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 Health Follow Digital Health Today: Browse Episodes | Twitter | LinkedIn | Facebook | Instagram Follow 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 Health Follow Digital Health Today: Browse Episodes | Twitter | LinkedIn | Facebook | Instagram Follow 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 MedRythms - 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 Health Follow Digital Health Today: Browse Episodes | Twitter | LinkedIn | Facebook | Instagram Follow 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 Health Follow Digital Health Today: Browse Episodes | Twitter | LinkedIn | Facebook | Instagram Follow 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 Health Follow Digital Health Today: Browse Episodes | Twitter | LinkedIn | Facebook | Instagram Follow 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 Health Follow Digital Health Today: Browse Episodes | Twitter | LinkedIn | Facebook | Instagram Follow Health Podcast Network: Browse Shows | LinkedIn | Twitter | Facebook | Instagram