RISW2025
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Roundtable

TL26-33 Roundtable Discussions

Thu, Sep 25, 11:45 AM - 1:00 PM Room Forest Glen Bethesda North Marriott Hotel & Conference Center

8 Presentations

TL26: Large Language Models in Regulatory Science and Real-World Evidence: Opportunities, Pitfalls, and Next Steps
11:45 AM - 1:00 PM
Tala Fakhouri (FDA)
Co-authors: Kajsa Kvist (Novo Nordisk A/S)
large language models (LLM)artificial intelligence (AI) / machine learning (ML)regulatory science and policyreal-world evidence (RWE)statistical analysis plan (SAP) and study protocol developmentpostmarketing surveillance and risk assessment
TL27: Integration of AI and MIDD (Model-Informed Drug Development) with a Special Focus on the M15 Guidance Document: General Principles for MIDD
11:45 AM - 1:00 PM
Zhiwei Zhang (Gilead Sciences)
Co-authors: Yuying Jin (Organon)
Model-Informed Drug DevelopmentM15 GuidanceArtificial Intelligence (AI)/Machine Learning (ML)Clinical Trial and Drug DevelopmentInnovation and TransformationReal-time data analysis
TL28: Credibility Assessment of Artificial Intelligence Usage in Clinical Trials
11:45 AM - 1:00 PM
Co-authors: Sudipta Saha (Astrazeneca)
Artificial Intelligence (AI)Clinical TrialsRisk of AI Model
TL29: AI-Driven Innovation in Clinical Trial Acceleration
11:45 AM - 1:00 PM
Andy Dang (Eli Lilly and Company)
Co-authors: Ju Ji (Eli Lilly and Company)
AILMMclinical trial accelerationautomated data curationsearch engine
TL30: Empower Drug Development Through AI-Based Digital Twins
11:45 AM - 1:00 PM
Co-authors: Haiyan Wu (Emory University)
GenAIDigitial TwinsDrug Development
TL31: Enhancing Pharmacovigilance Through AI: A Novel Approach to Safety Signal Detection
11:45 AM - 1:00 PM
Eren Demirhan (Nurix Therapeutics)
Co-authors: Jagannath Ghosh (Medivant Pharma, LLC)
PharmacovigilanceSafety signal detectionMachine Learning and Use of AIAssociation Rule Learning
TL32: Integrating AI/ML to Advance Drug Development: Innovative Methodologies and Regulatory Perspectives
11:45 AM - 1:00 PM
Co-authors: Hiya Banerjee (Eli Lilly)
AI/ML, Adjudication, CVM, metabolic diseases
TL33: Problematic Post-Hoc Graphics
11:45 AM - 1:00 PM
Co-authors: Theodore Lystig (BridgeBio)
IPTW-KMPrespecificationKaplan-MeierAKME
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