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Scope

Project

Scope 

This project team will define best practices for ensuring that similar types of adverse events are considered together for purposes of safety analyses. This project will develop efficient standardised processes and analyses that can leverage new technologies.



Journal Article 
Project LeadsEmails
Mary Nilsson (Eli Lilly)

nilsson_mary_e@lilly.com

Greg Ball (Novavax)gball@novavax.com
Katie Warren (PHUSE Project Assistant)katie@phuse.global 
Objectives & Deliverables 
White Paper 
Mac Gordon, Johnson & Johnson

rgordon2@its.jnj.com

Peg Fletcher, MedAssessmentpeg.fletcher@medassessment.com
Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


FDAClio Wu
Chinook Therapeutics
Emily GorenSeagen 
Hannah Palac AbbVie 
Mac Gordon Johnson & Jhonson 

Mika Tsujimoto

Eli Lilly 
Nhi Beasley FDA
Peg Fletcher MedAssessment 
Ramaiah MuvvalaInductive Quotient
Rebeka Revis IQVIA
Scott ProestelFDA
Shayami Thanabalasundrum Exelixis
Ying (Heather) HaoProthena 
Vaishali Popat

Status
colourBlue
titleCurrent Status
Q2/3 2022

New project for Q2 2022
Project Members Organisation 
Barbara HendricksonAbbvie 
Brian Panik MedAssessment 

Q3 2024

  • Draft white paper reviewed by Team and PHUSE LT. Comments incorporated and now out for public review. Comments due 6 September.



Objectives & Deliverables Timelines
Complete White Paper final draft Q2 2023