RGA 6680 — Project Management in Early Drug Discovery and Development
3 semester hoursGraduateLecture
Highlights the applicability and utility of project management tools to the biopharmaceutical development process. Presents an overview of the processes common to researching and developing a new biopharmaceutical product. Focuses on the early stages of this progression, from identifying active molecules to completing Phase 1 safety trials. Surveys the predominant biological and chemical techniques used in these efforts. Offers students an opportunity to prepare standard operating procedures and a pre–Investigational New Drug package. Emphasizes how to incorporate key data in writing the IND. Examines the procedures used to execute a Phase 1 safety study and the strategies available to prepare a persuasive clinical study report.