2/28/2024 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
FDA
Learn more here
Patients’ ideas, concerns, and expectations (ICE) in general practice: impact on prescribing (download .pdf)
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices | FDA (link)
Medical Devices; Laboratory Developed Tests (link)
Guidance Document- Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (link)
New Drug Therapy Approvals 2023 (link)
ACLA Comments on Proposed Rule, “Medical Devices; Laboratory Developed Tests” (link)
Framework for FDA’s Real World Evidence Program (link)
FDA’s Proposed Rule Regarding Laboratory Developed Tests (link)
Medical Devices; Quality System Regulation Amendments (link)
Webinar Transcript- Proposed Rule: Medical Devices; Laboratory Developed Tests (link)
MDIC
Join us at #ModSim2024
Click here to register
Join us at #MXR2024 (link)
Resources & Publications
Predicting patient outcomes after treatment with immune checkpoint blockade: A review of biomarkers derived from diverse data modalities (download .pdf)
H&E image analysis pipeline for quantifying morphological features (download .pdf)
SPOT/Dx Pilot Reanalysis and College of American Pathologists Proficiency Testing for KRAS and NRAS Demonstrate Excellent Laboratory Performance (download .pdf)
Whose Drugs Are These? (download .pdf)
Offer Taxpayers a Fairer Shake (download .pdf)
Offer Taxpayers a Fairer Shake (download .pdf)
Qureshi et al. Synergies and Challenges in the Preclinical and Clinical Implementation of Pathology Artificial Intelligence Applications (download .pdf)
Digital and Computational Pathology: What a Time to Be Alive! (download .pdf)
Moghadam et al. A Morphology Focused Diffusion Probabilistic Model for Synthesis of Histopathology Images (download .pdf)
Ateya et al. The value of structured data elements from electronic health records for identifying subjects for primary care clinical trials (download .pdf)
Larson et al. A comprehensive characterization of the cell-free transcriptome reveals tissue- and subtype-specific biomarkers for cancer detection (download .pdf)
Schöpf et al. Multi-omic and functional analysis for clas- sification and treatment of sarcomas with FUS-TFCP2 or EWSR1-TFCP2 fusions (download .pdf)
The World Health Organization Reporting System for Pancreaticobiliary Cytopathology (download .pdf)
van Leeuwen et al. Comparison of Commercial AI Software Performance for Radiograph Lung Nodule Detection and Bone Age Prediction (download .pdf)
Savage et al. Diagnostic reasoning prompts reveal the potential for large language model interpretability in medicine (download .pdf)
Lalani et al. US public investment in development of mRNA covid-19 vaccines: retrospective cohort study (download .pdf)
The National Clinical Trials Network: A Valuable and Undervalued Resource (download .pdf)
Horton et al. Diagnostic Outcomes of Concurrent DNA and RNA Sequencing in Individuals Undergoing Hereditary Cancer Testing (download .pdf)
Abel et al. Display Characteristics and Their Impact on Digital Pathology: A Current Review of Pathologists’ Future “Microscope” (download .pdf)
The future of the global clinical trial ecosystem: a vision from the first WHO Global Clinical Trials Forum (download .pdf)
Butterfield et al. Immunotherapy combination approaches: mechanisms, biomarkers and clinical observations (download .pdf)
Sen et al. Opportunities for basic, clinical, and bioethics research at the intersection of machine learning and genomics (download .pdf)
Petralia et al. Pan-cancer proteogenomics characterization of tumor immunity (download .pdf)
Pozzorini et al. GIInger predicts homologous recombination deficiency and patient response to PARPi treatment from shallow genomic profiles (download .pdf)
Subbiah et al. Clinical development and management of adverse events associated with FGFR inhibitors (download .pdf)
Subbiah et al. Clinical Development of BRAF plus MEK Inhibitor Combinations (download .pdf)
Nardo et al. Strategies for mitigating adverse events related to selective RET inhibitors in patients with RET-altered cancers (download .pdf)
Stoyan et al. Statistics did not prove that the Huanan Seafood Wholesale Market was the early epicentre of the COVID-19 pandemic (download .pdf)
Schukow et al. Remote Pathology Practice: The Time for Remote Diagnostic Pathology in This Digital Era is Now (download .pdf)
Angin et al. Coding undiagnosed rare disease patients in health information systems: recommendations from the RD-CODE project (download .pdf)
Friedlaende et al. Oncogenic alterations in advanced NSCLC: a molecular super-highway (download .pdf)
Hermes et al. The digital transformation of the healthcare industry: exploring the rise of emerging platform ecosystems and their influence on the role of patients (download .pdf)
Homilius et al. Perturbational phenotyping of human blood cells reveals genetically determined latent traits associated with subsets of common diseases (download .pdf)
Ulla et al. Challenges and barriers of using large language models (LLM) such as ChatGPT for diagnostic medicine with a focus on digital pathology – a recent scoping review (download .pdf)
Haqq et al. Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial (download .pdf)
Reid et al. Cancer-associated fibroblasts rewire the estrogen receptor response in luminal breast cancer, enabling estrogen independence (download .pdf)
Nadler et al. Magnitude of effect and sample size justification in trials supporting anti‐cancer drug approval by the US Food and Drug Administration (download .pdf)
Dy et al. AI improves accuracy, agreement and efficiency of pathologists for Ki67 assessments in breast cancer (download .pdf)
An intriguing vision for transatlantic collaborative health data use and artificial intelligence development (download .pdf)
Integrity matters in oncology: AORTIC takes a stand against research misconduct (download .pdf)
Sathiyapalan et al. Molecular Testing in Non–Small-Cell Lung Cancer: A Call to Action (download .pdf)
Oglevee et al. Losing Images in Digital Radiology: More than You Think (download .pdf)
de Souza et al. Multiplex protein imaging in tumour biology (download .pdf)
Shah et al. A Nationwide Network of Health AI Assurance Laboratories (download .pdf)
FDA Aligns U.S. Medical Device Quality System Regulation with International Standards (download .pdf)
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (download .pdf)
Future of Health: The Emerging Landscape of Augmented Intelligence in Health Care (download .pdf)
HSCC: Health Industry Cybersecurity – Strategic Plan (2024–2029) (download .pdf)
Health for All – transforming economies to deliver what matters (download .pdf)
Common Agreement for Nationwide Health Information Interoperability (download .pdf)
Current State of Diagnostic Safety: Implications for Research, Practice, and Policy (download .pdf)
Hiroshima Process International Code of Conduct for Organizations Developing Advanced AI Systems (download .pdf)
Hiroshima Process International Guiding Principles for Organizations Developing Advanced AI system (download .pdf)
Bruno, Linda- IQCP: Guideline and Helpful Tools for Implementation (download .pdf)
Developing an iQCp a Step-by-Step guiDe (download .pdf)
Trusted Exchange Framework and Common AgreementSM (TEFCASM) (download .pdf)
Shaban et al. MAPS: pathologist-level cell type annotation from tissue images through machine learning (download .pdf)