S3-E4.4 – NASH-TAG 2022 Wrap-Up: Improving Cost Efficiency of NASH Trials By Reducing Screen Fail Rates

NASh-TAG 2022 Screen Fail Rates
First-timers Amy Articolo (Novo Nordisk), Erin Quirk (Terns Pharmaceuticals) and Rachel Zayas (AGED Diagnostics) join the Surfers and guest KOL Ian Rowe to explore what NASH-TAG 2022 taught us about improving clinical trial efficiency by reducing screen fail rates.

Last weekend’s NASH-TAG 2022 was the best attended event in the conference’s six-year history, and probably the one that will have the greatest long-term impact on diagnosis, treatment and monitoring of Fatty Liver patients. In this wrap-up conversation, our seven-person panel (including two Pharma execs and one diagnostics entrepreneur) discusses strategies for improving cost-efficiency and patient participation in clinical trials.

As this conversation starts, Stephen returns to the “3 H&E” idea, mentioning that this will provide 60mm of tissue for review, instead of the current 20mm. Erin asks whether we should be looking at histopathology at all in view of the dismal (writer’s word) balloon hepatocyte findings, but Stephen reminds the group that for studies that have already begun, they will have to use histology data as the core endpoint measure. Erin expresses the concern that various patients might look at the data and its challenges and question whether or not they even want to take the drug, but Louise and Stephen suggest that different patients will react differently. The group kicks around more issues, concerns, and possible solutions around patient engagement and trial recruitment. In the end, the group expresses hope and expectation for what will have changed by NASH-TAG 2023. There is general hope and belief around having a positive set of Phase 3 results to review and some belief that digital histopathology will have made inroads in diagnostic algorithms and processes.