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consulted. As part of the project review, management should decide either to drop the original plan in favor of a new plan that plays to the strengths of the unexpected findings, or terminate the project outright. The important thing is that the project should not be allowed to stagnate or divert resources without a specific research or development objective in mind. |
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Communication is a key factor in termination of a project. A regular review cycle to assess progress against goals makes it obvious which projects are progressing and which are not. Termination of projects that have not met their objectives or have not overcome their problems should not come as a surprise to anyone. Management can ease the disruptions and disappointments caused by project terminations by pointing out to the R & D staff the need to maximize resource allocations on high-priority projects and reminding everyone of the benefits of staying focused on projects with the highest potential [13]. Scientists, like everyone else, want to be identified with a winner. If important strategic areas are clearly communicated to the company, workers will flock to them. |
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The financial realities of the future will dictate a much closer scrutiny of R & D expenditures than in the past, and smart management will become more pragmatic in the review of established projects, more selective in the approval of risky projects, and more willing to terminate those that repeatedly show no progress. |
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The purity, safety, and efficacy of drugs is taken for granted by the consuming public because of stringent regulatory requirements. In the past, drug companies viewed doctors and patients as their customers, for whom safety and efficacy were the only measures of product quality. In the future, the customers will include third party providers, formularies, and the government, and for them decisions of quality will be based on the quality of life and the cost of the product relative to its therapeutic benefit [29]. Successful companies in the future will be those that provide not only product quality but economic quality as well. Research and development resources must be concentrated on fewer projects, which are chosen to maximize the likelihood of producing truly important new drugs [17,21]. |
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Drug companies also recognize regulatory agencies as a key customer. If they are not satisfied, the product will not reach the market at all. Therefore, increased emphasis on quality regulatory submissions promises to produce drug applications that can be reviewed more quickly and efficiently by the agency and probably stand a better chance of approval. Also, much of the pharmaceutical industry is adopting Total Quality Management (TQM) techniques to improve internal operations and customer service. In-process improvements for manufacturing drug product are the most readily addressed, |
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