Interview with Cognivue CEO Tom O'Neill

0:00:10 - David Williams
Memory loss, dementia, Alzheimer's those are not things that most people want to think about happening to them, but it's all too common. The treatments haven't been available anyway, so it seems like a lot of worry for nothing. But my guest today has a different perspective, focused on empowering patients and caregivers in Alzheimer's prevention through cognitive health promotion and early detection to enhance patient outcomes in mild cognitive impairment and Alzheimer's disease. Hi everyone, I'm David Williams, President of Strategy Consulting from Health Business Group and host of the Health Biz Podcast, a weekly show where I interview top health care leaders about their lives and careers. My guest today is Tom O'Neill, CEO of Cognivue. If you enjoy this episode, please press that like button and subscribe. Tom, welcome to the Health Biz Podcast. 

0:00:56 - Tom O'Neill
Hey, david, thanks for having me. I really appreciate you taking the time. 

0:01:00 - David Williams
So we're going to do a memory test of sorts here it's not nothing as fancy as what you've got and ask you about your childhood. I guess those are the last memories to fade anyway, but in this case. I want to ask you a little bit about your upbringing and any childhood influences that have stuck with you. 

0:01:14 - Tom O'Neill
Yeah, so I grew up in Cleveland, Ohio, on the west side, Also mid-western boy, one of three sons and I grew up in a blue collar town, blue collar house. My dad worked for the local electric company. My mom was a medical transcriber, so it was interesting. My dad would literally go to work from seven in the morning till five at night and my mom would go to work from five at night to one in the morning, Monday through Friday. 

And so we grew up listen, we didn't want for anything. They always made sure we had what we needed. It was. You want to talk about influencers? It was both of them. They were the key influencers in my life. 

0:01:59 - David Williams
And then, what did you do for education past high school? What did you think you wanted to be? What did you end up studying? 

0:02:06 - Tom O'Neill
Yeah, it's an interesting story and I'll give you a little perspective. So in high school I wasn't exactly the best student and maybe known more for having fun than studying, and so when I went to college, I went to the university, excuse me, I went to Cleveland State my first year and it felt like senior high school. 

0:02:26 - David Williams
Yeah. 

0:02:27 - Tom O'Neill
Living at home, going to school, coming home still cutting the grass, washing the cars for my dad. And then I quit and I dropped out and I went and was a full time furniture mover truck driver. And I remember coming home one day and it was like it was a 16 hour day. It was a brutal day in the middle of the summer and I got home at one. I had to go back in at six and my dad said you know what he said you could have spent six or eight hours at the library at school and done a lot better for yourself and wouldn't be you know in his words humping triple dressers up three flights of stairs when you're 40 years old. 

Yeah, so I'm like, you know as much as I didn't agree with him at the time, he's smart. So so I ended up going back to school, went to University of Akron and I think it was a. It was kind of that turning point for me because I was listen, david, at best I was a two, three student in high school. But something changed and something just clicked and I wanted to do better, I wanted to do more and so I went and started being a. I was a three, eight student my first semester down at Akron, but I think it was also living away, you know, feeling the experience, but also kind of proven, wanted to prove people wrong, wanted to prove that I could do it, so. So I ended up getting a business degree, an undergraduate graduate, bachelor of science and business and business administration and marketing. 

0:03:58 - David Williams
You know, I see sometimes people are advised now to take what kind of a gap year and it's a sort of a similar philosophy, which is that you go out, you know if you just go straight onto school. It's sort of like taking it for granted. And you know, by the way, the parents. You know your parents. On the one hand they were working 16 hours a day, but it also meant you had coverage the other time because somebody wasn't working. So there you are, being you know somebody had an eye on you. You go to school all of a sudden whatever, I won't speak for you know what you were, what you were up to. But then actually, when you've got that experience sometimes in consulting we call it the self-discovered logic it's like, yeah, you know three stories, or maybe four stories, you're going to be humping the dressers up there. Then you can really go in and apply yourself because you're doing it, because you want to do it. 

0:04:36 - Tom O'Neill
Yeah, it sounds like so. Yeah, it really. And it helps me now because I mentor a lot of senior professionals but also young professionals coming out of college and I think everybody's in this race, yeah, and I try to explain to them it's not a race, it's a journey. Now I'm 54, so I actually have some experience to be able to say it. But I understand where they were. I was similar when I got out of school, but I want everybody to kind of slow down, enjoy what they're going through, because it matters, you know, the older they get. 

0:05:06 - David Williams
Now I see you know. So we're going to talk about healthcare today and that's mostly the focus for the podcast here, and you've got some stints at healthcare well-known healthcare companies, but I also see one for, I think, the National Biscuit Company, nabisco. How did that start off? 

0:05:20 - Tom O'Neill
So I started when I was in college. One of my best friends' dad was a sales manager at Nabisco. So I started working as a merchandiser during school, then, as I got closer to graduation, as a summer intern and then, once I graduated, they ended up making me a full-time offer. So I started off in consumer packaged goods with Nabisco. But if you think about it, my foray from Nabisco into Johnson and Johnson was also in CPG and consumer package goods. So I went from cookies and crackers to Tylenol and Motrin and you know Imodium. So it was just a different CPG business. It was OTC over the counter medications rather than you know, cookies and crackers. 

0:06:06 - David Williams
Gotcha All right, so there's a logic to it. But then somewhere you got into healthcare. How about Bausch and Lawn? What was that about? 

0:06:11 - Tom O'Neill
Yeah. So I'll actually even give you a little bit different perspective, because most people you talk to kind of grow up in one vertical, right, yeah, in one world, and I'm a bit of that tweener is how I define it, right. So 30 years in healthcare, but everything from consumer healthcare to pharmaceuticals, to vision care, the contact lenses and vitamins and drops to surgical equipment, chemistry, even no hematology at ortho clinical diagnostics, the molecular diagnostics and life sciences and ultimately here at Cognivue, where it's really. We're as much a medical device company in neurology as we are a tech company. 

0:06:52 - David Williams
Gotcha, okay. So let's talk about, let's talk about Cognivue, but in terms of just cognition, let's talk about that, and there's a lot of CO words here. So, concussions, yes, there's a lot of emphasis on concussions. Certainly, you know, we see it when we're talking about professional athletes, football players and so on. But also, just, you know, kids playing high school football or hockey or just stuff that happens, even not through sports, and you think about, okay, at the time you get a concussion, you recover from it and so on, right as you get toward, you know your age and my age, and I'm even a little bit ahead of you. What are we seeing in terms of you know those, those concussions, and what sort of an impact that may have long term on cognition? Any, any connection there between what happens earlier and you know what happens later on? 

0:07:37 - Tom O'Neill
Yes, so. So a couple of things. There is definitely a clinical connection between concussions, tbi and concussions versus traumatic brain injury and in longer term impacts, especially when it's multiple concussions over and over again. So we've we've worked closely. His name is Dr Jeff Kutcher at the Kutcher Clinic. It's out of Michigan and he's one of the easily one of the world's renowned sports neurologist. He works with the US Olympic downhill ski, the snowboarding team, the NFLPA, the NHLPA, and he's been using our technology for four or five years. 

And it's not necessarily that we're a concussion test by ourselves. We're not. We're a cognition test as it relates to concussion Right. So a lot of what you see, david, on the market are concussion tests. Those are FDA approved concussion tests but I don't think they necessarily go deep enough into the cognition, into mild cognitive impairment. So you know, ours is a deeper test, or assessment if you will, to give the doctor a better understanding of how that, how that athlete, whether it's a student athlete or whether it's a professional athlete how that athlete is progressing To be in bed, being able to be back on the field. 

But to your question, I don't know that there's the direct correlation to long term. I mean, you hear about CTE and football players and professional football players and other stuff. So I think there's clearly a correlation to it. I don't think you'd be able to talk to a doctor or a neurologist that wouldn't believe that, but I do think it matters. And I think it also matters to understand, if you do get a concussion, when is the right time. If you're going to go back on the field or on the court, when is? Or the ice, when is the right time to do that? And that's where you lean on the professionals the sports neurologist to help figure that out. 

0:09:41 - David Williams
Tom, when I think about cognition, certainly I worry about you know. I see older people, I know people even my age that have cognition issues and I hear sometimes about people saying, well, let's do an assessment, a cognitive assessment, and I guess, from my standpoint, even though I believe in the scientific method and all that, I sometimes think, well, what you don't know can't hurt you. And then even on the other side, what you do know might not help you. If they're just going to say, yeah, you could probably get Alzheimer's early. So it's like now I should start. Why don't I start worrying then as opposed to now? But what's the kind of the value and do you see potential downsides of doing early assessment? 

0:10:18 - Tom O'Neill
So, first of all, I think it's a great question and I hear it a lot, but I'll give you a couple of things. So, first off, in the real world experience, before COVID hit, we used to do employer health fairs. You know, in the cafeteria there's 20 tables set up, a lot of different vendors that come in and, do you know, different types of things testing and education and other stuff for the employees of that company. Well, we started getting hired by HR within these different organizations, and I mean everything from companies in Silicon Valley to waste management, to Cleveland Clinic, to local car dealerships and other stuff that would do this. We would bring David, we'd bring four devices, yeah, okay, and they would run the five minute screening four devices. Now, generally these health fairs are three hours long, okay, three to four hours long. We would have to stay an extra 90 minutes to two hours at every single one of those events not bar none, all 52 that we did before COVID every single one we had a waiting list of people that wanted to come in and be screened. And so, when, that would you know. 

Now kind of fast forward to this idea of what can I do? Right Cause, when we talk to primary care doctors. Many of them don't do enough cognitive screening or cognitive assessment and I think the reason being is the reason they tell us is they got to see patients every 10 minutes. Right, they don't have time, there's no prescription they can write for. And if they do do the assessment, sometimes the payers make it difficult for them to get reimbursed for their time. And I explained to the doctors I'm like I get that, I really understand. And they also say we already counsel our patients about diet, exercise and stuff. And I go, I get that, I really do understand that. But there's an inflection point here. So I didn't start taking my Lipitor and start watching my diet until I saw my numbers. I saw until I saw my cholesterol numbers. I think the same thing holds true. 

Like people it's there are things they can do. They call it the modifiable risk factors. So the World Health Organization, the CDC, healthy Brains Initiative, the Lancet, they've all come out and said diet, exercise, lifestyle, mindfulness, hearing, you know, cardiovascular, all these things matter and if we take care of those things early on, you could slow or stop the progression of MCI mild cognitive impairment before it becomes something more permanent. And now you got a report that makes it more meaningful to you. 

I think the other thing, david, is I don't know many people who haven't seen or been touched by dementia up to and including Alzheimer's. So whether it's mom, dad, grandma, grandpa, aunt or uncle, when we see that, we call the caregivers or the children of the caregivers, the worried. Well, yeah, so they wonder whether I have that or I'm gonna have that one day. And if you empower them by giving them data and then also actions they can take. And now recently, the FDA just approved the drug for mild cognitive impairment or early Alzheimer's. Now there's something they can do about it, yeah, but for us it's really those modifiable risk factors that make a difference. 

0:13:55 - David Williams
Now, Tom you're talking about. I'm just gonna jump on something else you said about before the pandemic health fairs, people lining up and so on and so forth. Obviously, a lot of things changed with COVID, one of which was just the sort of quick shift to digital health and remote monitoring and so on. And have you been part of that, or are we still talking about kind of an in-person, kind of an exercise? 

0:14:18 - Tom O'Neill
Yeah, so our device, our technology is in-person and I think there's real value in that right. 

So, not to get into super technical stuff, but when, and we're working towards mobile apps and mobile tablets and other things that will do some cognitive assessment on those too. But the reality is is when you go into the doctor and it's in the right healthcare setting. It's not. And I'll use my mom and dad as an example. They're both 79, if the tablet or a phone is something that you ask my 79-year-old parents to hold and use the other hand to take a test with, they're gonna have difficulty with that from a motor skill. If, like our technology, measures every one-twelfth of a second, so in 10 minutes we get 130,000 data points. If during that 10-minute assessment they had to like there was a glare from the lights, if they had to look around on the tablet itself and they're gonna miss seconds in being able to get to an answer, it all of a sudden starts to have an impact. So there is really something to there's real value in having you know mobile technology. 

0:15:35 - David Williams
You don't need to go to all the effort, in other words, to tell you that older people sometimes have more difficulty manipulating the latest device. You know that's not gonna be there. Related to that, though, is you mentioned, like when you didn't start taking your Lipitor until you see your numbers. Now it's still. The lipid profile is still like slightly complicated, but it's not nearly as complicated as trying to understand cognition. 

And I think one of the, you know, one of the big issues just has to do with just the differences among healthy individuals even that are all sort of similar. And then what's the normal aging, you know, versus an actual deficiency? And my understanding has been hard to sort that out, especially if it's not something that you're having, you know, every year. You didn't necessarily have a baseline assessment. How do you think about? You know how someone reads that report? Is it just that, wow, I got this report and I've got some reds and yellows on it? I better actually, you know, take it seriously, or can you? How do you deal with this sort of baselining? 

0:16:33 - Tom O'Neill
Yeah. So, first off, I think we as a country, but as a healthcare across the country, but the world needs to do more. With regards to cognitive screening. Our technology is gonna tell you. All the technologies are gonna tell you the DCAs, the digital cognitive assessments, are gonna tell you where you are with your cognitive function at that moment. Do you need a baseline? Not necessarily, right? I think that's what we give you and we give you and all the technologies do they give you versus a normative range, so they'll know by your age or your sex at birth or your ethnicity, where you should be, and then it tests you against that. So what I do think is almost think of it as the fifth vital sign. Right, there should be a really regular conversation with your doctor where they're testing MCI. 

We know that Alzheimer's doesn't just show up. It takes decades, decades to build that up. I think it's very complex and I'm not a scientist so I'm not gonna pretend to give you all the detail on this. But if you think about Alzheimer's, it's really three things it's inflammation, circulation and toxins. So if you think of those, even when one drug comes out, like Leqembi, it's removing that protein buildup, right, the plaques and tangles in the brain. But that's only one element. 

This is gonna take a very different approach to curing Alzheimer's one day, but I think it starts with where you started the question, which is if you're screening regularly and early and you catch it when it's mild cognitive impairment and, by the way, it could be many things right, david, it could be the medication you're on, it could be a concussion, like you had mentioned earlier in the show. It could be that you're smoking or maybe not taking care of yourself. If you understood that those had impact on your long-term brain health and capacity, you may change how you live your life for the benefit of longevity, more so than you would have before, because maybe again, you've seen mom or dad or grandma or grandpa been through it. So you mentioned a couple of drug approvals. 

0:19:05 - David Williams
Last, or I guess a couple of years ago, we had a new helm that was approved but then not approved for reimbursement by Medicare cost the FDA, commissioner, acting commissioner or her job and career probably and now you've got Leqembi, which seems to potentially actually work somewhat and it's a little bit less expensive and maybe it doesn't have as many side effects. 

At the same time, it's awfully pricey and the impact is gonna be modest enough that most people probably won't be able to really detect it and we're just talking about a slowdown. So I'm sort of answering my question as I'm asking it. But you mentioned more impact. More investment maybe needs to be made on the earlier side, maybe on the screening and the lifestyle modification, because for the 20, some thousand, whatever it's gonna be for a year of Leqembi, there's a lot of lifestyle modification that you could impact a lot of people. For that it doesn't help somebody who's already at that later stage, but you should be able to have a bigger impact up front. What's your view sort of from a public health standpoint, about how sort of the tie in between early assessment or early assessment, lifestyle modifications versus longer term treatments? How should that balance be adjusted? 

0:20:17 - Tom O'Neill
So I think it should always start with before it turns to medication. It always start with screening, empowerment, knowledge, and then the modifiable risk factors, the things that you can control. I also think, and even if you look back at Biogen's drug and now with A-size drug, with Biogen Leqembi, they're really breaking ground. So I don't want you to look at these drugs as the end all. I think it's really the opportunity that, finally, for the millions and millions of patients that have very real concerns about progressing from MCI to Alzheimer's, or from early Alzheimer's to full blown Alzheimer's, it gives them the first opportunity to treat themselves with and it's not insignificant. Right? So you had mentioned cost, but cost is just one factor, right? So it's $26,000. We'll see what CMS comes out and I think they'll cover, but there'll be a pretty significant copay. But even then, if you have millions of patients that want to try this, our health system isn't ready to do it, from policy makers to health systems, to payers, to the providers. So there's going to be bottlenecks along the way and we have to work closely with the health systems to figure that out. We have to work closely with the payers to figure it out. 

Give you an example besides the cost and that there's not enough neurologist or neuropsychs to be able to screen all these patients. Because it's so expensive and because the side effect profile is not insignificant there's brain bleeds and swelling of the brain. They're going to want to have a prior authorization process that includes a screening like Cognitive View, includes some blood biomarkers, maybe even a PET scan and some other neuropsych workup. Those are all steps that can only be taken through a specialist, not through primary care. And even then, let's say you have a radiologist that has done a PET scan. 

There's only a limited number of radiologists that really understand how to look for the amyloid at the stage the amyloid needs to be in to benefit from Leqembi and then ultimately it goes to an infusion center where you get in two infusions a month, one hour each time, and it's going to take. There's going to be MRIs involved because they're going to want to make sure there's no negative side effects. So the reason why I say all that is it goes back to the first comment, which is empower and control what you can control If you're on the medication. Remember this isn't going to be the first. 

There are 15 different molecules that are in phase three, which is the last step before they get approved Phase three trials. And 15 of those, or just about all of those, are expected to get approved in the next four years and they're going to get better and better as we go. So they're not going to be just stuck on the 27% improvement in the Leqembi or the 35% improvement with Lilly's drug. They're going to continue to improve both the side effect profile and the efficacy. 

0:23:38 - David Williams
To go back to what I had said before, perhaps, if not unfairly, but without the fuller context about the new helm approval is that I think what FDA was considering was there's been a lot of investment here and we've got something that is changing, a biomarker that we think should work. And we're not just looking at this drug, we're looking at everything that's in the pipeline, and we don't want to give a signal to the investors to say, hey, we know you spend billions of dollars on this, but we're going to have a standard that's so high that you're not going to be able to surmount it, and I think there is a broader public policy issue at stake. But of course, it has to be done at the level of an individual drug approval, and then Medicare is looking at that from that standpoint as well. I want to touch on a little bit what you were talking about, that the healthcare system is not ready to be able to administer Leqembi as an example, and I think in your role you won't be able to unblock every element of that chain. 

One of them, though, maybe does relate to primary care. So, if you think about, there's not enough neurologists, but also what happens is that those that are being referred. Sometimes those referrals are not appropriate or not necessary or they're not efficient in the sense that you refer to the wrong neurologist or the wrong specialist in general, and in working with primary care, are you able to help empower primary care to do more, sometimes maybe not to refer or to make those referrals when they're most appropriate, and so on. That might help at least one element of that whole chain. 

0:25:11 - Tom O'Neill
Yeah, listen, I think that would be the ultimately ultimate goal right to get primary care involved. I think until we get to that level, until we get to that point, I think it's going to sit with the neurologists, the neuropsychs and geriatricians who have been taught to be able to identify and diagnose Alzheimer's. So I think that's where it's going to sit. But the only way we're going to be able to take care of the millions of patients is it's got to start in primary care. Yeah, but in order for it to start in primary care, things have to change, and things have to change either from a payer side or even just a how do you see a patient in 10 minutes and get through everything that they need to do? I have a lot of friends who are primary care, internal medicine or family practice docs. They're they're great docs. They care about their patients. They are not looking to push the patients off, but they are under pretty strict requirements of how many patients they need to see and get through. 

Things are going to have to change and I keep explaining Alzheimer's is not just a health care issue but a society issue, and we have to figure that out. We, as Cog2View, we started broadening the screening class to include audiologists, some optometrist, retail pharmacist, because we know it can't all just rest in the very traditional channels. It's going to be needed, screening is going to be needed across the board and then allowing those clinicians to intervene how they can against the modifier risk factors. We know hearing is one of the most modifier risk factors and people generally take about seven years to get hearing aids when they should have gotten them earlier. So if we can help an audiologist have a much bigger, broader healthcare conversation with that patient, that then takes that patient to a point of where they take action sooner, great for the benefit of that patient. Same with optometry, same with pharmacy Impact, what they can. But if they can't do any more than that, then they refer them to an MD. 

0:27:20 - David Williams
Gotcha. So we've talked a lot about cognition and the issues in the market overall and a little bit about Cognivue and what you do as you look at your business. How do you see the main opportunities and challenges over the next three years or so, given what everything that's happened in the market to date? 

0:27:36 - Tom O'Neill
Yeah, I think it's. I think it's a very exciting time in the market for the patients. I think there are going to be patients that want to get access to not only the economy but the drugs that are going to come out in the future. I think, again, part of that's going to be this prior authorization process, which is going to include some type of cognitive screening. On the front end it may be AI driven and then it may be in the office with a technology like Cognivue, blood Biomarkers and Pet scans and other things, as the systems work through those. 

We're working closely and talking a lot with them to make sure that we're working through those challenges and those issues together, because I don't think it's going to be one size fits all. So I think it's going to take a year to actually figure some of that stuff out maybe even longer depending on the other drugs, because it's going to move, I would think, pretty quickly from infusions to injections, which will lend itself to other challenges, but will also lend itself to maybe a broader patient base that can have access to it. The good thing for us is, since we are in that screening and assessment space, it's starting to become a regular conversation where, when I started here at Cognivue five years ago, it wasn't Right. It was not something that was regularly discussed, but it is now a topic of conversation with every health system. 

0:29:08 - David Williams
Tom. Tom, I know your dad mentioned you should spend six to eight hours in the library per day, presumably, and I'm assuming you're not able to do that at this point. But have you had a chance to, to find any books that you like and any books that you would, that you would recommend, or I always ask also you know anything you would recommend to avoid? 

0:29:26 - Tom O'Neill
Yeah, no, I think it's a great question. So for me there's it. You know there's. There's plenty of business books out there and certainly that's where I, kind of, you know, focus my attention. But one of the ones is called Built Not Born Built Not Born by Tom Gallisano, and Tom is the owner of our company. But he also founded the company called Paychex. It's a payroll services company and he's got call it another 15 to 17 companies out of his family office that he there is the primary shareholder in, or the investor in or the full investor in. 

And what I love about working with Tom, but also with that book built not born is it's a practical guide for an entrepreneur who wants to build a business. It isn't theoretical, it isn't, you know, got stuff that's sitting at 30,000 feet. He gets really into the nuts and bolts of what's needed to be successful and he does that through his experiences. 

0:30:24 - David Williams
So that's when I'd recommend Well, he has a, I think, a good reputation and also, I think his wife is Monica Sellas, if I'm not mistaken. 

0:30:33 - Tom O'Neill
She's a lady. 

0:30:34 - David Williams
Certainly, certainly a good force there. Well, that is terrific advice. I'll get that from my library shelf. I want to say thank you, tom O'Neill, ceo of Cognivue. We've been talking about cognition. We've been talking about testing, early intervention and what we can do with the modifiable risk factors. Tom, thank you so much for joining me today on the health biz podcast. 

0:30:55 - Tom O'Neill
Great Thanks, David. I appreciate the time. 

0:31:24 - David Williams
You can find me on the website healthbusinessgroupcom.