Project Scope

This Project team will create a White Paper with recommendations for Treatment Emergent Definitions, with a focus on Phase 2-4 clinical trials. This White Paper will build upon a White Paper that outlines results from a survey on current practices, indicating variation that can likely be reduced. Recommendations will be based on the desired end-in-mind, and may or may not be consistent with current practices.

Project LeadsEmails

Mary Nilsson (Eli Lilly)

William Palo (Abbvie)

Katie Warren (PHUSE Project Assistant)

Objectives & Deliverables 


Finalise the summaries from the survey results

Q2 2022
Draft White PaperQ3/4 2022


Draft white paper by Q3/early Q4. Writing is underway, with work expected to continue into Q1 2023. 

Project MembersOrganisation
Alan ShapiroFDA
Beilei XuSanofi
Carolyn SetzeAbbVie
Cathy BezekAstellas
Charles BeasleyMNS
Elisa YoungSouthern Star Research
James GaiserPrometrika
Joanne ZhouGSK
Jon HaddadGSK
Jun LiSanofi
Kim MusgraveAmgen
Project MembersOrganisation

Kirthi Rangaraju

Laura GoebelJanssen Research & Development
Melvin MunsakaAbbVie
Meredith ChuckFDA
Monali Desai Alkermes 
Nancy BruckenCSG
Pranab MitraIndustry
Raj PhadtareCorvus Pharma
Ramaiah MuvvalaInductive Quotient Analytics
Robert (Mac) GordonJanssen Research & Development
Russell NewhouseEli Lilly
Shraddha GanooICON plc
Simin K BayganiEli Lilly
Tejas PatelBooz Allen Hamilton
Tiffany Davis Gillead
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