Biomarkers and Precision Medicine Community

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Leadership

Chair: Mohamed Hassanein | Vice Chair: Karen Quadrini | Past Chair: Amanda Hays | Secretary: Stephanie Cape | Learning Opportunities Managers: Lakshmi Amaravadi, Carmen Fernandez-Metzler, Joel Mathews, Yan Ni, Alok Pandey, Iris Qiu, Karen Quadrini, Honglue (Holly) Shen, Jianing Zeng | Member Engagement Manager: Stephanie Cape, Sasha Fraser, Amanda Hays

2023 Biomarkers and Precision Medicine Community Goals (PDF)

Community email address: aaps-biomarkersandprecisionmedicinecommunitybpmc@connectedcommunity.org


#Biomarkers
#Bioanalytical​​​​

Latest Discussion Posts

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Announcements

  • OSD on Featured 2023 PharmSci 360 Biomarker Posters: A Collection for Community Discussion

    Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) Community on the following topic:

     
    Featured 2023 PharmSci 360 Biomarker Posters:  A Collection for Community Discussion

    This OSD will showcase the following posters that caught our Biomarker Community's interest.

    ·         Use of Human Plasma as a Surrogate Matrix for Quantitation of Modified Protein Therapy across Multiple Tumor Tissues

    ·         Comprehensive LC-MS/MS Analysis of VSV-GP Lipidome


    Presenters:

    • Mackenzie Mellenbruch (ICON)
    • Yuecheng Xi (Boehringer-Ingelheim)

     
     Organizers:  Carmen Fernández-Metzler (PharmaCadence), Karen Quadrini (Prothena Biosciences) and Chunyan Tinder (Tasso, Inc.)

     
    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, Jan 30, 2024, 12 pm – 1 pm EST

    WherePlease 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.

    More
  • OSD on CDx for AAV Gene Therapy

    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

    WherePlease 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.

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  • OSD on Personalized Cancer Vaccines

    Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Personalized Medicine (PM) and Biomarkers and Precision Medicine (BPM) Communities on 17 October 2023, 12 pm – 1 pm EDT on the following topic:

    Precision Medicine in Oncology

    ·         How does AI/ML enable the development of on-demand, neoantigen-based cancer therapies?  Challenges with the advent of AI and personalized cancer medicine.

    ·         How does the path for approval vary between personalized cancer vaccines and traditional therapies?

    ·         Challenges in Translational Research – the translatability crisis

    ·         Suggestions to improve Translational Research

    Discussion Leaders:

    Guilhem Richard (EpiVax Therapeutics) and Attila Sayhan (Brown University)

    Organized by:  

    Vibha Jawa (BMS), Karen Quadrini (Passage Bio) and Carmen Fernández-Metzler (PharmaCadence)

    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: Tuesday, October 17, 2023, 12 pm – 1 pm EDT

    WherePlease 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.

     

    Thank you,

    The Leadership Teams of the AAPS BPM and PM Communities

    More

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