Full Hot Breakfast (Covered by registration fee)

Walter Young Memorial Session
Moderator: Alfred H. Balch

TITLE: Hybrid Frequentist / Bayesian Power and Bayesian Power in Planning Clinical Trials
SPEAKER: Andy P. Grieve
Moderator: Din Chen

Spatial Data Science Meets Bayesian Modeling and Inference
Sudipto Banerjee, UCLA
Moderator: Naitee Ting

Incorporating Uncertainty in Power Considerations of Clinical Trials with Applications on Equivalence Trials
SPEAKERS: Arne Ring and Rachid El-Galta, Sandoz
MODERATOR: Din Chen

Bayesian Methods for Sample Size Determinations
INSTRUCTORS: Sujit K. Ghosh, NCSU and Fei Wang, Boehringer Ingelheim
MODERATOR: Naitee Ting

Speaker’s and Awards Dinner (Optional Added Fee Event)

Monitoring the Data on Covid-19 Vaccines: The Challenges by Susan Ellenberg, University of Pennsylvania
Susan Ellenberg, University of Pennsylvania 
Ivan S. F. Chan

Statistical Topics in Outcomes Research: Patient-Reported Outcomes, Meta-Analysis, and Health Economics
Joseph C. Cappelleri, Pfizer Inc, and Thomas Mathew, University of Maryland Baltimore County
Wenjin Wang

Adjust Overall Survival in Randomized Clinical Trials with Treatment Switching
Songzi Li, Hong Tian and Kaifeng Lu, BeiGene USA Inc.
Jingjing Ye

Estimand in Real-world Setting and Targeted Learning in Generating and Evaluating Real-world Evidence
Jie Chen, Overland Pharmaceuticals and Susan Gruber, Putnam Data Sciences
Weili He

Statistical Translation of Extrapolation: A Tutorial for Demonstrating Efficacy and Safety of Investigational Medicines in Pediatric Populations
James Travis, FDA; Margaret Gamalo, Pfizer Inc; and Jingjing Ye, BeiGene
Jingjing Ye

Keynote 3: Innovative Real World Evidence Initiatives at FDA in response to the COVID-19 pandemic 
Speaker: Aloka Chakravarty, PhD, FASA
Moderator: William Wang

N-of-1 Trials for Personalized Healthcare
Christopher Schmid, Brown University and Naihua Duan, Columbia University
Alfred H. Balch

Machine Learning for Statisticians
Andy Liaw and Junshui Ma, Merck & Co., Inc
Ivan S. F. Chan

Using SAS PROC BGLIMM and MCMC for Bayesian Analysis of Mixed Models
Walter Stroup, University of Nebraska
Alfred H. Balch

Safety and Benefit-Risk Evaluation with Practical Visual Analytical Tools
Melvin Munsaka, AbbVie Inc and Jim Buchanan, Covilance LLC
William Wang

Combining Information from Different Studies with Meta-Analysis and Network Meta-Analysis
Christopher Schmid and Thomas Trikalinos, Brown University
Moderator: Alfred H. Balch

Multi-regional Clinical Development and Safety/Benefit-Risk evaluation 
INSTRUCTOR: Bruce Binkowitz, Aloka Chakravarty, Arcutis Biotherapeutics Inc, Gang Li, Eisai Inc, Jim Buchanan, Covilance LLC, and Judy Li, BMS
MODERATOR: Ivan S. F. Chan and William Wang