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and compare specific drugs with each other. Because of this, the evaluation criteria are different and should be chosen to assess the attractiveness of the research approach for discovery projects and the attractiveness of drugs as potential products for development projects. |
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C. Assessing the Discovery Portfolio |
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Assessing the discovery portfolio should be done in two ways. First, newly emerging research ideas should be evaluated as they arise, and a decision should be made whether to include them in the portfolio. Research is what keeps the pipeline stocked. Ideas that fit the strategic plan should be encouraged; those that do not should be redirected toward more suitable lines. Second, there should be a periodic review of ongoing research projects to determine whether the approach is making suitable progress and to assess whether each project still meets the original strategic expectations. |
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Some indices for assessing the risk and reward value of the projects in a research portfolio [35,36] are shown in Table 5. Risk can be divided into two categories: the risk associated with technical feasibility and that associated with therapeutic relevance. Either type of risk, if high, should stop the research effort. Technical feasibility assesses the wherewithal of the company to follow through on the research idea. Does the research staff have the right technical skills? Does the company have a critical mass of such manpower? Do these people have the proper facilities to test their ideas? Will the budget support this type of research effort, or is it too costly an approach? How much dependence is there on external resources to round out the technology base and are these resources complementary to the internal resources? How much time will it take to set up the appropriate technologies? |
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Therapeutic relevance assesses the relationship (or lack) of the drug's mechanism of action to its clinical efficacy. Does the pharmacologic mechanism of action target the etiology of the disease or symptomatology? How predictive are the laboratory model systems to clinical disease? Can the therapeutic target be influenced without disrupting other biological systems? |
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The relative reward potential can also be divided into two categories: the reward derived from the market value of the product and the rewards from having a favorable advantage over competitors. For research projects, there is no way to determine a market share because no drug has yet been identified. There is no way to predict with certainty which patients with the disease will respond to the drug, or whether adverse actions of the drug will limit prescribing to selected populations. Assessment of the market potential should therefore be limited to general questions. What is the size of the patient population for the target indication? If there are effective drugs already available to the patient, do they have limitations that this new product will overcome? Is this |
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