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Lead author Dr. Ali Aminian of the Cleveland Clinic joins the Surfers to discuss the recent SPLENDOR Study, which focuses on the effects of bariatric surgery on Major Adverse Cardiovascular Events (MACE) and Major Adverse Liver Outcomes (MALO). 

Stephen Harrison and Roger Green are joined by Fatty Liver Foundation President Wayne Eskridge.

9:02 - Ali Aminian begins to discuss the SPLENDOR study
11:38 - Ali explains the dual study outcomes
13:31 - Wayne has the first comment, then Stephen asks about sub-populations. Ali notes that the small sample size  of events limits the ability to do so.
16:25 - Stephen asks whether it will be a good idea to analyze for MACE and MALO together, rather than separately, and describes the large shift in trial enrollment thnking this might cause.
17:53 - Stephen asks whether study explored renal disease in a cardio-hepatic context. Ali discusses why not  
20:20 - Roger notes virtually identical declines in MACE (7.3%) and MALO (7.2%), asks whether  patients in the trial exhibited both 
23:30 - Ali shares preliminary analyses (not ye released) about the impact of bariatric surgery on disease outcomes. (CAN’T MISS)
24:35 - Stephen notes that these numbers look similar to the placebo group in the cenicriviroc trial
26:19 - Ali comments that having 100 F4 patients  does not provide much power for analysis. Stephen says it might be "25 times" what anyone else has.
28:51 - Ali asks Stephen whether he can envision new agents having the potential to drive regression in  cirrhosis patients.
30:02 - Stephen describes a small, recently reported efruxiferman trial that appears to do so,
goes on to hypothesize that over time we will find a strategy 
35:13 - Wayne worries whether "the siren song of surgery" will stop people from doing the hard behavioral work 
35:59 - Ali: the problem is 40% obesity, 10% severe and until recently, no way to treat it. Expresses optimism and hope for semaglutide and the GLP-1s to come
38:10 - Roger asks how the coming double and triple agonists that report 20+% weight loss will compare to surgery in outcomes
38:49 - Ali: we need to do trials, but effect should be the same. Stephen agrees
40:31 - Shardool Jain, Director of R&D at Altrix Bio, joins from audience to ask if members can envision a time where bariatric surgery becomes first line therapy for extremely obese patients
42:40 - Ali suggests it may make sense for severely obese patients with multiple weight-related morbidities, not otherwise
44:50 - Stephen asserts we do not have enough surgeons in the US to execute the strategy. His preference: solve challenges that will reduce adherence with the new weight loss medicines
46:29 - Roger makes three points. 1 -  surgery in cancer is not an early-stage strategy as Shardool suggests; 2 - from his own experience, diet and exercise can be exceptionally effective in the motivated patient; 3 - you get one shot at surgery, many at medication 
47:31 - Diet conversation continues...
50:57 - Shardool and Stephen exit
51:04 - Ali addresses NIT issue by noting that when data for these first patients were generated in 2004,  there were no practical NITs available
51:43 - Last question: the most powerful long lasting effects of SPLENDOR
52:03 - Ali: 1. Obesity is the main driver in Fatty Liver Disease. 2. Well populated, well-followed populations may provide unique insights
53:29 - Wayne: "the guidance that the heart-liver axis can be affected so dramatically is something we can use" with patients
54:12 - Roger: 1. Forecaster says investment in the double agonists and triple agonists becomes more attractive. 2. Advocate notes that weight loss can help patients all along the NASH spectrum
56:22 - Business section

SPLENDOR Study Lead Author Discusses The Effect Of Bariatric Surgery On MACE And LAGO

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.

SPLENDOR Study Lead Author Discusses The Effect Of Bariatric Surgery On MACE And LAGO

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