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
download slides presented for PIcc (download PDF)
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)