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or even treating such serious diseases as cancer in advanced stages is so exciting that the concept is scientifically irresistible. |
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Along with the evolution in the process of discovery and the tremendous influence of the revolution in information handling, changes in the participants in the development process will also have considerable impact. There is also an evolution occurring in the parties to the development process. Observing the trends makes one think of the theories of the origins of the universe with oscillations in mass: accumulations, explosions, and reaccumulations, forming large aggregates and small break-off components. Perhaps the process started with the entrepreneurs who led the field successfully and developed the large corporate giants of today. Merck and Hoffman-LaRoche are examples of the one-man enterprises that expanded into major companies. In fact, the major companies dominate the pharmaceutical industry to an unparalleled extent. Perhaps 10 to 20 companies represent over 90% of new drugs emanating from the corporate phalanx. In fact, over the last 20 years, mergers have continued and indeed the last few years have seen even further consolidation of the pharmaceutical industry. One analyst reported in the Wall Street Journal that for a company to survive it must be able to compete with the major players in the pharmaceutical field. This is not just because of funding requirements for drug development programs, but because of the development impediments established by these very large competitors. These impediments can be simple, such as the number of patients exposed to a new entity, or more complex, such as a survival study or the use of experimental ancillary technologies that are prohibitively expensive and would not be automatically required for the development of a compound. These impediments can create an impression, both to the FDA and other companies, that they are requisite, which makes development of a second or third agent in the field much more difficult, time consuming, and expensive. The time factor is especially important since the longer it takes to develop a compound, the more dominance in the market the first drug has gained. Time is the same as money and the loss of product lead can all but destroy the market potential for an agent. |
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VII. Small Development Companies |
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Considering all these obstacles to development and the considerable regulatory maze, the trend to conglomeratization with bigger and bigger companies is not surprising. What is indeed surprising is the simultaneous opposing trend of the development of the very small niche start-up companies proliferating |
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