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Capability Central

Eight years ago, we reflected on the laboratory needs of biotech and smaller pharmaceutical companies (1). We should remember the financial hype at that time: money was readily available to be invested in internet and biotech companies. Those sponsor companies which implemented efficient methods in the selection of their service providers could better cope with the difficulties that arose in the crisis to come in the years after 2002. Today, we are again facing an unprecedented financial crisis with global reach. As laboratory results have become even more important to evaluate the efficacy of new drugs, it seems useful to re-evaluate the use of centralised laboratories and to identify means of reducing the overall costs when performing multinational clinical trials.

AN INDUSTRY OFTEN CONSIDERED RECESSION-PROOF

Like many other industries, the pharmaceutical and biotech sector is following the trend towards consolidation, but at a significantly slower rate. Despite the need to achieve growth and renewal by merging with or acquiring competitors, the number of new and innovative drugs is decreasing. Interestingly, in 2009, the overall expenditure in R&D is expected to be comparable to previous years, leading to the estimation that either the number of clinical trials or the complexity of study protocols is increasing dramatically.

THE THREAT OF PATENT EXPIRY

There may be other explanations for this apparently contradictory effect. While the worldwide recession has resulted in banks being bailed out by governments, corporations of all sizes struggling and employment rates decreasing, many pharmaceutical companies have announced expectations to achieve the same or similar revenues as in 2008 (2). A real threat to such a rosy outlook comes from the expiry of patent protection of several blockbusters (drugs with annual sales of over $1 billion each). In the next five years, Pfizer, the world’s largest drug corporation, is expected to lose almost $10 billion of branded drug revenue to patent expiry, and Johnson & Johnson and Eli Lilly over $4 billion each. IMS Health has recently published market research which suggests worldwide losses in drug revenues will decrease by over $100 billion between 2009 and 2012.


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In 1994, Dr Hermann Schulz founded INTERLAB central lab services – worldwide GmbH in Munich and has since been the Chief Executive Officer. Before this, he held senior R&D positions within the pharmaceutical industry (Merck&Co, AstraZeneca/ICI and SCHWARZ) over 12 years and was responsible for R&D in the cardiovascular area. As a visiting professor, Hermann is Head Lecturer for Clinical Pharmacology in the post-graduate course Pharmaceutical Medicine at the Universities of Duisburg-Essen (formerly Witten-Herdecke) and Tübingen. He was a member of the Board of the German Society of Pharmaceutical Medicine for six years and is a founding member of the International Association of Central Laboratories (IACL), based in London. Hermann has written more than 35 scientific publications and is periodically invited to speak at international conferences such as the DIA or IIR.
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Hermann Schulz
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