Decision Gates

Drug development is a process that proceeds through several high-level decision gates from identification of a potential therapeutic agent through to marketing a new drug product [2] . A decision gate is a good analogy. For a drug candidate to progress further in drug development it must meet a set of criteria that have been agreed to by the decision makers before they will open the gate. It is "go/no go" because the future product life of the drug hangs in the balance. Once a new drug candidate has progressed through a decision gate, the organization should be committed to expend even greater resources (money and scientists' time) to do the studies to address criteria for the next decision gate along the development path.

Disciplined planning and decision making is required to leverage the value of the decision gate approach. An example of a decision grid applicable to the early phase of drug development is depicted in Table 1. Initially, a clear set of questions at each decision gate needs to be agreed upon and understood by the decision makers. In later stages of drug development these questions and criteria are often presented in a target product profile (TPP), which is, in essence, a summary of a drug development plan described in terms of labeling concepts. The FDA has formalized the agency' s expectations for a TPP in a

TABLE 1 Decision Gate Grid Defining Criteria Required to Move Through the Decision Gate "Safe to Give to Humans?"
Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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