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NAIL-NIT is both a response to the challenges of histopathology and an effort to create a different vision of testing liver patients.

This episode starts with Stephen Harrison describing the events that came to demonstrate how challenging current histopathology approaches: a series of drug development failures that reflect shortcomings in methodology rather than in the developmental drugs themselves. Sen Sundaram notes that the difference between the NAIL-NIT approach and that of other consortia is that NAIL-NIT seeks to link NITs directly to outcomes rather than correlating them to histopathology-based measures. Mazen Noureddin discussed the frequency at which patients with obvious NASH and fibrosis fail to screen into studies due to inability to find balloon hepatocytes in the biopsy-derived slides and raises the human ethical implications of excluding these patients. Amy Articolo encourages us to envision a future in which drugs are available to treat patients and make sure we have the best possible testing to diagnose and prescribe the proper therapeutic regimens to patients. From there, the discuss shifts as Stephen Harrison and Sen Sundaram discuss the quality of data existing today that links NITs directly to outcomes. Sen notes that "if we think about the amount of data that we have" for NITs and outcomes, "we probably have more data now than is cited to support histopathology in a current guidance."

S3-E11.2 - NAIL-NIT and the Challenges of Histopathology

Navigating NAFLD/NASH clinical trials through the pandemic

Dr. Stephen Harrison discusses several ways the pandemic is affecting the planning and execution of clinical trials and our panelists discuss implications for investors, C-suite executives, and forecasters in our first episode, COVID CHAOS: Navigating NAFLD/NASH clinical trials through the pandemic. 

(FULL TRANSCRIPT: https://bit.ly/COVID-Chaos)

Drug developers, investors, researchers, and corporate executives, wrestle weekly to understand what is happening in commercial development of NASH medications. Join hepatology researcher and key opinion leader, Stephen Harrison, star equity analyst, Yasmeen Rahimi, C-suite veteran, Peter Traber, and forecasting and pricing guru, Roger Green, as they discuss the issues affecting the evolving NASH market from their own unique perspectives on this week’s edition of Surfing the NASH Tsunami.

Roger Green (00:31): Hi. This is Roger Green, and welcome to the initial podcast of Surfing the NASH Tsunami, a podcast for people who are involved with drug development and commercialization in the liver disease space. We’ve developed this podcast because over the last month we’ve heard tons of questions from virtually everybody involved in this community about the impact of COVID, first, and then how that’s going to affect the entire domino chain of upcoming market events, product readouts, clinical trials, launches, all that going forward.

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

COVID CHAOS - Ep 1

What investors want to know about NASH development during the pandemic.

Yasmeen Rahimi poses five questions NASH investors ask her about the impact of COVID-19 on NASH clinical and commercial development and our panelists provide answers in our second episode, FIVE $IMPLE PIECES: What investors want to know about NASH development during the pandemic.
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Epsiode Transcription: https://bit.ly/WhatInvestorsWantToKnow

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Five $imple Pieces - Ep 2

Critical considerations for companies developing NASH drugs

Peter Traber focuses on ways COVID-19 can affect drug development and broader corporate strategies while our panelists weigh in on implications for clinical researchers, investors and forecasters in our third episode: C-SUITE COVID-19 CHALLENGES.

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Full Transcription: https://bit.ly/CSuiteCOVID19Challenges

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

C-Suite COVID-19 Challenges - Ep 3

Three possible scenarios for development of the NASH market.

Roger Green presents three possible directions for the NASH market over the next 5-10 years and asks our panelists, including our guest, renowned nurse and patient advocate Louise Campbell, to suggest critical market-driving factors.

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Full Transcription: https://bit.ly/Ep4-Surfing-NASH

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

When You Get To A Fork In The Road - Ep 4

Clinical trial results that are changing how we look at NASH

Stephen Harrison leads a review of two recent Phase 3 data statements: the outcome of GenFit’s RESOLVE-IT trial and Madrigal Pharmaceuticals’ recent press release on the extension of its MAESTRO Phase 3 NASH trial. Listen to a thoughtful, far-reaching sometimes funny conversation as the group explores WILD TIMES IN NASH-VILLE – PART I.

Full Transcript: https://bit.ly/Ep5-NASH-VILLE-Pt1

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Wild Times In NASH-Ville – Part I - Ep 5

Exploring the controversy over the name(s) to use when describing Fatty Liver disease(s)

Professor Quentin Anstee joins the Surfers for thoughtful consideration of the factors that should drive the decision on what name(s) to use for different Fatty Liver diseases. The group considers a range of issues from our level of scientific knowledge to the semiotics of naming to how patients react to certain disease descriptions, all in a stimulating, freewheeling discussion.

Full Episode Transcripts: https://bit.ly/Ep6-WhatsInAName

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

What’s in a Name: NAFLD or MAFLD? - Ep 6

Reviewing press releases reporting preliminary findings from six recently announced Phase 2 trials

Stephen Harrison leads the Surfers, with guest Louise Campbell, through an examination of six Phase 2 clinical trials that put forth press releases during the last three months. In all, the discussion created an air of optimism based on better clinical outcomes than we have seen with earlier NASH drugs, all from medicines with distinct but potentially complementary modes of action.

Full Episode Transcripts: https://bit.ly/Ep7-NASH-VILLE-Pt2

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

NASH-Ville - Part 2: Better Days Ahead? - Ep 7

Room for improvement

GenFit Head of Global Diagnostics Suneil Hosmane joins the Surfers in exploring the current strengths and drawbacks of Fatty Liver diagnostics. The conversation considers the needs of drug developers, clinicians and patients, and highlights opportunities for improving diagnostic options.

Full Episode Transcripts: https://bit.ly/Ep8-Diagnostics-Pt1

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Diagnosing Diagnostics – Part I - Ep 8

Surfing the NASH Tsunami celebrates a growing and increasingly important global event for the Fatty Liver community.

Global Liver Institute President & CEO Donna Cryer joins the Surfers to discuss the focus, passion, and advocacy that have shaped and grown International NASH Day. Learn how IND started and what it represents today. As you listen, envision the role you can play in the future of Fatty Liver advocacy and education.

Full Episode Transcript: https://bit.ly/Ep9-International-NASHDay

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

International NASH Day is Here! - Ep 9

What would create greater value for patients and providers?

Professor Mary Rinella of Northwestern University and Suneil Hosmane of GenFit join Stephen, Louise, and Roger to explore which of these strategies can do the most to improve patient diagnosis and management. The answer might surprise you.

Full Episode Transcripts: https://bit.ly/Ep10-Diagnosing-Diagnostics-Pt2

Apple Podcasts: https://bit.ly/NASH-Podcast-Apple
Spotify: https://bit.ly/NASH-Podcast-Spotify
Stitcher: https://bit.ly/NASH-Podcast-Stitcher
Buzzsprout: https://bit.ly/NASH-Podcast-Buzzsprout
YouTube: https://bit.ly/NASH-Podcast-YT

Diagnosing Diagnostics II: Tools vs. Teaching - Ep 10

Drug developers, investors, researchers, and corporate executives wrestle weekly to understand what is happening in commercial development of NASH medications. Hepatology researcher and Key Opinion Leader Stephen Harrison, M.D., C-suite veteran Peter Traber, M.D., and Forecasting and pricing guru Roger Green, M.B.A. discuss the issues affecting the evolving NASH market from their own unique perspectives on the Surfing the NASH Tsunami podcast.

S3-E11.2 - NAIL-NIT and the Challenges of Histopathology

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