Steering Committee

Workshop Co-chair
Wei Zhang (FDA/CVM)
Richard Zink (SAS)

Steering Committee

FDA

Freda Cooner (FDA/CDER)
Telba Irony (FDA/CDRH)
Terri Johnson (FDA/CDRH)
Shiowjen Lee (FDA/CBER)
Mark Levenson (FDA/CDER)
Jingyu Luan (FDA/CDER)
Hugh Rand (FDA/CFSAN)
Virginia Recta (FDA/CVM)
John Scott (FDA/CBER)
Yuqing Tang (FDA/CDRH)

Industry

Chris Holland (Amgen)
Rakhi Kilaru (PPD)
Caiyan Li (Takeda Global Research & Develop. Center, Inc.)
Ed Luo (PTC Therapeutics)
Theodore Lystig (Amgen)
Cristiana Mayer (JNJ)
Bret Musser (Merck)
Camille Orman (JNJ)
Inna Perevozskaya (Pfizer)
Erik Pulkstenis (MedImmune)
Yue Shentu (Merck)

Academia

Yu Cheng (University of Pittsburgh)
Anastasia Ivanova (UNC Chapel Hill)

Consultants

Greg Campbell (FDA/CDRH)
James Chen (FDA/NCTR)
Lisa LaVange (FDA/CDER)
Anna Nevius (FDA/CVM)
Estelle Russek-Cohen (FDA/CBER)

CMC Subcommittee

Stan Altan (JNJ)
J. David Christopher (Merck)
Xiaoyu Dong (FDA/CDER)
Meiyu Shen (FDA/CDER)
Yi Tsong (FDA/CDER)
Harry Yang (MedImmune)