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Drug Development: Influences on Regulatory Policies and Industrial Practices (ICS-11)

Summary of the impact

Drug development is a highly regulated environment. Identifying the need for an independent, academic-led centre of excellence in research and training of pharmacokinetics, we established the Centre for Applied Pharmacokinetic Research (CAPKR) to engage in problems of generic interest to the Pharmaceutical Industry. CAPKR has been highly influential by informing regulatory practice in Europe and the USA, by establishing and optimising industrial practices related to drug development, particularly those related to drug-drug interactions, by reducing the usage of animals in research and by allowing the commercial development and extensive use of simulation software tools for quantitative prediction of pharmacokinetics in order to improve patients' safety.

Submitting Institution

University of Manchester

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Health

Research Subject Area(s)

Mathematical Sciences: Statistics
Medical and Health Sciences: Pharmacology and Pharmaceutical Sciences

5. Research drives development and use of biocompatible dialysis solutions, and better patient outcomes in peritoneal dialysis.

Summary of the impact

More than 240,000 people with kidney failure are treated with peritoneal dialysis (PD) worldwide. Cardiff University pioneered novel test methods that identified deleterious dialysis solution components, leading directly to manufacturers introducing more biocompatible dialysis fluids that improve patient outcomes. Cardiff investigators designed and ran the early clinical studies on these new fluids, which now lead the PD solutions market worldwide, and are recommended in European clinical guidelines. Recent evidence suggests that their use reduces peritonitis severity, decreases peritonitis incidence by 40% and mortality by 30%, resulting in reduced hospitilsation and significant healthcare savings.

Submitting Institution

Cardiff University

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences, Neurosciences

Multi-country risk-mapping leads to more efficient delivery of mass-treatment for the control of river blindness

Summary of the impact

Onchocerciasis (river blindness) is a debilitating disease of major public health importance in the wet tropics. The African Programme for Onchocerciasis Control (APOC) seeks to control or eliminate the disease in 19 countries. Accurate mapping of Loiasis (eye-worm) was a requirement for implementation of APOC's mass-treatment prophylactic medication programme in order to mitigate against serious adverse reactions to the Onchocerciasis medication in areas also highly endemic for Loiasis. Model-based geostatistical methods developed at Lancaster were used to obtain the required maps and contributed to a change in practice of APOC in a major health programme in Africa. Our maps are used to plan the delivery of the mass-treatment programme to rural communities throughout the APOC countries, an estimated total population of 115 million.

Submitting Institution

Lancaster University

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Health

Research Subject Area(s)

Mathematical Sciences: Statistics
Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Public Health and Health Services

Reducing Waste in the Fresh Produce Supply Chain

Summary of the impact

Cranfield's work on ethylene supplemented storage is now exploited in the supply chains to major supermarkets in the UK, including Waitrose and Tesco, reducing waste and avoiding volatility in supply for fresh food products such as onions and potatoes. By prolonging storage life by up to six weeks it is also having a positive impact on the UK's self-sufficiency in these products, displacing imports from overseas.

Complementary work has also led to commercial ethylene scrubbing technologies for packaging, which typically save around 50% of in-store waste and add two days to the product life for a range of fruit and vegetables. Such packing is now in use in most mainstream UK supermarkets, and in the USA where it has created a new export market for the manufacturer.

Submitting Institution

Cranfield University

Unit of Assessment

Agriculture, Veterinary and Food Science

Summary Impact Type

Economic

Research Subject Area(s)

Chemical Sciences: Organic Chemistry
Biological Sciences: Genetics, Plant Biology

Improved animal health and welfare and economic benefits for farmers from better management of parasites in livestock

Summary of the impact

Research conducted at the University of Bristol between 2003 and 2012 on the ecology, epidemiology and control of parasitic flies and worms has improved animal health and welfare in the UK and is addressing a major constraint on global food production — animal disease, particularly in the context of climate change. These are some of the impacts:

  • In 2011, industry benefited from research on blowfly strike which has provided scientific evidence that strategic early treatment of sheep reduces season-long disease risk and results in financial savings for farmers, particularly where earlier emergence of flies occurs in response to warming temperatures.
  • Between 2008 and 2012, farmers realised a 73% direct saving in the monitoring of gastrointestinal nematodes due to the development of a composite faecal worm egg count (FEC) test and a decrease of up to 75% in the number of treatments given to lambs.
  • Farmers and livestock benefited from the slower development of anthelmintic-resistant parasites as a result of targeted treatment using the composite FEC test developed.

Submitting Institution

University of Bristol

Unit of Assessment

Biological Sciences

Summary Impact Type

Environmental

Research Subject Area(s)

Agricultural and Veterinary Sciences: Animal Production, Veterinary Sciences
Medical and Health Sciences: Public Health and Health Services

Feline chronic kidney disease: changes in clinical practice for routine diagnosis and management

Summary of the impact

Clinical research at RVC commencing in 1994 has changed clinical practice in management of feline chronic kidney disease (CKD) by transforming international consensus on diagnostic and treatment guidelines on proteinuria, hypertension and hyperphosphataemia. The research has informed the development of new products to manage hyperphosphataemia and diagnostics for identification of low level proteinuria in cats, deemed unimportant prior to publication of the RVC's research. RVC academics have worked in partnership with industry and used research results to change clinical practice guidelines through participation in consensus expert groups and increasing acceptance of new guidelines by outreach activities to general practitioners in UK, Europe, Asia and the USA in the form of publication of textbook chapters, lectures at major conferences and e- learning platforms to explain the underpinning research-based evidence.

Submitting Institution

Royal Veterinary College

Unit of Assessment

Agriculture, Veterinary and Food Science

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

Improvement of Biocompatibility of Peritoneal Dialysis Fluids

Summary of the impact

Research led by Professor Paul J Thornalley since 1993, (University of Warwick, 2007-present), revealed the formation of harmful reactive dicarbonyl compounds (also known as glucose degradation products, GDPs) within the glucose osmolyte of first-generation peritoneal dialysis (PD) fluids. Clinical studies confirmed the increased damage to proteins in patients on PD therapy. In response to these findings, major manufacturers of PD fluids changed their manufacturing processes to minimise GDP content by separating glucose and buffer components within two-compartment bags for heat sterilisation, and by using osmolyte that is resistant to thermal degradation. PD fluids with low GDP content have been associated with improved clinical outcomes for patients receiving dialysis, including maintained residual renal function, decreased peritonitis, and decreased fluid infusion pain. They have been widely implemented in clinical use since 2010. Globally, approximately 240,000 patients receive PD therapy.

Submitting Institution

University of Warwick

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences

Control Strategies towards eradication of Bovine Viral Diarrhoea

Summary of the impact

Interdisciplinary research at the Royal Veterinary College (RVC) has provided core evidence on which global efforts are based in order to eradicate one of the most economically damaging diseases of the cattle industry. The research findings have helped steer national programmes to eradicate Bovine Viral Diarrhoea (BVD) across Europe, South Asia and Australasia, reducing economic losses. Professor Joe Brownlie has additionally led pilot programmes in the UK, providing data for a national scheme, campaigned widely to highlight the issue and secured farming industry awareness and support through media exposure.

Submitting Institution

Royal Veterinary College

Unit of Assessment

Agriculture, Veterinary and Food Science

Summary Impact Type

Economic

Research Subject Area(s)

Agricultural and Veterinary Sciences: Veterinary Sciences
Medical and Health Sciences: Medical Microbiology, Public Health and Health Services

Preventing the gastroduodenal hazards of non-steroidal anti-inflammatory drugs and aspirin through widespread adoption of proton pump inhibitors

Summary of the impact

Non-steroidal anti-inflammatory drugs (NSAIDs) are valuable analgesics, but cause dyspepsia, ulcers and hospitalisation (UK: 3,500pa, USA: 100,000pa) for complications that can lead to death (UK: 400-1,000pa, USA: 16,500pa). Acid inhibition by proton pump inhibitors (PPIs), the only widely accepted preventative strategy, was proposed and systematically proved by studies from Nottingham. NICE now recommends PPIs for all patients using NSAIDs and PPIs are central to all major international guidelines. PPI co-prescription has increased worldwide (from 27.6% in 2008 to 44.1% in 2012, in the UK); and reduces the risk of hospitalisation for gastrointestinal bleeding by 54% and symptomatic ulcer by 63%, thereby preventing up to 540 deaths per annum in the UK.

Submitting Institution

University of Nottingham

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Pharmacology and Pharmaceutical Sciences

Improved patient care through new guidelines for antibiotic dosing and monitoring.

Summary of the impact

This research has improved the clinical use of powerful antibiotics. New guidelines for vancomycin use in adults have been adopted by the NHS throughout Scotland and in other parts of the UK. New neonatal vancomycin guidelines have decreased the time to achieve optimal antibiotic concentrations and reduced patient trauma and staff workload. These guidelines are used routinely in the Greater Glasgow area and other parts of the UK. Tobramycin guidelines improved the management of infection in patients with cystic fibrosis in the Glasgow and Edinburgh areas. Additional studies, which investigated guideline implementation across NHS Scotland, resulted in nationally supported resources designed to improve the quality of patient care when vancomycin or gentamicin is used.

Submitting Institution

University of Strathclyde

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Political

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences, Pharmacology and Pharmaceutical Sciences

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