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Roundtable

TL08-14 Roundtable Discussions

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

7 Presentations

TL08: From Images to Insights: Transdisciplinary Approaches to Enhance Ophthalmology Trial Designs

11:45 AM - 1:00 PM

George Capuano (Johnson & Johnson-Janssen R&D)

Co-authors: Fei Chen (Johnson & Johnson)

Joint modeling Longitudinal data analysis Time‑to‑event modeling Ophthalmology clinical trials Structural and functional endpoint Digital biomarkers AI‑assisted imaging Clinical trial design Go/no‑go decision‑making

TL09: AI-Assisted Reconstruction of BOP2-Comb Statistical Codes to Enable Efficient and Reproducible Workflow for Drug Development

11:45 AM - 1:00 PM

Co-authors: Yu Wang (Bristol Myers Squibb)

Artificial Intelligence Drug Development Reproducibility Bayesian design Simulation

TL10: Decision Making Under Pressure: Interpreting Emerging Data Responsibly

11:45 AM - 1:00 PM

Co-authors: Kimberley Hacquoil (Veramed)

Decision-making Data readiness Trial integrity Emerging data Operational risks Multidisciplinary collaboration

TL11: Cardiovascular Disease Risk Prediction in Outcome Trial Design and Decision Support

11:45 AM - 1:00 PM

Runjia Li (Eli Lilly and Company)

Co-authors: Kevin Chen (Eli Lilly and Company)

cardiovascular disease risk prediction outcomes trials trial decision-making

TL12: How PK/PD Modeling Can Support and Inform Probability of Success Assessments

11:45 AM - 1:00 PM

Co-authors: Luke Fostvedt (Pfizer)

Probability of Success PK/PD Model-informed Drug Development Go/No-go

TL13: DMC Decision-Making in Clinical Trials: Regulatory Considerations, Practical Challenges, and the role of the Independent Statistical Reporting Group

11:45 AM - 1:00 PM

Co-authors: Janelle Rhorer (Alira Health)

DMC DSMB Sequential monitoring Interim analysis IDMC

TL14: Practical Considerations of Bayesian Dynamic Borrowing of External Data in Pharmaceutical Research

11:45 AM - 1:00 PM

Co-authors: Ming-Dauh Wang (Bayer)

External data Dynamic borrowing Bayesian approach baseline differences outcome differences Regulatory acceptance

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