Greg Mayes, President and CEO of Reunion Neuroscience, and Dr. Manish Agrawal, the Co-Founder and CEO of Sunstone Therapies, shine a light on adjustment disorder, a disproportionate emotional or behavioral reaction to a significant life stressor such as a cancer diagnosis. This under-recognized condition lacks FDA-approved treatments and is often managed with SSRIs or talk therapy. The REKINDLE study evaluated the use of a psilocybin analog drug in development for treating adjustment disorder and has shown positive results by integrating emotional treatment into the standard of care for serious illnesses.

Greg explains, "In fact, there are no approved investigational assets that had been approved by the FDA for adjustment disorder. But it was an area of exploration that the FDA encouraged us to move into in light of people's disproportionate and really unfortunate reactions in terms of a depressive or anxiolytic reaction to cancer diagnosis or other major medical illness like Parkinson's disease, MS, ALS, or pulmonary fibrosis."

Manish elaborates, "Well, usually you have to have had some stress-related event. For example, it could be things like divorce or job loss. But here, specifically, this study is targeting an illness, and the ones that Greg had just listed out, the neurologic conditions, as well as the cancer diagnosis. And then usually it leads to symptoms, intense feelings of sadness or anxiety or hopelessness. You can have a depressed mood with its subtypes with depressed mood. Some people have more anxiety. And so both a stressor and the symptoms that present are associated directly with that. So, for example, for the study, the symptoms of sadness need to be tied to the illness, such as cancer or MS."

#ReunionNeuroscience #SunstoneTherapies #AdjustmentDisorder #MentalHealth #REKINDLEStudy #Psychedelics #PsychedelicMedicine #CancerCare #MentalHealth #ClinicalTrials #Psilocybin #Oncology #PatientCare #MedicalInnovation #Neuroscience

reunionneuro.com

sunstonetherapies.com

Download the transcript here

Russ Nix, Consulting Associate Director, and Dr. Stacey McCoy, Pharmacy Clinical Program Manager for the Clinical Surveillance and Compliance business at Wolters Kluwer Health, highlight the problem of drug diversion in healthcare environments and the shared responsibility to prevent this breach. AI-enabled software is becoming crucial in detecting suspicious patterns, the types of individuals most likely to steal drugs, and gaps in the supply chain from ordering to delivering drugs to the patient. While opioids are the most commonly diverted drugs, motivated by substance abuse and addiction, other medications, including non-controlled substances, insulin, and high-cost cancer drugs, are also at risk. Effective prevention programs focus on a culture in which staff feel safe reporting concerns and seeking help.

Russ explains, "Drug diversion is basically when you're in a healthcare system where the medications in that facility are not going to their intended destination. And that's typically what we see most of, a deliberate taking of those medications, whether it was a substance abuse issue or your healthcare practitioners or staff outside of the facility, are taking those medications and basically denying your patients that medication. And it is a pretty significant issue since the opioid crisis, again in the early 2000s or late 1990s."

Stacey elaborates, "So ideally, we want to be in a position where we're able to utilize software applications or a mixture of software applications to have oversight of what's being ordered, what's coming in, and what's going on inside our pharmacies, what's inside the machines on each hospital floor. Just imagine you have such a varied audience. Every single hospital floor has 15 or so nurses working. Those nurses need to grab medications from machines, like a vending machine. So the pharmacist is responsible for making sure that's taking place properly."

"Then that same team or person was also responsible for making sure that what's removed from the machines truly makes it to the patients in a safe and sound manner. So there are a number of breakpoints within the process that someone has to oversee. Ideally, we'd like to make sure that drug diversion prevention takes place using the most up-to-date software applications that are AI-enabled, and that we have multidisciplinary governance on these teams."

#WoltersKluwerHealh #AISurveillance #DrugDiversionPrevention #Sentri7DrugDiverison #PatientSafety #DrugDiversion #HealthcareSecurity #OpioidCrisis #PharmacySafety #HealthcareCompliance #PatientCare #MedicationSafety #HealthcareLeadership #AIinHealthcare

wolterskluwer.com

Download the transcript here

Meghan Gutierrez, CEO of the Lymphoma Research Foundation, and Jennifer Branstetter, the Executive Director, North America Corporate Affairs at BeOne Medicines, join me to discuss the growing use of AI in patient care with a specific focus on individuals with lymphoma and other blood cancers. Emphasis is on the necessity of a collaborative, patient-centric approach to developing AI tools, bringing together patient advocacy organizations, healthcare professionals, and pharma partners to provide accurate information to patients. The goal is to serve a diverse population by providing personalized, accessible information to help patients have more meaningful discussions with their healthcare providers, not to replace the clinician's role.

Jen explains, "We know that tens of millions of people are using AI tools in general, like ChatGPT, for health questions, including patients with blood cancers like chronic lymphocytic leukemia or CLL, they're all turning to the different AI tools that are out there. And from our perspective, we see this continuous growth of use, we want to make sure that the right healthcare information is getting fed into those AI resources and tools so that patients are getting the most accurate information possible."

Meg elaborates, "Many patients are using these AI tools to make sense of everything from their PET scans to their blood results, to some of the treatment language they receive in their clinician's or doctor's office. And one of the things that I heard recently from a cancer patient who had uploaded his scans and some test results into an AI platform. And he called me incredibly concerned. He was very concerned about his prognosis and the limited treatment options that he believed were available to him."

"So when I pressed further, I found out that this AI platform was the only source of information that he had. So I became concerned when I recognized that the information he received was antiquated. So the treatment results and some of the information he was working from in this incredibly anxious and anxiety-provoking moment were 10 years old. And so in this case, antiquated information was as dangerous as inaccurate information. And both of these remain top concerns at the Lymphoma Research Foundation. And I think across our sector, as we see more and more patients using these tools and platforms to help educate them about their disease and their treatment options."

#LymphomaResearchFoundation #LRF #BeOneMedicines #LymphomaAwareness #AIinHealthcare #PatientAdvocacy #BloodCancer #HealthcareInnovation #PatientEmpowerment #PrecisionMedicine #CLL #HealthTech #CancerCare

lymphoma.org

BeOneMedicines.com

Download the transcript here

Dr. Mike McCullar, CEO of RegCell, is developing a novel cell therapy to treat autoimmune diseases that specifically addresses the loss of tolerance, in which the immune system mistakenly attacks the body's own tissues. This approach contrasts with current treatments, which broadly suppress the immune system and may cause side effects. The key goals of the therapy are to achieve long-term disease control and restore the immune system's natural balance. The company's manufacturing process is designed to simplify cell therapies, making them more affordable and accessible to a broader population of autoimmune patients.

Mike explains, "The real driver of immunity, we believe, is what's called loss of tolerance, which is a system in our bodies that protects us from bad immune cells that attack our tissues. So that's a fundamental limitation in biology, and there really is not a curated treatment at this point. So our view has really been to try to restore the natural balance of our immune system by regulatory T cells, which are an indispensable non-redundant cell type to maintain tolerance against our autoimmune disorders. So we think the current treatments really don't address these challenges. They are broadly suppressing the immune system, and they don't offer curative potential."

"We've been using the same kinds of drugs for the immune disease for about three to five years, and they will broadly suppress the immune system. They are really unable to distinguish between a good immune cell and a bad immune cell. And I think that's the fundamental limitation of how these drugs work. They could be very affected, but they do really broadly suppress the immune system in an indiscriminate way."

#RegCell #AutoimmuneHepatitis #Biotechnology #MedicalResearch#AutoimmuneDiseases #CellTherapy #PrecisionMedicine #Immunology #Biotech #RegulatoryTCells #Innovation #HealthcareTechnology #ClinicalTrials

regcellbio.com

Download the transcript here

Amy Mendoza, Chief Marketing Officer at Alphaeon Patient Financing, highlights the advantages of working with a finance company that provides options for treatments in cosmetic, dental, vision, audiology, and veterinary care. This is an approach for patients who might delay or forgo treatment and preventive care due to cost, including those with average credit or who need subprime options. Working with providers, Alphaeon helps grow their practices and improve patient experience and outcomes.

Amy explains, "I think the most charming and attractive part of Altheon in healthcare is that it is opening access and providing solutions for patient financing. This includes access to treatments that providers can offer in healthcare markets, including cosmetic, dental, vision, audiology, and now veterinary care."

"Financing is access. And so it's not that patients lack a desire for care, they're lacking affordable pathways. And so, being able to deliver and present the right financing solutions opened the door to preventive care before something becomes urgent and to completing full treatment plans instead of piecemeal care. And then maybe more especially impactful for middle-income patients and families and patients without robust insurance benefits. So when patients can say yes to care earlier, outcomes improve, and that's clinically and financially."

"The setup is pretty straightforward, and the reality is the fees and terms are much more friendly, giving them the opportunity to open up a revolving access or line of credit that they can apply to taking care of their pet within the family, or maybe dental or vision, and support a handful of members within the immediate family."

#Alphaeon #PatientFinancing #HealthcareFinancing #PatientAccess #HealthTech #MedicalFinancing #HealthcareInnovation #PatientCare #HealthcareLeadership #DigitalHealth #FinTech #Healthcare

goalphaeon.com

Download the transcript here

Dane Stevens, Founder, CEO, and Director at Optimi Health, a Canadian company that manufactures MDMA and naturally derived psilocybin from mushrooms for use in therapy for PTSD and treatment-resistant depression. These psychedelic-based mental health treatments are being used in the regulated market in Australia and in Special Access programs in Canada, and showing real-world evidence of a positive impact. Dane emphasizes the importance of a clinical setting for the administration of psychedelic medicines and integration with traditional therapy.

Dane explains, "We exist to support the responsible use of psychedelic medicines within regulated healthcare systems. We are a manufacturer of both MDMA and psilocybin, and our company exports those products to the only truly regulated market in the world right now, which is Australia. There, our MDMA is being prescribed for PTSD, and our psilocybin, naturally derived psilocybin extract, is being prescribed for treatment-resistant depression. And so we're not your classic drug developer. We're on a mission to be in the clinic and inpatient today, and that's where we are."

"Right now, they're still scheduled substances, but in Canada specifically, you have what's called the Special Access Program, where if you're suffering from end-of-life distress or PTSD in a very serious way or treatment-resistant depression, you can apply directly to the health minister for an exemption to access psychedelics. But they are still scheduled and restricted."

"If you're looking at just the Australian model in Australia, they rescheduled specifically MDMA for the use in PTSD treatment. Specifically, around psilocybin, it's only to be used for treatment-resistant depression. And so, when we, as a company, actually export directly from Canada to Australia, the permits say it's only to be used within that framework. So it's not a take-home medicine, it's all done within the guidance of your healthcare professional at the clinic."

#OptimiHealth #PsychedelicMedicine #MentalHealth #PTSD #Depression #Innovation #Healthcare #Australia #TreatmentResistantDepression #Psilocybin #MDMA #PsilocybinTherapy #MDMATherapy #MentalHealthInnovation #FDAApproval #HealthPolicy #CanadaHealth #ClinicalResearch #RealWorldEvidence

optimihealth.ca

Download the transcript here

Renzo Luzzatti, Founder and CEO of US-Rx Care, discusses the role and practice of the Pharmacy Benefits Managers and the advantages of working with a company that uses a fiduciary model. Inherent conflicts of interest in the traditional PBM model, such as manufacturer rebates and requirements to use PBM-owned pharmacies, drive up prescription drug costs. US-Rx Care eliminates these conflicts by charging a flat administrative fee with its sole incentive to lower drug costs for the plan and its members.

Renxo explains, "We've been around since 2007. We do have about 5 million lives under management, both self-funded employers, which is the bulk of our business. Then we also tap into Medicare health plans and have some programs and offerings that we assist there to lower costs and improve the quality of care. Our approach is unique in that we've taken a fiduciary stance from day one. We can talk about that in a little bit. It is a legal term. It's defined under ERISA, which governs health plans. They have a fiduciary duty to the plan, the members, and the management of the plan assets. And the industry as a whole has shied away from any fiduciary obligation whatsoever, in part because it's rife with conflicts of interest, and you cannot have conflicts of interest as a fiduciary."

"That is really at the core of all of the issues and complaints that we're hearing about PBMs - they're driving up the cost of prescriptions rather than having the intended effect, which is to reduce the cost of prescriptions. And I would say in the last four or five years, employers have really started to ask the right questions because they're becoming more and more educated."

"For folks like us, we're growing like crazy because the industry finally gets that. The deal that they were getting through their traditional model is not so good. The other thing is when we move to a fiduciary model, savings are typically in the realm of 30% to 50% in the first year, and then we typically see additional savings in year two and three, and then after that, the goal and the intent, which we've been successful at, is to keep costs stable."

#USRxCare #PBM #PharmacyBenefits #EmployeeBenefits #HealthcareCosts #FiduciaryResponsibility #BenefitsConsulting #HealthcareTransparency #CostContainment #SelfFundedEmployers #HealthcareReform

usrxcare.com

Download the transcript here

Kory Daniels, Chief Security and Trust Officer at LevelBlue, discusses the multifaceted cybersecurity challenges in the healthcare industry and the risks posed by legacy systems not designed for secure internet connectivity. Artificial intelligence is being used successfully to defend against cyber attacks, while threat actors are using AI without ethical constraints to launch sophisticated attacks. Managing cybersecurity includes using digital twins to model vulnerabilities and to develop strategies for identity and access management for human and non-human identities, such as robots and AI agents.

Kory explains, "We must recognize that we're not starting from a clean slate - we have a lot of decades-old systems operating both within the physical footprint of the healthcare and hospital facility and in record retention and data management. Many organizations are looking at how to get ahead in identifying what needs to happen to embrace new technology and much of the innovation. At the same time, being conscious and cognizant of opportunities to retrofit, taking what's there already today and making it internet-connected as an example, making it Internet of Things-connected so that devices that weren't purpose-built to communicate to the internet now can communicate to the internet, but it creates some risks and it poses some challenges."

"We highlighted that some of these legacy systems or initial systems that have been in the organization for years, some 10 years or more, were not necessarily purpose-built or designed at the time of manufacturing, nor with the software needed for those tools to operate with current speed, expectations, and requirements. Healthcare entities are engaging both patients and supporting care doctors and patient care professionals in 2026 and beyond."

#LevelBlue #HealthcareCybersecurity #DigitalTransformation #AIinHealthcare #LegacySystems #PatientSafety #CyberThreats #HealthTech #DataSecurity #MedicalDevices #DigitalHealth #HealthcareIT #CyberDefense #HealthcareInnovation #RiskManagement #ComplianceMatters

LevelBlue.com

Download the transcript here