9/25/2024 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
Legislative Updates
Verifying Accurate Leading-edge IVCT Development Act of 2024 (download .pdf)
Association for Molecular Pathology Files Lawsuit Against FDA to Challenge Final Rule on Regulation for Laboratory Developed Testing Procedures (download .pdf)
FDA’S Laboratory Developed Test Proposed Rule (download .pdf)
FDA Updates
Predetermined Change Control Plans for Medical Devices: Draft Guidance (download .pdf)
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions: Draft Guidance (download .pdf)
FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA (download .pdf)
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings (download .pdf)
Europe and Beyond Updates
Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA (download .pdf)
Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities (download .pdf)
Predicting: The future of health? (download .pdf)
MDIC
Learn more about MDIC’s upcoming Annual Patient Summit!
Upcoming Events
Publications
Cancer organoids 2.0: modelling the complexity of the tumour immune microenvironment (download .pdf)
Bridging the divide: addressing discrepancies between clinical guidelines, policy guidelines, and biomarker utilization (download .pdf)
Nova-ST: Nano-patterned ultra-dense platform for spatial transcriptomics (download .pdf)
Evaluating multimodal AI in medical diagnostics (download .pdf)
When the somatic genome informs the germline: the example of TP53 (download .pdf)
Harmonizing Immune Cell Sequences for Computational Analysis with Large Language Models (download .pdf)
Credibility assessment of in silico clinical trials for medical devices (download .pdf)
Clinical benefit, reimbursement outcomes, and prices of FDA-approved cancer drugs reviewed through Project Orbis
in the USA, Canada, England, and Scotland: a retrospective, comparative analysis (download .pdf)
B cells and tertiary lymphoid structures promote immunotherapy response (download .pdf)
Immune-depleted tumor microenvironment is associated with poor outcomes and BTK inhibitor resistance in mantle cell lymphoma (download .pdf)
A global analysis of the value of precision medicine in oncology – The case of non-small cell lung cancer (download .pdf)
National policies to accelerate climate action in US healthcare (download .pdf)
Clinical outcomes and ctDNA correlates for CAPOX BETR: a phase II trial of capecitabine, oxaliplatin, bevacizumab, trastuzumab in previously untreated advanced HER2+ gastroesophageal adenocarcinoma (download .pdf)
Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges (download .pdf)
Outcome‐oriented clinicopathological reappraisal of sinonasal adenoid cystic carcinoma with broad morphological spectrum and high MYB::NFIB prevalence (download .pdf)
A Clinician’s Guide to Understanding Bias in Critical Clinical Prediction Models (download .pdf)
The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development (download .pdf)
Large language models could make natural language again the universal interface of healthcare (download .pdf)
Development of a residents’ needs assessment-based novel pathology residency boot camp designed on the graduated release of responsibility model (download .pdf)
Minimum number of lymph nodes to maximize survival in non-metastatic appendiceal adenocarcinoma (download .pdf)
Mapping the regulatory landscape for artificial intelligence in health within the European Union (download .pdf)
Stealing Part of a Production Language Model (download .pdf)
A Systematic Review of the Barriers to the Implementation of Artificial Intelligence in Healthcare (download .pdf)
STIE: Single-cell level deconvolution, convolution, and clustering in in situ capturing-based spatial transcriptomics (download .pdf)
Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression (download .pdf)
Smart FOX - Enabling Citizen-Based Donation of EHR-Standardised Data for Clinical Research in Austria (download .pdf)
Cancer Care Terminology in African Languages (download .pdf)
Cost-Effectiveness of Population-Based Multigene Testing for Breast and Ovarian Cancer Prevention (download .pdf)
Prospective Evaluation of Artificial Intelligence Triage of Intracranial Hemorrhage on Noncontrast Head CT Examinations (download .pdf)
Not all AI health tools with regulatory authorization are clinically validated (download .pdf)
Focusing the ecosystem lens on innovation studies (download .pdf)
German Medical Data Sciences 2024 (download .pdf)
Computational methods and biomarker discovery strategies for spatial proteomics: a review in immuno-oncology (download .pdf)
Pan-cancer single-cell dissection reveals phenotypically distinct B cell subtypes (download .pdf)
Next-generation precision medicine for suicidality prevention (download .pdf)
RAS-ON inhibition overcomes clinical resistance to KRAS G12C-OFF covalent blockade (download .pdf)
HER2-targeted therapies beyond breast cancer — an update(download .pdf)
Language Agents Achieve Superhuman Synthesis of Scientific Knowledge (download .pdf)
Factors for a broad technology assessment of comprehensive genomic profiling in advanced cancer, a systematic review (download .pdf)
Machine Learning to Enhance Electronic Detection of Diagnostic Errors (download .pdf)
Hot stage microscopy and its applications in pharmaceutical characterization (download .pdf)
Germline Pathogenic Variants Identified in Patients With Genitourinary Malignancies Undergoing Universal Testing: A Multisite Single-Institution Prospective Study (download .pdf)
The Anatomic Pathology Hospitalist Model A Novel Approach to Frozen Section Practice in a Tertiary Care Center (download .pdf)
Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration (download .pdf)
Secondary ACMG and non-ACMG genetic findings in a multiethnic cohort of 16,713 pediatric participants(download .pdf)
Ethical debates amidst flawed healthcare artificial intelligence metrics (download .pdf)
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks (download .pdf)
Differences in cancer rates among adults born between 1920 and 1990 in the USA: an analysis of population-based cancer registry data (download .pdf)
Scaling Laws for Neural Language Models (download .pdf)
Three ‘E’ challenges for siRNA drug development (download .pdf)
Durably reducing conspiracy beliefs through dialogues with AI (download .pdf)
Observational and genetic evidence disagree on the association between loneliness and risk of multiple diseases (download .pdf)
Targeted therapy guided by circulating tumor DNA analysis in advanced gastrointestinal tumors (download .pdf)
Future directions in regulatory affairs (download .pdf)
The importance of stupidity in scientific research (download .pdf)
A multimodal generative AI copilot for human pathology (download .pdf)
Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non–Small Cell Lung Cancer Treated With Chemotherapy (download .pdf)
Cybersecurity
How Provenance Is Modelled In W3C PROV-0 (download .pdf)
PNPL
The Panel of National Pathology Leaders Toolkit: Making the Business Case for Digital Pathology (download .pdf)
Resources
Good machine learning practice for medical device development: Guiding principles (download .pdf & download.pdf)
Artificial Intelligence and Machine Learning in Health Care and Medical Sciences (download .pdf)
The ‘Am I A Toxic Leader?’ Diagnostic Tool (download .pdf)
Next Gen Tech: Breakthroughs that will transform the world (download .pdf)
Diagnostic Stewardship as a Model To Improve the Quality and Safety of Diagnosis (download .pdf)
Machine Learning: The Basics (download .pdf)
Proposed Framework for Leveraging a Distributed Pan-cancer Profiling IVD as a Companion Diagnostic for Oncology Targeted Molecular Therapies (download .pdf)
Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (download .pdf)
INSIDE THE RUC: A Voice in Shaping Medicare Relative Values (download .pdf)