Empowered Patient Podcast

Lou Lintereur, Chief Engineer for automated delivery systems at Medtronic Diabetes, brought his knowledge from working as an aerospace engineer at NASA to developing technology for those living with diabetes. He introduces the MiniMed 780G, a closed-loop system that combines an insulin pump and continuous glucose monitor (CGM) with a control algorithm that tailors itself to each patient's unique physiology and Meal Detection technology, which helps manage their blood sugar levels. Patient feedback is essential to the continuing innovation of these hybrid closed-loop tools to manage diabetes.

Lou explains, "There are two main challenges we're always trying to deal with, and they kind of compete with each other. One is just the fundamental technology, trying to get the best therapy for the patients and the best outcomes for a long, healthy life where they're feeling good. With respect to diabetes, it's about keeping your blood sugar under as tight a control as possible within a normal glucose range. So that poses the technical challenges of how to design a control system to do that with all the uncertainties of human physiology and so forth."

"But on the other side, the systems we make at Medtronic Diabetes are almost consumer products. In order to get the therapy that they need, the patient often has to contribute to the therapy. They need to indicate when they're eating, for example, and then help the system calculate how much they're eating so that they can dose the insulin properly to manage their meals better. It requires some cooperation with the patients. So, on that side of the challenge is, how do you make the system easy enough to use so that the patient can get the best outcomes possible and do as little work as possible? Because the last thing the patient wants to do is be bothered all the time having to manage their therapy."

#MedtronicDiabetes #Diabetes #ContinuousGlucoseMonitor #CGM #InsulinPump

medtronicdiabetes.com

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Lou Lintereur, Chief Engineer for automated delivery systems at Medtronic Diabetes, brought his knowledge from working as an aerospace engineer at NASA to developing technology for those living with diabetes. He introduces the MiniMed 780G, a closed-loop system that combines an insulin pump and continuous glucose monitor (CGM) with a control algorithm that tailors itself to each patient's unique physiology and Meal Detection technology, which helps manage their blood sugar levels. Patient feedback is essential to the continuing innovation of these hybrid closed-loop tools to manage diabetes.

Lou explains, "There are two main challenges we're always trying to deal with, and they kind of compete with each other. One is just the fundamental technology, trying to get the best therapy for the patients and the best outcomes for a long, healthy life where they're feeling good. With respect to diabetes, it's about keeping your blood sugar under as tight a control as possible within a normal glucose range. So that poses the technical challenges of how to design a control system to do that with all the uncertainties of human physiology and so forth."

"But on the other side, the systems we make at Medtronic Diabetes are almost consumer products. In order to get the therapy that they need, the patient often has to contribute to the therapy. They need to indicate when they're eating, for example, and then help the system calculate how much they're eating so that they can dose the insulin properly to manage their meals better. It requires some cooperation with the patients. So, on that side of the challenge is, how do you make the system easy enough to use so that the patient can get the best outcomes possible and do as little work as possible? Because the last thing the patient wants to do is be bothered all the time having to manage their therapy."

#MedtronicDiabetes #Diabetes #ContinuousGlucoseMonitor #CGM #InsulinPump

medtronicdiabetes.com

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Mark Galvin, Co-Founder, President, and CEO of TALON, discusses the Transparency in Coverage rule in healthcare, which was added to the Affordable Care Act and requires commercial health plan sponsors to provide transparency in the costs of tests, procedures, and other medical services. The rule aims to provide patients with information on pricing and out-of-pocket costs before committing to services. The lack of awareness and understanding of the rule is in part due to the vested interests of certain stakeholders, such as insurance carriers, who are financially conflicted in driving down the cost of medical claims.

Mark explains, "I'm known as a disruptive innovator, as a serial startup guy. The Transparency in Coverage rule is a rule that was added to the Affordable Care Act, or Obamacare, requiring that commercial health plan sponsors predominantly the employers that pay for the lion's share of commercial health plans are required now under that law with the new rule to provide to million members an ability to go from total opaqueness in price to total transparency in the costs of the tests and procedures and other things that they're faced with in their medical journeys."

"The mistake many of us made as consumers is that we believed our insurance carrier was a good surrogate to represent us as consumers in the marketplace. And what we never, many of us still don't realize, but many of us kind of woke up to is there's this thing called the 80/20 rule or medical loss ratio, which puts insurance carriers in a conflicted position. Their businesses are damaged financially by driving down the cost of medical claims because their revenues and premiums are tied to the amount of medical claims."

"So this is something people didn't know. And so while we put our trust in people to represent us as consumers, not realizing that it's not in their best interest to do the right things for us as consumers in terms of their normal business metrics, that it causes a huge conflict, financial conflict and perverted financial incentives in the market."

#TALONHealthtech #TransparencyinCoverage #MedicalCosts #PatientCare #AffordableCareAct #ReduceHealthcareCosts #Hospitals #MedicalBills #Healthcare #HealthTech #HealthcareReform

talonhealthtech.com

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Mark Galvin, Co-Founder, President, and CEO of TALON, discusses the Transparency in Coverage rule in healthcare, which was added to the Affordable Care Act and requires commercial health plan sponsors to provide transparency in the costs of tests, procedures, and other medical services. The rule aims to provide patients with information on pricing and out-of-pocket costs before committing to services. The lack of awareness and understanding of the rule is in part due to the vested interests of certain stakeholders, such as insurance carriers, who are financially conflicted in driving down the cost of medical claims.

Mark explains, "I'm known as a disruptive innovator, as a serial startup guy. The Transparency in Coverage rule is a rule that was added to the Affordable Care Act, or Obamacare, requiring that commercial health plan sponsors predominantly the employers that pay for the lion's share of commercial health plans are required now under that law with the new rule to provide to million members an ability to go from total opaqueness in price to total transparency in the costs of the tests and procedures and other things that they're faced with in their medical journeys."

"The mistake many of us made as consumers is that we believed our insurance carrier was a good surrogate to represent us as consumers in the marketplace. And what we never, many of us still don't realize, but many of us kind of woke up to is there's this thing called the 80/20 rule or medical loss ratio, which puts insurance carriers in a conflicted position. Their businesses are damaged financially by driving down the cost of medical claims because their revenues and premiums are tied to the amount of medical claims."

"So this is something people didn't know. And so while we put our trust in people to represent us as consumers, not realizing that it's not in their best interest to do the right things for us as consumers in terms of their normal business metrics, that it causes a huge conflict, financial conflict and perverted financial incentives in the market."

#TALONHealthtech #TransparencyinCoverage #MedicalCosts #PatientCare #AffordableCareAct #ReduceHealthcareCosts #Hospitals #MedicalBills #Healthcare #HealthTech #HealthcareReform

talonhealthtech.com

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Alice Lin, DCT Solutions Director in the DCT Business Department of Tigermed Consulting, a global CRO, contract research organization, that provides biopharmaceutical and medical device companies with a range of services including digital technology to conduct decentralized clinical trials. Their approach focuses on patient-centricity, efficiency, and adaptability. By utilizing digital tools such as virtual visits, wearable devices, and mobile apps, Tigermed aims to make clinical trials more accessible and convenient for patients, improving recruitment and retention rates. They also emphasize the importance of DCT in including a diverse patient population in trials, particularly for rare diseases.

Alice explains, "While our headquarters is in China, we have grown into a global team of over 10,000 employees operating across over 180 locations worldwide. We recently celebrated our 20th anniversary, making two decades of dedicated collaborations with over 2,800 customers on their product journeys. DCT stands for decentralized clinical trials, which involves applying digital technologies to conduct clinical trials. Traditionally, most clinical trial activities are conducted at clinical sites. Still, with DCT, we can conduct some or even all of the trial procedures outside of these sites using digital technology."

"Currently, the hybrid DCT model is a common thing in clinical trials. It means some of the trial procedures could be conducted outside of clinical sites, but still keep some clinical trial activities at clinical sites. In our Tigermed DCT department, we are responsible for identifying the appropriate digital technologies for using in clinical trials, whether through self-development or collaboration with the various digital technology companies. We also manage the DCT daily operations in each clinical trial from the study beginning to the study completion."

"However, we get that every investigational product and the therapeutic areas bring its own set of challenges and patient needs. So, we make it a priority to figure out what digital tools work best for each study. Our CEO, Dr. Cao, and our head of the DCT business department always say our goal is not just to do decentralized clinical trials for the sake of it. It's about giving patients and caregivers options that fit their needs. This approach means patients and caregivers get solutions that work for them, showing that we are all about being flexible to what they need. Our decentralized clinical trials are all about making things easier for patients, lightening the load for our caregivers, and making the whole trial experience better for all stakeholders involved."

#TigermedGRP #CRO #ContractResearchOrganization #DCT #DecentralizedClinicalTrials #MedTech #RemoteMonitoring

TigermedGRP.com

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Alice Lin, DCT Solutions Director in the DCT Business Department of Tigermed Consulting, a global CRO, contract research organization, that provides biopharmaceutical and medical device companies with a range of services including digital technology to conduct decentralized clinical trials. Their approach focuses on patient-centricity, efficiency, and adaptability. By utilizing digital tools such as virtual visits, wearable devices, and mobile apps, Tigermed aims to make clinical trials more accessible and convenient for patients, improving recruitment and retention rates. They also emphasize the importance of DCT in including a diverse patient population in trials, particularly for rare diseases.

Alice explains, "While our headquarters is in China, we have grown into a global team of over 10,000 employees operating across over 180 locations worldwide. We recently celebrated our 20th anniversary, making two decades of dedicated collaborations with over 2,800 customers on their product journeys. DCT stands for decentralized clinical trials, which involves applying digital technologies to conduct clinical trials. Traditionally, most clinical trial activities are conducted at clinical sites. Still, with DCT, we can conduct some or even all of the trial procedures outside of these sites using digital technology."

"Currently, the hybrid DCT model is a common thing in clinical trials. It means some of the trial procedures could be conducted outside of clinical sites, but still keep some clinical trial activities at clinical sites. In our Tigermed DCT department, we are responsible for identifying the appropriate digital technologies for using in clinical trials, whether through self-development or collaboration with the various digital technology companies. We also manage the DCT daily operations in each clinical trial from the study beginning to the study completion."

"However, we get that every investigational product and the therapeutic areas bring its own set of challenges and patient needs. So, we make it a priority to figure out what digital tools work best for each study. Our CEO, Dr. Cao, and our head of the DCT business department always say our goal is not just to do decentralized clinical trials for the sake of it. It's about giving patients and caregivers options that fit their needs. This approach means patients and caregivers get solutions that work for them, showing that we are all about being flexible to what they need. Our decentralized clinical trials are all about making things easier for patients, lightening the load for our caregivers, and making the whole trial experience better for all stakeholders involved."

#TigermedGRP #CRO #ContractResearchOrganization #DCT #DecentralizedClinicalTrials #MedTech #RemoteMonitoring

TigermedGRP.com

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Dr. Marshall Fordyce, CEO and Founder of Vera Therapeutics, discusses the company's patient-centric approach to developing new medicines for autoimmune diseases. Vera is currently in Phase 3 with a molecule called Atacicept, which targets B cells in autoimmune diseases. They focus on IgA nephropathy, a rare kidney disease, and the third most common cause of kidney failure. A key concern is that declining kidney function is often misdiagnosed and not screened for because the early warning signs are so subtle.

Marshall explains, "Let me give you an example of our lead indication. So, our molecule in development is called atacicept. It targets the immune system in the specific area of B cells, and B cells are the factories of our antibodies, which we need to fight infection over our lifetime. But in patients with autoimmune disease, these B cells are overstimulated, they're overactive, and there are only a few medicines that target B cells with an appropriate balance of safety and efficacy. We had an insight that the science told us that by inhibiting two key factors in the body, BAFF and APRIL, we could normalize that overactivity of B cells and have better outcomes."

"Now traditional drug development may be long and expensive. We were very strategic in picking IgA nephropathy. This is an area that has had very little drug development over the last decade. A few small companies started to become interested in this area, and thankfully, because of patient advocacy, the FDA allowed a surrogate endpoint in Phase 3 trials, which made it more efficient to bring this molecule forward. So, there are now two drugs on the market for the first time in the last three or four years, for two new drugs in IgA nephropathy. They don't target B cells, which is really what's driving this disease. They work downstream, or they're nonspecific."

"What Vera did differently is that we thought that we could actually demonstrate that kidney function, which in these young patients is declining at an alarming rate, if we could demonstrate that kidney function doesn't decline, that would be meaningful. It would be a significant leap. We don't see that happen in "traditional" drug development often, in my view. So, I think what's different here is that we're picking an area where we think we can intervene and, in early-stage development, show a meaningful improvement in outcomes for patients."

#VeraTherapeutics #KidneyDisease #RareDisease #BCells #Immunotherapy #AutoimmuneDiseases #IgANephropathy

veratx.com

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Dr. Marshall Fordyce, CEO and Founder of Vera Therapeutics, discusses the company's patient-centric approach to developing new medicines for autoimmune diseases. Vera is currently in Phase 3 with a molecule called Atacicept, which targets B cells in autoimmune diseases. They focus on IgA nephropathy, a rare kidney disease, and the third most common cause of kidney failure. A key concern is that declining kidney function is often misdiagnosed and not screened for because the early warning signs are so subtle.

Marshall explains, "Let me give you an example of our lead indication. So, our molecule in development is called atacicept. It targets the immune system in the specific area of B cells, and B cells are the factories of our antibodies, which we need to fight infection over our lifetime. But in patients with autoimmune disease, these B cells are overstimulated, they're overactive, and there are only a few medicines that target B cells with an appropriate balance of safety and efficacy. We had an insight that the science told us that by inhibiting two key factors in the body, BAFF and APRIL, we could normalize that overactivity of B cells and have better outcomes."

"Now traditional drug development may be long and expensive. We were very strategic in picking IgA nephropathy. This is an area that has had very little drug development over the last decade. A few small companies started to become interested in this area, and thankfully, because of patient advocacy, the FDA allowed a surrogate endpoint in Phase 3 trials, which made it more efficient to bring this molecule forward. So, there are now two drugs on the market for the first time in the last three or four years, for two new drugs in IgA nephropathy. They don't target B cells, which is really what's driving this disease. They work downstream, or they're nonspecific."

"What Vera did differently is that we thought that we could actually demonstrate that kidney function, which in these young patients is declining at an alarming rate, if we could demonstrate that kidney function doesn't decline, that would be meaningful. It would be a significant leap. We don't see that happen in "traditional" drug development often, in my view. So, I think what's different here is that we're picking an area where we think we can intervene and, in early-stage development, show a meaningful improvement in outcomes for patients."

#VeraTherapeutics #KidneyDisease #RareDisease #BCells #Immunotherapy #AutoimmuneDiseases #IgANephropathy

veratx.com

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Pascal Prigent, the CEO of GENFIT, a French biotech that has been working on liver diseases for about 20 years and has developed a compound called elafibranor for conditions such as primary biliary cholangitis (PBC). The company is also developing assets in acute-on-chronic liver failure (ACLF). He highlights the high unmet medical need in ACLF, which currently has no approved treatment options and a high mortality rate. Prigent also discusses Genfit's partnership with Ipsen for the development and commercialization of elafibranor in PBC.

Pascal explains, "In reality, we don't have any approved option in ACLF, which is actually quite dramatic because you have a high mortality rate. To give you a little bit of context, people are suffering from chronic liver disease, regardless of the etiology. It can be too much alcohol consumption, it could be NASH, it could be viral hepatitis. Any kind of chronic liver disease will give us all the same journey, if you will."

"First, you have an injury to the liver. Then you have a progressive liver scar. You have the setup of fibrosis, that fibrosis becomes worse and worse. It becomes bridging fibrosis, but at some point, it will become cirrhosis. And that cirrhosis is first compensated, and then one day it can decompensate, and on that already failing organ, you have a precipitating factor."

"That precipitating factor could be an infection, binge-drinking, or drug-induced trauma. That stress on an already sick organ will get the liver to decompensate, and that decompensation of the liver will trigger additional organ decomposition, and that's what ACLF is. It's a syndrome at the very end of chronic liver diseases."

#GENFIT #LiverDisease #NASH #PBC #ACLF #LiverFailure #Hepatitis #ChronicLiverDisease #RareDisease

GENFIT.com

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Pascal Prigent, the CEO of GENFIT, a French biotech that has been working on liver diseases for about 20 years and has developed a compound called elafibranor for conditions such as primary biliary cholangitis (PBC). The company is also developing assets in acute-on-chronic liver failure (ACLF). He highlights the high unmet medical need in ACLF, which currently has no approved treatment options and a high mortality rate. Prigent also discusses Genfit's partnership with Ipsen for the development and commercialization of elafibranor in PBC.

Pascal explains, "In reality, we don't have any approved option in ACLF, which is actually quite dramatic because you have a high mortality rate. To give you a little bit of context, people are suffering from chronic liver disease, regardless of the etiology. It can be too much alcohol consumption, it could be NASH, it could be viral hepatitis. Any kind of chronic liver disease will give us all the same journey, if you will."

"First, you have an injury to the liver. Then you have a progressive liver scar. You have the setup of fibrosis, that fibrosis becomes worse and worse. It becomes bridging fibrosis, but at some point, it will become cirrhosis. And that cirrhosis is first compensated, and then one day it can decompensate, and on that already failing organ, you have a precipitating factor."

"That precipitating factor could be an infection, binge-drinking, or drug-induced trauma. That stress on an already sick organ will get the liver to decompensate, and that decompensation of the liver will trigger additional organ decomposition, and that's what ACLF is. It's a syndrome at the very end of chronic liver diseases."

#GENFIT #LiverDisease #NASH #PBC #ACLF #LiverFailure #Hepatitis #ChronicLiverDisease #RareDisease

GENFIT.com

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