7/27/22 Steering Committee Meeting

 

Please find the slides from the meeting here.

 

Please find the topics, all resources and content, along with a video recording of the meeting below.

We look forward to hearing from you.


Watch the recording of the meeting above.

0:00-2:56 Intro

2:57-5:13 Telehealth

5:14-7:38 MDUFA/VALID

7:39-9:15 PIcc Charter

9:16-16:28 FDA Corner

16:29-24:06 New & Updates

24:07-32:12 Resources

32:13-36:57 Project updates

36:58-54:05 Featured papers

54:06-end Closing remarks


Meeting Summary

Advancing Telehealth Beyond COVID–19 Act of 2022

  • Removing geographic requirements

    • Clear indication and alleviates national concerns

    • Is expected to pass the house and will result in a 2-year extension

  • Devices + diagnostics is not mentioned (remains TBD)

MDUFA/VALID – FDA oversight of LDT’s

  • CAP provided an update via a webinar on of LDTs and the VALID Act

PIcc Charter

  • We have received questions about how to join

  • Free, available, charter can be signed à symbol on the landing page and participation

  • Non-profits 501(c)(3) can join

  • Proposal to start a non-profit organization as a facilitator

FDA Corner

  • Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions (download)

  • Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry (download)

    • FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health (link)

  • FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic (link)

    • Analysis of User Fee metrics

    • Catalog of Regulatory Science tools (link)

  • FDA Drug safety podcasts (link)

    • Example: Ukoniq (umbralisib; PIK3CA inhibitor) withdrawal (link)

  • Update CDRH’s Electronic Medical Reporting (eMDR) System Enhancements (link)

    • Example: Coding resources for medical device reports

      • Adverse Event Codes (link)

  • Proposed Rule on Revising the National Drug Code Format (link)

  • Two special events

    • Brandon Gallas PhD; PIcc Liason agreed to 2 seminars (link)

      • 8/5/2022; 12:00 EST: Title: “Evaluating Medical Imaging Devices and Image-Based Algorithms with the Clinician In The Loop”

      • TBD:  2-hour online workshop: “Assessing Agreement and Reader Reliability in Medical Imaging Analysis: A Redux of a session from the 2023 Joint Statistical Meeting.”

News & Updates

  • Truthing & Validation WG updates (Brandon Gallas PhD, FDA) (link) (download)

  • Legislative Update: Food Safety Administration Act of 2022 (link)

    • Baby formula supply shortage

    • Proposes to separate “food” oversight from the FDA

    • New enforcement entity would be a separate branch under HHS

    • Relevance: drug development relies on intra-agency experience

  • Fabrication in scores of Alzheimer’s articles, threatening a reigning theory of the disease (link)

    • Image-based assessment of data fabrication

    • Regulatory science relevance: e.g., drug development

  • AI advancements in Sepsis diagnostics

    • AI speeds sepsis detection to prevent hundreds of deaths (link) multiple papers

    • Evaluation of a Multivalent Transcriptomic Metric for Diagnosing Surgical Sepsis and Estimating Mortality Among Critically Ill Patients (link)

Resources

  • MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

    • Clarifies EU decision steps to qualify MDSW (=US term SAMD)

  • IMDRF Machine Learning-enabled Medical Devices: Key Terms and Definitions (link) including “Introduction to Online ML” (link)

  • DATAcc Toolkit for Inclusive Deployment, Digital Medicine Society (link)

  • Prodigy: Radically efficient machine teaching. An annotation tool powered by active learning (link)

    • Big problem in data science and ML/AI: data annotation

    • Radically new approach to optimize annotation (text and image)

    • Very user friendly; and disruptive

  • WHO Breast Cancer Initiative (link)

    • New tool for capturing the full Care-cycle of breast cancer patients

    • Pre-diagnostic and diagnostic pillar to a four tiered cycle

Project updates

  • FDA cleared comments for Decision summary session (presentation June 2022) are up (link)

  • HER2-low (NEJM paper + ASCO, now change in paradigm of breast cancer testing)

  • Abemaciclib/Ki-67 in breast cancer project

  • ctDNA out of the dark session (link)

    • Friends hosted two sessions on the topic

    • review of draft guidance is up

    • received first comments

 

Featured Papers

  • Ochoa et al., Human Genetic findings support 2/3rds of the 2021 FDA approved drugs (link)

  • Mackey et al. Establishing a blockchain-enable indigenous data sovereignty framework for genomic data (download)

  • Antonelli et al. The Medical Segmentation Decathlon (download)

  • Rojansky et al. Rapid Deployment of Whole Slide Imaging for Primary Diagnosis in Surgical Pathology at Stanford Medicine (download)

  • Kelly et al. Job Stress, Burnout, Work-Life Balance, Well-Being, and Job Satisfaction Among Pathology Residents and Fellows (download)

  • Ricciuti et al. Association of High Tumor Mutation Burden in Non-Small Cell Lung Cancers with Increased Immune Infiltration and Improved Clinical Outcomes of PD-L1 Blockade Across PD-L1 Expression Levels (download)

  • Hutchinson & Grimm. Integrating digital pathology and mathematical modeling to predict spatial biomarker dynamics in cancer immunotherapy (link) (download)

  • Shinohara et al. Substantial improvement of histopathological diagnosis by whole-slide image-based remote consultation (link) (download)

  • Hassell et al. Pathology education powered by virtual and digital transformation (download)

  • Hongkui Zeng What is a cell type and how to define it? (download)

  • Neumann et al. Genomic architecture of FGFR2 fusions in cholangiocarcinoma and its implication for molecular testing (download)

Additional resources

  • Book: A Practical Guide for Health Researchers (download)

  • American Association for Clinical Chemistry: Point-of-Care Testing: A “How-To” guide for the non-laboratorian (download)

  • Tissue-Based Pathology Companion Diagnostic Development for Regulated Applications (download)

  • A standard for standards – principles of standardization (download)

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8/31/22 Steering Committee Meeting

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6/29/22 Steering Committee Meeting