|
|
|
|
|
|
|
Planning is the process of producing a plan. A good plan optimizes the process to achieve the target objectives of the project in the shortest possible time with the minimum resources. Planning, therefore, means optimizing the classical project management triangle Performance/Time/Cost. |
|
|
|
|
|
|
|
|
In addition, a plan is an essential means of communication between all project participants to achieve transparency, understanding, and commitment. Planning makes you free seems to be a contradiction, but, in reality, the efforts devoted to creating a good plan provide the reassurance and freedom of mind that everything that reasonably could be anticipated has been thought of and considered. Of course, unexpected events occur and make it necessary to review and adapt even the best prepared plan. |
|
|
|
 |
|
|
|
|
A plan for developing a drug gives answers to three questions: |
|
|
|
|
|
|
|
|
What program of experiments and studies need to be conducted and reported to reach the targeted project performance? |
|
|
|
|
|
|
|
|
What is the minimum time required to execute this program? |
|
|
|
|
|
|
|
|
What resources are required to carry out the work and what is the schedule? |
|
|
|
|
|
|
|
|
This article will focus on the aspects of performance and time planning. Time optimization planning should assume, initially, that resources are available as and when needed. In a second step it may be necessary to adapt a plan to available resources and existing priorities. |
|
|
|
|
|
|
|
|
The planning targets of high performance and short development time present a practical conflict. Performance is defined by the quality of the database to ensure rapid and broad registration approval and good positioning in the market. Adding more and larger studies to improve this performance inevitably adds to the time. Late market entry jeopardizes the commercial return because of shorter patent protection and increased risk of an earlier market entry by a competitor with a similar product. A short time to regulatory submission, however, is worthless if approval failure follows or if commercialization is compromised resulting in the need to add studies during the approval process. Planning, therefore, must carefully define the minimum program to achieve the target without unacceptable risk and, then, must minimize the time to complete this program. |
|
|
|
|
|