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European BioPharmaceutical Review

Risky Business in the Globalised Economy

Tom Roche at FM Global examines an approach designed to provide vital company protection for the long term as new risks emerge

All companies take risks – it’s a natural part of succeeding in a competitive business environment. In the pharmaceutical business, as in many others, it’s part of the art of commercial success to calculate a risk – the likelihood, the need to take it, the consequences if the risk becomes the reality – and to plan your business moves accordingly, almost certainly incorporating a healthy dose of risk prevention. That’s the theory, at least, and operating in a globalised economy that has increased the potential for risk at just about every step, it should also be the practice.

For all the organisational sophistication and slick operational performance at the heart of global success, the need for any commercial enterprise – including a major pharmaceutical company – to identify and consider at each stage the possibility of what could go wrong has not diminished. If anything, it has increased, because whether it’s a ‘big bang’ or something far more insidious and systemic, for every benefit globalisation offers there are potential pitfalls which a company ignores at its peril.

REPUTATIONS ON THE LINE

There have been several high profile examples of the reputational risks pharmaceutical companies run in the day-today task of bringing new products to market. Newspapers screaming ‘drug test disaster’ do circulation figures no harm at all, and those unfortunate stories are not easily forgotten. But commercial risks – events and occurrences that can severely damage a corporation if not properly managed – need not be of the headline-making variety.

Recent research in the US and Europe with executives from the world’s leading companies demonstrated that, in a global business, disruption to the supply chain comes second only to competition as a threat to a company’s well-being. In other words, the principle risk to the existence of a global business is largely defined by the way the company itself sets up its own business. An adequate response to this finding is a commercial imperative.


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After graduating from Lancaster University with Bachelor’s and Master’s degrees in Mechanical and Electronic Engineering, Tom Roche spent his initial engineering career in steel and water industries, working on industrial automation. Tom joined FM Global in 1993, and has worked within the loss prevention engineering team, working with local and international clients. In this role, he has helped clients to implement loss prevention programmes, successfully managed projects to install active fire protection systems, and has represented the company at numerous client seminars. Tom is currently the Engineering Manager for the UK Operations within FM Global. In this role, he is responsible for the team delivering loss prevention engineering services to plant and corporate level clients within the UK, Ireland, Scandinavia and Italy.
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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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