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CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices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
Latest version of VALID Act (download .pdf)
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