Empowered Patient Podcast

Ketan Mehta, Founder and CEO of Tris Pharma, is focused on developing non-addictive pain medication. Their lead drug candidate is designed to be an effective pain drug without the respiratory-depressive and addictive side effects of traditional opioid drugs. This drug works by targeting the nociceptin receptor and has also shown promise to help curb cravings and dependence on opioids. The goal is to provide doctors and patients with a non-opioid pain medication option that can help reduce reliance on highly addictive prescription opioids.

Ketan explains, "Tris is focused on neuroscience-based products, especially CNS, at a high level. More specifically, we focused on ADHD and neurodevelopmental disorders and the products that treat them. And also, more recently, we have been more active in the pain space."

"We're developing a drug, which is currently an investigational drug in Phase three clinical trials. It's called cebranopadol. And what we have seen is that it has an efficacy just on par with your typical traditional opioid. It's highly effective from what we have seen in more than 2,000 patients to date. But also, what we're seeing thus far is that there is no indication that it creates dependency. You can just taper off the patients, meaning you don't have to give lesser dose even after pain has subsided. And it does not give you the level of respiratory depression or failure that we see with the traditional opioid."

"Right now, we're conducting our first trials in acute pain, and then we will look at any kind of moderate to severe pain. Essentially like chronic pain, lower back pain, for example, the pain in arthritis, cancer pain, other disease conditions like fibromyalgia, or just any kind of injury that gives you pretty much any nociceptive pain that one would encounter, we expect, like diabetic peripheral neuropathy and so forth."

#TrisPharma #PainManagement #ClinicalTrial #Innovation #PainTherapy #Cebranopadol

trispharma.com

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Ketan Mehta, Founder and CEO of Tris Pharma, is focused on developing non-addictive pain medication. Their lead drug candidate is designed to be an effective pain drug without the respiratory-depressive and addictive side effects of traditional opioid drugs. This drug works by targeting the nociceptin receptor and has also shown promise to help curb cravings and dependence on opioids. The goal is to provide doctors and patients with a non-opioid pain medication option that can help reduce reliance on highly addictive prescription opioids.

Ketan explains, "Tris is focused on neuroscience-based products, especially CNS, at a high level. More specifically, we focused on ADHD and neurodevelopmental disorders and the products that treat them. And also, more recently, we have been more active in the pain space."

"We're developing a drug, which is currently an investigational drug in Phase three clinical trials. It's called cebranopadol. And what we have seen is that it has an efficacy just on par with your typical traditional opioid. It's highly effective from what we have seen in more than 2,000 patients to date. But also, what we're seeing thus far is that there is no indication that it creates dependency. You can just taper off the patients, meaning you don't have to give lesser dose even after pain has subsided. And it does not give you the level of respiratory depression or failure that we see with the traditional opioid."

"Right now, we're conducting our first trials in acute pain, and then we will look at any kind of moderate to severe pain. Essentially like chronic pain, lower back pain, for example, the pain in arthritis, cancer pain, other disease conditions like fibromyalgia, or just any kind of injury that gives you pretty much any nociceptive pain that one would encounter, we expect, like diabetic peripheral neuropathy and so forth."

#TrisPharma #PainManagement #ClinicalTrial #Innovation #PainTherapy #Cebranopadol

trispharma.com

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Beth Houck, Chief Executive Officer at SonarMD, works with payers and physician practices to provide proactive, value-based care for patients with chronic GI conditions. They use a digital platform to monitor self-reported patient symptoms and enable physicians to identify those patients that need attention. This approach aims to improve patient outcomes and reduce emergency room visits and hospitalizations.

Beth explains, "SonarMD manages patients with chronic gut health conditions, and specifically, we started with something called inflammatory bowel disease, which is the encompassing word for patients with Crohn's and ulcerative colitis. We develop a value-based contract with a payer, so somebody at risk for the cost of care of a patient, and then we bring that cost of care program to a physician's office. In collaboration with that physician, we manage a population of patients to have better outcomes for their chronic GI conditions."

"We just talk about this as a shift to proactive care from reactive care. So rather than the loudest patients being seen, we will have patients that we surface as the most important patients for them to see. So we reach out to our patients and do it very lightly with a text message or email. We tell them a little bit about the program. We talk to them about how we're doing this on behalf of their physician practice and in collaboration with them. So this isn't something that's being forced on you by a payer. We ping those patients, which is the term we use on a regular basis, to collect their reported outcomes or the symptoms they're having with their disease."

#SonarMD #DigitalHealth #Healthcare #VBC #ValuebasedCare #GI #IBD

SonarMD.com

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Beth Houck, Chief Executive Officer at SonarMD, works with payers and physician practices to provide proactive, value-based care for patients with chronic GI conditions. They use a digital platform to monitor self-reported patient symptoms and enable physicians to identify those patients that need attention. This approach aims to improve patient outcomes and reduce emergency room visits and hospitalizations.

Beth explains, "SonarMD manages patients with chronic gut health conditions, and specifically, we started with something called inflammatory bowel disease, which is the encompassing word for patients with Crohn's and ulcerative colitis. We develop a value-based contract with a payer, so somebody at risk for the cost of care of a patient, and then we bring that cost of care program to a physician's office. In collaboration with that physician, we manage a population of patients to have better outcomes for their chronic GI conditions."

"We just talk about this as a shift to proactive care from reactive care. So rather than the loudest patients being seen, we will have patients that we surface as the most important patients for them to see. So we reach out to our patients and do it very lightly with a text message or email. We tell them a little bit about the program. We talk to them about how we're doing this on behalf of their physician practice and in collaboration with them. So this isn't something that's being forced on you by a payer. We ping those patients, which is the term we use on a regular basis, to collect their reported outcomes or the symptoms they're having with their disease."

#SonarMD #DigitalHealth #Healthcare #VBC #ValuebasedCare #GI #IBD

SonarMD.com

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Dr. Chris Bouton, the Senior VP and Head of Artificial Intelligence at Certara, is exploring applying generative AI to drug discovery and development to improve efficiency and identify novel therapeutics across various use cases. The focus is on developing specialized secure AI models to integrate internal data with the Certara platform. Generative AI is particularly useful in areas with high specificity, such as antibody design and mRNA therapeutics, where modeling the underlying biology is crucial.

Chris explains, "Certara helps pharmaceutical and biotech companies throughout their process, from early basic research to regulatory filing and beyond. And we're quite a unique company in that we are not developing our own drugs but instead helping companies develop their drugs. And it's something like over 90% of all FDA approvals are projects that, in some way, shape, or form, Certara has helped with."

"Our philosophy is to start with the use case. Generative AI is an incredible novel technology. There are many different ways to apply it, but we're interested in how to turbocharge or otherwise ameliorate and create efficiencies in a wide range of the use cases that Certara works on. What we're doing is taking a look at each of those kinds of use cases, trying to identify whether generative AI is useful in those use cases. Then, build out technology-driven solutions that are a combination of gen AI plus services, plus data, plus other software for each of those use cases."

#Certara #GenerativeAI #HealthAI #DrugDiscovery #DrugDevelopment

certara.com

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Dr. Chris Bouton, the Senior VP and Head of Artificial Intelligence at Certara, is exploring applying generative AI to drug discovery and development to improve efficiency and identify novel therapeutics across various use cases. The focus is on developing specialized secure AI models to integrate internal data with the Certara platform. Generative AI is particularly useful in areas with high specificity, such as antibody design and mRNA therapeutics, where modeling the underlying biology is crucial.

Chris explains, "Certara helps pharmaceutical and biotech companies throughout their process, from early basic research to regulatory filing and beyond. And we're quite a unique company in that we are not developing our own drugs but instead helping companies develop their drugs. And it's something like over 90% of all FDA approvals are projects that, in some way, shape, or form, Certara has helped with."

"Our philosophy is to start with the use case. Generative AI is an incredible novel technology. There are many different ways to apply it, but we're interested in how to turbocharge or otherwise ameliorate and create efficiencies in a wide range of the use cases that Certara works on. What we're doing is taking a look at each of those kinds of use cases, trying to identify whether generative AI is useful in those use cases. Then, build out technology-driven solutions that are a combination of gen AI plus services, plus data, plus other software for each of those use cases."

#Certara #GenerativeAI #HealthAI #DrugDiscovery #DrugDevelopment

certara.com

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David Happel is President and CEO of Sagimet Biosciences, a company developing drugs to treat metabolic diseases by targeting the underlying cause of fat accumulation in the liver. The drug denifanstat limits the activity of fatty acid synthase (FASN), an enzyme that regulates fat accumulation. This approach is a fat inhibitor, not a fat burner, the focus of other MASH drugs.

David explains, "Sagimet was founded back in 2007 as a private company with a group of medicinal chemists that had a particular target in mind, and this particular target was called fatty acid synthase, or FASN. FASN is a rather ubiquitous enzyme throughout the body that functions as a regulating enzyme in many organs. When FASN becomes overactive or overexpressed, it sort of throws things out of balance and, in particular, certain cardiometabolic diseases, such as MASH and in the liver. So, this group of chemists, in order to resolve this overactivity, developed a portfolio of FASN inhibitors, led by our lead program denifanstat, that seek to target the underlying cause of MASH and, therefore, really work to limit the activity of FASN, try to normalize it essentially is what we do."

"For us and this particular molecule, it offers a differentiated approach to treating the disease. Our molecule, denifanstat, is the only fat synthesis inhibitor in development for MASH, making it rather unique. All the rest of the molecules are fat burners, fat oxidizers, and fat mobilizers, including GLPs, FGF, and THR-beta. They all function by trying to burn fat peripherally and in the liver to a degree. They rely on that fat-burning mechanism to translate into downstream reductions in inflammation and fibrosis, which is important to treating MASH, but they've had varying degrees of success. Our molecule targets each pathway independently: fat, inflammation, and fibrosis, and has had a rather pronounced treatment effect as a result."

#SagimetBiosciences #MASH #FattyLiverDisease #FASN #FASNInhibitor #Fibrosis #Obesity #NASH #GLP1Agonists

sagimet.com

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David Happel is President and CEO of Sagimet Biosciences, a company developing drugs to treat metabolic diseases by targeting the underlying cause of fat accumulation in the liver. The drug denifanstat limits the activity of fatty acid synthase (FASN), an enzyme that regulates fat accumulation. This approach is a fat inhibitor, not a fat burner, the focus of other MASH drugs.

David explains, "Sagimet was founded back in 2007 as a private company with a group of medicinal chemists that had a particular target in mind, and this particular target was called fatty acid synthase, or FASN. FASN is a rather ubiquitous enzyme throughout the body that functions as a regulating enzyme in many organs. When FASN becomes overactive or overexpressed, it sort of throws things out of balance and, in particular, certain cardiometabolic diseases, such as MASH and in the liver. So, this group of chemists, in order to resolve this overactivity, developed a portfolio of FASN inhibitors, led by our lead program denifanstat, that seek to target the underlying cause of MASH and, therefore, really work to limit the activity of FASN, try to normalize it essentially is what we do."

"For us and this particular molecule, it offers a differentiated approach to treating the disease. Our molecule, denifanstat, is the only fat synthesis inhibitor in development for MASH, making it rather unique. All the rest of the molecules are fat burners, fat oxidizers, and fat mobilizers, including GLPs, FGF, and THR-beta. They all function by trying to burn fat peripherally and in the liver to a degree. They rely on that fat-burning mechanism to translate into downstream reductions in inflammation and fibrosis, which is important to treating MASH, but they've had varying degrees of success. Our molecule targets each pathway independently: fat, inflammation, and fibrosis, and has had a rather pronounced treatment effect as a result."

#SagimetBiosciences #MASH #FattyLiverDisease #FASN #FASNInhibitor #Fibrosis #Obesity #NASH #GLP1Agonists

sagimet.com

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Dr. Gavin Magaha, Senior Director for External Affairs and Policy at Kalderos, describes the 340B drug discount program created in 1992 to help safety net healthcare providers obtain discounted drugs. Over time, this program has grown in complexity, and issues have arisen around duplicate discounts where Medicaid rebates are involved. The current 340B system makes it difficult for stakeholders to share data and lacks transparency. The Kalderos platform incorporates technology and AI and ML tools to address data sharing, validate claims, and prevent duplicate discounts.

Gavin explains, "Our platform primarily helps manufacturers. However, through the activities that we provide service for, we end up helping all stakeholders in a compliant manner or be more compliant with several different drug discount programs, primarily the intersection of the 340B and the Medicaid Drug Rebate programs. We work to help the states, the covered entities in the program, and the manufacturers. All come to a resolution of what's happening out there when you start looking at the data that's going through."

"Top of mind right now that you're hearing in the marketplace around 340B is the concept of who is a patient of a covered entity, what does it mean to be a patient of, whether it's a hospital or a federally qualified health center. The 340B statute is silent on how it defines who a patient is. A lot of the outpatient services that are taking place with hospitals are growing and reaching out into the communities to create more access to healthcare."

"And then you see this footprint of the hospitals growing and taking care of folks in the communities. And then how do you figure out who is a patient of a hospital, and are you a patient for just that one instance of care, or are you a patient of the hospital now in perpetuity? The question becomes, who's eligible for these 340B drugs? The statute, which again came around in the '90s, doesn't really define who a patient is. It puts a burden and challenge out there for almost all stakeholders to comply with this policy."

#Kalderos #DrugDiscountManagement #340BDiscount #MedicaidDrugRebateProgram #DuplicativeClaims #CoveredEntities #NoncompliantDrugDiscounts #SafetynetProviders #DrugManufacturers

Kalderos.com

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Dr. Gavin Magaha, Senior Director for External Affairs and Policy at Kalderos, describes the 340B drug discount program created in 1992 to help safety net healthcare providers obtain discounted drugs. Over time, this program has grown in complexity, and issues have arisen around duplicate discounts where Medicaid rebates are involved. The current 340B system makes it difficult for stakeholders to share data and lacks transparency. The Kalderos platform incorporates technology and AI and ML tools to address data sharing, validate claims, and prevent duplicate discounts.

Gavin explains, "Our platform primarily helps manufacturers. However, through the activities that we provide service for, we end up helping all stakeholders in a compliant manner or be more compliant with several different drug discount programs, primarily the intersection of the 340B and the Medicaid Drug Rebate programs. We work to help the states, the covered entities in the program, and the manufacturers. All come to a resolution of what's happening out there when you start looking at the data that's going through."

"Top of mind right now that you're hearing in the marketplace around 340B is the concept of who is a patient of a covered entity, what does it mean to be a patient of, whether it's a hospital or a federally qualified health center. The 340B statute is silent on how it defines who a patient is. A lot of the outpatient services that are taking place with hospitals are growing and reaching out into the communities to create more access to healthcare."

"And then you see this footprint of the hospitals growing and taking care of folks in the communities. And then how do you figure out who is a patient of a hospital, and are you a patient for just that one instance of care, or are you a patient of the hospital now in perpetuity? The question becomes, who's eligible for these 340B drugs? The statute, which again came around in the '90s, doesn't really define who a patient is. It puts a burden and challenge out there for almost all stakeholders to comply with this policy."

#Kalderos #DrugDiscountManagement #340BDiscount #MedicaidDrugRebateProgram #DuplicativeClaims #CoveredEntities #NoncompliantDrugDiscounts #SafetynetProviders #DrugManufacturers

Kalderos.com

Download the transcript here