Empowered Patient Podcast

Dr. Chris Duma, President and Founder of Regeneration Biomedical, is developing stem cell therapies to treat neurodegenerative diseases like Alzheimer's, ALS, and multiple sclerosis. Their approach involves directly injecting the patient's stem cells into the brain ventricles to stimulate the brain's innate stem cells to repair and replace damaged neurons. Current clinical trials are showing promising results and, notably, minimal side effects compared to other Alzheimer's drugs. Chris explains, "So our focus is to treat the full disease and make a difference in the disease's progression. The way the disease presents itself and the way that the disease is actually cured. The focus until now has been to target particular areas of abnormality in patients’ brains. Those with Alzheimer's disease, as we know, have plaques in the brain, and they have tangles in the brain. Alzheimer's disease was discovered or invented by a pathologist in the early 1900s. When they sliced the brain of an Alzheimer's patient, they found these abnormal collections of protein, and they called them plaques and tangles. The target of most research and most treatments have been monoclonal antibodies to these plaques and tangles. And we at Regeneration Biomedical do not necessarily feel that that is the cause of the problem. We think that they're the end product of cell death. So, what you need to do is fix the problem from the origin, and there might be nothing other than a stem cell that could do that. So that is our trajectory, and that's where we are today." "We had rogue stem cell clinics out there that were giving stem cells for every possible disease, and patients were lured to places like Mexico, Germany, and China to get very expensive stem cell treatments that were probably completely worthless. The difference between them and us is that we're an FDA-cleared trial. We have gone to the FDA to do this and believe me, you are right, the FDA opening up their arms to stem cells is absolutely brand new. We're actually one of the newest kids on the block who can do this. What we're doing with our stem cells, which is directly injecting them into the brain, which we can discuss later, is the first in the world. We're at that threshold now that the FDA is probably looking more and more into this and more and more into personalized medicine. And that's what this falls into the category of as well." #RegenerationBiomedical #AlzheimersDisease #AlzheimersResearch #RegenerativeMedicine #StemCellTherapy #NeurodegenerativeDiseases #MedicalInnovation regenerationbiomedical.com Download the transcript here

Will Ho, President, CEO, and Co-Founder of IN8bio, a company developing next-generation cellular therapies using gamma delta T cells, which play a unique role in bridging the innate and adaptive immune systems. GDT cell therapies may have reduced side effects compared to other T cell therapies as they can more selectively target tumor cells while sparing healthy tissue. IN8bio is conducting clinical trials using autologous and allogeneic gamma delta T cells for leukemia and glioblastoma with the goal of eliminating the cancer.   Will explains, "As you probably are aware, our immune system is generally broken down into two halves. One is the innate or the immediate portion of the system, which is why we're called IN8bio, the gamma delta T cells, which are considered innate immune cells. On the other, the adaptive is the memory part of our immune system. The gamma delta T cells bridge between both the innate and the adaptive. They actually have features across both. In particular, one of their natural functions is actually to discriminate and to distinguish between those cells that are healthy and safe versus those that are transformed or should be eliminated. That's the very challenge of cancer cells. At the end of the day, they're our own cells, and the gamma delta T cells have a unique ability to distinguish between what should be safe and left alone versus those cells that they should kill." "With the CAR T therapies, we have genetically engineered specific targets such as CD 19 or DPMA into an alpha-beta T cell - somewhat of a release and let it go. Those cells go and seek out every cell in the body that expresses its specific target and kills it. I kind of half-heartedly joke that it's a little bit like Terminator- once you let it go, it seeks its target to try to kill it, no matter the secondary damage. In many cases, we've had numerous toxicities, some of which have resulted in patient death. The gamma delta T cells are more nuanced in its approach. We have created CAR T, specifically for the biology of gamma delta T cells." "Early preclinical work shows they can discriminate between the leukemic cells that should be eliminated and the healthy tissue. This will become increasingly important as we try to target solid tumors. Solid tumors is a market that's nine times bigger than that of leukemias and lymphomas. It's challenging because the tumors, at the end of the day, are intertwined in an organ. Most likely, we need to keep those organs, whether they're your brain like in glioblastoma that we're targeting, or lung cancer or pancreatic cancer and others, we need to be able to discriminate and pick out the healthy tissue versus the tumor tissue because we can't just completely ablate the organ."  #IN8bio #CancerZero #Immunotherapy #Immunology #CancerResearch #TCellEngagers #GDTCells #CART #CellTherapy #GeneTherapy #Pharmaceuticals #BioTech #ClinicalResearch IN8bio.com Download the transcript here  

Patrick Mobley, CEO and Co-Founder of Vivid Health has developed a platform to address the inefficiencies in the post-acute care industry. Home health and hospice nurses often spend hours completing required paper-based forms and assessments to create personalized patient care plans and submissions for payments. This technology aims to streamline the workflow and collection of patient information while proactively monitoring patients and using AI-powered voice agents to improve patient engagement. Patrick explains, "So the way it works with your standard home health organization is that referral is received from a hospital, and most of the work from that point on takes place within any EMR. There are some other vendors that process places, but there is no getting around that form. It is required that you've got to complete every single step. There's really no difference no matter what state you're in or what jurisdiction; you might see slight variations between Medicare, Medicare Advantage, or Medicaid, but it's rather consistent across every single home agency." "Well, it's a mixture of the nurse and medical director. The nurses are often called startup care nurses. They go in the home and complete the work. It can take anywhere from two to three hours to be in the patient's home, and then once it's done, the response care goes to the medical director for sign-off. From there, there are a couple of extra steps to validate some of the information and coding associated with it. Then, it can be submitted to CMS for payment." "For that problem, we wanted to take those anywhere from one to four hours and get them down. Well, not because we're trying not to be thorough or rush onto the next patient or anything like that. It's just that there were better ways to do it, and the technology advances, especially in the AI space, have gotten to the point where you can be efficient, lower that timeframe, and still provide good quality care." #VividHealth #AIinHealthcare #HomeHealthAI #HomeHealth #HomeCare #Hospice #EmergingAI vividhealth.ai Download the transcript here  

Dr. Jonathan Usuka, CEO of Sapient, uses insights about proteomics and metabolomics to provide deep molecular characterization of diseases from a single sample to support drug discovery, development, and approval. The company's unique dataset combines real-world data with longitudinal molecular profiling of tens of thousands of samples across different diseases, ethnicities, genders, and ages.  By measuring proteins and metabolites, this data and insights engine helps pharmaceutical companies gain a significantly more comprehensive view of the molecular basis of disease, better understand drug targets, and predict potential drug outcomes and safety. Jonathan explains, "We support drug discovery and drug development, and a couple of things are going on in the industry right now in discovery and development. One is the overall pharma landscape of how a drug gets approved. That's been fairly static since the 1970s with the creation of the FDA. So clinical trials are well established, but the structure of it was based around not knowing much about the underlying drug target that your drug is interacting with. Since then, they've tightened up the requirements around mechanisms of action, but mostly, the process itself is almost protein agnostic in terms of the development process and how the drug interacts with patients." "So what we do, what has happened recently, is a revolution in understanding the molecular basis of disease and how the therapeutics interact with it at a molecular level. We support pharmaceutical companies in understanding the safety and the efficacy and being able to predict how their therapies will do in the clinic, and then really understanding a lot more about the available drug targets, which expands the arsenal of ways to fight disease."    "At Sapient, we don't just identify dynamic biomarkers, biomarkers that change with disease or change in response to therapy. We also give a lot of context about those biomarkers. We also say where we have seen those biomarkers occur and how they have changed in response to other therapies, disease conditions, and immunological responses. So, a pharma company can see better what it's getting into when it invests in a dynamic biomarker."  #SapientBio #Multiomics #Proteomics #Metabotomics #DarkProteome #BeyondtheGenome #Plasmaproteomics #Biomarkers  sapient.bio Download the transcript here

Dr. Joel Salinas, Co-Founder and Chief Medical Officer, and Dr. Julius Bruch, Co-Founder and CEO of Isaac Health, leverage virtual care and home visits to provide proactive, technology-enabled services for early diagnosis and treatment of dementia. Their mission is to reduce barriers to cognitive assessment and improve access to personalized care plans and treatments that can delay brain disease progression. The key is respecting the patient's decisions and building trust with the care team. Joel explains, "The first thing is really just meeting people where they're at. It's so hard to get access to high-quality care due to wait times and geographic reasons. What we're building at Isaac is meant to require zero distance and move a hundred times faster than the current care journey. The other piece is we develop these partnerships where we're much more proactive about identifying changes that someone might be having with memory or thinking. We are looking at risk factors that they may have within their health record and then actually doing some outreach to those who may have some undiagnosed cognitive impairment. Part of the goal here is by meeting people when their symptoms are at their earliest, we have an opportunity of really a golden window of time to be able to bring in interventions that can impact the long-term trajectory of their brain health." Julius elaborates, "We have built a very extensive technology platform that underpins the entire care journey, from identifying and screening patients to diagnosing, treating, and care management, and seeing as you specifically asked about the diagnosis part. So once we've identified that the member is at high risk, we reach out to them and enroll them in one of our programs. The first visit is generally a medical assessment, and we use a neuropsychologist who does that initial assessment. Still, our platform guides that whole interaction to make sure that we collect all the right information in the most efficient way possible. So it's still very much over Zoom because it is the most effective way to get to the information in this population. Our platform supports the whole care flow and makes sure that it's run as efficiently as possible." #IsaacHealth #BrainHealth #DementiaCare #Caregiversupport #GUIDEModel #DigitalHealth #HealthEquity #EarlyDetection #DigitalHealthcare #Telehealth #InnovativeHealthcare #PatientEmpowerment myisaachealth.com Download the transcript here

Dr. Traci Sweet, Co-Founder and COO of Holon Health has developed an approach to treating substance use disorder that emphasizes integrating physical and behavioral health with an awareness of the impact of social determinants of health. Focusing on serving a marginalized criminal justice population that has struggled to navigate the healthcare system, Holon Health is making treatments accessible with 24/7 digital support and human-to-human interactions. Features of the Vibe app include daily affirmations, lessons, and contingency management. The key is looking forward, not revisiting the past. Traci explains, "We developed Holon Health because so many people struggle with navigating the system, particularly in terms of integrated complete treatment, for so many years now. And I've been a doctor in the field for 31 years. For so many years, we've had such a spidered system where we look at the physical health of a patient, and we look at their behavioral health and SUD needs, and we never come together to look at that in a whole body space. So Holon focuses on fully integrating care between physical health needs, substance use disorder, behavioral health, and the additional social determinants of health. So housing, employment, education. We throw everything we can at the clients. On top of that, the addition of our digital app called Holon Vibe really makes treatment accessible 365 days a year, 24/7." "We serve predominantly folks at the intersection of criminal justice and healthcare. My co-founder is formerly very enmeshed in working with the criminal justice population from his former company. I also have some Department of Corrections in my background as well. This patient has been marginalized in many ways and has found just getting through the system without judgment, without stigma, without having to focus on their shame. Their trauma has found it very difficult to navigate. So we're focused on changing that experience, moving this patient in the direction of preventative care, rewarding pro-social behaviors, and offering support that is kind of like Planet Fitness, just judgment-free. And it's been an amazing experience so far." #HolonHealth #CriminalJusticePopulation #HolisticHealthcare #SDOH #SubstanceUseDisorder holonhealth.com Download the transcript here

John Orosco, CEO and Co-Founder of Red Rover Health is focused on interoperability in the healthcare industry and the potential impact of AI and automation in streamlining healthcare processes. The emergence of revised industry-wide standards has helped improve integration, but true ease of data sharing remains elusive. An app store approach and real-time data access are the next steps in the evolution of integration methodologies, allowing providers to access the best solutions and integrate them with the core EMR systems. John elaborates, "The app store concept, which goes back to what I was saying when I started in this industry in 1998, was the approach. It was to pick the best solution regardless of the vendor that solves this departmental workflow need and let's implement the best solution. Well, integration with the core electronic medical record system was so tough and so painful and so ugly that pretty much the entire industry shifted to one vendor of record. They were like, we're just going to select one vendor. We're going to forego and give up feature functionality. We know that other solutions are better, but everything will be integrated. So, the entire industry shifts to one vendor. With the advent of APIs and interoperability becoming less painful, that was the right model." "So an app store helps facilitate this notion that any provider, regardless of where you're in the country, should have access to the best solutions that any of these vendors offer. They should be able to integrate it with the medical record. It shouldn't be up to the EMR vendors, let's say, to dictate which solutions do and don't integrate or that their solutions are the only ones that are available. A true app store concept would open the door for all these great solutions that providers would have access to, and they get to decide which ones they want to implement and use." #RedRoverHealth #HealthcareInnovation #HealthTech #Interoperability #DigitalHealth #HealthIT #AIinHealthcare #SeamlessIntegration redrover.health Download the transcript here

Mike Esworthy, Chief Strategy Officer at EnableComp, understands the challenges that health systems face when dealing with complex health claims such as workers' compensation, Veterans Administration, motor vehicle accidents, Medicaid, and out-of-state claims. These exception-based claims require deep subject matter expertise to identify the right payer and process the claims correctly. Using AI-driven technology, EnableComp helps hospitals manage complex claims, minimize the number of denials, optimize revenue, and allow them to focus on their core commercial claims.  Mike explains, "I think the easiest example to provide in that context, if you look at a worker's comp claim, more often than not, when a patient comes into the hospital, they don’t know who their company's workers' comp provider is, and so often they hand over the commercial insurance card. If that doesn't get caught early, the commercial insurance gets billed, it results in a denial, and the claim sits out there in the ether for 30, 45 days before it comes back to the provider to go figure out who is the right payer class for this. So that's the big picture of the challenges. And then each of those claim types has unique nuances that make this challenging." "I think there are a lot of good things happening in the VA that are, in theory, improving access for veterans, and that's a great thing. From a claim standpoint, though, I think all of the core challenges still remain. And so I know that many of the EMRs have been putting a focus on interoperability, and all of that is great from a treatment care coordination, getting veterans seen in hospitals, and getting them through the door." "But once they've been treated, all of the same challenges that were prevalent before, all of these announcements are still out there. And I think the complexity still exists in terms of not being a normal payer pathway for providers and not knowing all the specific rules. One such example is that you were only allowed one appeal level within the veteran's claims, which means you have to get it right the first time. And so there's a really important component of knowing how to process the claim, getting it done correctly, and ensuring that you're maximizing the yield and the outcome of the claim itself." #EnableComp #VeteranCare #HealthcareInnovation #ComplexRCM  enablecomp.com Download the transcript here

Dr. Neal Kassell, Founder and Chairman of the Focused Ultrasound Foundation,  is working to raise awareness and drive the utilization of focused ultrasound to treat a wide range of medical conditions. This non-invasive technology uses medical imaging to precisely target and treat tissue deep in the body. Focused ultrasound has multiple mechanisms of action and can be used for destroying tumors, modulating neural activity, delivering drugs, and stimulating the immune system. Neal explains, "So focused ultrasound is a new, totally non-invasive therapeutic technology, and it's the intersection of medical imaging, which is either ultrasound or MR imaging, which is used to identify the portion of the body that we want to treat to plan the treatment, and then to guide the treatment. Then, the focused ultrasound technology delivers the energy that treats the tissue. The way it works is analogous to using a magnifying glass to focus beams of light and burn a hole in a leaf." "But at that focal point where all the beams converge, we now understand 30 ways ultrasound can affect tissue. That's in contrast to, for instance, radiation therapy, which is only one mechanism of action. Or a surgical robot, which is one mechanism of action. Focused Ultrasound has at least 30 mechanisms of action, including destroying tissue at that focal point by a variety of mechanisms,  stimulating or blocking neural activity in the brain called neuromodulation, and delivering drugs or other therapeutic agents precisely to a point in the body where they are needed. This increases both the effectiveness and decreases the systemic side effects, stimulates the body's immune response to tumor, and to the effectiveness of cancer immunotherapy agents." "The point in the body where the ultrasound is targeted is, as I said, previously guided and controlled by medical imaging, either ultrasound or MR imaging. Now, the fact that there are so many different mechanisms of action creates the opportunity to treat a wide variety of medical disorders. Today, around the world, there are more than 180 clinical indications or diseases in various stages of research and development in commercialization. Ten years ago or so, there were only three. That's how rapidly the field is growing."  #FocusedUltrasoundFoundation #FUSFoundation #FocusedUltrasound #Glioblastoma #ClinicalTrials #NeuroOncology #Innovation #Healthcare #MedTech #Oncology #Neurology fusfoundation.org Download the transcript here

Bryan Mazlish is CEO of Surf Bio, a company focused on novel subcutaneous formulations of biologics to enable patients to self-administer these treatments at home. The limitations of subcutaneous administration have historically made time-consuming IV infusions necessary for many biologics. The growing number of biologics and biosimilars in development will further strain the capacity of infusion centers, making subcutaneous administration a way to increase access, reduce healthcare costs, and improve patient adherence. Bryan explains, "Surf Bio is focused on enhancing the ability for patients to take a lot of the innovative and novel biologics that are currently on the market and in development. The vast majority of these historically have required a trip to the infusion center at the hospital, which is quite burdensome and takes a lot of time and resources from the patients and the healthcare system. We focus on creating novel formulations of those same drugs. These biologics can be self-administered at home in seconds instead of requiring a patient to spend the better part of the day commuting to and from an infusion center and sitting in a chair." "When you formulate biologics, they typically are formulated in water and concentrated to very high levels. They become extremely viscous and, consequently, not injectable. So, the ability to inject very high-concentration biologics subcutaneously is limited by the volume that can be administered and the concentration of the biologic that can be squeezed into that volume. As a consequence of this, historically, a large quantity of drug has been diluted at great levels and then dripped into your bloodstream through the intravenous route, which can typically take an hour or, in some cases, multiple hours." #SurfBio #BiologicsDelivery #SubcutaneousInnovation #HealthcareEfficiency surf.bio Download the transcript here