Steering Committee

Workshop Co-chair

Freda Cooner (FDA/CDER)
Ed Luo (PTC Therapeutics)

Steering Committee

FDA

Freda Cooner (FDA/CDER)
Margaret Gamalo (FDA/CFSAN)
Tom Gwise (FDA/CDER)
Martin Ho (FDA/CDRH)
Geoffrey Jackson (FDA/CTP)
Yuying Jin (FDA/CDRH)
Stephanie Keeton (FDA/CDER)
Shiowjen Lee (FDA/CBER)
Judy Li (FDA/CBER)
Xuefeng Li (FDA/CDRH)
John Scott (FDA/CBER)
Diqiong Xie (FDA/CDER)
Yun-Ling Xu (FDA/CDRH)
Wei Zhang (FDA/CVM)

Industry

Ed Luo (PTC Therapeutics)
Alan Hartford (Abbvie)
Weili He (Merck)
Xiaohong Huang (Vertex)
Jeffrey Joseph (Chiltern)
Caiyan Li (Receptos)
Feng Liu (GSK)
Jared Lunceford (Merck)
Theodore Lystig (Medtronic)
Inna Perevozskaya (Pfizer)
Erik Pulkstenis (MedImmune)
Hui Quan (Sanofi)
Yue Shentu (Merck)
Richard Zink (SAS)

CMC sub-committee

Xiaoyu Dong (FDA/CDER)
Meiyu Shen (FDA/CDER)
Harry Yang (MedImmune)

Academia

Yu Cheng (University of Pittsburgh)
Anastasia Ivanova (UNC Chapel Hill)
Fang Liu (University of Notre Dame)

Consultants

Bruce Binkowitz (Merck)
Christie Clark (Quality Data Services)
Christy Chuang-Stein (Chuang-Stein Consulting)
Gerry Gray (FDA/CDRH)
Telba Irony (FDA/CDRH)
Lisa LaVange (FDA/CDER)
Anna Nevius (FDA/CVM)
Dionne Price (FDA/CDER)
Matilde Sanchez (Arena Pharmaceutical)
Steve Wilson (FDA/CDER)
Lilly Yue (FDA/CDRH)

Key Dates