Empowered Patient Podcast

Simon Allen is the CEO and Director of Anebulo Pharmaceuticals, which focuses on finding an effective treatment for acute cannabinoid intoxication or ACI, particularly in an emergency department setting. ACI is a condition where an individual has consumed or smoked too much cannabis or products that contain THC or synthetic cannabis and is experiencing symptoms of psychosis, anxiety, elevated heart rate, or is unresponsive. Their drug ANEB-001 is designed to address the cause of the symptoms without the need for traditional methods like benzodiazepines and beta blockers, which have their risks.  Simon explains, "What we are seeing is individuals taking these high-potency edibles, for example, and also smoking and vaping. These are other forms that can create ACI outcomes. And essentially, they're out for several hours, if not overnight, in the hospital. This can get as serious as the escalation to a psychiatric ward if the individual is so psychotic, agitated, and anxious that the emergency department can't handle it or chooses not to handle it and pushes it to the psychiatric ward. And those expenses are in the tens of thousands of dollars to the healthcare system. Not only that, there are extremely poor patient outcomes." "What's important is that these molecules, the synthetic ones, are, unfortunately extremely strong binders to the CB1 receptor and do more to stimulate effectively. And very, very small doses of these synthetic cannabinoids can create very poor patient outcomes simply because they're much tighter binders to the CB1 receptor compared to THC. And when they do bind to that receptor, they're much more active. And so the street names like K2 and Spice are examples."  @AnebuloP #AnebuloPharmaceuticals #ACI #AcuteCannabinoidIntoxication #Cannabis #Overdose Anebulo.com Download the transcript here

Nancy Lurker, CEO and Board Director of EyePoint Pharmaceuticals, aims to prevent the progression of blindness by developing technology that addresses retinal eye diseases. These back of the eye diseases are age-related and an increasing threat to populations worldwide. Current treatments require regular injections in the eye. The micro inserts developed by EyePoint will allow the drug to work for six months, allowing patients more flexibility to maintain their vision.  Nancy explains, "We know that if you look at the current eye treatments on the market today, wet AMD, retinal vein occlusion, diabetic macular edema, and diabetic retinopathy, all of those are running close to $30 to $40 billion being spent to help to treat these terrible eye diseases which may lead to blindness." "So, what causes these diseases? There's a genetic component at times, but also age plays a factor. And then, of course, diabetic macular edema and diabetic retinopathy can be caused for patients who have diabetes. So. what happens is you get a proliferation of tiny, tiny micro capillaries in the eye and, in some cases, just general atrophy of these retinal epithelia. These cells help to allow you to see. And what happens is when you start to get this proliferative growth that goes on and leakage of fluid and cells into the back of the eye, it completely obstructs your vision, which grows over time." "The vast majority of patients have to get another injection every month or every other month to slow the progression or stop it. And if you miss a visit, that fluid will come right back, and remember, the fluid is very, very bad for the eye. And we can see in the large databases, it's the medical claims data from patients, millions of these patients, we can see that even though they go in and get their eyes injected, you miss visits. Why? Life happens." @EyePointPharma #EyePointPharma #Ophthalmology #RetinalEyeDiseases #WetAMD #RetinalVeinOcclusion #DiabeticMacularEdema #DiabeticRetinopathy eyepointpharma.com Download the transcript here

Dr. Gavin Samuels, Chief Business Officer at CinRx, a holding company currently with six portfolio companies, each focused on developing one drug. Providing these companies with the right resources at the right time makes for more efficient use of resources and can speed up drug development.  Their strength is understanding challenges and opportunities approximately a year before an IND is filed to help shepherd the drug through the IND-enabling study and through clinical development.  Gavin elaborates, "The disease areas that we're involved in, cardiovascular disease, metabolic disease, inflammatory diseases, these are problems that present a real challenge to patients and a real challenge to society and a real challenge to humanity. We want to try and address those problems by bringing innovative drugs and developing them as quickly and efficiently as possible and bringing to the patient." "The criteria we use is that it has to fit a specific unmet medical need. We have to have a large group of patients that are involved in the disease, that have the disease, and we want to make sure that we can make a meaningful difference to the way that the disease is treated as well as the quality of life for the patient. So we don't want incremental improvements. We're looking for drugs that are going to make step changes in the quality of life of the patients we are trying to bring the medicine to." #CinRx #CinRxSuperHighway #TransformationalMedicines #DrugDevelopment #Obesity #TypeOneDiabetes #T1D #Hypertension #Gastroparesis #IrritableBowelSyndrome #SolidTumors #Oncology #NeurodegenerativeDiseases cinrx.com Download the transcript here

Jennifer Quinn, Head of global pricing and health economics and outcomes research at Debiopharm, emphasizes the importance of reimbursement, not just regulatory approval, for a drug to be available to patients.  With patient-centered outcomes research, drug developers can use data for risk-benefit assessment relevant to regulators that reflect how patients consider the risks and whether they will undergo a procedure. Jennifer explains, "My team really tries to make sure that, when we're thinking about a clinical development program, we make sure we're capturing those value markers throughout from a very early stage. That is so that when someone out-licenses it and becomes our partner, they have the data they need not just to get through regulatory approval but to have the drug reimbursed and made available to patients." "It's so important that patients have not just the agency in their care, but we understand how treatments are impacting patients -- impacting their lives, impacting how they feel, impacting their activities of daily living. I think that is what patient-centered outcomes research encompasses: patient preference, patient functioning, and patient feeling. If we don't do that, we are not patient-centric in our drug development because we're missing this crucial part. A drug might shrink a tumor this much, or it might give you this many fewer bleeds if you're a hemophilia patient, but what does that mean to the patient? How does that impact them?" @DebiopharmNews #Debiopharm #DrugDevelopment #Biotech #PatientCare #PatientCenteredOutcomesResearch Debiopharm.com Download the transcript here

Ohad Arazi, CEO of Clarius, a medical imaging startup with a mission to bring accurate, easy-to-use, AI-assisted, and affordable hand-held ultrasound tools to a broad range of medical professionals. Traditional ultrasound is costly, stationary, and requires specialized training. The portable Clarius device communicates with an iPad or an Android or iOS phone. The ultrasound produces highly nuanced grayscale real-time images that, with the help of artificial intelligence, can be used safely in a wider point-of-care environment to make informed decisions. Ohad explains, "We're all about bringing together high-performance ultrasound imaging, cloud data, and artificial intelligence into this powerful ecosystem that improves patient care enabled by medical imaging in every setting. The key differentiation is that handheld ultrasound is not about replacing legacy systems in places where they're already well entrenched, like radiology or cardiology. It is rather about bringing medical imaging to new care settings and putting it in the hands of new practitioners that may not have had access to an ultrasound before." "We can even extend that outside of the walls of the hospital into the ambulance. Powered by AI, we have a feature called Auto Preset AI, which, as the EMT roam through the patient's body, looking for trauma, our AI will automatically adapt the view of that image to optimize it for the organ the EMT is looking at. This lowers that threshold for knowledge to enable them to make a more informed decision. For example, to see that there might be stenosis in the carotid and they should radio the hospital and get the thrombectomy lab ready because there's a stroke patient on hand." #Clarius #MedTech #Ultrasound #MedicalImaging #AI #DigitalHealth #HandheldUltrasound clarius.com clarius.com/2023-state-of-ultrasound-report/ Download the transcript here

Alina Czekai, Vice President of Strategic Partnerships at Cohere Health, points out the need to transform the often painful prior authorization process. The traditional approach takes a piecemeal view of requests and provides a yes or no response. The Cohere view looks at the process as a multidimensional challenge that requires understanding the entirety of care and leveraging technology and AI to help guide behavior toward what is most clinically appropriate. Alina explains, "You can think of it as an authorization for a credit card. Ensuring that what is going to be done or what medication or devices are going to be ordered is actually going to be paid for. The process and payments in the healthcare system today have become so complex. It's complex not only for the health plan that's administering payments for care but also for physicians and their staff. Most importantly, it's a confusing and stressful process for patients." "We believe that prior authorization is a process that can be automated, that should be automated and is really an opportunity in the patient journey to ensure all stakeholders are on the same page. We also think that tools like prior authorization can really be leveraged to understand what's next in a patient's care journey." "We have a joke at Cohere. None of us were super excited to get in the prior auth business, but we were super excited to get in the business of totally changing a part of the healthcare system that is so antiquated. Prior authorization, for years, has relied on fax. We're not trying to put the fax machine totally out of business, but we think that we can really automate this important process and make access to care even faster for patients." #CohereHealth #PriorAuthorization #CMS #DigitalHealth #HealthcareInnovation #HealthTech CohereHealth.com Download the transcript here

Jared Crapo, Head of Product and Technology at Kalderos, focuses on drug discounts paid by drug manufacturers to pharmacy benefit managers, commercial or government payers, and healthcare providers. Congress created the 340B Drug Discount Program and the Medicaid Drug Rebate Program to support healthcare for underserved patients. While these programs have dramatically grown, so too have the complexities and confusion about discounts and disagreements about payments. Jared explains, "The 340B program was created by Congress, and it's a subsidy from drug manufacturers to underserved healthcare providers. The Medicaid Drug Rebate Program is a similar program created by Congress that is a source of financial support for state Medicaid agencies, also provided by drug manufacturers. So drug manufacturers give a discount to state Medicaid agencies for drugs prescribed to Medicaid patients." "One way to think about it is there's a lot of information asymmetry, which means some stakeholders have access to a lot more data than other stakeholders. And without a shared common understanding of which discounts are available, which discounts are compliant, and which ones aren't, it's really difficult for these various stakeholders to understand what their obligations are and what they should be doing. That leads to the dysfunction that you've mentioned." "What Kalderos does to reduce this dysfunction is compile and curate data from dozens of different sources, to try and create a common understanding of what actually happened on a particular prescription. This is so that all stakeholders have access to the same information, which then reduces the disagreements about what should actually happen from a discount and a rebate perspective." @KalderosInc #DrugDiscountPrograms #340BDrugDiscountProgram #MedicaidDrugRebateProgram #MDRP kalderos.com Download the transcript here

Jessica Ackerman, the Vice President for Strategic Partnerships and Impact at Responsum Health, is focused on the insights that patients can provide drug companies and other people newly diagnosed or suffering from a chronic condition. Responsum is a digital-based educational community providing accurate scientific information, peer support, access to clinical trials, and a path by which drug companies can get real-world data.  Jessica explains, "Every disease focus that we have started has come from a partnership, some vested interest, from either a commercial sponsor or a pharmaceutical company, to build this robust community. Their interest is to gain the patient's voice and get insights, market research data, and real-world data from patients and family members to understand their gaps in care. So we have created a number of communities, like kidney disease CKD. We have glaucoma. We have pulmonary fibrosis, which is considered a rare disease, so we are in the rare disease and orphan disease space as well." "We also have a long COVID community. That's a newer one that was met purely out of need. Patients diagnosed with long COVID undergo a lot of stigma and have trouble finding resources that are credible. We also have a menopause community that has many, many women who are feeling empowered to figure out what's going on for a lot of unmet needs as well. We have a number of communities, and we're always willing and able to build new communities. Part of what we're doing here is building new communities." #Responsum #PatientExperience #PatientEmpowerment #DigitalHealth #PatientEducation #LongCOVID #HealthEquity #ClinicalTrials #HealthLiteracy #RareDisease ResponsumHealth.com Download the transcript here

 Dr. Phil Wagner, Founder and CEO of Sparta Science, is developing a movement health intelligence solution to better understand the overall health of a patient and their risk of injury.  They are interweaving movement ability and balance ability to analyze meaningful biomarkers to ensure top performance and safe mobility. From his experience as a sports trainer, Phil warns about making assumptions about performance at any age. Phil explains, "We do a balance assessment to assess that movement health, and it takes about 20 seconds on each side, and that will actually generate about a million data points on our device. This feeds into software that uses machine learning to compare you against yourself but also around others in a similar cohort, whether that's similar ages or sex at birth. So, being able to compare yourself against your own previous baselines and assessments, but also compare yourself for norms against others." "We're working with the military on a TBI biomarker, traumatic brain injury because movement is interwoven into all those different types of conditions. So, the biomarkers that are created are really based on those conditions you're trying to improve, maybe performance for an athlete, or it may be avoiding some sort of setback, like a fall. The biomarkers that are of interest really depend on the population. Still, because balance is such a global application, it really has the opportunity to create biomarkers in several different areas, depending on the population."  "On the other side, we've seen hospitals assign fall risk to individuals just based on their age. I spoke with a hospital CEO the other day who found that anybody over 65 gets yellow booties. They're automatically a fall risk when they are checked into the hospital. He encountered a woman walking around in these yellow booties at his hospital, and he told her to get back in her room because she was a fall risk. She ran back to her room. So, this is the idea that we're using age as a primary marker and assuming that we have these movement limitations that may or may not exist." #SpartaScience #MovementHealth #MovementHealthIntelligence #BigData #DigitalHealthTech #DigitalHealth #HealthTech #MachineLearning SpartaScience.com Download the transcript here

Dr. Clark Chang is a cornea and keratoconus, KC, specialist at Wills Eye Hospital in Philadelphia and the Director of Global Medical Affairs at Glaukos. Keratoconus is a disease of the eye where tissue thins and gradually bulges outward into a cone-like shape.  While changes in the cornea are small, vision becomes very blurry, and the underlying cause may be overlooked. Glaukos has introduced the iLink procedure, a minimally invasive outpatient procedure to slow or halt the progression of this disease and help patients preserve their vision. Clark explains, "It is associated with age, but it's in the different group of people than most of your audience is thinking. We're very familiar with conditions like age-related macular degeneration. Everybody knows that because it's very impactful to one's vision, and the fear of loss of vision has frequently been rated as one of the top one or two biggest fears in a person's life. Most diseases are age-related in that they can occur with time. This disease more commonly occurs during puberty or in younger patients."    "In order to be able to diagnose this condition, especially at an early stage when there is an extremely small amount of change in the alteration in the shape of the cornea, you really need sophisticated diagnostic technology that we usually call topographer or tomographer. Basically, it maps out the shape of the cornea, either just at the front or front and back of your cornea. Being able to, in a more sensitive way, figure out whether or not there's any small amount of area that's becoming misshapen more than what a normal cornea or tissue would look like." #Glaukos #Keratoconus #iLink #CornealCrossinglinking #EyeHealth #KCAwareness #LivingwithKeratoconus #EyeDisease #Cornea  glaukos.com Download the transcript here