PIcc23

A successful first in-person annual meeting was held in Arlington, VA on June 27 & 28, 2023.

Hosted by MDIC, the meeting titled Meet. Synergize. Impact: Unlocking the Potential of Digital Pathology and AI through Regulatory Science was attended by 65 representatives of various entities, including FDA, NIH, MDIC, FOCR, CAP, ACLA, and many more. Over two days, opportunities were abound to network with domain experts in regulatory science and various relevant interests, with overviews of distinct organizations provided and opportunities to share unique perspectives presented.

Download the program to learn more about our featured speakers as well as our convener MDIC.

Session I Panel: (L to R) Joe Sapiente, Doc de Baca, Susan van Meter, Ji-Yeon Kim, Alex Kalof

The meeting kicked off on Day 1 with thought-leaders and pioneers in digital pathology and regulatory science providing overviews of their unique organizations. In the first session, we heard from DPA, CAP, API, ACLA, and ADASP in impulse, update presentations, followed by a panel discussion hosted by Joe Sapiente of MDIC. The panel was on fire, and discussed important topics including where improvements can be made for existing regulations, what the pandemic taught us from an efficiency standpoint, goals for interoperability, and responsibilities of the educational community when training the next generation of pathologists.

 

This session was followed by an informative fireside chat session with Troy Tazbaz of DHCoE at FDA hosted by Jithesh Veetil of MDIC. During this session we heard straight from FDA on the sense of urgency within the agency; how they are looking for the community to help identify and prioritize the complexities that the field faces, and the importance of working collaboratively on a shared vision and objective.

 

Session II Panel: (L to R) Mark Stewart, Hannah Mamuskza, Mariano de Socarraz, Mickey Williams, Joshua Greenlee

In the second session we heard from a diverse group including FOCR, Alva10, CorePlus, NIH, and APPIA. During another exciting panel session, representatives covered topics from pre-analytics to patients, highlighting how understanding the clinical and economic benefits of innovation is key to success in the US. Following this session, we heard from Thomas Fuchs of Paige for a keynote presentation titled, A Vision for Digital Pathology and AI. This visionary presentation bridged the way to the final session of Day 1, hosted by Ed Margerrison of FDA to provide an overview of research ongoing within the FDA. We heard from FDA representatives covering OSEL, DIDSR, and PCCP.

 



Keynote I presentation featuring Thomas Fuchs

Session III Panel: (L to R) Ed Margerrison, Alexej Gossmann, Brandon Gallas, Ayobami Adebowale

Finally, Day 1 wrapped with introductions from the leaders of the breakout session, who provided a brief overview of their backgrounds and the topic to be discussed the following day during the working sessions. The topics determined before the meeting included Remote Work, PCCP, and Statistics. The final breakout session was an audience solicited topic. The voting took place, and the selected topic was Regulatory pathway for real world data collection and evaluation methodologies for AI driven devices. Attendees were then encouraged to join a networking dinner, where exciting conversations from throughout the day continued over delicious food and drink.



 

Curious about the content of the day 1 presentations? Download the master slide deck from the day 1 here.

 

We are extremely grateful to our Day 1 sponsors, Solaris and Roche.

 
 

Day 2 began with attendees getting straight to work, dividing themselves up amongst the four breakout sessions. In the first of two sessions, the four groups worked on identifying key elements, concerns, implications, and more for a proposed regulatory science deliverable. Group leads from each session then presented their group’s work, and robust conversations took place. Following the presentations, an audience vote was held to begin to identify which project the group was most interested in further pursuing.

 

In between the sessions, we had our second keynote presentation from Alex Kararygis on MedPerf Open and Standardized Benchmarking of Medical Artificial Intelligence.

A second session of all four breakout groups was held to further develop the ideas and deliverables discussed earlier in the day. Once again, each group presented an overview to the audience. The overview slides are below (and download here):

Real world data collection

(open topic)

Digital Diagnostic Signout

(replaced “Remote Work”)

PCCP

Statistics

Following the second round of presentations and another lively group discussion, a final vote took place to make the selection for a regulatory science project that PIcc will pursue for the year.

We are extremely grateful to our Day 2 sponsor, DDx Foundation

 
 

A huge thank you to all attendees, presenters, group leads, and sponsors who made PIcc23 a great success. Looking forward to continuing the work initiated over these two days, and for next year.

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