11/30/22 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.


0:00-2:44 Introduction

2:45-16:55 FDA Overview

16:56-19:09 WHO/IARC Updates

19:10-25:52 Legislative Updates

25:53-29:12 MDIC Updates

29:13-30:56 Professional Societies

30:57-34:58 Project Updates

34:59-37:01 Ethics, Diversity & Inclusion

37:02-40:51 Patient Advocacy

40:52-58:23 Resources

58:24-59:00 Payor

59:01- Events & closing

Watch the recording of the meeting above.


Meeting Summary & Content Links

FDA Overview

  • Spotlight: Digital Health Regulatory Science Research Opportunities

    • mentions digital pathology and collaborative communities

    • Download PDF

  • Collaborative Community Townhall on November 10, 2022

    • presentation by PIcc

    • FDA internal town hall meeting

  • Modeling & Simulation approach (download PDF)

  • MDDT Program (link)

    • a few new designations across different subcategories

    • example: CHRIS color additives

  • Cybersecurity - November 15 update (link)

    • possibility for a draft guidance coming soon?

  • November 18 news: official statement by Pazdur for FDA to look into an extension of companion diagnostic program (link)

  • DHCoE Digital Health Center of Excellence (link to overview)

    • Guidance Document - Clinical Decision Support Software (link)

      • link to information webinar on guidance document

    • Catalog of regulatory science tools (link)

      • Search interface

      • example: eeDAP system (link to github)

    • Digital Health Policy Navigator (link)

  • HTT Project Updates

    • trying to get pivotal study off the ground, aiming for beginning of new year

    • goal of project: provide methodology and dataset to validate AI algorithms

    • installing the WSI viewer caMicroscope on precision FDA for data collection

    • December 5-7, 2022 FDA Digital Transformation Symposium (link)

  • Real World Evidence Program (download)

    • illustration and outline in NEJM (download)

WHO/IARC Updates

  • Understanding the use of evidence in the WHO Classification of Tumours: a protocol for an evidence gap map of the classification of tumours of the lung (link)

  • Medicine should be considered a human right - WHO Model lists of essential medicines

    • working on extension of list to include essential diagnostics (link)

  • IARC Perspective on Oral Cancer Prevention (link)

Legislative Updates

  • Summary by Health IT Security - White House sets standards for healthcare cybersecurity (link)

  • VALID Act: the story continues…. (link)

    • might be attached to end of year spending bill

  • December 5 - Educational session for congress personalized medicine caucus (link)

  • Better lab tests can ensure precision medicine is truly precise (link)

    • recent annual report to the nation on the status of cancer (link)

  • What’s the difference between device and technology? (download guidance document)

  • Switzerland has decided to accept medical devices with FDA approval for the welfare of their own population (link)

  • Voluntary Alternative Pathway: Agile Regulation - system where you voluntarily submit performance updates/meaningful data creating an ongoing communication in terms of regulatory oversight (link)

MDIC Updates

  • New Approach to Clinical Trial Design Helps Medical Devices Better Meet Patient Needs and Priorities (link) (link)

  • Cybersecurity Threat-modeling Virtual Bootcamps: 12/12-12/16, 2022 and 3/13-3/17, 2023 (link)

  • Medical Device Cybersecurity Maturity: MDIC Industry Benchmarking Report 2022 has been released (link)

  • Coming Soon:

    • AI/ML in IVDs: Framework for a Predetermined Change Control Plan (PCCP) for AI/ML-Enabled IVDs, including both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)

    • 5G-enabled Healthcare Technologies: MDIC Landscape Report (Coming December 2022)

    • Computational Modeling & Simulation (CM&S) in Medical Device & Diagnostics: Case Studies and Landscape Analysis (Coming December 2022)

  • Please contact Noor Falah nfalah@mdic.org or Jithesh Veetil jveetil@mdic.org with any questions about MDIC initiatives

Professional Societies

  • AMP proposal for moderinization of CLIA regulations (download)

  • new CAP council - Council on Informatics and Pathology Innovations (link)

  • CAP received contract with FDA (link to press release)

  • DPA is currently planning next meeting and materials from Path Visions are now availble

Project updates

  • ctDNA

    • Liquid Biopsy for Precision Onology Summit February 14-16 (link)

    • Ruhen et al. Molecular Characterization of Circulating Tumor DNA in Pediatric Rhabdomyosarcoma: A Feasibility Study (pubmed link)

  • AI Grand Challenges

    • initial results from TIGER challenge were released (link)

  • CPIM

    • Special Issue: Proceedings of the STP 41st Annual Symposium: Toxicologic Pathology of the Hematopoietic System (link)

Ethics, Diversity & Inclusion

  • Nikolaos M. Siafakas. Do we need a Hippocratic Oath for artificial intelligence scientists? (download)

  • Carruthers et al. Representational ethical model calibration (download)

  • Miller et al. the Development of Children’s Gender-Science Stereotypes: A meta-analysis of 5 Decades of U.S. Draw-a-Scientist Studies (download)

Patient Advocacy

  • November 17 - FOCR annual meeting

    • HRD Harmonization Project data presented (download)

  • APPIA general tissue handling guidelines (link)

  • bioRxiv - A personal, reference quality fully annotated genome from a Saudi individual (link)

Resources

  • ML Tools for Pathology Images (link)

    • high-five to Heather from PixelScientia.com

  • Free No-Code NLP Platform (link)

  • Regulatory Aspects on Digital Pathology - Joe Sirintrapun seeking co-authors, soliciting volunteers. Reach out if you’d like to join him.

    • Book Title: Digital Pathology: Implementation in Clinical Practice: AI applications within Digital Pathology Framework

      Co-Editors: Meera Hameed and Matthew Hanna

      Publisher: Elsevier

    • Modesitt et al. How to write like a pro and publish like a boss (download)

    • Ecarnot et al. Writing a scientific article: A step-by-step guide for beginners (download)

  • Report from Deloitte: The future of diagnostics Technology driven personalised and preventative healthcare in Europe (link) (download)

  • Marine, Dawson & Dawson. Non-genetic mechanisms of therapeutic resistance in cancer (download)

  • Lomakin et al. Spatial genomics maps the structure, nature and evolution of cancer clones (link)

  • Lennerz et al. A unifying force for the realization of medical AI (download)

  • Huang et al. The landscape of mRANCE nanomedicine (download)

  • Bidgoli et al. Bias reduction in representation of histopathology images using deep feature selection (download)

  • Brynolfsson et al. Haralick texture features from apparent diffusion coefficient (ADC) MRI images depend on imaging and pre-processing parameters (download)

  • Zhou et al. Multi-Site Cross-Organ Calibrate Deep Learning (link)

  • Yamaguchi et al. Trastuzumab Deruxtecan in Anti–Human Epidermal Growth Factor Receptor 2 Treatment– Naive Patients With Human Epidermal Growth Factor Receptor 2–Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial (download)

  • Wan et al. Prediction of early-stage melanoma recurrence using clinical and histopathologic features (download)

  • Carobene et al. Where is laboratory medicine headed in the next decade? (download)

  • Jansen et al. The vendor-agnostic EMPAIA platform for integrating AI applications into digital pathology infrastructures (download)

  • Austin. Opportunities and challenges in translational science (download)

  • Kammula et al. Characterization of oncology clinical trials using germline genetic data (download)

  • Ledford. Closing in on cancer’s deadliest mutations (download)

  • Jorensen & Westergaard. Predicitive biomarkers abd personalized pharmacotherapy (download)

  • Sadik et al. Impact of clinical practice gaps on the implementation of personalized medicine in advanced NSCLC (download)

  • Wahid et al. The coming decade in precision oncology: six riddles (link)

  • Lami et al. Overcoming the interobserver variability in lung adenocarcinoma subtyping (download)

  • Kline et al. Multimodal machine learning in precision health: a scoping review (download)

  • Lyubetskaya et al. Assessment of spatial transcriptomics for oncology discovery (download)

  • Golden et al. Emerging approached to redressing multi-level reproductive health disparities (download)

  • Damrauer et al. Collaborative study from the Bladder Cancer Advocacy Network for the genomic analysis of metastatic urothelial cancer (download)

  • Kather et al. Medical domain knowledge in domain-agnostic generative AI (download)

  • Jiang et al. A quantitative proteome map of the human body (download)

Payor Updates

  • Abramoff et al. A reimbursement framework for AI in healthcare (download)

  • Parikh & Helmchen. Paying for AI in medicine (download)

Upcoming events

  • Final meeting of the year will take place on Wednesday, 12/21 based on results from in-meeting poll

  • December 2 Coming Reimbursement Opportunities for Digital Pathology (link)

  • December 8 FDA Forecast: What’s Next for the FDA in 2023 (link)

  • December 5-7 FDA Digital Transformation Symposium (link)

  • December 7 Public Workshop - Appropriate Use of Consensus Standards (link)

  • December 7-8 FDA Clinical Investigator Training Course (link)

  • Next in-person PIcc meeting in planning stages - March 4-5 OR March 18-19

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10/26/22 Steering Committee Meeting