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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

Supporting regulatory approval of poorly soluble drugs for HIV and Hepatitis C

Summary of the impact

Research by the School of Pharmacy played a key role in the 2008 regulatory approval of Janssen Pharmaceutica's HIV drug Intelence®. As a poorly soluble drug, Intelence® required specialist formulation and was the first formulation of its type to be approved by the FDA and EMA. Intelence® offers significantly improved clinical outcomes due to its efficacy in patients with HIV resistance. Global Intelence® sales in 2012 were $349M, with additional not-for-profit supplies to resource-limited countries. As a result of this landmark regulatory approval formulation development strategies at Janssen were adapted enabling a further poorly soluble drug to reach the market. Telaprevir, a second-generation Hepatitis C treatment (marketed as Incivek®, Incivo® & Telavic®), gained global regulatory approval in 2011. 2012 sales exceeded $1bn in the US alone.

Submitting Institution

University of Nottingham

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Technological

Research Subject Area(s)

Chemical Sciences: Analytical Chemistry, Macromolecular and Materials Chemistry, Physical Chemistry (incl. Structural)

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

Medical implants with biocompatible electropolymer surfaces

Summary of the impact

Our research has shown that functionalised poly(pyrroles) grown electrochemically on medical steels and other alloys as adherent, highly conformal coatings can enhance surface biocompatibility and provide a platform for implantable medical devices. Chameleon Biosurfaces Ltd. was founded to exploit this research by producing coatings for medical devices, including coronary artery stents and pacemaker implants. Up to 2009, Chameleon Biosurfaces Ltd. received £1.48M of venture capital and seedcorn funding. In 2011 all assets of Chameleon Biosurfaces Ltd. were sold to the US biomedical company Biotectix LLC.

Submitting Institution

University of East Anglia

Unit of Assessment

Chemistry

Summary Impact Type

Technological

Research Subject Area(s)

Chemical Sciences: Macromolecular and Materials Chemistry, Physical Chemistry (incl. Structural)
Engineering: Biomedical Engineering

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

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

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

Supercritical Fluids – Critical Pharmaceuticals Ltd (CS1)

Summary of the impact

The University of Nottingham's School of Chemistry has developed a novel method of incorporating thermally or chemically labile biologically active substances into polymers. This has been achieved by using supercritical carbon dioxide as a medium for the synthesis and modification of polymeric materials. The method has been employed as the basis for new drug-delivery devices whose viability in the healthcare sphere has been confirmed by patient trials. The spin-out company, Critical Pharmaceuticals Ltd, has delivered a range of economic benefits, including job creation, the securing of millions of pounds' worth of investment and a number of revenue-generating research collaborations.

Submitting Institution

University of Nottingham

Unit of Assessment

Chemistry

Summary Impact Type

Technological

Research Subject Area(s)

Chemical Sciences: Macromolecular and Materials Chemistry, Organic Chemistry
Engineering: Biomedical Engineering

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

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