10/26/22 Steering Committee Meeting
Please find the slides from the meeting here.
Please find the topics, all resources and content, along with a video recording of the meeting below.
We look forward to hearing from you.
Watch the recording of the meeting above.
0:00-2:27 Introduction
2:27-5:58 PIcc Update
5:59-17:30 FDA Updates
17:31-20:30 Legislative Updates
20:31-27:46 MDIC Updates
27:47-29:05 ctDNA
29:06-30:56 Diversity and Inclusion
30:57-32:32 Patient Advocacy
32:33-35:38 Resources
35:39-43:58 Publications
43:59-53:06 Events & closing remarks
Meeting Summary & Content Links
PIcc Update
Welcome to Aubrey Walker; joining PIcc as a Project Manager (email) (download)
Project Manager Team includes: Ula Green, Noor Falah, and Aubrey Walker
As of October 25th, 2022: N=647 members
FDA Update
FDA Superoffice: Office of Therapeutic Products (OTP) (link)
Statement of Organization, Functions, and Delegations of Authority (link)
OTAT Learn (link)
CTP/OTP => not center for tobacco products
OTP (CMS) => also not Opioid Treatment Program
Interactions with Office of Tissues and Advanced Therapies (link)
TPLC Advisory Program (PILOT)
CDRH Launches the Total Product Life Cycle Advisory Program Pilot (link)
Medical Devices; Voluntary Total Product Life Cycle Advisory Program Pilot (link)
First-Ever FDA 510(k) Clearance of an AP Control
Boston Cell Standards (link)
Boston Cell Standards Wins Frist-Ever FDA 510(k) Clearance for Anatomic Pathology Controls (link)
Immunohistochemistry Reagents And Kits (download)
Tissue Agnostic Drug Development
Tissue Agnostic Drug Development in Oncology (link)
Tissue Agnostic Drug Development in Oncology (Download)
Cancer diagnostics “is not mentioned”
Diagnostic considerations simply assume that
The “diagnosis of cancer” has been rendered
Immune-Mediated Adverse Events
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials (link) (download)
Bairi et al., The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group (download)
Gallas, Developing a Dataset to Validate Computational Models that Analyze Digital Pathology Images to Assess Tumor-Infiltrating Lymphocytes (TILs) in Breast Cancer
Gallas, 2015 Science Writers Symposium (download)
High-Throughput Truthing (HTT) Project (link)
Data-Collection Platforms: Digital
caMicroscope: Open Source (link)
PathPresenter (link)
Legislative Updates
FACT SHEET: Biden-Harris Administration Announces Key Actions to Advance Tech Accountability and Protect the Rights of the American Public (link)
Blueprint for an AI Bill of Rights (download)
Enforcement Discretion for the Use of SARS- CoV-2 Tests on Asymptomatic Individuals Outside of the Test’s Instructions for Use (RESCINDED) (download)
A Bill: To amend the Public Health Service Act with respect to the shortage of medical laboratory personnel. (download)
MDIC Updates
Cybersecurity Threat-modeling Virtual Bootcamps: 12/12-12/16, 2022 and 3/13-3/17, 2023 (link)
Medical Device Cybersecurity Maturity: MDIC Industry Benchmarking Report 2022 has been released (link)
MDIC Partners with PerkinElmer’s Horizon Discovery to Improve Accuracy of Next Generation Sequencing-Based Cancer Diagnostics (SRS Project) (link)
MDIC Live Online Series: On Medical Extended Reality (MXR) November 10, 2022 @ 1:30pm; LinkedIn Live
Coming Soon:
AI/ML in IVDs: A framework for a predetermined change control plan for AI/ML-enabled IVDs, including both software as a medical device (SaMD) and in a medical device (SiMD)
5G enabled healthcare technologies: MDIC landscape Report (Coming November 2022)
Computational modeling & simulation (CM&S) in medical device & diagnostics: case studies and landscape analysis (Coming November 2022)
Please contact Noor Falah nfalah@mdic.org or Jithesh Veetil jveetil@mdic.org with any questions about MDIC initiatives
Professional Societies
Council on Informatics and Pathology Innovation (link)
Pathology Innovation Collaborative Community overview for the Council on Informatics and Pathology Innovation
November 4th and 5th, 2022 in Mountain View, CA
Bartley et al., Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy (download)
Digital Pathology Association (link)
Garcia et al., The American Society for Clinical Pathology’s 2021 Wage Survey of Medical Laboratories in the United States (download)
World Heath Organization/ International Agency for Research on Cancer Open Positions
IT Database and Web Developer (link)
Scientist (Exposure) (link)
Scientist (Epidemiology) (link)
Scientist (Toxicology) (link)
Scientist (Toxicology) (link)
ctDNA
Combining liquid biopsy technologies may help improve tumour monitoring (link)
Diversity and Inclusion
Human Rights Campaign (link)
HRC works to provide employers the resources
they need to improve and promote fairness in the workplace.
Article: 5 Specifications That The FDA's Diversity Plan Needs To Include (link)
In April 2022, the FDA made available for public comment its Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (link)
Implement A Community Engagement Plan
Be More Inclusive With Your Eligibility Criteria
Provide Resources For Patients To Address/Overcome Barriers To Trial Adherence
Include Sites In Diverse Areas
Take On Accountability For Diversity Plan Adherence
Durmus, Cognitive Biases: A Brief Overview of Over 160 Cognitive Biases (download)
Take the Project Implicit Test (link)
Patient Advocacy
APPIA Group Pre-analytics (link)
Proposed Payor Agenda (download)
Resources
NIH-National Center for Advancing Translational Sciences: 4D MAPS (link)
Singh, Standardizing Lab Test Names: the TRUU-Lab Initiative (download)
Marasco and Kornblihtt, The physiology of alternative splicing (link)
Self-Teaching AI Algorithm Uses Pathology Images to Diagnose Rare Diseases (link)
AMA Releases 2023 CPT Code Set, Aims to Reduce E/M Coding Burden (link)
Stop Calling Everything AI, Machine-Learning Pioneer Says (link)
Publications
Chen et al., Fast and scalable search of whole-slide images via self-supervised deep learning (download)
Baxi et al., Digital pathology and artificial intelligence in translational medicine and clinical practice (download)
Topham et al., Integrative analysis of KRAS wildtype metastatic pancreatic ductal adenocarcinoma reveals mutation and expression-based similarities to cholangiocarcinoma (download)
Pritchard et al., Comparison of FDA Table of Pharmacogenetic Associations and Clinical Pharmacogenetics Implementation Consortium guidelines (download)
Archila et al., Development and technical validation of an artificial intelligence model for quantitative analysis of histopathologic features of eosinophilic esophagitis (download)
Loehr et al., Emergence of BRCA Reversion Mutations in Patients with Metastatic Castration-resistant Prostate Cancer After Treatment with Rucaparib (link)
Haymond & McCudden, Rise of the Machines: Artificial Intelligence and Clinical Laboratory (download)
Bellini et al., A survey on Artificial Intelligence and Big Data utilisation in Italian clinical laboratories (download)
Zhang et al., The spatial transcriptomic landscape of non-small cell lung cancer bran metastasis (download)
Jiang et al., Big data in basic and translational cancer research (download)
Yang et al., Nociceptor neurons direct goblet cells via a CGRP-RAMP1 axis to drive mucus production and gut barrier protection (download)
Mejia et al., Understanding the use of evidence in the WHO Classification of Tumours: a protocol for an evidence gap map of the classification of tumours of the lung (download)
May-Newman and Cornwall, Teaching medical device design using design control (download)
Gottlieb and McClellan, Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests (download)
Krings et al., Neandertal DNA Sequences and the Origin of Modern Humans (download)
Xu et al., Translating cancer genomics into precision medicine with artificial intelligence: applications, challenges and future perspectives (download)
Kristensen et al., Molecular pathology of tumors of the central nervous system (download)
Victor et al., Determining the credibility of commitments in international climate policy (download)
Blume et al., Rapid, deep and precise profiling of the plasma proteome with multi-nanoparticle protein corona (download)
Satinsky et al., Systematic review and meta‐analysis of depression, anxiety, and suicidal ideation among Ph.D. students (download)
Gomes et al., A mobile-optimized artificial intelligence system for gestational age and fetal malpresentation assessment (download)
Events
November 30th, 2022 Next PIcc Steering Committee Meeting
November 2-4, 2022 Digital Pathology AI Workshop at the University of Pennsylvania (link)
November 3, 2022 Unlock the Power of Digital Pathology in Cambridge, MA (link)
October 27-28 and November 3-4, 2022 Cancer Steering Committee Annual Scientific Symposium, Virtual Meeting (link)