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 (Janssen Research & Development), Johnson & Johnson | |
| Peg Fletcher (, MedAssessment) | peg.fletcher@medassessment.com |
| Nicola Newton (, PHUSE , Project Assistant) |
| Ying (Heather) Hao | Prothena
| ||||||
|---|---|---|---|---|---|---|---|
| Continuing work on a White Paper | |||||||
| Project Members | Organisation | ||||||
| Ashik Chowdhury | Cytel | ||||||
| Barbara Hendrickson | AbbVie | ||||||
| Brian Panik | MedAssessment | ||||||
| Charles Beasley | Independent | ||||||
| Clio Wu | Chinook Therapeutics | ||||||
| Daniel Wong | Genentech | ||||||
| Emily Goren | Seagen | ||||||
| Gayathri Mahadevan | Astrazeneca | ||||||
| Greg Ball | ASAPprocess | ||||||
| Jacob Rotmensch | Genentech | ||||||
| Jonathan Haddad | GSK | ||||||
| Jyoti Agarwal | Gilead | ||||||
| Hannah Palac | AbbVie | ||||||
| Harini Kunduru | Daiichi Sankyo | ||||||
| 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 | Genentech | ||||||
| Scott Proestel | FDA | ||||||
| Shayami Thanabalasundrum | Exelixis | ||||||
| Sunil Kumar Shantharaju | Boehringer | ||||||
| Suwen Li | Roche | ||||||
| Vaishali Popat | FDA | ||||||
Q3 2024 | |||||||
|
| Objectives & Deliverables | Timelines |
|---|---|
| Complete White Paper final draft | Q2 2023 |