nashtag

As the podcast hosts insights from our very own audience this week, we are extending three additional conversations from recent reviews of a particularly exciting NASH-TAG 2023. This session features dialogue from a one-on-one interview with Donna Cryer, hosted by Roger Green.

The episode begins with Roger mentioning what he found to be one of the most striking statistics from the meeting: an IQVIA study captured only 200,000 total ICD-10 codes for NASH in a total US population that should have yielded 16 million such codes. To Donna, this underscores a significant need: we have to find physicians that want to treat patients. As she puts it, “it would do more harm than good” to send patients to doctors’ offices before doctors are activated to screen and treat. Roger identifies a dilemma: if patients aren’t visiting doctors, doctors will not feel motivated to learn. However, if patients are seen by unmotivated doctors, a negative information loop emerges. Donna notes lessons from the hepatitis care cascade and that at the outset, there is the need to screen an “enriched population” with higher probability of NASH. Roger suggests this is easier in the US, where electronic health records are standard. In much of the rest of the world, ALT tests are not part of a standard blood panel and too many records are on paper. Donna then emphasizes the need to dramatically increase advocacy and energy among medical stakeholders. She also points to what drug and diagnostic companies can do to energize physician practices to identify the patients needing treatment after a drug is approved. Finally, Roger asks Donna to rate her level of enthusiasm emerging from NASH-TAG. He offers a scale ranging from 1 to 6, where 1 represents “thoroughly depressed” and 6 represents “over the moon.” Her response addresses organization around regulatory science in a way that makes what is undeniable inevitable. Surf on to hear her gauge.

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This week, Surfing NASH has focused on community engagement and incorporating insights and perspectives from the listeners. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and ideas in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond.

Stay safe and surf on!

As the podcast hosts insights from our very own audience this week, we are extending three additional conversations from recent reviews of a particularly exciting NASH-TAG 2023. This session highlights perspectives from patient advocates Tony Villiotti and Michael Betel as they join Louise Campbell and Roger Green for coverage of the first day at the conference.

The discussion begins with an idea from Tony and Michael that the cascading momentum the field is experiencing picked up steam at AASLD in November and carried on through the MOSAIC meeting in December. For advocates, the enthusiasm is largely centered on the likely approval of drugs in the near future and the sense of urgency this places, as Tony puts it, on expanding efforts to “get the message out.” Michael notes the importance of educating primary care physicians that there is something besides diet and exercise to support treatment. Louise adds that the alignment of specialties around screening is also critical to advancing Fatty Liver care. In response to a question from Michael, she makes explicit her belief that multidisciplinary alignment and statements will increase enthusiasm further. From there, Mike goes on to ask how the fact that diabetes and obesity patients might be on GLP-1s or dual agonists before being tested for liver disease might affect perceptions of the frequency of liver disease and/or the value of therapy. The remaining conversation focuses on the issue of how long patients must be on a medication. Louise likens it in her mind to autoimmune diseases, which will have flairs requiring medication. As the session winds down, Louise is discussing the breadth and depth of education she would like to see in the various medical stakeholder communities.

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This week, Surfing NASH has focused on community engagement and incorporating insights and perspectives from the listeners. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and ideas in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond.

Stay safe and surf on!

As the podcast hosts insights from our very own audience this week, we are extending three additional conversations from recent reviews of a particularly exciting NASH-TAG 2023. This session features highlights from the wrap-up episode chat with Amy Articolo and Naim Alkhouri joining Jörn Schattenberg and Roger Green.

The leading question asks the panelists to rate their levels of enthusiasm emerging from the conference in Deer Valley. The scale ranges from 1 to 6, where 1 represents “thoroughly depressed” and 6 represents “over the moon.” A similar question at the conclusion of NASH-TAG 2022 elicited 4s and 5s… This time the answers ranged from Roger’s relatively conservative “6” to 6.5 or 7 from the rest. The optimism primarily was a result of the idea that two Phase 3 drug trials appear to have hit FDA’s efficacy and safety standards, with resmetirom meeting the EMA’s more challenging “regress fibrosis while lowering NAS score” standard. Jörn describes the implications of this as having proven that “it’s doable and druggable.” Roger adds, and Amy agrees, that the efficacy levels the two drugs hit appear to leave significant room for new drugs and combination therapies to improve efficacy. From there, the group goes on to discuss the implications of what we are learning about the impact bariatric surgery can have on NASH. This leads Naim to make a cogent comment which Jörn describes as “hitting it out of the park.” Listen to the full segment to hear this powerful viewpoint.

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This week, Surfing NASH has focused on community engagement and incorporating insights and perspectives from the listeners. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and ideas in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond. 

Stay safe and surf on!

In a thematic debut, Jörn Schattenberg and Roger Green host interviews with three listeners from the Surfing NASH community to discuss four prominent questions around:

• the “straightjacket” of biopsy
• how we think about “tests” when not classed as "NITs" as compared to biopsy
• how do we all become better centered on patient needs
• the idea of combination therapy

In this final installment, Clinical Development lead at Sonic Incytes, Caitlin Schneider, joins Roger to discuss NASH-TAG 2023 and the future of Fatty Liver. After discovering that Caitlin and Roger share one unusual detail in their pasts, they dive into a discussion of the conference. Sonic Incytes developed and markets Velacur™️, an in-office imaging solution. Not surprisingly, much of Caitlin’s focus revolves around imaging diagnostics and their benefits against biopsy and larger imaging technologies like MRE and MRI-PDFF.

Each guest in these fully-featured interviews shares on-ground experiences which collectively cast invaluable light on how the information featured in Surfing the NASH Tsunami is digested and applied in everyday life. As the podcast enters its fourth season, and embarks on affiliated journeys like the Rising Tide series, we hope to grow our community engagement. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and perspectives in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond.

Stay safe and surf on!

In a thematic debut, Jörn Schattenberg and Roger Green host interviews with three listeners from the Surfing NASH community to discuss four prominent questions around:

• the “straightjacket” of biopsy
• how we think about “tests” when not classed as "NITs" as compared to biopsy
• how do we all become better centered on patient needs
• the idea of combination therapy

In this second installment, Jerry Mabary joins Roger to discuss NASH-TAG 2023 and the future of Fatty Liver. Jerry previously appeared on the podcast when he worked at Echosens and led their side of the LIVErHEALTHY launch. Now he has joined Chronwell, a LIVErHEALTHY partner and GE practice management support firm. As befits his background, Jerry’s conversation reflects heavily on non-invasive testing as well as the role digital apps will play in patient treatment. He weaves all this into an integrated vision of Fatty Liver care that incorporates the issues with the role of biopsy present and future. Finally, he notes ideas around the impact combination therapy will have on treatment over time.

Each guest in these fully-featured interviews shares on-ground experiences which collectively cast invaluable light on how the information featured in Surfing the NASH Tsunami is digested and applied in everyday life. As the podcast enters its fourth season, and embarks on affiliated journeys like the Rising Tide series, we hope to grow our community engagement. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and perspectives in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond.

Stay safe and surf on!

In a thematic debut, Jörn Schattenberg and Roger Green host interviews with three listeners from the Surfing NASH community to discuss takeaways from NASH-TAG 2023 and the future of Fatty Liver. The four prominent questions of each session focus around:

• the “straightjacket” of biopsy
• how we think about “tests” when not classed as "NITs" as compared to biopsy
• how do we all become better centered on patient needs
• the idea of combination therapy

In this first installment, the co-hosts are joined by Pamela Danagher, Senior Vice President for Regulatory Affairs at Terns Pharmaceuticals. This conversation explores the ways that biopsy has, as Pamela puts it, constrained and restrained drug development. Not surprisingly, she also offers strong viewpoints and tremendous insights about uses of testing and combination therapy - two issues pivotal to Terns. Finally, Pamela comments briefly on what Donna Cryer described in a recent episode as “regulatory science” and how the entire community can communicate in ways that support approval of resmetirom and OCA. 

Each guest in these fully-featured interviews shares on-ground experiences which collectively cast invaluable light on how the information featured in Surfing the NASH Tsunami is digested and applied in everyday life. As the podcast enters its fourth season, and embarks on affiliated journeys like the Rising Tide series, we hope to grow our community engagement. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and perspectives in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond.

Stay safe and surf on!

In a thematic debut, this episode comprises three interviews held with our very own listeners from the Surfing NASH community to discuss their takeaways from NASH-TAG 2023 and the future of Fatty Liver. 

Respectively, Pamela Danagher (Terns Pharmaceuticals), Jerry Mabary (Chronwell) and Caitlin Schneider (Sonic Incytes) join Jörn Schattenberg and Roger Green to explore four prominent questions around:

• the “straightjacket” of biopsy
• how we think about “tests” when not classed as "NITs" as compared to biopsy
• how do we all become better centered on patient needs
• the idea of combination therapy

Each guest shares insights which collectively cast invaluable light on how the information featured in Surfing the NASH Tsunami is digested and applied in everyday life. 

As the podcast enters its fourth season, and embarks on affiliated journeys like the Rising Tide series, we hope to grow our community engagement. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and perspectives in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond.

Stay safe and surf on!

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.

For our look back at NASH-TAG 2023, Jörn Schattenberg and Roger Green are joined by Amy Articolo and Naim Alkhouri for a discussion which dives into the therapeutic efficacy of recently announced data on resmetirom, NITs, bariatric surgery and more. Adjoining this session is a bonus interview with Donna Cryer on her impressions and key takeaways which largely look into the movement of regulatory science. In combination, this two-part episode encompasses contrasting and thought-provoking perspectives on addressing the opportunities and challenges in moving the Fatty Liver field forward.

Naim opens the first conversation by noting the positivity emitted, echoing Scott Friedman’s position that momentum from Madrigal’s emerging data on resmetirom animated the wider program. In addition, he highlights that granularity around Intercept’s study of patient response to obeticholic acid (OCA) revealed improvements among the F3 population. For Naim, OCA is a drug he has envisioned to be applied toward advanced disease and serves undermet needs of F3 patients. He concludes that in the wake of these aforementioned results, there remains plenty of opportunity to improve and other biotechs “are still in the game” with the energy to back them.

At this point, Jörn underscores the strong presence of academia and involvement of various consortia as further evidence of progress. Amy joins to comment on the vibrant and dynamic discussions around NITs and how to enrich trials. She suggests that the dialogue has reflected the advancements of the field and how work can be enhanced with collective contribution. This leads to thoughts on pharmacodynamic change and demonstrating value to payers. Roger distills a main idea: if only 24% of patients show a one-level regression of fibrosis in a given period of time, there is much to learn about the other 76%. Conversation continues around narrowing the indeterminate zone and improving biomarker concordance in NITs. After exploring considerations in moving beyond biopsy, the group investigates the role of bariatric surgery. While recognizing the validity of bariatric surgery as a treatment option, Naim points to a brighter future of preventative hepatology whereby action precedes BMI levels of 50 and higher. At the end of the session, Roger asks each panelist for one unexpected thing that might happen in the next year.

In the following interview, Donna opens with a powerful statement: hope is not a strategy, and optimism is not inevitability. Specifically, she is determined to match the trajectory of regulatory science to that of the momentous energies emerging from clinical science. In doing so, relationships and open lines of communication are key for meeting agreed endpoints. Next, the two talk about addressing the indeterminate zone in a different context and opportunities for harnessing real-world evidence. As this conversation moves forward, it becomes clear that Donna is committed to connecting patients to care today, and not only after a drug approval. In closing, she fields the same question as the preceding panelists, but offers a very different answer. Surf on to find out. 

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 Season 3, Episode 6, Roger Green assembles audio clips from Surfing the NASH Tsunami’s coverage of NASH-TAG 2022 to reveal an evolving view of the role combination therapies will play in the treatment and management of NASH patients. Discussion about “combination therapies” typically focuses on the idea of multiple agents prescribed concurrently to address a medical condition when monotherapy will not achieve desired goals. At NASH-TAG 2022, the concept of combination therapies took some interesting directions:

1. Longitudinal drug combinations — initial intervention designed to cause a fast reversal of fibrosis or defatting of the liver, followed by a longer-term therapy (mono or combination, but not with the first-round agent) designed to provide longer-term, more complete metabolic benefits in a regimen that is safer, more tolerable, less expensive, or some combination of these.
2. Longitudinal diagnostics — an early, inexpensive “rule out” test like FIB-4, followed by a liquid or machine-based test that provides more accurate disease staging.
3. Logical combinations — so far, most drug combination trials have resulted from a manufacturer trying to resuscitate a developmental agent that missed endpoints in monotherapy trials. It would be more logical to design combinations based on complementary modes of action.

This episode explores these and other combination therapy issues using quotes from the NASH-TAG 2022 coverage and Roger’s commentary.