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 on the following topic:
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 key considerations in this process? What resources are available and consortiums active in this process?
- A case study of 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)
Organized by: Yan Ni (Passage Bio) and Karen Quadrini (Passage Bio)
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: 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
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.
Thank you,
The Leadership Teams of the AAPS BPM and GCTPs Communities
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Karen Quadrini, PhD
Associate Director, Biomarkers and Precision Medicine
Passage Bio
Philadelphia, 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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