Program
All times are in EDT.
8:00 am – 9:00 am: Registration
8:00 am – 9:00 am: Refreshment
- 9:00 am – 9:10 am: Opening Remarks:
- Birol Emir, ASA CT Chapter President
- Ming-Hui Chen, University of Connecticut
- 9:10 am – 12:00 pm: Scientific Session I
- 9:10 am – 9:50 am: Sheraz Khan, Pfizer
- Automating Clinical Trial Regulatory Documents with Agentic AI: Generation and Evaluation of SAPs, CSRs, and LoTs
- 9:50 am – 10:30 am: Yanxun Xu, Johns Hopkins University
- Closing the Loop in Evidence Synthesis: High-Fidelity IPD Reconstruction from Kaplan-Meier Plots and Robust Inference
- 10:30 am – 11:10 am: Jingfeng Zhang, Insilicom LLC
- From Hallucination to Trust: Building Knowledge Graphs for Reliable and Explainable AI in Biomedical Discovery
- 11:10 am – 11:50 am: Hussein Ezzeldin, US Food and Drug Administration
- The FDA’s Risk-Based Regulatory Perspective on AI in Drug Development
- 9:10 am – 9:50 am: Sheraz Khan, Pfizer
12:00 pm -– 1:00 pm: Lunch
- 1:00 pm – 3:45 pm: Scientific Session II
- 1:00 pm – 1:40 pm: Pending
- Pending
- 1:40 pm – 2:20 pm: Meizi Liu, Takeda
- BEAM: Bayesian Hybrid Design With Adaptive Sample Size Through Multisource Exchangeability Modeling
- 2:20 pm – 3:00 pm: Ming-Hui Chen, University of Connecticut
- Quantifying Prior Information via Kullback-Leibler Divergence: A New Perspective on Effective Sample Size
- 1:00 pm – 1:40 pm: Pending
- 3:00 pm – 3:45 pm: Panel discussion on draft FDA guidance
- “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products”
- 3:45 pm – 4:00 pm: Closing Remarks: Junxian Geng, ASA CT Chapter Vice President