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B.
Differences of Planning in Research and Development. |
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The development of a new therapeutic drug runs through two major phases: |
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the research phase of selecting a suitable drug candidate from a large number of compounds screened for activity in vitro or in animal models and |
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the development phase in which a single compound is carried through the necessary nonclinical and clinical trials required to prove its efficacy and safety and to obtain regulatory approval. |
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During the research phase the plans for synthesizing new compounds are constantly adapted to the outcome of the screening assays. Long-term planning in this phase, therefore, is largely restricted to the overall scope of time and resources applied to the project. The work is done by a small team focused on the disciplines of chemistry and experimental biology. |
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In the development phase, however, the contributions of many disciplines must be closely coordinated to minimize the time to interim decision points and to the final project completion. This article will focus on the planning of development projects. Planning is facilitated by the fact that regulatory guidelines and directives are often available to help in designing the development program for a particular disease indication. Generally, development is structured in the phases shown in Table 1. |
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Planning of the development process is essentially a stepwise, continuous process starting with a defined target and ending with a detailed plan for action. The plan will be continuously adapted in the light of development findings and changing circumstances as shown in Table 2. |
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II.
The Basis of the Project Plan |
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A.
Defining the Project Target |
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Each plan describes the route to a target. A good plan requires and helps to clarify an exact definition of the target. The general target of drug development is an approved and commercially successful drug product. Drug performance targets are commonly described by target indication and route of administration. This is further specified in terms of efficacy, safety, and patient convenience parameters. Parameters, such as socioeconomic benefit, unique selling proposition, and maximum cost of goods may be added. Early in the development process, some companies use draft PI-sheets covering most of these parameters. Others start with a less detailed Target |
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