Welcome to the podcast, everyone. My guest today is Madeline Mady McCoury, and she is a senior medical science liaison with a company called Big Health. And she talks about everything that we need to know about digital therapeutics. She is really smart. It's a great conversation. I learned a lot. I think you guys are really gonna enjoy this. Don't forget to follow us on YouTube and Instagram, and connect with me on LinkedIn if you haven't already. Love to hear from you guys.
And, check us out on MSL Talk Live, which is on Clubhouse. It's the first Tuesday of every month at 1:30 PM EST. Thanks for joining me. Welcome to MSL Talk with Tom Caravella, a podcast specifically designed for MSLs and all things field medical. Hey, Maddie. How are you doing today? Thanks for joining me. Hi, Tom. Thank you so much for having me on your podcast. I appreciate it. Yeah. I am excited.
So for those of you, just to get you guys all up to speed, Maddie and I kinda sorta met at a conference. Actually, she met some folks on my team. I didn't actually get to meet her, unfortunately, but we talked after. And she had mentioned this idea of doing a podcast about digital therapeutics. And I was like, that sounds awesome because I don't really know that much about it. I kinda think I have an idea of what it is. So we're gonna talk about it.
But before we do that, why don't you do a quick intro so you could tell everybody who you are and where you're from and all that good stuff? Yeah. Absolutely. Hi, everyone that's listening. My name is Madeline or Maddie Macquarie. I'm originally from Nairobi, Kenya, and I moved to the states when I was really young and grew up, primarily on the West Coast in California and Washington. I have my doctorate of pharmacy degree from MCPHS University out in Boston.
And after school, I did a postdoctoral fellowship through the MCPHS University fellowship program, and that postdoc was in medical affairs and project management. And as we fast forward to where I'm at today, I'm currently a senior medical science liaison at Big Health. Wow. And I have to tell you, I've haven't really known Maddie long, but the times and the couple of conversations I've had with her, you guys are in for treat because she is super smart and really, really articulate.
So I'm really looking forward to learning about this digital therapeutic space. But let me ask you, so that was a really that was an awesome introduction. It was quick. How did how did you actually transition into industry? How did you get into the role that you're in now? Yeah. Absolutely. That's that's a fun question because, during pharmacy school, I was working at Boston Children's Hospital, and I was convinced I was going to do a residency and focus on kids.
But towards the end of my training, I actually took a class. I think it was called introduction to the biopharmaceutical industry at MCPHS University. And at some point, an, medical science liaison or an MSL came in, and they talked about their role. And I remember sitting there in class and being like, I want to do what she's doing. Everything she talked about just sounded fantastic and and really fit, my personality and my background.
And so from that point, I decided, I shifted, and I wanted to do a fellowship. And so I went out there. I went to ace it's ASH HP. I did all of those interviews, and I was lucky enough to land a a fellowship in medical affairs and and project management down in Dallas. And from that point on, after I was done with that, I moved on into the MSL role. And I worked primarily within immunology and dermatology. And I I supported products at BMS, Novartis, and Ortho Dermatologics.
And now I have made this big transition, and I'm working in the mental health space, the mental health care space. And I work actually at a digital therapeutic start startup company, a tech company, which I like I said earlier, is called Big Health. That's an awesome story. I I mean, I we talk a lot about that on the podcast about how important it is to position yourself and take go the extra mile and go through the networking and, try to get a fellowship or an internship.
So, I mean, you're living proof. You you did it, and and now you're, you know, you're an MSL. How you like it so far? Just out of curiosity. I love being at MSL. You know, it's a very fluid role. I've worked in a couple of, therapeutic areas. For me, I'm an introvert a little bit, so I love working from home. I love traveling solo. I love presenting and talking to people 1 on 1. So I I truly think I fit into the the the role and reflect what the role is.
And I love mentoring, so I really love getting people excited and the younger generation excited about the MSO role and kind of what that path may look like getting into industry. Well, I think you're gonna be awesome, and I know you're gonna be a really good ambassador for the role. I could just tell. That's that's my yeah. That's my opinion. So let's jump into this because I'm dying to learn more about this digital therapeutic space. So let's just let's jump right into it.
What is it, and what can you what can you tell us about it as far as an overview? Yeah. And, now I love talking about digital therapeutics, now that I'm in the field. You know? So digital therapeutics, they're not a drug or a biologic or or wellness app. A lot of people confuse that. With the digital therapeutic, it's actually a brand new product category.
And the simplest definition I can give it is that a digital therapeutic delivers evidence based interventions in a digital format that's going to be through either a smartphone, a tablet, or even a computer. And digital therapeutics tend to have a robust clinical evidence and real world outcomes, and I think that's what makes it stand apart versus a wellness app or some of those other definitions. They really do go through a rigorous development process that's driven by the latest science.
Right? So they can be used as a stand alone product, or they can be used together as an adjunct to a medication or even a device. And some of them actually do require a prescription from a provider in order to have access to them or to use them, and we call those a PDT or prescription digital therapeutic.
But, really, the bottom line here is that digital therapeutics are health interventions that really do help solve problems for patients, and they do so by delivering the evidence based clinically evaluated software to really help treat and manage and prevent a broad spectrum of different diseases and, disorders. Interesting. Alright. I gotta I gotta a 1000000 questions. I know it's a mouthful. Yeah. There's, like, a 1000000 questions.
So, so it sounds like this is you you mentioned the word lifestyle because at first, I'm like, this sounds very similar to a lifestyle app where you're getting advice through an app, but it sounds like it's also a lot more than that. So can you elaborate on, like, maybe how it's different from a lifestyle app? Yeah. You know, I can't stress enough, how digital therapeutics shouldn't be confused with the wellness or lifestyle app, which are absolutely great.
You know, we can all go on the App Store and download some of these things, learn some meditation, and things of that nature. And you can really think of these wellness apps and these lifestyle apps kind of like a vitamin or supplement. You know, we all need to take those, right, as prophylactic treatment, but they're not treating immediate underlying health challenges like a prescription drug would that you're picking up at the pharmacy.
So if you actually take a step back from this, from that and look at the broadest outlook, you know, digital health is really an umbrella term that's going to encompass all of these things. So we're talking about wearable technology, remote monitoring, telehealth, wellness apps. But then there are subsets of digital medicine and digital therapeutics that sit within or underneath that umbrella definition.
So then we have to ask the question of, you know, what actually differentiates a digital therapeutic within digital health? Right? We have the digital health umbrella. Now what is a digital therapeutic within that umbrella? And, really, the answer to that is that the software itself delivers the intervention just like the active ingredient in a pharmaceutical medication is going to deliver that through the mechanism of action.
So the software content and the algorithms within that are actually what are providing the treatment to either help manage or treat the disease. So this advice, let's call it, is coming from a software application. It's not coming from a key opinion leader or a physician? Yeah. And it depends on, you know, the digital therapeutic, company or tech, technology you're working with. So I can speak from our example.
Our digital therapeutics deliver cognitive behavioral techniques, which are the first line recommendation for a lot of mental health conditions and what you'd traditionally get from a therapist in life practice. Right? So now that we have the software that's delivering those cognitive behavioral techniques and initiating those behavioral changes for insomnia and anxiety in our case. But, CBT can be used across different, mental health conditions.
But that's just an example of how that software is transitioning transitioning that health care that you normally get maybe live in a way that it is in a software, in a way that you can do it at home, on your computer, on your phone at any time of the day. That's going to get you the same changes and the same clinical outcomes that you might get in person. And you mentioned there could potentially be a prescription attached to this.
So is part of the advice that comes from this digital therapeutics application software, you you know, in addition to this, whatever the the recommendation is, there's a prescription for x y z products. So does it combine a bunch of different ingredients into the recommended care, including the use of or maybe a prescription for medication? Yeah. And, again, that will depend on the company.
So our company, our our therapeutics are not, don't have that FDA clearance with that prescription, tied with it. There are other digital therapeutic companies that do, meaning you have to go see your provider. They have to write basically write a prescription for that therapeutic, and then you're able to download it and utilize it. So that can come in a combination of things. So you could be getting that with, medicine as well. You could be getting it as a stand alone.
And it's really between the provider and and the patient to decide what that's gonna look like when we're talking about a digital therapeutic that's prescribed. But, when we're talking about a digital therapeutic that doesn't go through that pathway and has different, ways of getting to the patient, they can also, again, like I said earlier, utilize that in a way that's con in conjunction with the medicine depending on the therapeutic area or alone or with the device. Got you.
So then how does this get to the patient? How does how does someone find out about the digital therapeutics that you guys provide? Yeah. And that's the that's the challenge I think we're all in right now, which is really exciting, I think, on our end, especially in medical affairs. It's the education piece. It's it's kind of a brand new category and kind of brand new to the the public, but, COVID has really helped accelerate that for many reasons.
So a large part of my role is really educating the community, educating, for my sake, PCPs or providers, and the general public because they're the ones that tend to treat mental health conditions and tend to prescribe, these medications up front. Obviously, psychiatrists as well.
And so there's a huge education gap and unmet need that I would say at this point where we are getting out there just like any other MSL in another company and educating, although from the very bottom up, because I might get in front of a provider, and they're like, I don't know what a digital therapeutic is. How does that even fit into, you know, what I'm doing?
And so I'm talking about ground up education education, understanding the clinical guidelines, and understanding where digital therapeutics and their outcomes. You know? How what are the outcomes? How are they measured? And how does that fit into this? And, you know, do I really see clinical efficacy here? You know, educating on all of that. So I would say it's really an uphill battle at this point. But, you know, the education's out there. Payers are starting to understand digital therapeutics.
There are digital formularies are that are popping up all throughout the nation. So the adaptation is happening, but we're in the middle of it. And and, again, that educational piece is so crucial at this moment. So you mentioned payers because that's one of the things that, again, is is going through my mind is, who pays for this? Is this something that you have your 3rd party payers, your insurance companies, and, you know, the powers that be?
Or is this something that that a patient can get reimbursed for or that they can actually have coverage for? Or is this one of those too early, so everything's out of pocket kind of thing? So, the fun answer to that is that we're all kind of keeping that information close to our chest because there is no standard pathway at the moment. So I don't wanna say we're competing, but we're all trying to lay down that pathway.
And so in that case, a lot of that is kind of internal information, how our company is doing it, and how maybe our competitors are doing it, because there is not one pathway at the moment. We all kind of have our different ways that we're reaching out and getting the product to the patients, whether it's through the payer, or anything like that. So I can't directly answer that question, but I would say that, you know, we are all working at it.
And it might look a little bit different, but, we're trying to lay down that foundation and figure out, like, what the guidelines are for that and what the the the, general pathway is for that. Interesting. So you you're an MSL, and like most other, if not all other MSLs, you're responsible for engaging with and having conversations with key opinion leaders and health care professionals. But do you also have any responsibility for the patient care community?
Because it sounds like there's applications. There's reasons for both. So what's your real main role? Is it to educate physicians, or do you have any responsibility for educating, you know, families and patients? Yeah. Absolutely. So when I actually joined this company, medical affairs was an n of 1. It was just my manager. She was a she's the director of medical affairs.
Mhmm. And so when I joined, a lot of my, counterparts or my, colleagues are actually psychologists by training in the clinical side of things. And so there was it was interesting to join a company that didn't really understand or know, you know, the capabilities of an MSL. And so there has been education even internally on, you know, what we're able to do.
They had, you know, written down definition of an MSL, but they didn't even, you know, know, like, where our hands can reach and what the type you know, all the different hats we could wear. So to that point, you know, I'm sitting on calls where I'm talking to different accounts. I'm talking to HR leaders. I'm talking to, physicians, to payers, all different types of groups.
At the moment, in terms of, patient education, that comes through the prescribers or any of the, the therapists or anyone that is taking on the digital therapeutic. We definitely take the time to educate them just like you would with a drug product that's launching. We would educate a a doctor on your product so they understand how to use it. They understand the the p the product labeling, the efficacy, the safety, all of those same things.
So that when, the the patient is getting the access to it, they understand what it's for, how they're supposed to utilize it, and what it's helping them, manage. Interesting. Yeah. You mentioned COVID, and you said that COVID was obviously an accelerator for this, which makes sense. Yeah. Do you so did was this a concept that just spawned out of the COVID pandemic because there was a need to have additional modalities of treatment? Or am I making that up?
You know, what I'll say to that, look, for my first answer for that is, you know, they were around. Digital therapeutics were around before COVID, but COVID was an obvious accelerator for that. And I think during, COVID, we're, you know, technically still in the pandemic, whatever your opinion may be. But, you know, it's I think it's no longer a luxury. Digital therapeutics, digital health is no longer a luxury in the sense that it might have been before.
Now it's a necessity and part of our health care system. And the pandemic has really highlighted within the medical community a lot of these unmet needs. And I think technology is helping, you know, fix or, close some with some of those gaps. So, yeah, I would say, obviously, you know, I think for a lot of sectors, but especially in medicine and in technology, COVID has really accelerated development.
And and we've all kind of scrambled to fill in those gaps where we need to just because of how our environment has has shifted tremendously. And so it's an exciting time to be in in in telemedicine, in any type of digital medicine, in digital therapeutics. And I think it's really opened up during COVID, and really shifted some eyes over to, you know, what are these company doings? Where do they help fill the gap?
And, you know, do we can we keep patients from going into the hospital all the time? Can we help them manage their diseases at home? And patients want solutions. We're humans. And in the generation we're in, we want we to use our phone. We want convenience at home. You know? We want to take control of our health and and help manage it day to day and have that real time, you know, update and that real, time, management of our diseases.
So this is this is something that obviously sounds like it's app based. So you would access this through your phone, through a tablet, through your computer? Yeah. Absolutely. So it it depends on, which company you're talking about. But, again, from my experience with SmartCompany, so the smartphone, and tablet and the computer are the 3 main categories. But, obviously, smartphone is always the easiest. You can transport it. You can use it in bed. You can use it on your couch.
You can use it any time of the day or night. You don't have to open up your computer for that. So it tends to be more so smartphones that are utilized. But, yes, they are they have those capabilities. Yeah. Because I think I could see one of the challenges being in order to really kinda get this out there to a lot of different patient populations, especially if we're talking about, for example, you're you're on the neuro side.
So when if we talk about folks with dementia, Alzheimer's, the elderly, there's challenges as it relates to the use and the adaptation of technology. I just know from, you know, my parents are are getting older. They're certainly very good with their phones and tablets and things like that. But some of their friends just don't they haven't embraced technology. They just they couldn't there's you can give them a phone and say, here, order an Uber.
And they would think that they were, you know, ordering food or takeout, or they would have no idea what that even meant. So is that a challenge? Is the technical piece of it still a barrier for for this sort of of of advancement in medicine? Yeah. It can be. And I always say there's no silver bullet for anything, really. So including us. You know? And a lot of physicians, a lot of people, including you, including I. You know?
We have questions for these digital adult therapeutics and digital medicine, and they're not answers yet. Right? We're in the now of this transformation. So there might not be an answer at the moment, but I will tell you this.
Digital therapeutics, you know, especially when we're talking about mental health and depression, anxiety, insomnia, and getting access to care, It really does help that, you know, with individuals that maybe live in areas that they don't have a therapist nearby, they live in maybe in the middle of a rural area. They don't have the means to get to the hospital, to a therapist, whatever it may be. Individuals like millennials like me or Gen z who have a strong affinity tech to technology.
There are people, and especially we talk about equity equity and access, there are people that really do benefit from digital therapeutics. It's not gonna be for everyone, just like medicine is not for everyone. Certain things are not just not for everyone. But there are individuals that utilize them, that want them. There's a consumer base for them, and they can supplement your health care or they again, they can be stand alone. So, absolutely, those challenges you brought up are there.
It's not going to help fix every problem. It's not going to address every disease state or every therapeutic area. But, you know, we're going we're all growing, and I think those answers will solely be answered, as we move forward. Yeah. I mean, I'm definitely novice at this. I don't really know much about this space, which is one of the reasons why I wanted you to come on. And I know that there's a lot of people that I'm sure are listening to this that feel the same way.
So, like, how is this going? What's the impact on the pharmaceutical industry? I mean, is this being widely accepted? Is it taking off? Is this like the next thing? And I mean that sincerely. I know that you're probably biased because you're in the space, but you see it. And and you probably get the reaction from whether it's, you know, the the KOL community or the the patient care community the patient community. What are you seeing? Is this thing really taken off?
Yeah. And, you know, I laugh because 4 months ago when I applied for this job, I I honestly didn't even understand the digital medicine community or the industry, and I didn't know the definition of a digital therapeutic. And I didn't know that it was this deep and the clinical evidence was this deep. So, you're not the only one.
I'm sure there's people listening that are also in the same boat, but it's really an exciting time in the pharmaceutical industry when it comes to, you know, fast paced digital innovation and capabilities when we're talking about disruptive technologies and AI or artificial intelligence. And, pharma has kind of always lagged behind when we talk about digital innovation, but now everyone's trying to keep up. Right? No one wants to be left behind. And this includes digital therapeutics.
And we've actually seen an increase in partnerships between pharmaceutical companies and tech companies when who create these digital therapeutics. And there are some big pharma names out there. You can Google them, but they're collaborating with some tech companies to really sit there and develop and study and launch these digital therapeutics together. So they don't wanna be left behind as well. And there is this partnership and this collaboration that we're seeing.
And I really think that pharma is seeing digitals as a way to meet its customers' needs and to really help keep costs down because we know it takes a long time and lots of money to bring a new drug to market. So digital therapeutics can, from that aspect, really bring down some of those cost savings and those efficiencies. So I really do think that, you know, digital is going to be a part of the, pharmaceutical company's development and production just the same way we see medical devices today.
There is adaptation happening. There's collaboration happening. I think the last estimate I saw was that this is going to be a $75,000,000,000 market by 2025. All of our companies are getting 1,000,000 in funding right now. Like, it is I I from my eyes, I know I am a little bit biased, but, you know, on paper, it's speaking for itself. It's it's really taking off. It's really exploding, and people are reaching out every day.
We're getting requests that and I have to meet with physicians and providers that are saying, how do I get access to this? How do I help get my patients to utilize this? This sounds really interesting. Can I learn more about these digital therapeutics? So it's we're getting those, proactive questions. And so to me as an MSL, that means that these providers are looking for other options in their toolbox besides just medication upfront for their for their patients.
Wow. So it is definitely I mean, from that answer, it sounds like it's definitely blowing up a bit. Yes. And I almost feel silly. I'm almost like, jeez, how do I not know a lot more about this? Because it seems like it's going on right under our nose. I don't feel like after you said that, it's like, clearly, I'm not releasing some kind of secret. The words out. Yeah. I just No. You're the other one. Yeah. Yeah. No. That's great.
So, I mean, the obviously, the wheels are spinning in my head as a recruiter being in the recruiting business. Mhmm. I see opportunity. I and I when I say opportunity, I mean, there's opportunities in the industry for pharmaceutical companies in partnership, in development, in collaboration, which means opportunity for individuals like yourself and folks similar where, there's gonna be hiring needs?
So do you anticipate like, are you hearing from, you know, whether it's folks in your company or or in in other similar companies, the opportunity for expansion because of this? Yeah. Absolutely. So the first thing I did when I I received this role was kind of start looking at competitors and seeing if they have MSL teams. And some of them do, and we're all expanding. I know our team, you know, I like I said, I was in the 1st MSL they hired, the second medical affairs personnel.
We're expanding this year. We have plans in the books to make an MSL full MSL team. And I know other companies are are doing the same thing. And with that being said, there really is an increased need to educate, you know, the medical and broader community about digital therapeutics. And, of course, that's exactly where medical affairs, the functionality, and the MSR role fit right in beautifully.
So, you know, we're we have the opportunity to put our our foot in the door in in in the tech company, and we will when we're there. We're absolutely there already. So I think it's exciting to educate people on digital therapeutics.
It's exciting to give MSLs, especially in medical affairs, another role that they could fit into, especially if they're, interested in kind of expanding outside of, you know, the the regular, cross collaboration that we're used to, you know, with regulatory, with marketing. Now it's even beyond that. Right? We're working with software engineers, storytellers, and designers.
So it's really fun to be able to have these conversations with people that I different professionals that I never would have, I don't think, communicated with or worked with on a project before.
So for anyone that's, you know, interested in kind of opening up that door and exploring a little bit more what the MSL role may look like or medical affairs may look like outside of, our traditional medicines, I think this is a great opportunity, and they absolutely need us as they figure out, you know, what medical affairs is, what MSLs bring to the table. The need is there, and, I think you're gonna see more job opportunities popping up all over to get in these roles.
Well, I'll tell you, if there's anyone out there that's in some kind of governing body that has anything to do with digital therapeutics, whether it's your company or some other entity, like, you're really doing an amazing job describing what this is. And and I'm pumped up, and I I think people that are listening to this are pretty pumped up because it sounds exciting.
It sounds like it's opened up another well, it's not a new category because, again, you said before that this has been around for a while, but the digital space is clearly anything digital is hot. Anything technology innovation, where we can do things better in our in our profession, whatever that might be, is obviously important.
This brings things to a different level in the pharmaceutical industry, And it's exciting, I think, for the medical affairs community because you just mentioned what it might look like as far as companies that are gonna need MSL teams for for this sort of initiative and for these sorts of companies. So I'm excited, and I think that people are learning a lot. So what do you think the I mean, you've been doing this for, you know, not for a long period of time.
Although, it sounds like you've been doing this forever. Thank you. What what do you think the future looks like? I mean, if you had to to to venture a guess as to what the next year to 2 years to 5 years might look like in this space and and what it's gonna do to kinda change the face of maybe the pharmaceutical industry? Yeah. Absolutely. So, you know, I think we all know this. There are advances in AI and mobile technology technology quite literally almost every day.
And now COVID has increased the role of digital therapeutics. So the sheer velocity of the digital revolution means that in recent years, we've seen more advances in capabilities, but also increased application in areas of previously unmet need, like I said earlier. So we have seen multiple therapeutic areas like the management of metabolic syndrome and psychiatric disorders, like where I work in, that have been transformed dramatically by digital therapeutics.
So, I really leave you with you know, I invite your listeners to take time regardless of the therapeutic area to research digital therapeutics and the digital medicine landscape and see how they complement or really overlap with their, practice or expertise. Like I said earlier, this is a $1,000,000,000 industry. It's only growing. We're in the now of building it out, launching, and scaling some of these solutions that are really going to help transform outcomes.
So I think it's it's a great opportunity now to get in from the ground up, especially when we're talking about start up companies. And, you know, acquisitions are starting to happen just like we've seen in big pharma and how that looks like, and partnerships are taking off.
So this is, like, the best moment to really try something new out, see where it goes, help build out the future, help with the guidelines, see where the FDA takes us because that's another, question mark at the moment is, what does that clearance look like, the FDA guidance, and where they're really gonna categorize that and lay the foundation off for that.
So if you're, you know, someone who's interested in being in in a new area, I think this is just honestly exploding, and and it's gonna be such an exciting time for all of us. Maddie, you're awesome. Thank you. Really are, and I look forward to seeing all the great things that you're gonna do in your career. And, and I we definitely should have a follow-up episode in in maybe a a year from now, like, a year later, what has transpired in digital digital therapeutics.
And I bet you it's it's going places. And and, I know you are, so I'll be rooting for you. So thanks again for joining me and for coming on. Yeah. Absolutely. And thank you so much, Tom, for having me on here. I appreciate it. Alright. We'll see you soon. We're gonna do this again. Take care now. Bye bye. Bye, everyone. Thank you so much for listening to the show.
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