Latest / Diagnosing Dx / Why AI Multiomics Will Replace Ultrasound in Liver Cancer Screening with Bharat Tewarie
Transcript
- Bharat Tewarie: Early detection is strongest weapon against ⁓ liver cancer. And our product, HelioLiver, gives patients a real fighting chance by catching it sooner. Of course, it's very important to understand that early detection only matters if patients can actually access it, What is important, is to understand that Helio Genomics is at this moment leading the way when it comes to early cancer detection. David Filby: Welcome to the show this week, Bharat. How are you? Bharat Tewarie: I'm well, thank you David. David Filby: Fantastic. Where in the world are you? It looks very sunny. Bharat Tewarie: I am in sunny Boston and it sounds very strange of course those two words together, right? David Filby: Yeah, there you go. This is the time of year to be in Boston, right? Bharat Tewarie: Yeah, exactly. That's true. So true. David Filby: Well, thank you for coming on the show. We've got a really exciting topic obviously to go through with Helio, but also your story. And Helio are getting a lot of press at the moment and some fantastic updates, which I'm really excited to dig further. But before we do that it'd be great to get get an introduction to yourself and your background and your onto Helio Genomics. Bharat Tewarie: Yes, well, David, and hello to everyone. Thanks, David, for having me. ⁓ I Dr. Bharat Tewarie, the CEO of Genomics. I'm medical doctor by training, and I also acquired an MBA later on. have decades of experience when it comes to global health leadership in pharma, biotech, digital health. And throughout my career, I have been driven by one goal ⁓ and that is the innovation, the innovative science into something which has real world impact for patients. And that is exactly what makes this role at Helio Genomics so meaningful for me, because it brings earlier cancer detection really within reach. And you know, if I just give a summary of my path Helio, have been working for remarkable ⁓ in many leadership roles. I work for a multinational company companies such as Boehringer Ingelheim at Roche. I was at EMD Serono later on acquired by Merck. I was EVP and Chief Marketing Officer at UCB. And from there I sat into, know, leading startups and then founding also consultancy on the way to be able to then hone my entrepreneurial skills. And when I reflect ⁓ on what these roles have taught me is how to bridge science, business and real world impact across pharma, biotech, diagnostic, med devices and ⁓ health. What is important for Helio and what I'm bringing to the table of course is the ability launched and have hands-on experience when it comes to bringing products to market on both sides of the ocean and of that experience from ⁓ big corporations to working in very nimble teams. I'm of course taking the role as the CEO of Helio Genomics and I came to Helio Genomics just at the time when Helio was getting ready or preparing itself for a commercial launch. David Filby: Hmm. that what attracted you to Helio at this point was the fact that there was this commercial launch on the horizon. Or what what was it exactly that because of your background, it's a really interesting background, isn't it, to bring to a company like Helio, but what was it that really attracted you to them at this point? Bharat Tewarie: You know what is very interesting is that has shaped me of course throughout journey and what brought me then to Helio is that I'm a physician, which means that I always have a patient first mindset. You have seen suffering up close and it never leaves you. So patients first always. And in transitioning to the commercial side after my MBA was a pivotal shift because now I was able to influence healthcare on a very large scale, not just one patient at a time. And then I learned how partnerships can multiply impact, how to integrate science, data and strategies without silos. So all of this actually is what you need to be successful at Helio, You need to bring this all to the table so that this journey that I had of blending clinical insight with strategic execution, that journey which led me to Helio, spot on because we have this ability ⁓ at Helio Genomics to truly change lives through earlier detection. David Filby: That makes sense. you went to do an MBA. Was that something that at that point in your career, was it really obvious to you that you wanted to do that or needed to do that to continue like on your journey and what you were motivated by? Bharat Tewarie: Yes. Yes, it was very clear to me that after having done my MD, I had roles within big pharma, you know, in medical affairs and clinical research. But when I really wanted to have this impact at scale, I needed to be grounded in the thinking ⁓ of business. And I to do an MBA because you see, thinking drives ⁓ action and action drives impact. So I wanted to make sure that that kind of thinking right, that ability to look at problems, challenges, and how to solve it from different angles that I had that business angle too. David Filby: So you've got a really unique perspective, right? Because it's not like you've been PhD scientist developing an early stage diagnostic test and then growing your career in diagnostics. You've really come from a rich pharma like great company names and navigated those, you know, those corporate structures as well. What was your impression of diagnostics, omics in the past and the evolution of that to where it is today. Bharat Tewarie: You know liver cancer, which is the disease area that Helio is in, is actually a great backdrop for the answer to your question. When you step back and you look at liver cancer surveillance, the reality is striking. For years, when you look at the diagnosis which are there, we been asking one of the most vulnerable patient population to rely on tools, ⁓ the that we have today, that simply are not built for the level of precision that we need and we want today, the standard standard approach, an abdominal ultrasound every six months, sometimes paired with AFP, is an important start, today ⁓ no longer enough. Why do I say that? This diagnostic ultrasound imaging can be very inconsistent. It is very operator dependent and far too likely to miss the small tumors that matter most. The ones that I say we need to catch early when patients still have a chance for a cure, And in the real world, adherence is also a major challenge and surveillance ⁓ Surveillance depends on the repeating imaging, which is very inconvenient, time consuming, difficult to access. So what happens then in the end? Too many patients ⁓ through the crack. And then when you add in factors, which are important liver cancer like obesity and advanced liver disease, where imaging becomes even less reliable, you begin to see what I call the real problem. It's not only a technology gap because ultrasound is more than four decades old. It's also a system gap now, And that's exactly when you then move to the advanced diagnostic, You shift to AI-powered ⁓ multiomics. when it gets so exciting because instead of depending on one limited snapshot, we can now bring together ⁓ multiple of biology, DNA methylation patterns, protein biomarkers, and clinical context. And all of this, we bring it and then we let advanced machine learning detect signals, that would otherwise stay hidden and this ability to detect signals that otherwise stay hidden changes the game. What you get is greater sensitivity, early detection and a much more scalable path to precision care. David Filby: Mm. Bharat Tewarie: So you see how we have moved from the diagnostics, like ultrasound imaging, to HelioLiver now, and this test addresses a lot of critical gaps that we have today in current surveillance And it offers, and we talk later about it, superior sensitivity to ultrasound, especially for early stage detection in populations, right, patients who are at high risk for liver cancer. David Filby: Right, you sound excited about the future of early and diagnosis. That I mean, unfortunately that's one of the things missing in the industry, is a healthy amount of optimism and is AI a crucial part of that? it all coming together now to create this precision medicine future that we should all be excited and optimistic about? Bharat Tewarie: Absolutely, I would say, What you see is that, especially in this area, you see that AI-powered multiomics, AI-powered tests, are being to the current tools that we have for precise ⁓ blood-based early detection, and in our case, for the early detection of ⁓ liver cancer. Think right? You have imaging for which you need appointment, inconvenient, and now you have a simple blood draw, something far easier patients to complete consistently, And so what you get is not only better science, but you also get an ability to understand what makes things more convenient for a patient. So we can build what I call a smarter, more practical, actually a more human-centric model of care, ⁓ at Helio, we see this as a true leap forward, where you move from reactive medicine where cancer is found too late, to very proactive medicine where we have a real opportunity to intervene earlier, improve outcomes. And in the end, save more lives. David Filby: Right. that leads us really nicely into who is Helio Genomics, the mission platform differentiators that you guys are bringing. Bharat Tewarie: Yeah, Helio Genomics is a tech biocompany founded in 2016 and we actually operate at the intersection of AI, advanced biology and multiomics data. We have our headquarters in Irvine, California and a CLIA certified commercial and R&D lab in West Lafayette, Indiana. Today, our mission is very clear. We want to save lives by detecting cancer earlier. Through simple, in case blood draw because that's what our lead product is exactly doing. And ⁓ mission really matters because when I look at HelioLiver for liver timing changes The earlier it is detected, the greater the chance to intervene when a disease is still treatable and potentially curable. With HelioLiver, which is our lead product, our flagship product that we have today, Helio is able to help patients at risk not to rely on a single signal, but we all those signals together to create something which truly can move the needle. David Filby: So what is the unmet need then in because you mentioned obviously the ultrasound side of the current state of affairs, current standard of care and and how ⁓ how long that's used for. But within ⁓ liver cancer, liver surveillance, what is that unmet need and how big is it in in say North America? Bharat Tewarie: Liver cancer is emerging as a silent epidemic in the US. very often going undetected until very advanced stages and that's because ⁓ there no early symptoms. It today ranks among the fastest rising causes of cancer related deaths. And when you look at incidence rates, they have been tripling. Mortality has been doubling since 1980. When you could identify, when you can identify this early on, the five year survival would be 70% or higher. High-risk patients today, and those are patients defined as having cirrhosis or hepatitis B, are supposed to get screened twice a year. Yet most early cancers still hide. Ultrasound, which is today the standard of care, the technology which is more than four decades old, misses too many of liver cancer although guidelines recommend ultrasound and with AFP, real performance is very poor. ⁓ to 90% of eligible adults skip the ultrasounds because it's There are issues with access and many other barriers. HelioLiver overcomes all these challenges because first it's blood-based. We facilitate very early detection when curative treatments are still very effective. Now, this is the data that we bring to the table. What we need to make sure is this data that we can bring to the table leads to decisions to start using it so that we can detect patients at risk at earlier stages. David Filby: So there's a massive uptick then on ⁓ education and as as the quality of the test. ⁓ It's actually that people are it because maybe they don't want to go get an ultrasound and they aren't even aware that these types of tests exist. Bharat Tewarie: Mm-hmm. Yeah, correct. awareness is a big thing. And let's not forget that there are many areas like in rural America where access is a problem, Getting access to imaging center, that in itself becomes a very logistic issue. You know, building awareness, a very important thing, and you touch of that. And what is important is that we take the scientific data that we have today. We have done a study called CLiMB where we have been proving how HelioLiver compares to the standard of care, Uttersound, and we were able to show our superiority. But that is one thing, right, the scientific validation. Now we have to make sure that we have as many real patients story to show how detection can dramatically change outcomes and we make providers and patients aware. for providers making them aware actually focused on very practical solution not only educating them about the studies did and the scientific data but making them also aware that it's easy to order the test that we provide very clear reports and that we keep sharing case examples where HelioLiver was able to catch cancers where ultrasound had actually missed it. ⁓ What we are trying to do is addressing the adherence gap head on by positioning our flagship product, HelioLiver, as a simple, reliable blood draw that fits into routine care. Because we not only have to work on a physician experience, we also have to work on a practice experience, There is a certain routine that they have when they care for their patients. ⁓ HelioLiver fits perfectly in that routine care, ⁓ And other thing what we actually are saying is you don't have to rely on operator-dependent imaging anymore. many patients anyway are skipping. For patients, building awareness is all about clear messages and making sure that they understand that one simple blood draw can give them answers when it really matters most. So we are shifting the conversation from reactive late-stage care to very proactive surveillance so that Helio can actually make early the new goal and assuring that what we are talking about, that every high-risk individual should actually go and get their test. We want to make sure that every one of these high-risk individuals knows what the options are and feels confident to ask them for a better screening. David Filby: Sounds like you've put real emphasis on the clinical workflow, right, and ensuring that this is easy to use and therefore will be picked up without too much disruption. was that a key part of the development of the product, but also within the CLiMB and how you would utilise that to enable sort of physicians to want to adopt the test? Bharat Tewarie: Yeah, there are two parts here, The CLiMB study, of course, ⁓ itself, and maybe we can dive deeper into that, was of course a clinical study where there is a certain protocol and we work with, you know, many the leading centers in the United States. Real world, real life, when you have a practice with its standard operating procedures, its workflow, is another thing. And for commercialization, it's very important that once you have validated the science and you make people aware of what the results are of science, like our CLiMB study, you also make people aware how HelioLiver fits in the So studied that also in the pre-launch. What would it take to make HelioLiver fit in the workflow so that the practice experience would also be optimal in addition to the physician and the patient experience. The practice experience is very important because in the end workflow actually determines how easy the prescription will travel through the system and we learned a lot. We learned for instance that we need connectivity to IT systems. We learned that we need to bring more ⁓ patient blood draw centers to the table so to make life easy for the patients. Also easy for the practice, to be able to advise the patients where their blood can be drawn, either in their own clinic or if the patient wants it closer home, somewhere else. And that's where partnering became important, to make sure that you can help with all of this. David Filby: I think it's great to hear because I think it's refreshing that we unfortunately in this industry, there's a graveyard ⁓ of great tests, great science they never considered clinical workflows and how ⁓ easy it would be to this test into the real world and that's where things fail. Especially when early stage founders maybe Bharat Tewarie: Mm-hmm. David Filby: have some naivety or a lack of experience in bringing new products through. they think the science is going to be enough, and then they get this punch in the face when it's time to commercialise, and nobody wants to change their standard operating procedures, or patients don't want to go and take that test for a lack of education and awareness. so it's great to hear that this has become a huge part and a huge emphasis of what you guys are trying to do. Bharat Tewarie: Yep. David Filby: And so you mentioned partnerships as a part of the Helio story. How does that come into it? Because it's a word that we hear a lot in the industry, but I think it's a flip of a coin. Half the industry are obsessed about partnerships and see the value of them and the other half are ignoring them and sort of I'll give my opinion later on why, but but what's the emphasis on partnerships for Helio? Bharat Tewarie: So, let's go back. At some stage, Helio Genomics or any company which is moving in the direction that we will have their science validated. You have done the study, you have your test, and the science is there. But are you there as a company? Have you helped the patients? Not yet. You need to go from the scientific validation to clinical adoption. That's a part of the workflow that the doctors do prescribe it, the patient can ask for it and experience of a practice of making this all happen works now. In between, need to build what I call an infrastructure, a commercial highway to go from the ⁓ to the adoption. And there are several elements that you need to bring to the table, right? You need to bring to the the table the ability to build a physician experience, a patient experience, a practice experience. You need to have the ability to connect to IT systems, How will this all work? You need to have the ability to have capabilities actually go and make people aware, boots on the ground. You need to have a publication strategy, a conference strategy. So there's so much which you need to put in place to go from scientific validation to this adoption. And then a CEO of course right you have choices like you buy, you build or you borrow. Now you could build it yourself, it would take a lot of capital, a lot of time and when it comes to scaling fast you need to have the capabilities in this case it means the experience and expertise ⁓ be able to do this. ⁓ here's where partnerships are a phenomenal way to actually do this ⁓ not only faster but to de-risk it also. Because if you work with partners who have been doing this ⁓ have the expertise and the experience, you can take the risk out of commercialization out and out becomes just logistics. So partnering David Filby: Mm. Bharat Tewarie: for me is a major leap forward in our commercial strategy and a de-risk the path to a broad market adoption for HelioLiver and that's why we have in the past months, in the first half of 26, we have partnered with a lot of companies and you will have seen people who are following the journey of HelioGenomics will have seen the press releases and the LinkedIn messages about how we are going to work with all these partners. ⁓ David Filby: Why do you think ⁓ the industry and is great coming from your perspective as someone who's come into this industry from an adjacent and obviously very relevant industry. Why do you think the diagnostics and omics industry doesn't always necessarily see partnerships the way you see it and the way Helio are developing partnerships? Bharat Tewarie: You know, I can't speak for all the colleagues out there. It is of course difficult, right? You have to have experience not only to build the partnership, but to manage the alliance that you have built, That requires, it's a certain ability. You also have to always make sure ⁓ why it that you want to build this partnership? What part of the commercial infrastructure, the highway that you build from scientific validation to adoption, which part do you actually want to fulfill with that partnership. you look at the partners that we have today, Quest Diagnostics is helping in a way. They serve half of the physicians and hospitals in the US. ⁓ One in American adults actually are familiar with And starting April, the healthcare providers with the Quest account can order the HelioLiver test through Quest's extensive network, which is phenomenal. ⁓ You just get a Quest order number. patients can have their blood drawn at approximately, you know, 7,700 patient service centers across the U.S. So this dramatically expands, of course, reach and convenience. The partnership also us this ⁓ seamless that we needed to all the electronic health record systems that you have in the U.S. so that ⁓ ordering result delivery is smooth and integrated in an existing clinical workflow. So ⁓ is a very important aspect that Quest brings to the table. We also partnered with another large commercial entity called Syneos Health and that we did for nationwide provider engagement, field execution and ⁓ support. Because of this collaboration, we have been able to strengthen Helio's ability to build and expand physician and patient awareness and engagement throughout the US. Syneos' commercialization expertise and the deployment capabilities that we have will help HelioLiver to penetrate much more efficiently, much faster in US market because they are bringing decades of experience and success building, executing a lot of commercial programs, especially in the area that we are focused on. These are just two of the partners. We also partnered with Microsoft and with Microsoft we are actually trying to help underserved communities in rural America where the barriers still are there when it comes to routine surveillance and preventive care. Because one of the biggest healthcare challenges in the US is sometimes not a lack of innovation, it's making sure that the innovations that we have can reach every patient, regardless of geography. And I have been repeating this many times in this conversation, early detection matters, but it only matters if a patient can actually access it. So this Microsoft Rural Health Transformation Collaborative, which they had created, is bringing a lot of leaders together across AI diagnostics, digital infrastructure, retail health and community care, the is strengthen healthcare access in ⁓ these rural And what is Helio contributing in this collaborative? Well, we are actually helping with HelioLiver to bring a very scalable blood-based surveillance test ⁓ for liver cancer detection in these underserved areas. Because you know for patients in rural America this collaboration truly means hope, real accessible hope. David Filby: Makes so much sense, especially just the sheer distribution and access that you're trying to achieve. Do those partnerships also with the awareness side of things with regards to liver cancer specifically and early detection? Bharat Tewarie: Yes, absolutely yes. All of this of course because you keep talking about the test, the background of the test, why we're doing it. And have a special awareness program we building together with Syneos for physicians and patients. We also have partnered with an entity called LiverRight And LiverRight is an entity which is basically nation's first and national virtual clinic focused liver disease. And they are serving adult patients via telemedicine in all 50 states. So they are trying to actually also contribute to get patients seen as quickly as possible so that they are also contributing to earlier diagnosis and we have partnered with them too. David Filby: Fantastic. And so what does commercialisation look from this point moving forward, and what does the sort of growth strategy look like under the new leadership? Bharat Tewarie: Well, what it is all about, of course is, going from scientific validation to commercial adoption, building the ⁓ patients, assuring that the practice understand how this fits in their workflow, making sure that people are aware that there is now an option for earlier liver detection, an option which allows them actually to start treatment much earlier where cure still could be a possibility. So that is one big thing. And then of course is looking into the future. We also are evaluating which other tests we can develop in the future, for the same target audience. And we have a platform which can detect many other cancers. So this is also what we're evaluating. David Filby: So further development and new product lines in the future. And what are the sort of upcoming milestones that people who want to follow the Helio story, what are the milestones we should be looking out for over the sort of next twelve, twenty four months? Bharat Tewarie: Yes. Well, the first one is, of course, the penetration of HelioLiver. The awareness about you are at risk, when you have cirrhosis or hepatitis B, you should be tested twice a year. And HelioLiver is one of the possibilities, a blood-based convenience test, which can help detect liver cancer at a stage that is still going to be cured. So that's one. The second thing is we are going further when it comes to product development to now see moving from early diagnostics if we can develop tests to show for instance whether liver cancer after the doctors have been giving you a liver transplant if it comes back again, if there is recurrence. So it's another test that we can develop ⁓ helping with prognosis ⁓ the disease itself. So these are a few examples of other tests that we ⁓ the moment are evaluating ⁓ it comes to further development. David Filby: Fantastic. Fantastic to hear. And Bharat, what's your opinion on where we are as an industry at the moment and the future of diagnostics and omics and AI, bio and and everything in between? Bharat Tewarie: I think looking ahead to 26 and beyond that AI powered multiomics that we have the ability to reshape, right? The industry, the ability to now actually show that AI true power is to help patients in our case, find the tech cancer much earlier where you can still do something about it, right? David Filby: Awesome. it's great to hear the Helio Genomics story, specific conditions, earlier detection, greater access, and an urgency to get this out to patients as quickly as possible and partnering with great companies to do that. It all comes across really optimistically and exciting, and I think this is what the industry needs. We need stories like Helio that we should all be getting behind and we should want to see you succeed, but it's fantastic to hear and we really appreciate you coming on to tell the story. Bharat Tewarie: Thank you. David Filby: Bharat, thank you so much for coming on. Bharat Tewarie: Thank you so much, David. All the best.