Biomarkers and Precision Medicine Community (BPMC)

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.
https://meet.goto.com/505947717

You can also dial in using your phone.
United States: +1 (646) 749-3122
Access Code: 505-947-717

Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 505-947-717
Or dial directly: [email protected] or 67.217.95.2##505947717

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

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

Thank you,

The Leadership Teams of the AAPS GCTP, BPM and BA Communities

#OSD  #OpenScientificDiscussions  #genetherapy  #Immunogenicity  #Biomarkers  #Bioanalytical

This looks great, but I'm not sure I can attend! Any chance this OSD be recorded and then shared?

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.
https://meet.goto.com/505947717

You can also dial in using your phone.
United States: +1 (646) 749-3122
Access Code: 505-947-717

Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 505-947-717
Or dial directly: [email protected] or 67.217.95.2##505947717

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

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

Thank you,

The Leadership Teams of the AAPS GCTP, BPM and BA Communities

#OSD  #OpenScientificDiscussions  #genetherapy  #Immunogenicity  #Biomarkers  #Bioanalytical