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Where are the pinchpoints going to be in the development process? This demands that data are gathered by key discipline together with some feel for interchangeability between disciplines. |
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How many people will be required over the time period under review? This requires that consideration is given to the real demands on staff time. Very few are available for 100% of their time because of training, sickness, time spent on administrative tasks, etc. Equally, it must not be forgotten that additional support staff may be required or that attrition has an impact on projected resource demand. |
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Cost estimation needs equally careful consideration and establishing conventions which fit corporate and legal financial imperatives. |
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Many projects give rise to a number of different indications or formulations. Should each of these bear a share of all the development costs, such as initial toxicology and pharmacokinetic studies? One pragmatic approach is to assign all such costs to the first registered indication and to allocate to later indications only those costs which can be directly associated with the additional work involved (particular formulations or clinical trials for example). But this approach potentially disadvantages the first indication to market. |
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Similar issues arise in allocating non-R&D costs to projects. Suppose that successful commercialization of a project demands a new manufacturing plant or line. Should the full cost of this be allocated to the project under review or only a proportion assuming that the plant will be used for other products at some time? If the latter, what would be the basis of cost apportionment? |
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Project attrition and identification of points at which expenditure becomes committed again must be considered. For example, a clinical trial program may cost $50M over 3 years; the total committed cost at the start of the program is unlikely to be $50M because of staged or progress payments. Ignoring this timing element distorts the real demands for finance. |
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D.
Commercial Attractiveness |
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The quality of assessing the commercial attractiveness depends critically on the robustness of the product profile. It considers a variety of factors, some highly quantitative others more qualitative. Health Economic issues must be considered throughout the development process. At the later stages of |
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