Alliance to Host Former Secretary of Health and Human Services, Others at Alliance 2020 Meeting

The Alliance is continuing to pave the way for regulatory science advancements in Digital Pathology. Hosting the Alliance 2020 meeting on February 27 & 28, the Alliance continues to successively bring in larger stakeholders in what is sure to be their most inspiring and productive event yet. The meeting is set to take place at the JW Marriott in Los Angeles in advance of the USCAP annual conference.

Taking center stage on Day 2 of this historic meeting is Mike Leavitt, 20^th US Secretary of Health and Human Services (05-09), 10^th Administrator of the Environmental Protection Agency (03-05), and 14^th Governor of Utah (93-03). Secretary Leavitt will open a day-long working meeting with eight working group projects:

1. Truthing

Collecting pathologist annotations using the microscope (sign up here!) to create a validation dataset for AI algorithms, and discussing gaps in knowledge for future truthing studies. There is a Webinar on Wednesday Feb. 19 at 12 for more info (link)

2. Pre-Analytics

Generating guidelines for pre-analytical standardization to promote pathways for regulatory clearance. Conducting searches for supporting literature, reviewing existing guidelines, and prioritize areas for the committee.

3. Slide Scanning

We want the review and approval of new scanners, or the updating of existing scanners can be standardized and expedited. Plan in two phases: Phase I: The standardization of the characterization of slide scanners. Phase 2: Proposals for Validation tests to become MDDTs that can be used to accelerate FDA review and approval for Technical Performance Assessments (TPAs).

4. Standards

Creating a standard image database: collection of digital whole slide microscopy images in DICOM format & DICOM software tools for digital and computational pathology.

5. Payor Strategies

Conversations with Mike Leavitt on plans to identify best practices, Approaching the cost-saving aspect against reduced reimbursement, and approach policy development.

6. ML/Continuous Learning

Approaching adaptive algorithms & Ethics of ML and Continuous Learning. This team will begin by characterizing adaptive algorithms and finding areas in current regulatory frameworks where more clarity is needed.

7. Practical Use Cases

Creating a biospecimen release form for common/standard use. Additionally, building a toolkit with return on investment calculator, allowing more sites to adopt digital workflows.