Program

Date: Friday, December 16

Location: Student Union 330

All times are US Eastern Time (New York)

• 09:30-10:00 Registration
• 09:30-10:30 Refreshments
• 10:00-10:15 Opening Remarks
• 10:15-12:30 Scientific Session Ⅰ
  • Na Hu (Boehringer-Ingelheim), Endpoint Identification and Validation for Generalized Pustular Psoriasis (GPP)
  • Yuqian Shen (Sanofi), A 2-Stage Design Combining Both Group-Sequential and Sample Size Re-Estimation for a Slope Endpoint in a Small Sample Size Setting
  • Glen Laird & Yaohua Zhang (Vertex), A Confirmatory Basket Design Considering Non-inferiority and Superiority Testing
• 12:30-14:00 Lunch & Networking
• 14:00-15:45 Scientific Session Ⅱ
  • Yuvika Paliwal (Pfizer), A CID Proposal for Somatrogon in a Single Master Protocol Across Three Indications
  • Mercedeh Ghadessi (Bayer), A Roadmap to Using Historical Controls in Clinical Trials: Results from DIA-ADSWG
  • James Signorovitch (Analysis Group), Federated Analytics for Timely Surrogate Endpoint Validation in Rare Diseases: An Application in AL Amyloidosis Combining Data across Institutional and National Boundaries
• 15:45-16:30 Open discussion / Panel discussion: Future directions for NERDS