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Surfing the NASH Tsunami
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Surfing the NASH Tsunami

Author: HEP Dynamics LLC

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Driving the Discussion in Fatty Liver Disease. Join hepatology researcher and Key Opinion Leader Stephen Harrison, Liver Wellness Advocate Louise Campbell, and Forecasting and Pricing Guru Roger Green as they discuss the issues affecting the evolving NASH market from their own unique perspectives on the Surfing the NASH Tsunami podcast. #NASH #NAFLD #FattyLiver
57 Episodes
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Manal Abdelmalek joins the Surfers to describe long-term changes in patient management that improved diagnostic and telecommunication technologies can drive in response to new COVID-19 induced challenges.How must we adapt to the changes in patient management caused by COVID-19? The Surfers, spurred by creative ideas from guest Manal Abdelmalek, think about ways to re-engineer patient communication and treatment, including innovations in patient-management and out-of-office diagnostics. Whether discussing "de-livery" vans loaded with complete sets of diagnostic tools or the use of colors, icons, and one-letter code to convey the results of lab tests, the Surfers surface an array of creative concepts for our future.
Question: If NALFD patients have poorer COVID-19 prognoses, how can we use this fact to drive broader population-based screening?This conversation asks a two-part question: How do we motivate primary care treaters and specialists who treat metabolic syndromes to manage NAFLD more aggressively? The conversation considers education and telemedicine in this context and then turns to two very ambitious concepts. One of these deals with screening, the other with treatment before approvals. Listen until the end then let us know what you think and what big ideas you, yourself might have.
The COVID-19 conversation continues with the group focusing on challenges in clinical trial execution and how innovative logistics and consistent education can lessen or overcome them.In this conversation, the group starts by discussing the significant number of patients who could benefit from NAFLD or NASH therapy centered around defatting the liver through medications and behavioral support and proceeds to address ways to manage these issues in a pandemic for a disease with no approved medications. Louise discusses the importance of broad monitoring for patients who might have an early-stage disease, Stephen comments on the importance of education and Manal provides examples of successful "out-of-the-box" patient management programs such as simple home-based "Lab and Leave" visits. The conversation is filled with real passion and enthusiasm for solving new challenges.
Manal Abdelmalek joins the Surfers to consider the three most important COVID-19 stories today.The conversation focuses on the British variant, the new vaccines, and the physical and emotional toll the pandemic continues to take on front-line physicians and other healthcare workers. Stephen and Manal each have a sibling who works as an ER physician and they provide heart-wrenching stories on how tough the front lines are. Louise discusses how Britain is reacting to government policy designed to contain the new, more contagious COVID-19 variant. Roger discusses possible epidemiological trends and explains why the US may eventually follow the UK policy of delivering the first doses of the vaccine as quickly as possible. Thought-provoking in its own right, the discussion helps frame treatment and policy choices as well as the rest of this episode.
Manal Abdelmalek joins the Surfers to discuss how recent COVID-19 news might affect Fatty Liver patients and what the medical profession and BioPharma companies can do to support patients better during this dangerous phase of the pandemic.Manal Abdelmalek joins the Surfers to discuss the implications of the new British COVID-19 variant, availability of the Pfizer/BioNTech and Moderna vaccines and impact of social distancing on patients with Fatty Liver Disease. The discussion starts by surveying the current situation and goes on to discuss challenges for patients and provider and then keys to maximum success in conducting clinical trials and treating patients. In the end, Stephen Harrison and Roger Green propose big, bold solutions to improve diagnosis and patient care.
Wayne Eskridge describes how hope fell and then rose as patients did not receive the drug approval they expected but then learned about exciting paths for new agents and non-invasive testing.Wayne Eskridge describes his excitement as 2020 ends, saying "The quality of the work that's being done overall says that this is a far more tractable problem than we thought it was a couple of years ago. The level of sophistication that's being applied was undreamed of by the profession five years ago. So I'm very, very confident that we're going to see effective therapies," before cautioning, "How many jumps we have to get past to get there, I don't know." His excitement centers around very positive Phase 2 trials for multiple drugs with innovative modes of action and major advances in research and acceptance of non-invasive tests.
Louise Campbell questions the implication of APASL and ALEH endorsing "MAFLD" as Fatty Liver Disease nomenclature and Stephen Harrison discusses behind-the-scenes activities to resolve this issue.Louise Campbell "wonders" where increased support for adopting the term "MAFLD" (Metabolic-Associated Fatty Liver Disease) instead of NAFLD (Non-Alcoholic Fatty Liver Disease) "is going to take us in the next 12 months and how we are going to come to a resolution." In response Stephen Harrison provides background on how the dispute started and discusses the current multi-regional efforts to create consensus around a nomenclature that describes the range of Fatty Liver Diseases accurately.
Joern Schattenberg discusses the public health implications of German newspapers beginning to discuss Fatty Liver DiseaseFor Joern Schattenberg, reading about Non-Alcoholic Fatty Liver Disease in a German newspaper "has two or three very important implications that we have discussed on the podcast in the past year," particularly in terms of educating patients with metabolic syndromes and families with obese children or adolescents. Increasing awareness of late-stage liver fibrosis and cirrhosis will bring short-term benefits to one set of patients, while reducing the frequency of liver disease in the young will have long-term benefits for these patients and the society at large.
Ian Rowe discusses how streamlined use of ELF, FIB-4 and FibroScan improves cost effectiveness and patient satisfaction associated with NASH screening.Ian Rowe comments on data from the landmark work he, Richard Parker and colleagues in Leeds, UK are conducting around the issue of population screening for NASH: "it's quite easy to show that you can identify more liver disease in the community and you can do so more efficiently." This short interview goes into detail.
Guests Ian Rowe, Joern Schattenberg and Wayne Eskridge join the Surfers to discuss key lessons learned in 2020 about Patient Treatment and Perspectives.Ian Rowe, Joern Schattenberg and Wayne Eskridge join the Surfers to explore some of the key lessons learned and issues uncovered in 2020. Ian Rowe discusses what population-level research in Leeds, UK, tells us about the benefits a streamlined liver testing model can yield not only in terms of better, faster diagnoses but also cost savings and improvement in patient satisfaction. Joern Schattenberg considers the implications when German mass media raises issues of Fatty Liver Disease in holiday season news stories. Louise Campbell questions what a patient-supported push to change the disease nomenclature from NAFLD to MAFLD implies for the future, while Stephen Harrison describes the emerging effort to get the most accurate and clearest nomenclature possible. Finally, Wayne Eskridge provides his perspective as patient and patient advocate on a year full of both happy surprises and disappointments and he finds himself surprised to be more optimistic at the end of 2020 than at the beginning.
Roger Green discusses why despite widespread concerns, FDA's Complete Response Letter to Intercept did not cripple progress in NASH drug development.Observers feared that after Intercept received its CRL, investment into NASH drug development would dry up and knowledge would slow. Instead, Roger Green describes how drugs that had reached Phase 2 development maintained sufficient momentum to move forward. As a result, therapeutic focus shifted from treating fibrosis in late stage patients (obeticholic acid's benefit) to treating the whole patient, including not only NASH but the full range of metabolic considerations. Net result: the vibrant, "boiling hot" market for NASH clnical trials and researchers that Vlad Ratziu described and the prospects that several exciting classes of NASH drugs will be here soon.
Stephen Harrison summarizes a year of progress in improving the tests and analyses used to derive clinical endpoints necessary to initial drug approvals.Despite reports earlier in the year, Stephen Harrison discusses the "aggressive, conscientious effort" an array of stakeholders is making to improve on the clinical endpoints that shape the decision to approve a Fatty Liver Disease drug before it has demonstrated positive outcomes for patients and the healthcare system. Three keys: (1) more rigorous human review of biopsy slides, (2) an eventual shift to incorporate Artificial Intelligence and, someday, (3) use of AI and non-invasive tests as a complete plan for developing these clinincal endpoints.
Mazen Noureddin describes a year in which biopsy's shortcomings are revealed at the same time as non-invasive testing becomes better and produces more robust data.Mazen Noureddin discusses the simultaneous loss of faith in biopsy as the clinical "Gold Standard" and the emergence of non-invasive tests that can become the standard and replace biopsy for three pivotal diagnostic needs:1. Identifying patients at risk, those with fibrosis levels equal to or higher than F2 2. Identifying patients who can serve as targets for clinical trial, which usually means they have NASH levels or at least N4 along with fibrosis greater than or equal to F23. Monitoring therapeutic responsiveness in both sets of patients over time without the need for serial biopsy.
Vlad Ratziu discusses a "boiling hot" field of emerging NASH drugs and "particularly rich" data coming from no-invasive diagnostic testing.Despite elafibranor failing, obeticholic acid not securing FDA approval and COVID-19 related limitations in the conduct of clinical trials, "this was a very good year actually for NASH clinical trials," with "some significant advances in terms of therapeutics for NASH" and . We had the results of several trials this year. We had the unfolding story of other molecules that are in development for NASH and all this makes for a very, very vibrant environment in terms of therapeutic research for NASH." Further, MRI-based methods "are becoming mainstream," starting to fulfill the promise of non-invasive testing.
The Surfers and guests Vlad Ratziu and Mazen Noureddin discuss key lessons learned in 2020 about Drugs and Diagnostics.Vlad Ratziu and Mazen Noureddin join the Surfers to explore some of the key lessons learned and issues uncovered in 2020. Vlad Ratziu provides a 10-minute overview of a fast-paced year of successes (and occasional failures) in clinical trials and novel diagnostics. Mazen Noureddin discusses the expanding role of non-invasive liver tests in diagnosis, patient treatment and monitoring and drug development. Stephen Harrison updates our knowledge about the use of clinical endpoints in obtaining conditional drug approvals. Finally, Roger Green places the entire year in a systems context with an eye toward the Law of Unintended Consequences and why the obeticholic acid Complete Response Letter was not the death knell many observers feared.
Donna Cryer and Global Liver Institute Director of Policy Andrew Scott return to discuss their 2021 US NASH Action Plan, garnering support for the new COVID-19 vaccines and the importance of aligning stakeholders with Stephen, Louise and Roger.The Surfers end the year on an optimistic note by talking with sometime-surfer Donna Cryer and GLI Director of Policy Andrew Scott about GLI's ambitious 2021 US NASH Action Plan, which should be released by the time you read this. The plan seeks to align all groups of key NASH stakeholders around common goals to provide appropriate diagnostics, therapy and support for NAFLD and NASH. The panel also considers time discussing acceptance and rate of uptake for the COVID-19 vaccines and the nature of leadership in a complex situation like the one NASH faces throughout the world. An episode full of new information, different viewpoints and positive energy to end what has been a truly challenging year.
Donna Cryer and Global Liver Institute Director of Policy Andrew Scott join Stephen, Louise and Roger to discuss the policy progress liver disease and NASH have made in the last four years.This is the first of two epiodes discussing Public Policy questions that affect how stakeholders view NAFLD andNASH as a disease as well as the process by which related drugs and diagnostics are evaluated. Today's episode addresses the many kinds of progress that liver policy has made in the past four years, ranging from a bipartisan NASH Act awaiting action in Congress to increasing alignment with other medical specialties and disease advocates to work together on NASH as part of a multi-system metabolic health platform. The theme was "convergence" -- people and organizations coming together to consider the liver more broadly in the context of overall health.
Dr Ian Rowe and Prof. Dr. Jörn M. Schattenberg joins the Surfers to explore the relationship between NAFLD and CVD in light of recent work questioning the strength of links between the twoThis episode asks how to reconcile results from a presentation at EASL suggesting that the primary cause of death from NAFLD patients is liver disease and the low level of CVD events in the STELLAR-3 and STELLAR-4 trials with significant other data identifying CVD as the leading cause of death in NAFLD patients. The group determined that design issues led to the low level of CVD events in the various study populations, then confirmed the importance of the link. Finally, we explored implications in terms of patient care and clinical trial design.
Guest Ian Rowe and Dr. Kris Kowdley join the Surfers to discuss how the 2nd COVID wave and arrival of the vaccine are likely to affect patient treatment and clinical development.In Episode 39, hepatologists Ian Rowe and Kris Kowdley, who divide their time more or less evenly between patient clinics and clinical trials, join the Surfers to discuss how the Second Wave of COVID-19 will affect patient treatment and clinical trials. This conversation turns conventional wisdom on its ear. The Surfers focused less on individuals' behavior and more on supply chain disruptions, growing shortfalls in the number of available healthcare workers and large-scale dislocations that will occur after the vaccine is in place. This episode challenges underlying assumptions about how the next few years might evolve and what will matter most.
Prof.  Vlad Ratziu, MD, and Prof. Dr. Jörn M. Schattenberg join the Surfers to wrap up our conversation about this year's AASLD meeting.Prof. Dr. Jörn M. Schattenberg erg and Prof.  Vlad Ratziu, MD join the Surfers for our wrap-up episode for TLMdX 2020. Joern focuses on a diabetes poster demonstrating the path of drug efficacy over a three-year period, while Vlad focuses on the successful Phase 2 trial of the pan-PPAR lanifibranor. The group also asks why placebo response varies so much between studies and whether the ratio of F2:F3 patients may be a factor. Finally, the Surfers focuses on what they consider the biggest lessons emerging from the meeting.
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