Day 1 Schedule (November 7, 2024):
Current Landscape of RWE
Speaker | Details |
---|---|
Pallavi Mishra-Kalyani (Deputy Director, FDA) |
Regulatory Considerations for Non-Randomized Studies in Drug Development |
Stephen Duffield (Associate Director, RWE Methods, National Institute of Health Care Excellence (NICE)) |
Novel Analytics at The National Institute of Health Care Excellence. What Matters Most? |
Weili He (Head of Medical Affairs & Health Technology Assessment Statistics, AbbVie) |
Current Landscape of RWE - An Industry Perspective |
Focused Sessions Day 1
Advanced Methods for Covariate Adjustment to Improve Precision in RCTs
Speaker | Details |
---|---|
Daniel Rubin (Statistician, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA) |
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products |
Kelly Van Lancker (Postdoctoral Researcher, Applied Mathematics, Computer Science & Statistics, Ghent University) |
Automated, Efficient and Model-Free Inference for RCTs via Data-Driven Covariate Adjustment Pre-read: Van Lancker K, Díaz I, Vansteelandt S. (2024). Automated, efficient and model-free inference for randomized clinical trials via data-driven covariate adjustment. arXiv preprint arXiv:2404.11150. |
Laura Balzer (Associate Professor, Biostatistics, UC Berkeley) |
Collaborative TMLE to Maximize Empirical Efficiency in Randomized Trials |
AI/ML Tools in Regulatory Submissions
Speaker | Details |
---|---|
Hana Lee (Senior Statistical Reviewer, OB, OTS, CDER, FDA) |
Artificial Intelligence and Machine Learning for Medical Product Development and Evaluation |
Gilmer Valdes (Director of Clinical AI and Associate Professor, Moffitt Cancer Center) |
Interpretable AI/ML: Improving Generalizability and Evaluation of Untestable Assumptions |
Gene Pennello (Senior Statistician, DIDSR, CDRH, FDA) |
Clinical Development of AI-Enabled Medical Devices: Challenges and Opportunities from Statistical and Regulatory Perspectives |
Day 2 Schedule (November 8, 2024):
Focused Sessions Day 2
Complex Innovative Trial Designs
Speaker | Details |
---|---|
Ramin Ebrahimi (Senior Director in Biostatistics, Gilead Sciences) |
Innovative Trial Designs in HIV Research at Gilead |
Veronica Miller (Director, Forum for Collaborative Research) |
Forum perspective on innovative trial designs in HIV research |
James Peng (PhD Student, Biostatistics, University of Washington) |
Surrogate Endpoint-Based Provisional Approval Causal Roadmap |
Lei Nei (Director, Division of Biometrics IV, Office of Biostatistics, CDER, FDA) |
Borrowing Information from Non-Concurrent Controls to Enhance Efficiency in Platform Trials |
Real-World Evidence Case Studies
Speaker | Details |
---|---|
Rachael V. Phillips (Biostatistician, CTML, UC Berkeley) |
Causal Targeted Machine Learning for Real-World Evidence Studies in Radiotherapy Oncology |
Edward Bein (Statistician, Division of Biometrics VII, Office of Biostatistics, OTS, CDER, FDA) |
Study 747-405: A Real-World Data Observational Study of the Efficacy and Safety of Ocaliva (OCA) for the Treatment of Primary Biliary Cholangitis (PBC) |
Romain Neugebauer (Research Scientist, Kaiser Permanente Northern California) |
Comparison of Type 2 Diabetes Pharmacotherapy Regimens using Targeted Learning and EHR Data: Approach and Results from the ONTARGET Diabetes Melitus Study |
Data Integration
Speaker | Details |
---|---|
Hector Izurieta (Associate Director for Novel Clinical Investigations, OVRR, CBER, FDA) |
Real-World Evidence Study Methods that May Help Address Unmeasured Confounding |
Kara Rudolph (Associate Professor, Epidemiology, Columbia University) |
How Measured Mediators can Help Achieve Identification for Transported Effects and Improve Understanding of Why Effects Differ Across Populations |
Henrik Ravn & Sky Qiu (Senior Statistical Director, Novo Nordisk & PhD Candidate, Biostatistics, UC Berkeley) |
Comparison of Type 2 Diabetes Pharmacotherapy Regimens using Targeted Learning and EHR Data: Approach and Results from the ONTARGET Diabetes Melitus Study |