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Topical formulation development using in silico and in vitro/ex vivo models

Summary of the impact

The university's Pharmacy and Pharmacology unit has developed and validated novel in silico and in vitro/ex vivo models for use by the pharma industry to select drug candidates, optimise formulations, determine the posology for clinical trials and show bioequivalence. This resulted in: the approval of two products for actinic keratosis (Picato® and Zyclara®); a generic nail formulation approved for use based on the demonstration of equivalence using the in vitro/ex vivo models described with no clinical testing (the first time this has occurred); and the translation and commercialisation of two dermal drug delivery-based patented technologies (licensing deals with Sinclair IS and major pharmaceutical companies).

Submitting Institution

University of Hertfordshire

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Pharmacology and Pharmaceutical Sciences

Commercial and health impacts of drug modelling tools

Summary of the impact

Research at the University of Sheffield developed pharmacokinetic tools that enable prediction of drug absorption, distribution, metabolism and excretion, and potential drug-drug interactions. In 2001 the University created a spinout company, Simcyp Ltd, to commercialise the technology. The impacts are:

  • Commercial: the company was awarded the Queen's Award for Enterprise in Innovation in 2010 and in February 2012 was sold for $32M to Certara, a leading provider of drug discovery and development software.
  • Commercial: the Simcyp population-based Simulator is now used in drug development by many of the world's leading pharmaceutical companies, saving them time and millions of dollars through more efficient and targeted testing.
  • Health: human and animal test subjects have benefitted by optimisation of the design of trials to minimise unnecessary drug exposure.
  • Health: the Simcyp Paediatric module has improved the care of children by providing reliable evidence to better guide dosage.

Submitting Institution

University of Sheffield

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Neurosciences, Pharmacology and Pharmaceutical Sciences

Developing improved pre-clinical testing strategies to reduce the drug attrition of inhaled drug compounds at pre-clinical assessment.

Summary of the impact

Edinburgh Napier University is internationally recognised for its research into the mechanisms that drive the adverse health effects of inhaled particles. Pharmaceutical company GlaxoSmithKline (GSK) required early understanding of the likelihood that inhaled drug particulates, used in the treatment of asthma, would evoke an adverse biological response, thus compromising the development of any novel drug. Through collaboration, via a Knowledge Transfer Partnership (KTP), we were able to develop improved in vitro methodologies to study toxicity and, thus, predict pathologies reported in vivo with the aim of reducing both the use of animals and pre-clinical drug attrition.

Submitting Institution

Edinburgh Napier University

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

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

Expressed hERG potassium channel bioassays in mammalian cell lines to evaluate safety and efficacy of new drugs

Summary of the impact

All new drugs are required to undergo cardiac safety testing to avoid dangerous side effects on contractility and excitability. Of particular concern is the risk of developing a lethal arrhythmia from inhibition of hERG (human Ether-à-go-go-Related Gene) potassium channels. The Bristol laboratory of Professor Hancox and colleagues demonstrated the utility of hERG-transfected mammalian cell lines for investigation of hERG-related effects and risk. Now most drug discovery programmes utilise hERG screens as part of an integrated assessment of cardiac risk (as recommended by the FDA and MHRA). Second, their work linked hERG inhibition to cardiac risk for certain psychotropics (and other agents) that have been either withdrawn or now carry warnings as to their cardiac safety.

Submitting Institution

University of Bristol

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Physical Sciences: Other Physical Sciences
Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Pharmacology and Pharmaceutical Sciences

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

Improved drug discovery and development through use of novel iridium catalysts

Summary of the impact

Labelled compounds form an essential part of drug discovery and development within the pharmaceutical industry. Novel iridium catalysts, developed by Kerr at WestCHEM since 2008, have introduced a step-change in the ability to label pharmaceutical candidate compounds with radioactive (tritium) or non-radioactive (deuterium) isotopes.

The catalysts are applicable to specific types of compounds that comprise approximately one-third of all drug candidates. Advantages of the catalysts include greater efficacy (less catalyst needed and higher yield of labelled product, giving cost savings), greater speed (efficiency savings), and a significant decrease in radioactive waste compared with previous methods (environmental and safety benefits).

Even since 2008, their adoption within the pharmaceutical industry has been extremely rapid; e.g., the multinational pharmaceutical company AstraZeneca now applies the Kerr methodology to 90% of their relevant candidate compounds. Additional impact has been achieved by Strem Chemicals who have been manufacturing and marketing the catalysts worldwide since October 2012. Even in that very short period, multiple sales have been made on three continents providing economic benefit to the company.

Submitting Institutions

University of Strathclyde,University of Glasgow

Unit of Assessment

Chemistry

Summary Impact Type

Technological

Research Subject Area(s)

Chemical Sciences: Organic Chemistry
Medical and Health Sciences: 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

Abraham solvation parameter approach benefiting the chemical industries

Summary of the impact

The Abraham solvation parameter approach developed at UCL has become integral to the work carried out by drug discovery teams at [text removed for publication] and other major pharmaceutical companies, as well as research and development groups at international chemical companies including Syngenta and [text removed for publication]. It enables chemists to predict physicochemical and biochemical properties of chemicals, including drugs and agrochemicals, rapidly and efficiently, without the need to conduct time-consuming experiments. The method helps drug discovery teams to identify and optimise the most promising compounds, and often results in fewer compounds being made before a candidate is selected, saving time and resources. The approach has been integrated into software used for drug discovery [text removed for publication].

Submitting Institution

University College London

Unit of Assessment

Chemistry

Summary Impact Type

Technological

Research Subject Area(s)

Chemical Sciences: Physical Chemistry (incl. Structural), Theoretical and Computational Chemistry
Biological Sciences: Biochemistry and Cell Biology

Development of more effective technologies for oral delivery of drugs via improved understanding of the physiological features of the gastrointestinal tract

Summary of the impact

Research by Professor Abdul Basit's group at the UCL School of Pharmacy is leading to improved treatments for ulcerative colitis and other conditions through increased knowledge of the complex physiology of the gastrointestinal tract. Improved understanding of in vivo drug release and uptake has allowed development of three patent-protected technologies for improved drug delivery: PHLORALTM, for release of drugs in the colon, and DuoCoatTM and ProReleaseTM formulations designed to allow intact transit through the stomach followed by immediate release upon gastric emptying. These technologies are the subject of licences and ongoing development programmes, with PHLORALTM currently in phase III clinical trials. The impact is therefore the introduction of enabling technologies that have positively influenced the drug development programmes of pharmaceutical companies.

Submitting Institution

University College London

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Clinical 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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