Steering Committee

Workshop Co-Chairs

Bo Huang, Pfizer Inc.
Gene Pennello, FDA/CDRH

Steering Committee

FDA

Thomas Birkner, CDER
Stuart Chirtel, CFSAN
Christopher Ellison, CTP
Xin Fang, CVM
Cherry Gupta, CVM
Lin Huo, CBER
Jennifer Kirk, CBER
Chia-Wen (Kiki) Ko, CDRH
Semhar Ogbagaber, CDER
Norberto Pantoja-Galicia, CDRH
Paul Rogers, NCTR
Claire Ruberman, CVM
Haiwen Shi, CVM
Hengrui Sun, CDER
James Travis, CDER
Sherman Xia, CDER
Xiaoqin Xiong, CDRH
Mengdie Yuan, CDER
Wei (Vivian) Zhuang, NCTR

Industry

Paul Bycott, Pfizer Inc.
Joe Cappelleri, Pfizer Inc.
Cong Chen, Merck & Co., Inc.
Jie Chen, Overland
Freda Cooner, Amgen
Qiqi Deng, Boehringer-Ingelheim
Frank Fan, Novartis
Bo Fu, Sanofi
Mandy Jin, AbbVie
Jeffrey Joseph, Covance
Hope Knuckles, Abbott
Ray Lin, Genentech
Jingyi Liu, Eli Lilly
Yabing Mai, AbbVie
Inna Perevozskaya, GSK
Elena Polverejan, J&J
Satrajit Roychoudhury, Pfizer Inc.
Sammi Tang, Servier
Sabrina Wan, Merck & Co., Inc.
Casey Xu, BMS

Advisers

Ivan Chan, AbbVie
Jian-Xiong (George) Chu, CDRH
Christy Chuang-Stein, Chuang-Stein Consulting
Sylva Collins, CDER
Scott Evans, GWU
Shiowjen Lee, CBER
Kannan Natarajan, Pfizer Inc.
Jose Pinheiro, J&J
Renee Rees, CBER
Gary Rosner, JHU
Estelle Russek-Cohen, Consultant
Dong Wang, NCTR
Richard Zink, Lexitas

Representatives

International Society of Bayesian Analysis (ISBA)
Gary Rosner, Johns Hopkins University

ASA Section on Medical Devices and Diagnostics (MDD)
Hope Knuckles, Abbott

Key Dates