Steering Committee

FDA

Chul Ahn (FDA/CDRH)
Thomas Birkner (FDA/CDER)
Martin Ho (FDA/CDRH)
Xin Fang (FDA/CDRH)
Tom Gwise (FDA/CDER)
Lei Huang (FDA/CBER)
John Ihrie (FDA/CFSAN)
Zhen Jiang (FDA/CBER)
Renee Rees (FDA/CBER)
Matilde Sanchez (FDA/CVM)
Haiwen Shi (FDA/CVM)
Ghideon Solomon (FDA/CTP)
Wanjie Sun (FDA/CDER)
Dong Wang (FDA/NCTR)
Yun Wang (FDA/CDER)*
Changming Xia (FDA/CDER)
Zhiheng Xu (FDA/CDRH)

Industry

Gary Aras (Amgen)
Neby Bikele (Gileard Sciences)
Freda Cooner (Sanofi)
Paul Gallo (Novartis)
Margaret Gamalo (Eli Lilly)
Weili He (AbbVie)
Pari Hemyari (Roche)
Jeffrey Joseph (Chiltren)
Rakhi Kilaru (PPD)
Yabing Mai (Merck)
Praloy Mukhopadhaye (Astrazeneca)
Satrajit Roychoudhury (Pfizer Inc.)*
Hong Tian (Johnson & Johnson)
Richard Zink (SAS)

CMC Subcommittee

Tsai-Lien Lin (FDA/CBER)
Jorge Quiroz (Merck & Co., Inc.)
Meiyu Shen (FDA/CDER)
Lanju Zhang (AbbVie)

Academia

Joseph Gardiner (Michigan State University)
Brian Hobbs (MD Anderson)

Advisers

Christy Chuang-Stein (Chuang-Stein Consulting)
Alex Dmitrienko (Mediana Inc.)
Frank Harrell (Vanderbilt University)
Robert Hemmings (MHRA)
Kannan Natarajan (Pfizer Inc.)
Estelle Russek-Cohen (FDA/CBER)
John Scott (FDA/CBER)
Heather Thomas (PRA Health Sciences)
Ram Tiwari (FDA/CDRH)