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 Leads | Emails | ||
|---|---|---|---|
| Mac Gordon (, Johnson & Jhonson)Johnson | |||
| Peg Fletcher | (, MedAssessment | )peg.fletcher@medassessment.com | |
| Nicola Newton, PHUSE Project Assistant | )katie@phuse | Objectives & Deliverables | |
| White Paper | |||
| Journal Article |
| ||||||
|---|---|---|---|---|---|---|
| Decide on deliverables and timelines in Q1 2023 | ||||||
| Project Members | Organisation | |||||
| Ashik Chowdhury | Cytel | |||||
| Barbara Hendrickson | AbbVie | |||||
| Brian Panik | MedAssessment | |||||
| Charles Beasley | Independent | |||||
| Clio Wu | Chinook Therapeutics | |||||
| Daniel Wong | Gene | |||||
| Emily Goren | Seagen | |||||
| Greg Ball | ASAPprocess | |||||
| Jonathan Haddad | GSK | |||||
| Jyoti Agarwal | Gilead | |||||
| Hannah Palac | AbbVie | |||||
| Heather Robinson | Bioxcel Therapeutics | |||||
| Karen Wade | Rhoworld | |||||
| Ketan Durve | Janssen Research & Development | |||||
| Kimberly Umans | Biogen | |||||
| Mary Nilsson | Eli Lilly | |||||
| Mengchun Li | TB Alliance | |||||
Mika Tsujimoto | Eli Lilly | |||||
| Nhi Beasley | FDA | |||||
| Pranav Soanker | Pfizer | |||||
| Radhika M. Rao | AbbVie | |||||
| Ramaiah Muvvala | Inductive Quotient | |||||
| Rebeka Revis | IQVIA | |||||
| Renee Halsing | Gene | |||||
| Scott Proestel | FDA | |||||
| Shayami Thanabalasundrum | Exelixis | |||||
| Sunil Kumar Shantharaju | Boehringer | |||||
| Suwen Li | Roche | |||||
| Vaishali Popat | FDA | Ying (Heather) Hao | Prothena||||
Q1 2024 | ||||||
|
| Objectives & Deliverables | Timelines |
|---|---|
| Complete White Paper final draft | Q2 2023 |