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European BioPharmaceutical Review

UK Multiple Sclerosis Society

The recent controversy in the UK over the cost-effectiveness and availability of beta-interferon (b-IFN) for people with multiple sclerosis (MS) has ignited a huge debate about the way in which health economic data are gathered and used to make health care rationing decisions on a national level. If ever an issue were to require serious attention from researchers and companies developing new biology-based therapeutics, and the patients they aim to treat, this is it. We are at the frontier of a 'new biology-based knowledge' which gives us an understanding of the mechanisms behind the functioning of healthy and diseased cells. Yet if the innovative new biology-based therapeutics we then generate are not deemed 'cost-effective', they may never get to the market and to the patients they are designed to treat (and may not reap the rewards the investors are backing).In this article, we will look at the background and key lessons to be learnt from the review process for b-IFN treatment of MS patients in the UK by talking to two out of three product manufacturers (Serono and Schering), as well as gaining the perspective of the UK Multiple Sclerosis Society.


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Glynn McDonald joined the MS Society two years ago from the UK Stroke Association. He has led on all aspects of the campaign to gain access to disease-modifying drugs for people with MS in the UK. Glynn previously worked on a range of policy issues as a career Civil Servant.
Dr Jackie Napier joined Schering Health Care in 1990 and has been Associate Medical Director since 1995. She is responsible for medical support of the secondary care portfolio, including CNS, CVS, oncology, diagnostics and radiopharmaceuticals. For 10 years Jackie has been closely involved with European clinical development and marketing strategy for Betaferon, including the National Institute for Clinical Excellence (NICE) appraisals and appeals, cost-effectiveness modelling and the Department of Health risk-sharing scheme. Last year she contributed to input from the Association of the British Pharmaceutical Industry to the Department of Health's review of NICE.

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Glynn McDonald
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Dr Jackie Napier
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Dr Helen Abbott
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4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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