4/26/2023 Updates Meeting

Steering Committee Series

There will be no live, virtual meeting this month. Please find updates below.


Voices of PIcc

 

0:00-0:25 Intro

0:26-2:51 PIcc is a collaborative community. What group do you represent?

2:52-6:00  PIcc is FDA recognized. Our FDA liaison is Dr. Brandon Gallas. How did you get involved?

6:01-6:55 MDIC is the official convener of PIcc. Can you tell us a bit about MDIC?

6:56-11:05 PIcc is a collaborative community. What do you value about the community?

11:06-14:40 PIcc is a regulatory science initative. We interact with a variety of organizations. Can you describe how your organization relates?

14:41-19:14 PIcc is working on digital pathology and AI. What do you consider the key pain points?

19:15-21:10 PIcc and regulatory science in pathology. Why is regulatory science so complicated?

21:11-27:50 PIcc is planning an in-person meeting. What are some of the topics we could tackle? Any ideas?

27:51-35:10 PIcc is very interested in innovation in diagnostics. What will be the most significant changes in the next few years?

35:11-end Closing

 


Download the slides that provide an overview of relevant updates from this month.


FDA

  • CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices

    • PCCP Project meeting on May 3 at 12-1PM ET

  • Publication by Chiu et reviewing the work of the Division of Applied Regulatory Science (DARS) “New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science(download .pdf)

  • Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (download .pdf)

  • Resource Capacity Planning and Modernized Time Reporting Implementation Plan (download .pdf)

Legislation

Schwartz et al.

DEI

  • NEJM: Schwartz et al. Why Diverse Clinical Trial Participation Matters (download. pdf)


Publications

  • Stacchiotti et al. Ultra-Rare Sarcomas: A Consensus Paper From the Connective Tissue Oncology Society Community of Experts on the Incidence Threshold and the List of Entities (download .pdf)

    #sarcomas #cancer #tumors #BCOR #EWSR1

  • Farres Obeidin. What’s New in Bone and Soft Tissue Pathology 2023: Guidelines for Molecular Testing (download .pdf)

    #molecular #bonetumors #bestpractices #guidelines #softtissuetumors

  • Liu et al. Etiology of oncogenic fusions in 5,190 childhood cancers and its clinical and therapeutic implication (download .pdf)

    #RNAseq #cancer #tumors #TCF3 #MYH11 #CBFB #translation #leukemia

  • Wang et al. Development of metaverse for intelligent healthcare (download .pdf)

    #healthcare #translation #humans

  • Truty et al. Patterns of mosaicism for sequence and copy-number variants discovered through clinical deep sequencing of disease-related genes in one million individuals (download .pdf)

    #cancer #genes #hematopoiesis #sequencing

  • Stenzinger et al. Supporting Biomarker-Driven Therapies in Oncology: A Genomic Testing Cost Calculator (download .pdf)

    #cancer #tumors #nonsmallcelllungcancer #fluorescence

  • Sanz-Garcia et al. Tumor-Naive Circulating Tumor DNA as an Early Response Biomarker for Patients Treated With Immunotherapy in Early Phase Clinical Trials (download .pdf)

    #PDL1 #tumors #ctDNA #plasmasamples

  • Druzak et al. Multiplatform analyses reveal distinct drivers of systemic pathogenesis in adult versus pediatric severe acute COVID-19 (download .pdf)

    #sepsis #glycocalyx #fibrinogen #criticallyill #lipids #rheology

  • Maiorino et al. Interleukin-20 circulating levels in obese women: Effect of weight loss (download .pdf)

    #obesity #IL-20 #IL-10

  • Leshchiner et al. Inferring early genetic progression in cancers with unobtainable premalignant disease (download .pdf)

    #cancer #tumor #squamouscellcarcinoma #exomesequencing

  • Sikaroudi et al. Generalization of vision pre‐trained models for histopathology (download .pdf)

    #tumor #cancer #learning

  • Yu, Mohajer, & Eng. External Validation of Deep Learning Algorithms for Radiologic Diagnosis: A Systematic Review (download .pdf)

    #deeplearning #imagebased

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