Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Product (GCTP), Biomarkers and Precision Medicine (BPM) and BioAnalytical (BA) Communities on Nov 2, 2023, 12 pm – 1 pm EDT on the following topic:
Development of Companion Diagnostics for AAV Gene Therapy
• Introduction to companion diagnostics (CDx) for AAV gene therapy
• Effect of pre-existing AAV immunity on gene therapy
• Biomarkers for patient enrollment into gene therapy trials and FDA guidance
• Pre-existing anti-AAV antibody assay formats
• Overview of CDx development process
• Regulatory strategies and landscape on gene therapy CDx development
• Regulatory strategies for Analytical and Clinical Validation
• FDA and EU regulatory landscape for Gene Therapy CDx
• Implementation of CDx for gene therapy
• The need for partnership
• Dx Partner engagement
• Challenges of CDx development for gene therapy
Discussion Leaders:
Yanmei Lu (Sangamo Therapeutics), George Bashirians (CompanionDx Consulting), Maham Ansari (Precision For Medicine) and Natasha Thorne (FDA CDRH)
Organized by:
Yanmei Lu (Sangamo Therapeutics), Yan Ni (Passage Bio), Karen Quadrini (Passage Bio), and Sanjeev Bhardwaj (Moderna)
We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.
(Please remain on mute unless asking questions)
When: Thursday, Nov 2, 2023, 12 pm – 1 pm EDT
Where: Please join from your computer, tablet or smartphone.
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