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include measurable parameters, etc.? How much dependence is there on external resources, and do these resources complement the internal support? |
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Therapeutic relevance assesses the drug's potential for satisfying an unmet medical need. Does the drug have attractive properties in terms of efficacy, selectivity, and acceptable adverse effects? Do these features lead to a high probability of regulatory approval? |
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The market attractiveness should be quantitated in terms of return on the R & D investment, profitability, and pharmacoeconomics. Can the company afford to make the capital and market launch investments required by the drug? What is the likely profitability in terms of market segment, third-year profits, number of years until profitability and/or total product profits? Is the product entering a growing or aging market? Will the drug improve the quality of life at an acceptable price? Is there sufficient patent life after market launch? |
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In addition to core competencies, the competition should be quantitated in terms of advantages over existing therapies and the status of competing drugs under development. Does the company have the internal know-how to develop and market the drug successfully against competing drugs? Does the drug have a competitive advantage in efficacy, safety, convenience, compliance, or quality of life? What is the status of the competitors in terms of product quality, number of competing products, intensity of effort, and time to market? |
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E. Quantitative Assessment of the Portfolio and the Review Cycle |
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Quantitative scales should be attached to each criterion, ranging from low to high risk and low to high reward [35]. Ranking the relative risk and relative reward of each project in the portfolio then becomes a simple mathematical calculation, and the results can be plotted on a two dimensional graph of risk versus reward [37]. Figure 6 shows the value of the portfolio by plotting one endpoint of risk (clinical feasibility) against one endpoint of reward (third year profits). Figure 7 shows an example in which all the selected endpoints have been aggregated to show a composite grid of all risk and reward factors. |
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Two-dimensional grids can be constructed in this manner for the discovery portfolio and the development portfolio. The risk-reward grids are convenient, pictorial summaries of the status of the R & D projects. The risk-reward analysis should be formally updated at regular intervals to reflect new information, but not more frequently than once annually. |
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In addition to the risk-reward analysis of the portfolio, new R & D projects should be assessed ad hoc when they enter the research and development portfolios, respectively. This analysis should be identical to that used for projects |
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