Empowered Patient Podcast

Vish Charan, Divisional Vice President of Product Development at Abbott's Cardiac Rhythm Management Business, explains some of the limitations of traditional pacemakers implanted in the chest with long wires connecting the pacemaker to the heart. Abbott has developed the AVEIR DR system, a dual-chamber leadless pacemaker that uses implant-to-implant technology to send electrical impulses between the upper and lower chambers of the heart.  The i2i technology allows these capsule-size devices to be implanted directly in the heart with the ability to communicate to synchronize the heart rhythm. Vish explains, "What we can do right now, is to get a very, very small access into the veins in the leg, and from the veins in the leg with a very small access, we're able to deploy these capsule-size pacemakers directly into the heart with a long tube. We call that a catheter. But that is how they're deployed. So, you don't have a surgical pocket. You don't have a big cut open in your chest, and the device is implanted in your upper chest. All you have now is a surgical axis in your leg, and you have two capsule-sized devices, which are much smaller than two AAA batteries directly implanted in the heart." "So, the technology involved with AVEIR DR is where you have these two capsule-sized devices directly implanted in the upper and lower chambers of the heart. The two chambers of the heart need to operate in synchrony. What we can do is that in the upper and the lower chambers of the heart, which are the atrium and the ventricle, we can sense and pace directly in those chambers."  "But the good thing and the technological advantage of this product is they communicate with each other. The communication scheme is what we call i2i technology, where we are sending electrical impulses between the upper and the lower chamber devices. These are electrical impulses that are very, very short, and very small, which cannot be felt by the person who has a device, but that is sufficient for the devices to register information between the upper and lower device and able to operate in synchrony. And this synchrony is extremely important for the person to get back to their normal heart rhythm." #Abbott #AVEIRDR #Pacemaker #LeadlessPacemaker #DualChamberPacemaker #HeartHealth #i2i #ImplanttoImplant AVEIRDR.com Abbott.com Download the transcript here

Laxminarayan Bhat, Founder, President, and CEO of Reviva Pharmaceuticals, is focused on developing next-generation therapies for neurological diseases, particularly schizophrenia. Their lead candidate, brilaroxazine, acts on multiple neuro receptors to balance imbalanced neurotransmitters in the brain that are responsible for causing schizophrenia. This new molecule shows positive results in efficacy and a low discontinuation rate, indicating the drug can be used for acute and long-term maintenance therapy. Lax elaborates, "Reviva is a late-stage pharmaceutical company. We are focused on developing next-generation therapies for diseases of neuro targets. That's our primary focus. So, currently, we are focused on CNS, inflammatory, and cardiometabolic diseases. We use chemical genomics-driven technologies to develop new chemical entities. Currently, we have two molecules in development. One is brilaroxazine, which is also called RP5063. The second molecule is RP1208. Both molecules were discovered in-house." "For schizophrenia, there are several treatments available. Collectively there are around 13 new drugs that got approved in the last 40 years. There are still significant unmet needs in the treatment of schizophrenia because schizophrenia is not a single disease. Instead, it's a mix of multiple symptoms. So, developing new therapies that can address multiple symptom domains is quite challenging. That's what we are currently working on in our drug brilaroxazine. We believe that it ideally can treat major symptom domains with benign or fewer side effects." "There are reports - all research-level - they're not accepted as a confirmatory test. For example, biomarkers called inflammatory biomarkers like BDNF and cytokines. There are several clinical research reports published, their links to or their association with the severity of schizophrenia. They're shown as the disease progresses the changes in these biomarkers. However, they are not validated to use as a definitive test for evaluating schizophrenia." "Then, recently, with the advancement of AI or computer techniques, there is the voice biomarker. The way schizophrenia patients speak, in general, psychiatric patients' speech has a distinguishable pattern. That's also being used as a marker to evaluate the severity in this patient population. So, in the just-completed study, we evaluated both blood-based markers as cytokines and are currently evaluating voice biomarker. So, the data will be available soon."  #RevivaPharma #Schizophrenia #Biomarkers #VoiceBiomarker #Neurotransmitters #Dopamine #Serotonin #AI revivapharma.com Download the transcript here

Robert Maxwell, Founder and CEO of ClinConnect, has created a platform that simplifies the process of patients finding clinical trials, shortens enrollment times, and focuses on providing support to ensure patient retention in the trials. The platform works in collaboration with sponsors, healthcare providers, hospitals, and other stakeholders to streamline communication and more quickly identify qualified clinical trial participants from a broader universe. Robert explains, "We make the process of not only finding the trial very, very simple, but we also shorten the enrollment times, which in the case of acute disease is distinctly important. But generally speaking, it's usually more advantageous to get into a trial more quickly than waiting unnecessarily. And so, while we don't claim to solve all clinical trial recruitment issues, we've found that our patients generally see about a 60% to 70% reduction in enrollment time by working with us and letting us be their advocate through the enrollment process." "On the flip side, with pharmaceutical companies who are sponsoring these trials or running them directly, 70% of trials don't meet their recruitment targets. And that's profoundly problematic for them." "So, we do not just work with the patient to get them into the trial. We will continue to advocate for them. And as we use the term, we'll hold their hand through the entire trial process. Then, we even have some post-trial services and some work we do with them after the trial. So we have found that because we don't just work with them in one kind of component of the life cycle of the trial, our retention rates are much higher as well. " #ClinConnect #ClinicalTrials #TrialRetention #TrialRecruitment #DigitalHealth #PatientAdvocacy clinconnect.io Download the transcript here

Chris Paradise, VP of Research and Development at Rion, is taking an acellular approach to developing next-generation regenerative medicines to treat degenerative diseases. The proprietary Rion system PEP, purified exosome product, uses extracellular vesicles or exosomes isolated from human blood platelets to send regenerative messages to cells to stimulate faster healing. This regenerative therapeutic allows for the administration in various forms, such as nebulization for pulmonary conditions and topical application for wounds. Chris explains, "What our focus has shifted towards at Rion is now an acellular approach, so it doesn't involve the use of cells or other components that have been proposed in the past. But we're focusing on extracellular vesicles or exosomes, and we can discuss those in more detail in a minute. But the point of emphasis is that it overcomes many of the limitations the field has previously faced. We're excited to offer reproducible, consistent, and, most importantly, accessible and affordable regenerative therapeutic with a significant impact." "If you think about how two cells communicate with one another, one of the ways they do this is to send messages in little packages between one another, known as extracellular vesicles. It's the fundamental way that cells and tissues more broadly communicate with each other, send signals to one another, and respond to their environment. And so what you find within these vesicles is essentially what one cell is trying to say to another. And they're designed such that they're incredibly stable and designed to do exactly that, which is deliver messages to cells." "I'll back up to the source of the material, which is human platelets. Most people are familiar with platelets as a key component of your blood. If we get an injury or a cut, the bleeding tends to stop relatively quickly. That's because platelets respond to that injury site and form a clot, which stops the bleeding. Much like the conversation about the newfound appreciation for exosomes, I've certainly gained a new appreciation for the impact platelets have, not only on the control of bleeding but, more importantly, the regenerative processes that are jump-started after that to heal the tissues." #RionTX #RegenerativeMedicine #RegenerativeTherapeutics #Acellular #PlateletDerived #Exosomes  riontx.com Download the transcript here

Fady Boctor, President and Chief Commercial Officer of Petros Pharmaceuticals, discusses the process of transitioning drugs from prescription to over-the-counter status, which includes conducting studies to determine label comprehension.  In this situation, the FDA reviews the package wording to determine if the consumer can self-select the drug safely without a physician's involvement. With a focus on men's health issues like erectile dysfunction, Petros also sees the opportunity to educate consumers, reduce healthcare costs, and potentially identify related conditions that might require further investigation. Fady explains, "Switches had been occurring, those prescriptions to OTC switches, have been occurring since really 1974, 1975. Over the past many years, about 106 products have been switched from prescription to OTC. The common denominator among those switches is that they're relatively safe products. We're talking antihistamines, allergy medications, and smoking cessation products. These are products that are relatively safe." "We're trying to establish a new technology platform that speaks to transience and instantaneous engagement with the product. Imagine in a retail pharmacy aisle or at home on your mobile or desktop computer, you look at the product, engage with the drug facts label, and if you are appropriate for selection, use technology that supports your appropriate self-selection. You purchase the product as an OTC non-prescription, an amazing new frontier we're excited to be a part of." "In 2022 or 2023, we're looking at roughly a 70,000 primary care physician shortage. By 2030, that's supposed to get into the triple digits of roughly 120,000 primary care physician shortages. We're already seeing it, where the waiting lists and the time to appointment are going into the weeks and months. Sometimes, these patients in a far more educated community with WebMD and the like, easily self-diagnosable conditions, should be actionable, with prescription medication switching to OTC to help meet that consumer where they need it and when they need it." #PetrosPharma $PTPI #STENDRA #OTCSwitch #ErectileDysfunction #Avanafil PetrosPharma.com Download the transcript here

Dr. Holly Miller, Chief Medical Officer at MedAllies, discusses the importance of data interoperability and usability to provide clinicians and patients with information that can lead to better-informed decisions.  The Sequoia Data Usability Project focuses on ensuring that data is trustworthy and useable. MedAllies is involved in the related Taking Root Movement, which promotes the adoption of the Sequoia Data Usability Implementation Guide. Holly emphasizes the need for solutions to provide a friendly user interface and software design that improves the providers' workflow.   Holly explains, "Medallies offers multiple interoperable networks, ensuring the secure transmission of critical health information among healthcare constituents. It's important that the listeners understand that we've moved to a world where a lot of data is being captured electronically. To optimize clinician-patient decision-making and patients being able to make decisions for themselves, that data has to move across the healthcare environment to wherever someone is being seen for care." "This project and Sequoia understand that for healthcare constituents to adopt and use interoperability, the data has to be usable, reliable, and trustworthy. The data usability workgroup, currently comprised of 391 organizations with 486 participants, has focused on ensuring that data received through interoperability is trustworthy and usable. The first implementation guide by this group was published about a year ago and focused on data provenance, effective use of codes, reducing duplicates, data integrity, data tagging for searchability, and the effective use of narrative captured in electronic health records."   "In many cases, it's about making the right thing to do the easy thing. And so, the system's user interface, where the data comes across into an end-user system, has to be easy to use. It has to be easy to integrate into the system that receives it and to be easy to reconcile it with the data that already exists in your system." #MedAllies #Interoperability #TEFCA #QHINs #HealthData #DataExchange MedAllies.com Download the transcript here

Dr. Mark Lomax, CEO of PEP Health, a new way to listen to the patient's voice. PEP, the Patient Experience Platform, collects and analyzes patient comments from various digital platforms to gain insights into the quality of care provided by healthcare organizations. Using AI to interpret and understand the sentiment of the comments, the company is providing real-time data that can help organizations make better management decisions and improve patient care.  The technology can also be used for risk management and early detection of problems within healthcare facilities to improve patient safety and outcomes. Mark explains, "We've got a few arms to it, but the fundamental part of what we do is collect all the comments that patients might post anywhere on the digital landscape from social media, online review sites, doctor review platform sites. We aggregate it all together and then make sense of it so that we can listen to a whole population. We listen to the whole US, and every location, every hospital, and every clinic that sits within the US. We are listening in real time with our technology. That's exciting because then it goes onto a ton of different insights and new ways of understanding good and bad care and why there is good and bad care in different places. We do all of that because, fundamentally, we want to improve the patient experience. Our mission at PEP Health is to enable organizations and individuals to make better choices so that care gets better for patients." "What is underpinning it is a science, a psychology science called the wisdom of crowds. We call it the wisdom of patients, and for every few that might be a bit off on the needle, most people can identify what's good and bad about healthcare, giving us the truth. It helps us zone in on what matters. This has been validated for a number of different tools now so that we know the insights we derive matter, and that's great for people when they come to use it." #PEPHealth #PatientExperience #PatientEmpowerment #CareQuality #HealthTech #HealthAI #SocialListening pephealth.ai Download the transcript here

Dr. Fiona Elwood, VP and Neurodegeneration Disease Area Stronghold leader at J&J Innovative Medicine discusses the challenges in developing new therapies for neurodegenerative diseases in part because of the heterogeneity of the patient population.  She highlights the difficulty in defining the subsets of these diseases and identifying the right patients for clinical trials. Emphasizing the importance of early detection, J&J Innovative Medicine is developing strategies to support the move to precision medicine in treating diseases like Alzheimer's and Parkinson's to prevent patients from moving to a symptomatic stage of disease.   Fiona explains, "For example, in Alzheimer's disease, as many people know, one of the primary symptoms is dementia, but dementia is a symptom. There can be other reasons why people develop forms of dementia. Alzheimer's disease is a specific disease where now we know patients can be defined by the pathology in the patient's brain. So specifically, the patients develop amyloid plaques, extracellular clumps or plaques of the amyloid beta peptide, and intracellular, inside neurons, tangles of a protein called tau. So, it's these pathological hallmarks that characterize or define Alzheimer's disease and lead to symptoms such as dementia." "We know that Alzheimer's, for example, starts about ten years before patients display symptoms. But we don't know exactly how quickly each person might progress or the specific subset of symptoms that each patient may be particularly susceptible to." "Then maybe the third thing I'll call out that's been a real challenge to us has been the time course of disease and the fact that the Alzheimer's pathology can start 10, 20 years before patients show up at their doctor's office. Historically, we weren't able to detect those very earliest stages of disease. Now, because of the field's investment in different biomarker technologies, imaging technologies, digital technologies, and even highly sensitive blood-based screening technologies, we can identify patients right at the beginning of that pathological cascade." #JNJInnovativeMedicine #Neuroscience #Neurodegeneration #AlzheimersDisease  jnj.com Download the transcript here

Dr. Ping Cao, Co-Founder and CEO of BridGene Biosciences, has developed IMTAC, a platform that can identify molecule ligands for hard-to-drug targets. This platform allows for proteome-wide screening for drug candidates from a small molecule library and has identified over 4,000 protein targets providing numerous opportunities for drug development. The lead candidate, BGI-9004, is a TEAD inhibitor of multiple cancers. BridGene is also in partnership with Takeda to focus on neurodegenerative disorders.   Ping explains, "For small molecule discovery, the major challenge right now is the limited druggable space. Human proteome consists of over 20,000 proteins, and approximately 12,000 of them have been confirmed to play a role in human diseases and may become targets for precision therapy."   "However, statistics analysis shows drugs so far approved by the FDA only target less than 10% of proteins. In other words, most potential drug targets within human proteome do not have associated drugs. Those targets are called hard-to-drug targets due to their biological or structural characteristics. Also, there is less understanding of their mechanism, making them undruggable using traditional methods."   "The significance of proteome-wide screening is that it addresses two kinds of major challenges of drug discovery. One is that some protein drugs contain shadow-binding pockets. The second one is some protein drugs only form transient and temporary binding pockets in live cell environments. For these two types of drugs, by using the chemical proteome approach, we can identify ligands. The process is basically like BridGene's process called IMTAC. They consist of three main components." #BridGeneBio #UndruggableTargets #SmallMolecules #Takeda BridGenebio.com Download the transcript here

Bronwyn Spira, Co-Founder, and CEO at Force Therapeutics, provides a comprehensive digital platform connecting patients to their rehab and recovery care team for musculoskeletal therapy.  The platform includes personalized treatment plans and allows continuous monitoring and real-time intervention to help reduce readmissions and complications. While patients have come to expect a digital alternative, providers have become more comfortable with digital tools, recognizing their ability to engage with more patients and reduce burnout by automating repetitive tasks.   Bronwyn explains, "Force is a comprehensive tool that patients access during their recovery to get all their personalized treatment plans, which might include exercises, education, videos, outcome forms, and anything they need when they're not in the presence of their providers. The platform is almost like an extension of the patient's care team, allowing patients to provide feedback that enables real-time intervention. We've seen that this feedback loop helps reduce readmissions, lowers the cost of care, and reduces complications." "We partner very closely with hospitals, health systems, ASCs, and large private practices to support their internal care teams of orthopedic surgeons, nurses, physical therapists, and navigators around that musculoskeletal patient's journey." "Patients not only embrace the experience but are starting to expect it. So this is certainly a sea change and a commentary on where we are in the world today. When we started Force Therapeutics, patients started to do their travel planning, banking, and even dating online. And now it's become the norm that everything you do should have a digital component. And so patients are very engaged. Funnily enough, the stakeholder that has made the biggest turnaround in accepting digital tools is the provider side of the house. Originally, a lot of providers were very resistant and said, "Patients won't do this. We want as much care as possible to be in person." #ForceTherapeutics #MSK #PhysicalTherapy #DigitalHealth #DigitalTherapy forcetherapeutics.com Download the transcript here