Empowered Patient Podcast

David Klein, a longtime healthcare innovator and Founder and CEO of Click Therapeutics, is a pioneer in the field of prescription digital therapeutics, PDT, which are defined as software as medicine. Click has received FDA authorization for an app to treat depression and migraine and had a successful pivotal trial for an app treating negative symptoms of schizophrenia. These digital therapeutics are designed to fill significant gaps in current care and there are opportunities to combine software with drugs and biometric data from wearables to determine personalized treatment plans.

David explains, "Click's approach towards digital therapeutics is, I would say, probably the most rigorous from a clinical evidence perspective in the industry. So we really take a drug-like clinical approach to these programs where we discover and then validate these programs in multiple randomized control trials, all culminating usually in a pivotal trial. And on top of that, you'll often see in some other areas of the world or even in this country, to some degree, folks might say randomized control trial, but they're really using standard of care as the control or wait list control, and so on and so forth. We actually test our interventions against sham active control, so against other apps that control for time on task, expectation of benefit, and so on and so forth."

"Just a few months ago, we announced with Behringer Ingelheim, our partner in schizophrenia, that we hit our primary endpoint in our pivotal trial for our app that's designed to be a treatment of negative symptoms of schizophrenia. So, the holy grail, in serious mental illness altogether, but certainly in schizophrenia, is trying to mitigate negative symptoms of schizophrenia. This is such a huge patient issue and frankly an economic issue that none of the drugs have been successful at actually hitting it. So that's a unique one because we showed that an app can actually effectively and safely treat a disease that even a drug can't."

#ClickTherapeutics #DigitalTherapeutics #DigitalHealth #FDA #MedicalDevices #SoftwareAsMedicine #HealthTech #Innovation #Migraine #Depression #Schizophrenia #PrescriptionApps #PDT #PrescriptionDigitalTherapeutics #ClinicalTrials #HealthcareInnovation

clicktherapeutics.com

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David Klein, a longtime healthcare innovator and Founder and CEO of Click Therapeutics, is a pioneer in the field of prescription digital therapeutics, PDT, which are defined as software as medicine. Click has received FDA authorization for an app to treat depression and migraine and had a successful pivotal trial for an app treating negative symptoms of schizophrenia. These digital therapeutics are designed to fill significant gaps in current care and there are opportunities to combine software with drugs and biometric data from wearables to determine personalized treatment plans.

David explains, "Click's approach towards digital therapeutics is, I would say, probably the most rigorous from a clinical evidence perspective in the industry. So we really take a drug-like clinical approach to these programs where we discover and then validate these programs in multiple randomized control trials, all culminating usually in a pivotal trial. And on top of that, you'll often see in some other areas of the world or even in this country, to some degree, folks might say randomized control trial, but they're really using standard of care as the control or wait list control, and so on and so forth. We actually test our interventions against sham active control, so against other apps that control for time on task, expectation of benefit, and so on and so forth."

"Just a few months ago, we announced with Behringer Ingelheim, our partner in schizophrenia, that we hit our primary endpoint in our pivotal trial for our app that's designed to be a treatment of negative symptoms of schizophrenia. So, the holy grail, in serious mental illness altogether, but certainly in schizophrenia, is trying to mitigate negative symptoms of schizophrenia. This is such a huge patient issue and frankly an economic issue that none of the drugs have been successful at actually hitting it. So that's a unique one because we showed that an app can actually effectively and safely treat a disease that even a drug can't."

#ClickTherapeutics #DigitalTherapeutics #DigitalHealth #FDA #MedicalDevices #SoftwareAsMedicine #HealthTech #Innovation #Migraine #Depression #Schizophrenia #PrescriptionApps #PDT #PrescriptionDigitalTherapeutics #ClinicalTrials #HealthcareInnovation

clicktherapeutics.com

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Tony Baldassarre, President and CEO of UniDoc Health, has a mission to provide accessible healthcare through remote technology and a Health Cube that can be deployed in a wide range of settings. This approach integrates into existing EMR/EHR platforms and includes a healthcare professional who works with the patient in the Cube to interact with medical devices and consult remotely with a doctor. There have been successful deployments in Ukraine, Italy, and Alaska, showing a significant reduction in emergency room visits and demonstrating capabilities for specialized care and management of chronic conditions.

Tony explains, "With the UniDoc solution, what we do is not just enable a conversation between a doctor and patient - it is not just a phone or video call. We actually provide real diagnostic medical devices for doctors to conduct a comprehensive medical visit remotely, just as if the patient were in their office. The important thing is that number one, we only use real medical devices. These are medical devices that are approved by Health Canada, the FDA, and the European Union. They are the exact same medical devices that you find at a doctor's office or a hospital. So the doctors are actually conducting the visit, and the data that they're receiving is exactly the same as it would be if they were together in the office."

"So, simply what happens first and foremost is that the patient, either through the browser, the UniDoc website, or through our app, chooses a doctor, be it male, female, different races, languages, etc. Once they have the appointment confirmed by the doctor, the patient just shows up at the Health Cube at the time that they requested the appointment, and they walk in. Once inside the Cube, there's a chair and a nurse, I'll call them a nurse for generality. There's a nurse on site, and the doctor is the only person who is remote. At that point, the nurse connects the doctor to the visit, and the medical visit starts."

"We have two Cubes in Ukraine right now, actually in Kyiv and at the border of Romania and Ukraine. That's been set up there since April of this year. We've already seen over 3000 patients, and a lot of it is actually being used by people in the town and for chronic diseases. On top of that, by law in Ukraine, we had to place these Cubes by the hospitals. That's a requirement. And the hospital is actually seeing a 35% decline in people going to the emergency room."

#UniDocHealth #HealthTech #RemoteHealthcare #MedicalInnovation #Telehealth #HealthcareAccess #Telemedicine #MedicalDevices #HealthEquity #DigitalHealth #RuralHealthcare #HealthcareInnovation

UniDocHealth.com

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Tony Baldassarre, President and CEO of UniDoc Health, has a mission to provide accessible healthcare through remote technology and a Health Cube that can be deployed in a wide range of settings. This approach integrates into existing EMR/EHR platforms and includes a healthcare professional who works with the patient in the Cube to interact with medical devices and consult remotely with a doctor. There have been successful deployments in Ukraine, Italy, and Alaska, showing a significant reduction in emergency room visits and demonstrating capabilities for specialized care and management of chronic conditions.

Tony explains, "With the UniDoc solution, what we do is not just enable a conversation between a doctor and patient - it is not just a phone or video call. We actually provide real diagnostic medical devices for doctors to conduct a comprehensive medical visit remotely, just as if the patient were in their office. The important thing is that number one, we only use real medical devices. These are medical devices that are approved by Health Canada, the FDA, and the European Union. They are the exact same medical devices that you find at a doctor's office or a hospital. So the doctors are actually conducting the visit, and the data that they're receiving is exactly the same as it would be if they were together in the office."

"So, simply what happens first and foremost is that the patient, either through the browser, the UniDoc website, or through our app, chooses a doctor, be it male, female, different races, languages, etc. Once they have the appointment confirmed by the doctor, the patient just shows up at the Health Cube at the time that they requested the appointment, and they walk in. Once inside the Cube, there's a chair and a nurse, I'll call them a nurse for generality. There's a nurse on site, and the doctor is the only person who is remote. At that point, the nurse connects the doctor to the visit, and the medical visit starts."

"We have two Cubes in Ukraine right now, actually in Kyiv and at the border of Romania and Ukraine. That's been set up there since April of this year. We've already seen over 3000 patients, and a lot of it is actually being used by people in the town and for chronic diseases. On top of that, by law in Ukraine, we had to place these Cubes by the hospitals. That's a requirement. And the hospital is actually seeing a 35% decline in people going to the emergency room."

#UniDocHealth #HealthTech #RemoteHealthcare #MedicalInnovation #Telehealth #HealthcareAccess #Telemedicine #MedicalDevices #HealthEquity #DigitalHealth #RuralHealthcare #HealthcareInnovation

UniDocHealth.com

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Dr. Jennifer Perusini, CEO and Founder of Neurovation Labs, is developing a precision medicine platform to create targeted therapeutics and diagnostic tools that treat specific brain regions to address central nervous system diseases. For the treatment of PTSD, the approach focuses on the overactive amygdala due to dysregulated glutamate signaling. This objective, brain-based approach of treating a discrete part of the brain rather than the whole brain moves mental health treatment beyond the current one-size-fits-all approach, reducing side effects and improving outcomes.

Jennifer explains, "What we are doing is really taking an objective, precision approach to treating mental health disorders, something like an oncology model. So what we really care about is that mental health disorders and psychiatric disorders are rooted in brain dysfunction, yes, but critically that dysfunction occurs in very discreet brain regions and circuits, not necessarily uniformly across the entire brain. So we have really developed a platform designed to identify compounds with dual potential. Precision therapeutics that act on specific brain regions, as well as diagnostic imaging agents that can reveal receptor-level dysfunction and circuit activity in the brain. And so our lead asset and main indication right now is for PTSD, post-traumatic stress disorder."

"I think that academics like to focus on this research in very specific brain regions, but that therapeutic angle really hasn't caught up yet. And so, really more specifically, what we're doing is focusing on a very particular signal, an excitatory neurotransmitter in the brain called glutamate, which is a key regulator of neural activity and cell firing. And so there are many disorders, including PTSD, that are affected by dysregulated glutamate signaling. However, the glutamate drugs that are on the market today really bind to the whole brain. So that's just something that hasn't caught up yet, and that's what we're trying to do."

#NeurovationLabs #PrecisionMedicine #PTSD #Neuroscience #MentalHealthInnovation #Biomarkers #DrugDiscovery #Glutamate #BrainHealth #DigitalHealth #HealthTech

NeurovationLabs.com

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Dr. Jennifer Perusini, CEO and Founder of Neurovation Labs, is developing a precision medicine platform to create targeted therapeutics and diagnostic tools that treat specific brain regions to address central nervous system diseases. For the treatment of PTSD, the approach focuses on the overactive amygdala due to dysregulated glutamate signaling. This objective, brain-based approach of treating a discrete part of the brain rather than the whole brain moves mental health treatment beyond the current one-size-fits-all approach, reducing side effects and improving outcomes.

Jennifer explains, "What we are doing is really taking an objective, precision approach to treating mental health disorders, something like an oncology model. So what we really care about is that mental health disorders and psychiatric disorders are rooted in brain dysfunction, yes, but critically that dysfunction occurs in very discreet brain regions and circuits, not necessarily uniformly across the entire brain. So we have really developed a platform designed to identify compounds with dual potential. Precision therapeutics that act on specific brain regions, as well as diagnostic imaging agents that can reveal receptor-level dysfunction and circuit activity in the brain. And so our lead asset and main indication right now is for PTSD, post-traumatic stress disorder."

"I think that academics like to focus on this research in very specific brain regions, but that therapeutic angle really hasn't caught up yet. And so, really more specifically, what we're doing is focusing on a very particular signal, an excitatory neurotransmitter in the brain called glutamate, which is a key regulator of neural activity and cell firing. And so there are many disorders, including PTSD, that are affected by dysregulated glutamate signaling. However, the glutamate drugs that are on the market today really bind to the whole brain. So that's just something that hasn't caught up yet, and that's what we're trying to do."

#NeurovationLabs #PrecisionMedicine #PTSD #Neuroscience #MentalHealthInnovation #Biomarkers #DrugDiscovery #Glutamate #BrainHealth #DigitalHealth #HealthTech

NeurovationLabs.com

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Dr. Paul Testa, Chief Health Informatics Officer who helped create the About Me Initiative at NYU Langone Health, and Dr. Katherine Hochman, Director of Hospital Medicine at NYU Langone Health, who envisioned the initiative, discuss the benefits of encouraging patients to provide non-medical information. The goal is to help care teams see patients as whole people beyond their diagnoses and to give patients an opportunity to share interests, hobbies, and fun facts that can help build trust and meaningful human connections. This About Me Initiative is being expanded from inpatient care to outpatient settings, such as infusion centers.

Paul explains, "The About Me section in our EHR Epic is something that NYU Langone developed with the inspiration of Dr. Hochman, and it's essentially a dedicated discreet space in the medical record to allow patients to declare themselves, allowing them to give them a space that is transparent to all the users of the electronic health record, which are many and vast in their rules. So let them articulate something beyond their disease process or their health. So often, we reduce records to pneumonia, a broken hip, or an infection. The patient is so much more than that, and patients want to share that with us. We know that from practicing for years, Kathy and I both know that the way you connect with patients is through a narrative. Our currency is narrative. This is a location where either a patient or, if they choose to defer, can have one of their nurses or care team members provide a small sample of who they are outside of the care environment."

Katherine elaborates, "So I'm a hospitalist. Every Tuesday, I come into 16 to 18 new patients. And at NYU Langone, our length of stay keeps getting shorter and shorter, which is fantastic for patients because we want to get them in and out of the hospital as quickly and as safely as possible. But by definition, if patients stay shorter and shorter, we don't have as much time to connect. So the About Me Initiative really kicks off that connection that Paul was talking about a second ago. So long ago, and this is how it started, I would tell my teams, slow down to speed up, get to know who this patient is before getting into the heart failure, the pneumonia, the COPD, and really try to establish a little bit of a connection and build trust."

#NYULangone #PatientVoices #PatientCare #HealthcareInnovation #PatientExperience #HealthIT #EHR #EpicEHR #HumanConnection #HealthcareTransformation #PatientCentered #MedicalTechnology #DigitalHealth #EmpathyInMedicine

nyulangone.org

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Dr. Paul Testa, Chief Health Informatics Officer who helped create the About Me Initiative at NYU Langone Health, and Dr. Katherine Hochman, Director of Hospital Medicine at NYU Langone Health, who envisioned the initiative, discuss the benefits of encouraging patients to provide non-medical information. The goal is to help care teams see patients as whole people beyond their diagnoses and to give patients an opportunity to share interests, hobbies, and fun facts that can help build trust and meaningful human connections. This About Me Initiative is being expanded from inpatient care to outpatient settings, such as infusion centers.

Paul explains, "The About Me section in our EHR Epic is something that NYU Langone developed with the inspiration of Dr. Hochman, and it's essentially a dedicated discreet space in the medical record to allow patients to declare themselves, allowing them to give them a space that is transparent to all the users of the electronic health record, which are many and vast in their rules. So let them articulate something beyond their disease process or their health. So often, we reduce records to pneumonia, a broken hip, or an infection. The patient is so much more than that, and patients want to share that with us. We know that from practicing for years, Kathy and I both know that the way you connect with patients is through a narrative. Our currency is narrative. This is a location where either a patient or, if they choose to defer, can have one of their nurses or care team members provide a small sample of who they are outside of the care environment."

Katherine elaborates, "So I'm a hospitalist. Every Tuesday, I come into 16 to 18 new patients. And at NYU Langone, our length of stay keeps getting shorter and shorter, which is fantastic for patients because we want to get them in and out of the hospital as quickly and as safely as possible. But by definition, if patients stay shorter and shorter, we don't have as much time to connect. So the About Me Initiative really kicks off that connection that Paul was talking about a second ago. So long ago, and this is how it started, I would tell my teams, slow down to speed up, get to know who this patient is before getting into the heart failure, the pneumonia, the COPD, and really try to establish a little bit of a connection and build trust."

#NYULangone #PatientVoices #PatientCare #HealthcareInnovation #PatientExperience #HealthIT #EHR #EpicEHR #HumanConnection #HealthcareTransformation #PatientCentered #MedicalTechnology #DigitalHealth #EmpathyInMedicine

nyulangone.org

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Dr. David Kirk, Chief Medical Officer at Regard, discusses the role and benefits of real-time clinical AI to help clinicians navigate patient charts and find critical information to prevent medication management errors and misdiagnoses. The Regard platform can also generate proactive documentation, allowing physicians to complete their documentation more accurately and efficiently, reducing note-bloat and the need for after-hours charting. One key goal of using AI is to free physicians to spend more time on the art of medicine, directly working with patients.

David explains, "So, Regard with real-time clinical artificial intelligence software, is helping clinicians propose the right diagnosis and information while they're working in the chart. Our mission is to make patient care as clear as possible. At the same time, we make sure that the doctors are getting the support they need so they can better support the patient. The charts of patients are getting bigger and bigger every year because more and more data is going into the charts. And as that happens, the really important thing that we as physicians need to find is diluted."

"Some research even suggests that maybe doctors are going to see 3% of the data that comes in in the chart when a patient comes into the hospital. As the physician, I'm trying to understand a patient's clinical story with only having access to three pages. Our goal is for artificial intelligence to find important information in that deep sea of data so the treatment team can make better decisions. Maybe you can correct the documentation. What that means is the physician is doing all the work in their natural workflow. We're not having to do prep work during downtime at home, and we're not trying to wrap up notes at night. We need the documentation to be done proactively in a way that is as accurate as possible for the patient at the time of care."

#Regard #HealthcareAI #DigitalHealth #MedicalTechnology #PatientCare #HealthTech #AIinMedicine #ClinicalDocumentation #HealthcareInnovation #MedicalAI #PhysicianSupport

Regard.com

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Dr. David Kirk, Chief Medical Officer at Regard, discusses the role and benefits of real-time clinical AI to help clinicians navigate patient charts and find critical information to prevent medication management errors and misdiagnoses. The Regard platform can also generate proactive documentation, allowing physicians to complete their documentation more accurately and efficiently, reducing note-bloat and the need for after-hours charting. One key goal of using AI is to free physicians to spend more time on the art of medicine, directly working with patients.

David explains, "So, Regard with real-time clinical artificial intelligence software, is helping clinicians propose the right diagnosis and information while they're working in the chart. Our mission is to make patient care as clear as possible. At the same time, we make sure that the doctors are getting the support they need so they can better support the patient. The charts of patients are getting bigger and bigger every year because more and more data is going into the charts. And as that happens, the really important thing that we as physicians need to find is diluted."

"Some research even suggests that maybe doctors are going to see 3% of the data that comes in in the chart when a patient comes into the hospital. As the physician, I'm trying to understand a patient's clinical story with only having access to three pages. Our goal is for artificial intelligence to find important information in that deep sea of data so the treatment team can make better decisions. Maybe you can correct the documentation. What that means is the physician is doing all the work in their natural workflow. We're not having to do prep work during downtime at home, and we're not trying to wrap up notes at night. We need the documentation to be done proactively in a way that is as accurate as possible for the patient at the time of care."

#Regard #HealthcareAI #DigitalHealth #MedicalTechnology #PatientCare #HealthTech #AIinMedicine #ClinicalDocumentation #HealthcareInnovation #MedicalAI #PhysicianSupport

Regard.com

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