Empowered Patient Podcast

Meri Beckwith, Co-Founder of Lindus Health, aims to transform clinical trials by changing the CRO model to leverage technology to improve patient recruitment, retention, and the experience of the sponsors and trial participants. While the compensation model for contract research organizations is often not aligned with trial outcomes, Lindus ties compensation to hitting milestones and outcomes. They emphasize the need for more flexible trial design and a decentralized and hybrid approach to reduce participant burden and bring drugs to market sooner.   Meri explains, "This comes back to how contract research organizations are paid and compensated where they’re typically paid per hour of input, and it’s not at all tied to the outputs being speed, patient experience, or quality of data. And so we’ve created this monster over the last 10 or 20 years where the cost of clinical trials keeps going up. Patient experience certainly seems to be getting worse. Above all, patients suffer because the direct experience in clinical trials is worse. Still, they have to wait longer and ultimately pay more for new treatments as the cost of those clinical trials is ultimately passed on to patients." "So essentially, we’re responsible for running the entire clinical trial end to end, but we do that in a very different way and with a very different business model from that of industry incumbents. On the business model front, we provide completely fixed costs for everything and our customers, the companies developing the drugs, only pay us when we hit milestones. In other words, our compensation is tied to the actual trial outcomes, moving the trial along, et cetera. The second difference is under the hood, we have the same level of concierge service - folks who oversee and design the clinical trials, medics and clinicians who are looking after patients. We also have our technology platform to help us find the right patients, get them enrolled in the right trial quickly, and monitor and capture the data as we go – leading to higher quality data." #LindusHealth #ClinicalResearch #CRO #ClinicalTrialRecruitment #DrugDevelopment lindushealth.com Download the transcript here 

Greg Hamilton, CEO of io9, aims to enable precision oncology treatments for patients globally.  The company has developed an AI-powered biomarker analysis platform called OncoGaze that can rapidly analyze digital pathology images to identify cancer biomarkers. This enables pathologists to efficiently and quickly digitize and analyze tumor samples and oncologists to start patients on the appropriate targeted therapy much faster.   Greg explains, "For many of these cancers, determining the right cancer treatment is the difference between life and death. When we look at how we treat cancer today, what hasn’t changed is that there’ll be a biopsy. So, they take a piece of the tumor out and send that tumor to a pathologist. Pathologists will take that tumor and put it in a glass slide. They usually use what’s called H&E, they kind of stain it to read it better. But basically, a pathologist is looking under a microscope at the cells, and that’s how we diagnose cancer. That’s the formal way that we diagnose cancer. And so the pathologist will send a report back to the oncologist at that point saying, yes, your patient has cancer."  "Now, once the pathologist has diagnosed the cancer, they can just scan that slide or take a picture of the slide and upload it to our cloud-based software. They get an immediate result on the presence or absence of the particular biomarker." "For instance, like ovarian cancer in the guidelines in ovarian cancer, if the patient is positive for ovarian cancer, she’s supposed to get a biomarker test for a biomarker called HRD. Now, we can do that immediately. When that pathologist gives the report back to the oncologist, now it can say your patient has ovarian cancer, she’s stage three, and she’s positive or negative for HRD. And the oncologist, on the day they tell the patient that they have cancer, can also tell them, you have this biomarker, and based on the guidelines, here’s the treatment we’re going to start you on tomorrow. In essence, we can get the patient on the appropriate frontline therapy weeks ahead of time. And at the end of the day, cancer is a race against time." #PrecisionOncology #PrecisionMedicine #AI #Cancer #BioMarker #Pathologists #Oncologists #Tumors  io9.ai Download the transcript here

Dr. Jeng Her, Founder and CEO of AP Biosciences, is developing T-Cube bispecific antibodies that can target cancer cells and engage T-cells to kill them more effectively and safely than existing treatments. The company is focused on treating hard-to-treat cancers such as HER2-positive breast cancer, lung cancer, head and neck cancer, and pancreatic cancer. The T-Cube bispecific antibodies use CD137 instead of CD3 to activate T-cells, which can lead to better efficacy and safety compared to other T-cell engager antibodies. Jeng explains, "So why not just take two, let's say, monospecific antibodies and then put them together and give them to the patient in the combination therapy? Instead, we wanted to develop bispecific antibodies by fusing two antibodies together into one single molecule. So what's the advantage? Eventually, what it comes down to is the therapeutic window of bispecific antibodies. This means you want your antibodies, your bispecific, to have better efficacy, better safety, and sometimes lower cost of goods since you are only expressing or producing one single drug molecule. So, the way we look at bispecific and the real advantage is not just the additive effect. It's not even the synergistic effect, which means we would like our bispecific antibodies to do something combination therapy cannot do. And that's the value of our bispecific antibodies." "Basically, we have two technology platforms. The first one is an antibody phage display library. We call it Omni-mAb. This library is a live library, which means it has more than 100 billion antibody sequences. That's a collection of the 100 billion sequences. And whatever antigen, whatever conformation of the structure of antigens you have, you could isolate a very high-affinity antibody from the library in probably 4-6 weeks."  #APBiosciences #Antibody #Biotech #Bispecific #ImmunoOncology #Cancer #SolidTumors APBioInc.com Download the transcript here

Sonia Veluchamy, CEO and Co-founder of Celegence discusses the increasing regulatory requirements and complexities faced by the medical device industry. Celegence works with companies to streamline their regulatory data management processes and adopt advanced technology solutions to manage compliance efficiently. Medical device companies are often slower than pharmaceutical companies to recognize the need to invest in data governance and process optimization to maintain compliance and avoid fines, delays in product approval, and loss of market access. Sonia explains, "The awareness is there, but medical device companies have traditionally been a bit slower in adapting and bringing in consultancy, expertise, and technology. That is partly because the sector’s regulations have not evolved at the same pace as in the pharmaceutical industry. More recently, though, the regulations have become more complex. For instance, the requirements under the EU MDR- Medical Device Regulation – are very heavy in terms of the information that needs to be submitted on an ongoing basis. So, the industry is starting to recognize what it takes to maintain documentation, specifically detailing post-market surveillance activities, which is required to be compliant with the regulations worldwide." "When you think about how medical devices are evolving, you get a sense of the growing complexity. For instance, there is now software that serves as a medical device. You also have AI being embedded into medical devices.   But ultimately, it’s about ensuring that the products placed on the market are safe and efficacious. The ability to prove that via proper documentation is important. That, in turn, enables different regulatory authorities to feel comfortable with the products that are being approved and being marketed in each region." #Celegence #RegulatoryAffairs #RegTech #RegulatoryStrategy #Pharmaceuticals celegence.com Download the transcript here

Dr. Ethan Korngold is the chief medical officer and divisional vice president of medical affairs at Abbott’s vascular business, which has developed a dissolvable stent technology to treat peripheral artery disease. PAD disproportionately affects Black and Hispanic communities and is often overlooked because early symptoms can be mistaken for other conditions. The Esprit BTK stent can help open up the smaller arteries below the knee and improve blood flow to the legs and feet to treat PAD and prevent severe complications and amputations. Ethan explains, "So peripheral artery disease refers to blockages in the arteries to the legs. When those blockages build up, it’s because of cholesterol typically that builds up in the walls of the artery and causes limited blood flow. Initially, people can have cramping or soreness in their legs when they walk. That gets better with rest. As the blockages get worse, people can develop infections, ulcers, or non-healing wounds of their legs with what we call chronic limb-threatening ischemia. And ultimately, that can put people at risk for amputation." "A lot of people aren’t aware of how common it is, and a lot of people aren’t attuned to the symptoms of it. People just sort of slow down. They do less and less, and they wind up being limited in their activities, and that really affects their health and their life, and ultimately, that can threaten their limbs. One of the things that Abbott is emphatic about is spreading awareness of the disease, trying to educate patients, trying to educate families, and trying to educate physicians so that people are more on guard for looking out for the signs and symptoms of the disease." "We have been working at Abbott for many years on techniques to help open up these blockages in the arteries of the legs. They start at about the belly button and go all the way down to the toes. At the belly button, the iliac arteries are quite large. They are about a half an inch in diameter. And then, as they go down all the way to the toes, they get narrower and narrower so that they’re about a quarter of an inch to an eighth of an inch in diameter. There are a variety of different techniques to get through those blockages, such as using catheters, and wires balloons, and stents and scaffolds to help open up those arteries and change people’s lives. One of the biggest challenges in this space has been those smaller arteries below the knee." #Abbott #AbbottVascular #PeripheralArteryDisease #PAD #DissolvableStentTechnology abbott.com PAD-info.com Download the transcript here

Dr. Jonathon Hill, VP of Science and Technology and Co-Founder of Wasatch Bio Labs has developed the Next-Generation Sequencing 3.0, NESSI-Seq platform, which can analyze blood to detect epigenetic changes and provide insights into current health and predisposition for diseases. This native-read third-generation sequencing tool can provide longer sequence reads and analyze epigenetic modifications to DNA. Epigenetics can change over time in response to diet, environment, and lifestyle. Advanced genetic testing has the potential to provide biomarkers to support personalized medicine for earlier detection and tailored interventions. Jonathon explains, "The biggest limitation with the Illumina sequencing was that it was only short sequences, so you had to get a lot of them to stitch them together and figure out what the human genome looked like. With this third-generation sequencing, we can get much longer reads, sometimes to the order of a hundred thousand nucleotide bases at a time. So we get these big complex reads." "The other thing we can do now with this third-generation sequencing is look at certain chemical modifications the body makes to the DNA to help regulate that DNA and help the body function. And looking at those chemical modifications can tell us a lot about someone's health. It can tell us their age, and it can tell us what disease they might have. We can get a lot of information out of that that just wasn't available to us in the previous two generations."  "If you think of classical genetics, it's the DNA sequence and the mutations you might have that might give you a propensity for the disease, etc. Those don't change throughout your life. Every cell in your body has that exact same sequence from birth until death. It never changes. But the epigenetics, these chemical modifications change. They change as you age. They are different in different tissues and organs within your body, changing even in response to pathogens or certain disease states. So they have a lot of information that we would not get otherwise." #WasatchBioLabs #Epigenetics #GeneticResearch #PersonalizedMedicine #DNAInnovation #GeneticTesting #NextGenSequencing #BiotechBreakthroughs #GeneRegulation #HealthcareInnovation #FutureofMedicine Wasatchbiolabs.com Download the transcript here

Bob Zemke, Director at Extreme Networks, provides network infrastructure and security solutions to help hospitals build resilient and secure networks. Critical security challenges hospitals face in managing networks include the proliferation of connected devices and the vulnerability of medical devices to cyber threats. In addition to education and collaboration between stakeholders, strategies for reducing security risks include network segmentation, AI-powered monitoring, and behavior analysis to help hospitals proactively address possible threats. Bob explains, "There are multiple factors that we take into play. First, how do we build a resilient network that can handle the amount of devices and traffic types? How do we prioritize the type of traffic flowing through, like the wires of the infrastructure and the wireless connectivity? And then how do we understand through analytics the behavior of those applications so that the healthcare organization, the security team can understand what is standard traffic or potentially rogue behaviors or traffic? What is performance impacting? So, visibility becomes just as important as the segmentation of device types and users on a network." "It's a security and performance risk. And if you think back to guest WiFi, when we started designing this about 20 years ago, we always laughed. It was like, well, we're building it, but how many people will bring a laptop into a hospital and want to connect as a guest user? Or even how many wireless devices compared to wired would be in a hospital network. Fast forward 20 years, you now have more mobile or wireless connected devices than wired in a given hospital network. So, you have to deal with RF performance management and security. And then you have the personal devices, which again, now with the mobile phone, people expect it."  #ExtremeNetworks #Cybersecurity #Hospitals #CyberThreats #MedicalDevices #AI #NetworkSecurity #HospitalNetworkSecurity #SecurityRisks #HealthTech #EnhancePatientCare #WiFi extremenetworks.com Download the transcript here

Wardah Inam is the CEO of Overjet, which uses AI to analyze dental X-rays to help dentists provide more comprehensive and objective diagnoses and treatment recommendations for patients. The Overjet platform can quantify dental disease progression and provide visualizations to help patients better understand their oral health. The use of AI in dentistry can improve patient outcomes, practice workflows, and the ability of dentists to communicate with patients about personalized data-driven care. Wardah explains, "One of our main challenges is that the dentist and the patients speak different languages when talking to each other. For example, a dentist licenses dental X-rays to communicate. Patients don't read X-rays, so they do not understand what the dentist says. So, for example, they might say, Hey, I see a radiolucency on tooth number four. The patient doesn't know what tooth number four is, and they don't know what atypical radiolucency is. And then they're squinting and trying to see what the dentist sees. And if you're not trained in reading dental X-rays, you don't see much. You see a lot of gray, white, and black, which causes confusion and lack of acceptance around the treatment and, in the end, what patients think. If it doesn't hurt, I don't need the treatment." "Overjet analyzes the dental data and identifies disease similarly how a dentist would, but we quantify the disease as well. So, for example, rather than just saying that there is bone loss, we'll measure the bone levels and say there are four millimeters of bone loss. And that helps look at what this state is. But also, you can start to say, how has it progressed since the last time you came and has there been a more longitudinal progression of disease as well?" #Overjet #Dentistry #Dentists #OralHealth #Xrays #DentalAI overjet.com Download the transcript here 

Dan Gallagher, Vice President for Strategy and Partnerships at Lyric, describes how Lyric uses advanced analytics to improve the coordination of benefits by proactively identifying coverage changes, verifying eligibility at the time of service, and transitioning patients to the correct payer. Coordination of benefits can be complex due to job changes, data lags, and situations like workplace accidents where multiple payers may be involved. Improving coordination of benefits can reduce patients' out-of-pocket costs and get providers paid faster.   Dan explains, "Simply stated, coordination of benefits is determining who or what entity has financial responsibility for an individual during a course of treatment. So, for a large portion of the population, it's pretty straightforward. You may have commercial insurance, and you may have one insurance card for your family, but there's not a lot to coordinate for other members of the population. You may have Medicare and you're still working over the age of 65. You may be under the age of 65 and have some conditions that make you Medicare eligible. You may have another spouse or two insured in the same family." "Then there are always remnant issues like work comp. Maybe you got hurt at work, had a motor vehicle accident, or had a slip and fall where there's another party responsible for the medical bills. Coordination of benefits is the process of identifying all the parties that might have a responsibility and then putting those parties in the right order so that the member pays the correct amount if they owe anything and that all the other parties pay their fair share." #LyricAI #CoordinationofBenefits #HealthInsurance #MedicalBills  lyric.ai Download the transcript here 

Yoona Kim, CEO of Arine,  a medication intelligence company, works with health plans and payers to ensure safe and effective medication therapy for patients. The Arine platform addresses polypharmacy, medication mismanagement, drug interactions, and proper dosing. Using AI and integrated databases, Arine is identifying patients who would benefit from medication management and shifting from reactive to proactive and preventative care. Yoona explains, "Our clients are health plans and risk-bearing providers. So these are the payers of the healthcare system, those who bear the financial burden of healthcare costs because medications can be very powerful, they can cure, or they can lead to detrimental consequences and even unnecessary fatalities and high-cost events like hospitalizations. So it's important to these customers to make sure that their members are on the right medications to avoid these unnecessary clinical and financial outcomes."  "I think it pertains to all of these situations. One of our biggest problems in healthcare is that 66% of Americans are on some prescription drugs, and in fact, more than 50% use more than three drugs a year. We need to search through a population and find who would benefit from a medication change with the population-based approach. This is why we spent so much time at Arine building our patient targeting model to identify in which patients would a small medication change lead to a difference in outcomes." "We're looking through all that patient's data, their medication history, their medical history, their demographics, and what their current clinical social, and behavioral risk factors are so we can identify that they're on the best medications, the safest and most effective for where they are in their health trajectory today. And, of course, the challenge is that their patient evolving health needs constantly change over time. On top of that, we have new medications being approved constantly and new advances being made. Our platform puts all this information together so that we can ensure that the best medication regimen is prescribed to the patients." #Arine #Medication #MedicationManagement #MedicationMismanagement #Prescription #SDOH #ArtificialIntelligence #Polypharmacy #Deprescribing #Overprescribing  #MedicationAdherence Arine.io Download the transcript here