Steering Committee
Workshop Co-chairs
Weili He (AbbVie)
Martin Ho (FDA/CDRH)
Steering Committee
FDA
Martin Ho (FDA/CDRH)
Freda Cooner (FDA/CDER)
Xin Fang (FDA/CDRH)
Tom Gwise (FDA/CDER)
Lei Huang (FDA/CBER)
Terri Johnson (FDA/CDRH)
Scott Komo (FDA/CDER)
Judy Li (FDA/CBER)
Xuefeng Li (FDA/CDRH)
John Scott (FDA/CBER)
Wanjie Sun (FDA/CDER)
Yun Wang (FDA/CDER)
Xiting (Cindy) Yang (FDA/CDRH)
Jialu Zhang (FDA/CDER)
Wei Zhang (FDA/CVM)
Industry
Abie Ekangaki (UCB)
Paul Gallo (Novartis)
Margaret Gamalo (Eli Lilly)
Alan Hartford (AbbVie)
Weili He (AbbVie)
Xiaohong Huang (Vertex)
Jeffrey Joseph (Theorem Clinical)
Feng Liu (GSK)
Ed Luo (PTC Therapeutics)
Theodore Lystig (Medtronic)
Yabing Mai (Merck & Co., Inc.)
Zhaoling Meng (Sanofi)
Sandeep Menon (Pfizer)
Richard Zink (SAS)
Jane Qian (Abbvie)
CMC Subcommittee
Meiyu Shen (FDA/CDER)
Tianhua Wang (FDA/CDER)
David Christopher (Merck & Co., Inc.)
Harry Yang (MedImmune)
Academia
Yu Cheng (University of Pittsburgh)
Scott Evans (Harvard University)
Sonia Davis (UNC Chapel Hill)
Advisers
Ivan Chan (AbbVie)
Matilde Sanchez (Independent Consultant)
Christy Chuang-Stein (Chuang-Stein Consulting)
Alex Dmitrienko (Mediana Inc.)
Jose Pinheiro (J&J)
Lisa LaVange (FDA/CDER)
Telba Irony (FDA/CBER)
Estelle Russek-Cohen (FDA/CBER)
Ram Tiwari (FDA/CDRH)
Christie Clark (Consultant)