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clinical pharmacology expertise, there is value in employing and enhancing this resource. |
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The purpose for this discourse is to describe both a scientific paradigm and an organizational model for applying clinical pharmacology skills in drug development and to make recommendations for moving into the future. |
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The marketplace has changed the way drugs will be developed. The high cost of development and the prospect of greater profits for true advances in unmet therapeutic needs is driving the industry to |
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consolidate into larger, multinational entities, |
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focus on novel ideas for new drugs, |
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rapidly increase R & D productivity several fold, and |
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question the core competencies (i.e., skills, intelligence) needed to retain versus contract out. |
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These changes have a direct impact on how clinical pharmacology is conducted in drug development. The high cost of getting a drug to market has risen from $80 M in 1970, to $350 M in 1988 [1], to about $500 M in 1995. Increasing costs to discover new drugs combined with decreasing profitability are forcing companies to increase productivity. In effect, do more with about the same or less resources by working smarter. |
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Investigating past practices gives clues about the areas that could become more productive. Common reasons for drugs failing during clinical development are unfavorable pharmacodynamics (poor efficacy, unacceptable toxicity), pharmacokinetics (poor absorption, short elimination half-life), and a poor market forecast. Before 1990, the information needed to know if a NCE was likely to be successful as a drug was not known until the results of the clinical Phase III studies were completed (Figure 1). By then all the money had been spent. Now companies are attempting to predict an NCE's success back in the discovery-to-early-clinical development phases both through new technologies for synthesizing and screening NCEs and linking information more effectively to make better decisions. Large contract research organizations are allowing the discovery companies to shift their internal resources to the early core phases. |
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The work environment is becoming increasingly chaotic. Companies are continuing to acquire, merge, and reorganize at an increasing rate. Even now the largest pharmaceutical company only controls about 5% of the global market. The challenge is increasingly difficult for individual scientists to maintain their research and development focus, to develop their skills and careers, and |
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