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Roundtable

TL23-25 Roundtable Discussions

Thu, Sep 17, 11:45 AM - 1:00 PM Room Middlebrook Bethesda North Marriott Hotel & Conference Center

3 Presentations

TL23: Bayesian Borrowing in Clinical Trials: Challenges, Type I Error Calibration, and Regulatory Acceptance

11:45 AM - 1:00 PM

Co-authors: Meizi Liu (Takeda)

Bayesian guidance Bayesian borrowing Type I error rate calibration

TL24: Implementing the FDA's 2026 Bayesian Draft Guidance: Prior Specification, Calibration, and What Sponsors Actually Need to Do

11:45 AM - 1:00 PM

Co-authors: Lu Qian (Zetyra)

Bayesian clinical trials Prior specification Operating characteristics FDA draft guidance

TL25: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: A New FDA Guidance

11:45 AM - 1:00 PM

Co-authors: Rianka Bhattacharya (New Jersey Institute of Technology)

FDA Guidance Bayesian analysis clinical trial drug development

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