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Drug development in the pharmaceutical industry has historically been a slow and expensive process. This has been exacerbated during the last decade by spiraling costs and ever-increasing demands by regulatory agencies worldwide on the content and quality of submission packages to support the marketing of new drugs. Recent estimates have placed the overall cost of successfully developing a single drug entity, from discovery to marketplace, at over $300 million. The potential for this cost to increase even further, considered against the backdrop of cost containment in the health care industry in generaland in pharmaceuticals in particularhas provided incentive to reexamine the drug development process and has provoked discussions as to how it can be made more efficient and cost-effective. |
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This text has been prepared with these goals in mind. Experts were invited to contribute chapters expressly to challenge current approaches to drug development used by industry and required by regulatory agencies and to present alternatives that may generate a better overall approach. Authors were asked to be provocative and to throw out ideas, however speculative, that might help improve what must be considered an extremely inefficient process. |
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Contributions were sought from a variety of areas. Experts with many years of experience in the business were invited to provide comment on the drug development process, where it is going, and where it should be going. Contributions were also sought from representatives from the many disciplines |
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