Empowered Patient Podcast

James McCullough, CEO of Renalytix, is focused on preventive care for those most likely to get chronic kidney disease. Diagnostics and risk assessment of patients earlier in the disease cycle emphasize maintaining kidney health rather than managing complications from late-stage kidney disease and kidney failure. Using a machine-learning algorithm to look at blood-based biomarkers and EMR data, the KidneyIntelX system provides the clinician with a risk score and guidelines for treatment. James elaborates, "There are five stages of kidney disease. We're focused on the early stages, so stages 1 through 3, before the majority of damage is done to the kidney. When you have therapeutic intervention, lifestyle intervention, you get specialist involvement, you have a pretty good shot at slowing or stopping the progression of the disease into the later stages, stages 4 and 5, where your options start to become limited." "With KidneyIntelX now, for the first time, we can start to see risk assessment taking place at the front end of the chronic disease with the primary care doctor. If you score high by KidneyIntelX, you are roughly 20 times more likely to experience significant kidney function decline over the next five years versus if you score low by KidneyIntelX. The stratification, for the first time, becomes a very powerful tool that we can implement very simply at the primary care level, where most people with early-stage kidney disease and diabetes are being seen." "This is an advanced prognosis. Prognosis is the key to controlling chronic disease, especially widespread chronic disease because you can't treat everybody. We know that probably close to half the people with kidney disease and diabetes aren't progressing over the next few years. The real question becomes because there are so many people with diabetes and kidney disease. and healthcare resources are limited, who do you treat? Who should you be concerned about now to be able to give drug treatments, specialist referrals, and significant lifestyle modifications?" @Renalytix #KidneyDisease #KidneyHealth #DIgitalHealth #AI #MachineLearning #Diagnostics  renalytix.com Download the transcript here

Yarone Goren, Co-Founder and COO of SteadyMD powers telehealth for providers by providing the clinician workforce licensed in the states where the patients are located.  Supported by behind-the-scenes clinical operations and patient interface, clinicians can give virtual care in addition to performing their traditional roles. With the growth in the demand for telemedicine, this solution provides a path for clinicians and digital health companies to meet the needs of patients for primary and disease-specific care and to manage chronic conditions on demand. Yarone explains, "What we do for a lot of our customers is provide the clinician workforce, the doctors, the nurses, the therapists, licensed, kind of a crazy Venn diagram of licensure across all the states where they need it. We do clinical operations, meaning we work closely with clinicians to schedule them to ensure that they appear for their scheduled shifts, train them on all the technology they need to use, and ensure that they meet all the clinical quality measures and SLAs." "Then the last piece is product and technology. Someone needs to provide the interfaces for the patients to sign up, to fill out their intake form, see their patient portal, and to schedule a follow-up appointment. We do a lot of that. We also do a lot of the product and tech for the clinicians, making it easy for them to do their job and efficiently handle visits across a handful of programs and modalities in all the states where they're licensed." "The challenge is to bring our expertise to the fore, support them in the way they need, and also help influence their product plans, product roadmap, and strategic thinking about this stuff. And it's definitely tricky to navigate. We also have a lot of customers. We do a lot of work in online urgent care, in condition-specific care, in online primary care, in lab ordering, lab order review and approval, and in online therapy as well. There are little differences in texture in all of those, but it's probably split pretty evenly. Folks come to us to design, build, and launch something from scratch, and then there are those who come to us and want help scaling and expanding." #Telehealth #DigitalHealth #Healthcare #VirtualHealth #VirtualCare #HealthcareInnovation #PoweringTelehealth  steadymd.com Download the transcript here

Dr. Tariq Arshad is the Senior Vice President and Chief Medical Officer at Qualigen Therapeutics, addressing multiple types of RAS-driven cancers. While researchers understand RAS's role in tumorgenesis and have identified which cancers are RAS-driven, RAS has been considered an undruggable target. With a pan-RAS approach inhibiting KRAS, HRAS and NRAS, the three isoforms of RAS, Qualigen is identifying drug candidates showing strong anti-tumor efficacy.    Tariq elaborates, "That was so difficult to do because when you look at the KRAS protein itself, it's a complicated, three-dimensional structure that constantly changes. The opening, or the aperture, where a small molecule can attach and inhibit the G12C moiety or specifically the cysteine amino acid, which is targeted by these inhibitors, it appears for a very, very short period of time. It's nothing short of a miracle of bioengineering, and specifically medicinal chemistry that we've been able to identify these inhibitors that can target that subcomponent, that very small aperture within the overall KRAS protein, without, as you're saying, impacting the function of the overall protein." "The field is moving towards understanding why this lack of durability exists and is trying to understand whether it's due to the emergence of other mutations, whether it's due to the emergence of wild-type RAS, or whether it's due to other factors. One of the theories that is emerging behind the emergence of this KRAS resistance is the fact that there are other RAS isoforms that exist in the same tumor. They allow a mechanism in which the tumorigenesis can bypass KRAS, even though it's inhibited, and signal into the cell to convert it into a cancer cell. It now becomes important for us to understand how we can address that potential mechanism of resistance." #QualigenInc #RAS #KRAS #RASDrivenCancer #Cancer  QualigenInc.com Download the transcript here

Patty Hayward, General Manager, Healthcare and Life Sciences at Talkdesk, is addressing staff burnout due to the increased demand for patient support and rising patient expectations to get questions answered, appointments scheduled, and issues resolved.  Through AI, chatbots, and automation of basic tasks, staff can spend more time with patients to address complex problems. While some patients still like to talk to a live person on the phone, the use of technology allows for real-time responses to many concerns through a patient portal or contact center that has access to patient EMR including history and current medical condition. Patty explains, "People come into healthcare specifically because they want to help people. Healthcare is very personal, and so when you don't have the time and space and resources often to deliver that empathetic experience to really help people, that can lead to a real high level of burnout feeling, a lot of frustration, and you're not having that job satisfaction that you got into healthcare for." "Everyone can use Amazon. You can do the same thing here with certain aspects that are simple. So it's a matter of those low-hanging fruit, those things that are easy, getting people used to that, getting them used to being able to go to that as a first step as opposed to the phone and calling someone first." "But then also, okay, if they want to go voice, let's create chatbots that are on the phone that are voice virtual agents that allow us to have a conversation on the phone. Because sometimes it doesn't matter how many times you push people toward the computer, a lot of people are still going to call you."  @Talkdesk #Talkdesk #EmployeeBurnout #PatientJourney #ContactCenter #PatientPortal #DigitalHealth #HealthcareIT #PatientExperience #HealthcareInnovation #Healthcare #AI talkdesk.com Download the transcript here

James Graham is the CEO of Recce Pharmaceuticals, a biotechnology company focused on the global antibiotic-resistant patient population. This new class of synthetic antibiotics takes a broad-spectrum approach to kill bacterial infections, which continue to mutate, rendering existing antibiotics ineffective.  The founding inventor of Recce is Dr. Graham Melrose, the grandfather of James, who has grown this idea into one of the top-performing biotech stocks in Australia. James explains, "As you may know, by my accent, I’m an Australian. I think Australia found the first penicillin, which worked well for everyone around the world for a number of years. But it’s time for a new penicillin, penicillin 2.0, or one entirely synthetic, not reliant on existing natural processes. And that’s what we’ve fundamentally started with, beginning with the end in mind that is Recce antibiotics. So I really say the challenge, the silent pandemic is right upon us. You only have to look at the AMR resistance rates. I think raising at about 10% each year, certainly in certain antibiotic or indication groups. If we don’t do something, we’re just going to have these useless drugs that no one will pay the price for anyway. The business model will be broken, and everybody will be out of options. It’s really the pandemic before us." "I hinted that R327 is synthetic. It’s entirely synthetic when all existing antibiotics to date are naturally derived. So the way antibiotics and bacteria have always worked is that you find something in nature by way of the antibiotic. The bacteria are too smart. They evolve too quickly, and let’s begin with the end in mind and create something that will work against all types of bacteria, gram-positive gram-negative in their hypercellular mutated forms, and keep on working with repeated use." "And in the case of my origins with Recce, the inventor, Dr. Graham Melrose, is actually my grandfather. He turned 90 years old about a little over a month ago, and he's the guy who was the head of Johnson & Johnson Australasia for about a decade. He is the foundational inventor of this compound. And he and I started this company. He's the inventor. I just gave him a bit of money, and off we went. That's the easy part. He started identifying the ideal compound in his garage in Perth in Western Australia. If anyone knows where that is, it's actually the most isolated city in the world."  @ReccePharma #AntimicrobialResistance #AMR #SuperBugs #Sepsis #UTIs #Urosepsis #SyntheticAntiInfective #Antibiotics #AustraliaBioTech recce.com.au  Download the transcript here 

Jennifer Jones-McMeans, Divisional Vice President of Global Clinical Affairs at Abbott, discusses Abbot's new diversity initiative to help address mistrust and societal barriers that underrepresented populations face in receiving healthcare and participating in clinical trials. Through partnerships, clinical research coordinators from diverse backgrounds working in smaller institutions are trained to work with these populations. Norton Health with the Institute for Health Equity is putting funding and infrastructure in place to build a research program model for historically Black colleges and universities to attract more diverse participation in trials and build more vital research institutions.      Jennifer explains, "I had a good conversation with a physician today from the New York area, and we talked about one barrier that is translation. We discussed that the clinical trial this individual is working on did not have the resources for translation services. And so, if you think about something as simple as that, it means that patients who are non-English speaking, their family members, and researchers cannot even approach them because they may not have the translated material. That's one very simple barrier. We can go back to also time - patient time is critical. If you think about individuals who are working and who have family obligations, how do we actually reduce the barrier of time?" "Well, this is where when we think about race and ethnicity, race is not biologic. Remember, it's a social construct. Ethnicity is a social construct. Yes, if you look geographically, we're 99.9% similar when it comes to human genomes. Who I am as an African-American female, I may have far more genetic similarities to someone who is not of African descent. We first have to dispel that. Yes, there can be genetic elements. We do know that geographically you may see a higher frequency of certain genetic associations and whatnot. But I think it becomes less about this because genetics and race are not biologic."   "When you think about who do I need to include? You have to bring in this whole concept of social determinants of health, or also concepts where people, cultures, groups, individuals are impressed not only by the biology but what their surroundings are."   #Abbott #ClinicalTrials #DiversityinClinicalTrials #DiversityResearch #Healthcare #SDOH #SocialDeterminantsofHealth  Abbott.com Download the transcript here

Que Dallara, Executive Vice President and President of the Diabetes Operating Unit at Medtronic, is enthusiastic about the MiniMed 780G system, a recently FDA approved solution for people with type 1 diabetes. This system has a continuous glucose monitor, insulin pump, and mobile app that connects with CareLink, which allows the physician and family members to follow the patient as well.  This automated insulin delivery eliminates the need to count carbs and calibrates to each individual's eating habits for more accurate dosing.  Que explains, "It's the first of its kind that has automated adjustments and corrections to insulin delivery without needing the patient to do anything. The existing systems on the market have automated basal delivery, which helps to some degree, but we've introduced this concept of meal detection technology. It can figure out that you're having a meal. For example, if you're undercounting your carbs, it can notice that you're actually having a meal and then provide order corrections so that you don't go too high. It can do that in a safe way without increasing the risk of hypoglycemia." "So it's very difficult with a CGM alone and with just the patient to make all these decisions throughout the day. What the MiniMed 780G does is automates all of that. There's a CGM, and with the specific algorithm that we have on the 780G. It knows when you're going low, when you're going high, how much insulin on board, the rate of change of all of this, when you might have under-counted carbs, when you may have missed a bolus. And it helps you make the decision automatically. You don't have to be involved. It's truly a hands-off system." @Medtronic #MiniMed780G #Diabetes #Type1Diabete #TypeOneDiabetes #CGM #ContinuousGlucoseMonitoring #MealDetection  medtronicdiabetes.com Download the transcript here

Joe Todisco, CEO of CorMedix, is developing a product that has broad spectrum activity against bacteria and fungus to impact the safety of receiving hemodialysis through a central venous catheter. With the recent acceptance by the FDA of the submission for DefenCath, CorMedix is hopeful of obtaining FDA approval for this therapeutic to prevent bloodstream infections. Since the active ingredient is not an antibiotic, the drug does not further the problem of antibiotic resistance. Joe explains, "The lead indication for the product is for the reduction in risk associated with catheter-related bloodstream infections in hemodialysis patients undergoing hemodialysis with a central venous catheter, CVC. Catheter-related bloodstream infections, or CRBSIs, are one of the most severe adverse consequences associated with getting hemodialysis through a CVC. The incidence rate in the general population is about 25% to 33%, and they can be fatal up to 25% of the time. So it's a critical unmet medical need. There is no current FDA approved therapeutic for the prevention of bloodstream infection in this patient population or any population, and we're hopeful to obtain FDA approval as a first-in-class therapy." "DefenCath is what's called a catheter lock solution. As I said, it's investigational. It has not received FDA approval yet. But it is designed to sit in the catheter between dialysis sessions or times that a catheter is accessed. We're pursuing our initial approval for the hemodialysis patient population. Still, the hope is to expand the label post-approval into some other therapeutic areas where patients have high levels of infection and high rates of catheterization. But the product sits in the catheter in between dialysis sessions. It's a combination of heparin, which is an anticoagulant, and our proprietary molecule, Taurolidine. Taurolidine is a molecule with the unique properties of being a non-antibiotic antimicrobial with broad-spectrum activity." #CorMedix #CRBSI #CLABSI #Dialysis #Infections #BloodstreamInfections #HealthcareInnovation cormedix.com Download the transcript here

Jeff Hackman, CEO of Comera Life Sciences, recognizes the need to find a more efficient, patient-friendly solution for receiving biologics rather than being administered by IV therapy. Using the SQore platform, a proprietary technology, Comera is reformulating IV biologics to Sub-Q utilizing small molecule chemistry and an understanding of excipients. Seven out of ten global medicines are biologics, and most are administered by IV, providing a tremendous opportunity to expand access to biologics using Sub-Q technology. Jeff elaborates, "Our mission is to transform these biologic therapies into a different form, a subcutaneous form. That form takes on the ability of these patients to administer these medicines for themselves, at home, at school, and at work. So really, what the summary of this mission is, through the freedom of self-injectable care, we hope that these patients can live a life without the burden of this therapy and the ability to be able to make their lives more livable." "Excipients have been around for decades. They often fail to reduce the viscosity necessary to get these high-potency biologics into these small spaces, these small syringes, as you said. Our technology, which is called the SQore platform, allows this to happen more often, and it's such a significant impact that we have had multiple partnerships and collaborations with large pharma over the years to work with them to be able to do this." "The issue you have around the science and the platform is that by taking and putting large molecules like this and these biologics into small spaces that are very potent, these biologics and antibodies stick together. So what our technology does is it's viscosity-reducing. That viscosity, you can think about it as when you put these biologics into a small syringe, they almost look like oil or glue." "The ability to be able to stabilize these and to be able to get them to flow around each other and to be injected at these high potency levels is what our SQore platform does." #ComeraLifeSciences #Biologics #IVInfusion #Subcutaneous #SubQ #Immunotherapy #SQore #Excipients Comeralifesciences.com Download the transcript here

Allison Jacob, Senior Medical Director at Adaptive Biotechnologies, uses their technology to decode the genetic language of the immune system and develop clinical diagnostics and therapeutics for hematologic malignancies. With a focus on the adaptive immune system and the receptors of B and T cells, the platform is used to identify, monitor and precisely quantify tumor cells over time. In the past, MRD stood for minimal residual disease, but due to more accurate testing, the goal now is measurable residual disease, MRD, negativity. Allison explains, "The clonoSEQ technology essentially looks at rearrangements in the DNA of proteins that are expressed on B cells, and we're harnessing something that the immune system created for us. So, unlike other genes that we talk about in cancer, let's say like BRCA1, where you have a normal version of that and a mutated version of that, B-cell receptors are constantly having to shuffle and create new gDNA sequences, again, to be able to recognize these foreign invaders." "What that means is that within this very small region of DNA, let's say 150 to 200 base pairs, there's a diversity upwards of 10-12. So, when we talk about clonoSEQ as a clinical diagnostic, what that means is that these sequences are unique and are expressed by that tumor cell and its progeny and can be used essentially as a barcode to track and quantify that tumor over time." "I think one of the most important aspects we spoke to a little bit ago is having a deeper understanding of how and if the patient is responding to therapy. So even if a patient is in a complete response, we know that if they're MRD positive, they have a higher likelihood of relapse. So, identifying patients with the best prognosis, complete response, and MRD negative can be very helpful in understanding what's coming." #AdaptiveBiotechnologies #PrecisionDiagnostics #PatientEmpowerment #MRD #Myeloma #clonoSEQ #Immunosequencing  AdaptiveBiotech.com  Download the transcript here