CPIM: WSI for nonclinical development
Implementing WSI in the regulated nonclinical development of pharmaceuticals and chemicals
8/1/2022 update: The FDA released their official minutes from the meeting. Download them here.
PIcc participated in the first joined CPIM meeting with BigPicture and representatives from the FDA on June 15th 2022 from 1:00-2:30 PM (EST). The meeting covered several topics relevant to histological examinations of tissues relevant for toxicology assessments (e.g., during drug development). The discussion was led by BigPicture representatives (Xavier Palazzi & Gabriele Pohlmeyer-Esch) and below is a summary of the main topics covered.
The meeting was not public and therefore we do not have a recording or detailed summary.
The PIcc representatives were:
Kemp Watson, Amanda Lowe, Jithesh Veetil, Aziza Nassar, Manu Sebastian, Esther Abels, Emma Gardecki, Derrick Forchetti
Topics discussed:
Faithful replica of the original slide (2D vs. 3D)
Archival of files for documentation (dual archiving vs. slide + read vs. retaining real slides only)
Peer review of findings (formal vs. informal)
Contemporaneous peer review
Comparison OECD guidance
Retention requirements (including requirements regarding electronic records)
Regulatory requirements regarding conversion of digital image file formats (DICOM)
File format (conversion into new format vs. reading out new format)
Concordance assessment between WSI and conventional microscopy
Pixel pathway and color reproducibility
Physical slide labeling requirements (human readability)
Suggestions:
Proposal for an outline of a validation study
CPIM Meeting: June 15, 2022 at 1:00-2:30pm EST
Project Overview:
Title: Implementing WSI in the regulated nonclinical development of pharmaceuticals and chemicals (regulated) toxicologic pathology
Authors: Gabriele Pohlmeyer-Esch and Xavier Palazzi, on behalf of IMI BigPicture
BIGPICTURE | IMI Innovative Medicines Initiative (europa.eu)
Addressed Parties: Pharmaceutical and (agro)chemical industry: Toxicologic pathologists, quality assurance specialists (nonclinical), regulatory affairs
Background: While many companies have already undertaken efforts to transition are transitioning to digital pathology in the regulated GLP environment, the regulatory framework and expectations are not completely laid out. Collaborating with health authorities in order to precise areas of uncertainty will allow for an accelerated transition and access to the advantages linked to digital pathology
Approach & Objectives: FOR INFORMATION OF Plcc IMI BigPicture consortium has organized a Critical Path Innovation Meeting with FDA to engage the conversation about major topics that will benefit from alignment
Deliverable(s): Expectation is to deliver a white paper that could serve as the basis for further regulatory guidance in nonclinical toxicologic pathology
Value proposition:
“How will the proposed project be valuable from each of these categories?” Address each in detail:
· Clinical: none (scope is nonclinical)
· Regulatory: better defining expectations and providing opinions on means to achieve these will encourage companies to invest in this transition with limited regulatory risks, and will speed-up the successful development of digital pathology in the nonclinical area
· R&D: digital pathology in the GLP environment offers advantages in terms of speed and accuracy, reduces the need and risks around specimens shipments, and opens the way to get immediate access to historical data and increase accuracy of diagnoses. Looking forward, this first step will pave the way for artificial intelligence developments in that field.
Funding sources: none
Benefit to patients: increased speed and accuracy of nonclinical pathology