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, March 29, 2023
| 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, March 30, 2023
| 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, March 31, 2023
| 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 |