Biomarkers and Precision Medicine Community

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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)

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  • OSD on Multi-Omics Part 3: Multi-omics integration in clinical decision making

    The Biomarkers and Precision Medicine (BPM) and Bioanalytical (BA) Communities are hosting a series of Open Scientific Discussions (OSDs) on Multi-omics in Drug Development.    Please join us for the third OSD in the series on July 18th, 12 - 1 pm ET:

    Part 3: Multi-omics Integration into Clinical Decision Making

    ·         What does the present regulatory environment look like for the application of multi-omics in clinical decision-making?

    ·         What challenges and considerations does multi-omics testing face, especially for adoption of MS-based proteomics, in clinical studies?

    ·         Case studies where multi-omics approaches have impacted clinical decision makings will be presented.

    Discussion Leaders:

    Robert Schuck (FDA) & Yuehan Feng (Biognosys)

    Organized by:  Jurre Kamphorst (Olaris), Iris Qiu (Novartis), Ayuko Ota-Selik (Regeneron) and Jianing Zeng (BMS)


    We start at 12:00 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: Tuesday, July 18, 2024, 12 pm – 1 pm ET

    WherePlease join from your computer, tablet or smartphone.

  • eChalkTalk: JUNE 12 - Cell Therapy: Leukopaks and PBMCs


    Cell therapy, a transformative branch of medical science, represents a paradigm shift in the treatment of diseases by harnessing the intrinsic power of cells to restore health and combat various ailments. Leukopaks and peripheral blood mononuclear cells (PBMCs), two indispensable components that propel the field forward. Leukopaks, are harvested through advanced apheresis techniques, epitomize the pinnacle of cellular enrichment, serving as reservoirs teeming with a diverse array of immune cells crucial for therapeutic interventions. These enriched collections of white blood cells, comprising lymphocytes, monocytes, and other vital cellular constituents, stand as veritable treasure troves for researchers and clinicians alike, offering unparalleled insights into the intricate mechanisms underlying immune responses and disease pathogenesis. PBMCs, a subset of leukocytes derived from peripheral blood, embody the versatility and adaptability inherent to cellular therapies, serving as versatile tools across a spectrum of applications. From the development of cutting-edge immunotherapies targeting cancer to the growing field of regenerative medicine aimed at tissue repair and organ transplantation, the applications of PBMCs offer promising novel avenues for disease intervention and personalized medicine. As the frontier of cell therapy continues to expand, propelled by groundbreaking discoveries and technological innovations, the profound impact of leukopaks and PBMCs in shaping the future of medicine illuminating the path towards a future where diseases once deemed incurable may be conquered, and where the promise of personalized, precision medicine becomes a tangible reality for patients worldwide.


    Learning Objectives:

    • Understand the process of acquiring leukopaks through apheresis procedures and explain their significance in cell therapy.
    • Understand the role of peripheral blood mononuclear cells (PBMCs) in research and clinical applications within the field of cell therapy, including their versatility and potential therapeutic uses.
    • Understand the impact of leukopaks and PBMCs on advancing innovations in cancer immunotherapy and regenerative medicine, and their potential for improving patient outcomes in various disease contexts.


  • 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.

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

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