Surfing the MASH Tsunami

00:00:00 Surf's Up, Season 6, Episode 6.

On April 23, 2024, our colleague and co-founder, Stephen Harrison, passed away suddenly. This week, Surfing the MASH Tsunami remembers Stephen with two of his closest associates and continues our annual MASH Drug Development roundtable held in his honor. 

00:00:04:24 - A Deep Dive into Drug Development, Part 2

The second portion of the Drug Development roundtable primarily focuses on three key issues. The first, uptake of resmetirom, starts with Naim Alkhouri discussing his experience in the Arizona Liver Health Clinics with over 650 patients in the year since resmetirom was approved and shifts t...

This week’s expert, Hepatologist and Key Opinion Leader Scott Friedman, joins Roger to discuss advances in acceptance of gene therapy and knowledge in other areas of basic liver science. When discussing science, he pays particular attention to findings on the diversity of stellate cells and his interest in CAR-T as a therapy for liver disease.

This conversation starts with Scott discussing gene therapy. Specifically, he applauds the idea that gene therapy is  becoming accepted in many diseases after a faulty start years ago, due to an unfortunate patient death in a badly controlled trial.  He comments that...

This weekend’s Newsmaker, Indiana University hepatologist and key opinion leader Naga Chalasani, joins Roger Green to discuss Early Experience with Resmetirom To Treat Metabolic-Associated Steatohepatitis with Fibrosis in a Real-World Setting, an article his group published recently in Hepatology Communications. He shares highlights from the paper and points out the one key area in which his group found room for improvement in their initial protocol. 

Naga and colleagues wrote this paper after learning from Madrigal Pharmaceuticals that they were among the largest early prescribers of resmetirom and, relative to others, had achieved reimbursement with virtually all the...

This conversation is the opening segment of SurfingMASH's April discussion, in memory of Stephen A. Harrison, on drug development. In addition to co-hosts Jörn Schattenberg, Louise Campbell and Roger Green, panelists include hepatologists and key opinion leaders Sven Francque and Naim Alkhouri. This opening discussion focuses on exciting advances in one drug class (FGF-21s) and, more broadly, on exploring ways to treat cirrhosis. 

As Naim points out in his opening comment, these two issues— cirrhosis as a challenge and FGF-21s as a possible solution path —intersect in clear and exciting ways. He notes that the FG...

00:00:00 - Surf's Up: Season 6 Episode 5

Host Roger Green briefly describes this episode’s three sections and introduces Roundtable guests. The Roundtable panel shares groundbreakers. 

00:10:39 - Roundtable: A Deep Dive Into Drug Development, Part One

The opening portion of this month's roundtable centers around two issues: exciting data for FGF-21s and, more generally, treating patients with cirrhosis. Naim Alkhouri sets the tone in his opening comments, which start by focusing on the exciting SYMMETRY data from efruxifermin and then hones in on FGF-21s and resmetirom in cirrhosis. The rest of the conversation fea...

This week's expert, Hepatologist and Key Opinion Leader Mazen Noureddin, joins Roger to discuss major advances in drug development over the past year. He covers a range of different drug classes, focusing on stages of development and the range of options within each class. 

First, Mazen discusses a tremendously exciting group of FGF-21 agents, specifically mentioning Akero Therapeutics's efruxifermin, 89bio's pegozafermin, and Boston Pharmaceuticals's efimosfermin. He points to efruxifermin’s 96-week results to suggest that FGF-21s might be appropriate for a wide range of patients, the idea that the drug's duration of effect may make the ide...

This weekend's Newsmaker, Fatty Liver Alliance Founder Mike Betel, joins Roger Green to discuss the wide range of conferences where he has been invited to speak or sit on a panel this year. Specifically, he shares his belief on what this says about interest in MASLD and describes the messages he delivers at the conferences he attends. 

The interview starts with Roger asking about the benefits societies and the broader community get from having Mike at these programs. As he puts it, "I feel quite fortunate that I get to be, as you've shared before, the one s...

This conversation is the concluding segment of  SurfingMASH's coverage of the AASLD Emerging Trends Conference on the SLD Spectrum diseases: MASLD, MetALD and ALD. In addition to co-hosts Louise Campbell and Roger Green, panelists include EASL Secretary General Aleksander Krag, hepatologist Alex Lalos and Jenn Leigh Jones, Founder of the Society for Sober Livers Survival patient advocacy group.

The conversation starts with Roger questioning whether it is a good or bad idea to conduct separate studies on medicines' effect on MetALD patients. He notes Anna-Mae Diehl's presentation at the Conference, which suggested that regardless of organ, all c...

00:00:00 - Surf's Up: Season 6 Episode 4 

Surfing the MASH Tsunami concludes its coverage of the AASLD Emerging Trends Conference on MASLD, MetALD and ALD. This week, the panelists focus on pivotal messages that attendees took away from the conference and what messages they would like to share with listeners. Our newsmaker, Fatty Liver Alliance and CEO Mike Betel, discusses the lessons he has taken from being invited to a far wider swath of conferences this year and shares the messages he delivers to these new audiences. Finally, our expert, hepatology research and key opinion leader Mazen Noureddin, discusses r...

This week's Expert is Jeff McIntyre, Vice President, Liver Programs at the Global Liver Institute. His major topic is how recent high-level FDA job cuts might affect MASH drug and diagnostics development. He also shares reactions to FibroSIGHT, HistoIndex's new digital pathology service for clinical practice. 

Highlight: Recent job cuts at the FDA will produce chaos in government and slow response to any emerging crises.

Second Highlight: Patient self-advocacy becomes even more important in this environment.

The conversation takes place on April 1, which lends context to Jeff's opening comment about the rate and n...

This week's newsmaker, Yukti Choudhury, Director of Clinical Development at HistoIndex, joins Roger Green to discuss FibroSIGHT, a new HistoIndex service that allows clinicians to use HistoIndex's Second Harmonic Generation (SHG) technology and analytics to determine specific CRN fibrosis level for patients with inconclusive NIT results.  

One reason FibroSIGHT is worthy of attention: This is the first time an in-depth analysis of clinical trial biopsy results is being placed at the service of clinical treatment. 

Another reason: Yukti states that demand for this technique could equal 163,000 cases this year, rising to one million by 2028. 

T...

Surfing the MASH Tsunami continues its coverage of the AASLD Emerging Trends Conference on MASLD, MetALD and ALD. 

This week, the panelists focus on what studies on bariatric surgery and drugs in development can tell us about future treatment and explore some clinical trial questions. Guest Surfers include Professor Aleksander Krag of the University of Southern Denmark, the current Secretary-General of EALS, hepatologist Alexander Lalos of Robert Wood Johnson hospital, and Jenn Leigh Jones, founder of the Society for Sober Livers Survival, now part of the Fatty Liver Foundation. 

Aleksander Krag starts by discussing a pr...

00:00:00 - Surf's Up: Season 6 Episode 3

Surfing the MASH Tsunami continues its coverage of the AASLD Emerging Trends Conference on MASLD, MetALD and ALD. This week, the panelists focus on what studies on bariatric surgery and drugs in development can tell us about future treatment and explore some clinical trial questions. Our newsmaker, HistoIndex Director of Clinical Development Yukti Choudhury, introduces us to FibroSIGHT, which provides clinicians with highly precise biopsy analysis. Finally, our expert, Global Liver Institute Vice President, Liver Programs Jeff McIntyre, discusses the implications of recent US government job cuts on future MASH treatment options...

00:00:00 - Surf's Up: Season 6 Episode 2

Surfing the MASH Tsunami continues its coverage of the AASLD Emerging Trends Conference on MASLD, MetALD and ALD. This week, the panelists focus on disease epidemiology and what it can teach us about the relative importance of alcohol and diet on disease progression. Our newsmaker, hepatology KOL and frequent Surfer Hannes Hagstrom, discusses what a recent paper demonstrates about the impact of MASLD on 15-year mortality and cause of death and how this information can improve patient care. Finally, our Expert, Shelbyville, Indiana internist Emily Ann Andeya, discusses her path from practicing...

00:00:00 - Surf's Up! Season 6 Episode 1

SurfingMASH kicks off our sixth season in our new format, with three major elements to each episode. This week's Roundtable and Newsmakers segments focused on two recent conferences that took a multispecialty perspective on the range of medical and psychological issues affecting steatotic liver disease (a new concept specialty: steatology.") Our Expert this week is our co-host Jörn Schattenberg, discussing the educational and conceptual challenges of readying Europe for the EMA approval of resmetirom later this year.

00:03:58 - Introductions and Groundbreakers

Host Roger Green describes the new v...

In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation reviews two sessions promoting healthy livers and asks panelists what they anticipate for #TLM2025.

This last conversation starts with Jeff describing the session that moved him most and praising a panel that Mike co-chaired on Lifestyle Management of MASLD and MASH. Jeff spoke on this panel, and he describes the breadth and quality of speakers and topics. While Jeff spoke about social determinants of health, others discussed commercial, regulatory a...

In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation considers the role of patient advocacy in replacing biopsy in clinical trials with NITs and reviews a session on the foundational principles for patien-centric clinical trials.

This conversation picks up at the end of Michelle's discussion of the FDA Corner session. Jeff starts by identifying this specific issue - replacing biopsy in clinical trials with NITs - as a place topic on which he believes patients must play a p...

In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation considers how the anticipated approval of a second MASH drug without biopsy might affect clinical trials and discusses two recent publications on patient genotyping and patient clusters.

The conversation starts with Roger asking the group whether the presence of two approved MASH medications that do not require biopsy will make recruiting clinical trials that require them more challenging. The group doubts this will not add a significant new challenge t...

In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation reviews the late-breaker presentation on efimosermin, a q4w FGF-21 agent and the "FDA Corner" session. 

Jörn begins the discussion by highlighting a paper from the later breaker session on efimosfermin alfa, an FGF-21 agent dosed q4w. He notes that after only six doses (24 weeks), efimosfermin alfa demonstrated significant increases in fibrosis regression and lowering NAS score. To Jörn, this result, coupled with others on efruxifermin and...

In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation reviews the ESSENCE trial, the Phase 3 trial demonstrating that semaglutide regresses fibrosis levels in some MASH patients. 

The conversation begins with each panelist sharing a word or short phrase they felt best captured their feelings about TLM2024. Next, panelists review the meeting's most consequential paper, the ESSENCE Trial. Naim starts by describing ESSENCE, a Phase 3 trial with semaglutide demonstrating significant levels of fibrosis regression in non-cirrhotic MASH patients. Jörn...

00:00:00 – Surf’s Up: Season 5 Episode 26 - Last month, close to 8,000 hepatology stakeholders convened in San Diego for The Liver Meeting 2024. Hepatology Key Opinion Leader Naim Alkhouri, Novo Nordisk International Vice President for Medicines Michelle Long, and patient advocates Jeff McIntyre from the Global Liver Institute and Michael Betel from the Fatty Liver Alliance join Jörn Schattenberg and Roger Green to discuss highlights.

00:03:23 - Introduction and Groundbreaker - Highlights include recent travel, cultural events, and the Third Annual Primary Care Summit from the Fatty Liver Alliance.

00:11:35 - Describing TLM2024 - Participants shared a word or short...

00:00:00 - Surf's Up: Season 5 Episode 25
On July 20, Clinical Gastroenterology and Hepatology released the paper, Expert Panel Recommendations: Practical Clinical Applications for Initiating and Monitoring Resmetirom in Patients with MASH/NASH and Moderate to non-cirrhotic Advanced Fibrosis. Corresponding author Maru Rinella joins the Surfers to share key points from the recommendations and offer her thoughts on what lay behind them.

00:02:26 - Introduction and Groundbreaker
The highlight was Louise's groundbreaker: having become a full Fellow in the Roal College of Physicians.

00:06:28 - Introducing the paper
Roger starts by discussing the importance of this paper...

Two weeks ago, the SurfingMASH Question of the Week asked, "What structural or educational changes do you anticipate will significantly improve Provider-Patient communication? Will these changes require more from the provider and more from the patient?" Today, S5 E23 panelists Mike Betel and José Willemse join Roger Green to review the three answers we received. 

Of the three questions from audience members, one from a patient/patient advocate suggested greater honesty, better listening, and, if possible, either longer appointments or better care team engagement. The second, from another patient, discussed being more honest about the Quality of Li...

In the second half of Roger Green's interview with Global Liver Institute Vice President, Liver Programs Jeff McIntyre, Jeff discusses the implications of his key EASL Congress takeaways for GLI and other patient advocacy groups.  

To Jeff, this trend makes patient advocates a more valuable player in the clinical trial design process, particularly when coupled with the FDA's increasing focus on diversity in trial populations. This will become particularly important because, today, the major use of incretin agonists like semaglutide and tirzepatide is in anti-obesity, where payers are frequently declining to pay for the drugs. Advocates like G...

This conversation contains the first half of Roger Green's interview with Global Liver Institute Vice President, Liver Programs Jeff McIntyre, during which the two discuss what Jeff considered the key strategic takeaways for GLI from the various EASL Congress presentations, abstracts and discussions. 

Jeff focuses on the "overriding sense of optimism" coming from the multiple pieces of positive drug data. He cites the data on Boehringer Ingelheim's survodutide, the follow-up work on Madrigal's resmetirom, an anticipated presentation on semaglutide at the AASLD in November, and strong FGF-21 results as proof that we are beginning to develop multiple r...

In the second half of Roger Green's interview with PharmaNest Founder and CEO Mathieu Petitjean, Matt discusses the implications of his key EASL Congress takeaways for PharmaNest.  

Matt starts this discussion with a simple question: Will biopsy-based analyses become part of a surrogate endpoint? As he points out, they are not today, and creating the necessary data might require a significant effort. If not, they are unlikely to remain relevant to the large, Phase 3 trials. Regardless of the answer to this question, Matt believes digital pathology will still be important in pre-clinical work and other efforts to d...

This conversation contains the first half of Roger Green's interview with PharmaNest Founder and CEO Mathieu Petitjean. After Matt tells the audience a little about his background and PhramaNest, the two discuss what Matt considered the key strategic takeaways for PharmaNest from the various EASL Congress presentations, abstracts and discussions. 

Before answering the question, Matt describes the core services his company offers: "PharmaNest specializes in digital pathology. Four years ago, we put down the hypothesis that the histological phenotype of fibrosis should be quantified in a high-resolution, sophisticated way." He goes on to state their core proposition f...

00:00:00 - Surf's Up: Season 5 Episode 24 
This week's episode on MASLD lessons from the EASL Congress 2024 includes three separate elements: individual interviews with PharmaNext Founder and CEO Mathieu Petitjean and Global Liver Institute Vice President of Liver Programs Jeff McIntyre,  followed by a discussion with patient advocates Mike Betel of the Fatty Liver Alliance and José Willemse from the Netherlands, now supporting EASL. 

00:02:45 - Introduction
Roger explains the episode format, including the two key questions for Mathieu and Jeff: (i) what were their key takeaways from the EASL Congress, and (ii) how have those takeaways changed how...

This week, Surfing the MASH Tsunami looks back on interviews Roger Green conducted during the EASL Congress itself. This conversation with SurfingMASH co-host and Tawazun Health Founder and Clinical Director Louise Campbell took place on the last day of the Congress This portion of the conversation was not included in the original S5 E19 but instead was reserved for a special conversation at a later time (now).

The specific focus of this conversation is on how practice patterns and guidelines are likely to change over the next several years. One driving factor involves the need...

This week, Surfing the MASH Tsunami looks back on interviews Roger Green conducted during the EASL Congress itself. This conversation with Hepatology Key Opinion Leader and EASL Educational Councillor Sven Francque took place 90 minutes after the EASL Congress closed. The discussion focuses on plans and hopes for the future, both the future of MASLD diagnosis and treatment and of the EASL Congress itself.

The conversation starts with Sven discussing all the positive energy coming from the Congress, not only for MASLD but for the entire Liver community. He describes the ambiance of the meeting as feeling "vibrant,"...

This week, Surfing the MASH Tsunami looks back on interviews Roger Green conducted during the EASL Congress itself. This conversation with SurfingMASH co-host and Tawazun Health Founder and Clinical Director Louise Campbell took place on the last day of the Congress.

This conversation centered on three major topics addressed at the EASL Congress, each of which made Louise "quite enthusiastic."

The first of these was the presentation of the new EASL/EASD/EASO Clinical Practice Guidelines and their practical implications (Season 5 Episode 21). Louise described this session as having "blown her mind" with its...

This week, Surfing the MASH Tsunami looks back on interviews Roger Green conducted during the EASL Congress itself. This conversation with SurfingMASH co-host and Tawazun Health Founder and Clinical Director Louise Campbell took place on the first day of the Congress.

Roger's first interview with Louise took place at the end of Thursday, the opening day of the formal Congress and the first day of research presentations and posters. She starts by describing the "really nice vibe" of the meeting, dampened by the fact that Stephen Harrison was not there, and is no longer with us.
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This week, Surfing the MASH Tsunami looks back on interviews Roger Green conducted during the EASL Congress itself. This conversation with Fatty Liver Alliance Founder and CEO Mike Betel took place Wednesday of Congress week, a day for special sections and industry presentations, but one day before the General Session opened.

The first part of the conversation centered  on the Patient Advocate session that Mike chaired with Shira Zelber-Sagi. (This is the focus of Season 5 Episode 23.) The goal of this session was to discuss barriers to addressing unmet needs in a clinical setting and explore potential solutions. H...

This week’s vault comes from our first episode with Shira Zelber-Sagi. She and Ken Cusi joined us during US Thanksgiving Week 2022 to discuss nutrition and behavioral issues related to MASLD. The episode’s original writeup explains:

Surfing the MASH Tsunami hosts its first episode dedicated to nutrition and NASH with distinguished guest, Prof. Shira Zelber-Sagi. Alongside this rich discussion are Ken Cusi, Jörn Schattenberg, Louise Campbell and Roger Green.

This final conversation starts with Jörn  recalling Shira's statement that “diet is every day.” He notes that for patients whose serious medical issues are related...

Co-chairs Shira Zelber-Sagi and Mike Betel and panelists Tom Marjot and José Willemse, all from the EASL Congress session "Patient Experiences in Clinical Settings," join Louise Campbell to the need for resources that allow MASLD patients to access shared experience programs and holistic MASLD support programs. 

This final conversation focuses on shared experience and holistic MASLD support programs. It starts with Tom suggesting that shared experience is a pivotal factor in patient support groups and patient-based supportive care. He goes back to viral hepatitis, where many of the patients had common background challenges related to the disease. In...

Co-chairs Shira Zelber-Sagi and Mike Betel and panelists Tom Marjot and José Willemse, all from the EASL Congress session "Patient Experiences in Clinical Settings," join Louise Campbell to discuss ways that socioeconomic and psychological issues impact the dynamic of the physician-patient consult, and, as a result, often patient adherence to therapy.

This conversation starts with Shira asking Tom whether he addresses diet with his patients and, more importantly, whether he does so in the context of socioeconomic challenges, such as not recommending food that is too expensive for the patient. Tom says "Yes" to the first part, a...

Co-chairs Shira Zelber-Sagi and Mike Betel and panelists Tom Marjot and José Willemse, all from the EASL Congress session "Patient Experiences in Clinical Settings," join Louise Campbell to discuss strategies and questioning styles that can improve the dynamic of the physician-patient consult.

This conversation starts with Tom stating that having multidisciplinary treatment teams would provide tremendous benefits in terms of being prepared for patients and fully responsive to the issues they are likely to raise. Jose agrees but adds that many countries have only a few nurses and no ability to create these kinds of teams. 
 

Co-chairs Shira Zelber-Sagi and Mike Betel and panelists Tom Marjot and José Willemse, all from the EASL Congress session "Patient Experiences in Clinical Settings," join Louise Campbell to discuss some of the key dynamics shaping the physician-patient consult.

This conversation starts with Mike asking Tom whether he reviews the patient's history before the visit. Tom says he does so because he considers preparation vital to a successful consult. That said, Tom notes the importance of being responsive to the conversation rather than using the chart review to decide the outcome of the visit. He provides some empathetic d...

Co-chairs Shira Zelber-Sagi and Mike Betel and panelists Tom Marjot and José Willemse, all from the EASL Congress session "Patient Experiences in Clinical Settings," join Louise Campbell to provide an overview of issues in physician-patient communication. 

The conversation itself has two elements. It starts with first-time surfers Tom Marjot and José Willemse introducing themselves to listeners. After that,  Shira starts by discussing the EASL Congress session within the context of a broader collaboration called "EASL Patient Synergies." This program led to the creation of the Patient and Advocate Forum as the EASL Congress, which led to this prog...

00:00:00 - Surf's Up: Season 5 Episode 23
During SurfingMASH's wrap-up interviews from the EASL Congress (S5 E19), Louise Campbell and Mike Betel mentioned a session Mike co-chaired on challenges in provider-patient communications. Today, the other co-chair, Shira Zelber-Sagi and panelists Tom Marjot and Jose Willemse join Louise and Mike to return to this topic. 

00:13:34 - Discussing the EASL Congress session
Shira describes EASL Patient Synergies, a broad collaboration to develop open, solution-centered dialog focusing on what patients need in working with providers. Mike shares a key takeaway.

00:16:31 - Stigma in what doctors say to patients