DTx Podcast with Eugene Borukhovich

Cognitive behavioral therapy (CBT) is an evidence-based form of therapy that has been in use for decades. My guest in this episode believes that CBT can be applied to create better therapeutics, and, in fact, that's exactly what his company is called: Better Therapeutics.Dr. Mark Berman, the Chief Medical Officer at Better Therapeutics, explained that the goal of CBT is to "help people change some of those core beliefs, which then directly influence what we do on a day to day basis."And while CBT was originally applied to help people with conditions like PTSD, anxiety and depression, the team at Better Therapeutics have developed their own variant of CBT to apply the core principles of CBT to the ideas that drive root behaviors like diet, exercise and other supportive lifestyle behaviors.Tune into this episode to hear how Better Therapeutics are creating new digital treatments to reverse the progression of cardiometabolic disease, improve quality of life and inform clinical decisions.In this episode, we cover: Patient experience using digital therapeutics for type 2 diabetes Nutritional CBT - Better Therapeutics innovative new form of Cognitive Behavioral Therapy Why companies are opting to create Prescription Digital Therapies rather than self-managed lifestyle apps What’s next in the Better Therapeutics pipeline and how these decisions are made The future of Digital Therapeutic infrastructure Guest Links and Resources: Connect with Mark Berman on LinkedIn | Twitter Visit bettertx.com Episode Mentions: Kevin Appelbaum - founder of Better TX: LinkedIn Margaret Moore - Founder & CEO Wellcoaches Corporation: LinkedIn Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram

Everyone knows it's important to get a good night's sleep, but what if nightmares are keeping you aware? Frequent nightmares can disrupt your sleep, cause stress and interfere with your ability to function during the day. A diagnosis of "nightmare disorder" can occur if disturbing dreams cause stress and keep someone from getting enough sleep.(1)This episode features Grady Hannah, co-founder and CEO of NightWare, the company behind an innovative prescription digital therapeutic that alleviates the effects of traumatic nightmares most often associated with PTSD.Through software on an Apple Watch, NightWare monitors a persons' sleep patterns, and uses machine learning to identify a patients' nightmares and intervene in them. Once a nightmare is detected, NightWare can activate the watch to wake the sleeper out of traumatic nightmares, but without actually waking them out of sleep.In this episode, we cover: The problem and solution that led to developing a DTx for Apple Watch The types of trauma that can lead to Nightmare Disorder or nightmares from PTSD Evidence generation required to support FDA "Breakthrough Status" in 2020 How to reach out and educate prescribers Guest Links and Resources: Connect with Grady Hannah on LinkedIn Visit NightWare on the Web Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram(1) Mayo Clinic: https://www.mayoclinic.org/diseases-conditions/nightmare-disorder/diagnosis-treatment/drc-20353520

The association between music and medicine has been discussed for decades, and the development of music therapy has been shown to improve outcomes for patients of all ages, and from the immune system to the mind. To tell us more about how music can play a role in digital therapeutics, we hear from Brian Harris, the Co-founder and CEO of MedRhythms.MedRhythms is a digital therapeutics company focused on the intersection music, neuroscience and technology. They understand that millions of people live with persistent walking deficits due to injury or disease, and, to address the needs of this patient population, MedRhythms is building the world's first prescription music platform. Thanks to MedRhythms' partnership with Universal Music Group, they provide patients with therapy via music that they know and enjoy. This enables their digital therapeutics to use music content that is curated and screened via a patented process, which carefully selects and customizes interventions to each user.Tune in for an interesting discussion that will make you want to sit up and hear the music!Topics covered: The genesis of MedRhythms - why it all started and going from hospital to home. How music can be used to improve walking following neurologic disease and injury  Evidence generation and how it is evolving Why MedRhythms decided to go the route of a PDT (Prescription Digital Therapeutic) rather than a consumer route Let's talk DTx business: what was the MedRythms original business hypothesis, and how did it change over time? Can you talk about pricing at all?  If you were to dissect your deal with Biogen, what is your business hypothesis on how this partnership will make you both money ? MedRhythms partnership with Universal Music Group, and what it means to users and much more! Guest Links and Resources: Connect with Brian Harris on LinkedIn | Twitter Visit MedRhythms, Inc. Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram

Join me for this conversation with M. Jason Brooke, MSE, JD, CSQE, Attorney and Managing Member of Brooke Consulting LLC. Brooke Consulting is a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant.Jason and I talk about the three main pathways through the FDA: the 510(k) process, De Novo process and PMA (Premarket approval) process. We discuss the pros and cons of each pathway, and the requirements for testing and clinical data. Jason also explains the types of different types of testing such as verification and validation (bench top) testing, non-clinical animal testing, and clinical testing. But what about cybersecurity and biocompatibility which may be required for some SaMD (Software as a Medical Device) and sensors used in DTx solutions? Yes, Jason shares some insights on that as well!In this episode, we cover: Key milestones over the past 10 years for the DTx industry from a regulatory perspective Pros and cons of pursuing one of the three main pathways for FDA approval for a DTx Jason's opinion about what is currently missing with DTx SaMD regulation to uphold it to the same standard as a medical device Comparisons of the regulatory developments in the US to other areas of the world (EU, APAC) The future of regulatory frameworks for DTx Predictions and suggestions for regulators as the DTx industry moves forward Guest Links and Resources: Connect with Jason Brooke on LinkedIn FDA Information about Sofware as a Medical Device (SaMD) Visit Brooke Consulting's website About Jason:Jason Brooke brings a focused expertise in the medical device industry that combines nearly 20 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance. Jason has conducted scientific research (pre-clinical and clinical) and technology development in academic and industry environments as a biomedical engineer, worked within the FDA’s Center for Devices and Radiological Health as a regulatory affairs program analyst, counseled clients as an attorney and consultant focused on the medical device and digital health space, and served as the chief executive officer, general counsel, and vice-president of regulatory and quality for small medical device companies. Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram

In this episode, we hear from Mike Pace, Founder & CEO of PalmHealthco. PalmHealthco provides market access, commercialization, evidence generation and go-to-market executive advisory and strategic consulting services to digital health, biopharmaceutical and medical device firms around the world. Mike and I talk about the differences in going to market and the commercial pathways for biopharmaceuticals compared to PDTs. Mike talks about what we are seeing in the marketplace with some of the early PDT trailblazers and the opportunity within the industry that exists for patient centric and value-based care. We discuss the conundrum of pricing PDTs, what other countries are leading the way in the industry… and more!In this episode, we cover: The work and progress we've seen in the marketplace with some of the early trailblazers and leaders Should the DTx industry continue to pursue claims-based reimbursement, or would it be better to jump straight to value-based reimbursement? What is the incremental benefit a digital therapeutic product gains in payment or reimbursement dollars by just labeling itself as a digital therapeutic versus not doing so? How do we build the adoption flywheel for DTx and not have price become an obstacle? Guest Links and Resources: Connect with Mike Pace on LinkedIn | Twitter Learn more about PalmHealthCo Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram

In this episode, we hear from Timothy Aungst, a clinician, academic, public speaker, writer and, of course, pharmacist. In 2016, Tim founded The Digital Apothecary as a blog specifically for pharmacists to provide news and resources related to digital health topics and interests. Tim is also an advisor at HealthXL, a Clinical Writer for GoodRx, a member of the Digital Therapeutics Alliance Healthcare Provider Advisory Group, and an Associate Professor of Pharmacy Practice at Massachusetts College of Pharmacy and Health Sciences.In this episode, we cover: The role of the Pharmacist as it relates to DTx How do we compare Prescription Digital Therapeutics (PDT) versus traditional standards of care? How are DTx dispensed? And how do pharmacists at the front lines feel about DTx? Do pharmacy services need to be redesigned in the context of DTx? Do DTx have drug interactions? How do we train current and future learners about DTx and the digitization of healthcare? Guest Links and Resources: Connect with Timothy Aungst, PharmD on LinkedIn | Twitter Visit The Digital Apothecary Episode Mentions: Megan Coder Risa Vatanka APhA - Annual Meeting and DigitalHealth.Rx Digital Therapeutics Alliance Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram

In this episode, we hear from Andy Molnar, CEO at the Digital Therapeutics Alliance. Andy dives into what they are working on to propel the DTx industry forward, and the international scope of his work in Europe, Asia Pacific and beyond.We also discuss the recent trends with commercial payers and reimbursements - or lack thereof - and much more.Key Takeaway: Be sure to check out the link to the DTx Value Assessment and Integration Guide put together by the DTx Alliance. It is designed to support healthcare decision makers as they assess and integrate DTx products into clinical use settings. Guest Links and Resources: Learn more about Digital Therapeutics Alliance | Twitter | LinkedIn Connect with Andy Molnar Download the DTx Value Assessment & Integration Guide Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram

We’ve got a very special guest on this episode. In Season 2 of DTx Podcast, we will focus greater attention on the evidence and commercialization of Digital Therapeutics. To bring even more context and insights to these conversations, I'm excited to introduce my partner this season: Dr. Chandana Fitzgerald, or as you’ll hear her own name of choice - "Dr No Craic"! Don't worry, the name will be explained in this episode.Join us as we briefly rewind the past year in DTx as we discuss SPAC’s and going public, new entrants and exits in the DTx space, and much more. Chandana also asks me a few questions about the history and goal of the DTx Podcast and what we have to look forward to in season two.But before we dive in… I remember when Martin Kelly introduced me to Chandana at one of the HealthXL events about 5 years ago. Chandana was witty, sharp and fun to speak with. Chandana comes from a clinical background as a physician, and is now the Chief Medical Officer and General Manager of HealthXL. And, as you'll here in this first episode of Season 2 of DTx Podcast, she's also my clinical and commercialization partner with all the tough questions for our guests! Links and Resources: Brian Dolan Martin Kelly Ed Cox Dan Kendall Better Therapeutics Pear Therapeutics Akili Interactive Pierre Leurent Cognito Therapeutics Digital Therapeutics Alliance Mark Sluijs Alex Therapeutics Karuna Labs Nightware Smiley Scope Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus HealthFollow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | Instagram

In this episode, we officially announce that the Digital Therapeutics Podcast is back for Season 2! And the good news keeps coming as Eugene Borukhovich resumes his role as the talented host of the series!Eugene is a serial intra- and entrepreneur, executive, venture builder, speaker & board advisor with a focus in digital health. He’s also the COO and co-founder at YourCoach.Health, the leading health coaching ecosystem working to deliver the power of health coaching to the world’s population. Eugene is using his voice to make some noise about the exciting things happening in healthcare and specifically in Digital Therapeutics. Tune in as we share the success to date, what caused him to resume his hosting duties, and what's in store for Season 2!Links: Season 1, Episode 13 with Chris Bergstrom April Fool's Post: A DTx to Overcome Podcast Hesitancy Host Links and Resources: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:> Presenting Partner: Amalgam Rx> Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus Health

In this final episode of Digital Therapeutics Edition, Eugene and his journalistic partner, Brian Dolan, reflect on the lessons learned, guest experts, and inspiring stories featured in season one. Brian is a journalist and the founder and lead writer of Exits & Outcomes, and in each episode, he asked the guests a pointed and challenging question about their digital solutions or their outlook on the DTx industry. It's been an eventful five months, Brian says -- companies have been bought, merged, and sold, and have raised impressive rounds of funding -- but there are other areas that have seen little progress since the podcast was launched.There may be a season 2 of Digital Therapeutics Edition, but in the meantime, head over to healthxl.com/dtx to continue the conversation with Eugene and other experts.What do you think the future of DTx will look like? >>Click here to read the transcriptHost Links and Resources: Connect with Eugene Borukhovich: Twitter | LinkedIn Follow Eugene's journey of writing his first book: Hard Pill to Swallow Connect with YourCoach.health: Website | Twitter Subscribe to Exits & Outcomes Brian Dolan: Twitter | LinkedIn HealthXL: Website | Twitter | Join an Event Follow Digital Health Today:Browse Episodes | Twitter | LinkedIn | Facebook | InstagramFollow Health Podcast Network:Browse Shows | LinkedIn | Twitter | Facebook | InstagramDigital Health Today is made possible by the support of our sponsors. Thank you to: Bayer G4A Cedars-Sinai Accelerator Takeda Roche