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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