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)

Key Dates

    Attend

  • September 25, 2017 – September 27, 2017
    2016 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop