Vlad Ratziu and Mazen Noureddin join the Surfers to explore some of the key lessons learned and issues uncovered in 2020. Vlad Ratziu provides a 10-minute overview of a fast-paced year of successes (and occasional failures) in clinical trials and novel diagnostics. Mazen Noureddin discusses the expanding role of non-invasive liver tests in diagnosis, patient treatment and monitoring and drug development. Stephen Harrison updates our knowledge about the use of clinical endpoints in obtaining conditional drug approvals. Finally, Roger Green places the entire year in a systems context with an eye toward the Law of Unintended Consequences and why the obeticholic acid Complete Response Letter was not the death knell many observers feared.
listen to each segment…
Vlad Ratziu discusses a “boiling hot” field of emerging NASH drugs and “particularly rich” data coming from no-invasive diagnostic testing
43.2 2020 Year In Review: Emergence of Non-Invasive Tests and Testing Strategies in Fatty Liver Disease
Mazen Noureddin describes a year in which biopsy’s shortcomings are revealed at the same time as non-invasive testing becomes better and produces more robust data
43.3 2020 Year in Review: Progress in developing clinical endpoints necessary to support drug approvals
Stephen Harrison summarizes a year of progress in improving the tests and analyses used to derive clinical endpoints necessary to initial drug approvals
Roger Green discusses why despite widespread concerns, FDA’s Complete Response Letter to Intercept did not cripple progress in NASH drug development.
Guests Ian Rowe, Joern Schattenberg and Wayne Eskridge join the Surfers to discuss key lessons learned in 2020 about Patient Treatment and Perspectives
44.1 – 2020 Year in Review with Ian Rowe: Simplifying NASH Diagnostics Saves Money, Improves Satisfaction
Ian Rowe discusses how streamlined use of ELF, FIB-4 and FibroScan improves cost effectiveness and patient satisfaction associated with NASH screening
Joern Schattenberg discusses the public health implications of German newspapers beginning to discuss Fatty Liver Disease
Louise Campbell questions the implication of APASL and ALEH endorsing “MAFLD” as Fatty Liver Disease nomenclature and Stephen Harrison discusses behind-the-scenes activities to resolve this issue
Wayne Eskridge describes how hope fell and then rose as patients did not receive the drug approval they expected but then learned about exciting paths for new agents and non-invasive testing
Stephen Harrison previews NASH-TAG 2021, the pre-eminent NASH drug development meeting, which will take place from March 10-12
Stephen Harrison discusses the history of NASH-TAG and what makes it special while previewing Day One of the 2021 meeting
Manal Abdelmalek and Ian Rowe join Roger, Louise and Donna to review the morning that Vlad Ratziu and Michael Charlton both identified as the highlight session of NASH-TAG 2021.