Empowered Patient Podcast

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  

John Mulcahy, President and CEO of SiteOne Therapeutics, is developing new therapies to treat hypersensitivity disorders.  Their approach focuses on targeting specific voltage-gated sodium channels. Their drug candidates are designed to treat acute pain, as well as hypersensitivity developed as a result of chronic pain. They have recently received an NIH HEAL grant to explore their drug candidate that targets one subtype of the sodium channel as a non-opioid therapeutic potential for treating different pain conditions. John explains, "At SiteOne, we're focused on a family of targets known as the voltage-gated sodium ion channels. These are proteins, ion channels, that are involved in transmitting pain signals from the site of an injury, like earlier we said, the skin or a joint, to the central nervous system, so to your spinal cord, to your brain. At SiteOne, we're basically focused on drugs that potentially dampen those signals. It kind of tunes down that pain signal before it ever reaches the central nervous system. So it's a very different approach compared to either the NSAIDs or the opioids." "We're very excited to partner with NIH and the National Institute on Drug Abuse on this program. A little bit of background on the HEAL Initiative. So HEAL stands for Helping End Addiction Long-term, and it's a major federal initiative with multiple agencies involved. The goal is to aggressively advance scientific solutions to the opioid crisis." #SiteOneTherapeutics #OpioidCrisis #Opioids #NonOpioidMedications #Pain #PainManagement #HEALInitiative siteonetherapeutics.com  Download the transcript here

Dr. Ahmed Hamdy, CEO and Co-Founder of Vincerx, is focused on targeting a specific antigen found on cancer cells. With a unique enzyme, it is effective with solid tumors and hematological malignancies, releasing a kinesin spindle protein inhibitor that inhibits the division of cancer cells. Their first bioconjugate VIP236 targets a specific molecule expressed on several metastatic tumors. Ahmed explains, "At Vincerx, we have a very exciting pipeline that's designed to solve a lot of problems with the current treatments for cancer therapies. In today's world, cancer continues growing exponentially. And thankfully, there are a lot of treatments out there for different types of cancer. Yet, the current treatments come with quite a bit of morbidities. Throughout my career, the morbidity of medicine has been something that I've always been concerned about, especially for patients and their caregivers. At Vincerx, we have very exciting, unique types of treatments that can be paradigm-shifting from a safety perspective and efficacy perspective." "For solid tumors, we have a compound that's currently in dose escalation phase 1 trial that is designed for advanced metastatic tumors, where we target a specific antigen that is found on the cancer cells themselves. And with a unique enzyme, it cleaves what we're describing as a warhead or the substance that can kill the cancer cell, which is an optimized camptothecin. And the word optimize means it's a well-known topoisomerase inhibitor designed to allow for very rapid permeability or intake by the cancer cell, with very low pumping out." #VincerxPharma #VIP236 #VIP943 #ADCs #Bioconjugates #Cancer #SolidTumors #Biotech #PrecisionMedicine Vincerx.com Download the transcript here

Nasha Fitter, CEO and Co-Founder of the FOXG1 Research Foundation and Vice President of Rare and Neurological Diseases at Ciitizen. Nasha describes the characteristics of the ultra-rare disease FOXG1 Syndrome and the global network that has been built to gain a better understanding of this neurological condition. Using real-world evidence, machine learning, AI, and genetic testing are showing a path to finding a treatment.  Nasha explains, "My daughter, Amara, was diagnosed at nine months of age. She began having hundreds of seizures a day. And at that point, there was information known about the FOXG1 gene. It's a really important gene for brain development. But no one was studying the syndrome and how to find a cure for it. So, I and a group of other parents, like-minded parents who, refused to just take that this is the way it is. Our children have this condition, and that's it. We started this foundation." "We've done a lot of work to get the entire world of FOXG1 to work together and then to collect patient data. That leads to my work at Ciitizen, to have all patients join the same platform, take the same surveys, and collect electronic medical records. We extract their data, so it's all on one platform. Again, that helps us understand this disease, which is critical when the population's so small." "In-person studies, which is how we collect data today, as the medical community, don't work for ultra-rare diseases. So we have to find other ways. And that's where real-world evidence comes in."  "We use machine learning and AI at Ciitizen when we're looking at something as simple as extracting data from an unstructured medical record. When you look in medical records, the part that's really interesting is the clinic notes, and they're totally unstructured. They're paragraphs. So can we start using machine learning and AI to go through these paragraphs and actually extract relevant data points to scale up our ability to understand how the disease has progressed?" #FOXG1 #FOXG1ResearchFoundation #Ciitizen #GeneTherapy #RealWorldEvidence #RareDisease #GeneticTesting FOXG1Research.org Ciitizen.com Download the transcript here

David Dodd is Chairman, President, and CEO of GeoVax, which is working on vaccines that overcome restrictions of mRNA vaccines to provide longer-term, more robust protection, particularly for people who do not respond well to primary antibody stimulation. There is a strong response from T cells from this vaccine which can be stored in a non-refrigerated freeze-dried form allowing for greater access in more regions of the world. David explains, "We are targeting those individuals who have compromised immune systems. This is a category of approximately 15 million individuals in the United States and almost 250 million worldwide, who, as a result of the conditions of their body or maybe even the therapies they may be on, or other conditions. Their body does not respond appropriately or well to the existing approved vaccines for COVID-19 or to the monoclonal antibodies. It's not that the other products have no value - it's that the individuals' bodies have been depleted of the ability to mount the proper response." "We also include what is known as the nucleocapsid protein, which is highly conserved across viruses. It's always there, and it induces a very strong T cell response which drives memory in vaccines or in the human body from an immune standpoint. So, it is memory durability and also that it enables people whose bodies may have been depleted in order to mount an antibody response. They now can rely upon their T cells system or their cellular immune system to give them a protective element to reduce the severity, hospitalization, and risk of death." #GeoVax #Vaccines #VaccineFatigue #Biodefense #COVID #VaccineAccess #VaccinePreparedness #TCells GeoVax.com Download the transcript here

Chris Hoyt, CEO of KeifeRx,  talks about the oral medication being developed that uses tyrosine kinase inhibitors (TKIs) and autophagy to remove unwanted proteins.  Research done by Georgetown University on leukemia, led by Dr. Charbel Moussa, found that lower doses of drugs like nilotinib and bosutinib could cross the blood-brain barrier and remove toxic proteins on an intracellular basis.  This research has been used to develop treatments for neurodegenerative conditions with promising results in reducing cognitive decline. Chris explains, "Essentially, the way TKIs work in the body, and particularly in the case of the neurodegenerative conditions that we're using them to treat at KeifeRx, is they trigger a mechanism called autophagy, which essentially is the cell's garbage disposal mechanism. What we're doing with TKIs is using that mechanism to remove toxic proteins. TKIs have mostly been used historically in cancer, and particularly in leukemia. The classic use would be in cancer to try to remove as much of the tumors as you can in leukemia. In that environment, use a fairly high dose of TKIs to trigger that effect. What KeifeRx has done through work at Georgetown University is find ways to utilize that same mechanism of action in the brain." "So over the course of a few years of initial work, we came to the conclusion that these drugs, in the case of specifically nilotinib and bosutinib, which are the two drugs where we have the use patent in neurodegeneration, that at much lower doses than what you see in cancer, these drugs can cross the blood-brain barrier and look to remove toxic proteins on an intracellular basis. So, it was a classic hunch, for lack of a better term, that Dr. Moussa had that he then carried out rigorous work over three years to first prove in animal models and then eventually through a series of small phase I and phase II trials at Georgetown."  @KeifeRx_Thera #KeifeRx #Alzheimers #TKI #Autophagy #ALS #LewyBodyDementia KeifeRx.com Download the transcript here