Okay, it's 1.30, so we'll go ahead and get started. I want to welcome everyone. It's not a big crowd, but you will hear, I think you will enjoy. This is, the name of the course, as you see, is Introducing Prescription Digital Therapeutics, PDTs. It's a new substance use disorder treatment. So, these devices are also called software as medical device or mobile medical app, but we'll be using the term PDTs. Disclosures, well, the three of us speaking, myself, William Lacy, Bill, and Terry Murphy, have no financial interest for this session and in our presentations, no financial interest in that, and our opinions are personal and do not necessarily reflect those of any employer or any other organization. The purpose of our talk today is really fourfold, as you see here, because PDTs are a new FDA-approved treatment class, potentially offering employers, patients, and prescribers significantly lower cost and greater efficacy relative to traditional treatments. We will discuss this relatively unknown methodology. We will review the evolution of digital health to the current PDT stage, and as a leading example, we will discuss the expected benefits of PDTs for opioid and other substance use disorders from a prescriber, employer, and patient's perspective. So, I will give you my views as a former CMO, and Terry is a professor at Cornell University on digital health and will share a lot of information about that, and then Bill Lacy is the CEO of the Association for Corporate Health Risk Management Employee Coalition called ACRM. We always say ACRM because it's easier, and referencing his PDT pilot results, and that was launched last year and leveraging about 350 events. Our educational efforts span the FDA approval history from this modality and the current pipeline of PDTs, which is impressive, and give an overview of the digital therapeutics industry as it stands right now. So, in a nutshell, our learning objectives are to describe the potential patient, prescriber, employer benefits of this utilization of PDTs, which is a new treatment class, and in particular to relevant to workforces, which is why I'm kicking it off here today, and we're going to focus on opioid and substance use disorders initially, at least, so we're going to introduce the PDTs and their applicability, and explore the practical application for an employer, and we're going to provide FDA approval process of timelines for PDTs, including those of substance misuse or abuse disorder, SUD, and discuss the challenges of market adoption, which are affordable. So why is this topic of interest to ACOM members? Well, ACOM is actually a member organization of the AMA's Substance Use and Pain Care Task Force, which was published in 2021, and this group has decided to increase access to multiple harm reduction strategies, more directly address the changing drug overdose epidemic, and remove barriers and improve access to evidence-based care for patients with pain, SUD, or mental illness. And as an aside, there was an interesting poster downstairs from Meharry University talking about what are barriers to care for substance use disorder, one of which was of the five was a lack of training medical students and residents about resources, and even training in this area. The second issue is that ACOM actually issued a guided statement in 2016 about better utilizing the tools aimed at avoiding pain or reducing pain medication abuse, and our current president, Doug Martin, actually co-authored that statement. So what is the impact of mental health disorders? It is substantial. There was an article, or actually a report from SAMHSA, and I have to reference this here in 2014, that SUD among workers is highly prevalent. The full-time number is estimated at 10.8 million, or 9.5% of the workforce. And for part-time, 3.3 million had that disorder, or 12% of that part-time workforce. Now remember that number of the first one, the 9.5%, I'm going to contrast that in a second. Hunt et al. did a study that was published in the Journal of Occupational and Environmental Medicine in 2019 about the concurrent treatment of pain and depression or anxiety, and occupational injuries were associated with large increases in claim cost and delayed return to work, which is not too surprising. But let's look at the cost to employers. In a recent article that was just published in JAMA Network this year, looking at, it was an economic evaluation of 162 million non-Medicare eligible enrollees with employer-sponsored health insurance, and the data set was from 2018. So they had all the claims from 2018, and they looked at how many had SUD diagnosis for a claim for medical care. It was 2.3 million, or about 1.4% of that population. Now if you look at that compared to the SAMHSA number of around 10%, we see about only one in 10 were actually getting care for their disorder. So it gives you a rough estimate of how undertreated this is. The mean annual attributable medical expenditure was around almost $26,000 per affected employee, and $35.3 billion, with a B, in the dollars in the population, and about half of that was due to alcohol or opioids. Now there was an ACOMP practice guideline, Kirk Hegman was on the first author, and was talking about the evidence. And so quality evidence, they concluded, quality evidence demonstrates that weak and strong opioids have consistently been associated with increased risk of motor vehicle crashes, which obviously can cost a lot of money, and increase the mobility and mortality of the workforce, or the people in the population. So is that as a, you know, why are we talking about this part of the presentation? I'm now going to turn it over to Terry, who really knows about digital health innovation. Thank you, Charles. Do we have a clicker? Yeah. Do we have a laser? Okay. That works. Okay. Well, hello, everyone. Thanks for joining us today. This is the after-lunch session, so I'm walking around to try and create some movement. See if that keeps you awake a little bit. Because God knows, maybe the slides won't. Hopefully this will help, though. Are you hearing me? Okay. First, what I really want to do is lay the groundwork for this. First of all, how many have heard of PDTs? Not a pesticide used on your weeds. Okay. We've got one. So that's kind of cool. That's why we're doing this. There's a ton of money that's gone into PDTs. There's a ton of investment. And they've entered the market. I'll just start with that little teaser. But where did they come from? So I'm going to walk you through four stages of what I call the development of digital health. Okay. This is my own invention. I teach. I've been teaching digital health for the last six years. And so I've kind of created this framework for kind of organizing the thinking. And the first place to start is to think about telehealth. Now, if we rolled it back four years, I don't know, y'all probably would have raised your hand. But had you ever done it, wouldn't have been so many, right? But now telehealth is everywhere. But what I want to do is just talk about the business model for a quick second. When this originated, it was DTE. When I say DTE, you see that up there? That's direct to employers. That was the original model. The health systems were not offering teletherapy or telehealth. So it was these insurgents, we call them. How many have heard of Innovator's Dilemma or Innovator's Prescription, the language of Clayton Christensen? How many have heard the term disruption? You know, disrupting this, disrupting that. Clayton Christensen coined that term. He was a Harvard Business School professor, and he created this research model about what disrupts industries. And, you know, of course, when he did his research, he was looking at, and a few of you, judging from the amount of hair on other people's heads, will agree, will understand this. But remember, we had mainframe computers, and they got smaller, and they became, what were they called at midsize? Mini, mini computers, digital. Remember, it was IBM with the mainframe, and then it went down to digital. And then people scratch their heads and say, what's a desktop? I was one of them. I was in college at the time, in graduate school at the time, and I thought, maybe I'd use a desktop, because I could do spreadsheets and things like that. But people were getting desktops. It sounded strange. And then they became laptops. And now I got one right here. But the point is, the companies that make what's in my pocket, Apple or Samsung, is not the companies. Do you remember Wang and Nixdorf and these weird names? Digital. Digital was the biggest mini computer. Gone. So when we talk about disruption, we're talking about those kind of innovations that change the business model, change the landscape, and make business in that field have to be run differently. And the computers are a good example. But Clayton Christensen looks at all these, and he wrote a book called Innovator's Prescription in 2012, focusing on what's going to happen in health care. Fascinating book. Highly recommend it. That's what I built my course around. So telemedicine, by going direct to employers, there was an element of disruption there, because now employers were doing things outside the health plan. By teledoc, going directly to the employer, why would they do that? Well, the employer's self-insured. They want to create some convenience. They want to make it easy for you to see the doctor instead of wait a week, and then you don't need it, and you get a prescription through your telemedicine doc. I know this sounds ridiculous now, but 10 years ago, that was pretty novel. So these companies emerged. Then they went to health plans. Health plans said, yeah, this will save some claims. This will get care going quickly, and people like it, but they didn't all like it until 2020, and then everybody went crashing into health care. Now it's the providers that have finally come around. It's the health systems who have created their own digital platform of telemedicine, but that was the start. That's what I call the first generation. Then along comes apps. I don't know what I did with my phone, but apps, some of them initially were computer-based, but increasingly right on your smartphone, and there's apps for everything. There's 30,000 different health care-related apps. By some counts, it's closer to 80. Health, wellness, trackers, generally sub-acute, non-clinical, and I've got a couple of logos up there. How many of you have heard of Calm, the behavioral health app that you can download, direct-to-consumer, D2C? That's why I put it under the business model direct-to-consumer. Then the health plans started picking up on these, and again, companies would offer a free subscription to apps in some cases, but generally they've been direct-to-consumers. How many have heard of Aura Health Ring? Very, very cool. I just had them in my class the other night. Their superpower is tracking sleep and your sleep patterns, which are the foundation for so many other aspects of good health. So that's apps. I'll show you in just a long second. Also emerging, and sort of as an outgrowth, and maybe even it's obvious if you think about it, but if you put clinicians together with apps, you can do a lot, and this is where it starts to get interesting. These are called digital therapeutics, not prescription digital therapeutics yet, but digital therapeutics. This is where they put a bunch of stuff on your phone. They'll give you a coach. It's a cognitive behavioral therapy model of training and guidance, and generally they're working on something like chronic disease management or behavioral health, chronic pain. How many have heard of digital physical therapy? Okay, nobody raised their hand. Oh, you did. I laughed when I heard that category, and this was only about a year and a half ago, maybe two years ago. Digital physical therapy, how are you going to do that? Well, it turns out, and the Germans have done a very good job of innovating some of the technology around this, from your computer camera, and especially your iPhone camera, it can detect and watch your movement, and it can test your range of motion, and while you're doing it, by the way, it'll tell you, you know, you're bending your knees, keep your knees straight, so it's going to self-correct you, and oh, by the way, everything you're doing in front of that camera is going to your coach or your physical therapist, so they can see, and then at the end of your session, you put in your pain score or any uncomfortableness. So there's somebody on the other side, and this is kind of the classic model, watching this stuff, watching your stats, looking at your comments, seeing how often you're doing this. Now, this beats the hell out of having to show up at 3.30 in the afternoon at my physical therapist's office, and so people, the adherence to the physical therapy regimen is higher with these digital physical therapy, so I bring that up as an example. Pretty sophisticated. In the case of chronic disease management, they'll get an endocrinologist and dietician. They'll get the right people involved, depending on what your numbers are. Continuous glucose, you're going to see the readings, and some people are wearing those on an ongoing basis, and then you can see there's a number of other areas, which is fascinating, by the way, what's happening in cancer. How many have heard of the GRAIL blood test, cancer-detecting blood test? Really fantastic, and JASPER is a cancer patient and family support tool with clinicians that will help you, advise you, coach you, and steer you towards second opinion. So all of that's existed. The new kid on the block, when you take it the next logical step, and, again, that third generation was direct-to-employer, is today direct-to-employer. Again, they're trying to keep you healthy by spending a little money and making it free for employees to do those things that we saw in the third generation so that you don't have to incur claims, and, by the way, no copay for the employee. There's a lot of good things in that. Now we get to the hard part. PAIR Therapeutics pioneered this field with the de novo application to the FDA before the FDA even really knew how to evaluate digital therapeutics. PAIR was after an approval, which was different than what they had before. So that was 2019. 2020, 2021, there were some special approvals due to COVID, emergency youth authorization. depending on how you count, there's 16 or 24 approved digital therapeutics. What's a digital prescription, sorry, prescription digital therapeutic? So I'm going to read you how it's defined in the 2022, now 2023, bipartisan, bicameral bill in front of the, in front of both houses. Bicameral, that means both houses, I figured that out. The legislation defines a prescription digital therapeutic as a product, device, app, or other technology that primarily uses software, has received clearance or approval from the FDA, has a cleared or approved indication for the prevention, management, or treatment of a medical disease, condition, or disorder. Also meaning a device that can safely be used without direct medical supervision. So fast forward to present, there actually is a reimbursement code, a single reimbursement code for managing care and reimbursement. I'll get to that in a second. So there's a handful of companies, you're going to see them in a moment. But this is an FDA approved, very expensive, very costly to do that. You have to get prescribers to be aware of the benefits and be prescribing this. It has to be on formulary, and the PBMs need to be playing ball. So just think, with all the payers out there, they own the PBMs. The PBMs get, participate in the rebates from the drug manufacturers, right? So all of a sudden along comes software that might displace, remember the comment about disruption a few minutes ago? We have software that could displace traditional pharmacy. So therein means there's going to be a lot of different people trying to slow this down while others are trying to speed it up. So how many, when I say paratherapeutics, it's the first logo there, how many have heard recent news about paratherapeutics? Man, you are on this topic. You are on this topic. Paratherapeutics filed for bankruptcy last week. Yeah. Now, I have no doubt they will do, they will be able to sell their assets, which include alcohol use disorder, opioid use disorder, and what's the next one? Opioid, alcohol, and general substance use disorder. And now chronic insomnia. But what they did is they went public also last year. So they had money, but they spent it developing a lot of different prescription digital therapeutics. So I'll get back to that. I'm a little ahead of myself. So this is what the ecosystem looks like. Why is there so many logos up there when I said there were, depending on how you count, 16 or 24, because that includes all the different prescription digital therapeutics that are in development. It takes a lot of money, it takes a long time, and the FDA process is incredibly burdensome. So this is compliments of Blue Matter Consulting. Now, if you're interested in this topic, this information, when we had to submit for this conference was the information available from Blue Matter Consulting on their website. They just updated the report about a week and a half ago. So there's new, it kind of looks the same because the entire industry has hit a brick wall in terms of funding. But here you go, central nervous system, that's where all the action has been. But there's some very interesting developments in digital companion developers, oncology, there's a couple of irritable bowel syndrome, prescription digital therapeutics, women's health, cardiometabolic. So this is the, did you have a question? I can. I had that prepared for you. I'll give you an example of a couple of products. Paratherapeutics, they currently have three software products that are FDA cleared, Reset, which is a 90-day prescription digital therapeutic to treat substance use disorder, Reset O, the opioid, and Summarist, which is the insomnia. They provide an associated dashboard for providers to use during treatment. It displays information about the patient's use of Reset, including patient-reported substance abuse, lessons completed. They use a thing called, what's the word for it, incentive. They use incentives to incent users to continue to report and to be adherent. It displays information, the patient's use, lessons completed, compliance rewards, patient-reported cravings and triggers, and here's another one, Free Spira, FDA-cleared digital therapeutic to reduce panic symptoms through guided breathing exercises and a respiration rate sensor. And this is an interesting one. Applied VR using virtual reality is an FDA-cleared at-home daily seven-minute immersive virtual reality VR pain treatment that is indicated as an adjunctive treatment for chronic lower back pain. It's clinically demonstrated to decrease pain severity in patients dealing with chronic lower back pain. So they've been through, these all have been all the way through and gotten approved. There's one called Akili Interactive, which is up there. That's for ADHD. They have gotten approved for one indication. They're now getting approved for an entirely different population. I think the kids was approved, and now they're getting it approved for adults. This is for cancer patients to self-manage their symptoms using evidence-based algorithms. You get the idea. It's a fast-moving area. And here are, now, what's great about this graphic, again, this comes from Blue Matter, so highly recommended if you're interested. The early development is the yellow, and this is what happened with PAIR recently, and also Akili, is they cut back on all their early development. So now that entire, on the new graphic, that's black. The yellow part is black. However, they have several on the market. Sorry, that's, we're looking at the, let's do it this way. There it is, PAIR Therapeutics, okay? You can see they have the most products on the market. That's the blue to the right. The orange is in early development, and you can see the, sorry, the yellow's early development. The orange is late development. So those companies that had products are out there. They're marketing them. They're getting codes and reimbursement. In the case of PAIR, they have several blues that have approved it. They've got several, they've got money from state opioid settlements, as you can imagine. Big opportunity in that arena. And I think I'm on to you, Bill. So yes, that's kind of an overview of the landscape of digital therapeutics in general, taking you into a bit of a map on prescription digital therapeutics. And I'm on to you, Bill. What's the advancement button? That's this one. Thank you. Glad I could help. Good afternoon. It's great to be in person. I have Terry and Charles, Dr. Yarbrough. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. And I'm going to start with Terry. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. It's great to be in person. Why did this all happen? And, sir, you asked a great question. I would suggest we weren't able to show the video here, but if you go to the paratherapeutics website, they have a quick video that tells you what is a PDT. I still have a difficult time trying to explain it. I like to say try and swallow your phone. But it is terrific technology. But why did this all happen? The U.S. has failed in treating opioid, alcohol, and substance use treatments. 2018, the FDA launched an innovative challenge to combat the continuously worsening opioid crisis. And as part of that, it included digital health technologies that detect, treat, and prevent. So PAIR was the first at the FDA's door when it came to digital therapeutics or prescription digital therapeutics. And it actually went through two different pathways, two different departments. Took a lot of time, effort, money. There was testing on a safety standpoint as well as an efficacy standpoint. PAIR is based in Massachusetts, Boston. And from a financial standpoint, it was about $250 million to get at least three of the PDTs approved. So how does that compare to a drug? MIT did a study, and their results were about $1.2 billion. So it can move a lot quicker. There can be greater safety. And so these are some of the reasons that PDTs came about. The first FDA-approved, Terry mentioned 2019, 2020. It was actually 2018 that PAIR got their first FDA-approved. And 2019 was when they commercially launched their first PDT. But as Terry mentioned earlier, the world is awash in apps. I thought the number was 25,000. But you've got to be right, 80,000. There are nine to about two dozen FDA-approved PDTs. So they sit far beyond and outside of these sea of digital therapeutics. The timeline and process is much faster. There's still a clinical trial or trials. And as Terry had mentioned, there's many in the pipeline right now. But for, like, many innovations, it takes a lot of capital and support in the industry. And I, like Terry, teach. I'm an adjunct professor as well. I teach a graduate program, MBA finance. And we ran into a couple of challenges here. The Fed has been increasing interest rates to try and slow the growth of our economy. Who has heard of Silicon Valley Bank? Guess who PAIR's bank is? Silicon Valley Bank. Fortunately, First Citizens acquired Silicon Valley Bank. So we're going to see some relief there. But high-tech firms like PAIR have fallen through, we can call it the cracks. But there's going to be opportunity here. Like all drugs, or all treatment regimes, trying to move through the pipeline, it does take a lot of capital. And many don't make it across the finish line. PDTs offer a new opportunity for everyone. Now, our world, ACRM, the Association for Corporate Health Risk Management, we focus on the employers. So I want to walk you through a case study. And if you're interested, there is an article that was written in Benefits Quarterly magazine. In the world of employer benefits, that's probably as close as we get to a medical journal. This is published quarterly, obviously, by the International Society of Certified Employee Benefits Specialists. And for those that are interested in the CEBS certificate, that's a program run right down the road here at the Wharton School. So in this article, I brought copies if you're interested. In the article, we identified the benefits of PDTs and the process. But the case that we focused on is the Teamsters Union, Teamsters of Philadelphia, which is a combination of several locals and truck drivers. Opioids, injuries can be a real challenge, not only for the drivers themselves, but also for dependents. A couple of advantages of this union compared to traditional employers. How many of us are chief medical officers or others that work for employers? Oh, wow. Terry, I got a lot more hands than you did. That was the challenge. Part of our experience as employers is becoming self-insured. There's two pathways to self-insurance. You can become self-insured with a major insurance carrier like a Blue United Signer Aetna. We like to call it BUCA. Or you can become self-insured with an independent non-insurance carrier-based third-party administrator, TPA. Or if you're really sophisticated, you'll process claims yourself. That's what Teamsters does. So an employer like that, you've eliminated the broker, you've eliminated the TPA, you've eliminated the insurance carrier. They have a much greater understanding of what the data is, what their pricing is, the different needs of their employees. They're not relying on a variety of other advisors or intermediaries. They also can work very closely with the medical community in partnering. So this is a unique situation. They were able to move very quickly, evaluate the PDT, write it into their plan. But interestingly, they didn't start educating their employees. Who do you think the first ones were that they educated? If you answer correctly, you get a free article. How about the prescribers? So if you have an employee or a dependent that shows up in the doctor's office and says, I want this, and that physician is going to look at him or her cross-eyed. I've never heard of a pharmaceutical digital therapeutics. So after they wrote it into their, after they evaluated, wrote it into their plan, their next step was they ran three sessions working with their prescribers. Now they worked through an EAP program, which went directly to the physicians. And that was a process that took them some time to make sure the prescribers were ready. Then the next step was educating the employees. What are the benefits of these? Why should we care? And I'm going to read you four quotes from this case study. We've identified several unique benefits of PDTs. Entering information over a smartphone creates a feeling of privacy. Remember, this is all HIPAA approved. Truckers have 24-7 schedules in multiple locations and are faced with an abundance of alone time. A PDT offers greater flexibility and can also help the patient through cravings and triggers while they are isolated. That was benefit number two. Increasing cravings for drugs or alcohol occur in the evening hours when the therapist is typically not available. A phone app is always at the patient's fingertips. Now, again, we're making the assumption that we all have these smartphones. Finally, PDTs provide users with rewards which keep them engaged and progressing. Terry characterized that as incentives. That's part of this pathway. Not to get too personal, but one of the two associates from the Teamsters, she actually has a personal situation. Her son struggles with opioid abuse. He has been in and out of clinical treatments, and they're seeing success with the PDT. So so far, there's been 50,000 prescriptions written, which is probably a teeny tiny drop in the bucket compared to the number of prescriptions that have been used for the treatment as usual, but this is a new technology. An awful lot of education is involved. When we walked into here, we had one person raise a hand on what a PDT is. Hopefully, we can get a couple more hands by the time we walk out of here, but I encourage you to research this. It's a new technology. Don't be discouraged by PAIR filing Chapter 11 bankruptcy. These situations, as many of us know, with many different drug regimes that are getting approved or trying to get through the three phases of the FDA approval process, don't make it across the finish line. PAIR has found that, and as Terry had mentioned, and I would place a bet on that as well, those assets are going to be acquired. Somebody else is going to advance the ball on this. So I'm going to close it out there. We have a few minutes for questions for either Charles, Terry, or myself. I want to thank you all for your time and for listening on this, and I'm going to return this microphone to the microphone stand because there's going to be a stampede of people that are ready for inquiries. All right. Thank you. Thank you very much. Very interesting presentation. So for those of us that are relatively new to this, and if we're not in an employer situation, as a private practitioner, how do you actually get started with this type of technology if you wanted to start to offer it to your patients? I mean, is there a point of contact? Who do we go to? Thank you. Yeah, that's been one of the big barriers, is how do you get the training for the physicians in case studies like this has not really happened. But I would suggest going to, you mentioned the website. That's a good example to see a video on that and how to get it done. So I would refer to a website because they are trying to get that promoted. That's obviously what they need to do. So if you find yourself interested in one of the, you know, ATOP, and you think you might be able to use, from Terry's information, a PD, you know, PDT, go to the manufacturer's websites and they will have a physician-oriented video, I can guarantee it. Thank you. Two-part question. First thing, is the lawyer, with insurance, is going to implement this, and how is that going to get integrated into the medical record? I mean, I think it's only this. How does that occur? Go ahead. I think the first part of your question. I can take a piece of that. Yeah. So the second part of your question was, how does it get implemented in the record? The first part of your question was, I think, related to payment? Yeah. Yeah. Okay. Well, first of all, one of the reasons that these companies have targeted the manufacturers, have targeted employers, because they want the employers to go to the payers and ask for this to be put on a formulary. So they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. And they have a process for that. It's in digital medicine. First author is Gordon. It's published, I think, last year, or this year, actually. And it's from Scripps. And it's open resource. It's called Beyond Validation, Getting Health Apps into Clinical Practice. And the way they describe, ideally, how this flow would work, clinical workflow. And I think it's coming. It has to be connected with your medical practice and your clinical practice. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. And I think it's coming. Just some data on the efficacy compared to standard therapies and such like that. Yeah. And I would reference this article. There's discussions on two of the clinical trials that they did. Yeah, good question. I don't know if it's available from the FDA directly. But it certainly should be for the manufacturer. They should be able to provide it. Just like you would ask for clinical efficacy information for a drug. I will say this. The FDA is really struggling with this. They call this category SAMD, software as a medical device. And they are very public about this. They're saying, look, we don't know how to evaluate. Now, they've been doing it. These guys have broken the ice. But they need to do a lot of them. And they need to do them more quickly. I'm reminded of the article that came out over the weekend about the IRS and how bad their IT is, right? The FDA doesn't have a good process for this. So they're assembling teams from industry to create a process that's going to work in the future. But they don't really have this figured out. The thing that I was wondering, if you were saying that, is I got to think, well, across all those different disease categories, across all those different products, what do they look for and what's their threshold to say that this is, in fact, efficacious? You know, how far do they go that way? I can't answer the question. But to me, that's what made me think of they're trying to figure this process out. Because it's not well-established. So you all came in here, only one of you having heard of PDTs. So that's why this is just the last couple years. So now you've got some new cocktail hour conversation topics. Prescription digital therapies. And I'll just expand upon what Terry said. And we don't mean to be praising Paris, but they were the icebreakers. But when they first approached the FDA, it was actually working with two different departments. So it did take some time and some coordination on their part in doing this evaluation. Yeah, Bill, I think there's another piece to this, and it needs to be raised. You talk about efficacious, but also safety. And we don't think of an app being harmful. But we talk about mental health and things like that. I mean, conceivably, an app like this could be harmful. Obviously, Hippocratic oath is we first do no harm. So to me, the attractiveness is at least I have a feeling and some substantiation through the FDA process that they're safe, first and foremost. And they have some evidence for efficacious being whatever outcome that is they're going to be trying to do. So that's, again, it's putting some – and the FDA is going to be working through this, obviously, more and more, because as they get more experience, this will come around and be more clear. You're absolutely right, Dr. Garbo. It's safety and efficacy that the FDA looks for in evaluating. But there are a lot of forces aligned against change in general, but certainly this kind of change, because potentially – I mean, you saw the companies up there and all the different disease indications. This is disruptive to a lot of business models of big pharma. So now, Chapter 11, paratherapeutics, assets up for sale, that's the kind of thing you watch for now is does big pharma. In fact, Otsuko is combining with – I'll say, is it Big Health? But this is relatively new. Are you with them? Click Therapeutics. Click Therapeutics, thank you. Otsuko working with Click Therapeutics, which is one of the big players. And that's in what disease area? Depression. Depression, okay. A lot of CNS, a lot of opportunities. Anything else? We're aware and pay attention to this stuff, but it is moving so quickly and it is so new. But hopefully at this program next year you'll have even more detailed information on the topic. It's almost 2.30, and so we want to thank everyone for being here and very good conversations. Thank you very much. Appreciate it. This ends the session.

prescription digital therapeutics

PDTs

substance use disorders

opioid addiction

FDA approval

software-based medical devices

lower-cost treatment

digital health

Teamsters Union