Our guest KOL liver pathologists continue their conversation from Part 1 following the FDA Webcast, by responding to more questions by Pharma companies and clinical investigators on how AI Digital Pathology (AI-DP) can aid pathologists with precise assessment to better interpret the disease biology of NASH.
We’d like to thank our Guests and Moderator for their kind participation and professional views!
Prof. Pierre Bedossa,
Professor of Pathology at the University of Paris; Consultant in Liver Pathology at LIVERPAT, Paris, France
Prof. Zachary Goodman,
Director of Hepatic Pathology Consultation and Research,Inova Fairfax Hospital, Falls Church, Virginia, USA
Prof. David Kleiner,
Senior Research Physician and Chief of Post-mortem Section, Laboratory of Pathology, Center for Cancer Research,National Cancer Institute, Bethesda, Maryland, USA
Dr. Nikolai Naoumov, Adviser for Clinical Research and Drug Development in Liver Diseases, Novartis Pharma AG.
Key Takeaways from the KOLs in this Special Episode (Part 2)
It was suggested that the liver biopsy should undergo a quality check
for adequate amount of tissue with a core length of 2cm. Digital-read of
stained glass slides would be possible only with a high level of
quality control and rigour in tissue preparation and staining.
- For liver histology adjudication in clinical trials, it was suggested that two pathologists will be adequate to reach an agreement without a need for a third pathologist. In the event of a disagreement, a consensus among the two pathologists could be achieved through a mutual discussion.
- AI digital pathology (AI-DP) could serve its purpose on two fronts during NASH clinical trials – to train younger pathologists in scoring/staging biopsies and aid expert pathologists in assessing borderline cases.
- AI-DP could be useful as secondary endpoints in NASH clinical trials to augment semi-quantitative read. Especially for quantitative parameters that cannot be seen or detected by the human eye, AI-DP provides additional data possibly into the biology of response or regression.
- For AI-DP to be considered as primary endpoints, more data is needed to show the magnitude of effect change that correlates to clinical outcomes. The data should come from longitudinal studies evaluating the natural history of NASH vs placebo.