4/21/21 Steering Committee Meeting
We had another packed steering committee meeting with >40 participants.
The topics and all resources and content, along with a video, are provided below. We discussed a landing page change, a biomarker and PD-L1 proposal from Roberto Salgado, the withdrawal of the federal notice, information blocking, privacy law, as well as new projects with calls to action. The Trainee and Payor workgroups provided an update and please take a look at the calendar of events.
We look forward to hearing from you .
Please find the powerpoint from the meeting here.
Logo 00:00-4:50
Proposal R. Salgado + discussion 5:09-20:08
Federal notice 20:08-22:56
Information blocking 23:04 - 26:02
Trainees update (Sarah Dudgeon) 26:03-28:14
Payor update (Esther Abels) 28:16-30:48
HTT update (Brandon Gallas) 30:49-32:30
MDIC update 32:35-35:45
FDA vocies 35:50-39:10
General updates 39:12-end
Meeting Summary
New landing page proposal:
If you would like your logo represented on our home page, please send the image to Ula (digipathalliance@gmail.com).
TILs topic:
The International Immuno-Oncology Biomarker Working Group (also called the TILs-WG) has launched a global survey on the potential use of Tumor Infiltrating Lymphocytes (TILs) for future trial designs and use in daily practice. This initiative was triggered by high level discussions at the Breast International Group and other trial-groups on the design of de-escalation of systemic chemotherapy and immunotherapy-trials using TILs, on discussions within the pathology community on how best to integrate TILs in daily practice and on patients’ input that knowing on the TILs may be useful for them to know on. Hence this survey was developed with specific questions for pathologists, oncologists, patients, and industry. This survey takes less than 10min of your time and can be found on the Homepage website of the TILs-WG -www.tilsinbreastcancer.org-; click on the Blue Bar stating “Your Opinion is Important. Please click HERE to tell how YOU think the TILs should be used!”. Once done, please do NOT forget to click “SEND”.
Your contribution will be treated anonymous and will not be disclosed in public. The results of this survey will be made public after summer 2021. Click HERE to access the survey.
Roberto Salgado Biomarker/PD-L1 proposal:
PIcc/Alliance discussed a proposal for discussion with the Oncology Drugs Advisory Committee of the FDA.
There was interest in joining the discussion and PIcc/Alliance is supporting the discussion.
Click HERE to download the proposal that will be submitted shortly.
Please find a powerpoint summary by J. Lennerz here.
Information Blocking:
“Section 4004 of the 21st Century Cures Act (Cures Act) defines practices that constitute information blocking and authorizes the Secretary of Health and Human Services (HHS) to identify reasonable and necessary activities that do not constitute information blocking (referred to as “exceptions”)” Click HERE to download the document.
Link HERE to CAP CURES Act Fact Sheet
Link HERE to CAP letter commenting on information blocking
Workgroup updates:
The next Payor meeting is on Tuesday, 4/27. Click HERE for more information.
Trainee Group Speaker Event with Lakshman Ramamurthy is on Friday, 4/23. Click HERE for more information.
MDIC updates:
MDIC Annual Public Forum is coming up on June 1-2. Click HERE to register.
On June 2 there will be a live session dedicated to collaborative communities
There will also be an on-demand session specific to PIcc
General updates:
Relevant articles from FDA Voices
Accelerating medical device innovation with regulatory science tools (HERE)
Leveraging real world evidence in regulatory submissions of medical devices (HERE)
Publication: Do not sell regulatory sciences short (HERE)
Privacy law changes: download the state map PDF (HERE)
NFDI4Patho (Peter Boor, Germany). National Research Data Infrastructure for (Digital) Pathology proposal; LOI
This will be discussed in more detail during the May Steering Committee Meeting
Nominate a 2021 STAT Wunderkind (HERE)
Important dates:
All important dates can be found in our calendar HERE
April 19-20 BWH cPath Symposium (HERE)
April 22 DPA Webinar Series: Enabling Interoperability for Digital and Computational Pathology in the Age of Artificial Intelligence – Current Status and Future Directions (HERE)
April 23 PIcc Trainees Group Speaker Event with Lakshman Ramamurthy (HERE)
May 1 - June 18 DICOM WG-26 Hackathon (HERE)
May 5 - 7 Pathology Informatic Summit 2021 (HERE)
May 24 - 27 SIIM 2021 Annual Meeting (HERE)