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But there is no such thing as a free meal, and one must also ask how much time is saved by an aggressive parallel track strategy and at what cost. And when would a decision on full development of a lead candidate be taken? The failure rates in development are highest in the early phases and only generically exceed 50 percent in phase 3. But as the chance of success increases during development, the costs of development increase dramatically. So, in general terms, hedging in early development makes sense from a cost/risk perspective. Parallel track development in phase 0 and phase 1 might save 2 years compared with a sequential strategy. The relationships of cost/risk reduction and value contribution for alternative strategies can be modeled. Such modeling, generally, supports parallel early phase development but with a holding rule that a single candidate be advanced for phase 3 development. |
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In the real world, limited capacities in early development are often totally occupied with drug candidates from alternative discovery programs. The opportunity cost, therefore, has to be considered in a portfolio context where the added value of early parallel lead development may be less than developing lead candidates from other programs. When only one lead is put into development and it is terminated, the delay may mean that a competitive position has been lost. It may be necessary to replace a failed lead not with a follow up rather than a back-up candidate to reestablish a competitive position in development. For this reason, if a company is serious in its intent to establish a market franchise it must sustain a discovery effort focused on follow-up candidates throughout development. |
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B.
Registration and Life-Cycle Development Strategy |
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Planning in mid-stage and late-stage development has been heavily focused on the first registration of the product with particular emphasis on addressing the regulatory requirements of core markets. |
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The market for pharmaceutical products has changed significantly in recent times with a broader range of groups now playing key roles in deciding drug usage. This must be reflected in development strategy to ensure that the information needed by key decision makers is available at the right time. Probably the biggest change in recent years has been the impact of cost constraints on health care expenditures which have focused attention on the cost effectiveness of new medicines. |
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1.
Health Economics Strategy |
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In the past the pharmaceutical industry has viewed the prescribing physician as the key customer for a new drug. However, increasingly, the pre- |
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