JSM2023
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Topic-Contributed Paper Session

CtDNA for Oncology Drug Development: Challenges, Opportunities and Statistical Methodologies

Mon, Aug 7, 10:30 AM
Sammy YuanChairFang LiuOrganizer
Biopharmaceutical Section

4 Presentations

Advancing the Use of ctDNA as an Early Endpoint through Collaboration
10:35 AM - 10:55 AM
Hillary Stires (Friends of Cancer Resarch)
Co-authors: Mark Stewart (Friends of Cancer Research)
Regulatory Perspectives on ctDNA in Oncology Drug Development
10:55 AM - 11:15 AM
Pallavi Mishra-Kalyani (Food and Drug Administration)
Co-authors: Joyce Cheng (FDA)
A simulation-based analysis to assess the potential benefit of ctDNA molecular response in oncology clinical development
11:15 AM - 11:35 AM
Xiao Ji (GSK)
Evaluating ctDNA utility in early clinical development
11:35 AM - 11:55 AM
Wei Zou
Co-authors: zoe assaf (Genentech), Zoe Zhang (Genentech, Inc.)

Discussant

Helen Zhou (GSK)
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