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Empowered Patient Podcast

Health, Home & Life

Empowered Patient Podcast with Karen Jagoda is a window into the latest innovations in digital health, the changing dynamic between doctors and patients, and the emergence of precision medicine. The show covers such topics as aging in place, innovative uses for wearables and sensors, advances in clinical research, applied genetics, drug development, and challenges for connected health entrepreneurs.

Location:

San Diego, CA

Description:

Empowered Patient Podcast with Karen Jagoda is a window into the latest innovations in digital health, the changing dynamic between doctors and patients, and the emergence of precision medicine. The show covers such topics as aging in place, innovative uses for wearables and sensors, advances in clinical research, applied genetics, drug development, and challenges for connected health entrepreneurs.

Twitter:

@karenjagoda

Language:

English


Episodes

Innovative Platform for Treating Periodontal Disease Regenerating Bone in Humans and Animals with Stella Vnook and Bill Breitenbach Oral Bio Life

3/18/2024
Stella Vnook, the Founder and President, and Bill Breitenbach, CEO of Oral Bio Life, talk about the prevalence and causes of periodontal disease and the limitations of current treatments. The Oral Bio Life PiezoGEL technology has shown effective removal of plaque and treatment of bacteria on teeth and regenerating bone for a long-term solution. Periodontal disease contributes to inflammation and infection and is showing links to other health conditions like cancer, heart disease, diabetes, and Alzheimer's disease. In addition to human trials, success is seen in trials with veterinarians to regenerate bone in dogs. Stella Vnook elaborates, "Dentists can identify the early warning signs, but in addition to oral hygiene, we also found, and it's supported by data, there are some people who are predisposed to just having issues with their gums and/or periodontal disease. There are genetic implications, and there are people that have comorbidities. The goal is to remove the plaque and the bacteria film. But the process is rather painful. One of the reasons why I founded this technology and this company is because of the scaling and root planing, which is quite painful." Bill explains, "I'd like to add there's a real recognition lately from scientists around the world that inflammation is the root cause of a lot of major diseases - cancer, heart disease, diabetes, and even Alzheimer's. What they're finding is that the fibrous bacteria travel from the mouth throughout the body, contributing to heart disease, diabetes, pregnancy complications, cancer, and Alzheimer's. Just recently, there's some NIH data that shows that P. gingivitis, the main pathogen for chronic gum disease, has been identified in the brain of Alzheimer's disease patients. So, it's not just about gum disease, it's about total body health, and there is a need to be taking care of that and being mindful of the downstream effects of not taking care of periodontal disease." #OralBioLife #GumDisease #PeriodontalDisease #Inflammation #Veterinarians #BoneRegeneration oralbiolife.com Download the transcript here

Duration:00:22:35

Avatars and Digital Personalities Breaking Down Communication Barriers in Healthcare with Chuck Rinker PRSONAS

3/14/2024
Chuck Rinker, CEO of PRSONAS, sees the next-generation workforce of digital healthcare components as digital personalities and avatars that will act as patient advocates and improve the communications between patients and clinicians. With an emphasis on building trust and showing empathy, these digital tools help gather accurate information and break down language and cultural barriers. Avatars can be customized for locations like hospital lobbies and purposes like clinical trial recruitment. With a background in game programming, Chuck brings a deep knowledge of how the emotional bond between gamers and avatars can be applied to building more robust patient engagement. Chuck explains, "Since technology has been predominant in the healthcare space, we've always had to teach people how to use technology, and the barrier is communication. So, we've said, well, let's just take a different approach. We're not trying to recreate humans, and we're not trying to replace humans. We're just trying to teach all this technology, this scalable healthcare, this improvement in healthcare technology that we have, and make it so that it can communicate to us as humans. We naturally communicate as humans. We don't naturally communicate as an IT specialist, so we're trying to flip it on its head and work it the other way around." "That was a concept we started way back in 2013. We originally built a few of these as product specialists in the pharmaceutical drug launch space. I think Genentech and Pfizer were probably the first ones to use it. It was meant to support the healthcare professionals. Okay, what's all the information you have, from prescribing information to all the complexities of a mechanism of disease and all that you have to relay over and over and over during a multiphase pharmaceutical launch? So, we built these repeatable humans to be those domain experts." "We've learned along the way that it was a great, wonderful piece but that the patients themselves are the ones who are getting "lost in the mix." So, our units are trained to speak whatever language is used by the patient population you're targeting. They can be culturally diverse. We do Sign Language - American Sign Language and British Sign Language. So it's really about creating that advocate, breaking down that communication barrier so that every patient feels represented and welcomed and has their own patient advocate to help them through that healthcare journey." #PRSONAS #Avatars #DigitalPersonalities #DigitalHealth #AI #PatientAdvocate #PatientEngagement #ClinicalTrials PRSONAS.com Download the transcript here

Duration:00:18:25

Creating Psychedelic Therapy Clinics That Ensure Patient Privacy and Comfort with Cody Shandraw Healing Realty Trust

3/13/2024
Cody Shandraw, President and Co-Founder of Healing Realty Trust, aims to provide robust mental and behavioral health treatment facilities. The lack of infrastructure has been a significant hurdle for expanding the commercialization of drugs that require longer in-office visits and space to accommodate the needs of patients undergoing treatments. The emerging field of psychedelics for treating neurological conditions like PTSD requires clinicians to understand the physical requirements for treatment facilities to provide privacy and comfort during the extended time necessary for many of these treatments. Cody explains, "In 2020, it was a really interesting stat that I was made aware of at one of the conferences down here in Miami. It was around a drug called Spravato, which is an intranasal ketamine drug. And they were very excited about the launch. It was in development for quite some time, and unfortunately, it didn't commercialize, I think, to their expectations. I asked one of the drug reps down here in Florida why he thought that was, and he said it was a really simple answer: the lack of infrastructure." "It's a unique drug, and we've only seen this a couple of times. Maybe proton therapy or dialysis centers where when a new therapy is approved, you need that infrastructure to go along with that therapy. And that is what Spravato was. You actually had to be in a clinic for two hours after administration for Spravato. So it was a very unique thing. And a lot of the legacy behavioral mental health providers that would be the target market for that drug, they didn't want to disrupt normal patient inflows into their clinic. So it took a couple of years. When that drug was launched, there were less than a hundred clinics in the United States offering that. Today, there are 2,700 of those clinics, and now Spravato is a blockbuster drug." #HealingRealtyTrust #CommercialRealEstate #BehavioralHealth #EmergingTherapies #PsychedelicAssistedTherapy #PatientAccess #HealthcareInfrastructure #ImprovingBehavioralHealth HealingRT.com Download the transcript here

Duration:00:18:29

Precision Fermentation Unlocking the Potential of Lactoferrin and Other Functional Proteins with Fengru Lin TurtleTree

3/12/2024
Fengru Lin, Co-Founder and CEO of TurtleTree, is applying precision fermentation technology to produce high-value ingredients for food and beverages without the need for animals. This biotech company's first goal is to expand the production of lactoferrin, a protein found in small quantities in milk that has been shown to promote gut health and immunity. Finding a scalable way to produce lactoferrin will lead to adding this iron-binding element to plant-based milks and energy drinks. Fengru explains, "A couple of years ago, I was learning how to make cheese as a hobby. It was quite a fanatic period of time. I went up to Vermont from Singapore for a couple of weeks to learn how to make cheese and I wanted to replicate this whole process back in Singapore. But in Singapore, we have no access to cows, we have no access to raw, fresh milk. So, I had to go down to Indonesia and Thailand to look for milk. In this journey, I was exposed to a lot of challenges around the dairy industry, things like contract farming, things like antibiotics, and hormones being pumped into the cows. As a result, the milk quality always suffers, the mozzarella couldn't stretch, it's not enough calcium, not enough nutrients in the milk. So, I gave up that whole idea and was still working for Google." "So, we bootstrapped initially, brought in some scientists, did a lot of research, and filed our first patent. The technology requires getting memory cells and culturing the cells to express full-function milk, all 2,000 different ingredients in milk. We had our early success and quickly brought this technology to some of the biggest dairy companies in the world, folks like Fonterra and Abbott, and told them, "Hey, we can make milk. What do you think?" "Very quickly they came back with feedback saying, "Well, great that you can make milk, but milk is $2 a gallon. I don't think you can get to the price point anytime soon. You should really be focused on high-value ingredients that are found in milk." So they gave us a list of half a dozen proteins and ingredients that we should look at, and at the top of the list is lactoferrin because of all these great benefits and the high price point it is today. You guys should be focused on the high-value ingredients that are low in supply across the market so you can address this accessibility problem and not try to reproduce a commodity like milk. So that's how we started and where we are today. We just got our FDA Self GRAS status in November last year, so we've started to commercialize this lactoferrin." #TurtleTree #FunctionalFood #Lactoferrin #Protein #PrecisionFermentation #Milk #SustainableFoodProduction #Nutrition turtletree.com Download the transcript here

Duration:00:18:03

Patient Advocates Call for Greater Awareness and Investment in Fighting C.diff and Other Infectious Diseases with Christian Lillis Peggy Lillis Foundation

3/11/2024
Christian Lillis, Co-Founder and CEO of the Peggy Lillis Foundation is a patient advocate in the fight against C. diff infection. Clostridium difficile is an opportunistic infection of the gut that often occurs after taking antibiotics and can lead to life-threatening complications. Christian shares his personal story of losing his mother to C. diff and highlights the progress made in raising awareness and the development of new treatments for the infection. The Peggy Lillis Foundation emphasizes the importance of patient voices in shaping infectious disease policies and research and the need for community support to fight C. diff and other preventable infectious diseases. Christian explains, "Last time we did our most recent C. diff awareness month campaign in November, it was our most successful one yet. We reached around 23 million people through a mix of earned, print, video, and podcast media and a strong social media campaign. We also had it bolstered by media partnerships with Contagion Live and Pharmacy Times. As part of our programming for the month, we held a virtual town hall, and about 200 people attended. More than half of them were C. diff patients, survivors, and family members." "Other progress was at the end of 2022, and then in early 2023, two new therapies. Technically, they are classified as preventative by the FDA, but they are basically microbiome restoration therapies. As I said earlier, when you take antibiotics, there can be other causes. Still, when your gut microbiome, gut bacteria, and viruses get out of whack or depleted, you become very vulnerable to C. diff. And a reason why people struggle to get over C. diff is because their gut microbiome remains degraded. So these new two therapies, one is done by enema, one is given by capsule over several days, it's a really huge change for people who are battling recurrent C. diff." #CDiff #PeggyLillisFoundation #ClostridiumDifficile #CDifficile #PatientAdvocacy #CdiffAwarenessMonth cdiff.org Download the transcript here

Duration:00:21:00

Role of Laparoscopic Surgery and GLP-1 Agonists in Weight Loss and Weight Management with Paul Hickey ReShape Lifesciences

3/6/2024
Paul Hickey, President and CEO of ReShape Lifesciences, discusses the company's role in the weight loss industry. The ReShape Lap-Band® and the new ReShape Lap-Band® 2.0 FLEX are tested surgical options for weight loss and weight management and are now being joined in the market by GLP-1 agonists such as Wegovy and Ozempic. While these options are effective for different individuals, Paul emphasizes the importance of a comprehensive approach that includes diet and lifestyle changes. As a society, we have normalized obesity, and more education is needed to inform those with obesity about these effective solutions. Paul explains, "The weight loss drugs people have been hearing about are the first step for weight loss, along with working with your physician and their team. And then as you move down, the more aggressive treatment, the ReShape products, and in particular the Lap-Band®, which has been around for over 20 years, is the first surgical step performed by a laparoscopic surgeon that goes in and helps to provide for a way to get back on the weight loss path for individuals. And then, beyond that, you have other procedures that are more aggressive that people also have to consider as they continue their journey." "We see physicians today using the GLP-1s as combination therapy for someone who has a Lap-Band® or a gastric sleeve or a gastric bypass who may have had any one of those procedures, including a Lap-Band® for five or ten years and started to plateau or reverse on their weight loss. Those GLP-1s can be administered and prescribed for those who want to get back on the path to weight loss." "There are a lot of differences in the type of obesity that someone has. There are a lot of differences in what treatments work better or worse for individuals. I think the side effect, part of the answer to the question is with the GLP-1s, there's going to be probably more studies to come out to show what side effects the GLP-1s have on different population sets. It is certainly being studied today, and the data out there now is part of the data used to get the drugs approved." #ReShapeLifesciences #LapBandLife #ReShapeLapBand #LapBand #LapBandFLEX #WeightLoss #GLP1 reshapelifesciences.com Download the transcript here

Duration:00:18:07

How Using AI to Integrate Clinical Notes and Hospital Clinical Registries Increases Speed and Accuracy with Matt Hollingsworth Carta Healthcare

3/5/2024
Matt Hollingsworth, Co-Founder of Carta Healthcare, has identified the need to change how hospitals complete clinical registries, which require information from clinical notes. Currently, nurses manually fill out the forms primarily based on their understanding of the notes from the doctors. Using AI to read through notes, extract relevant information, and enter the data into the clinical registry form saves nurses 95% of their time, improves accuracy, and highlights actionable data. This approach allows the abstractors to spend more time on complex cases and uncover overlooked medical conditions. Matt explains, "What we do is collect data for these things called clinical registries, which are required quality submissions that hospitals have to do. And we bring AI to the table so that we can make it a not-so-manual process. Historically, the way these forms have been completed has been with just nurse time. Also, I don't think there's a word in the English language to quite correctly describe form in this particular scenario. Just to give a concrete example, if a PCI, so a stent installation via cath is performed, it takes a nurse about an hour and a half to fill out the documentation required to do the submission to the registry. It takes a really long time." "The problem is that most of it is in the notes. So one of the questions in a registry was the patient hypertensive upon admission. And the way you figure that out is you look, in most cases, in the H&P note and read through it. It'll say somewhere in there that there's either a history of hypertension or they took a blood pressure, and now they have it, etc. And so, the nurse, to paint a picture about what this looks like here, what the nurse is doing is they have the EHR open on one screen, a form to fill out on the other, and they're reading through notes, reaching conclusions, and then filling out the form. So, most of the data needed for this whole process is in the clinical notes, not in some structured form." "Yes, so this is how we define quality in the whole shift to value-based care. A necessary component is that you measure quality in it. And this is just how the sausage is made for doing that. The way you measure something is you collect data for it. These registries are there to collect data, and in many cases, they are procedure-based. Sometimes, it's condition-based, like there's a COVID registry or what have you. Sometimes, it's a location-based thing like this patient was admitted to this unit like a CVICU or an acute care floor." #CartaHealth #GenAI #HealthSystems #2024MedicalPredictions #HealthTech #MedTech Carta.Healthcare Download the transcript here

Duration:00:18:57

Genetic Testing and Growing Demand for Genetic Counseling Revolutionizing Patient Care with Dr. Doron Behar Igentify

3/4/2024
Dr. Doron Behar, Co-Founder and CEO of Igentify, has a vision for the future of genetic counseling, where patients get the support they need to interpret and understand genetic screening results before the tests as well as after. With a shortage of genetic counselors, the solution, in part, lies in using technology to reduce waiting times and improve the interpretation of results while allowing the counselors to handle more patients effectively. The Igentify platform aims to support end-to-end services to provide precision medicine solutions to patients to meet specific needs and identify what test results might indicate about future health. Doron explains, "We need to first speak about the genomic revolution and the crucial role of genetic counseling in it. So, as we know, we are all currently going through the genomic revolution, which means that we are anticipating that each of us will have genomic information, the full content of the genome, inside the medical record. The genetic counselors are the ones who are responsible for interpreting for us and explaining to us what our genome is telling us about our future health." "And particularly, the genome can identify potential risks that we might want to know about, whether it is related to reproductive health, cancer risk, or the use of drug pharmacogenomics. We can see literature saying that even recently, there were more than 5 million genetic tests sold in 2021. Less than 6,000 genetic counselors can present the information to the patients, and they are in North America. And if we compare to the world, there are only 7,500 genetic counselors globally." "The force model will allow us to use the digital genetic assistant and send information back to the patients, creating an end-to-end solution. Very importantly, we are using advanced and sophisticated multimedia content to approach the patients either in the pre- or in the post-test scenarios. These multimedia components allow speaking with the patients about their own situation. So maintaining a very high level of personalization, even speaking different languages to the patients, is particularly important, for example, to make sure that patients understand." #Igentify #GeneticCounseling #GeneticScreening #GeneticTesting #GeneticMedicine #DigitalHealth #PrecisionMedicine igentify.com Download the transcript here

Duration:00:26:12

Early Detection of Lymphedema and Value of Compression Garments After Breast Cancer Treatments with Dr. Steven Chen ImpediMed

2/29/2024
Dr. Steven Chen, a breast surgeon and Chief Medical Officer at ImpediMed, discusses the early detection and treatment of lymphedema, a type of swelling that often occurs after breast cancer treatments. Visual observation and measurements using a tape measure are the current, inaccurate methods of determining early warning signs. The ImpediMed SOZO device measures subtle changes in time for simple interventions such as wearing compression sleeves, now covered by Medicare, which can reverse the damage. Unaddressed, this condition can lead to severe functional problems. Steven explains, "The whole goal of ImpediMed is to help people find this when it's in stage zero or stage one when it can be reversed. It's a very simple set of treatments when you catch it early, primarily wearing a sleeve, a compression sleeve, and/or a compression glove. And with that, you can reverse almost all the stage zeros and probably somewhere between 80% to 90% of stage ones. And so you can see that if you can catch it early, this will go away with a fairly simple set of treatments." "As you get into stage two and stage three, you're now talking about much more aggressive treatments - things like massage, pumps, and nighttime pumps to try to get the swelling down. And usually, that just provides temporary relief. It almost never goes all the way back to the way it was. Now, there are plastic surgeons and microsurgeons who have started doing things like transplanting lymph nodes to try to get more drainage. And that could be helpful as well. But again, it's rare once you get to stage two or three to see getting back to how you were before surgery." "In stage one, you can start to have measurement differences a little bit if you use a tape measure regularly. But as you might imagine, using a tape measure regularly takes time, but it's also somewhat hard to do. If you've ever tried to measure yourself with just a fabric tape measure, you do it two or three times in a row, and you might get two or three different measurements. So, trying to measure someone every three to six months and do it with precisely the same amount of tension is fairly difficult. But I think the real primary thing is people don't realize that this happens, and if it does happen, they can turn it around. So, patients don't complain to their doctors because they don't realize it's a consequence of their treatment." #ImpediMed #Lymphedema #LymphedemaAwarenessMonth #LymphedemaPrevention #BreastCancerCare #BreastCancer #Survivorship ImpediMed.com Download the transcript here

Duration:00:19:54

Unlocking the Power of Conversational Intelligence for Healthcare Stakeholders with Amy Brown Authenticx

2/28/2024
Amy Brown, CEO of Authenticx, uses conversational intelligence to analyze conversations between humans and between humans and chatbots to gain insights that can drive improvements in patient experience, operational efficiency, and faster resolution of problems in the healthcare environment. Using AI and trained professionals, the Authenticx solution helps pharmaceutical companies improve drug launches, personalize customer interactions and respond more effectively to patient needs. In clinical situations, the machine learning models help identify and address obstacles impeding more effective patient/provider/payer relationships. Amy explains, "At Authenticx, we really target bidirectional conversations. We can take in all types of unstructured data that exist: notes, social, etc. That said, we find the most insightful and contextually rich types of data sources are the ones that represent a back-and-forth between customer and company. And in our world, we're working with very large healthcare companies, like pharmaceutical manufacturers, health insurance companies, health and hospital systems." "They're typically having conversations with patients or caregivers, any type of healthcare consumer, they're also having conversations with other stakeholders in the healthcare system, like insurance companies talking to providers' offices, or doctors' offices talking to pharmaceutical manufacturers. We find that the research and study of that back-and-forth bidirectional communication, and doing that at scale, is incredibly insightful to the business." "We ingest the call recordings or the chat interaction files into our platform, and we apply AI to listen for the things that matter most to healthcare companies. We've spent five years curating our own proprietary training data, where we have listeners, human listeners, who have listened to hundreds of thousands of conversations. We intentionally hired social workers, healthcare workers, nurses, people who have worked inside the healthcare system, because we found that interpreting the communication they're listening to is so crucially important to making high-quality AI." #Authenticx #ListeningWithAI #ConversationalIntelligence #PatientExperience #AIinHealthcare Authenticx.com Download the transcript here

Duration:00:21:13

The Potential of a Functional Cure for HIV with Dr. Marc Conant Addimmune

2/27/2024
Dr. Marc Conant, Chief Medical Officer at Addimmune, has been working on HIV/AIDS for over 40 years and highlights the progress that has been made in developing effective HIV drugs. The mission at Addimmune is to develop a functional cure for HIV by modifying the patient's cells to enhance the immune system's ability to control the virus. This autologous cell therapy approach has been used successfully in treating leukemia and lymphoma and shows promise in suppressing HIV. Marc explains, "I started caring for AIDS patients in 1981, and it wasn't until AGT came along in 1988, '87, '88, that we even had anything that would work. Up until that time, everyone who contracted the disease died. HIV kills about 94% of people who are infected. What we saw early on with AGT was a drug that suppressed the virus, and then we found the next drug that suppressed the virus, and then the next one, and now we have close to 40 different drugs that can suppress the virus." "Now, there's been even a step beyond that. You all probably see on your television every night injections that can be given once every two months, and sure enough, that works and works great, so instead of taking a pill every day, you only need to see a doctor six times a year. Every two months, you go in for two injections, and you're good for two months. And compliance is better. Patients remember to take their drug because it's given to them in an injection." "All of that, though, still requires putting in a drug. We're hoping to take the patient's cells, modify them, put them back in the patient, and have a one-and-done treatment for the rest of his life with these modified cells, which helps the patient's immune system control the virus. The virus will be suppressed. The patient will not need to take more medication. The patient will not have side effects. The patient doesn't have to remember to take his drugs, and we've got a functional cure that will control the disease." #Addimmune #HIV #AIDS #HIVAIDS #CARTCell #CellTherapy #FunctionalCure #HIVTreatment #AutologousCellTherapy Addimmune.com Download the transcript here

Duration:00:18:30

Digital Assessments Offer Insight into Brain Performance and Cognitive Health with Dr. John Showalter Linus Health

2/26/2024
Dr. John Showalter, Chief Product Officer of Linus Health, shines a light on the current methods of measuring cognitive health and emphasizes the need for a more holistic approach to assessing brain health. Linus works on digital cognitive assessment tools and AI models to detect cognitive impairment and early warning signs of Alzheimer's and other dementias. These tools also consider anxiety, sleep patterns, and lifestyle factors and support personalized care plans for patients and their caregivers. John elaborates, "Right now, we have this performance-based understanding of cognitive processing and brain health. And I'm not sure that is the best way for us to be looking at brain health because, to me, as a primary care physician and someone who's very much into a more holistic view of the individual, brain health should be much more about your ability to achieve what you want to achieve, interact with the people that you want to interact with and have a higher quality of life. But there's not a real good definition of that." "One of the classic tests that your primary care physician would use was called the Mini Cog. It's when you were asked to remember three words, draw a clock, and then, after drawing that clock, repeat the words that you were given. We have taken that and put it on an iPad with an iPad pencil. We now analyze not only whether or not you remember the words but the pattern of speech when you said the words, the pauses, and the intonation of your speech when you were repeating the words back." "We also have multiple clock drawings, and because of the immense amount of sensors in the iPad and the iPad pencil, we're able to look at hundreds of features captured at 120 times a second and put them through machine learning models to understand how well an individual's brain is functioning. Then that translates very accurately to understanding if they meet the clinical diagnosis for cognitive impairment or the clinical diagnosis for dementia, understanding possible functional challenges." @LinusHealth #LinusHealth @JohnShowalterMD #CognitiveHealth #BrainHealth #Cognition #CognitiveDecline linushealth.com Download the transcript here

Duration:00:20:01

Path to Developing Gene Therapies for Treating Rare Diseases with Ha Tran Astellas Pharma

2/22/2024
Ha Tran, Medical Head, Cell and Gene Therapy at Astellas Pharma is developing gene therapy approaches to fight neuromuscular diseases, central nervous system disorders, and ophthalmology conditions. There is strong evidence that this approach can be a way to treat and possibly cure rare diseases. Ha explains the challenges of running gene therapy trials for rare diseases and the unique patient journey required to run a successful trial. Ha explains, "Currently, at Astellas, our platform is AAV gene therapy, which is a replacement. Additionally, in our early pipeline, we are looking at both gene therapy replacement and vectorized RNA knockdown. We also have a cell therapy division, which I also cover. For that, we’re looking at in vivo cell therapy." "Honestly speaking, gene and cell therapy trials have their nuances since they are often a single infusion or single injection. So, the preclinical data packages and long-term follow-up plans differ from standard drug development. But the biggest nuances actually for clinical trial design are in rare diseases. The FDA just finalized its guidance for the industry in December. For a long time it was just a draft guidance, but now it's final and I found it to be quite helpful." "There's this major need to understand the patient population, and I see this as threefold. So, understanding country-specific prevalence, the quality of the existing natural history data, and the different phenotypes to target the correct patient population. And there are major pitfalls here if you rush through the process. So you can grossly overestimate patient population if you're using averages instead of really looking into very specific data. So this can lead to slower recruitment and longer timelines once you actually start your study." #AstellasPharma #GeneTherapy #RareDiseases #Allogeneic #ClinicalTrials #CNS #NeuromuscularDiseases astellas.com/us/ Download the transcript here

Duration:00:20:36

Revolutionizing Metabolic Health with Accurate Calorie Measurements Personalized Testing with Hari Mix Calorify

2/22/2024
Hari Mix, Founder and CEO of Calorify, is a former elite endurance athlete and aims to bring to market an accurate, affordable measurement of calorie intake and expenditure to address metabolic health. Measuring metabolism has generally been inaccessible due to the complexity and cost of traditional testing. With an in-home kit, the mission is to help those looking to improve their energy levels, lose weight, athletes, and medical professionals working with patients with metabolic-related health challenges. Hari elaborates, "Our mission is pretty simple, and it's also pretty complicated. Simply put, our mission is to measure the world's metabolism. We believe that the world is facing a huge set of problems related to metabolic health, and nobody is measuring the key component of that, which is how many calories people are eating and burning, in an accurate way in a real-world setting. Our goal is to bring those measurements to the world, empower individuals to understand and improve their bodies and empower institutions to find solutions to metabolic problems and diseases." "The name of the approach is called doubly labeled water. It's been around for many decades. It was first invented in 1949. It was first done on mice in 1955, and it was first done on humans in 1982. For decades, it's long been known to be the gold standard method of measuring how many calories people eat and burn in a real-world setting. However, it's been very, very expensive, very slow, cumbersome, and so it just hasn't been accessible to regular folks. Only about 15,000 people have ever been measured; that's about one person globally per day since the technology was launched in 1982. And so we've solved a suite of problems to bring this test to the world, make it a lot faster so that people can use their results, and make it a lot cheaper so that it's possible for them to afford this testing." "Let's take an NBA team that we're working with. We find guys on the same team with the same lean body mass and the same job description, and yet one person is burning calories twice as fast as their teammate, and you couldn't tell by looking at them. It's extraordinary the degree to which you could put the same amount of food in your body and have it be completely different from the person standing next to you." #Calorify #MetabolicTesting #Metabolism #Calories #Diets #EnergyAvailability Calorify.com Download the transcript here

Duration:00:18:38

Medication Management Addresses Increasing Comorbidities Need for Tracking Usage and Reconciliation to Prevent Errors with Larry Margolis PersonalRX

2/21/2024
Larry Margolis, CEO of PersonalRX, provides medication management for patients and caregivers by delivering personalized dose packs to patients' homes with tracking functionality to inform when drugs are taken. The number of people with comorbidities is increasing, requiring complex regimens and medication reconciliation to ensure patient safety. PersonalRX works with healthcare providers, patients, and caregivers to ensure prescription, supplements, and over-the-counter drugs are used correctly. Larry explains, "Our typical patient profile is somebody, on average, who takes nine medications. We service the market of people with five medications or more, representing roughly 12.9% of the population, about 42 million people." "I think one of the most important tools that we use when we're looking at people who are living longer, have more complex cases and comorbidities, and are taking more medication is looking at the medical reconciliation tools that we've built. And we've spent a lot of time over the last year building and enhancing those tools." "So there is a safety hazard that many patients and caregivers don't realize that presents when you have multiple medications, multiple prescribers, supplements, and all of those kinds of things involved. Medications can negatively interact and can be mixed up by pharmacies and patients." "When we can align all of those things into a singular place, PersonalRX is that kind of pharmacy that has trusted supervision for medication management. Still, it improves patient safety and overall health. As complexity increases, we think it's something that becomes more and more important every day." #PersonalRX #Pharmacy #PrescriptionDrugs #MedicationManagement #MedicationDistribution #MedicationInteractions personalrx.com Download the transcript here

Duration:00:18:41

Advanced Standard of Care for Wounds Driven by AI-Powered Imaging Device to Predict Wound Healing with Wensheng Fan Spectral AI

2/20/2024
Wensheng Fan, CEO and Co-Founder of Spectral AI, understands that the ability to accurately determine whether a wound will heal is currently lacking in wound care. The Spectral AI predictive imaging technology uses multispectral imaging and AI to assess the viability of injured tissue and predict wound healing outcomes. The DeepView device is portable and easy to use, providing fast analysis and saving time in determining the appropriate next steps to treat acute and chronic wounds. Wensheng explains, "Ten years ago when we were founded, we were doing bed sore early detections. Then we transitioned into burn wounds, and the latest adventure is for the diabetic foot ulcer. We see all these acute and chronic wounds, and they all need a common thing to let physicians, clinicians, and patients know whether these wounds will heal or not. That's a simple question, but so far, we don't have a good answer to it with the technology on the market." "For example, let's use acute burn wounds. The current standard of care, per se, is actually the physicians have to wait and see, sometimes up to 21 days, to determine if a burn will heal or not. Why are they so careful? Because visually the wound changes and if it's a non-healing burn, what they need to do is clinically debride that area to take out the dead tissue so that they can put the skin substitute and other products on it to help the overall healing." "We look at the wound from near UV lights across the visible band seen in the human eye and into the near IR lights. We capture the injured tissue's spectral signature, like a fingerprint for those non-healing tissues. We found it and then realized ten years ago that the human brain is not good enough to process that information. We introduced AI, machine learning, deep learning, and all those advanced technologies in identifying non-healing burn tissue since 2014. So far, we have achieved 92% accuracy on day one of looking at a burn wound to decide where that burn wound will never heal or if there are healing tissues that you don't need to take into surgical consideration. So, this technology will become an assistant to burn professionals and ER doctors in deciding how to process the patients during that first encounter." #SpectralAI #AI #ArtificialIntelligence #WoundHealing #DiabeticFootUlcers #BurnInjuries Spectral-AI.com Download the transcript here

Duration:00:24:39

Identifying and Managing Allergies with Personalized Nasal Solutions with Dr. Shuba Iyengar Allermi

2/19/2024
Dr. Shuba Iyengar, Co-Founder and Chief Medical Officer of Allermi, is focused on providing better care and access to allergy treatments. Allermi has developed a personalized approach to diagnosing allergies and personalizing nasal spray formulations to provide a more precise solution to those suffering from nasal congestion, coughing, sinus pain, and itchy eyes. While there are seasonal allergies, doctors are seeing an increase in allergies related to climate change, pollution, and other changes in the environment. Shuba explains, "We want to make sure that everyone knows that allergies are a chronic problem and affect your everyday life. I have allergies, so I completely sympathize with people who have bad allergies. But when you get allergies, what's happening is the inside of your nose is getting a little bit swollen. But to some extent, in the beginning, you can kind of compensate. You can get by. So, if you can't breathe to one side, you'll breathe through the other. If you can't breathe through the side, you'll start to mouth breathe." "As allergists and even general doctors, the toolbox we have to treat allergies is okay but not great for everyone. A lot of times, if they can see their doctor, people might get a prescription nasal spray or be advised to take an oral antihistamine or an allergy pill. They might go to the drugstore and try to buy an over-the-counter nasal spray like Flonase or Nasacort. And for a lot of people, these medicines don't quite work as well or not enough." #Allermi #Allergies #AllergyCare #Telehealth allermi.com Download the transcript here

Duration:00:18:24

Mission to Encourage Early Detection Provide Treatments to Slow Progression of ALS and Other Rare Diseases with Joe Scalia Mitsubishi Tanabe Pharma America

2/16/2024
Joe Scalia, Vice President and Head of Commercial Market Access and Global Marketing for Mitsubishi Tanabe Pharma America, highlights the company's focus on rare diseases, particularly ALS, amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. The company's goal is to find a cure for ALS and improve the quality of life for patients while raising awareness to reduce the time to diagnosis. With a patient support program, JourneyMate, the company offers resources and support for ALS patients, caregivers, and healthcare providers. Joe explains, "When it comes to neuromuscular diseases, these are one of the hardest areas to treat and for medicines to impact patient's lives. So, when you look at neuromuscular diseases like ALS, Parkinson's, and Alzheimer's, these are diseases that impact millions of patients across the United States, and the treatments are very hard to come across. For example, on ALS, before our medication came out, there were over 20 years and 50 failures of medications. There's a high unmet need for these patients, so companies like ours are focused on finding these medications to help support them." "There's also a correlation with a higher rate of ALS for our veterans, and we're not sure exactly why. There's some belief that there may be some type of chemical exposure or vaccine exposure. We're not sure the reason why, but there is a higher incidence also for firefighters. So this is a population that we need to continue to help -- 20,000 to 30,000 patients who are desperately looking for additional support and potentially a cure in the future." "It goes back to, we've been investing in ALS for over 20 years, and it's taken that long to come up with the molecules to help these patients. So, an organization like ours has been around for over 330 years. We look at fighting diseases, not looking at one year, but decades of research to hopefully find medications that will help patients. So, it takes an organization that is committed to the space." #MTPA #RareDisease #RareDiseaseAwareness #ALS #EndALS #ALSAwareness #LouGehrigsDisease mt-pharma-america.com Download the transcript here

Duration:00:19:35

Developing Active Immunotherapy for Precision Prevention Vaccine and Treatment of Neurodegenerative Diseases with Andrea Pfeifer AC Immune

2/14/2024
Andrea Pfeifer, Co-Founder, CEO, and Director of AC Immune, is developing vaccines for neurodegenerative disorders such as Alzheimer's and Parkinson's. Unlike vaccines for infectious diseases, these vaccines target internal proteins that are misfolded and contribute to the disease. These new vaccines are active immunotherapies against the Abeta protein. Trials are showing significant progress in overcoming safety concerns and lack of strong immune response for prevention, treatment, or maintenance therapy. Andrea elaborates, "When you speak about vaccines, you always think about infectious diseases where you have this external virus or bacteria coming in, and you develop an immune system response against this virus or this bacteria, something external. In our area, in Parkinson's and Alzheimer's, we are activating the immune response of the body against an internal protein, but a misguided or misfolded protein." "This is why it's so difficult because you have to overcome the tolerance of the immune system and tell the immune system to develop an antibody response against a pathological toxic protein, which is endogenous. This requires special technologies to have the right immune response because you want the body to make antibodies only against the pathologic or the sick proteins, the misguided proteins, and not against the healthy proteins that are part of your body." "We believe that this vaccine, or we prefer to speak about active immunotherapy, makes the difference between the vaccine response against exogenous factors, such as viruses, and the endogenous, misguided proteins. We believe this active immunotherapy can be used in a treatment manner or for prevention. It can be used for maintenance therapy after one of these therapies, which are becoming available now, has already been used to reduce these plaques in the brain of people. This is related to a better cognitive response. So, I think we're seeing multiple applications. Of course, the reason is the advantages of these active immunotherapies." #ACImmune #ActiveImmunotherapy #AlzheimersVaccine #ABetavaccine #Neurodegeneration #VaccineDevelopment #CNS #Alzheimers #Parkinsons acimmune.com Download the transcript here

Duration:00:20:25

Treating Aging-Related Illnesses with Allogeneic Medicinal Signaling Cells with Wael Hashad Longeveron

2/13/2024
Wael Hashad, Chief Executive Officer of Longeveron, is focused on developing cell therapy for aging-related conditions such as aging frailty, dementia, and Alzheimer's disease. Using mesenchymal stem cells, also known as medicinal signaling cells, obtained from healthy donors 18-45, Longeveron is seeing promising results in clinical trials with improvements in brain volume and cognitive function. This approach is also being explored in the pursuit of a treatment for hypoplastic left heart syndrome, a rare congenital heart disease. Wael explains, "We believe there is a huge unmet need for bringing safe and effective products to try to slow the progression of the disease, improve the quality of life, and reduce the burden on the caregivers of such a disease. As for the aging frailty in general, as you know, with aging, there are a lot of things that affect the vascular system, muscle wasting, and all of those things that affect the quality of life during the aging years of an individual. Anything we can impact to improve the quality of life and the ability to lead a normal life in the aging years is definitely one of our goals." "Lomecel-B was initially licensed from the University of Miami to Longeveron. It is mesenchymal stem cells. As I said, we get GMP-grade donations of bone marrow from healthy adults and volunteers aged 18 to 45. Then we take this donation, harvest them in our facility in Miami, grow the cells, and then do all the required testing and release criteria to ensure safety. It is allogeneic, meaning that it is off the shelf, that any patient can take these cells. It is not autologous cells. It is allogeneic cells, giving it a much broader application. We are able to produce enough quantities from each donation to support these patients with aging frailty, Alzheimer's, or dementia." #Longeveron #CellTherapy #Aging #MedicinalSignalingCells #MSC #AlzheimersDisease #Dementia #AgingFrailty #RareDisease longeveron.com Download the transcript here

Duration:00:20:55