Biomarkers and Precision Medicine Community

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Leadership

Chair: Karen Quadrini  | Vice Chair: Stephanie Cape | Past Chair: Mohamed Hassanein | Secretary: TBD | Learning Opportunities Managers: Lakshmi Amaravadi, Carmen Fernandez-Metzler, Joel Mathews, Yan Ni, Alok Pandey, Iris Qiu, Karen Quadrini, Honglue (Holly) Shen, Jianing Zeng, Lindsay King, Jing Shi | Member Engagement Manager: Sasha Fraser, Amanda Hays, Jennifer Vance, Jad Zoghbi | Scientific Advisory Committee Regulatory Response Subcommittee Members: Robert (RJ) Neely, Joe Thomas

2025 Biomarkers and Precision Medicine Community Goals (PDF)

Latest Discussion Posts

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Announcements

  • Open Scientific Discussion (OSD) on Featured 2025 PharmSci 360 Biomarker Posters

    Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) Community on January 15th, 2026, 12 pm – 1 pm ET on the following topic:

     
    Featured 2025 PharmSci 360 Biomarker Posters:  A Collection for Community Discussion

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

    • Comparison of Exosome Isolation Methods for the Analysis of a Disease Biomarker in Serum and Urine by PCR Methodologies
    • Comparison of Novel Whole Blood Preservation Methods as Alternative to Cryopreserved PBMC for Immunophenotyping in Multicenter Clinical Trials


    Presenters:

    • Jean Paul Ouedraogo (Charles River Laboratories)
    • Thomas (TJ) Beadnell (Eurofins)

     
    Organizers:  Carmen Fernández-Metzler (PharmaCadence) and Karen Quadrini (Prothena Biosciences)

     
    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
    : Thursday, Jan 15, 2026, 12 pm – 1 pm EST

    WherePlease join from your computer, tablet or smartphone.

    Microsoft Teams Need help?

    Join the meeting now

    Meeting ID: 244 985 260 423 28

    Passcode: Mk6GJ95g

     

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

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  • Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays?

    The AAPS Journal just shared this editorial from the AAPS Biomarker & Precision Medicine Community on the 2025 FDA BMVB Guidance with authors spanning 19 organizations.

    AAPS Communities unite members with a common interest in a specific topic in a web-based, always-available, virtual environment. Join us in giving a round of applause to these Community leaders. 👏 👏

    More
  • OSD on Multi-Parametric Biomarker Signatures

    Please join us for an Open Scientific Discussion (OSD) hosted by the Biomarkers and Precision Medicine (BPM) Community on July 9, from 1-2 PM ET on the following topic:

    Multi-Parametric Biomarker Signatures

    ·         How do we go from identifying a potential biomarker with omics tools to an assay that is used in clinical trials?

    ·         Examples of biomarker panel assay use:  Renal safety biomarkers, Alzheimer’s disease, pharmacodynamic signatures

    ·         Challenges in establishing and translating multi-parameter biomarker assays to the clinic

    Discussion Leaders:

    Tom Lanz (Pfizer)

    Tim West (C2N Diagnostics)

    Chris Whelan (formerly Johnson & Johnson)

    Organized by:  

    Joel Matthews (Ionis Pharmaceuticals)

    Jurre Kamphorst (AstraZeneca)

    Carmen Fernández-Metzler (PharmaCadence Analytical Services)

    Karen Quadrini (Prothena Biosciences)

     

    We start at 1:00 ET sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

    (Please remain on mute unless asking questions)

    When: Wednesday July 9, 2025, 1 pm – 2 pm ET

    WherePlease join from your computer, tablet or smartphone.

    Microsoft Teams
    Need help?

    Join the meeting now

    Meeting ID: 279 600 469 385 3

    Passcode: jg3oC6Uj

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

    The AAPS BPM Community Leadership Team

    More
  • OSD onCAR-T: Preclinical Assessment of Potential for Secondary Malignancies - Clinical

    📅 Date: Monday, June 16, 2025

    🕛 Time: 12:00 PM – 1:00 PM Eastern Time

    📍 Location: Virtual Seminar @ https://global.gotomeeting.com/join/271724949

    🧪 OSD Overview

    Join us for an engaging 1-hour discussion featuring:

    Dr. Gabriela Hernandez Hoyos (BMS) and Dr. Ilayaraja Muthuramu (J&J)
    Experts in genomic risk analysis and safety assessments of CAR T platforms

    They will explore:

            Genomic risks in lentiviral vs. gene-edited CAR T products

            Key molecular and functional assays used in risk assessment

            Preclinical safety challenges in autologous vs. allogeneic approaches

            Insights from published case studies and FDA-approved testing strategies

    🧠 Who Should Attend?

    Scientists, researchers, and professionals working in:
    - Gene and cell therapy
    - Regulatory science
    - Oncology R&D
    - Translational medicine

    🔗 Why Attend?

    - Hear from leaders in the field
    - Participate in an open discussion on safety assessment strategies
    - Gain insights into regulatory and translational approaches for CAR T therapies

    More

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