Alliance 2020

February 27 & February 28, 2020

JW Marriott Los Angeles L.A. Live – Gold 4 Ballroom

(SUPPORTED IN PART BY THE DIGITAL PATHOLOGY FOUNDATION AND CENTER FOR INTEGRATED DIAGNOSTICS AT MASSACHUSETTS GENERAL HOSPITAL)

REGISTER FOR FREE HERE

Note: Attendees will need to coordinate their own travel and lodging.

Thursday, February 27, 2020 – Afternoon: 2:ooPM–6:3o PM

JW Marriott Los Angeles L.A. Live – Gold 4 Ballroom

2:00-2.05: Esther Abels (PathAI), Brandon Gallas (FDA), Joe Lennerz (MGH): Welcome to Alliance 2020

2:05-2.10: Esther Abels: Overview of the Alliance

2:10-2:45: Keynote by Lakshman Ramamurthy (GSK Sr. Dir. of Global Regulatory for Oncology, former Lead Reviewer at FDA/CDRH, former Global Regulatory Lead of Foundation Medicine): Regulatory Science from NGS to future endeavors

2:45-3.00: Q&A Lakshman Ramamurthy

3:00-3:25: Craig Mermel (Product Manager at Google, former Apple Engineer)

3:25-3:30: Q&A Craig Mermel

3:30-3:55: Ian Cree (Head of WHO Tumor Classification): The WHO international standards for tumor classification and diagnosis

3:55-4:00: Q&A Ian Cree

4:00-4:30: COFFEE BREAK AND NETWORKING

4:30-4:35: Brandon Gallas: Introducing 2nd part of Alliance 2020

4:35-4:50: Michael Grunkin (CEO of Visiopharm): Standardization in Tissue Diagnostics

4:50-4:55: Q&A Michael Grunkin

4:55-5:10: Frank Dookie (former contracting professional at Humana): Criteria for reimbursement decisions

5:10-5:15: Q&A Frank Dookie

5:15-5:30: David Dimond (CTO of Dell EMC): Dell University and David’s Vision

5:30-5:35: Q&A David Dimond

5:35-5:50: Charles Mathews (Principal at ClearView Healthcare Partners): Health economics, policies, and patient access

5:50-5:55: Q&A Charles Mathews

5:55-6:10: Ming Poi (Sr. Dir. of Scientific Affairs, M2Gen): Collaborative research with ORIEN (Oncology Research Information Exchange Network)

6:10-6:15: Q&A Ming Poi

6:15-6:30: Joe Lennerz: Overview over 2nd day and breakout sessions (Feb 28th) + Vision for the Alliance in 2020 + Reception.

6:30-9:00: Reception (location TBD)

Friday, February 28, 2020 – Full day: 9:ooAM-5:oo PM
JW Marriott Los Angeles L.A. Live – Gold 4 Ballroom

Full-day breakout session to accomplish some of the proposed deliverables.

Think about it as a hackathon where the output is a regulatory science deliverable (e.g. a white paper).

We have the following topics and session leads – for other topics or projects, please contact the steering committee members (e-mails provided below).

Pre-analytics (Amanda Lowe)  alo[[visiopharm.com

• A brief open discussion to capture any suggestions from new contributors

• Conduct a literature and guideline interactive search and review session

• Establish a framework and Table of Contents for the Pre-analytics Guideline document

Slide Scanning (Scott Blakely)  sblakely[[hamamatsu.com

• Concept of a phantom

• Validation of slide scanners

• Standardization of characterization of digital slide scanning

Truthing (Brandon Gallas, Sarah Dudgeon, Hetal Marble)  brandon.gallas[[fda.hhs.gov  or  sarah.dudgeon[[fda.hhs.gov  or  hmarble[[mgh.harvard.edu

• Tumor infiltrating lymphocytes (TILs) in breast cancer establishing ground truth dataset (HTT group).

• We are looking for board-certified anatomic pathologists and residents to contribute 30 minutes each to this effort on-site.

• Please see here for full data collection details: HTTatUSCAP.pdf.

• Share IRB and RCA materials and enlist partners to source slides at other sites and coordinate data-collection events. Discuss stat plan and agency feedback on MDDT submission.

Practical use cases

• Biospecimen release form

• Toolkit with ROI calculator

ML/Continuous Learning (Richard Huang)  rhuang6[[mgh.harvard.edu

• Approaching adaptive algorithms

• Ethics of ML and Continuous Learning

Standards (Markus Herrmann and Mike Isaacs) mdherrmann[[mgh.harvard.edu  or  isaacs[[wustl.edu

• Standard image database: collection of digital whole slide microscopy images in DICOM format

• DICOM software tools for digital and computational pathology

Payor strategies (Esther Abels and Joe Lennerz) jlennerz[[partners.org  or  esther.abels[[pathai.com

• Best practices

• Approaching the cost-saving aspect against reduced reimbursement

• Policy development

Source: Digital Pathology Alliance