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Sugaring the pills

The UK?s pharmaceutical industry has a proud record of commitment to R&D, but, says the Association of the British Pharmaceutical Industry, without investment there will be no future advances and no new medicines

The UK has a long, proud history of the research and development of life-saving medicines, with some 20 of the current world top 100 medicines being developed in British laboratories. This record of achievement looks set to continue as nearly 1000 potential future medicines are in the research and development pipeline of some 50 companies operating in the UK.

This commitment to research offers patients fresh hope in nearly 50 disease areas, including the government?s key priority areas. Industry investment has grown steadily, especially in the past two decades. Annual surveys by the Office of National Statistics show that total R&D expenditure by the pharmaceutical industry in the UK, including capital investment, has risen from £475m in 1984 to £3,308m in 2005. That works out as nearly £10m a day in the UK ? a quarter of all the nation?s private sector research and development funding ? and Britain is the largest single country in Europe for pharmaceutical R&D expenditure.

This consistent investment means the pharmaceutical industry is vital to the health and wealth of the nation. Its medicines touch the lives and wellbeing of each and every one of us. Research and development is the lifeblood of this industry and it bears results. In 2006, pharmaceuticals? positive balance of trade stood at £4.2bn ? a rise of over £700m from 2005 ? only the energy equipment and telecomms industries contributed more net trade to the UK.

According to an Association of the British Pharmaceutical Industry (ABPI) report, A-Z of Medicines Research, just over 950 compounds were in preregistration clinical development in 2006, compared with 561 compounds being researched when the ABPI published its last survey in 2002 ? although the report warns that many of these compounds will not make it through the stringent, 12-year development period. Of the compounds in development, 362 are in Phase 1 clinical trials, involving non-patient human volunteers; 349 in Phase 2, involving a small number of patients; and 240 in Phase 3, with a larger number of patients.

Overall, the largest numbers of compounds are being developed for cancer (170), cardiovascular diseases (109), mental disorders (62), diseases of the endocrine system (59), respiratory diseases (53) and dementia (20). This is a research programme that is well-aligned with the priorities of the NHS.

The report shows that the medicines pipeline is stronger than ever before, and that there are many exciting prospects in a wide variety of therapeutic areas, including some of humanity?s toughest disease challenges.

Without investment in R&D, there will be no future advances, no progress, no new medicines to tackle life-threatening diseases. Those who invest large sums in research are also investing in the future. And pharmaceutical companies in the UK, in partnership with academic institutions and government, are doing this in a way unmatched by any other industry. The UK?s share of global pharmaceutical R&D spend has remained consistently high at between nine and 10% over the past 10 years, although the UK market is only some 3% of the global total.

The UK pharmaceutical industry?s commitment to R&D over the past decade has been a huge success, with about a quarter of the world?s top 100 medicines being developed in British laboratories. The ability of the UK to attract and retain successful pharmaceutical R&D investment has been based on access to skills and knowledge via the worldclass standards of the UK?s university system. This consistent investment has also come about because of the stability that enables long-term planning embodied in the voluntary agreement between the UK government and the industry, the Pharmaceutical Pricing Regulation Scheme (PPRS).

This ensures that the NHS gets good value, while also acknowledging the significant costs incurred by companies in developing new medicines. The predictability of future returns in the UK enables companies to invest with greater confidence. The stability of its National Health Service makes it a superb base for reliable clinical trials and the presence of so many large pharmaceutical companies in the UK makes it a powerhouse for medicine development. Companies from Europe, the US and Japan recognise this and have based their research functions here.

This high investment in research is vital in an industry where hard-won and steady incremental innovation is much more common than big breakthroughs. One of the key facts about medicines research is that an advance is not usually made through sudden leaps in knowledge, but through small but vital steps in the understanding of a condition and how to treat it. It is therefore impossible to focus research solely on breakthroughs. Each of those 950 compounds currently in development has the potential to lead to a small but significant improvement to the treatment of disease ? and, over time, we shall be able to look back and see how far we have come.

It would be incorrect and unrealistic to assume that, by some miraculous process, we can jump the various stages of development and create the ?perfect? medicine for a disease. The ?first of kind? medicine is rarely the ?best of kind?. Emerging sciences will offer deeper understanding of diseases and new ways of tackling them. The completion of a draft sequence of the entire human genome has led to dramatic new insights, although an understanding of the function of these genes, the new science of proteomics and a better grasp of total systems biology will be an essential part of achieving success.

Gene therapies hold out the promise of treating many conditions ? including some forms of cancer, osteoporosis, rheumatoid arthritis and schizophrenia. Advances in molecular biology are having an enormous impact on new medicines discovery and development ? even though the majority of the products that emerge are still chemical in nature. It seems likely that over the coming 20 years we will see more medicines that are tailored to particular genetic types and are therefore more effective, with fewer side-effects. Bioinformatics has an increasing role to play. Medicines R&D is a data-intensive process and most aspects of the research process involve data handling, analysis, networking and integration.

One area of pharmaceutical R&D that would be impossible to conduct without bioinformatics is the large-scale generation of new ?lead? molecules through computerised drug design, combinatorial chemistry and high-throughput screening.

These are all technologies the UK is in the vanguard of pioneering and, with so many medicines currently in development; we can look forward to British laboratories producing life-saving new treatments for the generations to come.

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