Full Hot Breakfast (Covered by registration fee)

The Power of AI, Data Sciences, and Technology in Drug Development
Presenter: Venkat Sethuraman, Bristol Myers Squibb
Moderator: Ivan S. F. Chan

An Introduction to Machine Learning Methods for Optimal Dynamic Treatment Decisions in Precision Medicine
Speakers: Prof. Donglin Zheng, UNC and Prof. Yuanjia Wang, Columbia University
Moderator: Kalyan Ghosh

Evaluating Predictive Accuracy of Survival Models Using the ROC Curve and Related Measures in Clinical Trial Applications
Speakers: Kassu Mehari Beyene and Ding-Geng (Din) Chen, ASU
Moderator: Alfred H. Balch

Cell and Gene Therapy: Introduction and Overview of Important Regulatory, Statistical and Operational Considerations
Speakers: Shihua Wen, Novartis
Moderator: Ivan S. F. Chan

Bayesian semi-parametric approaches to exposure-response modeling with time-to-event outcomes
Speakers: Tim Waterhouse, Statistics Metrum Research Group
Moderator: Alfred H. Balch

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

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

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

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

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

Title: Interpreting Deep Neural Networks towards Trustworthy AI, 
Speaker: Prof. Bin Yu, UC Berkeley
Moderator: Alfred H. Balch

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
Speakers: Christopher Schmid, Brown University and Naihua Duan, Columbia University
Moderator: Alfred H. Balch

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

Introduction to Adaptive Design Methods for Dose and Treatment Selection
Speakers: Prof. Haitao Pan, St. Jude Children’s Research Hospital
Moderator: Naitee Ting

Bayesian Adaptive Statistical Approaches for Accelerating Drug and Medical Device Approvals in Rare Disease
Speakers: Margaret Gamalo, Jinma Ren, Wenjin Wang, Pfizer Inc
Moderator: Li-An Xu

Real-world Evidence in Medical Product Development
Speakers: Weili He, Yixin Fang, and Hongwei Wang, Abbvie
Moderator: Jerry Li

Statistical Analysis with Missing Data
Speakers: Prof. Rod Little, University of Michigan, and Prof. Qixuan Chen, Columbia University
Moderator: Alfred H. Balch

Real-world Evidence in Medical Product Development
Instructors: Weili He, Yixin Fang, and Hongwei Wang, Abbvie
Moderator: Jerry Li

Statistical Analysis with Missing Data
Prof. Rod Little, University of Michigan, and Prof. Qixuan Chen, Columbia University
Moderator: Alfred H. Balch