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Ep 30 – Six Months In: How COVID-19 Has Changed Our World!

On the six-month anniversary of SurfingNASH's first episode, the Surfers stop to consider how much has changed for NASH stakeholders since April

Browse Our NASH and COVID-19 Coverage
Thursday marks the six-month anniversary of SurfingNASH’s first episode. The last six months, have seen both setbacks and large steps forward in drug development, major advances in disease knowledge and increased breadth and depth of patient advocacy. The Surfers reflect on all these changes while remembering key steps in the podcast’s evolution. Past guest Surfers Tony Villiotti of NASH kNOWledge and Suneil Hosmane of GenFit add their own reflections about what has changed.

Roger Green: For everybody with an interest in NASH or, more broadly, fatty liver disease, surf’s up. Episode 30 of Surfing the NASH Tsunami starts now. So if it sounded like I said 30 in a funny way, it’s because I did. Last week was a special week, because we had really special content. This week is a special week because of two anniversary/coming of age moments at once. If you’re listening on Thursday, which is the first full day we drop the podcast, today is the six month anniversary of when we went up with episode number one.

Roger Green: It’s also episode 30. When I was growing up, 30 was the line of demarcation. You couldn’t trust anybody over 30. 30 was when people were mature and old and responsible. So I think these are both milestones I’ve mentioned before. The folks said podcasts never get past episode 12 because you run out of things to say, and we haven’t done that yet. Fortunately, we’ve found four people who really like to talk and like talking to each other. That helps a lot.

Roger Green: This week, it’s just the four of us, although we have a couple of comments from guests and friends of the podcast. As we talk about the last six months, and everything has changed, this podcast, fatty liver disease, and our own world. Just to give you a couple of examples: six months ago, it was publicly thought that there was a decent chance that elafibranor would succeed for Genfit. Most people were pretty confident that Ocaliva was going to come to market after the FDA ruled. When we did this podcast six months ago, people expected that both the ILC and The Liver Meeting would be face-to-face meetings, not digital. That should give you some flavor of the difference.

Roger Green: A couple of more things before we get started. Thanks again to Matt and to Perspectum for putting together COVERSCAN and then Matt for presenting your last week. Second fastest growing episode we’ve had to date after Day Two of the Digital ILC. So it actually was faster than Days One and Three. Many comments, something we haven’t seen a lot of, people having comments on comments, in one case, even a comment on a comment on a comment, including about eight or ten people who made comments somewhere along the chain who had never made any direct contact with the podcast. So that was pretty cool.

Roger Green: I promised last week we would talk a little bit about the Digital AASLD or TLMDx. Europeans, you’re now in America, the land of acronyms. As of now, we anticipate that we’ll be recording on November 14, 15, and 16. There are late breaker sessions on 15 and 16 and a lot of important, interesting stuff on 14. We’ll be putting those out the next day. We anticipate that we’ll probably record the wrap-up episode on Wednesday the 18th and put that on Friday the 20th. That will be the schedule for the event.

Roger Green: In terms of the previews, we are thinking we will do them October 29th and November 5th, if the schedule and publication of abstracts makes sense. I’m hoping to be able to start announcing our key opinion leaders next week.

Roger Green: Thank you, listeners who have called or emailed suggestions. We’re trying to take those into account. If you have any other suggestions or just want to stay on top of our planning, send us your email address. You’ll read before anybody else does. We’re still sorting out music, so we’re going to go quiet at the end of this week’s podcast. Please let us know whether you miss having music or not.

Roger Green: With that, onto the podcast. This week, we’ll talk about professional highlights, because we’ve been doing a lot of personal stuff recently.

Donna Cryer: So this is Donna. I have been so energized by our “October is for Livers” campaign and really getting a share of voice and so much partnership from around the world on this campaign, so in addition to the focus on liver cancer, really having a unified home to talk about and elevate the importance of the liver itself and liver health. It’s now its third year. Having “October is for Livers” being a real thing with celebrity auctions from Hamilton cast members and GLI Live members, with celebrity transplant families, it’s just been amazing to see. I’m so humbled that patients and other organizations and everyone is finding real value in it and a real home. I look forward to doing it for years to come until it is acknowledged that October is for livers, as is every other month, but we’ll start with October.

Louise Campbell: Hi. It’s Louise here. I don’t really have a professional. It’s just ticking over nicely, which is good. So that’s encouraging. We don’t have any sort of close-outs on the horizon, although we have just had new announcements from the government on starting to restrict various aspects of the country. So we’ll see how that affects the clinics as it closed on clinics, along with the rest earlier on in the year. So we’ll touch wood on that and we’ll see. But from a personal note, and I’m glad that the football didn’t play this week so that, Roger, you weren’t able to get one over on Liverpool.

Roger Green: Bale starts next week. In fact, Bale did not go for Wales so he could start next week. Very exciting, very exciting.

Stephen Harrison: This is Stephen. So from a professional note, I have a very nice highlight. So last Friday was our 15th annual National Liver Conference. I’ve been putting this on for quite some while in person in various cities throughout the state of Texas. For the first time ever, we went virtual this year, and I’m happy to say that we had an outstanding cast of characters, a wonderful group of speakers, and over two-hundred participants online, which was huge, given the circumstances. So I even had a gentleman from India on and another one I think from South America.

Stephen Harrison: We’ll speak about that in a little bit on changes that have occurred in the past six months, but at least virtually, if you want to take lemons and make lemonade, it allows us to reach an audience that we may not have been able to reach had we had the meeting in person, and I think it was a successful meeting.

Stephen Harrison: For me, delivering educational content is critically important. I do think we miss a little bit of the networking that goes along with that, and maybe that’s a topic of discussion for later as well. But all in all, I think it was a wildly successful National Liver Conference. We certainly look forward to having it in-person next year. But one thing we took away from it is we’re going to do a hybrid. We’ll offer a virtual venue for those that can’t make it, particularly those that live outside the country or in places that can’t travel to get here. So it was a good week.

Roger Green: That’s great, Stephen. For what it’s worth, I would bet that even when we can come together in person again, virtual venue will be a piece of everybody’s future.

Roger Green: For a whole bunch of reasons, I think that’s permanent. Lots of things are never going back to exactly what they were, even if they may not stay exactly the way they are right now. I think virtual venue will be part of everything from here on out, and people will want to meet in person when they can.

Roger Green: So the coolest things I did last week are only 92% of the way done, so I can’t talk about them. The one I can talk about that’s 100% done is goes back to, actually, the podcast and a comment I made already, which is that I met three people online this week because they went to lengths to figure out how to find me because they were so enthused by COVERSCAN. Obviously, there’s a lot more data coming out of that, and we’ll have Matt back and other things that we can do to stay abreast of it. Those are the weeks when I feel like what we’re doing here is really getting through on a scale that we might not have anticipated.

Roger Green: Let me start by talking a little bit about how we got here in the first place. It’s the end of March. Stephen and I are on phone. Stephen is concerned that people are unduly concerned or, more accurately, scared out of their minds that clinical trial recruiting, patient management, all that is going to completely fall apart in the pandemic. Stephen had put steps in place and had some rational rules about what could continue, what might be delayed, how to manage, and we were trying to figure out, how do you get that message out to the world at large?

Roger Green: One of us said to the other, “Well, why don’t we do a podcast?”, which is funny, because neither one of us knew the first thing about podcasts. I didn’t even know how to find someone to do podcasts for us. But we thought it out, and we decided that there might be interest in a podcast that dealt with the commercial issues associated with COVID and liver disease, found a very good C-suite executive, Peter Traber, a really good supply side analyst, Yasmeen Rahimi and away we went. All the responses we got at the end of the first week were from patients asking questions like, “Am I going to die?”. That was when we realized that this was going to be a different thing than we had in mind.

Roger Green: So, Stephen, I know we’re way out past what we originally intended, but how do you think the world has done at picking up the message about clinical trials? The followup question is going to be back to Louise’s comment. If, as expected, wave two comes in the fall and winter, how will we be prepared to adapt, and what do you think the challenges will be at that point?

Stephen Harrison: We’ve come a long way in six months. We’re not out of the COVID window. We still have COVID to deal with both in Texas and around the world and maybe a second wave coming. It’s interesting in the US. It seems like the states that didn’t have an issue early on are kind of gradually having their issues, right? So currently, we have six or seven states that have seen a surge, and those were states that hadn’t seen a surge previously. In states like New York and Texas and Florida and California that had a surge and a big issue, we’re starting to quiet down. But it’s certainly likely that we might see a second wave of this, if not here, in parts of the world.

Stephen Harrison: From a clinical trial enrollment perspective, there were most certainly delays, some delays in start-up, certainly delays in ongoing clinical trial enrollment, and while not a real burden, there were some endpoints that were missed in some patients who, for some reason or another, did not or could not come in for their end of treatment imaging study, liver biopsy, blood work, or whatnot.

Stephen Harrison: Having said that, we have found a new steady state. We have found a new equilibrium, and we are marching forward with that. Clinical trials are certainly underway, and new ones are starting. Old ones are finishing. We have found a new battle rhythm.

Stephen Harrison: In addition to that, we learned how to cope with good hygiene, with social distancing, with wearing masks, hand washing, sanitizing, cleaning things repeatedly numerous times a day. We also learned how to do telehealth visits. We learned how to ship drug directly to patients. We learned how to send phlebotomists to houses. We adjusted protocols. We made protocol amendments. We reached agreement with the FDA on how to manage this, how to deal with protocol violations and deviations as it related to extended screening windows and missed visits, missed blood draws, and that sort of thing.

Stephen Harrison: So I think with a second wave, we will be well in hand to deal with those particular attributes of clinical trial enrollment and maintenance of the study. But all in all, I think we have come through it better, having had to learn from that tribulation. Like with anything else, I always say you can’t have a testimonial without a test, and obstacles create opportunity. So we have learned from it, and I think we’ll be better prepared if it comes back again.

Roger Green: Somebody who isn’t a science journalist put an article in the Washington Post this morning suggesting that maybe the right way to think about how this is phased is that social distancing is part of it, but another part of it is at what point does climate force people to spend their time indoors instead of outdoors, if you think about it, the waves in Texas, Florida, Arizona came at the time of year when it was so warm that people couldn’t be outside. They had to be inside, in the air conditioning. Now y’all can live outside again. New York and New Jersey are rising again, and the states that you’re talking about are the cluster in the Upper Midwest, which are the first states to get pushed indoor by cold weather.

Roger Green: I don’t know that that’s important. I thought it was really interesting. It made sense to me. So if that’s the case, I expect that there will be a return in the fall. What I think I hear you saying is that so the new equilibrium that we’ve achieved, you think they’ll be able to address that even if it’s a worse wave than people expect?

Stephen Harrison: From a clinical trial perspective, we prepared for the worst and anticipated the worst, and we survived it. So I think we’re as prepared as we can be for another onslaught.

Stephen Harrison: And it may not be COVID. It may be another issue. Maybe COVID in the flu put together or some other pandemic. But I think we’re stronger for having gone through it and are better prepared. We may not know all the answers, but I think we’re in a much better position today to tackle it next time around.

Donna Cryer: You know, Roger, when I heard that statement as well about now we’re going to have to face being inside. I was like, “Who was outside? I haven’t left since March.” We’ve all reorganized certainly clinically and from a research standpoint in the ways that Stephen has so well articulated. From an employer workplace standpoint, we are remote. We will continue to be remote. For those of us who didn’t want to host the family holidays in the first place, we have a “get out of jail free” card. My family already knows this about me, so I’m not… And my friends who were preparing for Canadian Thanksgiving were freaking me out online. I thought that perhaps it had morphed into November, and I hadn’t noticed, which is entirely possible, but then I remembered how many lovely Canadian friends I had who were preparing for that holiday.

Donna Cryer: So I think we have been through the worst. We have reoriented. This is the new normal. We will continue to wear our masks, wash our hands, socially distance, things that patients with autoimmune diseases and transplants and cancer already were doing and knew how to do and navigate in the world. I also think there’ll be a lot more interest in snowboarding, skiing, snowshoeing, outdoor sports, and that may be able to create a business opportunity and the revenue flow for those who had normally had to shut down or curtail their outside activities in the past. Because people will need an outdoor outlet, and so just as we saw rises in camping from first-time campers in the summer, we will have, unfortunately, some first-time skiers — God help the ERs — and others who are seeking to be outdoors safely in new ways. But I don’t see the weather and the climate as posing an insurmountable challenge. Not that it’s not a real challenge, but an insurmountable challenge given what we’ve gone through so far.

Roger Green: Five years ago, I believed that I didn’t have to worry anymore about all those distancing and masking skills, because I was given a clean bill. And so for me, it was just like riding a bicycle. That was pretty simple. Not my favorite bicycle, but riding a bicycle. Stephen, are you planning to do any of the sessions in Park City in January outdoors before people go skiing?

Stephen Harrison: The networking takes place on the ski lift, so we will have plenty of time to do that. The sessions will be indoors, socially distanced, of course. Normally we have seating for close to 300. I think we’ve separated that and parsed that down to about ninety-fie. So give or take some, but it’s going to be done right, using all the guidelines that we know to be true and helpful. And it will also be a hybrid meeting where there will be a virtual aspect to it as well. But again, the beauty of NASH-TAG is the networking that takes place., and fortunately, most of that occurs outside already anyway.

Roger Green: So, we will come back and preview NASH-TAG right after Thanksgiving.

Donna Cryer: American Thanksgiving.

Roger Green: Yeah. That’s fair. American Thanksgiving. Thank you. Well noted. So, that’s week one. And then on week two, we start attracting advocates. And the first two advocates that I really got to know were Louise and Tony Villiotti, who actually has a thirty second recording we’re going to try and get to later in this podcast. So Louise, how’d you find out about us in the first place? I don’t think I’ve ever asked you that question.

Louise Campbell: I think it was just through Twitter or maybe even LinkedIn. I think actually it was LinkedIn, and I think I listened to the first couple of episodes, and I have to say… for medical topics, a lot of the time I don’t listen to it because sometimes they can be quite dry, as I’m sure we can all attest to. But actually, I really enjoyed it. And the time went by, and I think the discussion that you, that Yasmin, Peter, and Stephen were having, was actually educational as well as thought-provoking.

Louise Campbell: Obviously, I just left the NHS and was setting up and establishing Tawazun Health, so I was more into, and I’m still more into, finding out the whole rather than just the narrow view that sometimes we can have within certain aspects of healthcare. And I think Stephen and Donna and yourself can all share that because the view has to widen when you try to implement something that is more broad. So for me, it was about getting information, and that’s where I came across you guys, and that’s why I made a couple of comments. And I think then I got recruited in.

Roger Green: Where you got my attention was when you posted the Wuhan paper about the fatty liver versus non-fatty liver cohorts in Wuhan and their response to COVID.

Louise Campbell: I think they were one of the first ones, weren’t they, to come out with more on liver?

Roger Green: Yeah, they were. And you posted that between Week Two and Week Three, and actually, that was why I reached out to you because I said, “Gee, that’s great. These are articles I’m not reading, and she is. God bless her.” As you say you were starting Tawazun at that point in time. How did the six months worked out for you in the context of what you try to do with Tawazun and what you’ve been able to accomplish?

Louise Campbell: Well, I think like everybody external, it closed any of our real clinics more or less immediately in March, but I think being able to do the podcast, but also being able to do the reading and learn a little bit more about what was going on, and the opportunities that fatty liver presents. And it was interesting listening to Stephen and Donna talk there is that the both of them, I think, came up with more positives than maybe negatives. I think for a long time in clinical trials, we’ve needed a little bit of flexibility where patients are concerned, and I know they give us plus or minus a couple of days, but actually there is the ability to flex within clinical trials and get the outcomes. It be interesting about NASH-TAG. I heard a scientist presenting the other day that the virus is at optimum at four degrees and that everybody should be keeping their houses warm.

Louise Campbell: So it’d be interesting to hear and see, because that was the first time that ever did come up in anything that I had seen. I think there’s a lot more interest now in non-invasive techniques. They certainly speeded up the opportunity. Beyond the biopsy, as Donna’s promoted. I think we are getting there. With dynamic fat fracture, I would like to see that we isolate the patients who need dynamic fat fraction with FibroScan the same way as we do with FibroScan for liver biopsy, for example, and FIB-4, for exmaple, and other non-invasive techniques. The opportunity to develop now is bigger than it ever was, and I think we’ve got multiple health care areas enabled to deliver FibroScan with their staff being redeployed, and that may well happen again. And we’re able to pick up in a lot of areas to help out in that burden to try and not reduce people coming in for liver care.

Louise Campbell: Because I think as we know liver cancer and cirrhosis and “October for Livers”… It is vital that we start to get these people diagnosed, and I think the urgency has now become around obesity, type two diabetes, cardiovascular, and there is a lot more awareness of the co-morbidity of all of these conditions, and therefore people need to find it. And I think there is now a willingness to start those discussions which would not have been there six months ago. So that’s where I sit at the moment. Would I have been in any different? I think it takes a long time to establish a new business and a new way of thinking, but we’re trying to remove barriers, not and put them in. And I think COVID has offered those opportunities.

Roger Green: So over the next several weeks we did podcast, people came, people went. Louise gave me this brainstorm, another one of these “scramble at the last minute” things on the Thursday before our ninth podcast, that it was International NASH Day next week, and maybe we should do something about that. Through Stephen, we reached out to Donna who was good enough to come on the podcast, and was a huge hit. Eventually when we decided that we needed permanent people to do this, Donna asked what else could she do to help, and it was a serendipitous week because I was about to call her and ask her if she wanted to become a permanent member of the podcast. So that was good, and she’s been here ever since. So, Donna, the last six months… How have they been different for you than what you expected?

Donna Cryer: The last six months have been truly transformational. I think it’s been decades since I’ve spent more than two consecutive weeks at home. My doctors were very grateful that something was strong enough to take me off the road and give me some time here. As much as part of the strength and the superpower, I think, for the Global Liver Institute is my ubiquity, the dedication and commitment shown by showing up, whether it’s in Paris, or Utah, or Boston, or where have you, there was an opportunity to take all of that time, and particularly as a patient with ongoing conditions, to take that energy and the resources that were spent traveling and talking and things, and use them to be really thoughtful about the space, the field of hepatology, our organization, and myself and the family. And I would say that in a way, all three are stronger.

Donna Cryer: Certainly, COVID has impacted liver patient advocacy, and I’ll speak most from that point of view, in that we have this growing recognition and this opportunity for collaboration around liver health, and unfortunately, how COVID patients are liver patients. It has put a spotlight on the very nimble and wonderful liver-specific registries, research opportunities, studies, and allowed us a chance to highlight them. I want to compliment AASLD on their COVID-19 program. This past six months has really given this organization and their new CEO a chance to shine. I agree with Stephen that without a test, there is no testimony. And so this was their test, particularly for their first CEO. And I think he’s past it because their COVID-19 program has been useful, meaningful, nimble, in multiple languages, it has a patient member on the COVID-19.

Donna Cryer: So this past six months and COVID-19 has brought the advocacy community closer to the medical community, certainly to the medical society, in both the ASSLD and in our work and conversations with EASL. It has seen the growth of liver-specific initiatives, and the patient community’s ability to highlight them through new platforms online. Certainly GLI Live, but other webinars. From a policy standpoint, the past several months have seen… We have a liver bill that is in active consideration to be passed this year, either as part of a COVID package or independently. The ability to work across organizations, partner in new ways with obesity colleagues, diabetes colleagues, and viral hepatitis colleagues in a laser-focused way… And I want to give so much credit to my policy director, Andrew Scott… Has been something I haven’t seen, and I’ve been doing advocacy in this field since my own transplant twenty-six years ago when I was in Federal Affairs for UNO. We’ve brought things across the line, or they’re very close there, even, like, an immunosuppressive coverage bill.

Donna Cryer: We were talking about that when I was Andrew’s age, which is a long time. So it’s been amazing to see policy momentum. We’ve also had more conversations with the American Society for Transplantation, or with HHS, or with CMS, or we have a CDC Summit coming up on Wednesday. So there’s an engagement and interactivity in the liver advocacy community with the support of clinicians and nurses and others, KOLs from around the world, in a way that I haven’t seen before. So I think that the liver health field, and certainly liver health advocacy, is… We’re not emerging yet from COVID, but has experienced COVID and has been strengthened by this experience. Certainly GLI has, if not every organization, but I think

Donna Cryer: there are many, many advocacy organizations that have been delivering value and maybe not had as much visibility. Just like , in lot of cases, we were the best kept secret. But with greater visibility during COVID, we have gotten a lot of traction. We’ve gotten a lot of support and our impact has grown. It’s been an exciting time.

Roger Green: As I’m listening to you, one of the things I’m reminded by is that in the aftermath of the Intercept CRL letter, a lot of people had a shaky week. But then because they were fueled by passion and urgency, people just dusted themselves off and said, “Okay. What do we have to do to keep going and how does keep going change and what stays the same?” I think from the outside in, it might not have looked this way, but from the inside out, I actually saw more energy and optimism in some ways after that, that I had seen before that, which really surprised me. I don’t know if you folks thinks that’s a fair reflection.

Donna Cryer: I think what GLI was able to provide in that was a sense of clarity and stability, that not withstanding one company’s setback, that there was and is a very strong and robust NASH advocacy community in our seventy-member NASH council. That we, both patients and collectively stakeholders, are a unified presence and will speak and will persist. I don’t think regulatory bodies and many other aspects of that matter had yet recognized. I see this in the opportunity column. It gave us an opportunity to show up and to make our presence known. I think that that is a positive.

Donna Cryer: I’ve actually been working more with other stakeholders, even other advocacy organizations, who are rallying around and saying, “This is where they’ve drawn a line. That we just, as a NASH patient community and as a liver patient community, need to be respected in a way that we clearly were not before.” I think that will stand us in good stead moving forward.

Louise Campbell: Do you think it was also, when I looked back at that, it was the fact that everybody was angry about that decision?

Louise Campbell: Quite often it’s just the people who were affected by that decision who are often angry and everybody else goes, “Oh, well. That’s all right. I’ll carry on.” But, everybody was angry. Industry was angry. Healthcare was angry. Patients were understandably angry. Everybody decided to take a stand on it, which is unusual. Very good, but unusual.

Donna Cryer: Yeah. I think this one of the rare occasions where everybody does feel invested in this. I think the Liver Forum and others have done a great job of helping to knit this community together. But also, everybody was caught off guard. There wasn’t a segment that said, “Oh, I understand. I see where they’re coming from.” Everybody noted a lack of clarity of communication. Everybody noted that this was in discordance with what had been said before and what all the assurances are and what we had collaboratively developed.

Donna Cryer: It wasn’t just a strike against one company. It really was a strike against the entire field. I think that’s how at least how I interpreted the uniformity of the reaction, because everybody felt ill-served by the way it was done and how it was handled and how it continues to fail for lack of communication. I think that everybody was affected, not just one company.

Stephen Harrison: First of all, I think Donna and the other advocacy groups have been tremendous in this regard. Stepping up, stepping out, making a difference. In a lot of ways, leading the charge for change and clarity and refinement of the message that’s being delivered, particularly from federal agencies.

Stephen Harrison: What I’ve seen when I stepped back out of the weeds and looked at the field, I think we have seen a focus on what the perception was, what the underlying meaning of the CRL was. Because I haven’t seen it, as I noted before. None of us have seen it. It’s just between Intercept and the FDA. But based on the comments that were made, we were able to at least get what we think is a general idea about the message that was delivered.

Stephen Harrison: In a lot of ways, that focuses on liver biopsy and it focuses on safety. I think for better it has forced the folks in the therapeutic drug development world relative to NASH, I would include myself in that, to really take a hard look at the programs that are underway to see if we’re adequately addressing what we perceive to be the issues at hand. I think that is the endpoint, particular as it pertains to liver biopsy and all the nuances around that, and in safety.

Stephen Harrison: To that regard, we’ve seen significant strides. I mean, even at the Liver Forum where we did a deep dive on liver biopsy and the paper that we published earlier this year in J Hep, I think has really moved us forward on two fronts. It’s moved us forward on the need to understand the limitations of the biopsy, its variability and interpretation particularly relative to the Kappa statistics that we know. How do we work with that? How do we move the needle forward? I think we’ve made progress there.

Stephen Harrison: Then, more importantly, how do we take the next steps? What’s the role of fully quantitative assessment of the pathophysiologic features of NASH? In other words, what’s the role of artificial intelligence and machine learning and how can that bridge the gap to noninvasive testing. Then even in noninvasive testing, we’ve seen huge strides, just the Digital ILC, particularly relative to PDFF. You’ve heard that there’s been other data published on F-AST, FibroScan-AST, and NIS4.

Stephen Harrison: I think we know a lot more relative to that than we did pre-COVID. I think we are light years ahead. In fact, I would argue that 2020 from a NASH drug development perspective, we have seen more data come out. I counted nine press releases on drug therapeutics this year alone. That dwarfs what we’ve seen in other years. I suspect this is the tsunami, if you will, that is going to continue despite COVID. We’re still pushing through and we’re gaining more knowledge. We’re gaining better insight, clarity. I think COVID, if anything else, it’s caused us to tighten the aperture, become a little myopic, if you will, about what’s right in front of us, what needs to be fixed right in front of us so that we can have a better vision for the future in 2021 and beyond.

Roger Green: Steven, is tightening the aperture focus or myopia?

Stephen Harrison: I think it’s both. I think tightening the aperture gains a clarity and a focus, but I think we were missing stuff right in front of our noses that we really needed to pay attention to. I think it’s both.

Roger Green: About the time that Louise was doing Tawazun, I was disengaging from a marketing research career that I had burned out of and started a company called HEP DYNAMICS. The reason I named the company, had the word dynamics in there was watching Steven’s presentation about Kappa scores at NASH-TAG and listening to, in fact all of NASH-TAG 2020, one of the things I understood was how little anybody was talking dynamically about how the liver worked and dynamically about how the pieces went together. Some stuff on PDFF, but not nearly what’s evolved subsequently. I get a feeling that we understand more about what the drugs have to do, but even beyond that, we understand more about where the targets are. That may be the focus and myopia both at once, but it leads me to believe people will make fewer mistakes and get pulled off course less often, which is a really optimistic thing. Because it’s getting hopes up and dashed is what ultimately becomes the problem. If we can keep getting hopes up and then having them not dashed, that’s how you show real momentum over time.

Roger Green: We’ve got a little bit of time. I want to play with Tony had to say. Then I want to play what Suneil had to say. This is Tony first .Donna and Louise, I’m going to ask you two to comment on it first when we come back out of it. Here we go.


Roger Green: Okay. When we started looking at what people didn’t know, we realized we had to talk to the entire family at once. Louise, that sounds like things you’ve been saying.

Louise Campbell: I think it echoes certainly what I said the other week about education and by starting education young. That may be our biggest cost-effective way. If we know more about actually how our body works, we might actually understand how and when we need to look after it, because it is with us 365 days a year, 24/7. We do think more about other things than we think about our body sometimes.

Louise Campbell: I think Tony is right. I think starting with younger people is important now because these adolescents are going to be suffering if we don’t change things. Cardiovascular disease in their thirties, forties getting diabetes as we’re seeing now in their twenties. I don’t think any parent ever expects to do that with their children. I do think it is education. I think that’s an easy area to start with.

Louise Campbell: School, just make it part of the curriculum. There is some basic understanding of our bodies. I developed Tawazun Health was to find early liver poor health, to promote liver health. Because if we keep our livers healthy, we’re less likely to run into the developing of type 2 diabetes, cardiovascular disease. If we can keep people’s livers healthy, then we’re on a win-win.

Louise Campbell: I think that’s globally, whether it’s a non-communicable disease, it’s just a massive problem and education could be the key to it. I think Tony’s definitely got something there.

Donna Cryer: Louise is absolutely correct. I think Tony is right to focus on this aspect of the overall NASH problem. The Global Liver Institute’s Advanced Advocacy Academy is different from a lot of patient training you might see in the field because we work with people who are at that point of transitioning from patient to patient advocate. It’s less about us training them in how to do a hill day or something that we’re interested in, but really finding that intersection of their personal passion based on their experience and the strengths that they bring from their career.

Donna Cryer: The Villiotti family, because it was really a family affair, father, daughter, wife, Betsy and Gina had been such a part of this. Gina’s kids affected by what their grandfather was going through. As they became more experienced and thoughtful about what it meant to carve out an advocacy space that they could have an impact on, you need the most effective advocates as I teach and as we talk, focus on a problem that matters to a particular group in this, in our case the patients, always a great place to start, and to focus on that problem.

Donna Cryer: That’s how as an organization, they’ve evolved to focus in on pediatric NASH. It called to their heart. It calls to their family. It calls to the experience that they had collectively professionally. They connected with Thelma Thiel who was an originator and innovator in liver health advocacy who lost a child of her own to liver disease, has come up with fantastic materials, this great coloring book, Olivia and Oliver. They have formed this really fantastic bond. They’re executing on the specific issue and aspect of pediatric NASH.

Donna Cryer: I think they’ll be incredibly impactful and effective at it.

Donna Cryer: In 2017, when GLI established the NASH Council, we knew we couldn’t fix every problem in the field while creating the field itself from scratch. It was always about defining the framework and the key elements for what effective advocacy would look like in NASH, so that those with expertise and passion could each take a part of it.

Donna Cryer: And so, it is so exciting for me to see Wayne take a specific perspective of this problem, Tony taking a particular aspect of it, and others as well. So, the problem I am solving is effectiveness of the field as a whole, which keeps me plenty busy. But it really will succeed based on people and advocates and entities taking on individual questions, problems, challenges and aspects of this NASH problem, as you’re doing, Roger, frankly, so thank you, and all of us collectively bringing them forward. I think he is absolutely right. And I look forward to supporting him in every way that GLI can.

Roger Green: Suneil gave me three separate cuts. The first one was about the work that he’s been doing with GENFIT, and it’s for this year; and specifically the Lancet article and the acceptance of that; and then the LabCorp deal, which I think I could spend an hour talking about because I think it’s really fascinating. So, I’m going to leave that to the side for today. Maybe we’ll come back to it as part of another conversation within a few weeks.

Roger Green: Then he had two others, each of which run about a minute. Let me play this one and get reactions. And then, time permitting, we’ll play the other one.


Roger Green: I think that comment goes back to the points we’ve each made about PDFF and the emergence of dynamic fat-fraction as being one really helpful place to look and understand dynamically what’s going on and translate into what might be happening for the liver overall.

Louise Campbell: I think he was right on that. I think it speeded up the movements and actually supports Donna’s whole campaign of “Beyond the Biopsy”. I think there is now, more acceptance and more belief that that could be one of our end surrogate markets. But we have to do it in a way that are we going to be able to use dynamic fat-fraction for every single person that comes through the door. We’re not. So I think we do have to combine it with the other non-invasive therapies.

Louise Campbell: But I think there’s a greater acceptance now of non-invasive therapies, even though we’ve spent a number of episodes discussing how poor some of them are. Dynamic fat-fraction is definitely way up there with not needing to stick a needle into anybody if we do not have to. And selecting that population that then get to dynamic fat-fraction with other non-invasive therapies, Fibroscan, NIS-4, which Suneil was talking about before is going to be important. So I think again, COVID-19 has given us opportunities to fast track those areas.

Roger Green: With that, let’s go to Suneil, sorry we didn’t get to your other comment. We’ll see if we can get back to that in another week. Or get you in here another week. I’m hoping that Suneil will be part of our coverage of AASLD, talking about diagnostics.

Roger Green: So slightly different closing question than we usually have, but consistent with the episode and what we’re talking about. The one thing you couldn’t have predicted six months ago about COVID’s effect on liver and liver community that’s clear to you today, and maybe even looking back, it’s surprising that you didn’t see it coming.

Stephen Harrison: I’ll take that. To me, there’s so much information that’s come out in the past six months and I have to look back and think, what are we thinking might be most related to COVID-19? I mean, in a lot of ways we would’ve gotten a lot of this data maybe even sooner had we not had COVID.

Stephen Harrison: But one thing that we have learned or I’ve learned from the COVID pandemic is that we have learned how to reach people in a much more dynamic way. And what I mean by that is we’ve been able to take our technology that was there, but we basically put it on a fast track in its applicability to disease state awareness and education, as it pertains to the fatty liver disease. And not just fatty liver disease, but quite frankly, any disease. And just having people, and I’ll just bring it right down to home with my National Liver Conference, having somebody on from India. I mean, that would have never happened, quite frankly, had we not had COVID.

Stephen Harrison: So that’s just a small example of a much bigger way that this thing has really exploded. And I think it’s just something that’s going to be here. It’s going to stick around and we’re going to be able to move the field forward that much faster because of what we’ve had to learn from and go through.

Roger Green: People from, I think the last count we’ve got is at least forty-seven different countries, have listened to at least one episode of this podcast, which is unimaginable to me, but it seems to be what happened.

Donna Cryer: I wouldn’t have predicted this growth. GLI has doubled in size, both from a staff point of view and a revenue point of view. We still need to scale to meet the need, but I would not have predicted that this would have been such a catalyst for growth for the organization because of our ability to pivot and to respond to the needs in NASH and COVID as a whole.

Louise Campbell: I think without COVID I didn’t foresee the government introducing an obesity strategy, taking on food industries and restaurants to have to put calories on every piece of food eventually that they produce. And I think that’s led to potentially collaborations with obesity. And I think the data from COVERSCAN last week, that only fifty-percent of those who were obese actually had abnormal liver fat was key. That you just can’t tell by size. So I wouldn’t have seen any of that coming six months ago.

Roger Green: The thing I wouldn’t have seen coming, and I’ll go back to NASH-TAG, is people were so locked into biopsy, and people were looking at the world through such a biopsy lens. In fact, a biopsy lens and an OCA lens. And what happened with OCA was unfortunate. What’s happened with people dynamically looking a lot harder at how to do non-invasive tests better, is I think important.

Roger Green: But I’m impressed at how much more we know now than we knew then, or we’ve published now than we’ve published then. And that starts to make the disease make a lot more sense. And when you look at the Wuhan data that Louise put up on LinkedIn that caught my attention in the first place, we also understand as a result that liver plays a different role than other organs do, most other organs do at least. And we can start to see the reasons why.

Roger Green: So I don’t think I would have expected this explosion of knowledge around that set of issues. And I think it’s fantastic because what it does is presages a good future.

Roger Green: Alright. We are now at the end of today’s session. I want to thank Louise. I want to thank Donna. I want to thank Stephen for today. But frankly, I want to thank you guys for riding together on this for the last several months. Stephen talks about unbridled passion. This is an easy community to get very passionate about because you don’t come to liver because you want to get rich. You come to liver because you want to do the right thing. Some people will make money along the way, but I don’t think that’s the motivation. And that in and of itself is really refreshing and I think really helpful, and inspires me every day, every week, as I talk to this community, as my life moves in this direction.

Roger Green: So thanks to the three of you for inspiring me every day, every week in that way. It’s really been a tremendous experience. Thanks to everybody who supports the podcast; MiC, Eric, Poli, Ryan, Buzzsprout, who actually helps us figure out how we’re doing.

Roger Green: Thanks to everybody who listens. It is going to get more exciting as we go along. As I say, in a couple of weeks, we’ll be up talking about previewing AASLD, and then that will happen. And right after that, we’ll be previewing NASH-TAG. In the middle of that, we’ve got some other cool concepts and topics we’re going to talk about.

Roger Green: So everybody have a great week. If you’re in Canada, I hope you had a wonderful Thanksgiving. If you’re in the States, I hope you have a great Columbus Day or Indigenous People’s Day. Wherever you are, particularly if the second wave is coming, however small it might be, don’t get cocky. All right? Stay safe. Stay healthy. Surf on. We’ll see you next week on the podcast. Bye-bye now.

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