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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.



Project LeadsEmails
Mary Nilsson (Eli Lilly)

nilsson_mary_e@lilly.com

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

rgordon2@its.jnj.com

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

nicky@phuse.global


Status
colourBlue
titleCurrent Status

Q2/3 2022Project approved Q2 2022.

Q1 2024

  • Draft white paper is out for final project team review. Once incorporating these comments, it will then be sent for public review in early June. 



Objectives & Deliverables Timelines
Complete White Paper final draft Q2 2023
Project Members Organisation Barbara HendricksonAbbvie Brian Panik MedAssessment Charles BeasleyIndependent Clio WuChinook TherapeuticsEmily GorenSeagen Jyoti Agarwal GileadHannah Palac AbbVie Karen WadeRhoworldKetan DurveJanssen Research & DevelopmentKimberly UmansBiogenMac Gordon Johnson & Jhonson Mengchun LiTB Alliance 

Mika Tsujimoto

Eli Lilly Nhi Beasley FDAPeg Fletcher MedAssessment Pranav Soanker Pfizer Ramaiah MuvvalaInductive QuotientRebeka Revis IQVIAScott ProestelFDAShayami Thanabalasundrum ExelixisSunil Kumar ShantharajuBoehringerSuwen LiRocheWilliam Palo AbbvieYing (Heather) HaoProthena Vaishali PopatFDA