Drug Development: The Short Story
5. Timelines
According to average timelines from the industry collected during the past five years, drug development can require between twelve and seventeen years from the start of the research program to the final approval by the FDA. The process can be envisioned as:
At each stage of development, the project menagement team (and the research management team) meets to review progress. If the compound meets all of the criteria that have been established by the team, the compound is advanced to the next stage of development. If it fails to meet criteria for any number of reasons (e.g., advanced screening does not confirm initial activity, dosage forms cannot be developed, the compound shows poor bioavailability, the compound is toxic, etc.) development is halted. If the company has backup candidates, only a small amount of time is lost. If there are no candidates, the entire research program can be canceled.
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