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new patented process improvements; |
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new dosage forms which might be patentable and give some degree of protection from generic erosion, especially where they confer an additional clinical benefit over and above the molecule itself. |
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Involvement of Manufacturing in this late stage of the product's life is absolutely crucial and must lead in driving forward product changes which improve cost or patent protection. All such changes, of course, have R & D implications for supporting data and regulatory approval. Hence close liaison must be maintained through the project team structure and appropriate support within Manufacturing. |
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V.
An Interlocking Project Structure |
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Development programs and product introductions involve two groups of issues commercially related to cost, logistics, and supply, etc. and issues related to the technical development of the product itself. Both are, of course, linked and yet require different processes and different project management skills to deal with them adequately. In terms of interfaces, the commercial issues are very much linked to central and local Marketing regarding pack type, pricing, cost of goods, and demand for the product. The technical issues very much relate to the way in which R & D is developing the product, what is to be included in the dossier, and the support needed from R & D to improve the process after initial introduction. There are, of course, many issues where both coincide. For example, a decision by Marketing about the dosage form has a direct bearing on the R & D development program, which, in turn, has a major bearing on the way in which Manufacturing has to handle the product. Therefore, any approach to project management has to ensure that each issue is handled on its merits but also deals with areas of overlap. |
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Project Management is a relatively young discipline in the pharmaceutical industry, but increasingly the techniques are used to manage development projects. Part-time Project Leaders are also used in many companies, in conjunction with Project Managers or with strong planning support. In general there will always be a central project group with responsibility for planning and managing the development of a particular molecule and to whom the manufacturing aspects of the project must link seamlessly. To do this there must be a number of groups set up in Manufacturing responsible for integrating manufacturing into the overall project development. |
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The right representation of Manufacturing on the central project team is essential. These teams, most often led by R & D, are at one and the same |
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