Biostatistics Seminar guest speaker, Wen-Chi Wu, Merck & Co., Inc., will present, "Challenges and Prospect in the Drug Development – A Statistician’s Perspective."
In pharmaceutical industry, team collaboration works in different functional areas. To be able to convey clear statistical messages to other team members and work efficiently are two key elements on our daily basis. The drug development involves complex multi-stage processes to introduce a new drug to the market. In pre-clinical phase, the process starts from drug formulation development and moves into animal testing to determine the toxicities of the novel compound before conducting clinical trials in human subjects. In this presentation, the first half mainly focuses on the clinical trial development from the design of a protocol to the final reporting based on a statistician’s perspective. The second half will cover case studies including challenges occurred during the trial, practical solutions to overcome the challenges, and potential methods to approach patient-reported outcome questions.