Empowered Patient Podcast

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  

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

Hari Mix, Founder and CEO of Calorify, is a former elite endurance athlete dedicated to revolutionizing metabolic health. He discusses the significant gap in accurately measuring calorie intake and expenditure, critiquing traditional methods as insufficient. With the introduction of an innovative at-home testing kit, he emphasizes personalized metabolic assessment for everyone from casual dieters to athletes. Hari also shares his journey from athlete to entrepreneur, aiming to empower individuals and medical professionals with accessible, accurate metabolism measurements.

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

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

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

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

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

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

Joe Tucker, CEO of Enveric Biosciences, discusses the use of neuroplastogen therapies for the treatment of neuropsychiatric disorders, including depression, anxiety, and post-traumatic stress disorder. Enveric has developed the Psybrary, a portfolio of compounds inspired by psilocybin that bind to the serotonin receptor in the brain and induce neuroplasticity without the hallucinations. The lead candidate EB-003 is intended to be administered orally and taken regularly as a maintenance therapy. Joe explains, "This whole neuroplastogen space was recently discovered, and it was discovered through academic research that we're looking at the effects of these agents we call psychedelics, psilocybin being the active ingredient in magic mushrooms and a very well-known psychedelic agent. It was in looking at psilocybin and other molecules known to be psychedelic agents like ayahuasca and LSD and others that scientists realized that what's going on is you're activating a particular receptor in the brain - something called the serotonin 5-HT2A receptor. So, at Enveric we thought this was a great opportunity because of some of the early work that others had done in using the actual magic mushroom." "This is a whole new area of research and science. It is not known what shape of a molecule will induce a hallucination versus not inducing hallucination, for example, and what shape will strongly induce the neuroplasticity that we're looking for so that the brain can essentially be repaired versus not induce it. So, we had to develop our own internal artificial intelligence tool that was trained by the other molecules that had been designed previously or were naturally occurring. Then, we continued to train it as we made our thousand molecules and got our AI operating more and more intelligent."  #Enveric #Psilocybin #Hallucinogenic #MentalHealth #NeuroplastogenTherapies #NeuropsychiatricDisorders #PTSD #PostTraumaticStressDisorder enveric.com Download the transcript here