Empowered Patient Podcast

Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics, is dedicated to addressing unmet needs in breast cancer prevention and treatment. Dense breasts are a significant risk factor for breast cancer, and Atossa's lead drug candidate has shown effectiveness in reducing breast density and lowering the risk of cancer. This dual-action drug blocks estrogen receptor signaling and induces programmed cell death in cancer cells, potentially offering a more effective and more tolerable treatment option. Steven explains, "So we are very focused on breast cancer to the point that Princess of Atossa, the company is named after, was the first woman in recorded history with breast cancer about four 50 BC. She was the wife of Darius the Great, who had the Persian Empire, the largest piece of real estate before the Roman Empire. And she had a breast lesion. It was documented that her slave cauterized it with a hot poker from the fire. We didn't get a follow-up from that, but anyway, we are dedicated to all the women, including her, and since then, who have been dealing with breast cancer."  "So it's a very interesting molecule. We call it a Janus molecule. Janus is the two-faced goddess. In this case, it is two-faced in a positive fashion because she addresses two different ways that cancer cells control themselves to drive the growth. Its major activity is to block estrogen binding to the estrogen receptor. So, as I said at the beginning, if 75% of all breast cancers are driven by estrogen, our drug is going to really nail 75% of all breast cancers. But then it gets even more exciting because it also has a second activity in another pathway in cancer driving called PKC beta."  #AtossaTherapeutics #BreastCancer #Cancer #DenseBreasts #Estrogen atossatherapeutics.com Download the transcript here

Dr. Alex Meves, distinguished dermatologist at the Mayo Clinic and a spokesperson for SkylineDx, discusses the challenges in diagnosing and treating melanoma and how a new molecular test called Merlin can help improve risk stratification and treatment decisions for patients with early-stage melanoma. Diagnosis and treatment have traditionally used tumor thickness as a primary risk factor. This molecular test measures the expression of genes in the tumor biopsy and can help determine the extent of surgery needed and whether additional therapies may be beneficial. Alex explains, "My department, when I started to work here at Mayo, wanted me to do some translational research, and I had just come back from a postdoc in Germany, at the Max Planck Institute, and I was tasked to get some research going. And so I focused on melanoma because I thought at the time there wasn't a lot of molecular research going on in melanoma that could be translated to patients. And so we started to develop biomarkers, sort of molecular tests that we could apply to tissue, and then help patients with." "Yes, so the problem that our research is focused on is what to do once you're diagnosed with a melanoma. What you want to do is to match the right therapy to the right patient. That's the goal. There are lots of melanomas that might not be very aggressive, and you don't have to do a lot of treatment. And then there's some melanoma that's very aggressive, and you want to do lots of treatment, but it's not always obvious which melanoma is low risk and which melanoma is high risk. And so this idea of risk stratification at diagnosis becomes very important to match therapy to patients." #skincancer #melanoma #SkylineDx #PersonalizedMedicine #PrecisionDiagnostics skylinedx.com Download the transcript here

Elaina McMillan, a director of product marketing at Edifecs,  describes the challenges and opportunities around healthcare data interoperability with a focus on prior authorization. Standardizing prior authorization workflows and data submissions across payers is a major focus to reduce delays and errors. Ensuring data security and patient consent are critical concerns, especially for smaller payers with limited resources to comply with mandates.  Elaina explains, "Primarily, what I work on and what Edifecs is most known for is our healthcare data interoperability platform, which includes EDI standards and the new-ish since 2020 FHIR standards. So we're really focused on that. How I would explain it is the data engine that helps payers get things done with quality data through the standardization of that. In addition, we have a whole set of what we call workflow solutions or applications that you can actually build on top of the data platform. So it helps to do things like claims correction, enrollment management, value-based payments, risk adjustment, prior authorization, and consent management."   "So the one that actually comes to mind for me right now, and largely that's because of the recent interoperability and prior authorization mandate, is the prior authorization workflow. A lot of providers don't like the workflow itself and the prior authorizations. What happens today generally is that providers are contracted with a lot of different payers. All of these payers have their own systems and processes through which the provider needs to submit. So one problem is that the providers are managing multiple different workflows, processes, platforms, and technologies." #HealthTech #Interoperability #HealthcareInnovation #PatientCare #PatientAccess #WomenInTech  #WhatIRun edifecs.com Download the transcript here

Anmy Mayfield, Vice President and Dean for the Western Governors University College of Nursing in the Michael O. Leavitt School of Health, discusses the university's mission to provide accessible, online nursing education to address the nursing workforce shortage and encourage a more diverse population of nurses. The ReNEW Fund, a collaborative initiative with Social Finance, provides zero-interest, forgivable loans to nursing students. This model appeals to a diverse student population, including working adults and career-changers, by offering flexibility and employment opportunities for graduates. Anmy explains, "The ReNEW Fund is a collaboration with Social Finance, another nonprofit organization. And we have a shared goal of tackling the nursing shortage that is estimated to be about 30,000 to 40,000 fewer RNs entering the field compared to what's open to RNs. And there are a lot of barriers that can keep someone from becoming a nurse. And one of those is the cost of nursing school."   "We want to make sure that we can help in one way to help mitigate that barrier to becoming a nurse. And so it's trying to fill these gaps by placing an equal investment in return on employers. Also students get zero-interest loans that are forgivable if a graduate completes their program and then works at one of these ReNEW employer partners for at least three years. So it's a pay-it-forward model." "One of the things that our program is focused on is ensuring that we're training a nurse workforce that is related or reflective of what the community looks like, because we've seen from research that patient outcomes are often improved when that happens. And so this means more men in nursing, different minority groups, etc., in nursing. We at WGU have seen a higher number of students who are first-generation, who are coming from the military, who are coming from underserved or underrepresented groups, and we're excited about that. And I think a lot of it has to do with our model. We offer our coursework online, and so a lot of times it's easier for our students to balance work and life."  #FutureOfNursing #ReNEWFund #UpskillingHealthcare #NursingWorkforce #PayItForwardEducation #WGUHealth wgu.edu Download the transcript here

Dr. Frank Bedu-Addo, President and CEO of PDS Biotechnology, focuses on the challenge of cancer recurrence and the development of a targeted immunotherapy approach using nanoparticle technology. Their lead immunotherapy candidate is designed to train the immune system to detect and attack microscopic or undetectable cancer cells, prolonging survival by preventing recurrence. Early clinical results in cervical, head and neck, and other HPV 16-positive cancers have been promising, showing sustained immune response leading to long-lasting T cell memory.  Frank explains, "Recurrence of cancer after treatment is actually one of the bigger hurdles we face in successfully treating cancer. So, PDS Biotechnology, as you know, we have a sharp focus on advancing our targeted immunotherapy platforms to address significant unmet needs in treating cancer. And this is actually one of those key unmet needs in cancer today. The prevailing hypothesis on knowledge is that cancer treatment, whether it's done using radiation therapy or anti-cancer drugs such as chemotherapy, both methods actually work by destroying cancer cells or halting the growth."   "And so what may happen with time is that these remaining cancer cells may then grow until they can be detected or begin to cause symptoms. Now, even if the cancer has been removed by surgery, there is still a risk that some tiny microscopic cancer cells could still remain in the body. We would therefore expect the ideal immunotherapy to be able to detect these tiny microscopic cancer cells, even if they have spread to other parts of the body."  #PDSBiotech #Cancer #CancerVaccines #ImmunoOncology #CancerRecurrence PDSbiotech.com Download the transcript here  

Paul Romness, Chairman, CEO, and President of OS Therapies, and Olivia Egge, a member of the Board of Directors of OS Therapies, discuss osteosarcoma, a rare and aggressive form of bone cancer that primarily affects teenagers. OS Therapies is developing an immunotherapy that utilizes a weakened form of the listeria bacteria to stimulate the immune system and prevent the spread of cancer cells to the lungs and brain. Olivia's experience as a patient has motivated her to advocate for better treatment options and join the board of OS Therapeutics. Paul explains, "So osteosarcoma is quite literally bone cancer. It happens in teenagers like Olivia, after the growth comes together in the long bones, and there's some sort of miscalculation, and a very aggressive and very deadly cancer develops from that of the growth. And as a result, the cancer can usually spread to the lungs and then the brain. And that's where it gets very, very deadly. And our approach is to stimulate the immune system with a weakened or attenuated listeria that fires up the immune system and goes and finds these little culprits, little micro metastases that have survived the chemo and radiation that these kids go through. It tries to destroy those little micro metastases before they land in the lungs and the brain." Olivia elaborates, "I talk to patients all the time. Actually, I was introduced to people who became close friends during my actual treatment, but today I still do physical therapy and I'm constantly meeting kids who are in the middle of treatment and some of them have relapse, some haven't, but so I'm constantly meeting new patients and it's just evident that we need better treatment options. I see how weak they are from chemo. They're all, especially with osteosarcoma, you usually have to have a joint replacement or amputation, and chemo just weakens you. So it makes it even harder to recover from that. And I mean, these treatments are just so old. And so for sure, seeing all of these patients going through active treatment just reinforces how badly we need new treatment options, especially treatment options like surgery and immunotherapy." #OSTherapies #Osteosarcoma #SolidTumors #Immunotherapy #ListeriaCancerImmunotherapy #ComparativeOncology #CanineOsteosarcoma ostherapies.com Download the transcript here

Dan Schmitt, President and CEO of Actuate Therapeutics, is developing a cancer therapy that inhibits GSK3β, a key enzyme that is hijacked in cancer cells to drive tumor growth. Inhibiting this enzyme can impact the cancer cells and stimulate an immune response against the tumor. Actuate selected metastatic pancreatic cancer as their first target due to unmet need and promising data for their lead drug candidate. This could represent a significant advancement in the treatment of metastatic pancreatic cancer, offering a new standard-of-care option.   Dan explains, "So, GSK-3β is a known quantity across a number of inflammatory diseases. It was understood when we first started the company that, particularly in cancer cells, GSK is hijacked in its activity. Basically it's been shown that in normal cells, GSK-3β sits in the cytoplasmic domain and there it's involved in multiple paths, basically in glucose metabolism. But in cancer cells, it translocates into the nuclear compartment, and there it's accumulated at much higher levels and then sits upstream of a pro-oncogenic set of pathways, all mediated by NF-κB. NF-κB is notorious in cancer. It regulates gene expression involved in tumor growth and progression, chemoresistance, and protects tumor cells from death." "So it's been very difficult to target NF-κB directly, but we can target GSK-3β directly, specifically and potently, and therefore downregulate those key oncogenic processes. And that's really where we started the company, that set of activities of this protein. What's been shown since we've been in the clinic is that there is also a resulting upregulation of immune response from the host towards the cancer itself based on this inhibition of GSK-3β as well."  #ActuateTherapeutics #Cancer #PancreaticCancer #MetastaticPancreaticCancer  actuatetherapeutics.com Download the transcript here

Andrea James, Chief Financial Officer at iMDx, is focused on expanding access to innovative molecular diagnostic testing staring with a test for monitoring transplanted organ health.  The test measures the donor-derived cell-free DNA which can indicate the need for drugs to target organ rejection before invasive procedures are required. The company is developing a kit-based version of the test that can be run by hospitals rather than relying on centralized labs, to increase access to this diagnostic and improve transplant outcomes. Andrea explains, "We changed our name on June 17th from OncoCyte, as you had just referenced, to Insight Molecular Diagnostics Inc. We're now going by iMDx, and our mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes." "We actually have three pieces of IP, intellectual property, and we are initially commercializing in transplant. So we measure a biomarker called donor-derived cell-free DNA, don't get too hung up on it. That's a lot of words. It basically looks for fragments of DNA in the blood, which can indicate transplanted organ damage and therefore rejection. And so that is where we are commercializing first." "What's really interesting is that the innovations in this space are, okay, so let's say you've been on dialysis, that's a really tough life. You finally get your transplanted kidney, and now let's say your body is starting to reject it. You're one of those one in five who were a match, your kidney was a match for you, but then your immune system is attacking it anyway. That used to be almost a death sentence."  "Your options there were you're going to lose your kidney, you go back on dialysis, or you lose your life. But now there are therapies that are coming out to treat antibody-mediated rejection, or AMR, and our test is being used to monitor the efficacy of those therapies." #iMDx #MolecularDiagnostics #Molecular #Diagnostics #Healthcare #PrecisionMedicine #Genomics #Decentralized #LiquidBiopsy #DigitalPCR #Transplant #Localization #Labs #PointOfCareTesting #RapidCare #Democratization imdxinc.com Download the transcript here

James Hereford, President and CEO of Fairview Health Services, describes this Minnesota-based healthcare system's $600 million turnaround and the importance of focusing on people and processes, not just technology changes. Addressing staff shortages, quality of care, and patient experience led to finding a holistic approach that improved financial outcomes and changed the culture in a sustainable way. Investments have been made in community programs like food access and vaccination events, recognizing the impact of social determinants of health on patient outcomes. James explains, "When doing this, we have to think about sustainability, and there are things that you can do, like mass layoffs, that can change the short-term economics of an organization. They're just not sustainable. The work hasn't gone away. You haven't changed the nature of work, and we really tried to focus on the people in the process side of this and really make our focus on our processes." "The other problem with thinking only about the financial turnaround and the direct cost drivers is that it's not the only measure of success for a healthcare organization. It's also about the quality and safety of the care we provide. It's about the experience we provide for our patients, and it's about the culture and the environment in which our caregivers and others provide that care. And so we had to be thinking more holistically about the nature of the turnaround and what we had to do to achieve all of those outcomes." #FairviewHealth #Hospitals #Healthcare #FinancialTurnaround #HealthcareDelivery #FoodAccess #DigitalHealth #LeadershipSkills #Minnesota fairview.org Download the transcript here

Steve Butts, Co-Founder and CEO of Arrivo BioVentures, is a biopharmaceutical company focused on developing therapies that target the root causes of disease rather than just treating the symptoms. Their drugs treat major depressive disorder and acute pancreatitis through novel epigenetic mechanisms of action. Sex-based differences were observed in clinical trials where the drug SP-624 showed efficacy in females but not in males, which could lead to a paradigm shift in how depression is treated in men and women. Steve explains, "We've evolved over time at Arrivo and with our previous companies. What we're excited about right now is the fact that we have two drugs. One called SP-624 or Forvisirvat is the generic name, and the other one is code-named RABI-767. And as we've gotten into the science behind these drugs, what we're finding is that we're not just treating the symptoms of a disease, but we're really trying to get at what's causing the disease fundamentally and trying to make an impact there. And I think from a drug development standpoint - I've been doing this for 30 years - these are the two most exciting programs that I've had a chance to work on for a variety of reasons. One is the science, and they're both novel and new approaches to treating the diseases, but two, if we're right, they're going to create a situation where we're going to think about these diseases differently." "We ran a large Phase 2 study. It was the first study we had run in patients with depression, and it was really the first study that anyone had run with a SIRT6 activator in patients with depression. And so we were breaking new ground there, and it was a pretty large study. When we got the results, what we found was that there were really nice effects in females across all of the measures that we had and no evidence of efficacy in males. And that was really puzzling to us. It wasn't what we were expecting. And we started diving into, well, what could be going on here? Science is iterative, and I think you do a trial, and trials lead to more questions. And so we started diving into the questions that we had around “Why the sex difference?” #ArrivoBioVentures #MentalHealth #Neuroscience #WomensHealth #Depression #DepressionTreatment #Psychiatry #PrecisionMedicine arrivobio.com Download the transcript here