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The need to reach peak sales worldwide much earlier in the product life cycle means a rapid growth of product supply and hence the need for a more robust process. Therefore, manufacturability must be engineered in rather than bolted on. There is also a need for greater flexibility in the potential number of variants needed by the market to ensure that the molecule is maximally exploited during its short patent life. This presents the Manufacturing group with a range of potentially conflicting objectives which need to be managed within the overall product development context. |
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Increasing pressures on prices has led to pressure on margins and hence the need to understand the key costs in the process and ensure these are optimized. In this way profitability is maintained in the face of competition and price legislation. |
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Input from Manufacturing is now seen to start well before product launch right through to ultimate product withdrawal. Each phase of this life cycle presents different challenges to the project management structure. |
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More novel therapeutic approaches and presentations lead to more demands on Manufacturing and a need to understand every aspect of the process itself prior to launch to avoid technical problems and supply failure. |
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As overall corporate costs have come under pressure, the cost of infrastructure has been closely examined, and hence the number of facilities has been reduced. This places more demands on Development to ensure that the manufacturing process is robust and reproducible. Decisions about the location and type of plant in the light of the likely scale of the product are, therefore, critical. |
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All of these factors have combined to increase the demands made on Manufacturing and Manufacturing management. The process of product development must now be viewed in a holistic sense and Manufacturing can no longer be seen as an add on at the end of the development process. It must now be an integral part of the way in which a successful product is developed and introduced. It is essential that the key drivers of cost, supply logistics and, in the later stages of the product's life, competitive advantage through manufacturing innovation are well understood at the time that fundamental product decisions are being made. For branded products this becomes even more critical as patent expiry approaches. Generic threat can be turned into opportunity if the primary manufacturer understands the product, the process, and opportunities better than anyone else in the |
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