NAIL-NIT & the Path from Non-Invasive Testing To Outcomes
Co-director Mazen Noureddin and Steering Committee members Amy Articolo of Novo Nordisk and Sen Sundaram of Terns Pharmaceuticals join the Surfers (Stephen Harrison is also a co-director) to discuss the NAIL-NIT Consortium, an ambitious effort to link non-invasive testing (and specific tests) directly to outcomes. NAIL-NIT’s activities include a prospective six-year study of 1,000 – 1,300 patients and, separately, retrospective analysis of thousands more cases to establish the best ways to make use of the growing array of non-invasive testing methods in the treatment, diagnosis and monitoring of NASH patients.
Participants in this episode anticipate that the retrospective element will start generating elements with one year, and the prospective within four years. They describe the program’s goals as being practical and business-like (better drug and NIT development), but also profoundly human (never denying a patient with clear F3 fibrosis access to a trial because the pathologist could not find a balloon hepatocyte on the cell.