Please join for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM), Therapeutic Protein Immunogenicity (TPI) and Bioanalytical (BA) Communities on October 30th, 12 – 1 pm EST on the following topic:
Preclinical Immunogenicity Support and S6 Guidance Interpretation
- Immunogenicity Assessment in Preclinical Species to Support IND? How critical is the ADA data to support global submissions?
- Should an Immunogenicity assay be ready to support? Can such assay be qualified rather than validated?
- Can toxicology study reports be submitted without ADA data if the findings can be interpreted with changes in PK/PD?
- What is the practice among different sponsors? Some scenarios may include no ADA performed and rely on impact on PK/PD changes or planned but trigger-based to explain safety findings vs generate all ADA data?
- Decision tree to define when and under what circumstances ADA assays are developed and validated.
- Risk mitigation strategies that have been used by some sponsors
Moderator:
· Vibha Jawa
Panelists:
· Ellen-Marie Koehler-Stec [email protected]
· Lauren Stevenson [email protected]
· David G Waters [email protected]
· Laurent Malherbe [email protected]
· Luo, Lina [email protected]
· Starcevic Manning, Marta [email protected])
· Michael Partridge [email protected]
· Gerry Kolaitis [email protected]
· Jacob Lesniak [email protected]
· Jeannine Bussiere [email protected]
· Tong-yuan Yang [email protected]
Organized by: Vibha Jawa (BMS), Karen Quadrini (Prothena Biosciences), Carmen Fernández-Metzler (PharmaCadence)
We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.
(Please remain on mute unless asking questions)
When: Wednesday, Oct. 30, 2024 12pm – 1pm EST
Where: Please join from your computer, tablet or smartphone.
https://global.gotomeeting.com/join/305789893
You can also dial in using your phone.
United States: +1 (872) 240-3412
Access Code: 305-789-893
Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 305 789 893
Or dial directly: [email protected] or 67.217.95.2##305789893
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Please feel free to share with colleagues who may be interested in this topic.
Thanks,
On Behalf of The AAPS BPM, TPI and BA Community Leadership Tea
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Carmen Fernandez-Metzler Ph.D.
President
PharmaCadence Analytical Services, LLC
Hatfield 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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