Empowered Patient Podcast

Andrea James, Chief Financial Officer at iMDx, is focused on expanding access to innovative molecular diagnostic testing staring with a test for monitoring transplanted organ health. The test measures the donor-derived cell-free DNA which can indicate the need for drugs to target organ rejection before invasive procedures are required. The company is developing a kit-based version of the test that can be run by hospitals rather than relying on centralized labs, to increase access to this diagnostic and improve transplant outcomes.

Andrea explains, "We changed our name on June 17th from OncoCyte, as you had just referenced, to Insight Molecular Diagnostics Inc. We're now going by iMDx, and our mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes."

"We actually have three pieces of IP, intellectual property, and we are initially commercializing in transplant. So we measure a biomarker called donor-derived cell-free DNA, don't get too hung up on it. That's a lot of words. It basically looks for fragments of DNA in the blood, which can indicate transplanted organ damage and therefore rejection. And so that is where we are commercializing first."

"What's really interesting is that the innovations in this space are, okay, so let's say you've been on dialysis, that's a really tough life. You finally get your transplanted kidney, and now let's say your body is starting to reject it. You're one of those one in five who were a match, your kidney was a match for you, but then your immune system is attacking it anyway. That used to be almost a death sentence."

"Your options there were you're going to lose your kidney, you go back on dialysis, or you lose your life. But now there are therapies that are coming out to treat antibody-mediated rejection, or AMR, and our test is being used to monitor the efficacy of those therapies."

#iMDx #MolecularDiagnostics #Molecular #Diagnostics #Healthcare #PrecisionMedicine #Genomics #Decentralized #LiquidBiopsy #DigitalPCR #Transplant #Localization #Labs #PointOfCareTesting #RapidCare #Democratization

imdxinc.com

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Andrea James, Chief Financial Officer at iMDx, is focused on expanding access to innovative molecular diagnostic testing staring with a test for monitoring transplanted organ health. The test measures the donor-derived cell-free DNA which can indicate the need for drugs to target organ rejection before invasive procedures are required. The company is developing a kit-based version of the test that can be run by hospitals rather than relying on centralized labs, to increase access to this diagnostic and improve transplant outcomes.

Andrea explains, "We changed our name on June 17th from OncoCyte, as you had just referenced, to Insight Molecular Diagnostics Inc. We're now going by iMDx, and our mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes."

"We actually have three pieces of IP, intellectual property, and we are initially commercializing in transplant. So we measure a biomarker called donor-derived cell-free DNA, don't get too hung up on it. That's a lot of words. It basically looks for fragments of DNA in the blood, which can indicate transplanted organ damage and therefore rejection. And so that is where we are commercializing first."

"What's really interesting is that the innovations in this space are, okay, so let's say you've been on dialysis, that's a really tough life. You finally get your transplanted kidney, and now let's say your body is starting to reject it. You're one of those one in five who were a match, your kidney was a match for you, but then your immune system is attacking it anyway. That used to be almost a death sentence."

"Your options there were you're going to lose your kidney, you go back on dialysis, or you lose your life. But now there are therapies that are coming out to treat antibody-mediated rejection, or AMR, and our test is being used to monitor the efficacy of those therapies."

#iMDx #MolecularDiagnostics #Molecular #Diagnostics #Healthcare #PrecisionMedicine #Genomics #Decentralized #LiquidBiopsy #DigitalPCR #Transplant #Localization #Labs #PointOfCareTesting #RapidCare #Democratization

imdxinc.com

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James Hereford, President and CEO of Fairview Health Services, describes this Minnesota-based healthcare system's $600 million turnaround and the importance of focusing on people and processes, not just technology changes. Addressing staff shortages, quality of care, and patient experience led to finding a holistic approach that improved financial outcomes and changed the culture in a sustainable way. Investments have been made in community programs like food access and vaccination events, recognizing the impact of social determinants of health on patient outcomes.

James explains, "When doing this, we have to think about sustainability, and there are things that you can do, like mass layoffs, that can change the short-term economics of an organization. They're just not sustainable. The work hasn't gone away. You haven't changed the nature of work, and we really tried to focus on the people in the process side of this and really make our focus on our processes."

"The other problem with thinking only about the financial turnaround and the direct cost drivers is that it's not the only measure of success for a healthcare organization. It's also about the quality and safety of the care we provide. It's about the experience we provide for our patients, and it's about the culture and the environment in which our caregivers and others provide that care. And so we had to be thinking more holistically about the nature of the turnaround and what we had to do to achieve all of those outcomes."

#FairviewHealth #Hospitals #Healthcare #FinancialTurnaround #HealthcareDelivery #FoodAccess #DigitalHealth #LeadershipSkills #Minnesota

fairview.org

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James Hereford, President and CEO of Fairview Health Services, describes this Minnesota-based healthcare system's $600 million turnaround and the importance of focusing on people and processes, not just technology changes. Addressing staff shortages, quality of care, and patient experience led to finding a holistic approach that improved financial outcomes and changed the culture in a sustainable way. Investments have been made in community programs like food access and vaccination events, recognizing the impact of social determinants of health on patient outcomes.

James explains, "When doing this, we have to think about sustainability, and there are things that you can do, like mass layoffs, that can change the short-term economics of an organization. They're just not sustainable. The work hasn't gone away. You haven't changed the nature of work, and we really tried to focus on the people in the process side of this and really make our focus on our processes."

"The other problem with thinking only about the financial turnaround and the direct cost drivers is that it's not the only measure of success for a healthcare organization. It's also about the quality and safety of the care we provide. It's about the experience we provide for our patients, and it's about the culture and the environment in which our caregivers and others provide that care. And so we had to be thinking more holistically about the nature of the turnaround and what we had to do to achieve all of those outcomes."

#FairviewHealth #Hospitals #Healthcare #FinancialTurnaround #HealthcareDelivery #FoodAccess #DigitalHealth #LeadershipSkills #Minnesota

fairview.org

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teve Butts, Co-Founder and CEO of Arrivo BioVentures, is a biopharmaceutical company focused on developing therapies that target the root causes of disease rather than just treating the symptoms. Their drugs treat major depressive disorder and acute pancreatitis through novel epigenetic mechanisms of action. Sex-based differences were observed in clinical trials where the drug SP-624 showed efficacy in females but not in males, which could lead to a paradigm shift in how depression is treated in men and women.

Steve explains, "We've evolved over time at Arrivo and with our previous companies. What we're excited about right now is the fact that we have two drugs. One called SP-624 or Forvisirvat is the generic name, and the other one is code-named RABI-767. And as we've gotten into the science behind these drugs, what we're finding is that we're not just treating the symptoms of a disease, but we're really trying to get at what's causing the disease fundamentally and trying to make an impact there. And I think from a drug development standpoint - I've been doing this for 30 years - these are the two most exciting programs that I've had a chance to work on for a variety of reasons. One is the science, and they're both novel and new approaches to treating the diseases, but two, if we're right, they're going to create a situation where we're going to think about these diseases differently."

"We ran a large Phase 2 study. It was the first study we had run in patients with depression, and it was really the first study that anyone had run with a SIRT6 activator in patients with depression. And so we were breaking new ground there, and it was a pretty large study. When we got the results, what we found was that there were really nice effects in females across all of the measures that we had and no evidence of efficacy in males. And that was really puzzling to us. It wasn't what we were expecting. And we started diving into, well, what could be going on here? Science is iterative, and I think you do a trial, and trials lead to more questions. And so we started diving into the questions that we had around "Why the sex difference?"

#ArrivoBioVentures #MentalHealth #Neuroscience #WomensHealth #Depression #DepressionTreatment #Psychiatry #PrecisionMedicine

arrivobio.com

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Steve Butts, Co-Founder and CEO of Arrivo BioVentures, is a biopharmaceutical company focused on developing therapies that target the root causes of disease rather than just treating the symptoms. Their drugs treat major depressive disorder and acute pancreatitis through novel epigenetic mechanisms of action. Sex-based differences were observed in clinical trials where the drug SP-624 showed efficacy in females but not in males, which could lead to a paradigm shift in how depression is treated in men and women.

Steve explains, "We've evolved over time at Arrivo and with our previous companies. What we're excited about right now is the fact that we have two drugs. One called SP-624 or Forvisirvat is the generic name, and the other one is code-named RABI-767. And as we've gotten into the science behind these drugs, what we're finding is that we're not just treating the symptoms of a disease, but we're really trying to get at what's causing the disease fundamentally and trying to make an impact there. And I think from a drug development standpoint - I've been doing this for 30 years - these are the two most exciting programs that I've had a chance to work on for a variety of reasons. One is the science, and they're both novel and new approaches to treating the diseases, but two, if we're right, they're going to create a situation where we're going to think about these diseases differently."

"We ran a large Phase 2 study. It was the first study we had run in patients with depression, and it was really the first study that anyone had run with a SIRT6 activator in patients with depression. And so we were breaking new ground there, and it was a pretty large study. When we got the results, what we found was that there were really nice effects in females across all of the measures that we had and no evidence of efficacy in males. And that was really puzzling to us. It wasn't what we were expecting. And we started diving into, well, what could be going on here? Science is iterative, and I think you do a trial, and trials lead to more questions. And so we started diving into the questions that we had around "Why the sex difference?"

#ArrivoBioVentures #MentalHealth #Neuroscience #WomensHealth #Depression #DepressionTreatment #Psychiatry #PrecisionMedicine

arrivobio.com

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Daniel Blumenthal, VP of Strategy at MDClone, is building synthetic data models to mimic real patient data without the need to protect the identity of individuals. This type of data is being utilized in drug discovery and development, building predictive tools and new care models, and to better understand biases in clinical trials making them more representative. AI tools play an essential role in generating and validating synthetic data as well as integrating it into various processes and environments.

Daniel explains, "Synthetic data means different things to different people. So I definitely would want to start with sharing what it usually means to MDClone, which is creating data based on real populations of patients, real patient data. Learning from that real patient data, extracting essentially the statistics from that data, understanding the relevant patterns that exist inside that data, and then, based on the statistics alone, generating a brand-new set of data, a brand-new set of people, and the synthetic data that we generate."

"If you look at it, essentially with your naked eye, you wouldn't know it's not real people. It has the same structure, has the same content appearance, and yet, inside, synthetic data contains no real people. So very different from other approaches to protecting patient privacy, which take a patient data set and hash data, mask data, or remove information like IDs, names, or locations."

"Instead of taking that sort of approach, synthetic data actually generates a brand-new set of people, fake people, that in our case, as we build it, maintain the same statistical properties, such that any analysis you want to complete, you could accomplish using the synthetic dataset just as you would with the original dataset. That it will yield the same meaningful conclusions as the synthetic that it would with the original."

#MDClone #MedAI #AI #SyntheticData #DrugDevelopment #DrugDiscovery #ClinicalTrials #PatientPrivacy

mdclone.com

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Daniel Blumenthal, VP of Strategy at MDClone, is building synthetic data models to mimic real patient data without the need to protect the identity of individuals. This type of data is being utilized in drug discovery and development, building predictive tools and new care models, and to better understand biases in clinical trials making them more representative. AI tools play an essential role in generating and validating synthetic data as well as integrating it into various processes and environments.

Daniel explains, "Synthetic data means different things to different people. So I definitely would want to start with sharing what it usually means to MDClone, which is creating data based on real populations of patients, real patient data. Learning from that real patient data, extracting essentially the statistics from that data, understanding the relevant patterns that exist inside that data, and then, based on the statistics alone, generating a brand-new set of data, a brand-new set of people, and the synthetic data that we generate."

"If you look at it, essentially with your naked eye, you wouldn't know it's not real people. It has the same structure, has the same content appearance, and yet, inside, synthetic data contains no real people. So very different from other approaches to protecting patient privacy, which take a patient data set and hash data, mask data, or remove information like IDs, names, or locations."

"Instead of taking that sort of approach, synthetic data actually generates a brand-new set of people, fake people, that in our case, as we build it, maintain the same statistical properties, such that any analysis you want to complete, you could accomplish using the synthetic dataset just as you would with the original dataset. That it will yield the same meaningful conclusions as the synthetic that it would with the original."

#MDClone #MedAI #AI #SyntheticData #DrugDevelopment #DrugDiscovery #ClinicalTrials #PatientPrivacy

mdclone.com

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Rick Geoffrion, Founder and CEO of Cyrano Therapeutics, is developing a drug to restore olfactory function due to post-viral loss of smell and taste. As a result of COVID-19, there has been a significant increase in the number of people affected by long-term smell and taste loss, with no effective pharmaceutical options previously available. Smell loss can also be an early indicator of neurodegenerative conditions, suggesting future applications of the intranasal spray that aims to directly restore function to the olfactory receptor neurons.

Rick explains, "Taste and smell have a really strong connection, actually. First of all, they're two out of the five basic senses that we have as human beings. When you lose your sense of smell, people actually perceive that they've lost about 80% of their sense of taste. Now, technically, you're not losing your sense of taste. We actually just give our tongue too much credit. Our tongue is able to detect sweet, sour, salty, bitter, and umami. That's all it detects, and it detects them really in light monotone that are about 80% less intense if you've lost your sense of smell. In addition, if you no longer have your sense of smell, what you've really lost is the ability to detect flavor in food. So, to tell the difference between a peach, a pear, and a strawberry, maybe you'll tell that visually, but to tell it from a flavor perspective, you completely lose that ability.

"There really are no significant therapies to treat the condition right now. Essentially, if you've lost your sense of smell, a physician may recommend that you use smell training, which is essentially the regular smelling of intense essential oils, and they really haven't been shown to significantly treat or cure a chronic smell loss condition. It is thought that if your body is spontaneously recovering, say within those first few months, if you do undergo smell training, you may accelerate that recovery. But other than that, there's certainly no gold standard treatment or no significant treatments available right now, and no pharmaceuticals in the pipeline other than CYR-064, which is being developed by Cyrano."

#CyranoTherapeutics #Olfactory #LongCOVID #PostViralLoss #IntranasalSpray #SmellandTaste #LongTermSmellLoss

cyranotherapeutics.com

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Rick Geoffrion, Founder and CEO of Cyrano Therapeutics, is developing a drug to restore olfactory function due to post-viral loss of smell and taste. As a result of COVID-19, there has been a significant increase in the number of people affected by long-term smell and taste loss, with no effective pharmaceutical options previously available. Smell loss can also be an early indicator of neurodegenerative conditions, suggesting future applications of the intranasal spray that aims to directly restore function to the olfactory receptor neurons.

Rick explains, "Taste and smell have a really strong connection, actually. First of all, they're two out of the five basic senses that we have as human beings. When you lose your sense of smell, people actually perceive that they've lost about 80% of their sense of taste. Now, technically, you're not losing your sense of taste. We actually just give our tongue too much credit. Our tongue is able to detect sweet, sour, salty, bitter, and umami. That's all it detects, and it detects them really in light monotone that are about 80% less intense if you've lost your sense of smell. In addition, if you no longer have your sense of smell, what you've really lost is the ability to detect flavor in food. So, to tell the difference between a peach, a pear, and a strawberry, maybe you'll tell that visually, but to tell it from a flavor perspective, you completely lose that ability.

"There really are no significant therapies to treat the condition right now. Essentially, if you've lost your sense of smell, a physician may recommend that you use smell training, which is essentially the regular smelling of intense essential oils, and they really haven't been shown to significantly treat or cure a chronic smell loss condition. It is thought that if your body is spontaneously recovering, say within those first few months, if you do undergo smell training, you may accelerate that recovery. But other than that, there's certainly no gold standard treatment or no significant treatments available right now, and no pharmaceuticals in the pipeline other than CYR-064, which is being developed by Cyrano."

#CyranoTherapeutics #Olfactory #LongCOVID #PostViralLoss #IntranasalSpray #SmellandTaste #LongTermSmellLoss

cyranotherapeutics.com

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