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is not the dossier submission but the realization of the product's commercial potential. |
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Marketing has also contributed to a somewhat confrontational atmosphere by demanding the greatest possible flexibility in terms of presentations and the lowest cost design, thus challenging both R & D and Manufacturing in terms of the development program. All of this has often led to a situation where each unit tries to achieve conflicting objectives without trying to find the win:win situation that optimizes the overall outcome. Handling this conflict must begin at the top of the organization with the setting of appropriate strategic aims and shared objectives across functional boundaries. It can be argued, therefore, that good project management begins at the top by reducing the conflict of objectives and helping to set the agenda for collaboration. |
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Manufacturing can take its place at the drug development negotiating table in such a collaborative environment. It is no longer possible to stand apart from the process of developing the product and merely react as the approval for sale is achieved. Involvement in the process of development must be as a partner in the decision-making process accepting that not all outcomes are optimal for Manufacturing but are optimal for the overall product development effort. This requires a new breed of Manufacturing management and staff. They must have an intimate knowledge of the development process so that they take part in every stage of decision making and have a positive attitude toward the opportunity that innovation brings to them in new processes. Having a good strategic sense of the needs of the market and working in partnership with Marketing is also essential. Manufacturing must now put in place the right structures to deal with the technical and commercial issues that arise during the development of the product. This means dealing with a wide range of objectives, which can be conflicting, and seeking to optimize the overall outcome rather than any part of the process. |
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III.
Many Conflicting Objectives |
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As a result of the changing demands described above and with Manufacturing playing a positive part in development, they will face many and often conflicting objectives. The key ones are the following: |
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to collaborate with R & D to develop a robust and reproducible process which will meet the worldwide demand for the product, regulatory authorities' demands for data, and cost constraint targets. |
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