Co-Chairs
Membership for the Phase I effort – Co-chairs Weili He, Martin Ho
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Industry
|
Affiliation
|
Academic/FDA
|
Affiliation
|
|
Jie Chen
Yixin Fang
Doug Faries
Weili He 1
Qi Jiang
Kwan Lee 2
Xiwu Lin
Zhaoling Meng
Yang Song
Hongwei Wang
Roseann White
Richard Zink
|
Overland Pharma
AbbVie
Eli Lily
AbbVie
Seattle Genetics
Janssen
Janssen
Sanofi
Vertex Pharma. Inc.
AbbVie
The Third Opinion
Target Pharma. Solution
|
Ben Goldstein
Martin Ho 2
Telba Irony
Hana Lee
Mark Levenson 1
Pallavi Mishra-Kalyani
Frank Rockhold
Mark van der Laan
Tingting Zhou
|
Duke
FDA-CBER
FDA-CBER
FDA-CDER
FDA-CDER
FDA-CDER
Duke
UC Berkeley
FDA-CBER
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1 Co-leads of Workstream #1; 2 Co-leads of Workstream #2
† Liz Stuart (Johns Hopkins University) participates as non-member
Membership for the Phase II effort – Co-chairs Weili He, Martin Ho
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Industry
|
Affiliation
|
Academic/FDA
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Affiliation
|
|
Jie Chen 1
Li Chen
Liang Fang
Yixin Fang 3
Doug Faries
Susan Gruber
Weili He 2
Xiwu Lin
Telba Irony
Tricia Luhn
Zhaoling Meng
Herb Pang
Yang Song
Hongwei Wang
|
Overland Pharma
Amgen
MyoKardia
AbbVie
Eli Lily
Putnam Data Sci
AbbVie
Janssen
Janssen
Genentech
Sanofi
Genentech
Vertex Pharma. Inc.
AbbVie
|
Ben Goldstein
Sai Dharmarajan
Martin Ho 3
Hana Lee 1
Mark Levenson 2
Heng Li
Pallavi Mishra-Kalyani
Frank Rockhold
Mark van der Laan
John Scott
Tingting Zhou
|
Duke
FDA-CDER
FDA-CBER
FDA-CDER
FDA-CDER
FDA-CDRH
FDA-CDER
Duke
UC Berkeley
FDA-CBER
FDA-CBER
|
1 Co-leads of Team #1; 2 Co-leads of Team #2; 3 Co-leads of Team #3
Membership for the Phase III effort - Co-chairs: Jie Chen, Yixin Fang, and Hana Lee
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Industry
|
Affiliation
|
Academic/FDA
|
Affiliation
|
|
Jie Chen2,3
|
Overland Pharma
|
Peng Ding
|
UC Berkeley
|
|
Nadia Daizadeh
|
Novartis
|
Jennifer Kirk |
FDA |
|
Junrui Di
|
Pfizer
|
Mark van der Laan
|
UC Berkeley
|
|
Yixin Fang1
|
AbbVie
|
Joo-Yeon Lee
|
FDA
|
|
Doug Faries
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Eli Lilly
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Hana Lee1,3
|
FDA
|
|
Susan Gruber
|
Putman Data Science
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Shiowjen Lee |
FDA |
|
Weili Hea
|
AbbVie
|
Mark Levensona
|
FDA
|
|
Thomas Jemielita
|
Merck
|
Ying Lu
|
Stanford
|
| Herb Pang |
Genentech |
Pallavi Mishra-Kalyani
|
FDA
|
|
Mingyang Shan
|
Eli Lilly
|
Lei Nie2
|
FDA
|
|
Yang Song
|
Vertex
|
Andrew Potter
|
FDA
|
|
Haijun Tian
|
Novartis
|
Frank Rockhold
|
Duke
|
|
Hongwei Wang
|
AbbVie
|
Yuan Li Shen |
FDA |
|
Xiang Zhang
|
CSL Behring
|
Roy Tamura
|
U. of S. Florida
|
|
Jing Zhao
|
Merck
|
Yan Wang
|
FDA
|
|
Yihua Zhao
|
Flatiron Health
|
Shu Yang
|
NCSU
|
|
|
|
Tingting Zhou
|
FDA
|
1: Co-leads for subteam 1; 2: Co-leads for subteam 2; 3: Co-lead for subteam 3; a: Advisory role.