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Our biomarker research and underpinning technologies have commercially impacted upon the global R&D strategies of Unilever, Philips and Mars, realising new market areas for them, resulting in several million GBP invested in related R&D as well as "claim support" for products both in development and already available on shelves. Unilever have adopted biomarker outcomes as endpoints in clinical trials of new products, and Philips and Mars are developing with us saliva-based near-patient diagnostic tests for the human and small animal markets. We have also spun out two SME's: A) Oral Health Innovations (OHI) Ltd has developed online risk and disease analysis software for oral conditions, which was piloted, adopted and launched by Denplan, the UKs largest dental capitation plan operator (accessing 6500 dentists and 1.8 million patients), at the 2013 annual British Dental Association conference; and B) GFC Diagnostics makes SmokeScreen™ a non-invasive, sensitive and objective saliva test developed from our biomarker research at Birmingham University. Both technologies have already provided demonstrable social and commercial impact and given their uptake to date, will also deliver economic, environmental and health impacts.
Jayne's team have co-ordinated a sequence of randomised clinical trials, that have defined the standard of care for ANCA vasculitis treatment and shaped national and international guideline statements, NHS national commissioning guidance and an on-going NICE assessment. Together with Ken Smith his group have pioneered the use of the B cell-depleting agent rituximab, in vasculitis, contributing key evidence that led to its licence approval (USA and EU) for this indication. Ken Smith's group supported by Jayne's clinical team have discovered novel therapeutic biomarkers, patented and being assessed in Phase II clinical studies, that promise to deliver "personalised medicine" in this and related conditions. These activities have harmonised the management of vasculitis, are improving patient outcomes, and have provided a resource for on-going scientific and clinical studies.
Research conducted by Professor TM Cox has led to several advances in the management of lysosomal storage disorders; i) development of miglustat (Zavesca®); now available throughout the world (EMA and FDA approved) for adult patients with Gaucher's disease and throughout the European Union and five other countries worldwide for adult and pediatric patients with Niemann- Pick type C disease, ii) development of the potential successor eliglustat; now in Phase 3 clinical trials, iii) identification of a biomarker for Gaucher's: CCL18/PARC, now incorporated into NHS standard operating procedures for monitoring therapeutic intervention. His pre-clinical research into gene therapy for Tay-Sachs disease also helped establish the NIH-funded Gene Therapy Consortium and gain the FDA's pre-IND approval for clinical trials in 2013, which together have raised public awareness of this disease.
Researchers from King's College London (KCL) designed and trialled a series of Oral Mucosal Disease Severity Scoring Systems (ODSS) that are now used routinely in clinical assessment of both serious and common oral diseases. They have changed clinical practice and significantly improved patient care and quality of life. For example, using ODSS has changed the first line treatment for orofacial granulomatosis from drugs to diet control, optimising treatment and definition of disease phenotypes. ODSS has achieved national and international impacts by providing objective evidence for the efficacy of treatments and is now incorporated into international guidelines of good practice and core training for oral medicine specialists.
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.
Chronic, debilitating diseases such as arthritis, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD) could potentially be treated by damping down the underlying inflammation and therefore improving the quality of life of sufferers. Nrf2 is a protein that prevents inflammation when activated and many researchers have sought to manipulate its activity as a potential therapeutic strategy. However, this has had little success, due to a lack of suitable biochemical tools. We describe here the Nrf2-activating peptide TAT14, which was developed in Pharmacy and is now being marketed by biotech companies to study this important pathway.
Research from the University of Brighton's Diabetes Research Group (DRG) has underpinned the translation of beta-cell replacement therapy into clinical application for the treatment of type 1 diabetes (T1D) to establish the world's first government-funded islet transplant service at six new UK islet-transplant centres. As a consequence, the first 65 successful islet transplants were performed, reducing the incidence of hypoglycaemic events by >95% and providing a life- changing therapy for patients. Through a leadership role in Diabetes UK, BONE integrated the interests of stakeholders and professionals to establish a new model for diabetes care. With the Juvenile Diabetes Research Foundation, in 2013 he launched in Parliament the first UK T1D Research Roadmap.
Psoriatic arthritis (PsA) is a chronic inflammatory disease of joints, skin and tendons that affects 0.5-0.8% of the population worldwide. PsA can cause substantial psychological and social problems and also causes increased risk of death from cardiovascular disease. Research conducted by Prof Iain McInnes at the University of Glasgow in partnership with leading pharmaceutical company, Janssen, has provided robust evidence of the clinical benefits and safety of the cytokine blocker ustekinumab, leading to its approval for use for PsA by the European Medicines Agency in July 2013. This was the first approval of a PsA drug with a new mode of action in a decade, providing a novel treatment for approximately 1.25 million PsA patients across Europe.
Southampton research has been central to the development and international licensing of one of only two novel asthma therapies in the last 30 years, transforming asthma control and survival for severe allergic asthmatics.
Key studies by the Southampton Group have underpinned the development of immunoglobulin (Ig)-E as a key therapeutic target for controlling allergic asthma, with the Southampton-led first-in- man safety and efficacy trials critical to the registration of the anti-IgE therapy, omalizumab.
This contribution also generated significant inward investment in UK R&D and opened up wider investigation of anti-IgE therapy in a broad range of atopic and inflammatory indications.
When anti-TNF therapies (which block tumour necrosis factor) were first licensed in 1999 only a few hundred patients with rheumatoid arthritis had received them, most for relatively short periods of time. Although the drugs represented a major breakthrough, `real-world' effectiveness and safety were unproven. Research at the University of Manchester (UoM) has addressed this knowledge gap and has successfully refined the ways in which anti-TNF drugs are used around the world, leading directly to more effective prescribing and improved patient outcomes. The research has also provided strong evidence that women do not need to discontinue anti-TNF treatment prior to conception.