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The Innovations in NAFLD Care 2022 Series includes a recent webinar and a hybrid meeting planned for Barcelona in May. This new event is a key new element in the effort to drive more holistic multi-specialty approaches toward diagnosis, treatment and management of patients with NAFLD and NASH. In this conversation, Stephen Harrison, Louise Campbell and Roger Green join Professors Schattenberg and Lazarus to consider innovative elements for this and future programs and to discuss the outcomes they would like this program (and others like it) to produce.

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The Innovations in NAFLD Care 2022 Series includes a recent webinar and a hybrid meeting planned for Barcelona in May. This new event is a key new element in the effort to drive more holistic multi-specialty approaches toward diagnosis, treatment and management of patients with NAFLD and NASH. In this conversation, Stephen Harrison, Louise Campbell and Roger Green join Professors Schattenberg and Lazarus in discussing structural issues and social determinants of health that are shaping the growing Fatty Liver pandemic and why education is so important to combatting the pandemic.

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The Innovations in NAFLD Care 2022 Series includes a recent webinar and a hybrid meeting planned for Barcelona in May. This new event is a key new element in the effort to drive more holistic multi-specialty approaches toward diagnosis, treatment and management of patients with NAFLD and NASH. In this conversation, Stephen Harrison, Louise Campbell and Roger Green join Professors Schattenberg and Lazarus in reviewing the program scope and agenda elements with an eye toward the most important ways to increase patient awareness of NAFLD and NASH.

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The Innovations in NAFLD Care 2022 Series includes a recent webinar and a hybrid meeting planned for Barcelona in May. This new event is a key new element in the effort to drive more holistic multi-specialty approaches toward diagnosis, treatment and management of patients with NAFLD and NASH. In this 10-minute conversation, Professors Schattenberg and Lazarus outline the social and health system factors that motivated them to create this program.

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Program co-chairs Jeff Lazarus and Jörn Schattenberg join the Surfers to discuss their "Innovations in NAFLD Care 2022" series and how it promotes the broader NAFLD Public Health Agenda.

This far-ranging discussion focuses on the Innovations in NAFLD Care 2022 webinar and event series with the goal of understanding what makes this series special and why it is so important today. The NAFLD Public Health Agenda is challenged with high prevalence levels, year-on-year double-digit increases in the number of newly-diagnosed cirrhosis patients, worsening of diets and exercise regimens brought about by the COVID-19 pandemic and an array of issues stemming from the lack of efficacious and tolerable medicines approved for this indication.

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Roger Green assemblies audio clips from Surfing the NASH Tsunami's coverage of NASH-TAG 2022 to reveal an evolving view of the role combination therapies will play in treatment and management of NASH patients.

Discussion about "combination therapies" typically focuses on the idea of multiple agents prescribed concurrently to address a medical condition when monotherapy will not achieve desired goals. At NASH-TAG 2022, the concept of combination therapies took some interesting directions:

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

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

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Global Liver Institute Founder and CEO Donna Cryer and Key Opinion Leader Professor Scott Friedman joined Roger Green at NASH-TAG 2022 for a far-reaching conversation on drug development and scientific advances in Fatty Liver disease.

This episode includes the entire discussion, plus a shorter one with Roger and  SurfingNASH co-host Louise Campbell on some of the lessons emerging from NASH-TAG's first day.

Timestamps: 
2:17 – Roger Green introduces the agenda for today’s episode
5:42 – Donna Cryer: “Favorite phrase” from the NASH-TAG Day 1 is “lessons learned”
7:02 – Scott Friedman on NASH-TAG Day 1: equal parts sobering and promising, with a major conceptual change
7:34 – Scott’s “sobering” points: highly anticipated clinical trials “did not pan out;” “we don’t know where this disease starts” or where to start treating it; and “we tend to approach the disease as one size fits all”
9:06 – Scott’s “promising” points: digital histopathologies, gene regulation and epigenetics, diagnostics, organoid technologies and more
11:33 – Roger: We need to think of “combination” treatment strategies not only as static same-time combinations but also sequencing of medications as replacements or add-ons 
12:58 – Donna: To de-risks trials, include patients throughout objective setting and trial design
14:42 – Roger: Patient feedback may provide greater value to smaller companies with less margin for error
15:28 – Scott: Another consideration is patients’ disappointment "when things don’t work.”
16:20 – Donna: Patients realize the first drug “doesn’t have to be perfect”
17:13 – Donna: Interdisciplinary discussions at NASH-TAG are a very hopeful development
18:04 – Scott: We have a great deal to learn about underlying biology, but the efforts to do so make me hopeful
19:10 – Scott: Weight loss reverses a biology we can’t seem to accomplish with NASH drugs, which is promising
20:18 – Donna: We need multidisciplinary, multifaceted complete care approaches that do not rely on patients’ willpower and work for different types of patients
22:24 – Scott: “Personalizing” is not just about therapy, but also how the patient copes with the disease
23:02 – Donna: I remember early in my care being jealous of cancer patients for the holistic care they were able to receive that liver patients weren’t
25:55 – Donna: Will pruritis continue to be an ultra-rare indication when it exists with so many liver diseases?
26:25 – Scott: New, more elegant biologic definition of pruritis processes should lead companies to develop better therapies
28:59 – Donna: When they are approved, NASH drugs will be prescribed in as polypharmacy.  Patients have multiple healthcare costs. I hope manufacturers will act responsibly
30:14 – Donna: Pricing for pruritis agents might inspire a backlash. Patient advocates will not support current pricing
31:01 – Roger: Keep in mind that modeling comes from finance departments and targets cash management and budgeting issues
31:34 – FINAL QUESTION: What do you believe will change and hope will change in the next year?
31:40 – Scott: Hope to see a drug trial result that will points to approval. Expect to see advances in NITs and digital histopathology
32:41 – Donna: Hope and expect two things: alignment between advocates, researchers, manufacturers and regulators on what mark we need to hit and what will happen once we hit it, and clarity around best use of NITs
33:31 – Roger: Expect to see adoption of digital histopathology in 23, maybe even end of next year. Hope to see widespread acceptance that stabilizing fibrosis is a perfectly acceptable clinical outcome for drugs
34:33 – Scott: We’ve known all along that FDA considers non-progression from advanced fibrosis to cirrhosis an acceptable endpoint
36:03 – Louise and Roger chat about fine points from NASH-TAG sessions and the first part of S3 E2
45:55 – Business Section

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Last weekend's NASH-TAG 2022 was the best attended event in the conference's six-year history, and probably the one that will have the greatest long-term impact on diagnosis, treatment and monitoring of Fatty Liver patients. In this wrap-up conversation, our seven-person panel (including two Pharma execs and one diagnostics entrepreneur) discusses strategies for improving cost-efficiency and patient participation in clinical trials.

As this conversation starts, Stephen returns to the "3 H&E" idea, mentioning that this will provide 60mm of tissue for review, instead of the current 20mm. Erin asks whether we should be looking at histopathology at all in view of the dismal (writer's word) balloon hepatocyte findings, but Stephen reminds the group that for studies that have already begun, they will have to use histology data as the core endpoint measure. Erin expresses the concern that various patients might look at the data and its challenges and question whether or not they even want to take the drug, but Louise and Stephen suggest that differ patients will react differently. The group kicks around more issues, concerns and possibly solutions around patient engagement and trial recruitment. In the end, the group expresses hope and expectation for what will have changed by NASH-TAG 2023. There is general hope and belief around having a positive set of Phase 3 results to review and some belief that digital histopathology will have made inroads in diagnostic algorithms and processes.

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Last weekend's NASH-TAG 2022 was the best attended event in the conference's six-year history, and probably the one that will have the greatest long-term impact on diagnosis, treatment and monitoring of Fatty Liver patients. In this wrap-up conversation, our seven-person panel (including two Pharma execs and one diagnostics entrepreneur) considers how two key stakeholders -- FDA regulators and patients -- might respond to changes in clinical trial protocols that remove or de-emphasize biopsy-generated data.

This conversation is a continuation of 4.2, which focused on the NASH-TAG "fireside chats." This one starts with Erin Quirk's observation that events of the past year (presumably COVID-19 approvals) demonstrate that FDA is not slow to act when presented with clear need and high-quality data. Erin goes on to confirm that the statements FDA made during the fireside chat demonstrated a "real openness" to dialogue, which is what agencies do to signal that they consider it important to improve processes and/or solutions. Next, she suggests that a patient representative should be on future years' panels. FInally, she harkens back to Dr. Toerner's referral to HIV as a model for relatively fast, data driven change. The conversation shifts to focus on competing views on how to act in the patient's interest, with Erin, Ian and Amy all expressing points of view. Toward the end of the conversation, Roger shifts to discuss the practical implications of Stephen's suggestion that studies should review 3 H & E slides per patient instead of the current number (one) and the two of them discuss practical implications on screen fail rates and its flipside, patient acceptance rates in terms of study cost, timeliness and ability to standardize and simplify placebo response analyses.

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Last weekend's NASH-TAG 2022 was the best attended event in the conference's six-year history, and probably the one that will have the greatest long-term impact on diagnosis, treatment and monitoring of Fatty Liver patients. In this wrap-up conversation, our seven-person panel (including two Pharma execs and one diagnostics entrepreneur) discusses reactions to the closing conference session: two one-hour "fireside chats" exploring the potential to improve clinical endpoints for non-cirrhotis Advanced NASH and NASH cirrhosis clinical trials.

This conversation focuses on the two "fireside chats" that served both as climax and denouement to NASH-TAG 2022. The first fireside chat started with a presentation from Stephen Harrison titled, "Non-cirrhotic Trial Endpoints-Is It Time to Pivot?" and proceeded to discuss proper clinical endpoints for Advanced NASH trials. The second chat started with a presentation from Vlad Ratziu titled, "Cirrhotic Trial Endpoints-Are We Ready for NITs?" and focused on different strategies for endorsing clinical trial endpoints for cirrhosis trials. The first question to group members was about how optimistic they felt coming out of that session and why. The three commercial panelists all rated themselves "5" on a six-point scale, while Ian, the academic, rated himself "4" or perhaps even "3." The commercial panelists focused on the value of having all key stakeholders, including FDA, in the same conversation and on the group's practical problem-solving approach. Ian based his lower score on practical problems he anticipated in developing data that would move the field ahead quickly and confidently. Stephen noted that while we will need to rely on histopathology in the short run, FDA signalled clearly that they are open to data and suggestion on how to use these data more consistently and reliably in pursuit of drug analysis. He suggested first that researchers come forward with guidelines recommendations consistent with what FDA requested and also descried the importance NAIL-NIT initiative in "breaking down the stovepipes" between companies to create a large, integrated data set for large, complex analyses.