Stat4Onc 2019 Symposium Short Courses

April 25, 2019             Morning courses         8:30 AM to 12:00 noon          with one break

Afternoon courses      1:30 PM to 5:00 PM               with one break

Course 4    (Afternoon Course)  Innovative Cost-Effective Designs for Oncology Drug Development

Instructor – Dr. Cong Chen, Merck & Co., Inc.

Abstract

Following the tremendous success of PD-1 (or PD-L1) inhibitors, last few years have witnessed an explosive growth in number of oncology trials.  While the expectation is high for the new drugs or vaccines under development, it is unrealistic to expect all of them to have the same success, especially given the improved standard-of-care. It is imperative to apply innovative cost-effective designs to the development.

In this short course, after a motivating case study, I will introduce optimal basket designs for Phase 1B efficacy screening from various practical perfectives. I will then talk about advanced utilization of intermediate endpoints for making transitional decisions in an operationally seamless design with dose-selection and a statistically seamless 2-in-1 design. I will conclude with introduction of new Phase 3 designs for trials with a biomarker population (e.g., adaptive population expansions and simultaneous testing of a monotherapy and a combination therapy in a single trial). 

Biography

Dr. Cong Chen is Executive Director of Early Oncology Development Statistics at Merck & Co., Inc. He joined Merck in 1999 after graduating from Iowa State University with a Ph.D. in Statistics. He also holds a MS degree in Mathematics from Indiana University at Bloomington and a BS degree in Probability and Statistics from Beijing University, PR China.

As head of the group, he oversees the statistical support of oncology early clinical development at Merck. Prior to taking the role in March 2016, he led the statistical support for the development of pembrolizumab (KEYTRUDA), a paradigm changing anti-PD-1 immunotherapy, and played a pivotal role in accelerating its regulatory approvals. 

He is a Fellow of American Statistical Association, an Associate Editor of Statistics in Biopharmaceutical Research, a member of Cancer Clinical Research Editorial Board and a co-leader of the DIA Small Population Work Stream. He has published over 70 papers and 9 book chapters on design and analysis of clinical trials, and was twice invited to give an oral presentation at the AACR Annual Meeting in recent years on oncology drug development.