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While there may be no willful or deliberate intention to deceive in these cases, the impact of not telling it right, not hearing it right, or both, can have a severe impact on new product progress. Some drugs may never be discovered because there is a lack of management confidence, support, or understanding. Promising product candidates may languish for lack of a full commitment, in favor of others with which management is more familiar or values more because of personal knowledge. Worst of all, the perception that R & D staff are not free to report bad news discourages risk-taking, stifles the most creative elements of the company, and cuts off the most important sources of future commercial successes. The successful companies of the future will be those that foster an atmosphere of mutual confidence and trust. |
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A. Portfolio Considerations and Complications |
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Periodic evaluation of the R & D portfolio can have a major impact on improving R & D productivity. It can identify promising projects that are not being adequately resourced. It can identify projects that are not meeting the company's strategic objectives despite a major resource investment. It can identify projects that, although promising, do not fit the company's strategic plan. Taking appropriate actions, based on these findings, will focus R & D efforts along the most productive lines and divest those projects that do not fit. To be conducted properly, the portfolio analysis requires a considerable commitment from management and from many specialized functions. It is important therefore to approach this exercise with an appreciation of what things the portfolio analysis can and cannot accomplish and to be aware of the pitfalls that are commonly encountered while doing the analysis. |
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First, the accuracy of project assessment and the attractiveness of a product candidate change during the course of development, as more information is collected. All discovery projects are more risky than development candidates because very little is known about the product's characteristics. An early development candidate may be highly valued because it represents a novel mechanism of action that promises to treat refractory patients, whereas the same product in Phase III clinical trials may be rated very low because the novel mechanistic approach has not proven to be clinically beneficial. The market assessment will be much more realistic for a product nearing NDA submission than a product just entering clinical trials. These examples illustrate the importance of selecting standards and criteria for assessing projects that do not introduce biases due to the relative maturity of the project. All evaluation criteria should be normalized so that the product attractiveness is not distorted by unproven expectations. |
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