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S3-E11.1 – NAIL-NIT: The Thinking Behind a New NAFLD Consortium

NAIL-NIT Study Co-Directors and Steering Committee members from pharmaceutical companies discuss their motivations and why they encourage others to join them

NAIL-NIT is a new NAFLD consortium dedicated to exploring the direct relationship between non-invasive testing (NITs) and outcomes in Fatty Liver disease. In this opening conversation, study co-directors Stephen Harrison and Mazen Noureddin are joined by Steering Committee members Amy Articolo, Medical Director for NASH at Novo Nordisk, and Senthil Sundaram, CEO of Terns Pharmaceuticals.

NAIL-NIT: The Thinking Behind a New NAFLD Consortium

One at a time, the four panelists describe their motivations for forming and becoming a part of this consortium. Mazen Noureddin talks about the group’s common goal to produce data that will shape a shift from biopsy-derived drug approval analyses to NITs. Stephen Harrison describes the group’s strategy and two main efforts: retrospective analysis of the significant amount of available data that link NITs and outcomes, and a prospective study to be conducted over the next 4-6 years designed to establish correlations and links to outcomes not only for individual tests, for also for combinations of NITs. Sen Sundaram discussed his earlier work with a similar consortium that asked the same kinds of questions about PBC and demonstrated that alkaline phosphatase could provide the analyses necessary for drug approval.

Amy Articolo starts by noting that she has transitioned from a full-time treating OB/GYN to a corporate executive and brought with her a “passion” for “patient-driven, patient-centric care” and several ways that supporting analysis driven entirely by NITs can support that passion. One at a time, the four panelists describe their motivations for forming and becoming a part of this consortium. Mazen Noureddin talks about the group’s common goal to produce data that will shape a shift from biopsy-derived drug approval analyses to NITs.

Stephen Harrison describes the group’s strategy and two main efforts: retrospective analysis of the significant amount of available data that link NITs and outcomes, and a prospective study to be conducted over the next 4-6 years designed to establish correlations and links to outcomes not only for individual tests, for also for combinations of NITs. Sen Sundaram discussed his earlier work with a similar consortium that asked the same kinds of questions about PBC and demonstrated that alkaline phosphatase could provide the analyses necessary for drug approval.

Amy Articolo starts by noting that she has transitioned from a full-time treating OB/GYN to a corporate executive and brought with her a “passion” for “patient-driven, patient-centric care” and several ways that supporting analysis driven entirely by NITs can support that passion.

The Potential of NAIL-NIT

The NAIL-NIT initiative has the potential to transform how we evaluate drugs for approval and patients throughout the course of their disease. This is an important episode (and conversation) for anyone with a personal or professional stake in simplifying the NASH/NAFLD drug development process while simultaneously improving the quality of data for regulators and treating physicians alike.

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