Empowered Patient Podcast

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

Alicia Staley is the VP of Patient Engagement at Medidata and working to bring more technology and software solutions to clinical research. With a focus on creating patient-centric clinical trials, Alicia emphasizes the value of digital tools to drive diversity of participation and retention. As a cancer survivor and patient advocate, Alicia has deep insights into how clinical trials are run and who participates. Alicia explains, "I think the entire industry is still responding to what life looks like post-COVID. However, in particular, in clinical research, this gravitation toward more digital tools to support clinical research is still very much at the forefront. Topics like decentralized clinical trials and patient portals, patient registries, and ways to support the patient through the clinical journey using digital tools, sensors, and wearables are very much at the forefront of the conversations we're having today. Clearly there is an interest in going in that direction. And I think we learned during the pandemic that these tools are great resources for expanding the potential participation in clinical research to essentially a broader audience of participants." "It took the pandemic for the industry to realize that these tools are valuable resources. I think there had been historically quite a bit of hesitancy to embrace technical solutions like eConsent, eCOA, ePRO, or any of the eSource tools. And I think the pandemic made us realize that these tools are here, they're here to stay, and they work very, very well. But our hand was never forced in the way it was during the pandemic." #Medidata #DecentralizedTrials #Diversity #ClinicalTrials #LifeSciences #PatientExperience Medidata.com Download the transcript here

Dr. Holly Urban, the Vice President of Clinical Product Design at CliniComp, understands the need for a positive user experience for clinicians to use electronic health record software effectively. Clinician burnout is often blamed on the documentation burden and the time it takes to enter patient data. With a shift to a focus on the quality of the notes rather than the length, CliniComp is designing systems that aid in medical decisions and is considering ways to use natural language processing and generative AI to change how notes are created. Holly explains, "One of the challenges is that today's electronic health records, in my view, are very transactional focused. They allow you to place an order. A physician can write an order to have medications given to a patient, they can write a note where they document what happened in a patient visit or the results of a procedure, and they can get lab results." "But it's very transactional. We haven't yet achieved that ideal state where the electronic health record is helping the providers and other clinicians make decisions. A lot of the struggle has been around workflows that aren't supporting what they need to do and not getting to that third rail of advanced clinical decision support to help providers make better decisions based on their electronic health records." #CliniComp #EHR #ElectronicHealthRecords #EHRSoftware #ClinicianBurnout #HealthcareTech #HealthcareTechnology #HealthInnovation clinicomp.com Download the transcript here

Ashley Perry, Chief Strategy and Solutions Officer at Socially Determined, highlights the problems created by the Medicaid redetermination process. Building on their SocialScape social risk intelligence platform, Socially Determined is providing a new risk score that will help state Medicaid agencies and Managed Care Organizations identify and prioritize members needing help navigating the redetermination. Ashley explains, "As many of your listeners will know, on April 1st of this year, we started redetermining eligibility for the 95 million Medicaid beneficiaries nationwide. And that's a year-long process during which we expect that up to 15 million of them may be disenrolled from the program. So far, we've seen that as of June 16th, we've had about 1.3 million Medicaid beneficiaries nationwide disenrolled across the 22 states that have reported data to date." "What's notable about that, though, is on average across those 22 states, 74% of those who've been disenrolled have been disenrolled for procedural reasons. This means one of two things: either number one, they did not return the paperwork period, or number two they did, but they did not include some of the required documentation. So overall, a very high percentage of those who've been disenrolled to date are not necessarily no longer eligible for the program but have not been able to navigate that recertification process on their own." "We've done that for the entire United States community level across a number of different domains, so things like the food landscape and the housing environment. We've also done it for hundreds of millions of Americans at the individual level for similar domains. And so all of that data and insights around the SDOH and social risk factors that influence healthcare utilization costs, outcomes and equity was built into our social state platform. We've been working with organizations to use that data to inform their strategies for years." @SocDetermined #SDOH #SocialDeterminantsofHealth #Redetermination #Medicaid #MCO #HealthEquity #SocialRisk #DataAnalytics SociallyDetermined.com Download the transcript here

Lauralea Tanner, Chief Growth Officer at Acclara, describes the revenue cycle management critical decision points for hospitals, health systems, payers, and patients. In the hospital setting, there are lab tests, radiology, anesthesiology, surgeons, and other clinicians, all providing services that require proper coding and billing for collection. With many opportunities for errors and patient confusion, call center technology to handle questions, AI to address mundane coding tasks, and other technologies allow the professionals to take complex patient questions. Lauralea explains, "So revenue cycle management really starts when the hospital or health system engages with the patient. So it starts with that patient intake process, or what we call patient registration or scheduling process, and then when they present at the hospital or the doctor's office for services." "At that point, then it falls into clinical care. The patient is seen, and they're treated. After the patient leaves, that is really where the hefty part of revenue cycle management kicks in. You have doctors that have to document charges. They have to dictate what they've done to treat the patient. They have to get all of that clinical documentation in place before it goes to coding, then to billing and collections." "A lot is still paper-based. The submission of claims, the follow-up, even the remittance advice that the hospital gets back from the payers is largely electronic. But you still have some of these smaller payers that do send paper, and it is very much a challenge to try to deal with that." #Acclara #DigitalHealth #HealthcareReform #HealthTech #RevenueCycleManagement #RCM Acclara.com Download the transcript here

Maya Ber Lerner, Co-Founder and CEO of Chiefy, is focused on the complications and waste involved in the workflow related to surgery and the operating room. Realizing the root of the problem is communication between all participants in an operation, Chiefy is applying technology and AI to improve communication for these cross-functional teams. While collaboration tools have become well-accepted in other industries, the hospital environment has been slow to take advantage of these tools to benefit all stakeholders, including the patient. Maya explains, "The most important thing about our approach, and it just happened naturally, is that we focus on the surgeons and the nurses and the anesthesia teams and the other stakeholders, and we build a solution that would add value to them personally. And that was the first question I asked because my background is in team collaboration for software development and cloud infrastructure. It sounds completely out there and not related to what I do today. Still, it's a similar problem of cross-functional teams trying to collaborate and do iterative tasks together." "I believe this approach brings something radically different from looking at the same problem that I just talked about and saying, "Oh, we have a problem of waste in this surgical workflow, so we need better software to document all the supplies we're using." It's more about how you give people work tools that they can use in their own workflow, which would create, as a side effect, benefits in efficiency, quality, and patient safety." "The first thing we've been able to immediately show is a statistically significant reduction of 35% in last-minute requests. And these are things like miscommunications about the patient's position, trays being used in the operating room, equipment that should not have been open and was open, and things like that." #Chiefy #SurgerySuccess #OperatingRoom #OR #ORTeam #SurgicalTeam #PatientSafetyFirst #SurgicalInnovation #SafeSurgery #TeamworkinMedicine #ClinicalWorkflow #AI chiefyteam.com Download the transcript here