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drug candidates tend to be embellished with burdensome additional indications or dosage forms; a drug in trouble tends to be salvaged by performing extra work to uncover redeeming marketable attributes no matter how remote [21]. Both courses are risky and can be very costly in terms of time and money. Drug development is a major financial investment, and it should be treated as such [27]. Efficient management of the investment, however, requires diligence and discipline, to maintain focus on the long-range corporate goals and avoid the many powerful temptations to pursue interesting but perhaps less lucrative alternative development paths. |
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Knowing when to quit is just as important as maintaining focus and is a significant mechanism for improving efficiency. Companies no longer can afford to fund open-ended research, on the slim chance that a novel drug mechanism might eventually be found using some yet-to-be-characterized research approach. Neither can they afford to explore every possible option to explain adverse findings, with the hope of salvaging a poor development candidate. It is hard to stop research that might lead to a profitable new product. It is hard to stop work on a development candidate that might hold some advantage therapeutically, despite problems in preclinical testing. It is hard on the scientific staff, who have invested a big part of their career in the effort and have strong ownership of their project. They may be unwilling or technically unable to retrain for a new R & D initiative. These are strong and compelling forces, but they are not financially sound. Research and development often is a black box, but it should not become a black hole. |
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Failure to terminate unproductive projects is one of the greatest financial drains both on the company as a whole and on resources that should be allocated to projects with a greater likelihood of success. The average R & D project consumes approximately $300,000 per month in internal resources. Allowing unproductive projects to continue has two financial disadvantages. First, there is the obvious wasteful expenditure on a project that will not yield a marketable product. In addition, there is a loss of productivity on other projects, because they are deprived of resources that are instead committed to the unproductive product, as illustrated in the example in Figure 3. The development of priority projects may be less than optimal if resources are limiting and not able to be assigned to it. Taking swift action to redirect valuable R & D resources toward more productive product candidates maximizes the chance for success, shortens development time, and minimizes waste. |
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Major research discoveries are often not planned or predicted in advance. Because of this, the decision to terminate a discovery project cannot be based solely on the failure to demonstrate constant, steady progress. Research projects should be set up with specific and realistic objectives in mind, with suffi- |
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