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Program

 

Empower Clinical Development by Harnessing Data from Diverse Sources

For this virtual symposium, all times are US Eastern Daylight Time (GMT-4). All events will start 10 mins before the scheduled times to allow the speakers and the participants to login.

Wednesday, April 3, 2024

Time Short Courses # Instructors
9:00am – 12:00pm EST Introduction to Bayesian Methods for Clinical Trial Design and Sample Size Determination C1A Joseph Ibrahim
Real World Evidence Framework in Clinical Development  C2 Laura Fernandes, Freda Cooner
12:00pm – 1:00pm EST Break
1:00pm-4:00pm EST Introduction to Bayesian Methods for Clinical Trial Design and Sample Size Determination C1B Joseph Ibrahim
Regulatory/Statistical Consideration of Biosimilar Product Development C3 Thomas Gwise, Shein-Chung Chow
Multi-Regional Clinical Trial C4 Gang Li, Judy X. Li, Bruce Binkowitz

Thursday, April 4, 2024

 

Time Session/Event # Organizers
9:00am – 10:30am EST Opening Remarks and Keynote I
Xiaofei Wang, Yeh-Fong Chen
10:30am – 10:45am EST Break
10:45am – 12:00pm EST (75mins) Estimand in Oncology S1A Jingjing Schneider, Qing Xu
Patient Centric Trials S1B Colleen Russell, Shuyen Ho
Software and Data Standardization and Integrity  S1C Fang Chen, Shibing Deng
12:00pm – 1:30pm EST Poster Lightning Talk Session Hwanhee Hong, Marlina Nasution, Shuyen Ho
1:30pm – 2:45pm EST (75mins) Platform and Biomarker Stratified Trials S2A Anastasia Ivanova, Yeh-Fong Chen
Data Integration in Multi-Stage Adaptive Design S2B Freda Cooner, Qing Xu
Dose Optimization S2C Jingjing Schneider, Shibing Deng
2:45pm – 3:00pm EST Break
3:00pm – 5:00pm EST (120mins) Information Borrowing in Rare Disease and Non-Oncology Clinical Trials S3A Qiming Liao, Freda Cooner
Data Monitoring Committee S3B Marlina Nasution, Shuyen Ho, Robert Barrier
Centralized Statistical Monitoring Tools in Trial Conduct S3C Rakhi Kilaru, Colleen Russell

Friday, April 5, 2024

Time Session/Event # Organizers
9:00am – 10:30am EST Keynote II Xiaofei Wang, Shibing Deng
10:30am – 10:45am EST Break
10:45am – 12:45pm EST (120mins) Information Borrowing in Oncology Trials S4A Freda Cooner , Xiang Li
Utilizing Real-World Data in Late-Stage Clinical Trials – Methodologies and Example Sharing  S4B Yeh-Fong Chen, MiaoMiao Ge
Decentralized Clinical Trials (Challenges & Opportunities) S4C Herb Pang, Rakhi Kilaru