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New Approaches to Drug and Chemical Safety Assessment

Summary of the impact

The development of new paradigms for toxicity testing has benefitted the Scottish economy and population in Tayside through two biotechnology companies which, between them, employ up to 40 staff and have had a combined turnover of some £15M over the last five years. The benefits extend to the international pharmaceutical, cosmetic, chemical and consumer product industries, which have gained access to innovative new methods for safety testing at a time of acute need for more predictive methods to evaluate drug safety and better in vitro tests for consumer products. Patients and consumers in Europe and worldwide have benefitted indirectly from improved risk assessment of drugs, consumer products and environmental contaminants.

Submitting Institution

University of Dundee

Unit of Assessment

Clinical Medicine

Summary Impact Type

Political

Research Subject Area(s)

Medical and Health Sciences: Pharmacology and Pharmaceutical Sciences

Innovative approach to assessing drug harms has major impact on government policy and public awareness

Summary of the impact

A new, more structured way of assessing the various harms done to individuals, families, communities and wider society by a range of legal and illegal drugs was first articulated by Professor David Nutt and colleagues at the University of Bristol. The "rational scale" they developed in the light of their research has stimulated extensive policy debate and informed drug classification in the UK and overseas. The research underpinning the scale has been disseminated through numerous public lectures and discussions and has stimulated worldwide media coverage. As a consequence, public awareness of drug harms has increased and public engagement in important debates about drugs has intensified.

Submitting Institution

University of Bristol

Unit of Assessment

Psychology, Psychiatry and Neuroscience

Summary Impact Type

Societal

Research Subject Area(s)

Medical and Health Sciences: Pharmacology and Pharmaceutical Sciences, Public Health and Health Services
Psychology and Cognitive Sciences: Psychology

Meeting clinical challenges in the UK and sub-Saharan Africa via drug redeployment.

Summary of the impact

The provision of effective and sustainable healthcare is a major challenge for society. In the developed world escalating costs are placing a huge burden on finite resources; in the developing world, where financial resources are often extremely limited, providing affordable healthcare is an even greater problem. One innovative route to help alleviate these problems is through drug redeployment, whereby existing drugs are employed in new ways to tackle serious diseases. Combining their knowledge of haematological disease gained from their research over the past 20 years together with a drug redeployment strategy, researchers in the School of Biosciences have developed and trialled new interventions for two blood cell cancers, Acute Myeloid Leukaemia (AML) and Burkitt's Lymphoma (BL), based on the administration of a combination of the lipid lowering drug Bezalip (Bez) and the female contraceptive Provera (MPA). As a result:

  • Definitive significant outcomes have been demonstrated in terms of halting disease progression and / or diminishing disease load in patients suffering from AML and BL.
  • Successful drug redeployment, on the basis of efficacy, absence of toxicity and low cost of drugs has been achieved.
  • This intervention has created the means to reduce childhood mortality and improve the length and quality of life in areas of sub-Saharan Africa.

Submitting Institution

University of Birmingham

Unit of Assessment

Biological Sciences

Summary Impact Type

Health

Research Subject Area(s)

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

Safer treatment of childhood leukaemia through improved delivery of thiopurine drugs

Summary of the impact

A routine test to screen for patients genetically disposed to serious side effects from treatment with thiopurine drugs has been widely adopted following research by the Academic Unit of Clinical Pharmacology at the University of Sheffield. The test has spared patients painful and potentially life-threatening sepsis, and saved the considerable associated treatment costs which have been estimated to be over £9,000 per patient for a 17 day hospital stay. It has also led directly to a change in clinical guidelines and recommendations in both the USA and UK.

Submitting Institution

University of Sheffield

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Oncology and Carcinogenesis, Pharmacology and Pharmaceutical Sciences

Evidence-based safer injecting equipment for users of illicit drugs

Summary of the impact

The health of people who inject illicit drugs, the formulation of harm-reduction policies, and the work of associated businesses and social enterprises have all benefited from the University's laboratory and practice research into the safety and efficacy of materials and equipment used in needle-exchange programmes. The research has informed the development of safer acids for injection preparation, safer injecting paraphernalia (e.g., spoons and filters) and an information film which has been distributed from needle exchanges on DVD and viewed over 50,000 times online. The research has led to enhanced support and protection for injecting drug misusers, and to advances in harm reduction in the UK, France and Canada.

Submitting Institution

University of Bath

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Societal

Research Subject Area(s)

Medical and Health Sciences: Public Health and Health Services

2. ProTide Technology: Transforming drug discovery of nucleoside-based anti-viral and anti-cancer agents.

Summary of the impact

ProTide technology, discovered by the McGuigan team at Cardiff University, is a pro-drug strategy with proven capacity to generate new drug candidates for nucleoside-based antiviral and anti- cancer indications. In the assessment period the McGuigan team has attracted more than £2 million direct research funding through sustained collaborations on ProTide technology with global pharmaceutical companies and smaller biotech firms in the USA and Europe. In the same period, either through working directly with Cardiff or by independent adoption of McGuigan's research, eight ProTide entities have progressed to clinical trials as cancer, HIV and hepatitis C treatments. The technology is demonstrating significant commercial impact for companies with ProTide-based drug candidates.

Submitting Institution

Cardiff University

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Chemical Sciences: Organic Chemistry
Technology: Medical Biotechnology
Medical and Health Sciences: Pharmacology and Pharmaceutical Sciences

Ethnicity and Screening for Sickle Cell/Thalassaemia

Summary of the impact

Antenatal screening aims to identify genetic carriers of sickle cell/thalassaemia in order to provide prospective parents with "informed choice". Throughout the period January 2008-July 2013, the NHS in England has used a Family Origins Questionnaire in connection with sickle cell/thalassaemia screening derived from our research programme. The original policy issue concerned whether or not it is possible/desirable to target antenatal screening for sickle cell/thalassaemia by means of an ethnicity question. The policy problem was that socially constructed "ethnicity" categories correspond imperfectly and to an unknown degree with actual prevalence of genetic carriers. The screening question based on our research now guides the offer of initial screening and/or further laboratory tests for all pregnant mothers in England.

Submitting Institution

De Montfort University

Unit of Assessment

Social Work and Social Policy

Summary Impact Type

Political

Research Subject Area(s)

Medical and Health Sciences: Public Health and Health Services

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

A Treatment for Irritable Bowel Syndrome (IBS)

Summary of the impact

Research at the University of Sheffield contributed to the development by GlaxoSmithKline (GSK) of a drug to treat Irritable Bowel Syndrome (IBS) that has transformed the lives of thousands of patients and generated significant revenue. The drug, alosetron, which blocks 5-HT3 receptors in the gastrointestinal tract, was approved by the Food and Drug Administration (US) (FDA) in 2000 and launched under the trade name Lotronex. It is currently the only drug on the market aimed specifically at the treatment of diarrheal IBS. Although GSK voluntarily withdrew the drug from the market following concerns over possible side effects, Lotronex was relaunched in 2004 following petition from IBS sufferers and user groups. The licence for Lotronex was sold in 2008 to Prometheus Laboratories, Inc. and annual sales of the drug now exceed $34 million. In 2011 Prometheus was bought by Nestle for an estimated $1.1billion. This case study has significant impact on commerce and health and welfare.

Submitting Institution

University of Sheffield

Unit of Assessment

Biological Sciences

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Neurosciences, Pharmacology and Pharmaceutical Sciences

Inhaled delivery of life-saving medicines - The Vectura story

Summary of the impact

Innovative formulation science to create and develop the commercially successful PowderHale® technology was undertaken within the Department of Pharmacy & Pharmacology at the University of Bath, and subsequently by Vectura. This has directly provided the basis for novel, potentially life-saving treatments for chronic obstructive pulmonary disease (COPD). Seebri® Breezhaler® and Ultibro® Breezhaler® are once-daily, maintenance bronchodilators for the relief of various symptoms due to airways obstruction caused by COPD. Seebri® Breezhaler® was approved in the EU and Japan at the end of 2012 and has now been launched by Novartis. Ultibro® Breezhaler® a first-in-class combination bronchodilator was approved in Japan and the EU in September 2013. Under the terms of the licence agreement with Novartis concerning these products, Vectura has already received $52.5M with an additional >$100M anticipated upon achievement of regulatory and commercialisation targets. These medicines are major advances to treat and manage a disease that, according to the WHO, affects an estimated 210 million people worldwide and was the third leading cause of death in the developed world in 2012.

Submitting Institution

University of Bath

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Engineering: Chemical Engineering
Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Pharmacology and Pharmaceutical Sciences

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