The discovery and development of new therapies is a major human endeavor which contributes to the continued improvement in global health. While a considerable amount of both public and private resources are allocated towards the development of new therapies the success of an individual programme is dependent on a variety of criteria, with the likelihood of success often difficult to assess . The aim of this module is provide the student with an experiential overview of the process by which a new therapy is discovered, developed and finally approved for human use. The module also uses case studies to introduce the student to the importance of various strategic, scientific & technical and operational criteria which can contribute to the success, or failure of an individual new therapy programme. At the end of the module it is hoped the student will have an understanding of the process by which new therapies are discovered, designed and approved and have developed a framework by which they can evaluate the strengths and weakness of current new therapy programmes.