Steering Committee

Workshop Co-Chairs

Thomas Birkner, FDA/CDER
Yabing Mai, AbbVie

Steering Committee

Academia

Ionut Bebu, GWU

FDA

Stuart Chirtel, FDA/CFSAN
Christopher Ellison, FDA/CTP
Xin Fang, FDA/CVM
Cherry Gupta, FDA/CVM
Lin Huo, FDA/CBER
Shuya (Joshua) Lu, FDA/CBER
Semhar Ogbagaber, FDA/CDER
Norberto Pantoja-Galicia, FDA/CDRH
Gene Pennello, FDA/CDRH
Renee Rees, FDA/CBER
Wanjie Sun, FDA/CDER
James Travis, FDA/CDER
Steven Wang, FDA/CFSAN
Sherman Xia, FDA/CDER
Yaji Xu, FDA/CDRH
Mengdie Yuan, FDA/CDER
Wei (Vivian) Zhuang, FDA/NCTR

Industry

Bo Huang, Pfizer
Joan Buenconsejo, AstraZeneca
Freda Cooner, Amgen
QiQi Deng, BI
Frank Fan, Novartis
Bo Fu, Astellas
Jeffrey Joseph, Covance
Judy Li, Celgene
Jiajun Liu, Biogen
Bret Musser, Regeneron
Elena Polverejan, J&J
Yue Shentu, Merck
Yang Song, Vertex
Lothar Tremmel, CSL Behring
Sabrina Wan, Merck
Xin Wang, AbbVie
Qiang (Casey) Xu, Celgene
Tinghui Yu, AstraZeneca

Advisers

Scott Evans, GWU
Sylva Collins, FDA/CDER
Shiowjen Lee, FDA/CBER
Yun Wang, FDA/CDER
Lilly Yue, FDA/CDRH
Paul Gallo, Novartis
Weili He, AbbVie
Erik Pulkstenis, AbbVie
Satrajit Roychoudhury, Pfizer
William Wang, Merck

Key Dates

    Attend

  • August 13, 2020
    Early Conference Registration Closes
  • September 3, 2020
    Registration Cancellation Deadline
  • September 22, 2020 – September 25, 2020
    2020 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
  • Program Participants

  • July 7, 2020 – August 25, 2020
    Abstract Editing
  • July 30, 2020
    Speaker/Participant Registration Deadline
  • August 23, 2020
    Short Course materials due from Instructors