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| Table 1 Differences Between the Discovery and Development Environments | | | | | Overall objective | Select a development candidate | Submit NDA or PLA | | Corporate mandate | Broad, loosely defined | Narrow, focused | | Compounds tested | Many and diverse | One | | Types of studies used | Few | Many | | Regulatory control | Little or none | Extensive | | Timetable | Loose, flexible | Strict, constrained | | Basis of recognition | Innovation | Speed | | Culture | Chaotic | Structured | | Workstyle | Entrepreneurial | Interdependent |
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standing these differences and creating an environment where both cultures can thrive and maximize their contribution to successful new products. |
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The goal of discovery scientists is to propose new substances for development. Typically they are given a great deal of latitude in how to go about this, as long as they stay within the company's general mission, which is usually defined in terms of targeted therapeutic areas or market segments. In fact, because innovative and breakthrough drugs are thought to have a significant market advantage, discovery scientists are encouraged to explore novel approaches in their attempts to discover a therapeutically beneficial substance, rather than follow a course already established by other drugs. One is more likely to see the entrepreneurial spirit in discovery laboratories, where individual scientists or small groups are free to explore their ideas without strict goal setting and accountability. This is because no timetable can be set for selecting a new development candidate until one of the hypotheses being tested shows promise and produces a chemical or biological lead substance as a starting point for further research. Even then, the timetable for optimizing a chemical series to select an acceptable development candidate cannot be predicted with certainty. Optimization may in fact not be possible. In the process of hypothesizing and testing, thousands of substances may be evaluated in a few, carefully chosen assay systemsa process that may be repeated many times until a sound hypothesis is validated by using a feasible assay system to produce a lead substance that fits the criteria for activity. All of this takes place in a culture that is at times chaotic and constantly changing direction, and for which the highest rewards and recognition go to those who produce a novel substance with commercial promise. |
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The scientists and physicians who support drug development work in a much different environment. For them, the drug substance, delivery system, |
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