Summary of the impact

The UK Rail Industry has set itself a target of increasing capacity by a factor of two within 30 years for both passengers and freight. A central problem is to increase the capacity and performance of the (existing) rail network. Signalling systems and their safety is a major consideration. It is towards this long-term goal that we direct our research activity on signalling. Our research impacts both current practices and strategic planning within the Railway Industry:

• Current practices: Our research has led to (i) the adoption of formal verification techniques at Invensys Rail, a multi-national technology leader, as well as (ii) changes in the operation and organisation of the company - involving personnel, structures and forward thinking - that successfully address commercial challenges faced by the company.
• Strategic planning: The adoption of the European Train Management System (ETMS) - a proposed replacement for track-side signalling - is aimed at reducing maintenance costs, enhancing performance and improving safety. But its adoption presents a major challenge for the UK. In addressing this, our research produces data and thinking in support of change, which we deliver through various working groups and initiatives that are developing national policy for the development of the UK railway. By releasing UK railways from the strictures of track-side signalling, ETMS represents the step-change transformation necessary for meeting the industry's ambitious 30-year target.

Summary of the impact

The transition, at the end of the 20^th century, from ozone-depleting chlorofluorocarbons (CFCs) to hydrofluoralkane (HFA) propellants in metered dose inhalers (MDIs), for drug delivery to the upper airways in the lungs, taxed the ingenuity of formulation scientists and device design engineers. The regulatory requirement for clinical equivalence between the CFC and HFA products demanded an unchanged drug dosing regimen and identical lung deposition profiles.

Research funded by Chiesi Farmaceutici (Parma, Italy) in the Centre of Drug Formulation Studies (CDFS) at the University of Bath led to development of the Modulite^® technology which met the challenges posed and mimicked the performance of CFC MDI using HFA propellants. The proprietary technology enabled Chiesi to re-formulate and commercialise a number of products, which now represent mainstay therapies in the treatment of asthma and chronic obstructive pulmonary disease (COPD).

The Modulite^® technology has provided the greatest contribution to both the turnover and the global development of the Chiesi group, via several successful in-house developmements and collaboration agreements with leading pharmaceutical companies. Global sales of Chiesi's Atimos Modulite^®, Fostair/Foster (25% of sales) and Clenil Modulite^® (14.4% of sales) MDI products produced revenue of in excess of $450 Million in 2012.

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.