Software Medical Treatments known as Digital Therapeutics with David Klein, Co-founder, Executive Chairman and CEO at Click Therapeutics, Inc.

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: Welcome back once again to the Outcomes Rocket Podcast where we chat with today’s most successful and inspiring health leaders. I really thank you again for tuning in. And I welcome you to go to outcomesrocket.health/reviews where you could rate and review today’s podcast because my guest today is a distinguished health care investor and entrepreneur. His name is David Klein. David is a healthcare investor and entrepreneur with over 16 years life science industry experience. He’s played key roles in founding financing and operating more than 10 life science companies. In 2012 Mr. Klein cofounded Click Therapeutics which develops and commercialize a software as medical treatments also known as Digital Therapeutics, a name that they coined their other company. Following a groundbreaking clinical trial clicks industry leading smoke cessation program is available nationwide through a variety of payers providers and employers. Clicks lead prescription program is entering into a multicenter randomised control parallel group Phase 3 FDA registration trial for the treatment of major depressive disorder in adults. He formerly served as managing director at Opus Point Partners, Senior Consultant to Pfizer and strategic advisor to numerous publicly traded and privately held life science companies. I’m so excited to have him on the podcast today and can’t wait for him to expand on that introduction. David welcome to the podcast.

: Thank you Saul. Thanks for having me. Yeah, that was a pretty comprehensive intro, I’m the co-founder and CEO of a company called Click Therapeutics. And my background really is in life science specifically biotech investing and actually operating companies and co-founded Click Therapeutics to about actually almost six years ago to focus on developing and commercializing software as medical treatment.

: Fantastic. And it’s interesting that you are going in that direction because more and more today, we’re looking at technology and other options other than medications to prescribe to alleviate issues so I’m excited to dive into some of your thoughts there David. But first I’d love to hear why you decided to get into the healthcare sector to begin with?

: Sure that’s a great question. I think I kind of fell into the health care sector at least after college to some degree. You know I can focus a bit on why I decided to go into healthcare technology which might be a more interesting answer.

: Sure.

: Really. In 2012 I was at a biotech hedge fund I’ve been there for years and was working with a fellow at the time was that had a clinical neuro psychiatric for now and we saw a lot of money really going out of farm minus CNS space. I think that the feeling was that the endpoints in the studies were were very hard to hit. Obviously you know for the most part’s objective, that’s not like let’s say shrinking a tumor or something of that nature. And at the same time we saw this real real rise in mobile phones and the kind of increasing prevalence of mobile phones and really seemed like it was a movement to some degree that was sweeping over the country. And we saw that mobile phones were actually changing people’s behavior. So it was very noticeable that the mobile phone was changing people’s behavtior and we thought well wow what if we can use the phone as a vehicle to drive clinical outcomes. And in 2012 we found that Click Therapeutics based on that premise and actually created a turnout digital therapeutics which has since then been popularized. I think other other people’s credit is just great.

: It really has been popularized from treatments of A.D.H.D. to I mean just it’s amazing what’s what’s happening on the space digital therapeutics. Pretty cool that you guys came up with that. Didn’t know where it originated. Now we do.

: Yeah. No we originated that term in 2012 really based on the fact that software can drive kind of drug like clinical outcomes or or really work in conjunction with pharmacotherapy is to make for a more effective treatment.

: So within digital therapeutics. David what would you say is a hot topic that needs to be an every leaders agenda on healthcare today?

: Sure. So within the field of digital therapeutics I think there’s a there’s a number of hot topics that say commercialization is one very hot topic. So best practices in commercialization and the different routes to take. There is obviously in theory you commercialize an app, even direct to consumer if you want or there’s more a call it business of business kind of managed care for companies actually targeting employers and the health care insurance companies. And then there is the more I’d say somewhat traditional route. You know call it a pharmacotherapy business model of actually garnering FDA clearance for the programs and commercializing really direct to physicians who will ultimately prescribe the apps to patients. I think that’s a that’s a really hot topic and you know which products to go which route on and and which is this business angle I guess ultimately will will prevail or or maybe all three will.

: Yeah that’s interesting that you bring that out David because a lot of people getting into this space building companies oftentimes run into some big problems with commercializing their technology. What advice would you give to the people listening that are building companies to really tackle this hot topic?

: Sure. So advice that I would give companies is really to you know I’d say to be open minded I’d say and I think that people really need to serious to approach this space in the seriousness that any new therapeutic deserve. So really focus on robust and meaningful clinical validation and really proving that these programs work. Very similar to like maybe a small biotech would prove that their new compounds work but then at the same time I think that there really has to be a healthy balance. And technology and user experience and data science and engagement really need to be respected as well. So I think really understanding the balance between call it neuroscience and data science and engagement science is a very important ingredient to succeeding in this space and really getting that balance right I think is key and it does require really respect for for all the fields involved.

: It’s a really great takeaway. And so as you guys work to build your companies, can you give us an example of a company or or something that you guys have done to get results and improve outcomes?

: Sure. So our first program and that’s as I noted there’s a number of different business lines in this space. Our first program is actually a program that’s being marketed to employers in managed care companies albeit our follow on programs are we are seeking FDA clearance for it. But our first program is click a team and it was designed really as a smoking cessation program.

: I like that.

: Click a team for smoking session and say it’s a fully digital program. Actually we’re on our sixth peer reviewed publication granted 416 person clinical study. And at the six month mark, 35.3% So it’s 147 of the participants had achieved 30 day sustained the abstinence so that’s an … analysis of about 35% quick rate. I think potentially even even more importantly it really is our engagement with our engagement numbers and we average about 2 app opens per user per day over the eight week courtship period. So 2 app opens per user per day. And that’s really those are numbers that have carried over really into our commercial population so we’re very excited about the levels of engagement that we’re seeing and are continuing to see and really actually working very hard to optimize in terms of creative results as if Q2 actually Click at Team will be implemented in really as a result of our partnership with Magellan Health for the most part Click a Team can be implemented in 20 employers will be in seven different payers and covering 7.1 million lives and counting. We’re actually and it’s very very meaningful RFPs now has actually multiples of that hopefully by the end of this year or early next year so.

: That’s outstanding. David congratulations on that.

: Oh, Thank you. We’re super excited about it as well.

: You know smoking is one of those things that definitely deserves to be looked at under wellness programs and I think it’s great that you took the model of companies you know and employer benefits to offer this type of service.

: Yeah, no we think that that’s great to it. It seemed like the logical business route to take for a program like this. I will say our next program CT152 which will hopefully be the first ever FDA cleared program for the treatment of depression. We’ve now actually been through two randomized controlled trials and shown almost 50 percent reduction in handpiece a clinician rated depression symptoms against a sham control group in both studies which show between 20 and 25% reduction. So we’re extremely excited about our depression program and we actually. The program has also been through a objective FMRI study and that really resulted in data which also supports our hypothesis that the program has a neuroplastic effect. So two positive randomized controlled trials and a biomarker. And we’re super excited about that program. I’d say the ultimately albeit direct to business is great. It’s a very viable avenue with things like smoking cessation which businesses purchase already. But ultimately if somebody has whether it’s high cholesterol or if they have insomnia or depression, it’s really the physician that people go to their doctors for help for these things they don’t really get help from let’s say their H.R. departments. So I’m a firm believer that the direct to physician and prescription model holds a great deal of promise.

: That’s pretty neat and exciting too. But also a demonstration of your commitment David to this you know you’re you’re in a long game right when you decide to get into a an FDA approved device. You’re automatically in the long game right you’re committed to making sure that this thing gets approved and that it gets addressed and utilized as a medical device. And it’s interesting that you’ve decided to take the prescription model on this one and your logic is totally totally on. Listeners, when I want you to think about and observe is how thoughtful Dave it is in a way that he approaches these businesses when you stop and think about how you’re going to have the biggest impact you really have to be thoughtful about your approach because if you’re not, then all your efforts could really suffer. And really the people that could benefit from your technology won’t. So we’ve got to get our act together as it relates to this. And so let’s make sure we learn from David and his way of doing things. Really appreciate your sharing those things David. What would you say today is something that happened a mistake a setback that caused some pain. And what did you learn from that?

: Sure. So in terms of you know mistakes or failures. Look we’ve made plenty of mistakes and you know I personally have made mistakes and I’ve had failures so I’m no stranger that I think that the key is really to learn from those mistakes and you know I think that in general on somebody that can accept when I’m wrong or I’ve made a mistake and can really try to learn from it. I’d say our mistakes in general or things we haven’t been terribly successful at are probably misjudged timelines in the healthcare industry. So when we first started the company in 2012, we thought that the industry would move much quicker. So when we created this term digital therapeutics we thought it was very natural and that people would get it right away. And we thought it would take off much much quicker than it did. And I think you know largely due to other companies who started using that term a couple of years later and really have made giant strides and progress for the industry largely due to many other companies have really helped the space gain acceptance so I think that timelines in really understanding the timelines in health care has been somewhat of a failure. We did think that the space would gain acceptance and traction much quicker. I say that you know just in general we’ve worked we’re kind of for the most part X biotech people clinical trialist and investors and investors and operators and we probably have too little of a focus on things like public relations and have not made great efforts towards PR kind of things of that nature that I think were could have done a better job on and I’d say in the beginning something we learned very quickly was really to rely kind of too heavy or too too heavily I’d say on clinicians for designing the app. So in 2012 when we were first created it was really the kind of core of our program if not the whole program was really designed by our cofounded by a neurologist and then also a clinical neuropsychiatrist. And without really taking into consideration user experience and data science then engagement and for example when you first opened the beta version of Click a Team five years ago it asked you to answer 40 questions and then answer them on a … scale from 1 to 7.

: It’s a lot of questions.

: Yeah it’s a lot of questions. We’re still learning on that front really. You know how to get better and better at engaging patients I think is key but learning that there has to be a balance in the products of best practices from all fields not just nueroscience.

: That’s such great shares David and really appreciate you sharing them with regard to not being able to commercialize or socialize this digital Therapeutics. The whole timeline thing in healthcare is tough. So definitely leveraging those around you and just kind of almost being as close as you can to the pulse of what’s being accepted, how it’s being accepted to help you better understand and just kind of like when you’re doing construction on a house you always have to put in a little fudge factor there for 15 20 percent extra time won’t you say?

: Yeah at least.

: At the very least. So you guys have come a long way. You’ve pivoted from the lessons learned. What would you say today. We’ve talked about a lot of things and the innovative things you guys are up to. What’s an exciting project that you’re working on and why?

: In terms of an exciting project we are actually in the process right now of planning and hopefully starting or initiating a multicenter randomized controlled parallel group FDA registration study to gain clearance for our depression program to actually treat depression. So I think that’s a very very exciting project that we’re working on. It is tough to liken it just to a project because it’s such a core focus of what we’re doing. So I’d say that that’s that’s one very very exciting and kind of core project that we’re working on is planning and preparing to begin a relatively large randomized controlled trough.

: Now that’s really great and congratulations on that. You know I was speaking with a physician entrepreneur and one of the things that she brought up to me was even within the medical student and practitioner communities depression is a big problem. And so I think what you guys are doing with this technology not only you’re going to be able to help patients but also physician patients that are struggling and need help. And so I think there’s that quadruple aim that you’re doing there by being able to help the people that provide the care.

: Yeah I agree. I think that in many different therapeutic areas depression included. We’re really talking about a win for everyone. There’s a need for new products in these in these areas and is really this you know very significant unmet need. I mean in depression alone you’ve got two thirds of more patients would prefer a nonformal logical intervention for depression. So there really is a significant need. And even in spaces that you wouldn’t really think too much about when it comes to digital therapeutics but in cardio for example what’s the kind of areas where medications are sorely needed and there are some very very good medications for. But if someone has a heart attack, there is terrific medications out there for them now but really what’s the number one thing that a patient could do to prevent having another heart attack and that’s really changing their behavior. So there really is a huge opportunity for our programs and and other companies’ programs to help a great deal of people and I think that this space in general we’re talking about really a win win win situation where the patients win by having access to more effective and efficient treatments. And whether it’s pharma companies or payers win by whether it’s increasing profits or decreasing health care spending and physicians win by having healthier patients and being able to prescribe apps whether it’s in conjunction with drugs or in lieu of drugs that are effective treatments. So I think unlike many other revolutions in technology, this is one that really doesn’t have a lot of victims in the business world it’s really a win all around.

: I think that’s a great point David. And for the listeners that want to get involved, where should they reach out. How should they reach out to get involved.

: Yes. Anyone can reach Click Therapeutics really at any time by just emailing info@clicktherapeutics.com. So anyone who whether somebody has a technology that they might be looking to commercialize a health care technology or kind of a business opportunity or whether it’s a payer, or an employer that wants to launch Click a Team to their population or even if it’s research scientists who want to work on some of our studies, we’re pretty open to people getting and really becoming involved with the company.

: And that’s info@clicktherapeutics.com.

: Exactly.

: Fantastic. Listeners, there you have it and that’s what the Outcomes Rockets all about, right. Just bringing down those silos we call a silo crushing here. And so David has just walked us through all the amazing things he and his team are up to. Why reinvent the wheel right. Why reinvent the wheel, reach out to David and see how you guys could collaborate. Info@clicktherapeutics.com is the best way to reach him. And David really appreciate you walking us through this stuff. Now here we’re close to the end. Let’s pretend you and I are building a medical leadership course on what it takes to be successful in medicine. It’s the 101 of David Klein and so I’ve got a lightning round quick four questions for you followed by a book that you recommend to the listeners. You ready. Sure.

: All right. What’s the best way to improve health care outcomes?

: I think even ahead of and I focus on my area which is digital therapeutics. But even even ahead of really clinical science would be engaging the patient I think that that’s one thing many many people and companies overlook are you know we’ve got this great way to help people we’re going to put-up an app and it’s going to help everyone and people have to understand, the average app gets opened one or two times and then it’s never opened again. And there really needs to be a focus on engaging the patient and really understanding how to get people to use your programs. So I think that if I was going to you know let’s say teach a course on a you know as you put it 101 course it would be. There has to be a focus on engagement and a good product can help anybody if nobody is using it.

: And what would be the biggest mistake or pitfall to avoid?

: I think that you know I can back up into that a bit but really ignoring engagement and design science and user experience and you know I can again it’s it’s kind of a repetitive answer to some degree. But I would say really ignoring that is certainly kind of detrimental fall on top of that ignoring validating your program it’s not really good enough to just base a program on on evidence. You’ve really got to run robust and meaningful clinical trials very similar to like really formal therapies studies. I think what we can learn from these studies and mimic them to some degree when it comes to healthcare technology and there’s a reason why pharma and biotech companies run clinical trials. And I think that that’s a pretty significant pitfall to just think you can develop a great technology and that it can help people without actually going out and proving it.

: So how do you stay relevant as an organization. Despite all the change?

: So I’d say you’ve got to be able to change with it. And you know I think we stay relevant by being nimble. It’s really critical that companies in our space are nimble and really are capable of pivoting. I think that it’s I would say that staying relevant as an organization is really the forefront of what we’re doing and really getting better and better and better at what we’re doing. Protecting what we’re doing in the forms of intellectual property and trade secrets I think is critical. So just never never stopping and really striving to get better and better. I hope we’ll we’ll track us relevant. And I think has kept us relevant so far.

: Awesome. And finally what’s one area of focus that should drive everything in a health organization?

: Ultimately helping people really is should be the driving force in healthcare and that’s Click does it through the creation of engaging and efficacious clinically validated technology. When you start from the early and kind of build around it. But I think that remaining and kind of keeping the patient at the center and creating patient centric technologies is really at least what drives us. And I believe should be a very very important factor in every health care technology what’s best for the patient and how do you really create patient centric technology. I think it’s absolutely critical. And ultimately that’s a formula that all that are really win for everybody.

: That’s great. What book would you recommend on the syllabus?

: That’s a good question. I could tell you. The last book I read and like this kind of off topic so it’s not really on the syllabus it’s a book called Red Notice. And you know very very interesting story for people who need a break from healthcare I guess about.

: It’s good to get a break.

: That’s called Red Notice and it’s by Bill Browder. Again a very very interesting story about one of the first Western investors in Russia. So I certainly recommend that book.

: Fascinating. So there you have listeners an interesting off the beaten path book. Some great information here on the syllabus that we’ve constructed for you. Don’t worry about writing anything down. You could find it all on outcomesrocket.health/click as in click therapeutics and you’ll be able to find our transcript as well as David’s bio and everything that we discussed here. David, this has been a ton of fun if you can just leave the listeners with a closing thought and then the best place where they could get a hold of you or follow you?

: You now closing thought is look I think we’re we’re really nearing a revolution in healthcare. Were apps in the very near future so 5 or 10 years or in the coming months or a year or two we’ll be prescribed by a physician in conjunction or in lieu of pharmacotherapies so will be prescribed by physicians. And I think that’s extremely exciting and if there’s one thing I’d love to leave the listeners here is to really understand that that revolution is happening apps will be prescribed by physicians. There will be reimbursement from payers and it will be a I think disruptive but welcome force in healthcare so patients who go to the physician whether it’s insomnia with depression or some sort of heart disease. I think that people are going to start having nonformal logical interventions prescribed in lieu or in conjunction with pharmacotherapies and I think that’s very exciting. I know that your listeners that the time is coming in the very near future where you might go to your physician and they might offer to prescribe a app. And I think that’s terrific and exciting. In terms of following therapeutics or getting in touch with us, anyone can always I guess visit our website at clicktherapeutics.com or email info@clicktherapeutics.com or you can follow us on Twitter. I believe it’s @ClickThera on Twitter. So @ClickThera on Twitter and I think we post most of our kind of more public updates on on their system could follow us there for like.

: Wonderful. David this has been a blast and a really innovative discussion. So listeners take David’s advice and start planning about how you’re going to fit digital therapeutics into your practice into your business. And David I can’t tell you how much we thank you for your perspective and your insights and looking forward to staying in touch my friend.

: Great well thanks again for having me. And now feel free to reach out for anything you need.

Thanks for tuning in to the outcomes rocket podcast if you want the show notes, inspiration, transcripts and everything that we talked about on this episode. Just go to outcomesrocket.health. And again don’t forget to check out the amazing healthcare Thinkathon where we can get together took form the blueprint for the future of healthcare. You can find more information on that and how to get involved in our theme which is “implementation is innovation”. Just go to outcomesrocket.health/conference that’s outcomesrocket.health/conference. Be one of the 200 that will participate. Looking forward to seeing you there.

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