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III's clinical studies. To be utilized successfully and cost effectively, a nursery production facility needs equipment ensuring that the reduced scale manufacture is representative and provides a home for future technology investigations. The plant management process should clearly recognize that pharmaceutical R & D development work is one of its major customers as well as providing commercial material. This further contributes to the collaboration at an early stage and reduces the need for last-minute process modifications as market entry batches are manufactured. |
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The launch phase may involve a number of new dosage forms to increase penetration into the available market. Even at this very early stage of the product's life cycle, cost reduction and process optimization should be going on. At all times during the product's life cycle, the primary inventor of the molecule seeks greater expertise than anybody else in producing the entity. Very demanding specifications may be used as a potential barrier to entry, especially where they are monographed. Hence the organization must continue to address the process innovatively to improve the value-creating potential of the product constantly. The leadership of this activity should be Manufacturing itself and hence the project management system required will change to take more of a leadership role in partnership with R & D and Marketing. There also needs to be a clear partnership between Regulatory and Manufacturing functions to ensure that the product is consistently manufactured in conformance with worldwide product registrations and changing regulatory needs. |
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In the mature and declining phases of a product's patent life, the involvement of Manufacturing is even more crucial if the revenue from major products is to be defended as much as possible against competitive and generic erosion. The patent expiry defense strategy should be in place long before the patent actually expires to create barriers to market entry. Although this has only limited success, retaining the revenue from a top-twenty-selling prescription product, even for a short period, is worth a great deal of money to the organization. Strategies for defending the revenue include |
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switching the molecule to the OTC market, where possible, and building on the brand strength and recommender support acquired during the prescription life; |
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supply agreements with generic companies to control the introduction of unbranded versions of the drug and yet continue to generate a revenue stream for the original inventor; |
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lowest possible cost processes to compete with generics; |
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