1/25/2023 Updates Meeting

Steering Committee Series


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

We look forward to hearing from you.

Download the slides from the meeting here



FDA

  • CDRH Liason, Brandon Gallas, presented PIcc at Collaborative Communities SLT Update on 1/19/23

  • Guidance:

    • Format and Content of a REMS Document: Guidance for Industry (download PDF)

    • REMS Document Technical Conformance Guide Technical Specifications Document (document PDF)

    • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (download PDF)

    • Clinical Decision Support Software (download PDF)

    • DRAFT: ICH Harmonised Guideline - Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Template (download PDF)Novel Drug Approvals for 2022 (link)

  • Advancing Health Through Innovation: New Drug Therapy Approvals 2022 (download PDF)

  • Health Canada and FDA eSTAR Pilot (link)

  • Statnews Article: Four types of bias in medical AI are running under the FDA’s radar (link)

  • 2023 OSEL Summer Research Program (link)

    • Applications will be accepting on a rolling basis through March 2023

    • The OSEL Summer Research Program Project Catalog Summer 2023 (download PDF)

  • CDER: What’s New in Regulatory Science is a quarterly newsletter (download PDF)

  • Congressional Research Service: FDA Regulation of Medical Devices (download PDF)

  • TriNetra Glio has been awarded Breakthrough Designation by the US FDA making it the world's first non-invasive liquid biopsy platform to be granted this designation for use in Glial tumors (download PDF)

Legislative Updates

  • Article: Exclusive: FDA Leader on Impact of New Medical Device Law (link)

  • Preparing U.S. Clinical Trials Infrastructure for Emergencies: A White House Virtual Roundtable Discussion (link)

  • Code of Federal Regulations: 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions (link)

  • Consolidated Appropriations Act 2023 (download PDF)

    • Section-by-section summary: Restoring Hope for Mental Health and Well-Being (download PDF)

VALID Related

  • FOCR: Precision Oncology News – Absent Resolution on FDA’s LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements (link)

  • Article: AACC Statement on Excluding VALID from End of Year Legislative Package (link)

MDIC

  • Video: MDIC Live with Maryellen de Mars (link)

  • Events:

    • Early Feasibility Studies Best Practices Workshop- February 1, 2023, Boston

    • Cybersecurity Threat-modeling Virtual Bootcamps: 3/13-3/17, 2023

  • Publications:

    • White Paper on Using Patient Preference Information for Coverage Decision Making

    • 5G Security Enhancement One Pager

  • Call for Volunteers! MDIC Digital Health Software Vertical

WHO

  • Launch of website for the Mapping the Evidence for the WHO Classification of Tumours: a Living Evidence Gap Map by Tumour Type (WCT EVI MAP) project (link)

  • IARC to support the launch of the flagship EU Mobile App for Cancer Prevention (link)

  • Gender and health (link)

Resources

  • Article: Regulatory specialist, generalist, or generalized specialist: Weighing the options (link)

  • Andrew Tutt, “An FDA for Algorithms” (download PDF)

  • Deep Reinforcement Learning - Lecture notes from Ben-Gurion University of the Negev (download PDF)

  • Saudi Food & Drug Administration: Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices (download PDF)

  • Advisory Board: 16 Things CEOs Need to Know in 2023 (download PDF)

  • Machine Learning: Definition, Learning Methods: Supervised Learning, Unsupervised Learning, Semi-Supervised Learning, Reinforcement Learning. (download PDF)

  • Nature Medicine: 11 clinical trials that will shape medicine in 2023 (download PDF)

  • How to (actually) use ChatGPT: A simple guide to unlocking infinite potential (download PDF)

  • Canva + ChatGPT Hack: Create 10 slides in less than 5 min (download PDF)

  • The IJMEDI checklist for assessment of medical AI (download PDF)

  • Office of the National Coordinator for Health Information Technology: (USCDI) United States Core Data for Interoperability - Draft version 4 (download PDF)

  • STAR Journal of Biomarkers (download PDF)

    • STAR Journals A Journey to Publish (link)

  • IBM Trustworthy AI (link)

  • IBM Research AI FactSheets 360 (link)

  • Mapped: The Most Innovative Countries in the World 2022 (link)

  • CAPMINDS: FHIR Vs EDI In Healthcare: Which One Is Right For You? (link)

  • Introduction to Modern Statistics (link)

  • NCI GWAS Explorer (link)

  • Margaretta Colangelo: How The Evolution Of AI In Healthcare Aligns With Thomas Kuhn's Structure (link)

Upcoming Events

  • February 7 - NHS Pathology Conference North 2023 | Manchester, UK (link)

  • March 11-16 - USCAP Annual Meeting: Facing the Unknown | New Orleans, LA, UA (link)

  • June 14-17 - 19th European Congress on Digital Pathology (ECDP 2023) | Catania, Italy (link)


Papers

  • Romanchikova et al. The need for measurement science in digital pathology (link)

  • López-Otín et al. Hallmarks of aging: An expanding universe (link) (download PDF)

  • Wendell A. Lim. The emerging era of cell engineering: Harnessing the modularity of cells to program complex biological function (link) (download PDF)

  • Yang et al. Loss of epigenetic information as a cause of mammalian aging (download PDF)

  • Etienne-Grimaldi. Current diagnostic and clinical issues of screening for dihydropyrimidine dehydrogenase deficiency (download PDF)

  • Clinton et al. Genomic heterogeneity as a barrier to precision oncology in urothelial cancer (download PDF)

  • Gichoya et al. AI recognition of patient race in medical imaging: a modelling study (download PDF)

  • Riciti et al. Clinical Validation of Artificial Intelligence–Augmented Pathology Diagnosis Demonstrates Significant Gains in Diagnostic Accuracy in Prostate Cancer Detection (download PDF)

  • Hind et al. Experiences with Improving the Transparency of AI Models and Services (download PDF)

  • Kung et al. Performance of ChatGPT on USMLE: Potential for AI-Assisted Medical 2 Education Using Large Language Models (download PDF)

  • Sidiropoulos et al. Integrated T cell cytometry metrics for immune-monitoring applications in immunotherapy clinical trials (download PDF)

  • Horgan et al. The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality (download PDF)

  • Reddi et al. Nondestructive 3D Pathology Image Atlas of Barrett Esophagus With Open-Top Light-Sheet Microscopy (download PDF)

  • Gao et al. Application of Machine Learning in Intelligent Medical Image Diagnosis and Construction of Intelligent Service Process (download PDF)

  • Perez et al. Ex vivo 3D scanning and specimen mapping in anatomic pathology (download PDF)

  • Otaki et al. Investigating the evolution of undergraduate medical students’ perception and performance in relation to an innovative curriculum-based research module: A convergent mixed methods study launching the 8A-Model (download PDF)

  • Wu et al. All HER2-negative breast cancer patients need gBRCA testing: cost-effectiveness and clinical benefits (download PDF)

  • de Baca et al. Ordo ab Chao Framework for an Integrated Disease Report (download PDF)

  • Bartoletti et al. Number Needed to Treat in Trials of Targeted Therapies for Advanced Ovarian Cancer (download PDF)

  • Wang et al. Optical ptychography for biomedical imaging: recent progress and future directions [Invited] (download PDF)

  • Siegel et al. Cancer statistics, 2023 (download PDF)

  • Castaneda et al. Mechanisms of cancer metastasis (download PDF)

  • Mario Plebani. Quality Indicators to Detect Pre-Analytical Errors in Laboratory Testing (download PDF)

  • Ioannidis, Klavans, & Kevin W. Boyack. The scientists who publish a paper every five days (download PDF)

  • Mark D. Stewart & Valsamo Anagnostou. Liquid biopsies coming of age: biology, emerging technologies, and clinical translation- An introduction to the JITC expert opinion special review series on liquid biopsies (download PDF)

  • Marston et al. A polygenic risk score predicts atrial fibrillation in cardiovascular disease (download PDF)

  • Agrawal et al. Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021 (download PDF)

  • Kadri Altundag. Triple-Negative Receptor Conversion at Metastatic Sites Might Show Better Efficacy in Patients Who Received Sacituzumab Govitecan (download PDF)

  • Cima et al. Decline of case reports in pathology and their renewal in the digital age: an analysis of publication trends over four decades (download PDF)

  • Light et al. Germline TP53 mutations undergo copy number gain years prior to tumor diagnosis (download PDF)

  • McGenity et al. Survey of liver pathologists to assess attitudes towards digital pathology and artificial intelligence (download PDF)

  • Brazel et al. Genomic Alterations and Tumor Mutation Burden in Merkel Cell Carcinoma (download PDF)

  • Shah, Rooke-Ley, & Brown. Corporate Investors in Primary Care — Profits, Progress, and Pitfalls (download PDF)

  • Bates et al. The Safety of Inpatient Health Care (download PDF)

  • Park, Leahy, & Funk. Papers and patents are becoming less disruptive over time (download PDF)

  • Parwani et al. An update on computational pathology tools for genitourinary pathology practice: A review paper from the Genitourinary Pathology Society (GUPS) (download PDF)

  • Valstar et al. The tubarial salivary glands: A potential new organ at risk for radiotherapy (download PDF)

  • Heidari et al. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use (download PDF)

  • Osinski et al. Artificial intelligence-augmented histopathologic review using image analysis to optimize DNA yield from formalin-fixed paraffin-embedded slides (download PDF)

  • Gerasimavicius, Livesey, & Marsh. Loss-of-function, gain-of-function and dominant- negative mutations have profoundly different effects on protein structure (download PDF)

  • Davis et al. Long COVID: major findings, mechanisms and recommendations (download PDF)

  • Mattick et al. Long non-coding RNAs: definitions, functions, challenges and recommendations (download PDF)

  • Ruijter et al. Whole-body CD8+ T cell visualization before and during cancer immunotherapy: a phase 1/2 trial (download PDF)

  • Kotani et al. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer (download PDF)

  • Summary of Zhang et al. Machine learning identifies long COVID patterns from electronic health records (download PDF)

  • Vivek Subbiah. The next generation of evidence-based medicine (download PDF)

  • Soenksen et al. Integrated multimodal artificial intelligence framework for healthcare applications (download PDF)

  • Classen, Longhurst, & Thomas. Bending the patient safety curve: how much can AI help? (download PDF)

  • Greenberg et al. Automatic ganglion cell detection for improving the efciency and accuracy of hirschprung disease diagnosis (download PDF)

  • Stein et al. SARS-CoV-2 infection and persistence in the human body and brain at autopsy (link)

  • Stockley et al. A Canadian Ring Study to Optimize Detection of NTRK Gene Fusions by Next-Generation RNA Sequencing (download PDF)

  • Vikas et al. Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy: ASCO Endorsement of College of American Pathologists Guideline (download PDF)

  • Villani et al. The clinical utility of integrative genomics in childhood cancer extends beyond targetable mutations (download PDF)

  • Wu et al. Graph deep learning for the characterization of tumour microenvironments from spatial protein profiles in tissue specimens (download PDF)

  • Lin et al. Multiplexed 3D atlas of state transitions and immune interaction in colorectal cancer (download PDF) (link)

  • Mayer et al. A tissue atlas of ulcerative colitis revealing evidence of sex-dependent differences in disease-driving inflammatory cell types and resistance to TNF inhibitor therapy (download PDF)

  • Vink et al. All is nice and well unless she outshines him: Higher social status benefits women’s well-being and relationship quality but not if they surpass their male partner (download PDF)

  • Dorgham Khatib & Genela Morris. Dual role for dopamine in shaping spontaneity (download PDF)

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2/22/2023 Updates Meeting

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12/21/22 Steering Committee Meeting