Abstract
In new drug research and development, unexpected new data and issues are often obtained and a project team need to be flexible to deal with those, however, still the spirit of "front-end planning" is important and to prospectively identify target product profile (TPP) of a candidate compound is extremely valuable. Minimum project profile (MPP), which is essential to give a project valuable, makes a team easily evaluate a go/no go of a project based on new data and information. In this session, we will discuss three sets of target product profiles and their implication to effective management of drug development and project risk assessment, as well as decision making mechanism including project go/no-go.