Co-Chairs
Group Advisors
- Rajeshwari Sridhara, FDA Oncology COE
- Elizabeth Barksdale, LUNGevity Foundation
The SWG consists of six workstreams (WS)
Combination Therapy/ Dose-Optimization WS (Co-leads: Yuan Li Shen (FDA) and Rong Liu (Regeneron)):
- Members: Olga Marchenko (Bayer), Qi Jiang (Pfizer), Cindy Lu (AZ), Nicole Li (BeiGene), Hong Tian (BeiGene), Ying Yuan (AD Anderson), Ruitao Lin (MD Anderson), Suman Sen (Novartis), Heng Zhou (Merck)
Master Protocols/ Tumor Agnostic Approvals WS (Co-leads: Nicole Li (BeiGene) and Cindy Lu (AZ)):
- Members: Qi Jiang (Pfizer), Kristine Broglio (AZ), Hong Tian (BeiGene), Yevgen Tymofyeyev (J&J), Paul Bycott (Pfizer), Anna McGlothlin (Berry Consultants), Jingjing Ye (BeiGene), Jianchang Lin (Takeda), Jun Yin (Mayo Clinic), Jie Chen (Overlandpharma), Godwin Yung (Roche), Linda Sun (Merck), Sammy Yuan (GSK)
Enrichment Designs / RWE in Oncology Development/ Interim Evaluation of OS WS (Co-leads: Sunhee Ro (Prelude Therapeutics) and Weidong Zhang (Sana Biotechnology)):
- Members: Olga Marchenko (Bayer), Qi Jiang (Pfizer), Jing Zhao (Merck), Rong Liu (Regeneron), Nicole Li (BeiGene), Cindy Lu (AZ), Linda Sun (Merck), Zhenzhen Xu (FDA), Yuan Li Shen (FDA)
Pediatric Trial Designs WS (Co-leads: Jingjing Ye (BeiGene) and Jonathon Vallejo (FDA)):
- Members: Pallavi Mishar-Kalyani (FDA), Weidong Zhang (Sana Biotechnology), Yuan Ying (MD Anderson), Rong Liu (Regeneron), Satrajit Roychoudhury (Pfizer), Lindsay Renfro (COG), Haitao Pan (St. Jude’s), Yuan Ji (UChicago), Gregory Reaman (NIH/NCI), Cindy Lu (AZ)
Joint Modeling WS (Co-leads: Yan Gao (MCW) and Houcheng Yang (Edwards)):
- Peng Zhao (University of Delaware), Jiawei Xu (Gilead), Francois Mercier (Roche)
Treatment Switch WS (Co-leads: Erik Bloomquist (Merck) and Meijing Wu (Sanofi)):
Members: Bingxia Wang (Takeda), Ananya Roy (Merck), Vickie Zhang (Servier), Qing Liu (Amgen), Suk-Young Yoo (Regeneron), Kaifeng Lu (Beigene), Cindy Chen (Vanderbilt), Laura Fernandes (COTA), Hongwei Wang (Abbvie), Charu Guptu (Astra Zeneca), Ya Wang (Gilead), Abhijoy Saha (Lilly), Wenjuan Gu (FDA), Yufei Wang (GSK), Ray Lin (Genetech)