nash

Surfing the MASH Tsunami continues its 2023 wrap-up conversations with Global Liver Institute Vice President of Liver Health Programs Jeff McIntyre, along with co-hosts Louise Campbell and Roger Green. The conversation focuses on Jeff's mixed assessment of 2023, focusing largely on drug approvals and the new nomenclature.  

In 2023, the field of fatty liver disease experienced both setbacks and progress, encapsulated in Jeff's phrase, "Two steps back, one step forward." Central issues included drug approval processes, nomenclature changes, and advancements in understanding and treating Non-Alcoholic Steatohepatitis (NASH). The year was marked by significant efforts to address fatty liver disease, but results were mixed, partly due to the complexities and inefficiencies in the drug approval process.

A notable moment was the FDA Advisory Committee's review of obeticholic acid, which highlighted issues with the clarity and reliability of the FDA's drug approval endpoints. This process was perceived as bureaucratic, sometimes disheartening, and not always effectively engaging with patient communities. Jeff underscores the importance of enhancing communication between various stakeholders in healthcare, including medical societies, patient communities, and regulatory bodies.

The conversation also reveals a consensus on the need for more involvement of patients and nurses in decision-making processes. Jeff stresses the necessity of educating the FDA about liver disease and the impact of drug approvals on patient safety, advocating for a stronger voice for patients and nurses in redefining the FDA’s approach to safety.

Roger adds to the discussion by expressing concerns about institutional risk aversion in regulatory processes, which can impede drug approvals. He points out that some FDA committee members lack basic knowledge about fatty liver disease, leading to naive questions and decisions. Louise highlights the reclassification of fatty liver disease as metabolic dysfunction and its potential benefits, suggesting that integrating liver disease treatment within endocrine and cardiology care could be beneficial due to the interconnected nature of these fields.

Looking ahead to 2024, Jeff anticipates positive developments in drug approvals and increased patient involvement. He notes the change from International NASH Day to Global Fatty Liver Day, indicating a shift in nomenclature and expectations of more patient engagement in regulatory discussions and decision-making processes.

In conclusion, the conversation reflects a blend of optimism and caution regarding the future of fatty liver disease treatment. The importance of patient-centered approaches and collaborative efforts among healthcare stakeholders is emphasized, highlighting the ongoing need for patient advocacy organizations to play a significant role in navigating the complexities of the disease. This includes dealing with the challenges posed by the new nomenclature and the potential for new treatments. The dialogue underscores the necessity for a more integrated, patient-focused healthcare system that prioritizes the perspectives and needs of those directly affected by fatty liver disease.

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.

This week on Surfing NASH, host Roger Green embarks on a series of one on one interviews with KOLs and patient advocates to talk about the Liver Meeting 2023 (held in Boston from November 10 - 14) and much more. In this conversation, friend of the podcast, Naim Alkhouri, joins to discuss this highly anticipated event as well as offer a glimpse into his current work and research interests.

The Liver Meeting is known for its exceptional educational content and amazing presenters. This year will be no exception and, if you can't make it to Boston, the state-of-the-art lectures will also be available online. If you have questions or comments stemming from this conversation, the Liver Meeting, or our interview series in general, 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, host Roger Green embarks on a series of one on one interviews with KOLs and patient advocates to talk about the Liver Meeting 2023 (held in Boston from November 10 - 14) and much more. In this first conversation, Jörn Schattenberg joins to discuss this highly anticipated event as well as offer a glimpse into his current work and research interests.

The Liver Meeting is known for its exceptional educational content and amazing presenters. This year will be no exception and, if you can't make it to Boston, the state-of-the-art lectures will also be available online. If you have questions or comments stemming from this conversation, the Liver Meeting, or our interview series in general, 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!

In continuation of the Surfing NASH interview series, Roger Green talks to Professor Oren Shibolet, Head of Gastroenterology and Hepatology at the Tel Aviv Medical Center. This is a powerful discussion which touches on the Hamas invasion on October 7 and its aftermath on the Israeli people and the practice of medicine today.

This conversation From the Vault reprises our earlier interview from June with Tetiana Deshko, Director of Programs for the Alliance for Public Health in Ukraine. Dr. Deshko shared her own experience with the challenges of providing health for patients in the midst of an invasion, particularly in occupied and battleground areas.

Think of this From the Vault episode as a dramatically expanded  weekly business report, in which Roger discusses the situation in Ukraine. Dr. Deshko's description is powerful and provokes emotions that words cannot describe. You can support her vital public health work by making  donation to the Alliance for Public Health, one of the largest non-governmental organizations in Ukraine, (click this link to donate and read more about their important work).

If you have any question or interests around the event or Ms. Deshko's  experiences in Ukraine, 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! Перемагаймо разом!

In continuation of the Surfing NASH interview series, Roger Green talks to Professor Oren Shibolet, Head of Gastroenterology and Hepatology at the Tel Aviv Medical Center. This is a powerful discussion which touches on the Hamas invasion on October 7 and its aftermath on the Israeli people and the practice of medicine today. In this conversation, Oren discusses how the events of October 7 have affected the Israeli medical system, focusing largely on the practice of hepatology. Along the way, you will get a flavor of what it is like to live in a place where air raid sirens ring 5-6 times per day and there are strict, life-saving protocols about what to do when you hear the sirens. This description cannot begin to touch on the gravity of this conversation, so surf on for the full account.

If you have questions or comments stemming from this episode, or the interview series in general, 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!

In continuation of the Surfing NASH interview series, this week Roger Green talks to Professor Oren Shibolet, Head of Gastroenterology and Hepatology at the Tel Aviv Medical Center. This is a powerful discussion which touches on the Hamas invasion on October 7 and its aftermath on the Israeli people and the practice of medicine today. This first conversation starts with Professor Shibolet talking about his career history. From there he shifts to discuss his experiences of October 7, the devastating day of the Hamas terrorist attack.

If you have questions or comments stemming from this episode, or the interview series in general, 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!

In continuation of the Surfing NASH interview series, this week Roger Green talks to Professor Oren Shibolet, Head of Gastroenterology and Hepatology at the Tel Aviv Medical Center. This is a powerful discussion which touches on the Hamas invasion on October 7 and its aftermath on the Israeli people and the practice of medicine today. Surf on to learn more about this current complex issue and more.

If you have questions or comments stemming from this episode, or the interview series in general, 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!

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. This episode From the Vault reviewed a model that Ian Rowe and Richard Parker developed to determine the most cost-effective strategy for F2/3 diagnosis.

In this conversation, Ian Rowe describes the factors that motivated him and Richard Parker to build a decision model focusing on early NASH diagnosis. He identifies three data points demonstrating how severely NASH stakeholders need a better early diagnosis paradigm and then describes the five diagnostic strategies his model will test. :

1. the high percentage of people whose liver disease is picked up for the first time when they present in the ED with decompensating disease or hepatic encephalopathy
2. the fact that roughly four in ten of these patients will die during treatment for this initial round of liver disease
3. the inefficiencies around diagnostic current methods, whereby practitioners flag abnormal liver enzyme tests and refer to specialists, where it may take months to get a specialist appointment.
4. He then describes the five early diagnostic strategies that will be tested and contrasted in this decision curve model.

This week on SurfingNASH, we introduce the audience to new guest, Dr Roberta Forlano, who's been awarded an EASL Juan Rodes PhD Fellowship and has completed a PhD in Translational Hepatology at Imperial college London in 2022. Her current research interest are screening strategies for NAFLD in primary care, automated quantitation of histological features , lifestyle management, CV risk assessment and non-invasive markers in NAFLD. These interests and much more are shared and discussed with Jörn Schattenberg, Louise Campbell and Roger Green in a compelling episode with an overarching theme focusing on screening strategies for gender-based SLD challenges. To offer an example of how immensely productive and busy Roberta and her team have been, they recently presented 6 posters at the recently concluded SLD Summit.

This final conversation covers the other paper discussed in the episoe at large, a literature review looking at how MASH and MASLD might differ in women compared to men. Roberta starts by noting the gap in literature about gender differences in MASH studies, and that women appear represented in most clinical trials. Most of the rest of the conversation involves Roberta and Louise commenting on gender differences and the impact of menopausal status on MASH and MASLD in women. When this finishes, Roger asks Louise and Jörn to describe one thing we discussed that might affect their practices or patterns. He also asks Roberta what she would like listeners to take away from the conversation.

With that as a very brief introduction to a fascinating conversation well-worth a listen, surf on to learn more about Roberta and critical ideas around screening strategies and much more. If you have questions or comments stemming from this episode, or any others for that matter, 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 SurfingNASH, we introduce the audience to new guest, Dr Roberta Forlano, who's been awarded an EASL Juan Rodes PhD Fellowship and has completed a PhD in Translational Hepatology at Imperial college London in 2022. Her current research interest are screening strategies for NAFLD in primary care, automated quantitation of histological features , lifestyle management, CV risk assessment and non-invasive markers in NAFLD. These interests and much more are shared and discussed with Jörn Schattenberg, Louise Campbell and Roger Green in a compelling episode with an overarching theme focusing on screening strategies for gender-based SLD challenges. To offer an example of how immensely productive and busy Roberta and her team have been, they recently presented 6 posters at the recently concluded SLD Summit.

This conversation starts with Roger asking Roberta to describe the demographics of the population in the northwest London region where the study of interest was done. Roberta comments on the robust diversity of the population, after which Louise amplifies this point by noting the large number of Arabic and South Asian patients in the study population. She discusses why culturally this might matter and the challenges that those populations might present. From there, we discuss the P-values associated with different diabetes drug therapies and their impact on MASH and simple diagnostic methods. Finally, ideas are shared around challenges which may present to patients which ultimately persuade them not to participate in a study. 

With that as a very brief introduction to a fascinating conversation well-worth a listen, surf on to learn more about Roberta and critical ideas around screening strategies and much more. If you have questions or comments stemming from this episode, or any others for that matter, 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 SurfingNASH, we introduce the audience to new guest, Dr Roberta Forlano, who's been awarded an EASL Juan Rodes PhD Fellowship and has completed a PhD in Translational Hepatology at Imperial college London in 2022. Her current research interest are screening strategies for NAFLD in primary care, automated quantitation of histological features , lifestyle management, CV risk assessment and non-invasive markers in NAFLD. These interests and much more are shared and discussed with Jörn Schattenberg, Louise Campbell and Roger Green in a compelling episode with an overarching theme focusing on screening strategies for gender-based SLD challenges. To offer an example of how immensely productive and busy Roberta and her team have been, they recently presented 6 posters at the recently concluded SLD Summit.

This conversation starts with your Jörn returning to a key point from Roberta's paper around a 38% false negative rate for FIB-4 screening. Jörn notes that while this feels like a high rate for false negatives, it might not present as much of a diagnostic challenge if treaters repeat the screening every 2 to 3 years. Roberta agrees and notes how remarkably cost effective this screening strategy is. Even in an environment with no approved drugs for MASH, Louise notes that the false negative rate for Enhanced Liver Fibrosis (ELF™) Test was far higher, which Roberta attributed to the test thresholds which were set for severe disease. She suggests that if health is to be used in these situations, the cutoffs need to be far lower. From there, the group goes into several issues of the paper the value of VCTE diagnostics, the common theme that most patients come from a background of lower socioeconomic status and the idea that simple ultrasound produced reasonably reliable results. This last point matters tremendously because primary care clinics throughout the world are more likely to have access to ultrasound than VCTE, and in some countries, ultrasound is the only imaging technique reimbursed by the health care system.

With that as a very brief introduction to a fascinating conversation well-worth a listen, surf on to learn more about Roberta and critical ideas around screening strategies and much more. If you have questions or comments stemming from this episode, or any others for that matter, 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 SurfingNASH, we introduce the audience to new guest, Dr Roberta Forlano, who's been awarded an EASL Juan Rodes PhD Fellowship and has completed a PhD in Translational Hepatology at Imperial College London in 2022. Her current research interest are screening strategies for NAFLD in primary care, automated quantitation of histological features , lifestyle management, CV risk assessment and non-invasive markers in NAFLD. These interests and much more are shared and discussed with Jörn Schattenberg, Louise Campbell and Roger Green in a compelling episode with an overarching theme focusing on screening strategies for gender-based SLD challenges. To offer an example of how immensely productive and busy Roberta and her team have been, they recently presented 6 posters at the recently concluded SLD Summit.

This conversation starts with Louise introducing our new guest Surfer and why she felt the various recent papers might be so important for our audience. For Louise, the common thread in much of Roberta's work, and certainly the two papers we discuss in this episode, is the focus on at-risk populations, patients with Type-2 diabetes in primary research, and postmenopausal women in literature review. Most of the conversation entails Roberta discussing the reasons she and her team pursued the issue of screening done by frontline treaters among a high-risk patient group, and in this case, patients with Type-2 diabetes in the northwest area of London. She describes all the key elements of the paper, from how the group selected patients to screen and how to screen them to then what the researchers learned in the process of doing the study. When she finishes, Jörn commends the study and notes that the results described are similar to what he has seen when evaluating patients in this clinic 

With that as a very brief introduction to a fascinating conversation well-worth a listen, surf on to learn more about Roberta and critical ideas around screening strategies and much more. If you have questions or comments stemming from this episode, or any others for that matter, 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 SurfingNASH, we introduce the audience to new guest, Dr Roberta Forlano, who's been awarded an EASL Juan Rodes PhD Fellowship and has completed a PhD in Translational Hepatology at Imperial college London in 2022. Her current research interest are screening strategies for NAFLD in primary care, automated quantitation of histological features , lifestyle management, CV risk assessment and non-invasive markers in NAFLD. These interests and much more are shared and discussed with Jörn Schattenberg, Louise Campbell and Roger Green in a compelling episode with an overarching theme focusing on screening strategies for gender-based SLD challenges. To offer an example of how immensely productive and busy Roberta and her team have been, they recently presented 6 posters at the recently concluded SLD Summit.

With that as a very brief introduction to a fascinating conversation well-worth a listen, surf on to learn more about Roberta and critical ideas around screening strategies and much more. If you have questions or comments stemming from this episode, or any others for that matter, 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, SurfingNASH offers an episode comprising two seperate interviews which focus on stories around career trajectories, transitions and entrepreneurship. Host Roger Green talks with Rachel Zayas (AGED Diagnostics) and Michelle Long (Novo Nordisk) about their unique stories and creating new opportunities amidst a field with broadening but sometimes opaque horizons. These discussions will be very informative for those who may be wondering about what's on the other side, whether it be commercial medicine or academia. Surf on to learn more as Rachel and Michelle expand on bridging these gaps, managing challenges and their excitement for new ways forward.

In this final section of our interview with Michelle, we focus on the advice that Michelle would give a person in academia who wants to consider a corporate career and, conversely, what she now looks for in a corporate candidate coming from academia. Finally, Michelle discusses how she expects to spend the bulk of her research and conference time over the next year.

If you have questions or comments around these interviews or any of the topics discussed in this episode, 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, SurfingNASH offers an episode comprising two seperate interviews which focus on stories around career trajectories, transitions and entrepreneurship. Host Roger Green talks with Rachel Zayas (AGED Diagnostics) and Michelle Long (Novo Nordisk) about their unique stories and creating new opportunities amidst a field with broadening but sometimes opaque horizons. These discussions will be very informative for those who may be wondering about what's on the other side, whether it be commercial medicine or academia. Surf on to learn more as Rachel and Michelle expand on bridging these gaps, managing challenges and their excitement for new ways forward.

This conversation with Michelle shifts focus to why she considers herself to have been naïve about commercial life. She then talks about the traits and characteristics that make an individual a good candidate to succeed and enjoy being in industry, and alternatively, the characteristics that suggest an individual might not enjoy it so much or perform as well.

If you have questions or comments around these interviews or any of the topics discussed in this episode, 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, SurfingNASH offers an episode comprising two seperate interviews which focus on stories around career trajectories, transitions and entrepreneurship. Host Roger Green talks with Rachel Zayas (AGED Diagnostics) and Michelle Long (Novo Nordisk) about their unique stories and creating new opportunities amidst a field with broadening but sometimes opaque horizons. These discussions will be very informative for those who may be wondering about what's on the other side, whether it be commercial medicine or academia. Surf on to learn more as Rachel and Michelle expand on bridging these gaps, managing challenges and their excitement for new ways forward.

This conversation features the first part of our interview with Novo Nordisk International Medical Vice President, Michelle Long. The discussion focuses on the process by which Michelle came to leave academia and transition to corporate life. Along the way, she covers the importance of mentorship as well as deeply understanding what an individual finds exciting about a career in academia and, more specifically in Michelle’s case, academic research.

If you have questions or comments around these interviews or any of the topics discussed in this episode, 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, SurfingNASH offers an episode comprising two seperate interviews which focus on stories around career trajectories, transitions and entrepreneurship. Host Roger Green talks with Rachel Zayas (AGED Diagnostics) and Michelle Long (Novo Nordisk) about their unique stories and creating new opportunities amidst a field with broadening but sometimes opaque horizons. These discussions will be very informative for those who may be wondering about what's on the other side, whether it be commercial medicine or academia. Surf on to learn more as Rachel and Michelle expand on bridging these gaps, managing challenges and their excitement for new ways forward.

This final part of Roger’s interview with Rachel shifts quickly from a discussion around fundraising to one about intentionality. Rachel shares the journey of how her company began with focus on hepatocellular carcinoma, the listening process that led to a refocus on NASH and NAFLD, and some of the opportunities that have accrued as a result of this switch. The rest of the conversation exemplifies the importance of strategic partnerships by focusing on AGED’s partnership with the US Department of Defense through the Henry Jackson Foundation.

If you have questions or comments around these interviews or any of the topics discussed in this episode, 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, SurfingNASH offers an episode comprising two seperate interviews which focus on stories around career trajectories, transitions and entrepreneurship. Host Roger Green talks with Rachel Zayas (AGED Diagnostics) and Michelle Long (Novo Nordisk) about their unique stories and creating new opportunities amidst a field with broadening but sometimes opaque horizons. These discussions will be very informative for those who may be wondering about what's on the other side, whether it be commercial medicine or academia. Surf on to learn more as Rachel and Michelle expand on bridging these gaps, managing challenges and their excitement for new ways forward.

If you have questions or comments around these interviews or any of the topics discussed in this episode, 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 episode From the Vault comes from last year's SurfingNASH review of the 2022 NAFLD Summit with Mazen Noureddin, Sven Francque and Hannes Hagström.

The 2022 NAFLD Summit uniquely presented a range of perspectives and insights on fatty liver and metabolic diseases.

Program speakers Mazen Noureddin, Sven Francque and Hannes Hagström join Surfer, Roger Green, on site from Dublin to review their reactions immediately after the conference ended. At the outset of this episode, the group discusses the benefits of participating in a smaller conference more focused on the challenges presented by the field of NAFLD. Mazen likens the NAFLD Summit to NASH-TAG, asserting that these specific conferences advance the field and address deeper layers around the issues that matter most. “You start being provocative.”

Mazen goes on to raise the issue of glycemic control and the impact of glycemic control on NASH drug performance. This bleeds into a brief point about the value of simply stopping fibrosis progression instead of the need to prove regression. He then identifies two sessions he considered particularly valuable: the Saturday morning autopsy of failed Phase 3 trials and therapeutic discussion about drugs at different stages in development. This segues into a discussion of optimism which can derive from the recent Akero and Altimmune results. In terms of Altimmune, Mazen asks whether the drug should go directly from Phase 1b to Phase 3. In general, the group believes that Phases 2a and 2b have value here. The panel agrees that the presentations on three failed Phase 3 trials were richly valuable and that each offered its own clear lessons for researchers.