cycle of disease in MS. Alemtuzumab acts by re-setting the immune system, leading to long-term arrest or remission, without increasing the risk of infection or malignancy. Large-scale studies since 2008 have shown that treatment is more effective and better tolerated than conventional forms of therapy. In June 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that the drug be licensed for people with active relapsing-remitting MS. The research by Oxford University and its collaborators into the use of alemtuzumab in MS has been shown to benefit patients; it offers hope to millions of sufferers worldwide; and has had a major impact on the pharmaceutical industry.
This case study summarises a body of research on Multiple Sclerosis (MS) developed at Plymouth University under the leadership of Professor Zajicek and Professor Hobart. Hobart's work on linical outcome measurements has directly influenced clinical research, trials and drug licensing, especially in MS and Alzheimer's disease. The MS scales developed by Hobart have been endorsed by the United States FDA and are in demand by commercial organisations in the development and trialling of treatments for MS and have led to the licensing of new drugs. Zajicek has led the topical field in evaluating the potential benefits and risks of cannabis for treating MS, contributing to the evidence base behind the medical use of cannabinoids in general, and pioneering its global potential use to slow neurodegeneration.
Research at the University of Aberdeen has directly contributed to the development of the cannabis-based medicine, Sativex®, which was licensed in the UK in 2010 for relieving neuropathic pain and spasticity of multiple sclerosis (MS), removing the need for patients to self-medicate with illegal, "unregulated" cannabis. The research has both enhanced patient welfare and promoted collaboration with industry. Several other countries have also approved Sativex®. Apart from such direct benefits, the research has also increased understanding of the benefits of cannabis-based medicines among the general public, and the main researcher has advised the Home Office on pertinent legislation. Therefore the claimed impact here includes benefits to health and welfare guidelines and on the public understanding of science. In addition industry has invested in research and development and a new product has been commercialised.
A novel technique named Selected Ion Flow Tube-Mass Spectrometry, SIFT-MS, has been researched and developed by Professor David Smith and Professor Patrik Spanel at the Institute for Science and Technology in Medicine (ISTM), Keele University. This technique allows real time, on-line analysis of trace gases in air and exhaled breath. This development stems from basic research into the reactivity of ions in the gas phase, in which Smith & Spanel are recognised international experts, combined with a complete understanding of the engineering and technical requirements of successful analytical instrumentation. SIFT-MS instruments have been developed initially from large laboratory devices to the current, transportable commercial instruments that are produced by two independent manufacturers and sold worldwide. They are used in various fields of research, including immediate analysis of exhaled breath and urine headspace for clinical diagnosis and therapeutic monitoring, cell biology, and in environmental and food sciences. They have important practical use in the safety of customs workers in container ports and in prospecting for oil and gas. SIFT-MS instruments manufactured in the UK have been exported to Austria, Czech Republic, China and the USA.
Multiple Sclerosis (MS) is the most common disabling neurological disease of young adults in the UK, affecting 1 in 800 of the population. In most patients the early years are characterised by relapse and remissions; relapses are often disabling and permanent disability occurs when remissions fail to recover fully. Research at the UCL Institute of Neurology — from early MRI studies through phase 1-3 clinical trials — has resulted in the licensing of natalizumab for highly active relapsing remitting MS. Natalizumab is now widely used to treat such patients with very good efficacy and close monitoring. Natalizumab is a potent treatment that has reduced relapse rate by two-thirds and relapse-related disability by 50%. By July 2013, over 115,000 patients around the world had received this treatment.
Researchers at the Biomedical Research Network (BRN) at The Open University (OU) have developed two novel technologies:
These patented technologies have been adopted by industrial partners, who have either invested in their further development and the automation of the production process to generate neural tissue model kits or have adopted the technology for their own use following licence transfer and/or temporary industrial contracts.
Q-Technologies Limited is an award winning company spun out from the University of Liverpool (UoL). The company mission is to bring to market the novel, patented technology developed through research undertaken by Taylor and colleagues in the Mass Spectrometry (MS) research group in the Department of Electrical Engineering and Electronics from 1995. Impact is economic resulting from formation of a profitable business, currently employing 7 people, and via IP assignment generating £1.2M in 2013. Impact is also environmental via the realisation of a novel sensor with unparalleled monitoring capabilities providing improved water quality monitoring.
Professor Platt and colleagues at the University of Oxford have developed the drug miglustat, the first oral therapy for rare lysosomal storage diseases. These are primarily neurodegenerative diseases that affect 1 in 5,000 live births, always leading to premature death. In 2009, miglustat became the first treatment to be licensed for treating neurological manifestations in Niemann-Pick disease type C (NPC). It is now prescribed for the majority of NPC patients worldwide, and has led to significant improvements in both life expectancy and quality of life. Miglustat was approved for type 1 Gaucher disease in 2002 and, since 2008, has proved an effective treatment for patients previously stabilised with enzyme replacement therapy; miglustat has the additional benefit of improving bone disease. Sales of miglustat since 2008 have generated CHF 315 million in revenues for Actelion, the company sublicensed to sell the drug.
Research into novel immunotherapies has given rise to a novel drug (EtxB), which is now in Phase II clinical trials, and to a profitable contract research company partnering with the pharmaceutical industry to develop their compounds. Trident Pharmaceuticals was formed around patents filed by the University of Bristol, has received investment of [text removed for publication], successfully completed Phase I trials (2011) and is in the midst of Phase IIa trials in humans with inflammatory disease (2013). KWS BioTest arose as a result of the underpinning research and experience gained from developing EtxB, and is now a leading contract research organisation working with pharmaceutical and biotechnology companies developing novel treatments for human disease. KWS has directly contributed to the development of therapies at more than 75 different companies, employs 28 people, has exported [text removed for publication] and was 2012 winner of a Biomedical iNet Award for outstanding business achievement.