Meeting Credentials:

Agenda:

Advancing Telehealth Beyond COVID–19 Act of 2022 (3 minutes)

• 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 (5 minutes)

• CAP Update *(webinar) of LDTs and the VALID Act

• VALID Act support letter CAP, ASCO, FOCR, Pew, etc.

• Statnews article (Sen. Burr press release)

• AMP comments + advocacy (link LDT)

• AMP letter

PIcc Charter (2 minutes)

• We have received questions about how to join

• Free, available, charter can be signed

• 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 (15 minutes)

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

• Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry

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

  • Conducting Remote Regulatory 2 Assessments 3 Questions and Answers 4 Draft Guidance for Industry (link)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 recources 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

      • 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.”

      • Thank you very much

Workgroup update (5 minutes)

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

News & Updates (3 minutes)

• 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 (5 minutes)

• 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 used 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 (2 minutes)

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

• 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

  • Friends 2 session on the topic

  • review of draft guidance is up

  • received first comments

  • draft is being prepared and will be circulated for comments

N=11 Featured papers (10 minutes)

• 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

• Antonelli et al. The Medical Segmentation Decathlon

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

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

• 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

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

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

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

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

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

• Other resources:

  • Book: A Practical Guide for Health Researchers

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

  • Tissue-Based Pathology Companion Diagnostic Development for Regulated Applications

  • A standard for standards – principles of standardization