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of Medco, a mail-order pharmacy business, by Merck at a cost of US $6B. Similarly, SmithKline Beecham acquired Diversified Pharmaceutical Services Inc. for US $2.3B and Pfizer aligned with Caremark International Inc. and Value Health Inc. Moreover, traditional research companies, such as, SmithKline Beecham, Hoechst, Marion Merrell Dow, Rhone Poulenc-Rorer, Upjohn, and Ciba-Geigy among others, have moved into the generic drug business. In addition, the over-the-counter market is now being pursued aggressively by the major companies. For example, Merck and Johnson & Johnson formed Centra Healthcare in the UK to market Pepcid whereas Warner-Lambert and Glaxo formed a joint venture to market Glaxo prescription medicines [5,9,10]. |
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On the research side, the industry is adopting more efficient means of identifying and optimizing new product leads such as robotic screening methods, structure-based de novo drug design, combinatorial chemistry, and the use of diversity libraries that include small organic molecules through oligomers and natural products [8]. However, as the most sophisticated and efficient approaches available to any one pharmaceutical company have not been adequate to ensure a healthy product pipeline, virtually all companies have turned to joint ventures, mergers, and acquisitions for survival. Importantly, one of the key participants in these initiatives has been the biotechnology industry; innumerable agreements have been signed between pharmaceutical and bio- technology firms in the first half of this decade [11]. |
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Irrespective of source, the most promising product leads are now typically incorporated into global development programs. The goal is to reduce the number of redundant clinical trials, reduce the time to market, and reduce the overall cost of drug development in the interest of enhancing profitability. Today the global approach to product development is often essential for maximum return on R & D investment. International regulatory harmonization efforts, the development of worldwide reporting requirements for adverse drug reactions, and a gradually increasing uniformity in clinical practice are all facilitating the global development process. |
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III. Enter the Clinical Research Organization (CRO) |
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In spite of the strategies that have been embraced on both the R & D and sales ends of the pharmaceutical business domain, the profitability and ultimate survival of the industry could not be achieved without radical restructuring and downsizing of the work force. Over 30,000 layoffs were announced in 1993 in the pharmaceutical industry. This trend has continued into 1995. In parallel, pharmaceutical, biotechnology, and medical device companies exhibited an ever-growing commitment to conduct their clinical research programs through |
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