Prescription Digital Therapeutics, from Trials to Treatment: Click Therapeutics’ David Benshoof Klein
Digital therapeutics are poised to transform healthcare as we know it, delivering Software-Enhanced Drugs™ to patients that extend and expand on traditional treatments, as well as valuable data and new commercial opportunities to pharmaceutical companies.
Click Therapeutics is a leading light in prescription digital therapeutics, and CEO David Benshoof Klein’s insights into their design and implementation are second to none. He joins Medidata Solutions’ CEO Anthony Costello to explore the growth of evidence-based, Software-Enhanced Drugs™ and the art of creating effective technologies that change lives.
Join David and Anthony to explore the vast potential of digital therapeutics for treating everything from migraines to cancer, and how to build solutions that genuinely benefit patients. They discuss the new Regulatory Considerations for Prescription Drug Use-Related Software (PDURS), and what new legislation means for the growth of software-based treatment adoption around the world.
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Anthony Costello 00:00 How are bold ideas born, and which ones survive to eventually shake up the status quo? We'll hear straight from our industry's greatest visionaries who are making waves, and learn how they turned their dreams into disruptive reality. This is "from Dreamers to Disruptors", a podcast powered by Medidata. When people think about disruption in medicine, their minds often go straight to a new molecule, a cutting-edge drug or the next big device. But there's another frontier that's just as powerful: software, not as a tool or a companion, but as the treatment itself. Today's guest, David Klein, has spent the last decade building Click Therapeutics around that idea that Click’s prescription software now treats serious conditions like migraine and depression, backed by clinical trials and FDA review, with additional work underway in cardiometabolic immunology and oncology, among other areas. Click’s migraine therapeutic, CT-132, recently became the first FDA-authorized digital treatment in its class, and unlike many startups in digital health, Click isn't just pitching ideas, it's clearing regulatory hurdles partnering with pharma and proving that prescription digital therapeutics can work in the real world. This shift is also catching the attention of regulators. The FDA’s recent draft guidance on prescription drug use related software, or PDURS, outlines how software can be formally recognized when it's part of a prescription treatment. And the impact is big. More clarity means more confidence in using software, making this a key moment to rethink how software can reach patients faster, more safely, and more effectively. Medidata and Dassault Systèmes recently became a Series C investor to Click Therapeutics, and together, we are closely partnering to bring digital therapeutics to market. In this episode, we talk about what it takes to create a new category of medicine, how software-based treatments can scale to reach patients, and how a moonshot idea became something real. So thanks everyone for joining us on "from Dreamers to Disruptors". I'm very excited today to have David Klein, CEO and founder of Click Therapeutics. And you know, David, as you know, the title of our podcast is really about having a dream, usually a pretty big one, and then in a fairly complicated industry for innovation, somehow turning that dream into a reality that can be disruptive and really move the industry in some kind of new way. So you've got a great story around the origins of Click Therapeutics, and I thought it might be great to just start there.
David Benshoof Klein 2:53 Okay, cool. Well, first of all, thanks, thanks for having me. Very grateful for Medidata. And yeah, called dreamers, dreamers and disruptors. To that point when I saw that title of your podcast. I was disappointed I didn't go first, but, but I think I'm, you know, fourth or fifth, and I'll take it and, you know, as a as a lifelong dreamer, and I'd say attempted disruptor, you know, I think it's a great forum and happy to give like,
Anthony Costello 3:19 You don't think the digital therapeutics are already disruptive?
David Benshoof Klein 3:23 Oh, I think we're at best in the bottom of the first inning. I think you're going to see a complete paradigm shift in medicine, which is now unstoppable because of how quickly AI is pushing technology. So I think it's at best just starting, but it's super exciting, and it's a great time to live, you know, if you look at how life is improving, and, you know, I don't know about you, but like this weekend, I was an electrician, a plumber. I mean, I was all these things that I've never been because of AI. And, you know, just imagine that happening to medicine. And you know, we're going to be living in a different world, and it just can't be, can't be more exciting. But, yeah, happy to give the kind of origin story. I won’t go back, you know, I was born in New York Hospital, you know, some, some years ago. And it's interesting, because this lady in the hallway just did my whole astrology readout, right? And she said
Anthony Costello 4:20 Using AI.
David Benshoof Klein 4:21 She I don't think she used AI. So this was old-school, and she said that a Mercury Leo and that Mercury is in retrograde, and it's like a Leo-affiliated retrograde, and the full moon's gonna be on tonight, so apparently it's a really good day for me to do a podcast. So she predicted that we would just have a home run. So I hope that happens.
Anthony Costello 4:44 None of those words you just used mean anything to me, but if they mean something to you, I think that's great.
David Benshoof Klein 4:49 Well, I’m still figuring it out, but you know, it's great to have that kind of free service. When I walk around here and I will say that we founded Click maybe, you know, a little bit over 10 years ago, and at the time, I don't know if people remember even, or, you know, it seems like so long ago, but, you know, we didn't have smartphones right back then, or 15 years ago. You think about, you know, you had your flip phone. Then, you know, all of a sudden. I mean, even before the flip phone was a different thing, and your flip phone, and then you had your Blackberry, and, you know, all of a sudden you started to see the, you know, real smartphones. And this was just so clearly changing everyone's behavior. I mean, you go in New York on the subway, and people are attached to this thing, and, you know, just everything about someone's daily activities was being changed because of this phone. And I was working with the fellow at the time who was the head of Clinical Neuropsychiatry from Cornell, and we also surmised that in addition to the behavioral modification, that it was also really rewiring people's brains. So we're like, “Look, if we could kind of harness this power of behavioral and cognitive modification for good and really target diseases with that that can be, you know, as good, or potentially, you know, better than medications. They can be, they can be combined with medicines to be safer and more efficacious treatments.” So we had this idea to create this term called Digital Therapeutics, and this company called Click Therapeutics, and it was really our intent to kind of prove that this works. And we were biotech people, right? I was working at a biotech investment firm at the time, and you know, our world was randomized, controlled trials and clinical rigor and regulatory scrutiny. And so we set out to really prove that we can develop software that'll drive clinical and ultimately economic outcomes. And the concept was, it was always a dream, right? Because we're thinking, Well, imagine if you could, you know, essentially have behavioral modification as a pill, right, you know, and, and I think we're, we're, we're really on the cusp of seeing that enter into mainstream medicine. And in some respects, it really has started to so it's, it's an exciting time to be alive. It's an exciting time to be here, and thanks again for having me. So yeah, that's a short version. You. You've heard the long version.
Anthony Costello 7:18 That's a very short version, but, but I think it's good. So maybe, I mean, we're going to talk about a lot of things in between then and now, but maybe if you just sort of fast forward quickly to the end of the story to sort of frame this up, what is for the person in the audience that's never heard of any of this, or maybe someone who thinks that what you mean is a companion app. Let's define a digital therapeutic the way you think about it and the way Click has really put the focus on a regulatory process and a clinical development, kind of a clinical proof point mechanism for developing one of these, and, and, frankly, I think creating the category of software-enhanced drugs, which is very different thing than a companion app.
David Benshoof Klein 8:05 Sure, sure. Yeah. So, so let me, let me walk you through it, yeah. And I'll start kind of from the beginning, then on, on that front. So what we're really talking about are software that's medicine. And you can't call your software medicine if you're not going through, if you're not going through robust, randomized control trials, if you're not going through FDA and other international regulatory bodies clearance, right? So we're going through these processes. I can take our migraine app as an example. I think it would help kind of frame it for everybody, right? So Click developed a program for migraines, right? We for the preventive treatment of episodic migraine, which you know, almost 40 million people in America have a billion people worldwide have episodic migraines, about right? So, huge, huge problem. The you know, drugs are great. You've had these new CG, RPS and and new categories of drugs that are helping and helping, but they don't fully help. Really, almost anyone like with it has episodic migraines. They're still getting migraines per month, and you almost never run into someone who gets migraine or who has a episodic migraine, and you know, “how you doing?” “Oh, well, I'm on my drug so I'm perfect now.” Right? So it's this, you know, unmet need that's very clear. It's a chronic condition, and so many people have it, and we really believe that we could drive outcomes in that. Based that there were certain mechanisms that we could target certain regions of the brain, certain behavioral aspects, and that really influenced that disease. So we so we set up, or we set out, to develop this program for migraine, right, based on our platform. So some of the pieces we already had and and we first built this program, did, you know, number of smaller studies, and then put it in a in what we call pivotal study, right? So it's akin to a pharma, you know, registrational trial. And that study was, you know, a relatively large study between five and 600 patients. It was a double blinded, essentially randomized, controlled trial. So you have to imagine the it was essentially a study of two digital therapeutics, right? So we have a sham app that we created, and look, we could devote this whole hour to sham apps.
Anthony Costello 10:23 Yeah, I want to come back to Sham apps.
David Benshoof Klein 10:25 Which is a whole other story. And, you know, the most heated arguments at Click are probably about sham apps. It's and I don't know if that's fascinating or boring, but it really is the case. And we've even published on on a sham apps and how to create them and so on, right? So we're creating these. You know, if you look at a drug study, you have a placebo pill, right? And patients don't know. So how do you do that in the digital world? And so we're creating these kind of sham apps that really try to control for a time on task, expectation of benefit, clinician, staff, attention. I mean, you name it. So we, so we ran this, this this pivotal trial of of our intervention, which we call CT-132 against this sham app, we had it in about the most rigorous kind of protocol you can imagine, the same way that the new class of drugs are are studied. And at the end of the study period, the end of the 12 weeks, the intervention group actually had an average reduction of a little bit over three monthly migraines. So the average patient, if you can imagine in in the intervention group, went from about seven and a half monthly migraine days to four and a half, right? And that was statistically significantly greater than the control. And just imagine how profound that is, right? That's, you know, three monthly migraine days. Instead of having seven monthly migraine days, you're having four, right? That's meaningful to people. And we, you know, took these data and actually also a bridging study that also studied, you know, other medication. We essentially studied this on top of every medication, almost you can imagine, a migraine. And we took these data to FDA, and FDA granted us to granted FDA authorization as the first ever migraine app that's a treatment for migraine. So specifically, it's indicated as the as as a preventive treatment for episodic migraine in adults, right, adjunct to chronic and preventive mass. So, you know, broad indication, right? So pretty much, what, what, what FDA is saying there. So you can market this as a medicine, right? This is a preventive treatment. You can go out and say, this is you can make that claim, which is huge. And it's not just huge for the industry and for the world. If you look at that, you have, you have an app now that's, that's, that's FDA authorized for the preventive treatment of episodic migraine. But it's really huge for for for the world and for humankind. If you look at, you know, imagine if these people with a billion migraine, or these billion people are having, you know, on average, three less monthly migraine days. I mean, that has, I don't know what it has trillions of dollars of potential healthy economic value alone, right? You know, this is why people miss work and, you know, do all these kind of things. But even more importantly, it just has tremendous amount of value to patients. So hopefully, by that example, I'm kind of driving home, what is a digital therapeutic versus a companion app? Which are is my understanding. I don't, frankly, know a lot about companion apps, but you know, it's my understanding that companion apps, you know, don't attempt even to treat a patient, right? And they're really, you know, they're collecting data and do all these kind of things, which, which is, which is great, but, you know, and I'll, and I'll go back to a quick story, if you'll forgive me for this, just to the start of my career, which kind of reminds me a bit about companion apps. Right? So when, when I first founded Click in 2012 you know, had this concept, these apps are going to drive, you know, clinical outcomes, and we're going to treat diseases with apps and add these to drugs to make them more effective. And I thought it was, like, just genius. I thought Pharma would go nuts, and the industry would and KOLs and payers, you know, my that my door would essentially be kicked down by stakeholders to, like, you know, grab my brain and put it in a jar and say, Why can't, you know, all these kind of things. So, again, dreaming, right? And attempting to disrupt that didn't quite happen, as we know, like, took, took more, more time, and we're still not there.
Anthony Costello 15:06 You have to have a you have to have the dream. Killed a couple times, totally
David Benshoof Klein 15:08 killed. Yeah, and, and so, but so then eventually we start meeting with pharma. We're like, hey, you know, this is what we're doing. And they're like, well, that's great, but you know, we just want an app that's just gonna sit in someone's phone and just collect all their data. I'm like, “All right, well, you know, I could see why that would be beneficial for you.” And I think it's kind of this missing piece, right? People have to really understand that to really realize these benefits of of digital that everyone wants. They want these data. They want the real-world evidence. They get the the potential power of digital. But to really realize that, you've got to be doing something for the patient, right? That is, that's got to be your primary focus. And, you know, so all of our programs really focus on, first, actually developing this therapeutic alliance with the patient, right? That this is here to help you, and so on and so forth. So, so that's, that's really, you know, just helped, helped, I'd say, solidify that in our view, we were on the, on the right path,
Anthony Costello 16:19 yep. Okay, so I think that's really helpful. And I think, you know, as long as we're on the topic of migraine, which is a digital therapeutic, that Click developed kind of solo, right? Like you guys took that on. You wrote the protocol, you ran the trials, you sent the data to FDA, you followed through with the approval process of that, but it was actually your second approved. Well, yeah, yeah, it was your second approval. In, in, in, in the pharma space, the first being Rejoin, yeah, and which is also a massive market and a first of its kind, yeah. So maybe, maybe, if you just touch on the Rejoin story for a second, because I want to talk about some of the validation and some of the module development that you've done along the way. I think it goes to this story about whether it's a companion app or whether it's a real se product or a real digital therapeutic. There's a lot of there should be a lot of optimism in the industry now about the type of real clinical validation that you guys have done, not just for your truly approved products, but also for the modules that could make up future digital therapeutics.
David Benshoof Klein 17:22 Sure, so I'll, I'll touch on that. So in in collaboration with our partner, Otsuka, Click and Otsuka had the first ever app FDA authorized for the treatment of major depressive disorder symptoms. Again, just this huge disease, this monumental event. I mean, imagine now. You know, as we speak, people are using and being prescribed by physicians an app to actually treat their depression. You know, importantly, that's an Otsuka product, and they're the commercializers of it, and so on and so forth. So I can't get too much into that. That's really theirs to market and commercialize, but it is something that we're enormously proud of. And, you know, you can go online and see the data and the publications and the protocol, which is, you know, as as robust as you can imagine, and again, that's also adjunctive to medication. So these are things that we've, you know, proven, you know, if you look at migraine, also right, that work on top of medication. So, you know, you'll have a disease like migraine, for example, or many other diseases where, you know, people are on meds and they're seeing the physicians and they're doing everything they can to try to get this disease treated. But it's simply not enough. Yeah, so that's the area that we've been kind of living in. We think it's a really important space. It's the most common one and, and that's what's so exciting about this space for us, right? We, you know when, when this PDURS guidance came out in September?
Anthony Costello 18:58 Just describe the PDURS guidance.
David Benshoof Klein 19:00 So there's new FDA draft guidance that came out right in the beginning of or, sorry. Right, in the end of 2023 and it's called the Prescription Drug Use Related Software Draft Guidance, right? And it's essentially clarifies that if an that, if a software is a medical device, demonstrates an additional clinically meaningful benefit to a drug, that that benefit can be included directly into the drug label right, which, for us is something that we've always wanted to do, as I said, when we were even just dreaming about this space, that was, that was one core idea is that these software would be, you know, essentially married to drugs to create one single more efficacious and and potentially, in some cases, even safer treatment that is, not only is it safer and better, but it's more persistent and enables real-world data and, you know, better payment models and all these other benefits that everyone wants from digital right? And so it was music to our ears, and not just for the patients and stakeholders who we thought would would have benefit which, which is the most key thing, but because, frankly, Click is the only company that that I know of that has really been consistently demonstrating that we're driving clinically meaningful outcomes on top of medications in robust pharma quality like studies, right? There's just no one else doing that. So for us, it's also, you know, there was a business when also we're like, Well, you know, this is a space we could really be leading, because no one else has the proof points, no one has the clinical data, the publications, definitely not the platform. So that, yeah, that's when I started knocking on your door. Anthony, so
Anthony Costello 20:42 yeah, well, we should talk about the Medidata partnership in a few minutes. But you've mentioned a couple times now that one of the real differentiators here is the clinical value, the clinical trials, the sham, the ability to create a sham app as any clinical trial would have a true kind of control arm for the research. Talk a little bit about the Click team, right? So you guys aren't just another technology company. You have a very highly specialized team designed by you in order to be able to move beyond companion apps and create the right kind of protocols, right kind of scientific rigor, the right kind of clinical operations groups and clinical oversight groups to be able to work closely with pharma in many cases, but also in the case of migraine, to be able to run the trial alone. And I think it's one of your big differentiators in the market. Is just the team that you've assembled there that takes this to another level, beyond companion apps, and from that team, and from the research that you've done already in these key therapeutic areas, including oncology too, which you which you haven't touched on yet, but I'm sure you will, you have created with this team a bunch of validated I call them modules because I think of them as bits and pieces of a digital therapeutic that can be reassembled for new use cases in other therapeutic areas. And I think that's one of the big advantages of what you've done. And our industry loves a validated set of modules that can be reconfigured for a different protocol. And I think for the digital therapeutic for the SE space. That's exactly what you've done, but, but by design, right part of the dream was to have this kind of Dream Team, if you will, that knows how to go down this brand new direction where the industry has never been. So talk about that piece.
David Benshoof Klein 22:32 Yeah, that that's a good point. And and it reminds me, like sometimes I get, you know, I'll be on these conferences, and I'll be speaking, and some audience will ask me, like, if there was one thing that you'd like people to know about your company that they can't really see. And I just have such a quick response for that, because it, it's really the the strength of our team, if it and it takes people to really get to know us, like, once people start working with us, the reaction that I think, and I hope you guys had, is really consistent throughout the industry. Wow, this is a great team, and I'm so honored, really, to get to work with this group. I mean, it's, in my view, the really best and brightest of all their fields. And yet, to your point, we're not just a tech company, although we are certainly a tech company, and, you know, we've got a everything we do is in house. We have all the things that are, you know, I guess typical tech company would have from product managers to software engineers to machine learning engineers to data scientists to, you know, UX researchers and product designers and so on. And they're all really at the top of their fields. I mean, these are people who, you know, generally, if they wanted to go work at a, you know, Google or Uber or wherever, or Medidata a tier one company, they, they, you know, certainly could, but they, but they choose to work at Click and so, and then there's we, you have to remember, our products might be apps, but technically, we're a medical device company, right? So, you know, every there's a, we have a ISO, 13485, quality management system that kind of wraps, is wrapped around everything. And so we have, you know, a pretty substantial medical device quality group and a regulatory group. And then on top of that, we have a full science and clinical and medical team. So we have, you know, health psychologists, experimental psychologists. We have neurologists and neuropsychiatrists and neuroscientists and, you know. And it's this kind of, you know, getting that all to work in tandem, right, and smoothly and collaboratively and evenly, I think is, you know, I don't want to say that we've perfected it, right? I never believed. I don't, if you ask me, I'll in, you know, 80 years, when I die like I'll have never perfected anything, right? I just don't, don't believe in that concept. But we're at a pretty good state with that, where, you know, people really are very collaborative. You know, it's one of the risks, is that, you know, any of these things are too heavy, right? So if you can imagine, and we had this, actually, this might be a story you don't know, like when we were first founded. We're founded by myself and I had co founders. It was a two different neuropsychiatrists and a neurologist and a UX designer and a quant. And so our first app was essentially developed by scientists, right? The scientists had the strong, the inner, strongest voice, right? So, you know, this is back on 2014 we, you know, we have this first version of the app and, and you open it up, and you answer 40 questions on a Likert scale, right? That's the first thing you do, 40, right? So, you know, like, like, do you respond better to, you know, being threatened or being motivated? Are you, you know, you answer these things a scientist like, yeah, we need all these data. Like, the more this we get, the better we'll treat the patient. And so we start, so we raise our first round of capital right in the beginning of 2015 we hire our first real kind of software engineers and product people and so on. And we start user testing this thing, people like crazy, like, like, no one's sitting through here answering these 40 questions, right? So, you know, we got that down to seven, which was, you know, where we tested vigorously, like, seem to be the right amount, where we're not losing a lot of people, and we're getting enough data that we're, you know, still able to really personalize the treatment in an effective way. And that's the beginning of that journey of, like, how do you get all that group together? But there, but, you know, in a way that's kind of even right if, if you know, we could have the best science in the world and just the greatest science, like an app that's going to cure you of, you know, this horrible disease and but if people don't engage with it, it's just not going to work. So really, in many respects, the kind of, I believe that, the kind of, you know, secret sauce in this industry, they're kind of people who are really successful will be the people that know how to get someone to essentially do something right. And how do you get someone to use the app every day? We call them missions, right? Do your mission every day. And that, I think, is really core to our platform. What we're really good at doing is getting someone to do that mission every day.
Anthony Costello 27:39 Yeah, well, and it's funny because you know your 40 question example, you just described the entire eCOA industry that still does that kind of thing largely today. But it's a very different thing to get patient centricity and compliance and adherence in a clinical trial. Yeah, then when people are on protocol, when you're paying them, you're paying, well, sometimes you're paying them, but they're, they're having regular site visits, they're, they're told that they will be dropped from the study if they don't do certain things, and so on and so forth. And also, we're talking about very modest numbers of people right at the sample size in a clinical trial is nothing like the sample size in the commercial space once the SE drug or the digital therapeutic is commercialized, and you've got hundreds of 1000s or millions of people using it. So there's a different bar for user Centricity or for user acceptance, that I think is what you're talking about. And that's why I really want to get to these modules, because you guys have done something very special by creating a set of, you know, I think, like interoperable modules that can be mixed and matched for different use cases. And I think a big part of your disruption, if we look into the future, will be the ability to take these pieces of functionality that that, I'll say, target different behavioral mechanisms and sort of move them around and perfect them for certain therapeutic areas or add new ones for therapeutic areas. So can you describe a couple of those? You know, some of the some of the patterns around sleep or around exercise. I mean, the things that people think of when they think of behavioral modification. You've done a lot of work in this area,
David Benshoof Klein 29:20 yes, so and, and we have some of those that kind of form the basis of our platform. Even right. So many of these, what we call mechanisms of action, are essentially trans diagnostic. Or you, you, you know, in so many areas you want to deliver some type of at minimum sleep hygiene, right? You know, if you look at migraine, for example, you know harmonising that sleep. You know someone's going to sleep at 9pm one night, 1am the next, and so on so forth. That could really exacerbate that condition. And there's so many other diseases like that as well that you know, it's just critical that you know people at least understand this, right? So what Click is really good at doing is our programs actually personalized. They they work quickly to identify these things, right? If, if you know you drinking coffee at 6pm is part of your problem, the program will let you know that, right? It identifies that quickly, and it, you know, messages you about it, and it drives home that that's part of your problem, and so on and so forth. And that's not your problem. You don't hear about it, right? So, you know, it's really about, about a give and take, between the use, between the patient, I'd say, and and the program you're you're getting these data from the patient, but you're using it to help them, and that creates this circle of engagement where, oh, the more I use this, the more help it's giving me, as opposed to that one way thing that I told you, that story, where the dream app was just to collect data from people that people will never use. It doesn't create that loop. And there's great examples of this. And I see that, let me tell you, a new app gets launched. I download it and I play with it because I'm, you know, fascinated by all these different engagement methodologies that every company is using and this and that. And I would just, I just downloaded this app the other day, you know, I'm just gonna leave it unnamed for probably a good idea, yeah, but, I mean, you know, it was a perfect example of just take and not give, right? Like, I could see why this would be a wonderful thing in theory for a pharma company to have, right? Yeah, you're gonna get this, you're gonna get that, you're gonna get this, you're gonna get that. And this goes to more the companion theory, right? But what are you giving back to that patient? Why are they going to be using it long term? And frankly, they're already using their Apple Health app to do all these things anyway, right? So now they have to enter it here, either it's not syncing the data, right? And, you know, all of these things. So we definitely have these core groups of mechanisms of action that we're deploying in many of the programs. But then Click has very novel mechanisms too. So that, that's one thing that you know, I think it's important for people to understand as as a as a differentiator for what we're doing, is we're we're not just using behavioral mechanisms to treat diseases. We're marrying those behavioral mechanisms with proprietary, patented or patent pending, generally neuromodulatory tasks that are addressing specific circuits in the brain that we believe are faulty in because or of whether it's because of that drug, like in the recent cancer study that we just ran, or, or, or whether it's because of the the disease itself, right? And, and, and, and our cancer data is, is a great example. It's as novel as is you can get right? It's this, it's this intervention that, essentially, you know, trains people to focus their mind on more neutral stimuli, as opposed to going through really bad or and so on so forth. And we just tested that novel neuromodulatory task in breast cancer patients and in the randomized control trial demonstrating clinically significant outcomes of pain, fatigue and and and meaningful outcomes and mood symptoms and anxiety and depression and so on. And we and we just presented those data at ASCO, and it's a very proud moment for me as somebody who's, you know, mom passed from cancer and has seen so many people who have cancer in in in my life, and what they go through outside of just the, you know, the pure blood tumour, and you know, outside of just that, you know, treatment, it's very, very meaningful for me, and I, you know, truly believe that i. Um, that the combination of digital plus oncology drugs will drive these treatments to drive better overall survival, longer progression free survival. I mean, I think that's where this space is going. If we had we had more time, I could explain exactly how, but I have very good reason for for thinking that.
Anthony Costello 34:06 Well, I think at this point you probably have to say something about it. But I know, I know the oncology work has been a big moment for Click, and one of the reasons, I think, is that there's a tendency to think that these apps are particularly made for the CNS space, and there, really, there won't be any room for them in other therapeutic areas. And you know, you guys have already started to see the interest around lots of other TAs you have some proof points in oncology, but we also talk a lot about the GLP, one space, even rare diseases. I mean, there's really no limit to the therapeutic areas for which an SE companion, you know, digital therapeutic companion, could be beneficial, not just beneficial for the patient and for the pharma company, but also reimbursable, according to the research and the data that you guys have collected by talking with payers and what their interest may be, may be different in different countries, but around the world, there's a lot of interest for reimbursing these things, because they do have such a broad applicability once they've been clinically proven.
David Benshoof Klein 35:11 Yeah, no, true. And, I mean, look, that's, that's one of the exciting areas about SE, right, is that they don't have the same kind of reimbursement hurdles that we've seen in the standalone space that are being overcome. So that's exciting. But, you know, these software enhanced drugs that we're talking about are essentially another formulation, if you will, to use that word of a drug. I mean, just like you'd have a, you know, drug extended release version, you'd have a drug software enhanced version. And it's in, you know, in the case of a small molecule, supplemental NDA filing, or in biologic and bla and and, and that essentially becomes part of the treatment you're getting one prescription that patient is getting the software and the drug, and that's being reimbursed in the current drug reimbursement pathway that it's already in. And And to your point on payers and physicians and so on and, and look, I would encourage. And Click is doing this all the time, right? And, you know, shameless plug, if, if people are watching this, they can contact us or Click or Medidata, and we'll look at your drugs, and we'll look at your portfolio and put together a proposal of, you know, if and how we can drive outcomes and ultimately, better commercial success for different drugs. So we're constantly looking at these things, and you know, how can our platform drive additional outcomes to these drugs? We'll take a TPP about we'll call it, you know, drug SE for now, right? And we'll and we'll take a TPP, and we'll take it to payers, and we'll talk to key opinion leaders, and so on and so forth. And that's what's really interesting about this space, is we're not talking about, oh, some tiny, incremental change in prescribing behavior or so on. I mean, we have some areas where we're going to providers, and we're showing them, you know, that might be some super competitive spaces with the like, whether you're talking about atopic dermatitis or rheumatoid arthritis or GLPs, right? That, hey, well, what if this drug also disrupted the it scratch cycle or what if this drug resulted in less lean muscle mass loss, right? All these things, and you're talking about, in some instances, just an incredibly substantial shift in prescribing behavior, right? And some instances, you're talking about payers who are saying that they would potentially enhance the formulary position of these drugs. So you're talking about a just enormous potential to expand these drugs markets, and frankly, to provide better care for patients, to allow for doctors to provide better treatments to patients, and it really is a win for for everyone there.
Anthony Costello 38:04 Yeah, yeah. So maybe it's a good idea to turn a little bit to the partnership that we have. You know, obviously Medidata has had as one of our core strategic principles. For years, we've been focused on patient Centricity and better ways to engage patients and bring more user friendly technology to patients. Obviously, Click is leading in that space when it comes to digital therapeutics and the commercial space, but we also, I mean, when you and I met, I guess it's been over well over a year now, one of the first things I remember we talked about when it came to what will happen with the digital therapeutic market is, I think we agreed right away that this would turn into a race. Yeah, right. Get to the point where se apps, se drugs, become a thing. The contest will be, how quickly can you design the right study to get through the clinical development phase, get the positive signal, take it through regulatory approval and make your drug climb in the formulary and in the minds of payers, because it's better. It's the one plus one equals three se combination, rather than the drug alone. And I think at least it really hit me at that point, if it's a race, and the idea is that we have to accelerate through the clinical development process, which is a complicated, difficult process, as fast as we can, why not take a company like Medidata that's running 1000s of these trials all the time and working with, you know, companies all over the world and the company that has the true innovative digital therapeutic and find a way for customers to use those two in combination. Yeah, and I think that that really became the genesis of our partnership. And you know, you mentioned, people can reach out to us now in order to get some help on the research, to look at their drug and to look at maybe the economics or the potential viability of an SE product for that drug and in that therapeutic area. But the other thing that we're doing together is helping design a better trial, make a patient friendly trial, drop in an EDC, drop in an eCOA, drop in a randomization scheme that manages sham arms, like all these things that a new a pharma company new to digital therapeutics would have to go figure out with a host of vendors. We've sort of created this as a package, and it seemed pretty natural for us to do that, which I think is why we've evolved the partnership to the point that we have,
David Benshoof Klein 40:30 yeah, yeah. And, I mean, look, I can selfishly talk about what's in it for us too, and so on. And if you look at that, right, we're standardizing this SE drug development, right? And, and that's huge. It means we can do it quicker, better, cheaper, higher probability of success than than really, anyone else. And to your point on this being a race, which I do believe. I think both of us believe it, it will become, you know, when this space first came out, and then these guidance, and it was clear that, you know, drugs would be combined with software. Click, I went around personally, meeting with and speaking with, you know, many different of the larger kind of, we'll call them clinical services and technology kind of companies and, you know, and, and, yeah, I mean, we, we saw huge alignment with Medidata, the fact that you're global, which means essentially, on, on our on our joint platform, and our programs on your platform, you know, right now or Before Click good. Essentially, we could launch in the US, obviously, you know, we've, we've built some European infrastructure. We have some infrastructure in Japan and so on so forth. But, you know, it's limited, small company, limited. I mean, you know, this is a great example. You have your whole shirt with your thing and disruptors, you know, I have a little pin that, like someone's dad made at, like, Clicks office, right? And I'll give you a shirt. Yeah, there we go. And so, you know, being able to kind of leverage those resources to, oh, yeah, well, we can also launch in South Korea, and we can launch in Italy, and we can do all these things and maintain all the technology and operate it and have the right compliance. And, you know, all these things is, is a huge, huge win for for Click, and the other side of it, and, and this is, you know, just more more direct is, look, I didn't want to go out and hire like, you know, all of a sudden this, this space, looks like it's going to become Hugh, and I don't want to go out and hire 300 sales people and marketers and, you know, All all this. It's not really the DNA of Click where, you know, we have a tiny BD team also does Alliance management, right there. Also, which, which, by the way, I always think is a good thing, because our BD people like accountable for the success of a partnership too, right? Um, and, you know, so tiny little team, we don't have any, like, real sales people, anything like that. And Medidata has, like, 1000 sales people and marketers. And, you know, people can't see what's around me here. But, like, whole, you know, they have this whole, frankly, in house production unit, like, there's not even external people who are terrific and I love, and just all of these things that, in some ways could detract our focus from, you know, discovering, developing, you know, great medicines with our partners and and improving the world of medicine. So I think it's, it's highly synergetic like that. We're able to, kind of, you know, focus on what we're good at. You guys are doing what you're. Good at and together, we will have, and do have the fastest, least expensive and best pathways to combine drugs with software, and it's going to be very hard to catch us, I think, in that, in that
Anthony Costello 43:46 world, yeah, yeah, agree. So you, I know it's a long story, but you touched a couple times on internationalisation, and I think you know talking about it in the context of capabilities, Medidata, has got international offices, international infrastructure and so on. But the other piece of this is that there is a very different international appetite, and internationally different countries are on different parts of the adoption curve for digital therapeutics. Yeah, do you want to just touch on that briefly?
David Benshoof Klein 44:15 Sure, yeah. I think generally the good news is these medical device regulations usually harmonize kind of globally, and you're already seeing some countries, very excitingly, embrace PDURS, which is awesome
Anthony Costello 44:28 and but I was gonna ask about that in particular, yeah? So PDURS is an FDA clarification. It's a US regulation, but it's being picked up by others, yeah.
David Benshoof Klein 4 But you know, you know, all these countries have also have their, you know, sends a clarification on the drug device combo regulation, right? But all these other countries also have drug device combo regulations, so it's not a heavy lift to say, Yeah, we agree with that. So that is being harmonized and but at the same time, a lot of these countries don't have access to the same kind of medications. You know, Europe, for example, you're seeing a real rise in coverage for prescription digital therapeutics. You're seeing, you know, some prescription digital therapeutics are on the verge of doing, you know, cracking the nine figure mark in revenue from from their programs, right? So I think that the things are different all over. The advantage of what we're doing is, right? I mean, we could start a program, Click plus Medidata, do an app for a Korean pharmaceutical company in Korea, right? And then that company could say, hey, we want to launch it in 80 other countries next year, right? Or in six months, and we can facilitate that, and it's the same data layer, and all of these things are harmonized, right? Whereas, in the past, you know, a lot of these companies are building apps with local vendors and this and that, and then, you know, they even, they're global. People can't even access those data, right? So it's a, it really introducing a really, you know, frankly, unique set of capabilities to the industry with understanding that all the markets are different, but the core of the apps will all work the same, yeah. And
Anthony Costello 46:07 when you think about, you know, you mentioned launching in 80 countries, so that sounds like a good dream, but I think the point is that we both agree. I believe that Pharma has an opportunity here to become the real patient platform. Yeah. I mean, this isn't a this is an experience out beyond the clinical trial. I'm not talking about whether we make more patient friendly eCOA apps. We're saying in the commercial space, an SE product that a patient has in their pocket, that they use every day, that they're prescribed over and over and over again as part of their normal healthcare journey, like someone will own this space as a true day to day, reach out and touch the patient in their real life, not at doctor's visits, not when they just got decide to go update their prescription and they go to the drugstore once in two months, or whatever it is, But day to day, creation of of that handshake, creation of a true experience, creation of a whole new classification of what I would call like real world data related to adherence of the app, adherence of the drug, right? There's a whole universe there waiting to happen that I would call a patient-centred experience in healthcare that somebody is going to need to own, and lots of companies would want to own that, yeah, but what's the reason for pharma to want to sort of bite that off? Yeah, now or soon.
David Benshoof Klein 47:29 And, and that's a great question. And I think, you know, I would argue that there's probably urgency, you know, due to how fast AI is now driving new technology, right? So again, like I told you, I was an electrician. This weekend, I was putting, you know, the blue why
Anthony Costello 47:44 your hair is all like they were crazy, you know, what? Actually stick your finger in the socket accident. I'm having a good hair
David Benshoof Klein 47:52 day. Yeah, sometimes it's a little crazier, but I think today it's actually not. It looks really good. But the so, you know, basically, the the for pharma, this, this kind of, you know, there's always been a perception, right, that people are, well, they're pill manufacturers, or whatever that is. And I. This not only represents a a avenue for pharma to, you know, keep doing what they're great at, which is disease area expertise, commercializing medicines and payer relationships and provider relationships and you know, so on and so forth. But to, you know, stay current, to leverage digital in all these other ways that they want to, but really to transition from the perception of pill manufacturer to really these, you know, holistic providers of healthcare solutions and, and there's, there's actually, you know, more companies than one would think that, you know, get that and are like, on that path, right, that want to become, you know, healthcare as a service companies and all these kind of different, you know, acronyms that people are using for different things. So certainly I'm not, you know, telling everyone things that some people don't know. But it becomes particularly important now, because, to your point, people are starting with how powerful AI has gotten. People are starting to form these therapeutic alliances with random technology, things like your watch is like, people are looking at it as for better or worse, they're cardiologists. And, you know, I've got a, you know, frankly, like a pretty decent lawyer in my pocket right now, right? And you know, this is going to be, and it's just going to be much better next year. And so, so medicines will become, you know, more of just a part of that journey, because the patient will be so surrounded by technology and the payers and all the kind of ecosystem will have so much data, right? And kind of, as I've said before, we're, you know, probably not very far away from your bed knowing if your GLP is working, or, you know, all of these different things and and, you know, I would argue that, you know, pharma needs to be the, you know, the group that has those data, that it's the group that has the data on their medicines they're sharing with the payers they're entering into these, you know, value based contracts, which, you know, everyone says always going to happen, but never has, right? So I hesitate to talk about it, but I think that we're probably at a tipping point here. And, you know, look at, I won't name a big pharma, let's say one of these big pharma makers, you know, all of a sudden, Nike is gonna know if your GLP is working, but you don't, right? That's not gonna work. And it and and it. So these companies will change one way or another, right? I would argue, be proactive. Don't be the reactive person who, you know, Nike selling your data to Amazon was one insurance company away from, you know, essentially, being the largest, you know, integrated system. They're calling the GLP company. They're like, All right, well, we want a million doses for 10 bucks each, right? And I would be proactive. I think that that's important. The reason why I think all of us think this is going to be a race is because some drugs are on the cusp of their competitors launching with an SE that's going to take some of their market share, and their CEOs are going to, you know, have to revise their analyst estimates. And, you know, I think that this also gives the digital groups at these pharma companies, like, a much, much bigger stake in the whole game, right? When you're talking about extending, expanding the label of drugs, or integrating digital into every different clinical development plan, you know you have a real seat at the table. And so I think that that's incredibly important. And just generally, to your point, I I do think that the prevalence of these data and these technology are just going to be too broad, that it's not only going to be the, I think the pharma that move quickest, that that win, but and something we're really focused on is design and experience and so on and so forth. But it's going to be like, back to the, you know, covid times, where, you know, if you'll remember, all of a sudden, right? For the first time ever, people were identifying with these pharma companies. Oh, I took the Pfizer shot and, oh, I got Moderna and I got, you know, J and J, and people were like, Oh, and, you know, all these kind of things right there, all of a sudden, you know, different view, and what drug and what, you know, company, and that was a first for me, and it was really enlightening, right? And I think that that's where we're headed. And people are going to be like, well, you know, I'm on the, you know, X company, GLP, that they know has this amazing experience. It's the, it's the apple experience of GLPs, right? And, and, and I would encourage folks to embrace that and not end up being the, you know, I've used this example for, but the the Blackberry of experiences, right? So I think we're entering a new world. People are going to know the brands and. Pharma companies, they're going to know the experience that comes with that, and they're going to want to be on these treatments that have the best, user friendly, patient focused experiences, if they can.
Anthony Costello 53:27 Yeah, great. Well, look, we always end these podcasts with a little bit of a look into the future. Think of it as a prediction. I think you might have already touched on it in your last answer a little bit. But if I asked you kind of, what's your prediction for the next I know you've got you think everything is going to happen really fast because of AI. I agree with you. So I normally ask about a five year prediction. Well, let's cut that back. Let's make a two and a half year prediction from David Klein and with a little call to action sprinkled in there. So what do you want our listeners, the pharma industry, the CRO industry, payers, providers, you name it like. What do you want the world to do as a call to action for digital therapeutics? And where do you predict this goes in the next two and a half years?
David Benshoof Klein 54:15 Yes, so two and a half years again, long time. Look and again, this is more dreaming, but I think I'm right on this. And I'll say, if you look at what's gonna happen in two and a half years, I mean, just imagine in two and a half years. And hold me to this bookmark, this, right? Language barriers are going to be gone. I mean, you know, that's where we're headed, right? Like you're not going to know, you're not going to need to know. You know Vietnamese to operate in Vietnam, you're going to have a Star Trek thing or something like that, where you speak Vietnamese, right? That's where we're headed here. It's going to happen before two and a half years, I would argue. But two and a half years come back to this podcast, and you'll see language barriers gone, and I can go on and on and on about the changes in the world that I think will happen and and the pharma industry is not going to be immune from that right drug. People are going to want drugs that get better, that aren't the same in treatment that was approved 20 years ago, that they're getting now, and people are gonna have expectations that those treatments and experiences get better and better, just as everything else in their life is right. And you know, so if you ask me for a call to action, I mean, I'd say, again, we're happy to look at, you know, people's portfolios, or certain drugs or drugs in development and and analyse, and say, Hey, here's what we think you can do. Here's again, Click. Even goes and speaks to KOLs and payers and so on. And we'll say, we think that there's a great play here for the patients, and there's a there's a really meaningful commercial opportunity. Or we'll come back and we'll say, you know, look, we did a ton of free work for you, but, and, you know, but, you know, we don't have the greatest news, right? We, we don't think that this is an ideal candidate for this, for these six reasons, right? You know, more often than not, we're kind of getting these really good analysis is back where, hey, it does really make sense to do something, but, you know, we're really transparent and direct. And if we don't see that, and Click’s model generally is we're, we don't operate as a vendor, really. So it's not like, it's like, you know, if the pharma company is not benefiting, we're not either. And you know, so we're very, you know, if we don't want to do something, we'll be really candid on why, and all these kind of things. But, you know, I'd say you can reach out to Medidata. You can reach out to BD at Click Therapeutics, calm, that's boy David at Click and we'd be happy to, you know, do an analysis for anything that data people want. And I would encourage people to, you know, embrace this space before your competitors do and and it's really exciting to see all the digital people at pharma that are embracing it, and that, you know, all the all the sudden, have, like, a really meaningful way to engage in the core, core of the conversation. And we'd love to help people, you know, get into that conversation.
Anthony Costello 57:06 Yeah, great. I think that's a great place to end. So you're offering to profile the opportunity, do some of the research. We can jointly accelerate the clinical trial. We can usher through the regulatory process, get to a full approved SE and then help, importantly, as you're saying, Help the pharma industry find better ways to be this experience that I think they want their patients to have that builds the kind of brand loyalty and differentiation that you saw during the covid area with the vaccines. Yeah, so I agree. Thanks, David, been a great conversation. Appreciate your partnership. Thanks for being on the podcast, and we're all going to bookmark this and come back two and a half years, less than two and a half years to make sure our Star Trek thing, like teaches us Vietnamese in real time. Okay, cool. All right. Thank you, sir. Hold me to that. Thank you. Thanks, all of you. You.