Real World Evidence Scientific Working Group

Co-Chairs

Membership for the Phase I effort – Co-chairs Weili He, Martin Ho

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

 

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

Industry 

Affiliation

Academic/FDA

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

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

Eli Lilly

Hana Lee1,3

FDA

Susan Gruber

Putman Data Science

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.