5/25/22 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.

0:00-2:47 Intro

2:48-3:41 PI Summit 2022 Review

3:42-18:48 CPIM: WSI for nonclinical development

18:49-20:53 Advancing Cancer Research Through Collaboration

20:54-27:34 OV SCOUT

27:35-30:16 Paige Decision Summary Event

30:17-35:51 SEER 2.0

35:52-38:24 Sepsis Summit

38:25-42:50 “VALID Update”

42:51-45:24 CPT Codes AMA Digitization of slides

45:25-52:13 Truthing & Validation Update

52:14-52:51 CDER Newsletter

52:52-53:53 Cell Free Working Group

53:53-58:15 General Updates

58:16-end Discussion and close


Meeting Summary

Pathology Informatics Summit 2022

CPIM: WSI for nonclinical development

  • Critical Path Innovation Meeting (CPIM) overview slides from CDER (download)

  • Recent guidance on Digital Pathology toxicology (link)

  • Policy and procedures (download)

Download the project overview slides

Advancing Cancer Research Through Collaboration

OVarian Cancer Subtype Classification and OUtlier DeTection (OV SCOUT)

SEER 2.0 Cancer Diagnostics: Current State to Future Trends

Planning phases:

  • Paige Decision Summary Event

Tentative presentation date: June 22 at 10AM

  • Sepsis Summit

VALID Update:

  • Food and Drug Administration Safety and Landmark Advancements Act (FDASLA)

  • The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition (link)

  • FDA: Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication (link)

  • FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTs (link)

CPT Codes AMA Digitization of slides

  • May 2022 CPT® Editorial Panel Meeting Agenda (download)

Truthing & Validation Working Group

CDER Newletter

Proposal: Cell Free Working Group

  • The main aim of this project is to increase clarity on an evolving and important topic

  • In May 2022, the FDA released a draft guidance entitled ”Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development Guidance for Industry”.

General Updates:

  • May 25-27 EFLM Meeting (online)

  • APPIA officially joined PIcc

  • Upcoming events:

    • June 3-6  ASCO Annual Meeting Chicago IL (link)

    • June 6, 10AM ET PathML Presentation (link)

    • June 14/15th Digital Path & AI Congress New York Long Island (link)

    • June 15-18th ECDP2022, Berlin, Germany (link)

    • October 16-18 Pathology Visions Las Vegas NV (link)

    • November 18-19 ICDP2022, Paris, France (link)

See you next month on Wednesday, June 29 at 3:00-4:00PM ET

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6/29/22 Steering Committee Meeting

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4/27/22 Steering Committee Meeting