5/31/2023 Updates Meeting

Written By PIcc Alliance

Steering Committee Series

Please find the slides from the meeting here.

Due to technical difficulties, we do not have a recording from the meeting.

Please feel free to reach out to digipathalliance@gmail.com with any questions regarding the content.

FDA

  • DHCoE

    • Cybersecurity update (link)

      • Video: Tips for Health Care Facilities (link)

    • The Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge (link)

  • CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative (link)

  • Oncology Center of Excellence: Project Optimus (link)

  • Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (download. pdf)

  • Draft Guidance

    • Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment (download .pdf)

  • News:

    • CDRH What’s New in Regulatory Science (download .pdf)

    • FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing (link)

    • FDA Takes Additional Steps to Advance Decentralized Clinical Trials (link)

    • FDA’s International Collaboration on Food Safety is a Top Priority (link)

  • 5/9/23 SAMSHA and CDER letter on buprenorphine (download .pdf)

  • FDA CBER OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases (download .pdf)

  • Medical Devices

    • Supply and Shortages of Medical Devices: Frequently Asked Questions (link)

    • List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (link)

  • Events:

    • June 5-9 Regulatory Education for Industry (REdI) Annual Conference 2023 (link)

Government

  • European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines (link)

  • European Parliament: AI Act: a step closer to the first rules on Artificial Intelligence (link)

  • The White House: Executive Order on Modernizing Regulatory Review (link)

  • Article: ChatGPT chief says artificial intelligence should be regulated by a US or global agency (link)

WHO

  • Watch the official inauguration of the new IARC building (link)

  • IARC opens data to researchers via new Scientific IT Platform (link)

DEI

  • Matthew Cobb & Nathaniel Comfort. What Watson and Crick really took from Franklin

    (download .pdf)






CMS

  • Clinical Laboratory Improvement Amendments of 1988 (CLIA) Post-Public Health Emergency (PHE) Guidance (download .pdf)

Digital Pathology

  • Report: Digital Pathology - World 2023 (link) from Signify Research

  • National Cancer Institute Imaging Data Commons (IDC) Collections (link)

  • Article: New CPT Codes Could Lead to Reimbursements for Digital Pathologists (link)

Advocacy

  • FOCR Real-World Evidence Portfolio (link)

  • Video: What is ctDNA? (link)

Resources

  • Article: Why Advances in Imaging Will Revolutionize the Way We Detect and Treat Disease (link)

  • Article: Fake scientific papers are alarmingly common (link)

  • Cochrane UK - Guide to writing abstracts for systematic reviews (download .pdf)

  • Public Health Strategy 2022 (download .pdf)

  • Article: Powering public health with genetics (link)

  • Façade of Evidence: How Medicare’s Coverage with Evidence Development Paradigm Rations Care and Exacerbates Inequity (download .pdf)

  • ISO 15189:2022 Medical laboratories — Requirements for quality and competence (link)

  • Podcast from NEJM: INTENTION TO TREAT - Is Medicine Ready for AI? (link)

  • AAMC: Physician Specialty Data Report (link)

  • MEthods for LOcalization of Different types of breast lesions (EUBREAST 4) (link)

  • KarenAI - “Your personal Karen that fights for you” (link) (example)

Don’t forget to register for PIcc23 Meet. Synergize. Impact: Unlocking the Potential of Digital Pathology and Artificial Intelligence (AI) through Regulatory Science! Learn more, including the agenda, speakers, location, and more here.

Publications

  • Akkari et al. Exploring current challenges in the technologist workforce of clinical genomics laboratories (download .pdf)

    #cytogenetics #education #technologists #genetics #workforce

Akkari et al.

DePeaux & Delgoffe

Fernandez-Martinez et al.

  • Kristin DePeaux & Greg M. Delgoffe. Metabolic barriers to cancer immunotherapy (download .pdf)

    #memory #metabolism #PD1 #tumor #hypoxia

  • Fernandez-Martinez et al. Prognostic and Predictive Value of Immune-Related Gene Expression Signatures vs Tumor-Infiltrating Lymphocytes in Early-Stage ERBB2/HER2-Positive Breast Cancer A Correlative Analysis of the CALGB 40601 and PAMELA Trials (download .pdf)

    #gene expression #cancer #tumor #EFS #TIL #lapatinib

  • Gold et al. Perspectives of Rare Disease Experts on Newborn Genome Sequencing (download .pdf)

    #rare disease #mucopolysaccharidosis #NBSeq #OTC

  • Huang et al. The oral microbiome in autoimmune diseases: friend or foe? (download .pdf)

    #autoimmune #P. gingivalis #pathogenesis #translocation #dysbiosis

  • George M. Ibrahim & Michael D. Taylor. How thought itself can drive tumour growth (download .pdf)

    #neurons #brain cancer #tumor #tumorigenesis

  • Jan Trøst Jørgensen. Companion and complementary diagnostics as tools of precision medicine (download .pdf)

  • Krishna et al. Glioblastoma remodelling of human neural circuits decreases survival (link)

  • Zehra et al. A suggested way forward for adoption of AI-Enabled digital pathology in low resource organizations in the developing world (download .pdf)

  • Berholz et al. A Mixed-Methods Study of Clinicians’ Attitudes Toward Pathology Explanation Clinics (download .pdf)

  • Chen et al. Computational pathology improves risk stratification of a multi-gene assay for early stage ER+ breast cancer (download .pdf)

  • Polleys et al. Structure-forming CAG/CTG repeats interfere with gap repair to cause repeat expansions and chromosome breaks (download .pdf)

  • Aggarwal et al. Assessment of Tumor Mutational Burden and Outcomes in Patients With Diverse Advanced Cancers Treated With Immunotherapy (download .pdf)

  • Bean et al. Hospital-wide natural language processing summarising the health data of 1 million patients (download .pdf)

  • Beauchamp et al. Integrative Diagnostics: The Time Is Now—A Report From the International Society for Strategic Studies in Radiology (download .pdf)

  • Berkhout et al. Supporting local institutions for inclusive green growth: Developing an Evidence Gap Map (download .pdf)

  • Helen Burstin & Karen Cosby. Measuring Performance of the Diagnostic Process (download .pdf)

  • Bychkov et al. Integrating cytology into routine digital pathology workflow: a 5‐year journey (download .pdf)

  • Foster et al. Clinical implications of tumor‐based next‐generation sequencing in high‐grade epithelial ovarian cancer (download .pdf)

  • Weeks et al. Prediction of Risk for Myeloid Malignancy in Clonal Hematopoiesis (download .pdf)

  • Gao et al. The landscape of tolerated genetic variation in humans and primates (download .pdf)

  • Harada et al. Rare molecular subtypes of lung cancer (download .pdf)

  • Hoffman et al. Comparison of a Target Trial Emulation Framework vs Cox Regression to Estimate the Association of Corticosteroids With COVID-19 Mortality (download .pdf)

  • Hollan et al. Artificial-intelligence-based molecular classification of diffuse gliomas using rapid, label-free optical imaging (download .pdf)

  • Van den Heerik et al. QPOLE: A Quick, Simple, and Cheap Alternative for POLE Sequencing in Endometrial Cancer by Multiplex Genotyping Quantitative Polymerase Chain Reaction (download .pdf)

  • CAP Today. In-house or send-out? Lab approaches to gene panels (download .pdf)

  • Irmakci et al. Tissue contamination challenges the credibility of machine learning models in real world digital pathology (download .pdf)

  • Miguel A. Hernan, Wei Wang, & David E. Leaf. Target Trial Emulation: A Framework for Causal Inference From Observational Data (download .pdf)

  • Shirley V. Wang, PhD, ScM; Sebastian Schneeweiss, MD, ScD; and the RCT-DUPLICATE Initiative. Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses Results of 32 Clinical Trials (download .pdf)

  • Thiyaphat Laohawetwanit, Raul S Gonzalez, Andrey Bychkov. Learning at a distance: results of an international survey on the adoption of virtual conferences and whole slide imaging by pathologists (download .pdf)

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