大咖对话「特别续集 part1」(音频):对话肝脏病理KOL
Special Episode (PART 1) - Conversation with KOL Liver Pathologists
We’re very excited to bring you a Two-Part Special Episode of Dialogues on AI Digital Pathology!
Listen to our guests, KOL liver pathologists as they discuss the recent FDA Webcast on NASH drug development and utilization of AI digital pathology as potential clinical trial endpoints.
Here’s Part 1, where the KOL liver pathologists will discuss key
takeaways from the recent FDA Webcast on NASH Drug Development, and
respond to questions sent in by Pharma companies and clinical
investigators on potential clinical trial strategies using AI digital
pathology following the Webcast.
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.
Moderator
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 1)
- 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.
大咖对话第4期(音频):诺华Nikolai Naoumov博士-AI数字病理学的对话
新加坡医疗科技公司HistoIndex,是杭州筹图科技有限公司的母公司,我们利用人工智能的图像分析技术和全球独创的无染色成像技术相结合应用于疾病进展的评价,特别是NASH新药开发的病理评价中。目前该技术平台已经在NASH临床前的多个动物模型和多个II,III期临床试验上做了深入研究和算法验证,已经参与完成近四十家国际国内知名药企、大型CRO公司和科研机构主办的相关试验。
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