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.
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.
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
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
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
benefit to the company.
Our research on cannabis, ketamine and MDMA (ecstasy) has used pioneering
methods to provide a unique new evidence-base on which illegal drugs can
be evaluated. This work has influenced government policy and legal
proceedings in the UK and abroad. We have engaged widely with drug users,
other members of the public, drug services and the media to disseminate
our findings widely, and increase public knowledge of the topic. Our
research on the effects of recreational drug use thus has changed national
and international media discourse about this topic, and has increased
public awareness and engagement.
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].
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.
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:
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.
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.
University of Dundee-led research has changed the international approach
to illicit drug deaths. Though reducing deaths was a national priority, no
systematic research into Scottish deaths had previously occurred.
Highlighting the heterogeneity of the deceased, Dundee researchers
identified deficits in care processes and multi-agency data sharing,
making recommendations regarding monitoring. This directly influenced
government response, introducing a standardised mandatory annual review
process, enhancing understanding of drug death in Scotland and
facilitating targeted prevention approaches. This, and subsequent
Dundee-led research, now informs strategy development in the UK via the
national programme on Substance Abuse Deaths (np-SAD) and the European
Union (European Monitoring Centre for Drugs and Drug Addiction; EMCDDA).