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with all sorts of discoveries, often not oriented to any goal other than the understanding of some biological process. These discoveries, frequently paid for by government or foundation funds, are what produce the conceptual basis that culminates in the drug discovery screen. The lag time from discovery to development of the screen can be years or decades, and it is the drug discovery and development process that enables these earlier discoveries to be translated into improvements in health care. Factors that impede this process block the earlier discoveries from achieving their potential for improving the health of the public. |
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Another oversimplification is the idea that work progresses directly from preclinical research to clinical development. There is a clinical research phase between preclinical research and clinical development as a drug moves along the path to becoming a medicine. This clinical research phase provides information that is essential for the rational development of the drug. Clinical research can also substantially impact on preclinical research and candidate drug selection. Innovative compounds that may never be useful medicines can be used to test novel drug concepts that are of critical relevance to a major drug discovery program. In fact, when done imaginatively and well, some of this clinical research meets the Comroe and Dripps definition of basic research: it searches for mechanisms of observed effects. When done by rote and poorly, it adds nothing to the drug discovery process and leaves to chance aspects of the pivotal Phase III trials that will spell the success or failure of a new potential breakthrough drug. |
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During the new era of cost containment, when prices are being discounted and time means money to the innovative pharmaceutical company, the drug development process must be carried out with maximum efficiency and cost-effectiveness. Making such platitudinous statements and implementing them are very different things. The unpredictability of some human responses to drugs makes managing drug development more challenging and difficult than managing an industrial process that obeys the laws of physics and chemistry. Maintaining a corporate culture that supports a scientific point of view during the studies in humans while maintaining an appropriate focus on product without dulling the imagination of the scientist doing the discovery part of drug development is a major management challenge as money gets tighter, formularies become more restrictive, and liability seems to grow. Yet this is precisely what is needed to continue to develop innovative products that society needs, and for which society has invested in the basic researchand continues to invest for the future. |
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The contributors to this book have thought and written about a variety of subjects that need to be considered in re-engineering the drug development process to meet the challenges of the future. This book gives the reader the opportunity to think with these experts as they address specific problems faced |
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