From Small Data to Big Data, from
RCT to RWE, the Impact of Statistics

September 23–25, 2019
Washington Marriott Wardman Park

Steering Committee

Workshop Co-chairs

Judy Li, Celgene
Renée Rees, FDA/CBER

Steering Committee

FDA

Thomas Birkner, FDA/CDER/DB1
Charles (Yinkiu) Cheung, FDA/CBER
Stuart Chirtel, FDA/CFSAN
Theo Dipita, FDA/CVM
Xin (Shane) Fang, FDA/CDRH
Lin Huo, FDA/CBER
Yuqun (Abigail) Luo, FDA/CBER
Renée Rees, FDA/CBER
Susie Sinks, FDA/CDER/DB2
Ghideon Solomon, FDA/CTP
Guoying Sun, FDA/CDER/DB8
Dong Wang, FDA/NCTR
Yun Wang, FDA/CDER/DB2
Jincao Wu, FDA/CDRH
Changming (Sherman) Xia, FDA/CDER/DB7
Yaji Xu, FDA/CDRH
Jingjing Ye, FDA/CDER/DB5
Aloka Chakravarty, FDA/CDER

Industry

Greg Ball, Merck
Alun Bedding, Roche
Joan Buenconsejo, AstraZeneca
Freda Cooner, Sanofi
Paul Gallo, Novartis
Margaret Gamalo, Eli Lilly
Weili He, AbbVie
Elaine Hoffman, PPD
Jeffrey Joseph, Chiltren
Jingyi Liu, Eli Lilly
Yabing Mai, AbbVie
Bret Musser, Regeneron
Satrajit Roychoudhury, Pfizer Inc.
Yang Song, Vertex
Lothar Tremmel, CSL Behring
Harry Yang, Medimmune

CMC Subcommittee

Charles (Yinkiu) Cheung, FDA/CBER
Jincao Wu, FDA/CDRH
Harry Yang, Medimmune

Academia

Bo Zhang, University of Massachusetts Medical School

Advisers

Mike Branson, Celgene
Aloka Chakravarty, FDA/CDER
Erik Pulkstenis, AbbVie
John Scott, FDA/CBER
William Wang, Merck
Lilly Yue, FDA/CDRH
Richard Zink, Target

Key Dates

  • July 9, 2019 – August 22, 2019
    Abstarct Editing
  • Attend

  • August 12, 2019
    Advance Conference Registration Closes
  • September 1, 2019
    Hotel Reservations Deadline
  • September 3, 2019
    Registration Cancellation Deadline
  • September 23, 2019 – September 25, 2019
    2018 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
  • Program Participants

  • August 23, 2019
    Short Course materials due from Instructors