Drug development project planning

This chapter focuses on the clinical development of new medicines. This is an area where companies can plan and control much more of their activity. As more drug development projects... 

This chapter discusses the various types of project teams that are involved in the drug discovery and development process. It also provides a detailed example of a drug development logic plan for what many developmental pharmaceutical scientists consider to be the most difficult and time- and resource-consuming drug candidate to develop into a therapeutic product. 

One of the primary functions of the project team is to coordinate the various studies necessary for the successful development of a drug candidate and to ensure that the timeline for development is on schedule, both for time and budget. As mentioned above, this coordination is usually accomplished by preparing a detailed drug development logic plan and monitoring the research process. The required studies and the extent of the development plan depend on at least four criteria of the proposed drug candidate, which are... 

Advance planning with development personnel can begin in many different ways. Typically, a project planning committee defines key stages in a new drug entity s life cycle. The committee will usually include the QA professional as a part of the team, which allows him or her to arrange a plan for monitoring the development life cycle from concept to submission. 

Portfolio and Project Planning and Management in the Drug Discovery, Development, and Review Process... 

All drug discovery projects depend on luck to be successful, but research and careful planning can improve chances of success and lower the cost. Project teams can streamline the discovery process by using the tools that can lead to a discovery most directly. These tools are drawn from the repertoires of modem biology, chemistry, robotics and computer simulations. In comparison with older processes of in vivo screening of huge numbers of molecules, however, these innovations have not been associated with shortening of the development... 

Drug development could be improved by planning to develop and apply PM models along with novel pathways to approval, improved project management, and improved program development. Recent advances in computational speed, novel models, stochastic simulation methods, real-time data collection, and novel biomarkers all portend improvements in drug development. 

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