5/31/2023 Updates Meeting
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
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Draft Guidance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
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)
MPHLW Coalition Workforce Letter (download .pdf)
SALSA Support Letter (download .pdf)
SMPPA Support Letter (download .pdf)
Massachusetts - An Act relative to patient access to biomarker testing to provide appropriate therapy (download .pdf)
WHO
Matthew Cobb & Nathaniel Comfort. What Watson and Crick really took from Franklin
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
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)
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
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)