Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) and Gene and Cell Therapy Products (GCTPs) Communities and feel free to forward the invitation to others.
The Road to Biomarker Qualification: FDA Guidance, Path to Approval, Considerations, and a Case Study
- What is biomarker qualification and how does a biomarker get approved by the FDA for use in drug development?
- What are the key considerations in this process? What resources are available and consortiums active in this process?
- A case study of the successful submission of a safety biomarker qualification will be presented
Discussion Leaders:
Jiri Aubrecht (Passage Bio), @Abbas Bandukwala (FDA), Terina Martinez (Critical Path Institute), and Sudhir Sivakumaran (Critical Path Institute)
When: Tuesday, Nov 8, 2022, 12 pm – 1 pm ET
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
Organized by: @Yan Ni (Passage Bio) and @Karen Quadrini (Passage Bio)
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Allison Radwick Ph.D.
Pharmacology SME
LearningMate
New York NY
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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