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periodic and rational adjustments in research direction in order to maintain focus. |
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D. Assessing the Development Portfolio |
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As with the discovery portfolio, the development portfolio should be assessed in two ways. First, each new drug candidate should be assessed when it is proposed for development to determine where it falls in the portfolio. Second, there should be a regular review of all the development projects to ensure that each project is making acceptable progress and that it still is fulfilling its original strategic expectations. |
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Since development candidates are known entities with specific properties, it is much easier to quantitate and rank the strengths and weaknesses of projects in the development portfolio. Some of the criteria that can be used to assess development projects [27,35,36] are shown in Table 6. |
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Technical feasibility assesses the wherewithal of the company to follow through with the development plan and generate a high-quality regulatory submission. Does the utilization of resources match the company's ability? Does the company have the right facilities to develop and manufacture the product? Is the clinical program designed to ensure patient recruitment, to |
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| Table 6 Criteria for Assessing Development Projects | | | Examples of quantitative endpoints | | Risk | Technical feasibility | People skills
Development facilities
Clinical feasibility
Type of external support required | | Therapeutic relevance | Clinical efficacy
Clinical selectivity
Clinical side effects
Probability of regulatory approval | | Reward | Market | Return on investment
Profitability
Long-term market trend
Pharmacoeconomics
Patent protection | | Competition | Advantage over existing therapies
Value of core competencies
Status of competitors | | Sources: Refs. [27,35,36]. |
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