Clinical pharmacology studies conducted at Newcastle have led to
optimisation of the administration of the chemotherapy drug carboplatin in
children with neuroblastoma and other cancers. The research provided the
rationale for carboplatin dosing based on patient renal function, with
individualised dosing resulting in increased drug efficacy and reduced
toxicity. This approach is now in widespread use in national and European
treatment protocols, benefitting over 2,500 children. Similar drug
monitoring approaches are being implemented for an increasing number of
important drugs. Following a recent Newcastle-led national clinical trial,
new dosing guidelines for the drug 13-cis retinoic acid have been
adopted for high-risk neuroblastoma patients across Europe.
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:
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.
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.
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).
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.
Biomedical devices that need to be implanted into the body typically
experience the so-called foreign-body reaction: proteins adhere to the
surface of the devices, leading to rapid loss of function and, eventually,
to a requirement for replacing the device. Between October 2006 and
September 2011, The University of Reading, in collaboration with the UK
SME BioInteractions Ltd., developed and evaluated a range of new
polymers for coating implantable biomedical devices, especially coronary
stents and catheters. The result was a coating system that can deliver a
drug controllably over a pre-defined period, leading to the commercial
biomaterials platforms AdaptTM and AssistTM. This
work resulted in capital investment by Biointeractions Ltd and a
substantial increase in their research staffing.
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.
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.