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Steering Committee Meeting

Agenda: Download .docx version here

Updates

  • CLIAC meeting (link) (download agenda)

    • API Public Comment April 2022 (download)

    • Tim Stenzel presented (among may topics: Collaborative Communities and PIcc)

    • Keith Kaplan presented “Digital Pathology: The Past, Present, and Future”

  • Decision summary PAIGE prostate (download)

    • PIcc and Paige regulatory team engaged in the planning process. Look out for time and announcement

  • Grand challenges discussion session took place on 4/25

    • Touched upon key elements from a regulatory submission (link)

  • AACR New Orleans – brief review

  • Reminder: CLIAC waiver project – if interested please e-mail (link)

  • Microsoft Teams channel established

    • Direct file exchange with FDA enabled (major accomplishment)

    • GANTT chart web-design CALL FOR HELP

      • Does anyone have web-dev skills to assist us?

Patient advocacy

  • FOCR 2021 annual report (download)

  • APPIA protocol development (next meeting pending; interest => email join)

  • Sepsis alliance (follow-up meeting)

EMA corner = “outside the box”

  • ICH guideline Q14: Intended for analytical procedure development (download)

    • ICH Harmonization for better Health EMA

FDA corner: “thinking beyond”

  • New guidance for certain products between “drug” and “device”

Papers

  • Nirmal et al., The spatial landscape of immunoediting in primary melanoma at single cell resolution (download)

  • Bhate et al., Tissue schematics map the specialization of immune tissue motifs and their appropriation by tumors (download)

    • Setty. Tissue Schematics: A framework to decipher tissue architecture and assembly (download)

  • Vasudevan et al., Digital biomarkers: Convergence of digital health technologies and biomarkers (download)

  • Moses and Pachter. Museum of spatial transcriptomics (download)

  • Nurk et al., Complete sequence of the human genome (3/31/2022) (link) (download)

Resources

  • HAL: Nicolas Rougier, Scientific Visualization (download)

  • Python ML (download)

  • Report 2022: Clinician of the Future (download)

  • Bruce Quinn 2022: Cancer Patient and Access to Molecular Diagnostics (download)

News and Events

  • May 9-12 API Summit Pittsburgh; PIcc events 5/10 and 5/11 at a TBD location

  • June 3-7 ASCO meeting Chicago; Question => joint (formal) event?

  • June 6 at 10-11 AM ET PathML: an open-source software toolkit for computational pathology research (link)

Meeting Credentials:

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April 25

AI Grand Challenges Project Meeting

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May 9

API Pathology Informatic Summit