8:30 AM

Rare Disease Clinical Trials: Challenges and Opportunities presented by Dr. Emily Morris, FDA Office of Biostatistics CDER

9:30 AM

Collecting and Applying Evidence to Interpret Clinical Outcome Assessments (COA)-based Endpoints in
Clinical Trials presented by Dr. Weimeng Wang, FDA Office of Biostatistics CDER

9:00 AM

Evaluating Frequentist and Bayesian Confidence Intervals for Study Size Adjusted Risk Difference presented by Mr. Ben Duncan, Abbvie

10:00 AM

Enhancing the DMC Data Package Using Open Source Software, Artificial Intelligence, and LLMs presented by Dr. Melvin Munsaka, Abbvie

11:00 AM

A Structured Approach to Designing Pivotal Diagnostic Accuracy Studies for Noninvasive Tests Using Meta-Analytic Techniques presented by Dr. Ryan Butterfield and Dr. Ed De Vol, Siemens