Empowered Patient Podcast Karen Jagoda

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
Listen to the podcast here

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
Download the transcript here

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
Listen to the podcast here

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
Download the transcript here

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 nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and 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
Listen to the podcast here

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 nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and 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
Download the transcript here