| Reimagining a Safety Submission – Vision of Interactive Safety Reviews |
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During this Community Forum, you’ll hear about various efforts related to interactive safety reviews. The presentation will be followed by a discussion on the end goal, potential impact on submissions, and different models for creating and sharing interactive safety review tools. This Community Forum event will take place over Zoom on 27 March 2023, 14:00–16:00(GMT)/09:00–11:00 (EST). Register here! |
TENATIVE AGENDA:
| Topic | Presenter(s) |
|---|---|
| Welcome | Greg Ball & Mary Nilsson, Safety Analytics Working Group Leads |
| Interactive Safety Review – Some Thoughts on the Vision | Mary Nilsson & Wei Wang Eli Lilly |
| PHUSE Interactive Data Visualisations for Submissions project team | Zak Skrivanek, Eli Lilly & Xiangyun Wang, Genentech & Raj Kiran, Takeda |
| PHUSE Interactive Forest/Volcano Plot | Melvin Munsaka, Abbvie & Neetu Sangari, Pfizer |
| DIA-ASA Interdisciplinary Safety Evaluation (DAISE) Working Group: Interactive Safety Graphics project team | Jeremy Wildfire, Gilead |
| Accumulus Synergy | Khushboo Sharma & Bill Gibson, Accumulus |
| Discussion | |
| Presenter | Bio |
|---|---|
| Greg Ball, ASAPprocess Greg Ball served in the Navy and taught High School maths and physics before earning his master’s in statistics from Purdue and his PhD in Biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). With Mary Nilsson, Greg co-leads the PHUSE Safety Analytics Working Group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement. |
| Mary Nilsson, Eli Lilly Mary Nilsson is Executive Director-Statistics, Safety Analytics at Eli Lilly. Mary received her master’s degree in statistics from Iowa State University in 1989 and has been employed at Eli Lilly since then. She is currently a researcher in the Safety Analytics group. Mary consults with molecule teams on safety analysis planning for Phase II to III studies and integrated submission documents. Her primary interests include analyses of adverse event data, analyses of laboratory data, statistical analysis plans, and collection and analysis of suicide-related events. Additionally, she co-leads the PHUSE Safety Analytics Working Group, creating cross-functional education and cross-industry recommendations for standard safety analyses and displays. |
Wei Wang, Eli Lilly | |
Zak Skrivanek, Eli Lilly | |
Sharon Wang, Gene | |
Raj Kiran, Takeda | |
Melvin Munsaka, Abbvie | |
Neetu Sangari, Pfizer | |
Jeremy Wildfire, Gilead | |
| Khushboo Sharma, Accumulus |
| Bill Gibson, Accumulus |
