Latest / Diagnosing Dx / What If We Could Test Depression Drugs Before Patients Take Them? Dr Talia Cohen Solal - NeuroKaire
Transcript
- David Filby: Welcome to the show this week, Talia. How are you? Talia Cohen Solal: Great, thank you. David Filby: Awesome. And where in the world are you? Talia Cohen Solal: I'm here from Tel Aviv today. Nice peaceful place. David Filby: Tel Aviv but with a strong British which is awesome. Talia Cohen Solal: Exactly. London born and raised. ⁓ many years there. And only here the last ⁓ eight years or so. David Filby: Great. We've got a lot to get into today and I'm actually really looking forward to 'cause I think it's super exciting what you guys are doing. the insights you're gonna be to give and the work you guys have already done is super interesting. ⁓ At the forefront of precision medicine, which is a great buzzword at the and people are excited about it. But before we do that, ⁓ it'd be great for you to introduce yourself and your background and career everything about you. Talia Cohen Solal: Great, sure. I'm Dr. Talia Cohen Solal, I'm a neuroscientist originally. I spent about a decade in academia and research, ⁓ first at Oxford, studying neuroscience and genetics, then a PhD at University College London, ⁓ and a postdoc and independent position at Columbia University, all dedicated to understanding ⁓ mechanisms of illness. I've been very frustrated my whole life by not knowing exactly what's going on inside our minds, especially when I know, suffering. I was very ⁓ passionate about more and more about the underlying causes of illness in the brain. I then moved to Minneapolis for a year, joined a precision medicine startup, new therapies to children with child-onset epilepsy, using drug repurposing before starting NeuroKaire David Filby: When did the interest in in neuroscience specifically first come up and was there sort of reasons behind that? Because it sounds like that was quite early on in your life that you had that interest and intrigue. So where did that come from? Talia Cohen Solal: I think it began as early as I think around seventeen years old or something when I started to get deeper into biology and ⁓ realised fascinating it was to learn how this incredible, incredible thing that is our body works, the beauty of the design, the beauty of the Krebs cycle, the pathways, everything about the magnificence of creating a human that can think and do and exist the way we did. Always fascinated me. And the most, you know, essential part of that, the most unique and key and exceptional part of that is the brain and the way that we can think and ⁓ have ⁓ and thoughts. And it's just an incredible thing that these neurons together make such a complex creature that we all are. so I've always been fascinated by that, understanding that, and also been drawn to what we can do. when it goes wrong and so upset to see, you know, it's so fragile and delicate. Everything needs to be such a delicate balance to make a healthy individual. You small, subtle changes can cause so much trauma and difficulty in individuals' lives. ⁓ And seeing through career that I could do something about solving that. David Filby: And you said you were in academic for for a long time. Did you see yourself or did you always see yourself going into the start up world and as a leader or CEO of a startup and and creating your own thing? Or or how did that sort of transition come around? Talia Cohen Solal: Yeah, very much I thought I was gonna be a research scientist. So first thing I did to really kind of solidify my passion for research and and neuroscience as a field ⁓ I did a position at the National Institute of Mental Health in Bethesda, Maryland. It was just a summer internship, but I saw how amazing it was to have a career where you get to constantly learn and grow and break the boundaries of discovery and create new knowledge for the world, especially in an area that helps people directly that are suffering. So at that point I I was sure I wanted to be an academic. I went down the path, I did my undergraduate, my PhD and my postdoc. ⁓ through my PhD and postdoc, I started to see how far I felt from patient lives, how far I felt from making an impact that I could see in my lifetime. Obviously, there's the butterfly effect of important publications that help us improve our understanding and knowledge of the mind, of the brain, and of disease mechanisms. But I felt like I could be closer to what motivated me, which was improving mental health, improving behavioral health and so that's when I went off into industry. And really I've never looked back. It's Just an incredible feeling to have your workday, your purpose, one third of however much your make career and work your purpose, ⁓ you know, doing something that really an impact on this world and seeing the patients being impacted by what you do, ⁓ and hearing physicians feeling that this make a difference in their day-to-day lives to actually help patient outcomes. And I felt that first in Minneapolis. at the company Pairnomix I was with and now I feel that on a day to day basis. So ⁓ have never looked back and I'm very excited to be able to have a career that is so meaningful and purposeful. David Filby: That's awesome. And and you went into the private sector with with a start up initially, right? So you went straight into the start up world as well, which is obviously completely different again. But how was how was that experience of when you went into the start up world and and was it successful? Talia Cohen Solal: So I had you know, investigated earlier in my career going into one of the established big pharma's, like and I felt that, you know, as a research scientist joins those communities, you're a very, very small cog in a very big picture. So I don't think you you necessarily get that feeling of direct impact. and so when I was offered this opportunity To join precision medicine startup. I was the lead scientist for the for the whole company. I was the second hire of the company. I was really given an opportunity to be at that direct intersection between the science and the outcomes for patients. And it would have been very ⁓ to get that opportunity in a big pharma company to go straight into that like position of responsibility and intersection between what's going on inside the company and what's going on in the patient lives. ⁓ And I was very lucky to get that chance. And now especially as a CEO, ⁓ you are piece between the outside and the inside world of your company. And so I really am the interface between ⁓ what's the technology that we're developing and that ability to bring it into the outside world and into patient lives. David Filby: That's a really nice transition into NeuroKaire. Who are NeuroKaire? Talia Cohen Solal: So, NeuroKaire is our company. We've developed together with my co-founder, Dr. Daphna Laifenfeld, ⁓ was also a PhD neuroscientist, spent many more years in industry, and was before that the ⁓ of precision medicine at Teva Pharmaceuticals together with Iris Grossman. ⁓ we both felt that there was a lack of precision medicine taking place in the space. ⁓ Oncology precision medicine through and through these days. And psychiatry was being practiced very much in a non-evidence based way, and definitely in a non-precision medicine way. And that's what we aim to fix, and that's what NeuroKaire is. Basically, we saw a cutting-edge technology, which I was working on at Columbia University, we create neurons for every patient and we expose those neurons to all the different antidepressants and see which antidepressant is best for each patient. ⁓ for the first time, we have a biopsy of the brain without touching the patient's brain from blood. ⁓ And we finally start to practice precision medicine ⁓ for psychiatry neurology. So this allows us to start by helping with depression. We'll be expanding ⁓ into other indications. we also help pharma companies bring new drugs into the market with precision medicine in their design. So Understanding what types of patients might respond to their drugs, understanding what the mechanism of action is for some individuals or all individuals. So that's the two parts of NeuroKaire. The test to help patients get the best drug for them and the platform to help pharma companies in their precision medicine drug development pipeline. So, you know, precision medicine in a way can be practiced individual physicians, right? When you start to really understand a patient's family history, a patient's background, a patient's previous drug history, as things as possible, you start to create an individual picture for that patient and you try and fit the drug that's best for them. That is what physicians are trying to do. And the more you know a patient, the better you can do that. So say you get a couple of hours, you have a chance to try and tailor that drug to that patient. But not many people get a couple of hours with a psychiatrist. Most people don't even get to a psychiatrist. They get 15 minutes with a primary care physician before they're prescribed their first antidepressant. If that, sometimes five to ten, depending on your healthcare system. And so That's like the the baseline is, you know, some personalization if you have access but and that's the status quo. There are tests on the market that do look at your liver processing enzymes. These are pharmacogenetic tests, and they do help you understand whether you're going to be able to process or metabolize a drug predominantly. There is some small neuronal readouts that have a bit of an impact, but mostly we're telling you drug metabolism. So that did start to bring psychiatry into the precision medicine space. This is tailored to your individual liver processing genes. and that's kind of where as far as we've gotten today, in terms of trying to kind of tailor a medication to an individual. David Filby: And so where are you guys up to in terms of the the science and the data you've collected and and sort of validation for the for the product? Talia Cohen Solal: So we've conducted now two clinical trials across two different entirely different sites. So one was took place in America, across a couple of different sites, and followed patients up to a year. And the second study it took place in Israel, also with a long follow-up of 12 weeks per patient, trying to understand their responses to different antidepressants and what we've been able to do is demonstrate in these two cohorts, ⁓ Very, very high prediction accuracy and being able to read out whether a patient responds to an antidepressant, far higher than we're seeing by treatment as usual and by the pharmacogenetics platforms. David Filby: How long has the company been in in existence? How long have you been in development and sort of what capital have you raised, the growth you've seen already? Give us sort of insight into where you guys are in the journey in the background. Talia Cohen Solal: So we were founded in August 2018 or September 2018. we the first years kind of developing the platform and and validation ⁓ So another important of what NeuroKaire has developed is we've basically made neurons accessible to everybody, your neurons accessible to everybody. You know, biopsies have become standard of care in oncology, and now we have neurons as that could be a standard of care across the brain space. In order to make that commercial reduced, cost effective, turnaround time that's palatable for individuals, ⁓ we a lot of product development there. And it's really robust now it's a regulatory approved platform, CE and CLIA approval. So we're regulatory approved in the United States and in That's where we've basically taken the company to today. We've raised 25 million, including four million dollars of non-dilutive equity from grants from the Israel Innovation Authority, as well as the Horizon 2020, now called the EA European EIC program. And along the way, we've been partnering with pharma companies to help them with drug development as well. So we've partnered in the in the psychedelic space, in the psychiatry space, and also in the Alzheimer's space, measuring cognition decline with different medications. David Filby: interesting. So and so what your in terms of the going back to the two sides of the business in terms of developing a test, but also developing the platform to help drug development, the drug development side is already being utilized. Is the test commercially available through a clear lab in the US? Or how how is that set up? Talia Cohen Solal: Exactly. So NeuroKaire now has a CLIA lab in New Jersey, in Kearny, New Jersey. We CLIA regulatory approved. We are we have a distribution agreement with Quest Pharmaceuticals, so we're available all around America. ⁓ And can just click on our site, ⁓ www.neurokaire.com, and access to our tests. Any individual could come straight to us, ⁓ and can also come through the platform and start prescribing for their patients. So we've had hundreds of physicians so far using our test. ⁓ making their patients better and we're seeing in the real world happy endings already and that's something really powerful for us. order to get distribution. We're still, ⁓ you know, only halfway across America. We need to get Labcorp and then we've kind of got full coverage for everywhere. We also have at-home phlebotomy services, so we've partnered with an at home phlebotomy test platform. and we also in the future hope to offer at-home testing with these new skin patches which can take ⁓ significant amounts of blood, which may be able to allow this test to be happening. Take place wherever you're located. So distribution is a really important piece. And also reimbursement is another really important piece. So we're lucky that we are able to get reimbursement for Medicare. So the elderly community can access this test. Everybody can access this test, but there is an out-of-pocket cost at the moment for most people with private insurance. David Filby: Mm. Talia Cohen Solal: yeah, this code already that we're able to utilise for Medicare ⁓ makes much more favorable. There are already some private insurers like Humana who are covering it, and Cigna Health. So yeah, we're on the right path. A couple of years we should have quite dramatic improvements in coverage nationwide. David Filby: Awesome. And talk to me about sort of the education and awareness side of what we we hear this a lot in the diagnostics world in terms of ⁓ if you've got great science and you're ready to commercialize, if nobody knows about the test or clinicians are reluctant to use it and change existing workflows. How how do you guys go about? creating more awareness and educating the system that this is a step forward and a how how does that how's that addressed? Talia Cohen Solal: so we have kind of two approaches. First of all, it's important that the clinicians learn about us. So we make it ⁓ priority to be at all the top conferences, have a presence at then the American Psychiatric Association, Neuroscience Education Institute, which is a fantastic conference, which happens twice a year. We also have some of the opinion leaders on our board. So they are telling our story as well. ⁓ the head of psychiatry from Harvard University, the head Psychiatry from Columbia University, of the lead psychiatrists from University Pennsylvania, ⁓ and of the psychiatrists, Stephen Stahl, who basically writes the book in prescriptions ⁓ The Guide, is published every two years that most psychiatrists hold in their hands. ⁓ So having the advocates for the is super important because, you know, they they believe in what we're doing and people believe in them and people trust them. So it's really important to have that link. and finally we're also moving from kind of physician level to also a customer level, a patient level, the final user. So unfortunately, Z is suffering terribly ⁓ from psychiatric It's quoted that 46% of Gen Z have a diagnosis of psychiatric illness, ⁓ which is devastating. we saw these numbers coming up through the system. As they were teenagers, we saw high levels and now they're in their 20s. And so that population we want to really help as fast as possible. We want to create awareness and we're going to do kind of work with campuses and able to help them get access to this test. A most important stage in their lives, you know, success at university, making it to the end, getting the grades they need to start in the workforce. ⁓ So we really hope can make a big impact there. So that's a kind of top down, bottom-up approach to create market awareness. David Filby: Staggering number, isn't it, in Gen Z? that's unbelievable. Talia Cohen Solal: Yeah. It's very sad. I mean we've got depression, anxiety, OCD, PTSD, ⁓ others and obviously terrible the more difficult ones, schizophrenia, bipolar. There's a lot of things there that we can be traumatized by. And I've you know, living through, you know, COVID, living through the the telephone era, the social media era. ⁓ it's all provided a lot and the and changes in upbringing it's all provided a lot of stress this Gen Z population. David Filby: social media era. Interesting one to pick that apart. Of which side of the business do you see bigger, the sort of pharma services and helping drug development or the testing side of the business? Which one do you will be the the biggest commercial avenue for you? Or is it hard to say? Talia Cohen Solal: It's hard to say. They're both they're first of all they're symbiotic, right? So the bigger we build this commercial arm of the test, the more incredible that data asset becomes to pharma to help them with drug development, understand, you know, ⁓ populations exist in the world. Obviously everything is totally anonymous, but we're understanding population level psychiatric illness. that's one piece, but and the test is just the beginning of what we have to offer, right? We have to offer all psychiatric illness, moving into neurological illness like Alzheimer's and Parkinson's as drugs become available. ⁓ And we have data to support a diagnostic itself for predicting ⁓ for telling if you have mental illness and which one. ⁓ And so that's an that and of itself is an incredible opportunity. And then the pharma partnership is, you know, a very, very path and it's a very, very large path but they both are. So we have the chance to be a very important company in this space. David Filby: Yeah, there's so much development going on in neurology at the moment, I guess feels like you guys are ⁓ are almost gonna be set up so as things start being released, you're gonna be there to sort of with product development ready to go. Okay, 'cause now now that's available, we can support that. And that's interesting, isn't it? The especially as more and more drug development gets approved. Talia Cohen Solal: Exactly. So a lot of pharma companies say, ⁓ I don't really know what to do with biomarkers, because once I've got a biomarker, how do I commercialise that biomarker? How do I make it accessible so that people know that my drug's the right fit for them? And because we already have a whole clinical arm, we know exactly how to get kind of specific question tests, specific biomarker tests into patient lives. David Filby: That's super interesting. The future product development as well. Is is there is there much required growth from where you are today to the sort of next phase and and sort of future raising of more capital to go on to achieve the next milestones and goals? Talia Cohen Solal: Yeah, we are we're at the beginning of an exciting phase of the company. So the money we've raised to date has fueled our de-risking of the science ⁓ and regulatory barriers, et cetera. Now it's time for growth scale up. So we need to build the sales engine or expand the sales engine and really bring this make sure that having built a technology, as you said, a technology that can have such a strong impact on patient health, on well being. make sure it gets into patient lives. So we will we are raising capital for that growth. And I think there's gonna be this and this and a bit more till we can be profitable and allow this to get into patient lives through our own revenues. David Filby: Traditionally the US is the biggest market. You've got your Clear Lab set up, but you've also, you know, your Tel Aviv based, you've raised capital in the EU and got approvals there as well. ⁓ Where I I was gonna say where's where's the priority? But at the same time, what how do you manage that? Because it's you know, it feels like you've got three really big, robust markets to go after. Are you trying to do it simultaneously or do you sort of prioritize what how does that work? Talia Cohen Solal: Yeah. Mm-hmm. I've never heard anybody describe Israel as a big robust market. So we have a teeny market on our doorstep that we are serving organically, through word of mouth, and we are happy to help ⁓ you know, in our own country, and there's a lot of stress and a lot of trauma here, and people are suffering from mental illness as a result, and we do want to help that population, but our commercial arm is all focused towards the US for now. until we get our stable footing and some revenues and then we have the chance to expand into Europe. David Filby: So what are the future milestones that we should really be looking out for as a company and if if you know for people that want to follow the the product development and success of it, but also you know, the the company holistically, what what's sort of the upcoming milestones that we should be looking out for? Talia Cohen Solal: Well, we have this pivotal paper coming up, which is going to be able to allow us to release these nice clinical trials demonstrating our effectiveness. We've just started a partnership with Mindful Care, a fantastic telemedicine company, through a BIRD Foundation grant from the Israel-American government of a million dollars. So we'll be running a prospective clinical trial. ⁓ we'll be releasing those data, and that'll be also supporting the company. Next year we hope to launch, ADHD. ⁓ so bringing or maybe early twenty twenty eight, so bringing a new education online as well as making sure that we're serving anxiety, which has strong overlaps with the depression, the depression medications. So we've a lot of growth, lots of opportunity and we look forward to, you know, announcing our various new pharma partnerships as well along the way. David Filby: You've got it's a lot going on, isn't it? Because the clinical trials, you're gathering data, you that proof of concept is obviously really important. also commercialising simultaneously, which some a lot of companies unfortunately put mainly mainly due to a lack of capital, if I'm honest, start parking their trials and and start commercialising, hoping to gather data as they go, but let's be honest, they're also trying to revenue because, you know, it's harder to raise capital at the moment. And I actually think that's one of the biggest tragedies in the industry over the last few years is the amount of clinical trials that have been left on the shelf because that companies can't afford to pursue them. Is that part of the ongoing sort of strategy to ensure that trials and big data and great data that ultimately creates the big long term success of the company is still maintained and capital is raised to ensure that those things progress whilst also commercialising. Is that is that really important to you guys? Talia Cohen Solal: Exactly. It's very important. cannot change the standard of care without large scale prospective clinical trials. And while we've conducted very elegant clinical trials, the size isn't enough to change the guidelines. ⁓ we have to change the guidelines. If we're going to get into everybody's hands ⁓ we're going to be accessible to everyone suffering from mental illness, then we need to change those guidelines. And that's what our clinical trials are funding. It's part of our fundraising efforts we're doing today. David Filby: Right. Talia Cohen Solal: We're very happy that we won a BIRD grant to support one of those clinical trials, ⁓ BIRD Foundation and we are looking forward to also, you know, raising it ourselves and working with different grant bodies to see if we can even expand the sample size through through grants as well. David Filby: What's your outlook on the diagnostics market and and especially neurodiagnostics? Where are we in that sort of that life cycle and where are we going? Talia Cohen Solal: I think it's best to just speak about the neuromarket, which is exploding right now. We've had some major acquisitions by BMS and AbbVie of major assets in the psychedelic space, and there are like exciting things going on in the kind of therapy space around in psychiatric health and then lots and lots of new like mediums for getting access to care, which is a real, you know, tragedy and travesty that so many people can't even get access to care. The diagnostics market, ⁓ I think it's a tough market for diagnostics. ⁓ lot of VCs are focusing in on their kind of core domains. So you really have to find the VCs that are open to diagnostics, but ⁓ it's still an amazing time to be the brain space and so we're happy to be well and truly in that in that area as this explosion takes place. David Filby: That's awesome. sounds for me, it's exciting because I think that we're still, you know, scratching the surface about what can be achieved and what is still yet to be achieved in in the near future, and things are really speeding up as well. And we could talk about AI another time, but AI is obviously contributing to the efficiency of things. ⁓ It feels NeuroKaire have a really balanced ⁓ approach to. Building a business that's not just trying to survive but ultimately thrive. And that's where the industry gets testing wrong sometimes, they drop things to go do but you've got this really nice balance across clinical trials, accessing partnerships, approach to reimbursement and progress already, and engagement of KOLs that will, you know, have a profound impact and compound the the success of the business, then feed that into the future product development opportunity, this feels like a really exciting one. and I love that. I love coming across exciting companies companies. Talia Cohen Solal: Mm-hmm. Great. I couldn't agree more. Thank you. David Filby: Talia, thank you so much for coming on and sharing the story. This was super insightful and genuinely really exciting. Talia Cohen Solal: Thank you very much.