Empowered Patient Podcast

Matty Culbreth-Notaro is the Chief Operations Officer at ObvioHealth and developing a new model for virtual decentralized clinical trials. Accelerated by the pandemic, there is widespread global acceptance of DCT. This digital solution and mobile app are an efficient approach to identifying and recruiting trial participants and significantly increasing trial completion rates. Matty elaborates, "When I joined ObvioHealth, I had been in the industry for almost 30 years, I didn't know that it would actually work as well as it has. And now, being with Obvio for five years, I've seen the huge impact it's made, the technology has made to our patients, to our industry in general. And it's just been a great way for us to marry the tech and the service and leverage all the technological innovations that we have to tackle those inefficiencies in our industry." "Our technology has built-in intelligence that it's able to say, well, you qualify, or you don't qualify, at least from the pre-screening questionnaire. And then, we send them, if they do qualify, a link to the app to download onto their smartphone. From there, we onboard them. We'll do the consenting process right on the phone. We'll ask them all the screening questionnaires right there. And then they're assigned to a virtual site team that's going to help them along the way. They're using their own smartphones to complete all of the study-related visits or study-related procedures." "Now, not every trial can be done 100% in a decentralized way. Some trials have to be done with still a brick-and-mortar site involved in the process. And for that, that's called a hybrid model. We support that as well, so the participant can go to the office for some visits, but they don't have to go to the office for all the visits like they used to. And in many cases, none of this has to be done at the office anymore. It can be done remotely." #ClinicalTrials #ObvioHealth #DecentralizedTrials #VirtualTrials #DCT #PatientEngagement #PatientCentricity #HybridClinicalTrials #DecentralizedClinicalTrials #DCTs #PatientAdherence #PatientCompliance #ClinicalResearch #RareDiseases obviohealth.com Download the transcript here

Dr. Paul Sherman is the Chief Medical Officer of the Community Health Plan of Washington, the only nonprofit managed care organization for Medicaid in Washington state. They have also expanded into offering Medicare Advantage plans and providing a public/private low-cost insurance option for low-income people who do not qualify for Medicaid. Paul is enthusiastic about the new benefits that have been added to provide alternative approaches to healthcare that are less invasive and have better options than opioids for pain management. Paul explains, "Treatments that we're offering with this new benefit are a package of chiropractic, acupuncture, and massage therapy. So those traditional plans have offered services on a medical necessity or another basis. Still, we're trying to offer them in a much more patient-centered way where it's much easier for them to access it, to access the treatments that are important to them." "We're starting with those three benefits, but as we work with our members across the state and listen to their needs, we're talking to various populations about what other alternative therapies we should consider offering. We're talking to Native American tribes and our Mexican communities to really understand if there are other treatments that are important to them that we should think about adding to this benefit." @MyCHPW #CommunityHealthPlanofWashington #AlternativeTherapies #Medicaid #Medicare #Acupuncture #Chiropractic #MassageTherapy #PatientCentered chpw.org Download the transcript here

Dr. Alison Darcy is the President and Founder of Woebot Health, an engaging method of delivering self-guided cognitive behavioral therapy on a mobile device. Using only text, Woebot allows the user to interact with a fully automated system with no human intervention but using smart technology that is infinitely patient and never sleeps. Alison explains, "That also makes it really flexible and flexibly delivered through the health system because it's kind of complimentary to traditional therapy. It can also be and has been used as a very easy on-ramp into the experience of working on one's mental health. It's also been used by people who have already been through therapy and looking for a refresher. It's also been used as a way to just engage with solid mental health-promoting ideas and skills prior to any diagnosable issue." "What's interesting, actually, from our data, we see that the longest conversations people have with Woebot occur between 2:00 AM and 5:00 AM. I think that's so interesting because these are the moments when there's nobody really around to talk to. And, of course, 80% of all the conversations Woebot has occur outside of traditional clinical hours. So they're happening between 5:00 PM and 8:00 or 9:00 AM the next day. That is a key advantage that a digital solution has." @HiWoebot #Woebot #DigitalTherapeutics #DigitalHealth #PrescriptionDigitalTherapeutics #MentalHealth #AITechnology woebothealth.com Download the transcript here

Paula Brown Stafford is the President, CEO, and Chairman of Novan, which is focused on the research, development, and commercialization of therapies for skin diseases using a novel chemical entity.  The first target indication is molluscum contagiosum, a highly contagious viral skin infection caused by molluscipoxvirus with no current FDA-approved treatment. Paula explains, "The prevalence in the U.S. is around 6 million people, in terms of who gets it. In our clinical trials, which seem to be indicative of the normal population, the average age of the patient is about six and a half, primarily children, one year of age to 14, are the ones who get or are susceptible to this virus." "Our product candidate is Berdazimer gel 10.3%. It's a topical gel under investigation here at Novan to be a first-in-class therapy for the treatment of molluscum. The active ingredient is Berdazimer sodium, which is a nitric oxide- releasing agent. Our other products potentially for acne, potentially for other areas like psoriasis, et cetera, may have a different percentage number after Berdazimer gel because it refers to the amount of nitric oxide that's in the final product." @Novan_Biotech #Novan #Dermatology #Molluscum #Pediatrics novan.com Download the transcript here

Jordan Mauriello is the Chief Security Officer at Critical Start and points out the cybersecurity challenges that healthcare organizations, hospitals, individual doctors' offices, and private practices face to protect against cyberattacks. With an eye to how data is stored, Critical Start is looking to reduce opportunities for cybercriminals while, at the same time, planning for a response to a cyberattack. Jordan explains, "The amount of change that is happening in healthcare actually needs a little bit of a boost. There are changes that have been made, but most healthcare is governed when it comes to cybersecurity by HIPAA. Most of your listeners are familiar with Health Insurance Portability and Accountability Act, which was formed in 1996. And the last time we had a significant change to HIPAA was in 2013. And so when we see the regulatory requirements lagging almost a decade behind what we see here, there's actually quite a bit of change that needs to happen still in healthcare." "I think the biggest blind spots are still understanding the potential impacts. We've seen hospitals kind of gain notoriety from attacks in the last couple of years. And it's because they have been slower to evolve. Cybercriminals are not slow to evolve. They're always looking for the fastest, most profitable way to monetize a cyberattack. Because they're all about money. It's much different than it was when we saw the hacking movies that came out 20 years ago." @CriticalStart #HospitalCybersecurity #Cybersecurity #ManagedDetectionandResponse #Cybercriminals #Cyberattack #HIPAA CriticalStart.com Download the transcript here

Yishai Knobel is the Co-Founder and CEO of HelpAround, which is focused on the interoperability of data from providers, payers, vendors, and pharmacies that are part of the specialty patient journey. The HelpAround gateway enables patients to quickly get appropriate drugs with all necessary support to ensure patients can fill specialty prescriptions and stay on their therapy. Yishai explains, "What we did is basically connect all these silos and create a gateway in the middle that basically gets the right information from all the vendors and makes sure that it is served to the patient in a way that is appropriate and manageable and consumable and actionable. For example, if the patient leaves the office, some of these vendors are not allowed to reach out to the patient until they have a consent signature from the patient that says, "Yes, I'm willing for the pharma company and their proxies to reach out to me." Collecting that consent at the right time is a critical step." "Just really automating and digitizing a lot of this experience, and meeting the patients where they are, which is literally on their phone, on the go, in a very high-quality personalized experience. Not requiring them to download an app, not requiring them to go through hoops in order to just sign a few forms. Just making it very easy, click, click, click, and check all the boxes you need to check and get on with your life." #HelpAround #SpecialtyDrugs #SpecialtyPharmaceuticals #SpecialtyPatient #RareDiseases #Oncology #DigitalHealth HelpAround.co Download the transcript here

Joe Hernandez is the Chairman and CEO of Blue Water Vaccines, a spinoff deploying technology from Oxford University. The original focus was on creating a universal flu vaccine that, with one shot, would provide immunity for all the known variations of influenza throughout an individual's lifetime. While continuing vaccine development with partners such as St. Jude's Children's Hospital, Blue Water has expanded its portfolio by identifying transformative vaccines in academic and research labs that can be preventative and prevent long-term diseases. Joe elaborates, "Where we come in as corporate entities is that we take those technologies and really move them to the next level of development. We find out how we can manufacture them in a way that allows us to create enough material for broad distribution. We design clinical trials, we execute clinical trials, and we deal with the regulatory agencies to get the product approved. Then ultimately, we commercialize with commercial partners. That's kind of the modality that we use here at Blue Water." "The technology that we in-licensed from the U.K. from Oxford was really derived from a mathematical model that was invented by a scientist there named Sunetra Gupta. Sunetra is by training a mathematician, although she focuses on epidemiological trends in different infectious agents, including malaria and COVID, and a number of other infective agents. But what she discovered, what she stumbled upon as it related to influenza, was that, in fact, influenza was not as diverse as we gave it credit for." "What we noticed is that the virus, while elusive, really only has a limited ability to hide from the immune system. It has what we call "jackets" or these external codes that the virus uses, but it tends to use it again after a number of iterations. For example, the virus that was present in 1918, the one that was present in 1934, and the current virus have used some of those original "jackets" in the exterior, so we're able to deduce what those are." @VaccinesInc #BlueWaterVaccines #Flu #Influenza #Vaccines #Vaccinations #FluVaccine #HealthcareInvesting #BigData BlueWaterVaccines.com Download the transcript here

Dr. Bill Williams is the President and CEO of BriaCell, which is bringing a cellular approach to cancer immunotherapy. Building on their knowledge about HLA molecules, BriaCell is genetically engineering multiple HLA types of therapy to match the HLA types of cancer patients. Breast cancer and other cancers like prostate cancer, lung cancer, and melanoma are being explored for treatment with this approach. Individuals have up to 14 different HLA molecules, and BriaCell has seen that a single match is a strong predictor of the success of treatment. Bill elaborates, "So, what we notice is that with our cellular therapy, we can predict patients that are very likely to respond based on the HLA type of a patient matching the HLA type of our cellular therapy  The way that we do this, practically speaking, is we take our cells, grow them under GMP conditions, good manufacturing practice conditions  Then after we harvest them, we irradiate them so they can't grow anymore, but they're still alive  They are viable, but they don't really grow anymore." "Then we freeze them down, and they're stable in that state for years, as we have proven at this point. Then, when the patients come in, we can ship them overnight to the clinic, where they can pull them out. Then they're injected into the skin of the patient in the upper back of the thighs to generate a very potent immune response, and the immune response generated will then attack the cancer of the patient." @BriaCell #Immunotherapy #Tumors #Cancer #BreastCancer #HLATypes briacell.com Download the transcript here

Tom Gibbs is the Director of Debiopharm's Innovation Fund, which is focused on in-licensing early-stage assets to help innovators bridge the gap between invention and bringing solutions to market. Investments are being made in technology that might help in drug development and digital technology that is enhancing the patient treatment pathway. Tom elaborates, "Debiopharm is actually a quite successful pharma company that most people haven't heard of. And this is really down to the business model. We were set up more than 40 years ago with the idea of taking molecules that have been dropped in development, bringing them into the clinic, proving that they really worked, and then getting them out to as many patients as possible. And so, the business model then is an in-licensing model where we go around the world looking for new compounds, typically at a pre-clinical stage, then we in-license them and develop them with our own money." "We invested in a company based out of California called VeriSIM Life, and they're modeling exactly this translational stage, and they've modeled six different species. So you can see what might happen in a mouse and see how that translates to a human. This is super important because we all start our studies in mice and rats and dogs and monkeys. Then we try and move them into humans, and often the results don't correlate so well because humans aren't monkeys and monkeys aren't rats and so on and so forth. So that I think is coming, but also has not been greatly exploited up to this date." "Another aspect is about psycho-oncology. We recently invested in a German company called Fosanis that has a platform called Mika, and that's all about supporting cancer patients. In fact, they don't even have a provider-facing component. It really is direct to patients and it gives cancer patients psychological support. This is information, training, and coaching tools that can help them get over the psychological effects of having a cancer diagnosis and being in treatment, which is super important, as I think we all know." @DebiopharmFund #DebiopharmInnovationFund #DigitalHealth #DrugDevelopment #Oncology #Pharma #ClinicalTrials #Biopharma #ClinicalResearch #DigitalBiomarkers #DigitalTherapeutics debiopharm.com Download the transcript here

Trisha Bordelon is a patient advocate and active participant with the PatientsLikeMe organization. Trisha talks about her journey from when the doctors first diagnosed multiple sclerosis through her attempts to find an effective medication.  Along the way, she discovered some genetic and environmental factors in developing this disease.  She also found a community of patients and advocates on PatientsLikeMe, where she found guidance and where she shares resources and advocacy support. Trisha explains, "I found PatientsLikeMe just by surfing the internet, and I didn't want somebody else to go through what I went through when I was first diagnosed. My doctor, when I was diagnosed with MS, handed me two brochures. One was for Copaxone, and the other one was for, I believe, Avonex. And he said, "Take these home, take a look at them, come back next week, and we'll decide which medicine you're going to start on." I didn't know anything about MS, in my mind's eye, since I had a relative that had it, I'm thinking, "Oh my gosh, I'm going to end up in a wheelchair within six months. I won't be to work anymore. My life as I know it is over." I want to spare somebody else going through that agony." "I stayed off work from 2017 to 2021 and then went back to work full-time for one of the hospitals. They were so short-staffed and could not get enough people that they were reaching out to people that might have a disability or might have a problem. I did not try to hide my MS from them, but I also didn't volunteer it. I put down that I had been formally on disability, and I told my boss that I did have some limitations, but no one ever asked, so I did not disclose them." @PatientsLikeMe  #MultipleSclerosis #MS #ChronicKidneyDisease #PatientAdvocacy #ChronicIllness PatientsLikeMe.com Download the transcript here