30% attendance

10% Homework 1, 10% Homework 2, 10% Homework 3: Homework is due on July 18th, 2024. Office hours will be provided as indicated below.

40% project slides and presentation. As indicated in the course description, we will take a project based learning approach. The project we will work on is a real drug. Background materials and data are available in the course content area. The background material includes the phase II and III protocols and related publications for Brodalumab-a drug to treat Psoriasis and other autoimmune disease. In addition, it includes the full package for the FDA advisory committee meeting, one summary from sponsor and one summary from FDA. The data are simulated pseudo data to mimic the summary statistics in the publication of results. It would be beneficial to read the full package of background materials to understand the big picture of drug development process, especially the clinical stage.

You are encouraged to form teams by yourselves to work on the course project. You may create a post in Discussion Board to recruit members. If you successfully form a team, please inform me at Xiaofei.stat@gmail.com and Dooti.roy@boehringer-ingelheim.com by 5:00PM EST on July 13. If we don't hear from you before that, you will be assigned to one of the teams and the teams will be announced by July 17. You will have one more chance to switch teams by sending emails to us before 5:00PM EST on July 19. After that, the teams will start to work on the projects. We encourage the team members to set up calls as needed among themselves to discuss the project. If you have any questions, feel free to reach out to us by email or come to our office hours.

Included in your course is the access to Statistics in Pharmaceuticals (SIP) conference August 15-16, 2024. We will provide a code to waive your registration fee. It can be on-site or virtual attendance. Although it is not required, it is highly encouraged that you submit your poster for SIP conference. If your poster is selected for the conference presentation, you will need to deliver the poster presentation in person. The instruction for submission in at Statistics in Pharmaceuticals (SIP) 2024: Posters (uconn.edu). The poster submission deadline is on August 12.

Once completed, please send your presentation to us. On August 12, we will have presentations for the course project. Each team will have up to 30 minutes to present. Details of the slot and order will be provided later based on number of teams formed. Dooti and Xiaofei will grade your project work based on your presentation.