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.

Membership for the Phase IV effort - Co-chairs: Hana Lee, Hongwei Wang and Shu Yang

Industry

Affiliation

Academic/FDA

Affiliation

Xiang Zhang1

CSL Behring

Shu Yang1

NCSU

Ran Duan

Vertex

Pallavi Mishra-Kalyani  

FDA

Yixin Fang

AbbVie

Jianjin Xu

FDA

Rima Izem

Novartis

Lei Nie

FDA

Birol Emir

Pfizer

Mark van der Laan

UC Berkeley

Herb Pang

Genentech

Yuan Ying

MD Anderson

Chenguang Wang

Regeneron

Peng Yang

MD Anderson

Weili Hea

AbbVie

Ke Zhu

Duke & NCSU

Demissie Alemayehu2

Pfizer

Mark Levensona

FDA

Zhaoling Meng

Sanofi

Hana Lee2

FDA

Tristan Naumann

Microsoft

Hussein Ezzeldin

FDA

Hongwei Wang3

AbbVie

Spencer Haupert

FDA

Kaijie Pan

Pfizer

Sue-Jane Wang

FDA

Tu Xu

Novo Nordisk

Gabriel Innes

FDA

Binbing Yu

AstraZeneca

Yong Chen

U Penn

Haitao Chu

Pfizer

Frank Rockhold

Duke

Susan Gruber

Targeted ML Solutions

Nikki Freeman

Duke

Cindy Lu

Astrazeneca

Gilmer Valdes

Moffitt Cancer Center

Haijun Tian

Eli Lilly

Alexej Gossman

Mayo Clinic

 

 

Sky Qiu

UC Berkely

 

 

Yun Lu3

FDA

 

 

Richard Forshee

FDA

 

 

Yong Ma

FDA

 

 

Fang Tian

FDA

 

 

Kendrick Li

St Jude Children’s

 

 

Xu Shi

U Michigan

1: Co-leads for Team 1; 2: Co-leads for Team 2; 3: Co-lead for Team 3; a: Advisory role.