Podcasts about global liver institute

In this episode of the Vital Health Podcast, host Duane Schulthess sits down with patient advocate and Global Liver Institute founder Donna Cryer. They trace her journey from Harvard and the DOJ prosecutor’s office to becoming a liver transplant recipient and a leading voice in healthcare policy. Donna shares insights on orphan drug incentives, the Inflation Reduction Act’s impact on research, the politicization of mRNA innovation, and the current crisis in NIH funding. Key Topics:- Patient Advocacy Evolution: Donna reflects on her transition from DOJ prosecutor to founding the Global Liver Institute and amplifying patient voices in healthcare policy.- Rare Disease Incentive Gaps: An examination of the orphan drug exclusivity landscape and its impact on treatment pipelines for ultra‑rare conditions.- Inflation Reduction Act Fallout: Insights into how Medicare price controls under the IRA are reshaping research priorities and patient access for older and rare disease populations.- mRNA Platform Politics: A discussion on the politicization of mRNA vaccines and the threat this poses to future cancer and therapeutic innovations.- NIH Funding Emergency: A look at the dramatic NIH budget cuts, stalled clinical trials, and the broader implications for biomedical research. Throughout this episode, Donna Cryer and Duane Schulthess unpack the challenges and potential solutions shaping patient‑driven policy, drug innovation, and research funding – insights critical for anyone invested in the future of healthcare. Patient advocates, healthcare policymakers, and industry leaders will find this discussion indispensable for navigating the complexities of innovation incentives and research ecosystems.See omnystudio.com/listener for privacy information.

This week's Expert is Jeff McIntyre, Vice President, Liver Programs at the Global Liver Institute. His major topic is how recent high-level FDA job cuts might affect MASH drug and diagnostics development. He also shares reactions to FibroSIGHT, HistoIndex's new digital pathology service for clinical practice. Highlight: Recent job cuts at the FDA will produce chaos in government and slow response to any emerging crises.Second Highlight: Patient self-advocacy becomes even more important in this environment.The conversation takes place on April 1, which lends context to Jeff's opening comment about the rate and nature of change in Washington, DC. He and Roger quickly focus on high-level job cuts at the FDA. Jeff believes that the clearest outcome from these changes is that the government will be less able to respond promptly and in a medically appropriate manner to future health crises. Jeff agrees with former FDA Commissioner Rob Califf's comment that the FDA as we know it "is dead," and that we have little idea what the future holds. A slower-moving, more chaotic government with a Secretary of HHS who minimizes pharmacotherapies for alternative therapies presents a challenge for all SLD patients. Jeff states that patients need to become more vigilant self-advocates (even more than they are today). He also identifies patient advocacy organizations like GLI as a place patients can go to seek the guidance and support they need from patient advocates. Finally, the conversation turns to discuss FibroSIGHT. Jeff describes FibroSIGHT as "exactly where we should be and should not be at the same time," a technology that takes a significant step forward in understanding and patient support, but one that ties us to biopsy as a standard for clinical care. Jeff and Roger agree this issue will play out over the coming years. 

In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation considers the role of patient advocacy in replacing biopsy in clinical trials with NITs and reviews a session on the foundational principles for patien-centric clinical trials. This conversation picks up at the end of Michelle's discussion of the FDA Corner session. Jeff starts by identifying this specific issue - replacing biopsy in clinical trials with NITs - as a place topic on which he believes patients must play a pivotal role in this discussion. He notes that patient advocacy has been involved already but anticipates this role will grow as the discussion progresses. After Michelle agrees how vital this issue is for patients and notes that manufacturers are "taking on this increased workload" for that reason, Jeff shares what he considers the key issue: FDA is not only a scientific agency but also a political one, and patients can serve as the "tip of the spear" toward political ends here. Mike describes a poster he presented (and was lead co-author), titled Patient Voice in MASH Initiatives:  Foundational Principles for the Conduct of Patient-Centric MASH Research. He lists the groups participating in this broad effort and describes the goal as "reimagin[ing] clinical trials for MASH and how they're designed and delivered... focusing on what matters the most for patients." The outcomes were a set of patient-centric principles:Transparency in explaining trial-related issues. Mike gave the example of placebos, how they are used, and what happens to a patient in the placebo cohort at the end of the trial."Whole person focus," including not only the medical issues but also emotional and practical issues that can emerge throughout the trial as patients' needs and life situations change."Patients as partners," treating them as collaborators instead of subjects.Family and caregiver awareness, noting how deeply involved family members are through the trial process.Responsiveness to patient needs through surveys and checkpoints throughout the process.Mike closed his comments by stating that all these points "put the patient at the center of the process," which meant considering not only diversity and inclusiveness in the trial population but also knowing and acting on what diversity will be in the context of these five principles.Speaking from their perspectives as researchers, Michelle and Jörn were both highly supportive of the principles (Michelle called them "fantastic.") Jörn noted that the entire trial process starts with patient-centricity since the research is inherently designed to benefit patients.

In this episode, Naim Alkhouri, Mike Betel, Michelle Long and Jeff McIntyre join Jörn Schattenberg and Roger Green to look back at The Liver Meeting 2024. This conversation reviews two sessions promoting healthy livers and asks panelists what they anticipate for #TLM2025. This last conversation starts with Jeff describing the session that moved him most and praising a panel that Mike co-chaired on Lifestyle Management of MASLD and MASH. Jeff spoke on this panel, and he describes the breadth and quality of speakers and topics. While Jeff spoke about social determinants of health, others discussed commercial, regulatory and lifestyle determinants, all intermixed with practical advice on managing patients' lifestyle issues. Finally, he comments on a presentation from Meena Bansal discussing several concurrent posters in the meeting that aligned with the discussion in the session.  After Jeff shares the content of the meeting, he comments on the large number of providers and industry executives who attended this patient-centered session. Roger notes a similar distribution of attendees at the Health Livers, Healthy Lives session on building momentum for prevention. In wrapping up the session, Roger does not share another presentation but notes how many modes of action have produced successful Phase 2/3 trial results. He notes that we may have 4-5 different modes of action available five years from now. In the rest of the session, panelists describe what they believe will be different and exciting at #TLM2025. Answers vary, but most focus on advances in drug development and/or NITs.

00:00:00 – Surf's Up: Season 5 Episode 26 - Last month, close to 8,000 hepatology stakeholders convened in San Diego for The Liver Meeting 2024. Hepatology Key Opinion Leader Naim Alkhouri, Novo Nordisk International Vice President for Medicines Michelle Long, and patient advocates Jeff McIntyre from the Global Liver Institute and Michael Betel from the Fatty Liver Alliance join Jörn Schattenberg and Roger Green to discuss highlights. 00:03:23 - Introduction and Groundbreaker - Highlights include recent travel, cultural events, and the Third Annual Primary Care Summit from the Fatty Liver Alliance.00:11:35 - Describing TLM2024 - Participants shared a word or short phrase they felt best captured their feelings about TLM2024. 00:14:51 - The ESSENCE Trial - Naim starts the session by describing ESSENCE, a Phase 3 trial of semaglutide in non-cirrhotic MASH patients, which he describes as "the most exciting news of the meeting." Panelists describe the benefits of this trial from a variety of perspectives. 00.22.49 - A Challenge to Trial Recruitment? - Roger asks the group whether the presence of two approved MASH medications that do not require biopsy will make recruiting clinical trials that require them more challenging. The group doubts this will not add a significant new challenge to already-challenging trial recruitment. 00:29:22 - Other keys in drug development - Naim begins a discussion of two topics: the value of synergy between resmetirom and the GLP-1 agonist, and the importance of different genetic polymorphisms in predicting the impact of drugs on specific patients. Michelle mentions a recent paper in Nature identifying distinct clusters of patients based on how their SLDs progress over time. Roger identifies two particular challenges in this area, one posed by Lean MASH and the other specific to Hispanics in the US. 00:34:42 - FGF 21s - Jörn highlights a paper from the later breaker session on efimosfermin alfa, an FGF-21 dosed q4w. Roger and Mike comment. To Jörn, this and other studies demonstrate the place FGF-21s are likely to have in MASH therapy.00:40:29 - FDA Corner and the Role of Surrogates - Michelle praises the FDA Corner session, particularly the agency's transparency and willingness to engage industry and academia in finding paths to move away from biopsy. She is optimistic about the scientific community coming together to address these issues. Jeff notes the pivotal role he believes patients must play in this process. 00:48:33 - Patient Insights - Mike describes a poster he presented (and was lead co-author), titled Patient Voice in MASH Initiatives:  Foundational Principles for the Conduct of Patient-Centric MASH Research. He lists the groups participating in this broad effort and the foundational principles that emerged. Michelle and Jörn share their thoughts on which principles have the greatest impact on them in clinical research. Jeff praises a panel that Mike co-chaired on Lifestyle Management of MASLD and MASH. He praises the breadth and quality of speakers and topics. He also comments on the large number of providers and industry executives who attended this patient-centered session. Roger notes a similar distribution of attendees at the Health Livers, Healthy Lives session on building momentum for prevention. 00:58:36 - Wrapping Up - Roger comments on the breadth of modes of action that have produced successful Phase 2/3 trial results. He notes that we may have 4-5 different modes of action available five years from now. In the rest of the session, panelists describe what they believe will be different and exciting at TLM2025.01:06:01 - Question of the WeekListeners and readers, What do you consider the most essential paper or theme of TLM2024??01:06:38 - Business ReportChanges coming in 2025 with SurfingMASH v2.0

On so many issues, Congress has not been willing or able to act. But when faced with horrifying stories of death and mismanagement, Congress finally passed legislation to reform the US organ transplant system. They did so because people like Donna Cryer, a transplant recipient and patient advocate, demanded a better system for Americans who need lifesaving organ transplants. Now, as the new law moves into implementation, the work continues. In this episode, Donna and I discuss:The new legislation that is breaking up the deadly organ transplant monopolyHow ignoring the expertise and insights of patients dooms us to slow progress making healthcare safer and better Her advice for young people: “take your shot”Donna says we all need to start listening more closely to patients with lived experience:“I often think if you... had many people with great deals of experience and intelligence who were highly motivated to help you achieve your goal. Why would you not want to use them? Why would you not want to partner with them? Why would you work really, really hard to keep them away from solving the problem? And that's how people treat patients and patient advocates.”Relevant LinksDonna Cryer's testimony to the Senate Finance Committee on organ transplant system failures (just past the 48:00 mark)Summary of the new law to break up the organ transplantation monopolyMore about the Global Liver InstituteSee more details about the Advanced Advocacy Academy Donna's organization launchedVisit UNOS' websiteAbout Our GuestDonna R. Cryer, JD is the Founder and former Chief Executive Officer of Global Liver Institute, the only patient-driven liver health nonprofit operating across the US, EU, and UK. GLI convenes the NASH, Liver Cancer and Pediatric and Rare Liver Disease Councils, as well as the Liver Action Network, collectively more than 200 organizations.Mrs. Cryer has channeled her personal experience as a patient with inflammatory bowel disease and a 29-year liver transplant recipient into professional advocacy across a career in law, policy, consulting, public relations, clinical trial recruitment, and nonprofit management. At GLI, Mrs. Cryer has raised more than $10 million for liver health initiatives. She is a frequent speaker on the topic of patient-centeredness and patient engagement in healthcare transformation and created a unique model for advocacy that mobilizes patients, influences policy, and coalesces clinicians to improve patient outcomes.Mrs. Cryer serves on the Boards of Directors for the Council of Medical Specialty Societies, Sibley Memorial Hospital/Johns Hopkins Medicine, the Innovation and Value Initiative (IVI), and the Clinical Trials Transformation Initiative. She was the first patient to serve on the ABIM Gastroenterology Specialty Board, was one of the founding members of the AASLD Patient Advisory Committee and is the Community Representative on the AASLD NASH Task Force. She has been named one of the Top Blacks in Healthcare by the Milken Institute at GW School of Public Health and BlackDoctors.org, one of the Top 10 Patients Who Make An Impact by Health 2.0 and one of PharmaVoice's 100 Most...

In the second half of Roger Green's interview with Global Liver Institute Vice President, Liver Programs Jeff McIntyre, Jeff discusses the implications of his key EASL Congress takeaways for GLI and other patient advocacy groups.  To Jeff, this trend makes patient advocates a more valuable player in the clinical trial design process, particularly when coupled with the FDA's increasing focus on diversity in trial populations. This will become particularly important because, today, the major use of incretin agonists like semaglutide and tirzepatide is in anti-obesity, where payers are frequently declining to pay for the drugs. Advocates like GLI will be pivotal in ensuring that patients who need MASLD drugs will still get the drugs they need, particularly at earlier stages of fibrosis. This discrimination may allow patients to receive incretin agonists during the pre-fibrosis stage based on diabetes and anti-obesity medications and reserve the fibrosis drugs for patients with more advanced MASH. The entire scenario of early metabolic, later MASH treatment with different agents is at least 4-5 years in the future. In the meantime, Jeff sees a need to advocate for underserved groups in the population while at the same time laying the foundation for the longer-term case. In this context, the United Nations General Assembly side effect (covered in S5, E22) is an exciting and vital event.

This conversation contains the first half of Roger Green's interview with Global Liver Institute Vice President, Liver Programs Jeff McIntyre, during which the two discuss what Jeff considered the key strategic takeaways for GLI from the various EASL Congress presentations, abstracts and discussions. Jeff focuses on the "overriding sense of optimism" coming from the multiple pieces of positive drug data. He cites the data on Boehringer Ingelheim's survodutide, the follow-up work on Madrigal's resmetirom, an anticipated presentation on semaglutide at the AASLD in November, and strong FGF-21 results as proof that we are beginning to develop multiple robust, safe and effective modes of action for drugs to treat (at least pre-cirrhotic) MASH. His second positive point is that due to the drug trials and nomenclature change, GLI and other advocates are starting to have "more enlightened discussions" about MASLD in the context of the whole patient and related metabolic conditions. As a result, he comes to the third point, which is that multiple modes of action will teach us why what works in one patient might not in another and, ultimately, reshape clinical trials so that the target might not be fibrosis (or at least not only fibrosis), but instead exactly how each drug works. Jeff envisions this line of inquiry as a step down the path away from requiring biopsy. 

00:00:00 - Surf's Up: Season 5 Episode 24 This week's episode on MASLD lessons from the EASL Congress 2024 includes three separate elements: individual interviews with PharmaNext Founder and CEO Mathieu Petitjean and Global Liver Institute Vice President of Liver Programs Jeff McIntyre,  followed by a discussion with patient advocates Mike Betel of the Fatty Liver Alliance and José Willemse from the Netherlands, now supporting EASL. 00:02:45 - IntroductionRoger explains the episode format, including the two key questions for Mathieu and Jeff: (i) what were their key takeaways from the EASL Congress, and (ii) how have those takeaways changed how they do their jobs or plan for the future? Roger also sets up the Question of the Week discussion that is today's third section. 00:04:04 - Meet Mathieu PetitjeanThis is the SurfingMASH debut for Mathieu Petitjean, Founder and CEO of PharmaNest. He tells the audience a bit about his background and his love of Harleys.00:07:10 - First question to MattMatt begins by describing the core services Pharmest, a digital pathology company, offers MASH drug developers. Then he answers Roger's question by describing three phases in MASLD clinical trial designs. His point is that over time, drugs have gotten better, and histology requirements have become more onerous. At some point in the not-too-distant future, Matt believes non-invasive tests (NITs) are likely to suffice in large Phase 3 trials of the future.00:21:01 - Second question to MattMatt starts the answer with a conditional: if biopsy-based analyses become part of a surrogate endpoint, the role is large and clear. If not, they are unlikely to remain relevant in Phase 3 trials. Regardless of the answer to this question, Matt believes digital pathology will remain important in pre-clinical work and in other continuous liver diseases with less-defined targets. Also, he says, digital pathology is valuable in an array of non-hepatological markets, notably including pathology. 00:29:11 - First question to JeffJeff describes an "overriding sense of optimism" he felt due to the many positive drug trials presented in Milano. This suggests that the MASLD community is developing safe and effective MASH drugs with many different modes of action. This is allowing GLI and other advocates to start to have "more enlightened discussions" about MASLD in the context of the patient's overall metabolic state. All this means that what works in one patient might not in another. This can reshape clinical trials so that the endpoint target might not be change in fibrosis but impact against specific NIT targets. Jeff envisions this line of inquiry as a possible step away from biopsy. 00:39:34 - Second question to JeffConcurrently, FDA is beginning to require greater diversity in clinical trial populations. To Jeff, all this makes patient advocates like GLI more valuable to the clinical trial design process and pivotal in ensuring that metabolic and advanced MASH patients will still get the drugs they need. Starting today, Jeff sees advocates as championing underserved groups in the population while at the same time laying the foundation for the longer-term case. 00:55:20 - Discussing previous "Question of the Week"This is a 15-minute discussion of the Question of the Week we posed at the end of S5 E23. This section will constitute S5 E24.5, which we will post in the next day or two. A more complete summary will appear there. 01:11:23 - Question of the WeekThe Question of the Week is the first question Roger asks Matt and Jeff during this episode.01:12:58 - Business ReportPreviewing Episode 25, with Maru Rinella discussing the recently-published expert recommendations on use of resmetirom, along with comments on office hours the reason we will not have a vault conversation this week.

This conversation includes the first half of Jörn Schattenberg's and Roger Green's interview with Donna Cryer. While the question is about Stephen's most outstanding contribution to MASLD, the focus is more on his remarkable ability to trigger increased awareness of MASH in many different ways.Roger starts the conversation by asking Jörn and Donna to describe one outstanding contribution (okay, maybe two) that Stephen made to the field of MASLD. Jörn talks about Stephen's role as integrator, talking to all different kinds of players, designing trials, focusing on issues and needs of patients, regulators, investors. To Jörn, Stephen was "a lens focusing that something that was needed to spark the fire..." Picking up on this insight, Roger asks specifically about Stephen's role in the founding of NAIL-NIT (along with Mazen Noureddin). Jörn harkens back to Stephen's earlier work on the LITMUS Cohort Study and contributions to the field to describe the process that led him and Mazen to start NAIL-NIT, and notes the consortium's tremendous success to date.Continuing this theme, Donna describes Stephen's ability to bring people together and his providing "unique space for having smaller, intimate conversations: when necessary. She cites NASH-TAG, another event he co-founded, as a meeting designed specifically for this purpose and a remarkably fertile place for making progress on big issues.  Roger recalls Stephen bringing Donna to the early podcast to describe International NASH Day 2021, and goes on to comment that Stephen was the rare individual who embodied Malcolm Gladwell's three legs of the Social Virus stool: scientist, innovator and salesman. Although he doesn't say so in the interview, the implication is that Stephen's ability to play all these roles at once has sped the social awareness of MASLD and MASH and the efforts to advance solutions.Finally, Roger recalls Stephen becoming "ticked" during an early SurfingMASH episode on the FDA's first Complete Response Letter for obeticholic acid as proof of his passion for the work.

This conversation includes the second half of Jörn Schattenberg's and Roger Green's interview with Donna Cryer. It focuses largely on Stephen's inclusive approaches towards bringing stakeholders to pivotal discussions. Donna starts this conversation by noting an important thing she learned early in her career: when patients, advocates and physicians work together, their collective power is far more than the sum of their individual impacts. She commends Stephen as one KOL who always made certain that patient voices (including Donna's) and organizations had seats and voices at the table. She says, "I will be forever grateful for all the times he held space..." to that Donna and other patients/advocates could be involved in a major discussion. Jörn concurs and notes that this podcast was a key element in sharing different stakeholders' perspectives throughout the entire MASLD community, particularly during the COVID-19 pandemic when meetings were held virtually.  Finally, Roger notes that Stephen sought to include allied health providers the same way Donna describes him including patients and advocates.When Roger asked for "Harrisonisms", Donna does not offer a specific one. Roger recalls Stephen's surprise that Roger knew the meaning of the phrase "Hoddy Toddy" to Ole Miss grads and how he quickly integrated phrases of others into his own conversations and presentations. WIth that, the interview ends.

Global Liver Institute Founder and CEO Donna Cryer and hepatology researcher and industry executive Dimitar Tonev join Jörn Schattenberg and Roger Green to share memories of our co-founder and  MASLD leader Stephen Harrison.  00:00:00 - Surf's Up: Season 5 Episode 16Standard lead-in, including quotes from panelists00:02:55 - IntroductionRoger describes the structure of this episode.00:04:04 - Conversation with Donna and Jörn, including groundbreakers Good personal and professional news from Donna, Jörn and Roger.00:07:32 - Stephen's most outstanding contribution to MASLDIn response to Roger's question, Jörn describes the breadth of Stephen's contributions and interests. To Jörn, Stephen was "a lens focusing that something that was needed to spark the fire." Roger asks him to discuss  Stephen's role in founding NAIL-NIT. Jörn's answer covers Stephen's earlier work on the LITMUS Cohort Study and other contributions to the field as well as  NAIL-NIT. 00:10:34 - Personal notes about StephenDonna continues this theme by speaking to Stephen's ability to bring people together and his providing "unique space for having smaller, intimate conversations: when necessary. Roger talks about Stephen bringing Donna to the early podcast to describe International NASH Day 2021 and comments that Stephen was the rare individual who embodied Malcolm Gladwell's three legs of the Social Virus stool. 00:14:33 - Stephen's advocacy of patient advocates and allied providersDonna discusses having learned early in her career about the synergistic power of patients, advocates and physicians. She commends Stephen as one KOL who always made certain that patient advocates and organizations had seats and voices at the table, 00:19:06 - "Harrisonisms" and Harrison storiesDonna did not have Harrisonisms. Roger recalled Stephen's surprise that Roger knew the meaning of the phrase "Hoddy Toddy" and how he quickly integrated phrases of others. WIth that, the interview ends.00:21:39 - Meet Dimitar TonevDimitar starts off by telling the audience a bit about his history. His "one unique thing" is about his competence as a skier. This leads Roger to ask about his description in the SurfingMASH note of a "clumsy skier." Dim states that Stephen's form wasn't the best but that he skied with energy and passion. He goes on to tell a story about breaking Stephen's glasses the first time they met and how Stephen was able to laugh about it with him.00:26:41 - Stephen's visionary approach to trial recruitment Dimitar describes how Stephen developed his process for recruiting patients into what were then called NASH studies through the "first iterations of Summit," the idea of a site network. 00:31:19 - Another Harrison innovationDim discusses one more innovation: recruiting in neighborhoods that received lower levels of medical care and then recruiting within families. Roger shares that this podcast started to educate sponsors and researchers about the ability to keep trials running in a site network like Summit. 00:34:35 - What made Stephen Special and Wrap-UpTo Dim, Stephen special was his in his "enormous capacity to work long hours,"  Dim and Roger agree about the energy and enthusiasm Stephen devoted to everything he did. 00:37:48 - Special Stephen storiesDim tells a story about Stephen flying over the Atlantic with his family. You'll have to listen to learn it. He goes on share two more special stories about Stephen. .  00:43:29 -Question of the WeekRoger asks listeners who attended DDW last weekend which paper or presentation struck them most forcefully, and why.00:44:02 - Business reportThis week's news on the Stephen Harrison memorial, our new private membership list, upcoming episodes, and listener updates.

Jeff McIntyre uses the discussion between Louise Campbell and Mike Betel as a jumping-off point for discussing some of the larger care challenges and barriers associated with MASH patient care. Jeff says the previous conversation between Louise and Michael provides "a really great synopsis" of the challenges and barriers to patient diagnosis and care. He reports that the Global Liver Institute is planning to release its first "Best Practices in LIver Health Policy" report.  For GLI, these challenges are more complex due to the need to find solutions that will work in countries around the world.  He also states that GLI believes the system needs to be intentional not only about diagnosis but also health system follow-through. This requires patient access and country systems set up for success.  Roger raises the issue of having safe spaces for people to exercise in less developed countries. Louise recommends tier systems so that the solution for each country reflects the country's economics. Roger discusses a recent study showing a link between food insufficiency in 4-year-olds and MASLD and MASH later in childhood. Jeff describes the Stockdale paradox: policymakers cannot get caught up in the big picture without dealing with the short-term issues ahead of longer-term success. Jeff describes two US health policy cases that reflect the Stockdale paradox:  the VA's initial decision (later reversed) to require biopsy for Rezdiffra and lobbying by the giant food companies to have added sugar included in the list of attributes of healthy food. Louise describes "a big to-do" in the UK about children's teeth and access to dentists because poor dental health drives a 7x increase in the risk of liver cancer. She would like to see a generalized dietician who can work with patients on the range of metabolic issues. Mike says it "scares" him about where to start small. Louise gives an example of boiling water before dressing wounds and taking other health actions in Angkor Wat, which led to dramatic declines in diarrhea and the spread of many diseases. 

This conversation centers around the Global Fatty Liver Day 2024 theme and the rationale behind focusing on screening.It starts with Jeff describing how much has changed in MASLD in the past year and why this calls for a new focus. Jeff identifies the breadth of the global challenge of treating MASLD and related conditions, which is far broader than "just having one medicine for one aspect of the disease in one country." To Jeff and GLI, the best immediate path forward is to bring more patients into the system through screening, which provides the rationale for GLI's theme for the day, "Act Now. Get Screened."Roger states that this effort will drop a large number of patients "in the top of the funnel," and notes that earlier podcasts demonstrate limited adoption of clinical care pathways or other ways to manage an increased patient volume. He asks Jeff where the care pathway issue fits in the "Act Now. Get Screened" vision. Jeff states this is an issue for the entire field, not just patients, and that the field needs to collaborate on a turnkey way for PCPs to screen easily. Roger describes the concern raised Naim Alkhouri (Season 4, Episode 50.3) that the current clinical care pathway approach might create chaos in the system. Also, Roger asks whether US reimbursement policy is far enough along for the various actors to participate. Roger asks about the most effective action that patients and advocates can take. Jeff replies, "Get Screened."Mike Betel suggests that while this may be an issue for the entire field, he believes the onus for keeping this issue in front of providers must come from patients assertively asking questions and seeking support. Jeff agrees, but describes the relationship between patient and provider in this case as "symbiotic." 

This conversation is part of a March, 2023 interview between co-hosts Louise Campbell and Roger Green and Jeff McIntyre of Global Liver Institute, one of the guests on the S5 E2 panel. This particular conversation focuses largely on Jeff's insights around the imminent anticipated drug approvals of obeticholic acid (which was withdrawn several months later) and resmetirom (whose PDUFA date is next month). Jeff's analysis includes mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft's reference to NASH as a non-progressive disease - a position which the panelists readily refute. Jeff's positive note is that the report carefully considers patient perspective and he was able to participate as an expert reviewer.The conversation shifts to speculations around the future standard for noninvasive testing and biomarkers. Jeff emphasizes the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines' referral to FIB-4 as such a test. This summons quote of Quentin Anstee's repeated admonition that “we not let the perfect be the enemy of the good.” For whatever shortcomings of FIB-4, if it can be done now and it's two generations of successive approximation of what we've had before.As the session winds down, Louise Campbell asserts further comments around the ICER draft and NASH as a progressive disease. She recollects the podcast's recent conversation with Tim Jobson, founder of Predictive Health Intelligence, (S4 E5) which discusses developing a simple tool to identify patients at risk of liver disease by analyzing the results of blood tests given throughout their lives.

00:00:00 Surf's Up: Season 5 Episode 2 Co-hosts Louise Campbell and Roger Green sit with four leading MASLD patient advocates (Tony Villiotti of NASH kNOWledge, Wayne Eskridge of the Fatty Liver Foundation, Jeff McIntyre of the Global Liver Institute, and  Milan Mishkevikj of the European Liver Patients Association) to discuss their plans and actions for MASH patients in 2024. The discussion covers the advocates' hopes and concerns for the year and the programs and efforts each considers top priority.  00:04:09 Meet Milan MishkovikjNorth Macedonian patient advocate  Mishkovikj, a key leader in the ELPA, discusses how he became involved in liver patient advocacy and shares one fact about himself that might surprise you.  00:11:25 Groundbreaker Panelists share one piece of good personal or professional news from the previous week. 00:15:52 Anticipating Pi DayEvery year, Pi Day is March 14. This year, that date has extra significance: the PDUFA Date for resmetirom approval at FDA. Advocates describe their "guarded optimism" regarding whether resmetirom will be approved. Wayne notes the potential for confusion and disappointment because not every patient who anticipates receiving the new drug will do so. Louise and Milan describe how US approval might affect their respective countries and regions. Jeff describes the extensive planning GLI is doing to prepare for a PDUFA decision that might raise as many questions as it answers, particularly around coding, reimbursement and definition of appropriate patients. He also describes a possible approval path for countries outside the US. 00:26:42 Post-Approval Planning As Jeff puts it, "We have to be planning for the second half while we're playing the first half on this," with essential questions about the implications of labeling on the topics he mentioned earlier. Roger asks what role patients might play in access decisions, to learn that the advocates have largely been "blocked out" of the process. GLI anticipates driving conversations with health systems around policies and access. The other US advocates do not anticipate doing so. Milan describes how ELPA will work with EMA, the European Parliament and other relevant groups. Louise adds private insurers and governmental payers to the critical post-launch lobbying and discussion targets.00:38:43 Where Does the Patient Fit? Roger asks where patients fit in the decision paradigms and how that might change over time. Louise shares her view that while patients might consume the medications, the real customer is either the prescriber or payer. Tony describes payers as "the last frontier" in learning how patients feel. Jeff returns to a range of "here and now" access issues GLI can address now. Milan and Roger discuss perspectives on the interplay of regulators, payers, providers and patients.00:49:13 Advocates' Key Programs Each advocate describes one key program they will run in 2024. Wayne describes FLF's State of NASH Care in America survey. Tony describes NASH kNOWledge's children's education programs. Milan describes continuing pilot programs ELPA started in 2023 to education the European Parliament. Jeff discusses GLI's Advanced Advocacy Academy, which "grew roots" worldwide in 2023. At different points earlier in the discussion, each advocate commended the support they get from GLI.00:56:30 Closing QuestionRoger asks what will tell each advocate whether they've been successful when they look back on 2024, 12 months from the recording date. Answers are powerful and vary by organization. 01:02:55 Business Report News on audience metrics, the upcoming Question of the Week, next week's nomenclature discussion and this week's Vault conversation.

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.

The liver is one of our essential organs performing hundreds of functions that keep us healthy and alive. It's a vital, yet often overlooked, part of our digestive system that deserves our love and attention. This episode features Donna Cryer, a 28 year liver transplant survivor. Donna joins us to share her patient journey, which led her to become the Founder and CEO of The Global Liver Institute. We discuss why the liver is so important, some lifestyle habits that may contribute to liver disease and how we can support our liver health. For more information about the Global Liver Institute and related resources visit globalliver.org. 

While in law school at the age of 27, Donna Cryer found herself with colon cancer and in need of a liver transplant, all the result of a rare autoimmune disease born of inflammatory bowel disease (IBD). “It is really an honor to use my lived experience, especially the painful part of my journey, to help solve problems in the the healthcare system,” she tells CoveyClub founder Lesley Jane Seymour in this vital conversation. Cryer founded the Global Liver Institute, the only patient-driven liver health nonprofit operating in the U.S. and Europe. Discover how Cryer (and women like her worldwide) are developing advocacy nonprofits to help other patients cut through the fear and confusion of various health issues. Learn how to priortize your liver health, the unexpected colon cancer symptoms you should look out for, and how to advocate for yourself in any doctor's office.   Timestamps: 2:50 - Discovering she had colon cancer in her 20s 8:31 - Understanding the importance of liver health 14:50 - How many people suffer from liver disease? 21:30 - How to transition from patient to patient advocate 27:22 - Learning how to talk to your doctor and take care of yourself first   Free gift! Grab our new ebook, 5 Days to More Time for You! We've packed it full of our favorite time management hacks to help you conquer your to-do list and create more time for the things that matter most. Join us in NOLA: CoveyClub's Connection Convention   Connect with Lesley Jane Seymour & CoveyClub: Website Instagram LinkedIn Join CoveyClub  

Did you know that there are more than 100 types of liver diseases that affect 1.5 billion people worldwide? Join us as we explore the importance of collaboration and innovation in addressing liver health issues, the role of digital health and equity, and the future of liver health with Donna Cryer, J.D., Founder, President and CEO of the Global Liver Institute. Get the inside scoop on the latest developments in the field of liver health and how they can improve patient outcomes and access to care.

On Friday May 19, 2023, an Advisory Committee for the FDA convened to discuss the benefits and risks of obeticholic acid (OCA) 25 mg for treatment of non-alcoholic steatohepatitis (NASH) with fibrosis. As reported in a press release from Intercept Pharmaceuticals, twelve of 16 voting-eligible members of the ADCOM voted “no” (with two abstentions) on the voting question, “given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?” Fifteen of 16 voting-eligible members (with no abstentions) voted to “defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered.” In this episode, Founder and CEO of the Global Liver Institute, Donna Cryer, joins Surfers Jörn Schattenberg and Roger Green for a session which draws from raw reflections on the FDA ADCOM meeting and its outcome for OCA. The reactions and discussion that unfold are both sobering and constructive as the group reckons with the unfavorable results and the way forward for the liver community. Critically, the group agrees on the idea that this event simply should not be dubbed “another NASH drug goes down.” Rather, the focus remains on the Committee message that goes, “If a drug under this definition of efficacy has a safety profile where we can trust doctors to be able to manage it, we'll go with it because we understand the patient needs.” Listen on for the full analysis and stay tuned as Surfing NASH continues its coverage in subsequent episodes this week with different KOLs and stakeholders.If you enjoy the episode, have questions or interest around the outcome of the FDA ADCOM meeting and OCA, 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!

Donna Cryer, CEO of the Global Liver Institute, previews liver disease patient advocates' testimonies ahead of an ICER meeting on two new treatments; the House Health, Employment, Labor and Pensions Subcommittee holds a hearing titled Reducing Health Care Costs for Working Americans and Their Families; the House Energy and Commerce Health Subcommittee hosted its own meeting about the importance of addressing unaffordable costs in healthcare; and correspondent Kathi Luis lives in Michigan's 9th district and sees how Copay Accumulator programs are hurting patients. Global Liver Institute Webpage CNBC News Article: FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease Patients Rising Webpage: Patients Rising Stories

This week, Surfing the NASH Tsunami celebrates its 3rd anniversary since the debut episode posted on April 15, 2020. We are offering a jam-packed special featuring individual interviews with guests Amy Articolo of Novo Nordisk, Donna Cryer of the Global Liver Institute, and Frédéric Cren of Inventiva Pharma.In this conversation with Amy, Louise Campbell and Roger Green, the group reflects on the last three years in NASH-ville and predict what the next three will look like. Amy discusses ‘ah-ha' moments, the power of collaboration, clinical care pathways and the therapeutic trajectory of fighting fatty liver disease. If you enjoy the special, have questions or interest around Fatty Liver disease, please let us know your ideas by writing to questions@SurfingNASH.com and leaving a review wherever you download the discourse.Stay Safe and Surf On!

This week, Surfing the NASH Tsunami celebrates its 3rd anniversary since the debut episode posted on April 15, 2020. We are offering a jam-packed special featuring individual interviews with guests Amy Articolo of Novo Nordisk, Donna Cryer of the Global Liver Institute, and Frédéric Cren of Inventiva Pharma.In this conversation, Louise Campbell and Roger Green sit down with Donna to reflect on the last three years in NASH-ville and predict what the next three will look like. Among other notes, Donna describes the ongoing process of activating all within the NASH community to fight fatty liver disease. If you enjoy the special, have questions or interest around Fatty Liver disease, please let us know your ideas by writing to questions@SurfingNASH.com and leaving a review wherever you download the discourse.Stay Safe and Surf On!

This week, Surfing the NASH Tsunami celebrates its 3rd anniversary since the debut episode posted on April 15, 2020. We are offering a jam-packed special featuring individual interviews with guests Amy Articolo of Novo Nordisk, Donna Cryer of the Global Liver Institute, and Frédéric Cren of Inventiva Pharma.In this final interview, Frédéric, Louise Campbell and Roger Green exchange ideas around, among other topics, the history and development of Inventiva's lead product candidate, PPAR agonist lanifibranor.If you enjoy the special, have questions or interest around Fatty Liver disease, please let us know your ideas by writing to questions@SurfingNASH.com and leaving a review wherever you download the discourse.Stay Safe and Surf On!

This week, Surfing the NASH Tsunami celebrates its 3rd anniversary since the debut episode posted on April 15, 2020. We are offering a jam-packed special featuring commentary from the original Big Band of Stephen Harrison, Jörn Schattenberg, Louise Campbell and Roger Green. The second leg of the special features individual interviews with guests Amy Articolo of Novo Nordisk, Donna Cryer of the Global Liver Institute, and Frédéric Cren of Inventiva Pharma. These conversations reflect on the last three years in NASH-ville and predict what the next three will look like. Plus, listeners also can enjoy throwbacks to key moments in the podcast's history of when we met our beloved Surfers.  0:00 Introduction to the Surfing NASH 3rd Anniversary Special2:31 Co-Surfer Roundtable: Revisiting Highlights from 3 Years on the Podcast2:48 Catching Up with Stephen Harrison8:28 How It All Started13:24 Throwback to Meeting Stephen Harrison16:02 Throwback to Meeting Louise Campbell18:34 Throwback to Meeting Jörn Schattenberg21:32 Strongest Emotion Recorded on the Podcast22:39 Throwback to Meeting Donna Cryer24:42 The Expected vs the Unexpected Over 3 Years in the Fatty Liver Space39:45 The Straightjacket of Biopsy45:30 Canary in the Coal Mine48:06 Predictions for the Surfing NASH 6th Anniversary58:35 Interview with Amy Articolo of Novo Nordisk1:12:43 Interview with Donna Cryer of the Global Liver Institute1:28:11 Interview with Frédéric Cren of Inventiva Pharma1:40:30 Business ReportIf you enjoy the special, have questions or interest around Fatty Liver disease, please let us know your ideas by writing to questions@SurfingNASH.com and leaving a review wherever you download the discourse.Stay Safe and Surf On!

Thursday, June 9, 2022 was the 5th International NASH Day (#NASHDay). Global Liver Institute, the largest liver patient advocacy organization in the world, and 200 partner organizations held a day of education, awareness and motivation for Fatty Liver stakeholders across the globe.For its wrap-up panel, GLI invited the SurfingNASH co-host team to sit with Jeff McIntyre and review some of the day's major themes as well as major developments since the last International NASH Day. Like a typical SurfingNASH episode, there were equal parts big-picture thinking, references to recent events, and laughs. Listen for a fast-paced discussion of big-picture items, most of which are different from the Episode 28 discussion.

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10. This wrap-up conversation explores what the panels believe will be the impact of the ICER document for different stakeholder communities. Louise Campbell focuses on how stakeholders will look at price. Jörn Schattenberg uses Veronica phrase, "the genie is out of the bottle," to describe its impact. Veronica suggests that the paper will make an impression on how people think about the drugs, which is challenging given the analytical issues raised throughout the preceding conversations. Jeff asserts that patient involvement can help resolve some of these challenges and issues raised. He suggests the fact that ICER has introduced patients into the process as an excellent step forward. Hannah provides a variety of reasons why patients will be particularly important in this story. She notes that the generations of patients who are most affected by this disease, including Gen X and millennials, are people who tend not to visit primary care doctors. To hear the rest of her take and the final thoughts of Roger Green, tune in for this final session.This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at questions@SurfingNASH.com. 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.Stay Safe and Surf On!

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.Veronica begins this segment with comments alluding to the dichotomy of the biopsy. On one hand, there is an emergence of AI-assisted histological assessment of fibrosis that lends fascinating insights into the nuances of the liver as an organ. On the other hand, the field is still stuck with a very blunt tool inadequate in assessing the effectiveness of a drug. She states that it “hurts to see that this is what happens when we are not applying the right diagnostic markers and tools.” She goes on to say that “in a couple of years we'll be in a totally different data zone” in terms of having much more quantitative data to employ when assessing the safety and efficacy of these drugs. This leads Roger Green to read out his least favorite sentence from the document: “the exact prevalence of NASH is uncertain since diagnosis requires liver biopsy and many patients with NAFLD do not undergo biopsy.”The group goes on to discuss some more of the challenges in the document and data sets and before shifting to a payoff question around the impact of the ICER report. The panel notes that ICER has produced what is fundamentally private draft report with no impact on how the drug is assessed by the FDA. However, Hannah points out  that while ICER sometimes issues updates, it's uncommon. She suggests that this trial provides no guidance on how we determine which patients are F2 or F3, which will provide a real challenge for payers trying to determine the economic impacts of the drugs. While ICER is a private organization, its recommendations carry weight with those assessing the value and pricing of new medications. As such, this report has the potential to leave a significant footprint in commercial space.This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at questions@SurfingNASH.com. 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.Stay Safe and Surf On!

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.In this opening conversation, Roger Green introduces the ICER document and prompts panelists to share initial impressions around the assumptions and platforms that underlie it. Before diving in, Jörn Schattenberg briefly recaps the benefit behind obtaining relatively large datasets on safety and efficacy for resmetirom and obeticholic acid. Veronica asserts that she is “quite astounded” that this report would be generated before the emergence of a formal, peer-reviewed publication on the data. This leads Roger to note the competing interests of acquiring unassailable data (which can take endless time) versus serving the more immediate needs of patients desperate for solutions now.Jeff discloses that while he is pleased with ICER's inclusion of patient participation in the report, several critical shortcomings need addressing. The major concern: a statement claiming that NASH and NAFLD are not progressive diseases. Jörn responds to this statement with an anecdote from his specialty care clinic where patients do in fact arrive symptomatic as related to their troubled liver health. Surf on to the next conversation to hear what the others think.This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at questions@SurfingNASH.com. 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.Stay Safe and Surf On!

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.The session begins with questions from Roger Green around the report's dated figures on disease prevalence. This leads Louise Campbell to note the intensity and speed in which the Fatty Liver field has developed over the previous decade. Provided this explosion in knowledge, she wonders whether we are able to effectively collect and implement the changes reflected by all this emerging data. Jeff and Roger add that socioeconomic shifts and the COVID-19 pandemic further amplify already swelling rates of incidence.As this session winds down, Jörn Schattenberg poses a cogent line of questioning to consider in establishing a cost-effective intervention:Who was enrolled in the clinical trials? Where's the evidence that there is a subgroup of patients benefiting from the therapy?How can we identify them moving forward and outside of clinical trials?This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at questions@SurfingNASH.com. 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.Stay Safe and Surf On!

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.Hannah begins this conversation by asserting that the report “understates the problem of the size of population we're talking about.” She notes that it fails to consider the strength of data linking NAFLD and NASH to cardiovascular disease, liver cancers and even extrahepatic cancers. Hannah goes on to outline the relevant questions of commercial payers in the assessment of prospective pharmacotherapies: What is the size of the patient population and what is going to be the effect of coverage in terms of how many patients are we going to prevent from progressing to liver transplant? How many patients are we going to keep out of the hospital with chronic events?Ultimately for Hannah, the analysis by ICER misses much of the potential cost savings of an effective drug. Louise echoes concerns surrounding the “difficulty in the communication and the language used throughout the report.”This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at questions@SurfingNASH.com. 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.Stay Safe and Surf On!

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.10:05 Introducing the ReportJörn Schattenberg briefly revisits the relatively large datasets on these two drugs. Veronica is “quite astounded” that this report would be generated before the emergence of a formal peer-reviewed publication. While Jeff is pleased with ICER's inclusion of patient participation in this report, he underscores critical concern around a statement claiming that NASH and NAFLD are not progressive diseases.21:31 Assessment of Disease PrevalenceHannah asserts that the report “understates the problem of the size of population" and fails to consider the strength of data linking NAFLD and NASH to cardiovascular outcomes, liver cancers and beyond. She suggests that commercial payers are looking to address the following questions in their assessment of the drug candidates: What is the size of the patient population and what is going to be the effect of coverage in terms of how many patients are we going to prevent from progressing to liver transplant? How many patients are we going to keep out of the hospital with chronic events? Ultimately for Hannah, the report's analysis misses many of the potential cost savings of an effective drug.29:06 Keeping Pace with Field AdvancementsLouise notes the intensity and speed in which the Fatty Liver field has developed over the previous decade. Provided this explosion in knowledge, she wonders whether we are able to effectively collect and implement the changes reflected by all this emerging data. Jeff and Roger add that socioeconomic shifts and the COVID-19 pandemic amplify already swelling rates of incidence. Jörn poses a cogent line of questioning to consider in establishing cost-effective interventions:Who was enrolled in the clinical trials? Where's the evidence for a subgroup of patients benefiting from therapy?How can we identify them moving forward and outside of clinical trials?38:55 Biopsy and BiomarkersVeronica describes the dichotomy of biopsy. On one hand, AI-assisted histological assessment of fibrosis lends fascinating insights into the nuances of the liver as an organ. On the other, biopsy is still a very blunt tool inadequate in assessing the effectiveness of a drug. She states that it “hurts to see that this is what happens when we are not applying the right diagnostic markers and tools” and that “in a couple of years we'll be in a totally different data zone” in terms of having much more quantitative data to employ when assessing the safety and efficacy of these drugs.48:36 Implications and Final ThoughtsAs the session winds down, the group considers various other aspects for which this document can potentially have an impact. Comments range from notes on pricing to what FDA factors for approval.This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at questions@SurfingNASH.com. 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.Stay Safe and Surf On!

Last year on Thursday, June 9th we covered #NASHDay 2022, the 5th annual celebration of International NASH Day by the world's largest liver patient advocacy organization, the Global Liver Institute. To celebrate the occasion, Stephen Harrison joined Jörn Schattenberg, Louise Campbell and Roger Green to comment on one crucial trend or event that most signified what the last year has meant in the Fatty Liver community.This conversation includes three sections:First, Roger discusses the Law of Unintended Consequences in the context of the FDA Complete Response Letter to Intercept Pharmaceuticals over obeticholic acid. This was an event that many feared would bring all momentum around Fatty Liver disease to a standstill but, two years later, has driven real bursts of creative energy and innovative problem solving centered around the disease rather than a drug.Second, Stephen and Jörn offer impassioned statements that the providers will never give up on addressing the challenges of NASH, both because, as Stephen describes, it is not in their character and because, as Jörn describes, “this disease is not going away.” As long as people are dying too young from the effects of NASH and HCC, he contends, the fight will continue.Finally, Roger asked the panelists for bold predictions about what will have changed before we come together a year from now to celebrate the 6th International NASH Day.

The Surfers are joined by Jeff McIntyre of the Global Liver Institute for a thought-provoking impromptu session on what's happening thus far for the Fatty Liver field in 2023. This session features Jeff's insights around the imminent drug approvals of obeticholic acid and resmetirom. His analysis includes mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft's reference to NASH as a non-progressive disease - a position which the panelists readily refute. Jeff's positive note is that the report carefully considers patient perspective and he was able to participate as an expert reviewer.The conversation shifts to speculations around the future standard for noninvasive testing and biomarkers. Jeff emphasizes the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines' referral to FIB-4 as such a test. This summons quote of Quentin Anstee's repeated admonition that “we not let the perfect be the enemy of the good.” For whatever shortcomings of FIB-4, if it can be done now and it's two generations of successive approximation of what we've had before.As the session winds down, Louise Campbell asserts further comments around the ICER draft and NASH as a progressive disease. She recollects the podcast's recent conversation with Tim Jobson, founder of Predictive Health Intelligence, which discusses developing a simple tool to identify patients at risk of liver disease by analyzing the results of blood tests given throughout their lives.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! 

The Surfers are joined by Jeff McIntyre of the Global Liver Institute for a thought-provoking impromptu session on what's happening thus far for the Fatty Liver field in 2023. The panelists touch on topics which elicit responses ranging from positive excitement around scientific developments to head-scratching concern over public policy positions.06:31Jörn Schattenberg opens with comments on diagnostic and therapeutic advancements which follow the momentum gathered at an energizing NASH-TAG conference in January. He specifically points to the numerous abstracts (estimated at over 2500!) submitted that will contribute to a scientifically-stimulating EASL Congress held in Vienna this June. Jörn emphasizes that while drugs are leading the way, diagnostics are closely following and contributing to "excitement on both borders.” Louise Campbell adds her thoughts around the recent AASLD guidance and its focus on clarifying CAP scores for improved FibroScan assessment. Roger Green notes emerging competitor technologies, such as E-Scopics, and their influence on industry uptake of NITs.19:17Jeff expands on the trajectory of imminent drug approvals of obeticholic acid and resmetirom. He goes on to express mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft's reference to NASH as a non-progressive disease - a position that the panelists clearly debunk. He next speculates on the future standard for noninvasive testing and biomarkers. His comments emphasize the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines' referral to FIB-4 as such a test.29:31Jeff introduces collaborative work by GLI which sets out to more formally “medicalize” obesity as a term considerate of genetic backgrounds and metabolic dynaminisms. He relates this discussion around nomenclature to that experienced in the Fatty Liver space. Conversation segues to the subject of nutrition and the often ominous landscape of public health policy.37:14Roger introduces a timely Lancet paper which coincided with Surfing NASH's focus on pediatric and adolescent NAFLD and NASH. The US-based study suggests that in five randomly allocated centers from 2002 to 2018, annual increase in incidence of Type-2 diabetes among 10-19 year-olds was a staggering 5% per year. He connects the findings to the aforementioned ideas around public health policy and nutrition. As the session winds down, Roger invites the panelists to provide the most significant and optimistic thing they will be touching over the next three months followed by the greatest fear each has in the same space. Listen to the full feature to hear their responses and the rest of this well-balanced conversation.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. 

Donna Cryer This week Ivy Slater, host of Her Success Story, chats with her guest, Donna Cryer. The two talk about the journey that led her to start the Global Liver Institute to create a space for the betterment of the process of transplants for the patient, what happens at the Advanced Advocacy Academy, and how they make sure that patients have every ability to be the most influential and “dangerous” person in the room. In this episode, we discuss: What catalyst caused Donna to devote this portion of her life to being an advocate for liver health  How she transitioned from an accomplished career in law, and created a space for the betterment of the process of transplants for the patient What questions propelled Donna to begin building the Global Liver Institute What the Global Liver Institute does, and what they do to equip and empower patients How they built a sustainable advocacy infrastructure for the field as a whole, using the knowledge of patients, doctors, and researchers alike What happens at the Advanced Advocacy Academy, and how they make sure that the patient has every ability to be the most influential and “dangerous” person in the room Why the metrics speak for themselves, and how they collect data What GLI has in store for the future Mrs. Cryer is Founder and CEO of Global Liver Institute, the leading patient advocacy organization in liver health, convening more than 200 organizations across 70 countries. A graduate of Harvard and Georgetown Law, she serves on several boards, including Sibley Memorial Hospital/Johns Hopkins Medicine and the Council of Medical Speciality Societies. She is widely recognized as an expert on the topics of patient engagement in research, digital health, and high-value equitable care. Website: https://globalliver.org/Facebook: https://www.facebook.com/GlobalLiver Twitter: https://twitter.com/GlobalLiver Twitter: https://twitter.com/DCPatient YouTube: https://www.youtube.com/channel/UCLYtkzOVI9GuFMPuEVde8vA Instagram: https://www.instagram.com/globalliverinstitute/ LinkedIn: https://www.linkedin.com/company/global-liver-institute LinkedIn: https://www.linkedin.com/in/donnacryer/

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. 

Thursday, June 9, marked #NASHDay 2022, the 5th annual celebration of International NASH Day by the world's largest liver patient advocacy organization, the Global Liver Institute. For the #NASHDay Wrap-up Panel, Global Liver Institute invited NASH Tsunami co-hosts Jörn Schattenberg, Louise Campbell and Roger Green to join NASH Programs Director Jeff McIntyre to discuss themes of the day and major issues in the Fatty Liver community.This conversation includes the last fifteen minutes of the GLI NASH Day wrap-up panel. Jeff McIntyre asks two questions to the group. First, he asks each panelist to respond to the slogan #StopNASHNow and its implication that for patients, it might be enough simply to arrest the progression of fibrosis. Therefore we should devote efforts in research and regulatory energy to stopping the progression instead of focusing entirely on regression. For his last substantive question, he asks each of us to discuss something that puts a twinkle in our eyes as we consider the next 3-5 years of progress in the fight against Fatty Liver disease. Surf on for great questions that yield interesting and diverse answers.

This week, we sit down with Donna Cryer, President and CEO of the Global Liver Institute, to discuss equity in healthcare, being a Black woman at the forefront of healthcare awareness, and raising awareness about liver disease in women.

This week, we sit down with Donna Cryer, President and CEO of the Global Liver Institute, to discuss equity in healthcare, being a Black woman at the forefront of healthcare awareness, and raising awareness about liver disease in women.

Bernie Williams interview! Andrew is joined by Yankees legend Bernie Williams to talk about the ‘90s dynasty years, why that era of Yankees baseball is becoming more appreciated as the years go by, Aaron Judge's free agency, Bernie's experience in free agency after the 1998 season, championship memories, favorite teammates, appearing in Seinfeld, and so much more.  Bernie is working with Blue Faery, the Global Liver Institute and Eisai, to launch the “One Liver to Love” initiative to raise awareness about liver cancer and encourage others to be proactive when it comes to liver health. Go to OneLiverToLove.com to see a video featuring Bernie sharing the 4 bases of liver health.  Go to AthleticGreens.com/pinstripes for a FREE 1-year supply of immune-supporting Vitamin D and 5 FREE travel packs.  Go to Manscaped.com and use code BRONX21 for 20% off + free shipping.    Get in touch:   @YankeesPodcast   @Andrew_Rotondi   @ScottReinen     Submit to the mailbag: bronxpinstripes.com/podcast   Call the voicemail line: 646-480-0342   Intro/Outro music: One Way Ticket, by Anitek Learn more about your ad choices. Visit podcastchoices.com/adchoices

Just in time for Liver Cancer Awareness Month, we interview Donna R. Cryer, JD Founder, President, and Chief Executive Officer of Global Liver Institute. GLI is the only patient-driven liver health nonprofit operating across the US, EU, and the UK. GLI convenes the NASH, Liver Cancer and Pediatric and Rare Liver Disease Councils, as well as the Liver Action Network, collectively more than 200 organizations. In the episode we chat with Mrs. Cryer about how she has channeled her personal experience as a patient with inflammatory bowel disease and a liver transplant recipient into professional advocacy across a career in law, policy, consulting, public relations, clinical trial recruitment, and nonprofit management. At GLI, Mrs. Cryer has raised more than $10 million for liver health initiatives. Among her many accomplishments with GLI, she developed a program featured by the White House on Solving Organ Shortage/Transplantation. She has launched numerous other successful programs at GLI, including the Cure Campaign, Advanced Advocacy Academy (A3), Liver Matters Blog, Liver Matters Health Policy Memo, the NASH Council, the Liver Cancers Council, and the Pediatric and Rare Liver Diseases Council.

Our week of "Greatest Hits" episodes from the vault continues with this conversation from the episode reviewing the NASH Patient-Focused Drug Development meeting sponsored by the Global Liver Institute and held at the FDA on November 4, 2021. This conversation focuses on the perspectives that patient advocates brought to this session.Late 2021 and early 2022 traced a series of events that sensitized FDA to the need to look "beyond the biopsy" (or at least semi-quantitative reads) to an approach that would more accurately reflect the benefits of NASH drugs in development and the extreme need patients and their advocates felt for new medications. One critical event on this path was the patient-focused drug development (PFDD) meeting the Global Liver Institute organized and held at FDA on November 4, 2021. At this meeting, FDA reportedly acknowledged that if they had understood patients' perspectives better a couple of years earlier, the path of NASH drug development might have been different.As I wrote at the time: In this conversation, Global Liver Institute Founder, President and CEO Donna Cryer describes the history of the basic Patient-Focussed Drug Development concept and this particular NASH event. Patient and patient advocate Terri Milton discusses the message she hoped regulators would take away from this session and why she believes the group may have succeeded. Finally, the group discusses why regulators and advocates vary so greatly in terms of how they view the efficacy:safety tradeoff for first-in-class drugs.

On this episode, we discuss an all-too-often underdiagnosed disease: NASH, a.k.a. nonalcoholic steatohepatitis, a severe form of “fatty liver” disease. Though NASH can affect people who are obese or diabetic with high cholesterol, it can also hit someone who's relatively healthy and who doesn't even drink alcohol. It's because of this and other factors that liver disease can be easily underdiagnosed, leading to dire consequences.A few months ago, there was a great roundtable discussion about approaches to care and treatment – and hopeful early diagnosis – for people with NASH. In April 2022, NCQA together with a team from Novo Nordisk published a white paper summarizing this roundtable. The paper was titled "A Rallying Cry: Improving Coordinated Care for People With Nonalcoholic Steatohepatitis."In our interview, we hear from Donna Cryer, President & CEO of the Global Liver Institute, and Dr. Mary Barton, NCQA Vice President for Performance Measurement, exploring new ideas for optimal primary care for liver patients.Donna Cryer, JD, is Founder and Chief Executive Officer of Global Liver Institute (GLI), the premier patient-driven liver health nonprofit operating with offices and partnerships across five continents. Moved by her own experience as a 27-year liver transplant recipient, Mrs. Cryer serves as a fierce advocate for the transformative potential of patient engagement in health policy, research, data, and system design.Mrs. Cryer serves on numerous committees and boards, including the Boards of Directors for the Council of Medical Specialty Societies (CMSS), Sibley Memorial Hospital/Johns Hopkins Medicine, and the Color of Crohns and Chronic Illness (COCCI). She holds an undergraduate degree from Harvard and a Juris Doctorate from the Georgetown University Law Center.Dr. Mary Barton, MD, serves as NCQA's Vice President for Performance Measurement. In her role, Dr. Barton oversees the development, use and maintenance of techniques NCQA uses to evaluate health care quality. She ensures the scientific integrity of NCQA measurement and research. She also leads NCQA in winning and executing health care quality measurement contracts for federal and state governments.

You don't want to miss this episode with Alexis Story, a former recent grad bootcamp student! She discusses her journey from college to the career field, and how she just obtained her CHES certification! We dive into leveraging your network to find a job, navigating college and dealing with all the pressure of figuring out your next move, as well as dealing with ADHD and figuring out how to navigate the professional world. Alexis is a recent graduate of the Health Education and Promotion major at Towson University. Although new to the workforce, Alexis has gained a vast amount of experience as an intern at the District of Columbia Department of Health, and various organizations throughout her college career. Alexis currently works as an Advocacy Program Coordinator at the Global Liver Institute. This episode discusses: - How to identify support systems that can help propel your career forward - The importance of having a mentor (virtually or in-person) - Landing a job through informational interviews - Changing your major in college and deciding your next steps - How Recent Grad Boot Camp helped Alexis Secure the Bag! Connect with Alexis on LinkedIn: http://linkedin.com/in/alexisstory22 Don't forget to like and subscribe to this podcast! Also make sure you check out our online courses designed to help you land the career you want! Don't forge to check out Recent Grad Bootcamp to learn more about how this course can help you elevate your career. (For those that graduated less than 5 years ago) Recent Grad Boot Camp If you graduated from college [Bachelors, Masters or Doctorate] 5 years ago or less then this boot camp is for you! Dr. Des takes you through everything needed to land a job in the field you love. Whether you looking to land your first career starting job, or you looking to transition into a higher position then this course will get you all the way together! Developing Your Career Goals Resume Development [ATS Compatible Templates] Cover Letter Development Digital Portfolio Development Networking + LinkedIn Tips Interview Prep Check out the Young Black and Professional Website to sign up for our free email list! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

In this episode of Black Power Moves, part of the Ebony Covering Black America Podcast Network, we're speaking to Donna Cryer, Founder, President & Chief Executive Officer of Global Liver Institute. https://www.globalliver.org/ GLI is the premier patient-driven liver health nonprofit operating across the globe. Moved by her own experience as a liver transplant recipient, Donna has become a powerful force in liver health, health policy, and patient advocacy. At GLI, she has raised more than $10 million for liver health initiatives. She has been featured by and worked with Congress and the White House to advance equitable healthcare in both organ procurement and information technology. Donna is a frequent speaker on patient centricity in research and healthcare delivery and patient engagement in healthcare transformation at meetings of Biotechnology Innovation Organization, Pharmaceutical Research and Manufacturers of America, America's Health Insurance Plans, National Quality Forum, National Comprehensive Cancer Network®, and the National Academy of Medicine.  She frequents the stage of national platforms, including The Washington Post Live, SXSW, and The Atlantic's People v. Cancer. Learn more about your ad choices. Visit megaphone.fm/adchoices

Andrea Wilson Woods is a writer who loves to tell stories, and a patient advocate who founded the nonprofit Blue Faery: The Adrienne Wilson Liver Cancer Association. Andrea is the CEO and co-founder of Cancer University, a for-profit, social-benefit, digital health company. With Cancer U, Andrea synergizes her talents of coaching, writing, teaching, and advocacy. For over ten years, Andrea worked in the education field as a teacher and professor for public and private schools as well as universities. Andrea obtained her master's degree in professional writing from the University of Southern California; her nonfiction writing has won national awards. Her new book, a medical memoir titled Better Off Bald: A Life in 147 Days, is a #1 Bestseller on Amazon in multiple categories.Andrea Bio:In 2002, Andrea founded Blue Faery: The Adrienne Wilson Liver Cancer Association after losing her 15-year-old sister Adrienne, whom she raised for seven years, to stage IV liver cancer. Blue Faery's mission is to prevent, treat, and cure primary liver cancer, specifically hepatocellular carcinoma (HCC), through research, education, and advocacy. Andrea established the articles of incorporation; wrote the bylaws, mission statement, and goals; and developed the organizational structure of the corporation. Currently, she attends board meetings, serves on committees, stays informed about liver cancer, and governs the organization. Andrea represents Blue Faery and its mission at conferences, seminars, and special events. Blue Faery has been honored for community service by U.S. Congressman Adam B. Schiff, California State Senator Jack Scott, and the County of Los Angeles, and was inducted into the Burbank Business Hall of Fame for receiving the Best of Burbank Charity Award from 2013 – 2017.Since serving on an HCC Patient Advisory Board for Eli Lilly in 2014, Andrea has received numerous scholarships to attend various conferences around the country to tell her story, increase her knowledge, advocate for more funding, and continue her professional development. Organizations that have granted scholarships/sponsorships include Academy Health, American Association for Cancer Research, American Society of Clinical Oncology, American Liver Foundation, Caring Ambassadors, Conquer Cancer Foundation, Global Liver Institute, National Comprehensive Cancer Network, National Viral Hepatitis Roundtable, and more.In 2017, Andrea won an e-Patient scholarship for Stanford Medicine X where she presented her talk, “How Euphemisms Help Us Deal With Death.” More recently, she spoke to more than 100 liver cancer researchers at the Hepatobiliary Cancers: Pathology and Translational Advances conference sponsored by Virginia Commonwealth University School of Medicine. Her presentation titled “Why We Need To Choose To Cure Liver Cancer” left the room speechless.As a patient advocate, Andrea serves on many committees and advisory boards including NCI Hepatobiliary Task Force, Target Pharma Solutions HCC Advisory Board, and ASCO's Systemic Therapy for Advanced Hepatocellular Carcinoma Guideline Panel. She is a patient advocate representative on the Mayo Clinic Hepatobiliary SPORE, which is devoted to improving the diagnosis and treatment of liver cancer and bile duct cancer. Andrea serves as a Consumer Reviewer on the Department of Defense's Peer-Reviewed Cancer Research Program. Andrea represents Blue Faery as a member of AASLD, ASCO, Deadliest Cancers Coalition, and GI Cancers Alliance. She was formerly a member and co-chair of the awareness group of the Liver Cancer Roundtable. Currently, Andrea is the only American serving on the Canadian Cancer Survivor Network's Liver Cancer Advisory Council. She is also a WEGO Health Expert and member of the International Coach Federation.

Donna Cryer began her career in health care after a seriously debilitating autoimmune liver disease. For her work in this area, she has been writing the book of  advocacy in liver disease and recently received the Distinguished Service Advocacy Award from the Hepatology Medical Society partner. Key points include: 08:16: Key issues in unequal access to transplants 14:37: Top priorities for the advocacy organization 21:40: Ethical issues and incentives 24:58: What would most surprise her college self

Jennifer Cohen interviews Nicole Wells, MA, Program Manager, Pediatric and Rare Liver Diseases at Global Liver Institute, who discusses her experiences with liver transplantation, her advocacy, and her interest in healthcare policy. Nicole is a native of Kentucky and taught school in the US Virgin Islands. As a transplant recipient herself, Nicole provides valuable insights on the process of diagnosis and realizing the need for transplant, and then walks our listeners through the process of how the donor list works and how she found her liver donor.