Biomarkers and Precision Medicine Community (BPMC)

OSD Speaker Consent for:

Please join for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) Community and Gene and Cell Therapeutic Products (GCTPs) Community on March 24^th, 12 – 1 pm EST on the following topic:

The New FDA Guidance on Bioanalytical Method Validation for Biomarkers 2025

• How do the BMV 2018 and the BMVB 2015 compare?
• PK vs Biomarker assay validation: common parameters and different approaches
• Biomarker assay Context of Use and Fit-for-Purpose assay validation
• Perspective from EBF and AAPS BPMC leaders

Discussion Leaders:

• Lakshmi Amaravadi (AstraZeneca)
• Kyra Cowan (Merck Healthcare KGaA), EBF
• Lindsay King (Pfizer)
• Steve Piccoli (SPARC)
• Karen Quadrini (Prothena Biosciences)
• Lauren Stevenson (Immunologix)

Organized by:  Yan Ni (Passage Bio), 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: Monday, March 24, 2025 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

New to GoToMeeting? Get the app now and be ready when your first meeting starts:
https://global.gotomeeting.com/install/305789893

Please feel free to share with colleagues who may be interested in this topic.

Thanks,

On Behalf of The AAPS BPM and GCTPs Community Leadership Teams