Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Product (GCTP) Community on Tuesday October 15 from 12 pm – 1 pm EDT on the following topic:
From Parallel Paths to Intersection: Bioanalytical Sciences and CMC Analytical Development
- What are the roles and responsibilities of Bioanalytical Sciences in R&D vs. CMC Analytical Development?
- What strategies can be employed to create synergy between these two functions, particularly in advancing gene and cell therapy drug development?
- What are the key differences in approaches to assay development/qualification and relevant regulatory requirements between these two areas?
Discussion Leaders:
@Yanmei Lu, PhD (Sangamo Therapeutics)
@Savita Nair, PhD (Sangamo Therapeutics)
Mark Galbraith, PhD (Transposon Consulting)
Organized by:
@Allison Radwick (USP), Ami Patel (Boyds), @Yanmei Lu (Sangamo)
We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until the Q&A starts.
(Please remain on mute unless asking questions)
When: Tuesday, October 15, 2024, 12 pm – 1 pm EDT
Where: Please join from your computer, tablet or smartphone.
https://meet.goto.com/505947717
You can also dial in using your phone.
United States: +1 (646) 749-3122
Access Code: 505-947-717
Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 505-947-717
Or dial directly: [email protected] or 67.217.95.2##505947717
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Please feel free to share with colleagues who may be interested in this topic.
Thank you,
The Leadership Team of the AAPS GCTP Community
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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