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 Leads | Emails |
|---|---|
Mary Nilsson (Eli Lilly) | |
William Palo (Abbvie) | |
| Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
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|---|---|---|---|---|---|---|
Survey has been completed but left open for FDA feedback/ participation. Have a draft completed for Q42022 |
| Objectives & Deliverables | Timelines |
|---|---|
Finalise the summaries from the survey results | Q22022 |
| Begin draft White Paper with recommended definition(s). | Q22022Q42021 |
| Project Members | Organisation |
|---|---|
| Alan Shapiro | FDA |
| Beilei Xu | Sanofi |
| Carolyn Setze | AbbVie |
| Cathy Bezek | Astellas |
| Charles Beasley | MNS |
| Elisa Young | Southern Star Research |
| James Gaiser | Prometrika |
| Joanne Zhou | GSK |
| Jon Haddad | GSK |
| Jun Li | Sanofi |
| Kim Musgrave | Amgen |
| Project Members | Organisation |
Kirthi Rangaraju | Pfizer |
| Laura Goebel | Janssen Research & Development |
| Melvin Munsaka | AbbVie |
| Meredith Chuck | FDA |
| Nancy Brucken | CSG |
| Pranab Mitra | Industry |
| Raj Phadtare | Corvus Pharma |
| Ramaiah Muvvala | Inductive Quotient Analytics |
| Robert (Mac) Gordon | Janssen Research & Development |
| Russell Newhouse | Eli Lilly |
| Simin K Baygani | Eli Lilly |
| Tejas Patel | Booz Allen Hamilton |