Project | ScopeScope |
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 Leads | Emails |
|---|---|
| Mary Nilsson (Eli Lilly) | |
| Greg Ball (Novavax) | gball@novavax.com |
| Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
| Objectives & Deliverables | |
| White Paper | |
| Journal Article | |
| Mac Gordon, Johnson & Johnson | |
| Peg Fletcher, MedAssessment | peg.fletcher@medassessment.com |
| Nicola Newton, PHUSE Project Assistant |
| ||||||
|---|---|---|---|---|---|---|
| New project for Q2 2022 | ||||||
| Project Members | Organisation | |||||
| Barbara Hendrickson | Abbvie | |||||
| Brian Panik | MedAssessment | Chinook Therapeutics | ||||
| Emily Goren | Seagen | |||||
| Hannah Palac | AbbVie | |||||
| Kimberly Umans | Biogen | |||||
| Mac Gordon | Johnson & Jhonson | |||||
| Mengchun Li | TB Alliance | |||||
Mika Tsujimoto | Eli Lilly | |||||
| Nhi Beasley | FDA | |||||
| Peg Fletcher | MedAssessment | |||||
| Ramaiah Muvvala | Inductive Quotient | |||||
| Rebeka Revis | IQVIA | |||||
| Scott Proestel | FDA | |||||
| Shayami Thanabalasundrum | Exelixis | |||||
| Ying (Heather) Hao | Prothena | Vaishali Popat | FDA||||
Q1 2024 | ||||||
|
| Objectives & Deliverables | Timelines |
|---|---|
| Complete White Paper final draft | Q2 2023 |