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This Vault conversation stems from the wrap-up to TLM2022. In the episode, the panel (Jörn Schattenberg, William Alazawi, Naim Alkhouri, Laurent Castera, Ken Cusi, Wayne Eskridge and Roger Green) addresses several topics from the program. This one focuses largely on NITs. 

This conversation focuses on several papers of interest to Laurent. The first is a prospective screening study on patients with diabetes seen in either primary care or a diabetes clinic in the US. Using NITs to screen for NASH and MRE to screen for advanced disease, they identified 65% with NAFLD, 14% with advanced fibrosis and 5% with cirrhosis. When 164 of these patients moved into biopsy, they identified 61% with NAFLD, 30% advanced NASH and 9% cirrhosis. Laurent contrasts these results to a similar study conducted in a French diabetes clinic-treated cohort with transaminase greater than 20 in women and 30 in men. This yielded 58% NASH, 38% advanced fibrosis and 10% cirrhosis.

The panelists then explore the implications of both studies in terms of how screening should be conducted today. Laurent estimates that we might miss ~25% of advanced patients using current VCTE cutoffs without additional parameters. He also notes that neither duration of diabetes nor A1c levels were predictive. The group concludes that, as Ken puts it, studies like these push the needle toward action in both primary care and diabetes settings.

Throughout the month of July, Surfing NASH embarks on a series of episodes dedicated to takeaways emerging from a busy last few weeks at both the 2023 EASL Congress in Vienna and the American Diabetes Association's 83rd Scientific Sessions meeting in San Diego. This first installment comprises two distinct 1:1 interviews with Tsunami co-host Roger Green, one with key opinion leader Mazen Noureddin and the other with co-host Jörn Schattenberg.

This final conversation between Roger and Jörn begins by moving beyond the subject of drugs to the importance behind noninvasive testing and the myriad ways by which the term artificial intelligence is being claimed. Jörn talks about a poster he shared at EASL around an AI-assisted mode called qVessel which investigates the ability of researchers to quantitate changes in blood vessels and liver architecture as fibrosis progresses. This example provides contrast between how we develop diagnostic scientific insight versus drug approval process versus clinical applications and patient treatment. The conversation continues on to highlight some of what Jörn and Roger consider to be some of the most exciting drug development pieces to emerge from the EASL and ADA meetings. This leads to comments around how the nature of the questions being asking in 2023 versus 2019 demonstrates how much the field has learned about liver disease over the last few years. Our entire key opinion leader and advocate team has been struck forcibly by how many studies in the last month provided significant advances in knowledge and how some of these advances may change an underlying appreciation of drugs, diagnostics, artificial intelligence, machine learning and how we think about Fatty Liver disease overall.

Both conversations with Mazen and Jörn explore different perspectives around the complexities associated with drug development and the wider field's understanding of Steatotic Liver Disease (SLD). Stay tuned for more in the subsequent conversations to be released. If you have any questions or comments around these meetings, the discussed therapeutics or the new nomenclature, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.

Stay Safe and Surf On!

This week on Surfing NASH, Stephen Harrison speaks with Louise Campbell and Roger Green about challenges and opportunities in NASH drug development. The conversation comes aptly after the outcome of FDA’s ADCOM meeting for obeticholic acid (OCA) as a treatment for pre-cirrhotic fibrosis due to NASH. The group considers and comments on the safety profile of OCA and what the FDA requires in a first drug approval. However, this session extends much farther to offer a positively stimulating deep dive into the ongoing developments of a range of other therapeutic candidates and research directions for Fatty Liver disease. From the outset, Stephen shares that he is more convinced that we can move the needle in the toughest to treat patient populations prior to them developing decompensating disease. “There is hope that this population is not too far gone and we can be impactful.” Listen on to discover just what is so convincing in this space and what are the elements that give the group hope for the future of Fatty Liver disease.

00:00 Introduction

04:26 What has Stephen been working on since last being on the podcast?

06:21 Stephen's take on the outcome of the FDA ADCOM meeting on OCA for NASH

12:52 Discussing drugs with strong metabolic foundations

16:29 2023 Nature article on challenges and opportunities in NASH drug development

21:40 Disease progression in the diabetic population and screen fail rates

32:17 Deeper dive into histopathology

36:55 Closing question on the future of clinical trial design

If you enjoy the episode, have questions or interest around NASH therapeutic development, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.

Stay Safe and Surf On!

This week on Surfing the NASH Tsunami, we are offering a co-host ‘roundtable’ catch-up between Jörn Schattenberg, Louise Campbell and Roger Green. This is a fun, casual conversation that looks into first quarter highlights and a preview of what’s to come in quarter two of 2023. 

• Jörn recounts a productive trip to California where he attended the 3rd Annual Liver Connect Conference organized by the Chronic Liver Disease Foundation. He shares his highlights from the meeting, including a summary of a powerful presentation by Scott Friedman on ‘hot’ versus ‘cold’ fibrosis, cirrhosis, combination therapies and more. 
  
  
  
• Louise speaks to the intensity involved in reviewing publication for FibroScan approval in primary care pathways in the UK. One benefit of the lengthy protocols that NICE considers is that it ultimately produces world-leading cost-benefit analysis. The group goes on to discuss how different systems contribute to the field through their different strengths. 
  
  
  
• Roger uncovers a new metaphor for describing fatty liver disease and announces exciting plans for the podcast’s 3rd anniversary special.
   
  
  
• Among a number of other insights emerging from this session, the Surfers also discuss what is happening in the space of drug development and impending approvals, the strength in allied health professionals and primary care pathways for fighting fatty liver.

If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at questions@SurfingNASH.com.


Stay Safe and Surf On!

In the final conversation on AASLD’s new practice guidance, Roger Green contextualizes a new project he is embarking on with Ken Cusi. Together as co-hosts, they will be debuting a new podcast series from next week titled The NASH Tsunami in Diabetes: Getting Ahead of the Rising Tide. The content featured will largely be targeted toward healthcare professionals who treat diabetic patients, the patients themselves and their caregivers. The NAFLD-diabetes dual prevalence is alarmingly high:

• 15% of diabetic patients may have fibrosis
• In one study, 70% of diabetics had fatty liver and 35% had NASH
• 25% of deaths in people with NAFLD are related to cardiovascular disease
• NAFLD is an independent risk factor for development of diabetes, cardiovascular and chronic kidney diseases

After the group exchanges comments around this exciting news, conversation shifts back toward the practice guidance. Louise Campbell notes approvingly of its array of considerations which include polycystic ovary, menopause, testosterone alteration and the thyroid to name a few. She goes so far as to describe its succinct qualities as “one of the best written guidance documents I think I've ever read.” Jörn Schattenberg adds his appreciation for the inclusion of some high level hepatology concepts around histology and cell ballooning. Roger compares this document to the new generation of hard-cover suitcases that can appear sleek and compact while in fact being stuffed full of important, neatly organized materials. After which, he prods the group in a final question focused on the greatest practical impact of this guidance in the next couple of years. Louise believes it may be the document that strikes the ultimate chord in raising awareness in primary care: “It’s readable, it's digestible and it's implementable.” Jörn reckons the document is a strong step toward embracing multidisciplinary models of care where the NAFLD patient sits at the intersection of many different disciplines. Ken follows with a sizeable wishlist and offers an apt final comment: “If a dream comes true in a lifetime, you didn't dream big enough.” Surf on to discover these thought-provoking final insights.

Late last week, AASLD published new practice guidance on the clinical assessment and management of NAFLD. The Surfers convene with Ken Cusi, who contributed to the previous iteration published in 2018, to explore its key features and implications. The updated document reflects the many advances pertinent to any practitioner caring for patients with NAFLD. This conversation focuses around the influence the guidance imparts outside of the US.

Jörn Schattenberg shares that an EASL guideline commission has been set forward which will refer to the AASLD guidance in supporting its development. Louise comments on the density of information made available through the guidance, commending its extensive list of references. She expresses concern that NICE will not tap into what’s available here by remaining restricted to data obtained exclusively within the UK. She goes on to advocate for the enormous potential in constructing a guideline that collectively harnesses the “masses of evidence” available in the different guidances emerging throughout the world. When Roger Green asks whether this will be possible, Louise suggests that NICE might be headed in a less insular direction and cites the approval of FibroScan in primary care settings as a recent “leap of faith.” Lastly, she discusses her desire for an investigation into the dynamics of CAP scores to be included in these documents. Jörn agrees and adds that CAP ultimately provides a barometer for metabolic health. At the end of the session, Ken circles these ideas back to the importance behind screening in at-risk populations. 

Late last week, AASLD published new practice guidance on the clinical assessment and management of NAFLD. The Surfers convene with Ken Cusi, who contributed to the previous iteration published in 2018, to explore its key features and implications. The updated document reflects the many advances pertinent to any practitioner caring for patients with NAFLD. This conversation focuses on the impact this guidance may have on patients: will it make a difference and if so, how?

Ken asserts his position that both patients and providers need to be educated on solutions available today. Measures range from effective diet modifications to bariatric surgery and anti-obesity drugs. Louise Campbell reminds that not all patients interact with physicians and that nurses, dieticians and other allied health professionals experience more numerous contact points in terms of co-morbidity management. She asserts that guidances and guidelines need to make an effective impression on the frontline professionals, caretakers and even the patients themselves. This prompts Ken to share some exciting news with regards to the ADA formally recognizing NASH as a problem associated with diabetes. He reveals that he is chairing a committee which will work to create a consensus statement on this subject through consulting an array of stakeholders. Notably, they are inviting the participation of dieticians, diabetes educators, pharmacy representatives, obesity management leaders, primary care representatives and hepatologists among other groups. Ken expresses his optimism for the momentous energy and convergence of fields in an unprecedented effort to collectively combat Fatty Liver diseases. Jörn adds that such collaboration will drive stronger patient advocacy and better education around what specific questions they should be asking their treaters. 

Late last week, AASLD published new practice guidance on the clinical assessment and management of NAFLD. The Surfers convene with Ken Cusi, who contributed to the previous iteration published in 2018, to explore its key features and implications. The updated document reflects the many advances pertinent to any practitioner caring for patients with NAFLD. This conversation introduces differentiating factors which define a Guidance document versus Guidelines.

The conversation starts with Ken introducing the new guidance by placing it in the context of the last five years of thinking about screening and treatment of Fatty Liver patients. He highlights significant events including both let downs in terms of drug development and the emerging optimism surrounding new candidates in the NASH therapeutics pipeline. He notes that this guidance offers an affirmative consensus on the screening of patients with Type 2 diabetes - a contentious topic for the committee Ken participated in formulating the preceding guidance. In this initial high-level overview it already becomes evident that the new practice guidance is comprehensive in a myriad of applications, presaging it to be a highly effective resource.

Jörn Schattenberg joins to voice his initial impression and suggests this document offers an excellent viewpoint as to how the field is moving forward. He points to Table 7 - a summary of key concepts to guide clinical practice - as a particularly comprehensive point of reference for the latest recommendations. Roger Green also commends Table 7, highlighting four bullet points embedded which are dubbed Pearls for the assessment of NAFLD: 

• Aminotransferase levels are frequently normal in patients with advanced liver disease due to NASH and should not be used in isolation to exclude the presence of NASH with clinically significant fibrosis.
• Normative values for ALT reported by most laboratories exceed what is considered a true normal. As a general rule, ALT >30 U/L should be considered abnormal.
• Although standard ultrasound can detect hepatic steatosis, it is not recommended as a tool to identify hepatic steatosis due to low sensitivity across the NAFLD spectrum.
• CAP as a point-of-care technique may be used to identify steatosis. MRI-PDFF can additionally quantify steatosis. 

Ken notes that this document will “rectify some confusion from past guidelines." Specifically, it holds special value for primary care professionals who may not be familiar with the field but whose role is expected to grow dramatically over time. One key point: the role of front-line treaters will not be simply to screen for fat in the liver, but to identify patients in high-risk subgroups with clinically significant fibrosis. He notes that we can support these patients today through a combination of lifestyle interventions and currently available anti-obesity and diabetic medications.

As the session winds down, Jörn previews more detailed discourse around follow-up data on NITs and how best to establish evidence for progressing patients. Lastly, Louise Campbell adds her ideas on using this document to further support and develop local pathways and areas of care. In example, she would like to see updated guidelines from NICE following access to FibroScan in the community setting.

In an introduction to Fatty Liver in Australia, Louise Campbell is joined by Tony Rahman, Director of Gastroenterology & Hepatology at The Prince Charles Hospital in Brisbane and Adjunct Professor in the College of Medicine and Dentistry at James Cook University.

Louise leads this final conversation by highlighting the prospect of imminent drug approvals in the Fatty Liver space. She asks Tony for impressions on Australia’s positioning to identify its patient population and its ability to distribute limited resources in response to accessing expensive new drugs. Tony describes the approval pathway in Australia and suggests that the ultimate challenge will involve finding what he terms the “hidden cohorts” of patients who would benefit from these drugs. This will take time and money. Louise points to the Predictive Health Intelligence project outlined in S4E5, which sounds promising but will be challenged by Australia’s lack of state-of-the-art electronic records. Tony hopes within the next ten years this can be an area of massive improvement.

The last part of this discussion focuses on the future of Fatty Liver for Australia. Louise asks for what Tony envisions in the next 2-3 years for the field. Tony first highlights optimism around use of semaglutide and other GLP-1s as a major wall of defense. He then looks to the mission of driving education in public health and for hepatology and gastroenterology societies to heavily petition for the fact that NAFLD and NASH is an escalating dilemma in need of addressing now.

One of the most important challenges facing Fatty Liver stakeholders involves improving early diagnosis for patients with clinically relevant or advanced fibrosis (F2/3). Today, a significant percentage of patients learn they are living with cirrhosis in the Emergency Department during a decompensating event. Four in ten of these patients in the UK do not leave the hospital. In this episode From the Vault,  panelists review a model that Ian Rowe and Richard Parker developed to determine the most cost-effective strategy for F2/3 diagnosis.

As this conversation starts, Louise Campbell notes that John Dillon reported in Barcelona that slightly over half of patients identified as having Fatty Liver via iLFT never returned for their appointments. Ian Rowe points out that this will reduce the costs in the model due to missed diagnoses but questions whether this cost reduction is truly beneficial since missed patient visits translate into non-treatment. More important, he reminds us that iLFT is under constant improvement so that data collected earlier in its lifecycle might not accurately reflect its costs and benefits today.

Upon Roger Green’s invitation for other questions Louise Campbell asks whether “we” (presumably the UK NHS) should do a better job supporting positive diet and exercise activity for healthcare professionals inside the system. On a more serious note, this leads Ian and Louise to focus on the policy issues that can support patients better (particularly those in the workforce). Ian points out that alcohol is issue #1 for many of these patients. He and Louise go on to point out the importance of public policy around things like soda and sweet food advertising in shifting consumers’ focus or craving for bad foods. Roger suggests that this is a two-element issue: stopping advertising for soda and sweets will reduce disease over time but we also need to treat patients who already have developed disease. As he puts it, policy can “put your foot on the hose,” but even if we stop the in-flow of new Fatty Liver and metabolic patients, we still have “the patients in the hose” and they will need therapy.

As a final thought before wrap-up, Ian shares his belief (which Louise also holds) that VCTE might be more effective in causing changes in patient behavior than blood tests, even if they point up the exact same patient need. The difference: feedback from VCTE comes in real-time where patients get face-to-face feedback and respond, whereas bloodwork results comeback to the patient several days later and delivered impersonally.

From here, the group moves to the wrap-up question, which addresses research we should be doing and action steps/changes in behavior we should be promoting.

NASH-TAG 2023 proved to be a watershed moment for Fatty Liver disease as exciting drug development readouts, powerful academic work on non-invasive tests and the willingness to dive into the toughest questions aligned in Deer Valley, Utah. In this weekend’s conversation series, Surfing NASH reviews its diverse coverage of the conference by showcasing key excerpts across six recordings with various KOLs, patient advocates and stakeholders.

This conversation consists exclusively of an exchange between Donna Cryer and Roger Green. The session begins by Donna noting that while the data is cause for enthusiasm, she is concerned that this alone does not guarantee an inevitable approval. In addition to good data, she suggests, is the need for good regulatory science. As she points out, Intercept hit its endpoints in 2020, yet no approval was gained at the time. “Good regulatory science” is, in her words, conclusive, granular and contains a simplified message. Roger asks for an example of what might not constitute good regulatory science. This leads Donna to recall that the fireside chat, although titled regulatory, focused more on clinical trial designs than how to prepare for advisory committees, health technology assessments and Phase 4 trials. She notes that during this discussion, a good question surfaced regarding how equipoise will change once drugs are approved. The implication: what FDA is currently seeking in Phase 4 becomes unrealistic once drugs reach the market. At this point, Roger returns to Scott Friedman’s comment about the “straitjacket of biopsy” and how that impacts thoughts around trial design and “proof.” Donna adds that real-world evidence is the up-to-date approach these days, and it will be available once we have more experience with the medicines. 

As the session winds down, Roger goes back to the adiponectin analyses predicting non-response as being his favorite part of the meeting and explains why. Donna shares that one of her favorite moments came when Claude Sirlin, a radiologist, asked how they can become more involved here. Roger responds that radiology may succeed biopsy as a “hard standard” of efficacy. In the final moments, Donna discusses some of the presented data and questions that embodied a public health perspective. 

NASH-TAG 2023 proved to be a watershed moment for Fatty Liver disease as exciting drug development readouts, powerful academic work on non-invasive tests and the willingness to dive into the toughest questions aligned in Deer Valley, Utah. In this weekend’s conversation series, Surfing NASH reviews its diverse coverage of the conference by showcasing key excerpts across six recordings with various KOLs, patient advocates and stakeholders.

This conversation includes analysis by Scott Friedman, Rachel Zayas, Jörn Schattenberg, Louise Campbell and Roger Green. Roger leads by asking the group to detail the “sit up and take notice” moment of the meeting. Scott immediately describes the “800-lb gorilla in the room,” the resmetirom data, which casts a positive light around everything within the meeting at large. He goes on to discuss other key points, namely, compelling results for other drugs in earlier stage trials and NITs. Rachel agrees with Scott, stating that “the narrative has changed.” She also mentions Mary Rinella’s nomenclature talk and the discussion of combination therapies. Jörn praises the high energy level and well-rounded nature of the talks. Louise points to previously unpublished efruxifermin data from the HARMONY trial that suggested to her we can place drugs in primary care practices if we also ensure they have appropriate tools and tests to monitor patients.

Scott underscores perhaps the most staggering number in the meeting: only 3% of patients treated for NASH are treated by a hepatologist. Jörn concurs with this observation, adding that this casts light on the importance of using the NITs at hand to identify patients. Scott then referred back to Will Alazawi’s presentation on pathways and a brief presentation from Siemens evaluating four different test strategies in terms of lowest cost and highest prediction. Roger comments that the wealth of NIT data is actually starting to point to simple strategies for using them in clinical trials and treating patients. The uses may vary, but the paths seem clear. For Roger, Fagan’s nomogram, which Mike Charlton presented, was the moment at which the paths became clear. He next asks Scott to describe what he considers most pivotal here. Scott goes on to discuss the need to identify non-responders better and figure out how to best manage them. Jörn agrees in the profundity of this analysis and, in that context, calls into question whether our definition of “response” might change from fibrosis regression to something more broadly metabolic. As the talk winds down, Louise notes that we have seen some promising data about combination therapies. Lastly, Scott notes that we have far more scientific ways to approach combination therapy than simply seeing what drugs a company has in its portfolio.

NASH-TAG 2023 proved to be a watershed moment for Fatty Liver disease as exciting drug development readouts, powerful academic work on non-invasive tests and the willingness to dive into the toughest questions aligned in Deer Valley, Utah. In this weekend’s conversation series, Surfing NASH reviews its diverse coverage of the conference by showcasing key excerpts across six recordings with various KOLs, patient advocates and stakeholders.

This conversation featuring Stephen Harrison, Mazen Noureddin and Jörn Schattenberg begins with Mazen describing how exciting and informative the new sessions on non-invasive tests were. Specifically, he details his own surprise at how much LITMUS and NIMBLE were able to share. Jörn’s main point: we will find more NITs, but do not need them to be able to push treatment far forward today. Roger Green suggests that correct classification metrics (based on the percentage of patients classified correctly) might be more important in practical treatment than other tests which have better positive or negative predictive values but have large “indeterminate zones” of patients the test does not predict for at all. Stephen compliments the NIT discussion and commends Mazen’s observation that NASH is not the only disease area working its way through predictive non-invasive tests. Mazen shifts discussion onto the next session, where Vlad Ratziu, Rohit Loomba and Stephen Harrison investigate important areas in clinical trial design. Vlad discussed combination therapies, Rohit discussed gene SNPs and Stephen discussed cirrhosis.

Stephen refocuses on the idea that by providing continuous scoring, NITs appear to provide better guidance on whether drugs are “working” or not. Mazen agrees, pointing out how high the bar is to label a patient treated with drug a success. As the talk winds down, Jörn notes that Intercept and Madrigal are providing data we can dive into for years. Lastly, Stephen describes the high value that AI-based digital pathology will provide in sorting out how many patients are improving using continuous measures.

NASH-TAG 2023 proved to be a watershed moment for Fatty Liver disease as exciting drug development readouts, powerful academic work on non-invasive tests and the willingness to dive into the toughest questions aligned in Deer Valley, Utah. In this weekend’s conversation series, Surfing NASH reviews its diverse coverage of the conference by showcasing key excerpts across six recordings with various KOLs, patient advocates and stakeholders.

This conversation features our patient advocate discussion with NASH kNOWledge founder, Tony Villiotti, and Fatty Liver Alliance Founder and CEO, Michael Betel. Tony and Michael begin by describing the high levels of enthusiasm that began at AASLD and carried through to NASH-TAG as it became clear that there are drug trials appearing to meet all criteria for approval. Louise Campbell extends this sentiment further, commenting that new medications combined with greater awareness of the breadth of integrated metabolic disease is leading to a surge in collaboration with other specialists. Specifically, she refers to the involvement of cardiology and endocrinology specialists as a “game changer.” 

Mike shifts focus to the idea that patients with diabetes and/or obesity might be taking GLP-1s or dual glucagon agents for those diseases. He points out that should new NASH drugs be approved, this might lead to de facto combination therapy. Louise suggests reasons why this might be a double-edged sword. The remainder of the episode focuses on things we do not know about the drugs – how they interact, how long they will work and what downsides may be. Louise offers a final thought which emphasizes the importance of providing professional and patient education and training to make sure the new medicines are used properly.

In Part 2 of our real time coverage of the highly anticipated NASH-TAG 2023 conference, friends of the podcast Scott Friedman and Rachel Zayas join Louise Campbell, Jörn Schattenberg and Roger Green to review key takeaways from Friday and Saturday in Deer Valley. Following this session, Jörn, Louise and Roger review high points from the Saturday night “Potpourri” and “Regulatory Fireside Chat” sessions. The final feature of this episode is an enthralling and exclusive interview with HistoIndex Co-Founder and Chief Scientific Officer, Dean Tai, who shares captivating data from an AI-assisted histologic assessment of Phase 2 trials on aldafermin and resmetirom.

Scott opens the leading session with a concise summary of his highlights distilled from an event burgeoning with impressive moments. His main suggestion is that the positive momentum of the recent Madrigal announcement energized the wider program. Rachel echoes the idea that “the narrative has changed” as the field enters a promising New Year. Next, Louise points to her interest in the presentation of previously unreleased Phase 2 results from the HARMONY Trial on efruxifermin. And finally, Roger speaks to the evolving roles that NITs play in clinical trial and primary care settings. As analysis advances, Scott nails down an important question: what are the factors that distinguish the responders from the non-responders in the resmetirom trial? This leads the group down a compelling line of interrogation. The question also proves pertinent later in the episode as Dean teases tools to uncover the nuances of how and where these drugs act in the liver and beyond. Other topics explored in the opening session include insights on combination therapy, covert alcohol use, bariatric surgery, nomenclature, NITs, genetics and more.

In the second conversation, Jörn, Louise and Roger dive deeper into Saturday’s session. A major theme: the increasing focus on the role of bariatric surgery in liver disease. Jörn also underscores discussion around moving the field forward with an NIT that predicts outcome as an acceptable surrogate for conditional drug approval. Roger comments that addressing how drugs get used - not how they get approved - shifts focus from the needs of regulators to those of the payers.

Lastly, Dean joins Jörn and Roger to investigate fibrosis dynamics on a continuous scale using AI-based analysis and quantification of NASH features for treatment efficacy. The main idea: highly-precise assessment of liver slides has arrived, sparking a spate of new questions surrounding therapeutic possibilities. It becomes clear that advancements in AI digital pathology are paving a path for an entirely new, imaginative line of thinking for the Fatty Liver field. Surf on to the full feature for more on this illuminating topic.

This episode of Surfing the NASH Tsunami, including the accompanying discussion on zonal and liver-volume corrected analysis of fibrosis and steatosis, is sponsored by HistoIndex, the world’s leading specialist in stain-free imaging for NASH clinical trials. HistoIndex is transforming diagnostic standards and drug development for NASH with its second harmonic generation based AI digital pathology solution.

In a riveting debut of Season 4 on Surfing the NASH Tsunami, the podcast offers real time coverage of the highly anticipated NASH-TAG 2023. This episode includes two recordings. In the first conversation, NASH-TAG 2023 co-course director Stephen Harrison, scientific advisory board committee member Jörn Schattenberg and fellow Key Opinion Leader Mazen Noureddin join Roger Green to review presentations and themes from the Friday afternoon session. This conversation centers largely around Friday afternoon’s presentation on NITs. The group focuses on the expansion in NIT knowledge in terms of the number of NITs available, the breadth of knowledge they cover and the ways NITs can be used to manage patients wisely today. The conversation also focuses on the features that make NASH-TAG such a unique meeting.

In the second conversation, Fatty Liver Alliance Founder Michael Betel and NASH kNOWledge Founder Tony Villiotti join Roger and Louise Campbell. This discussion highlights how the momentum of recent pivotal trials in NASH drug development is changing patient advocacy today. The main insight: as more information becomes available and as we see successful Phase 3 drug trials, the number of stakeholders needing information increases and what each group needs to know varies. All this portends an exciting future for patients and their caregivers.

To discover the energy for yourself, surf on to the episode and stay tuned with our continued coverage. 

In a monumental moment in the never-ending pursuit of putting a major dent in Fatty Liver disease, Madrigal Pharmaceuticals announced positive topline results from the pivotal Phase 3 MAESTRO-NASH clinical trial of resmetirom for the treatment of NASH and liver fibrosis. Madrigal’s leadership intends to file for resmetirom’s accelerated approval with the FDA in the first half of 2023. If approved, the drug may become the first NASH medication introduced to market, depending on the outcome and timing of Intercept Pharmaceuticals’ refiling of obeticholic acid.

To recognize this special occasion, Surfing the NASH Tsunami hosts its largest ever suite of panelists who react to the enthusiasm, synergy and implications surrounding the news. This first conversation from the series incorporates highlights of our exclusive discussion with Donna Cryer, Founder and CEO of the Global Liver Institute. Donna focuses her initial comments around the MAESTRO-NASH data and the ways it benefits the overall field and demonstrates sustainability for NASH therapy as a whole. She extends her notes to consider the breadth of the Madrigal program and its implications for the full range of patients. Another consideration explores the program’s impact on practical use of NITs in demonstrating value in patient management and to the various stakeholders interested in building integrated systems. As Roger describes, this conversation is “pulling on all threads” of what these results and this energetic moment mean for sustainability in the field. This is a rich dialogue with many more notes and insights on how this story develops our understanding of where the liver fits in both the biological system and what efforts are required to integrate healthcare systems with timely, seamless adoption. 

NASH-TAG 2023 co-course director Stephen Harrison and scientific advisory board committee member Jörn Schattenberg join Louise Campbell and Roger Green to preview what is shaping to be a highly anticipated conference leading the field into a promising New Year. In light of Madrigal’s announcement of positive topline results from the MAESTRO-NASH trial of resmetirom, the first half of this conversation focuses on Stephen’s assessment of the emerging story. He then provides an overarching walk through of the format and schedule for the event held in Park City, Utah on January 5-7. The group notes there to be a full stack of “wow” presentations embedded in the program in addition to the developing takeaways from Madrigal’s announcement. Jörn looks forward to discourse on what he calls the “next generation of NITs” and Louise highlights an interest in updates on moving pathways forward. Surf on for the full preview and visit the NASH-TAG 2023 website to review this riveting agenda. 

Yesterday, in a monumental moment in the never-ending pursuit of putting a major dent in Fatty Liver disease, Madrigal Pharmaceuticals announced positive topline results from the pivotal Phase 3 MAESTRO-NASH clinical trial of resmetirom for the treatment of NASH and liver fibrosis. Madrigal’s leadership intends to file for resmetirom’s accelerated approval with the FDA in the first half of 2023. If approved, the drug may become the first NASH medication introduced to market, depending on the outcome and timing of Intercept Pharmaceuticals’ refiling of obeticholic acid.

To recognize this special occasion, Surfing the NASH Tsunami hosts its largest ever suite of panelists who react to the enthusiasm, synergy and implications surrounding the news. Alongside regular Surfers Jörn Schattenberg, Louise Campbell and Roger Green are friends of the podcast, Michael Betel, Donna Cryer, Scott Friedman, Kris Kowdley, Mazen Noureddin and Rachel Zayas. This is an unmissable, full house discussion which surveys what is primed to be a momentous breakthrough for the field. Read the Madrigal press release and surf on to hear what is to be a memorable episode.

The latter half of December marks the Surfing the NASH Tsunami annual NAFLD Year-in-Review. In Part 1 of this Season 3 finale, Surfers Jörn Schattenberg, Louise Campbell and Roger Green interview Scott Friedman, Hannes Hagström and Donna Cryer to discuss putting a dent in Fatty Liver disease in 2022 and beyond. This episode features compiled excerpts from our respective guest interviews. Each interview in its entirety will debut as this week’s conversations, releasing Friday through Sunday.

Surf on to hear the diverse and powerful perspectives provided by a handful of the field’s Key Opinion Leaders who made headlines and advances in Fatty Liver disease in 2022.