2/22/2023 Updates Meeting
Steering Committee Series
Find a recording of the meeting above.
0:00-2:39 Introduction & welcome
2:40-16:57 FDA & regulatory updates
16:58-25:04 Discussion topic 1: in-person meeting planing
25:05-34:43 Discussion topic 2: establishing a “library” resource
34:44-38:16 MDIC Updates
38:17-41:48 Professional societies & organizations
48:49-45:00 Resources & publications
45:01-47:35 Events
47:38-end Closing remarks & additional discussion
Meeting Content
links and documents mentioned during the meeting can be found below
Find the slides from the meeting here.
FDA
CDRH’S Experiential Learning Program (Read Here)
Announcing newly released full-time research staff openings in regulatory science of medical diagnostics, artificial intelligence at OSEL/CDRH/FDA (Read Here)
CDER 2022 Annual Reports:
Office of Pharmaceutical Quality (download .pdf)
Office of Clinical Pharmacology (download .pdf)
Guidance for Industry CGMP for Phase 1 Investigational Drugs (Learn More)
Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (Read More)
A Report in Response to the Executive Order on Lowering Prescription Drug Costs for Americans (download PDF)
2022 OCE Annual Report (Available Here)
Personalized Medicine Coalition at FDA: The Scope & Significance of Progress in 2022 (download .pdf)
CERSI Workshops and Training (link):
FDA-MCERSI Workshop on Application of Artificial Intelligence and Machine Learning for Precision Medicine (2/17/23 Virtual Public Workshop) (download agenda .pdf):
European Medicines Agency
Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR) (download .pdf)
Legislative Updates
Biomarker Patient Access Coalition: An Act relative to patient access to biomarker testing to provide appropriate therapy (Get The Facts)
SENATE DOCKET NO. 1687 FILED ON: 1/19/2023: An Act relative to patient access to biomarker testing to provide appropriate therapy (See Bill)
Rhode Island Bill: Biomarker Testing Health Insurers Will Be Required To Cover Cancer Testing In RI (Beginning 2024)
ACS (Cancer Action Network) Biomarker Testing: Advancing Precision Medicine in Cancer Care (Fact Sheet)
COLLECTIVE ACTION: Support Insurance Coverage for Comprehensive Biomarker Testing (Make A Difference)
IN THE NEWS: White House announces new cancer initiatives on Moonshot anniversary (Read Here)
Laboratories: CMS Flexibilities to Fight COVID-19 (download .pdf)
MDIC Updates
MDIC Releases Landscape Report on Medical Device Computational Modeling and Simulation (link)
Join MDIC on March 30 for an informational webinar on the Medical Device Computational Modeling and Simulation Landscape Report
Join MDIC at the 2023 Molecular and Precision Med TRI-CON Conference (link)
Dr. Maryellen de Mars will moderate a lively panel on Artificial Intelligence and Machine Learning for In Vitro Diagnostics at TRI-CON
Cybersecurity Benchmarking Webinar available On Demand (link)
Watch now and acquire key takeaways from the world’s first-ever Cybersecurity Maturity Benchmarking Report and receive focused best practices on implementing the tool and report findings into your cybersecurity posture
Call for Volunteers! MDIC Digital Health Software Vertical
The MDIC Digital Health Software Vertical is looking for software experts with experience in deploying software in various formats like: embedded in medical device/diagnostics, mobile apps, and desktop apps, among others. We also seek more regulatory experts who have experience with Class III software submissions to participate in these activities. Selected volunteers work with abrader group to develop an MDIC framework
For more information, please contact: Jithesh Veetil jveetil@mdic.org or Taylor Matheny TMetheny@mdic.org
Seeking Subject Matter Expert volunteers to support Science of Patient Input Post-Market Patient Engagement Working Groups (link)
Leadership Engagement Culture Initiative
The Leadership Engagement program implores leaders to focus on company performance with quality and safety as pillars. Presented as an essential toolbox with personalized messaging and training to organizational leaders, the program is looking for leaders to transform their organizational culture by applying this novel, practical approach.
Interested? Contact cfqcc@mdic.org to get involved with Case for Quality initiatives.
MDIC Publishes First Landscape Analysis of 5G in Healthcare (link)
Professional Societies
FOCR: 2022 Scientific Report on Regulatory Advancements for Patients (download. pdf)
CAP 2023 Pathologist Leadership Summit | April 15-18 (link)
CAP Laboratory Medical Direction Program Options (link)
Resources
WHO: SURVCAN Cancer Survival Statistics in Africa, Central and South America, and Asia, Volume 3 (Find Here)
Precision Medicine Conference: Paying for artificial intelligence in medicine (download slides)
World Medicine Association: Handbook of WMA Policies (download .pdf)
HOW THE JETSON’s PREDICTED THE FUTURE AND WERE SHOCKINGLY ACCURATE (Read More)
Non-Small Cell Lung Cancer: (Research By Tumor Type)
EMory BrEast Imaging Dataset (EMBED) (Find Here)
NIST: AI Risk Management Framework (Read Here)
Generative AI: What’s all the hype about? (Listen Here)
HIPAA TRAINING FOR COVERED ENTITIES (Find Here)
Research on Potential Long-Term Health Effects of Tattooing (Learn More)
Our World Data: Why is life expectancy in the US lower than in other rich countries? (Discover Here)
Industry Insights: How to Apply for a CLIA Certificate? Filling out CMS-116 (Available Here)
Meet our Health Equity Research Initiative awardees (Find Here)
Publications
Khan et al. Computer-Assisted Diagnosis of Lymph Node Metastases in Colorectal Cancers Using Transfer Learning With an Ensemble Model (download .pdf)
Geneviève Belleville. Sit Down and Write Your Thesis! Practical and Motivational Tips for Scientific Writing (download .pdf)
Bracamonte et al. Communicating Uncertainty in Surgical Pathology Reports: A Survey of Staff Physicians and Residents at an Academic Medical Center (download .pdf)
Liu et al. Applications of Artificial Intelligence in Breast Pathology (download .pdf)
Sheffield et al. Cost Savings of Expedited Care with Upfront Next-Generation Sequencing Testing versus Single-Gene Testing among Patients with Metastatic Non-Small Cell Lung Cancer Based on Current Canadian Practices (download .pdf)
Sande et al. Rapid and Automated Semiconductor-Based Next-Generation Sequencing for Simultaneous Detection of Somatic DNA and RNA Aberrations in Myeloid Neoplasms (download .pdf)
Bilal et al. Role of AI and digital pathology for colorectal immuno-oncology (download .pdf)
Shamai et al. Deep learning-based image analysis predicts PD-L1 status from H&E-stained histopathology images in breast cancer (download .pdf)
Pennings et al. Copy number variants from 4800 exomes contribute to ~7% of genetic diagnoses in movement disorders, muscle disorders and neuropathies (download .pdf)
Chuprin et al. Humanized mouse models for immuno-oncology research (download .pdf)
Wilson et al. Hallmarks of neurodegenerative diseases (download .pdf)
Ravi B. Parikh and Lorens A. Helmchen. Paying for artificial intelligence in medicine (download .pdf)
Paper: The End of Endomyocardial Biopsy? A Practical Guide for Noninvasive Heart Transplant Rejection Surveillance (Continue Here)
Reclassification of the Etiology of Infant MortalityWithWhole-Genome Sequencing (JAMA)
Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma (THE NEW ENGLAND JOURNAL OF MEDICINE)
Mismatch repair deficiency, next-generation sequencing-based microsatellite instability, and tumor mutational burden as predictive biomarkers for immune checkpoint inhibitor effectiveness in frontline treatment of advanced stage endometrial cancer (Original Research)
AI-Powered Biomolecular-Specific and Label-Free Multispectral Imaging Rapidly Detects Malignant Neoplasm in Surgically Excised Breast Tissue Specimens (Original Research)
MODERN PATHOLOGY: Expanding the Molecular Diversity of CIC-Rearranged Sarcomas With Novel and Very Rare Partners (Read More)
Cancer Debugged: Tumors are rife with bacteria and fungi. Their ubiquity is proving useful in detecting cancers, categorizing them, and even determining whether certain interventions will work. (Learn More)
Validation of a breast cancer risk prediction model based on the key risk factors: family history, mammographic density and polygenic risk (Epidemiology)
Cancer: Arginine limitation drives a directed codon-dependent DNA sequence evolution response in colorectal cancer cells (Science Advances: Research Article)
How to regulate evolving AI health algorithms (Worldview)
Locally sourced: site-specific immune barriers to metastasis (nature reviews)
Article: Erroneous Patient Tissue Contaminants in 1574 Surgical Pathology Slides (Continue Here)
Building a knowledge graph to enable precision medicine (Scientific Data)
Review: Triple-Negative Breast Cancer and Predictive Markers of Response to Neoadjuvant Chemotherapy: A Systematic Review (Continue Here)
Human-specific genetics: new tools to explore the molecular and cellular basis of human evolution (nature review)
Alzheimer’s risk gene works the gut–brain axis (Read More)
BioGPT: Generative Pre-trained Transformer for Biomedical Text Generation and Mining (Read)
Environmental sustainability in cardiology: reducing the carbon footprint of the catheterization laboratory (Read Here)
Paper: Next-Generation Morphometry for pathomics-data mining in histopathology (Download Link)
Assessment of Human Resources in Medical Laboratory Sciences In Timor-Leste (Read Here)
Review: Application of Artificial Intelligence in Pathology: Trends and Challenges (Continue Here)
Paper: Assessment of Cancer Predisposition Syndromes in a National Cohort of Children With a Neoplasm (Continue Here)
Future on a Flashdrive: Timely Considerations for the Imminent Adoption of Whole Genome Sequencing in Pediatric Healthcare
Burnout Interventions for Resident Physicians (Read Here)
Article: Characterization of PVL-Positive MRSA Isolates in Northern Bavaria, Germany over an Eight-Year Period (Continue Here)
Article: Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up† (Continue Here)
Article: Spatially resolved transcriptomic profiling of degraded and challenging fresh frozen samples (Continue Here)
Article: Systematic assessment of prognostic molecular features across cancers (Continue Here)
Article: Germline predisposition to pediatric Ewing sarcoma is characterized by inherited pathogenic variants in DNA damage repair genes (Read Here)
Paper: Adult hippocampal neurogenesis in Alzheimer’s disease: A roadmap to clinical relevance (Continue Reading)
Paper: How do providers of artificial intelligence (AI) solutions propose and legitimize the values of their solutions for supporting diagnostic radiology workflow? A technography study in 2021 (Download Link)
The genomic landscape of rare disorders in the Middle East (Read Here)
Review Article: Liquid biopsies to monitor and direct cancer treatment in colorectal cancer (Download Link)
Estimation of cell lineages in tumors from spatial transcriptomics data (Article)
Somatic mutations can induce a noninflamed tumourmicro environment via their original gene functions, despite deriving neoantigens (BJC)
Functional analysis of circulating tumour cells: the KEY to understand the biology of the metastatic cascade (BJC Article)
Next-Generation Morphometry for pathomics-data mining in histopathology (nature communications)
Article: Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer (nature medicine)
PI5P4Kα supports prostate cancer metabolism and exposes a survival vulnerability during androgen
receptor inhibition (Science Advances)
Locally sourced: site-specific immune barriers to metastasis (nature reviews immunology)
nature reviews genetics: Obtaining genetics insights from deep learning via explainable artificial intelligence (Read Here)
Paper: The small GTPase regulatory protein Rac1 drives podocyte injury independent of cationic channel protein TRPC5 (Kidney International)
nature reviews genetics: Molecular mechanisms of environmental exposures and human disease (Article Here)
The Health Benefits of Resistance Exercise: Beyond Hypertrophy and Big Weights (Exercise & Sports Movement)
Paper: Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer (Download PDF)
Circulating Tumor Cells in Cancer Diagnostics and Prognostics by Single-Molecule and Single-Cell Characterization (ACS Publications)
BioGPT: generative pre-trained transformer for biomedical text generation and mining (Oxford Academic)
Pharmacogenomics: current status and future perspectives (nature reviews genetics)
Transcriptome analysis of newly established carboplatin-resistant ovarian cancer cell model reveals genes shared by drug resistance and drug-induced EMT (British Journal of Cancer)
A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study (Science Direct)
Upcoming Events
19th European Congress on Digital Pathology (ECDP 2023) | Budapest, Hungary | 14-17 June, 2023 (Participate)