Empowered Patient Podcast

Wael Hashad, Chief Executive Officer of Longeveron, is focused on developing cell therapy for aging-related conditions such as aging frailty, dementia, and Alzheimer's disease. Using mesenchymal stem cells, also known as medicinal signaling cells, obtained from healthy donors 18-45, Longeveron is seeing promising results in clinical trials with improvements in brain volume and cognitive function. This approach is also being explored in the pursuit of a treatment for hypoplastic left heart syndrome, a rare congenital heart disease.

Wael explains, "We believe there is a huge unmet need for bringing safe and effective products to try to slow the progression of the disease, improve the quality of life, and reduce the burden on the caregivers of such a disease. As for the aging frailty in general, as you know, with aging, there are a lot of things that affect the vascular system, muscle wasting, and all of those things that affect the quality of life during the aging years of an individual. Anything we can impact to improve the quality of life and the ability to lead a normal life in the aging years is definitely one of our goals."

"Lomecel-B was initially licensed from the University of Miami to Longeveron. It is mesenchymal stem cells. As I said, we get GMP-grade donations of bone marrow from healthy adults and volunteers aged 18 to 45. Then we take this donation, harvest them in our facility in Miami, grow the cells, and then do all the required testing and release criteria to ensure safety. It is allogeneic, meaning that it is off the shelf, that any patient can take these cells. It is not autologous cells. It is allogeneic cells, giving it a much broader application. We are able to produce enough quantities from each donation to support these patients with aging frailty, Alzheimer's, or dementia."

#Longeveron #CellTherapy #Aging #MedicinalSignalingCells #MSC #AlzheimersDisease #Dementia #AgingFrailty #RareDisease

longeveron.com

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Wael Hashad, Chief Executive Officer of Longeveron, is focused on developing cell therapy for aging-related conditions such as aging frailty, dementia, and Alzheimer's disease. Using mesenchymal stem cells, also known as medicinal signaling cells, obtained from healthy donors 18-45, Longeveron is seeing promising results in clinical trials with improvements in brain volume and cognitive function. This approach is also being explored in the pursuit of a treatment for hypoplastic left heart syndrome, a rare congenital heart disease.

Wael explains, "We believe there is a huge unmet need for bringing safe and effective products to try to slow the progression of the disease, improve the quality of life, and reduce the burden on the caregivers of such a disease. As for the aging frailty in general, as you know, with aging, there are a lot of things that affect the vascular system, muscle wasting, and all of those things that affect the quality of life during the aging years of an individual. Anything we can impact to improve the quality of life and the ability to lead a normal life in the aging years is definitely one of our goals."

"Lomecel-B was initially licensed from the University of Miami to Longeveron. It is mesenchymal stem cells. As I said, we get GMP-grade donations of bone marrow from healthy adults and volunteers aged 18 to 45. Then we take this donation, harvest them in our facility in Miami, grow the cells, and then do all the required testing and release criteria to ensure safety. It is allogeneic, meaning that it is off the shelf, that any patient can take these cells. It is not autologous cells. It is allogeneic cells, giving it a much broader application. We are able to produce enough quantities from each donation to support these patients with aging frailty, Alzheimer's, or dementia."

#Longeveron #CellTherapy #Aging #MedicinalSignalingCells #MSC #AlzheimersDisease #Dementia #AgingFrailty #RareDisease

longeveron.com

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Joe Tucker, CEO of Enveric Biosciences, discusses the use of neuroplastogen therapies for the treatment of neuropsychiatric disorders, including depression, anxiety, and post-traumatic stress disorder. Enveric has developed the Psybrary, a portfolio of compounds inspired by psilocybin that bind to the serotonin receptor in the brain and induce neuroplasticity without the hallucinations. The lead candidate EB-003 is intended to be administered orally and taken regularly as a maintenance therapy.

Joe explains, "This whole neuroplastogen space was recently discovered, and it was discovered through academic research that we're looking at on the effects of these agents we call psychedelics, psilocybin being the active ingredient in magic mushrooms and a very well-known psychedelic agent. It was in looking at psilocybin and other molecules known to be psychedelic agents like ayahuasca and LSD and others that scientists realized that what's going on is you're activating a particular receptor in the brain - something called the serotonin 5-HT2A receptor. So, at Enveric we thought this was a great opportunity because of some of the early work that others had done in using the actual magic mushroom."

"This is a whole new area of research and science. It is not known what shape of a molecule will induce a hallucination versus not inducing hallucination, for example, and what shape will strongly induce the neuroplasticity that we're looking for so that the brain can essentially be repaired versus not induce it. So, we had to develop our own internal artificial intelligence tool that was trained by the other molecules that had been designed previously or were naturally occurring. Then, we continued to train it as we made our thousand molecules and got our AI operating more and more intelligent."

#Enveric #Psilocybin #Hallucinogenic #MentalHealth #NeuroplastogenTherapies #NeuropsychiatricDisorders #PTSD #PostTraumaticStressDisorder

enveric.com

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Joe Tucker, CEO of Enveric Biosciences, discusses the use of neuroplastogen therapies for the treatment of neuropsychiatric disorders, including depression, anxiety, and post-traumatic stress disorder. Enveric has developed the Psybrary, a portfolio of compounds inspired by psilocybin that bind to the serotonin receptor in the brain and induce neuroplasticity without the hallucinations. The lead candidate EB-003 is intended to be administered orally and taken regularly as a maintenance therapy.

Joe explains, "This whole neuroplastogen space was recently discovered, and it was discovered through academic research that we're looking at the effects of these agents we call psychedelics, psilocybin being the active ingredient in magic mushrooms and a very well-known psychedelic agent. It was in looking at psilocybin and other molecules known to be psychedelic agents like ayahuasca and LSD and others that scientists realized that what's going on is you're activating a particular receptor in the brain - something called the serotonin 5-HT2A receptor. So, at Enveric we thought this was a great opportunity because of some of the early work that others had done in using the actual magic mushroom."

"This is a whole new area of research and science. It is not known what shape of a molecule will induce a hallucination versus not inducing hallucination, for example, and what shape will strongly induce the neuroplasticity that we're looking for so that the brain can essentially be repaired versus not induce it. So, we had to develop our own internal artificial intelligence tool that was trained by the other molecules that had been designed previously or were naturally occurring. Then, we continued to train it as we made our thousand molecules and got our AI operating more and more intelligent."

#Enveric #Psilocybin #Hallucinogenic #MentalHealth #NeuroplastogenTherapies #NeuropsychiatricDisorders #PTSD #PostTraumaticStressDisorder

enveric.com

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Vish Charan, Divisional Vice President of Product Development at Abbott's Cardiac Rhythm Management Business, explains some of the limitations of traditional pacemakers implanted in the chest with long wires connecting the pacemaker to the heart. Abbott has developed the AVEIR DR system, a dual-chamber leadless pacemaker that uses implant-to-implant technology to send electrical impulses between the upper and lower chambers of the heart. The i2i technology allows these capsule-size devices to be implanted directly in the heart with the ability to communicate to synchronize the heart rhythm.

Vish explains, "What we can do right now, is to get a very, very small access into the veins in the leg, and from the veins in the leg with a very small access, we're able to deploy these capsule-size pacemakers directly into the heart with a long tube. We call that a catheter. But that is how they're deployed. So, you don't have a surgical pocket. You don't have a big cut open in your chest, and the device is implanted in your upper chest. All you have now is a surgical axis in your leg, and you have two capsule-sized devices, which are much smaller than two AAA batteries directly implanted in the heart."

"So, the technology involved with AVEIR DR is where you have these two capsule-sized devices directly implanted in the upper and lower chambers of the heart. The two chambers of the heart need to operate in synchrony. What we can do is that in the upper and the lower chambers of the heart, which are the atrium and the ventricle, we can sense and pace directly in those chambers."

"But the good thing and the technological advantage of this product is they communicate with each other. The communication scheme is what we call i2i technology, where we are sending electrical impulses between the upper and the lower chamber devices. These are electrical impulses that are very, very short, and very small, which cannot be felt by the person who has a device, but that is sufficient for the devices to register information between the upper and lower device and able to operate in synchrony. And this synchrony is extremely important for the person to get back to their normal heart rhythm."

#Abbott #AVEIRDR #Pacemaker #LeadlessPacemaker #DualChamberPacemaker #HeartHealth #i2i #ImplanttoImplant

AVEIRDR.com

Abbott.com

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Vish Charan, Divisional Vice President of Product Development at Abbott's Cardiac Rhythm Management Business, explains some of the limitations of traditional pacemakers implanted in the chest with long wires connecting the pacemaker to the heart. Abbott has developed the AVEIR DR system, a dual-chamber leadless pacemaker that uses implant-to-implant technology to send electrical impulses between the upper and lower chambers of the heart. The i2i technology allows these capsule-size devices to be implanted directly in the heart with the ability to communicate to synchronize the heart rhythm.

Vish explains, "What we can do right now, is to get a very, very small access into the veins in the leg, and from the veins in the leg with a very small access, we're able to deploy these capsule-size pacemakers directly into the heart with a long tube. We call that a catheter. But that is how they're deployed. So, you don't have a surgical pocket. You don't have a big cut open in your chest, and the device is implanted in your upper chest. All you have now is a surgical axis in your leg, and you have two capsule-sized devices, which are much smaller than two AAA batteries directly implanted in the heart."

"So, the technology involved with AVEIR DR is where you have these two capsule-sized devices directly implanted in the upper and lower chambers of the heart. The two chambers of the heart need to operate in synchrony. What we can do is that in the upper and the lower chambers of the heart, which are the atrium and the ventricle, we can sense and pace directly in those chambers."

"But the good thing and the technological advantage of this product is they communicate with each other. The communication scheme is what we call i2i technology, where we are sending electrical impulses between the upper and the lower chamber devices. These are electrical impulses that are very, very short, and very small, which cannot be felt by the person who has a device, but that is sufficient for the devices to register information between the upper and lower device and able to operate in synchrony. And this synchrony is extremely important for the person to get back to their normal heart rhythm."

#Abbott #AVEIRDR #Pacemaker #LeadlessPacemaker #DualChamberPacemaker #HeartHealth #i2i #ImplanttoImplant

AVEIRDR.com

Abbott.com

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Laxminarayan Bhat, Founder, President, and CEO of Reviva Pharmaceuticals, is focused on developing next-generation therapies for neurological diseases, particularly schizophrenia. Their lead candidate, brilaroxazine, acts on multiple neuro receptors to balance imbalanced neurotransmitters in the brain that are responsible for causing schizophrenia. This new molecule shows positive results in efficacy and a low discontinuation rate, indicating the drug can be used for acute and long-term maintenance therapy.

Lax elaborates, "Reviva is a late-stage pharmaceutical company. We are focused on developing next-generation therapies for diseases of neuro targets. That's our primary focus. So, currently, we are focused on CNS, inflammatory, and cardiometabolic diseases. We use chemical genomics-driven technologies to develop new chemical entities. Currently, we have two molecules in development. One is brilaroxazine, which is also called RP5063. The second molecule is RP1208. Both molecules were discovered in-house."

"For schizophrenia, there are several treatments available. Collectively there are around 13 new drugs that got approved in the last 40 years. There are still significant unmet needs in the treatment of schizophrenia because schizophrenia is not a single disease. Instead, it's a mix of multiple symptoms. So, developing new therapies that can address multiple symptom domains is quite challenging. That's what we are currently working on in our drug brilaroxazine. We believe that it ideally can treat major symptom domains with benign or fewer side effects."

"There are reports - all research-level - they're not accepted as a confirmatory test. For example, biomarkers called inflammatory biomarkers like BDNF and cytokines. There are several clinical research reports published, their links to or their association with the severity of schizophrenia. They're shown as the disease progresses the changes in these biomarkers. However, they are not validated to use as a definitive test for evaluating schizophrenia."

"Then, recently, with the advancement of AI or computer techniques, there is the voice biomarker. The way schizophrenia patients speak, in general, psychiatric patients' speech has a distinguishable pattern. That's also being used as a marker to evaluate the severity in this patient population. So, in the just-completed study, we evaluated both blood-based markers as cytokines and are currently evaluating voice biomarker. So, the data will be available soon."

#RevivaPharma #Schizophrenia #Biomarkers #VoiceBiomarker #Neurotransmitters #Dopamine #Serotonin #AI

revivapharma.com

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Laxminarayan Bhat, Founder, President, and CEO of Reviva Pharmaceuticals, is focused on developing next-generation therapies for neurological diseases, particularly schizophrenia. Their lead candidate, brilaroxazine, acts on multiple neuro receptors to balance imbalanced neurotransmitters in the brain that are responsible for causing schizophrenia. This new molecule shows positive results in efficacy and a low discontinuation rate, indicating the drug can be used for acute and long-term maintenance therapy.

Lax elaborates, "Reviva is a late-stage pharmaceutical company. We are focused on developing next-generation therapies for diseases of neuro targets. That's our primary focus. So, currently, we are focused on CNS, inflammatory, and cardiometabolic diseases. We use chemical genomics-driven technologies to develop new chemical entities. Currently, we have two molecules in development. One is brilaroxazine, which is also called RP5063. The second molecule is RP1208. Both molecules were discovered in-house."

"For schizophrenia, there are several treatments available. Collectively there are around 13 new drugs that got approved in the last 40 years. There are still significant unmet needs in the treatment of schizophrenia because schizophrenia is not a single disease. Instead, it's a mix of multiple symptoms. So, developing new therapies that can address multiple symptom domains is quite challenging. That's what we are currently working on in our drug brilaroxazine. We believe that it ideally can treat major symptom domains with benign or fewer side effects."

"There are reports - all research-level - they're not accepted as a confirmatory test. For example, biomarkers called inflammatory biomarkers like BDNF and cytokines. There are several clinical research reports published, their links to or their association with the severity of schizophrenia. They're shown as the disease progresses the changes in these biomarkers. However, they are not validated to use as a definitive test for evaluating schizophrenia."

"Then, recently, with the advancement of AI or computer techniques, there is the voice biomarker. The way schizophrenia patients speak, in general, psychiatric patients' speech has a distinguishable pattern. That's also being used as a marker to evaluate the severity in this patient population. So, in the just-completed study, we evaluated both blood-based markers as cytokines and are currently evaluating voice biomarker. So, the data will be available soon."

#RevivaPharma #Schizophrenia #Biomarkers #VoiceBiomarker #Neurotransmitters #Dopamine #Serotonin #AI

revivapharma.com

Download the transcript here

Robert Maxwell, Founder and CEO of ClinConnect, has created a platform that simplifies the process of patients finding clinical trials, shortens enrollment times, and focuses on providing support to ensure patient retention in the trials. The platform works in collaboration with sponsors, healthcare providers, hospitals, and other stakeholders to streamline communication and more quickly identify qualified clinical trial participants from a broader universe.

Robert explains, "We make the process of not only finding the trial very, very simple, but we also shorten the enrollment times, which in the case of acute disease is distinctly important. But generally speaking, it's usually more advantageous to get into a trial more quickly than waiting unnecessarily. And so, while we don't claim to solve all clinical trial recruitment issues, we've found that our patients generally see about a 60% to 70% reduction in enrollment time by working with us and letting us be their advocate through the enrollment process."

"On the flip side, with pharmaceutical companies who are sponsoring these trials or running them directly, 70% of trials don't meet their recruitment targets. And that's profoundly problematic for them."

"So, we do not just work with the patient to get them into the trial. We will continue to advocate for them. And as we use the term, we'll hold their hand through the entire trial process. Then, we even have some post-trial services and some work we do with them after the trial. So we have found that because we don't just work with them in one kind of component of the life cycle of the trial, our retention rates are much higher as well. "

#ClinConnect #ClinicalTrials #TrialRetention #TrialRecruitment #DigitalHealth #PatientAdvocacy

clinconnect.io

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Robert Maxwell, Founder and CEO of ClinConnect, has created a platform that simplifies the process of patients finding clinical trials, shortens enrollment times, and focuses on providing support to ensure patient retention in the trials. The platform works in collaboration with sponsors, healthcare providers, hospitals, and other stakeholders to streamline communication and more quickly identify qualified clinical trial participants from a broader universe.

Robert explains, "We make the process of not only finding the trial very, very simple, but we also shorten the enrollment times, which in the case of acute disease is distinctly important. But generally speaking, it's usually more advantageous to get into a trial more quickly than waiting unnecessarily. And so, while we don't claim to solve all clinical trial recruitment issues, we've found that our patients generally see about a 60% to 70% reduction in enrollment time by working with us and letting us be their advocate through the enrollment process."

"On the flip side, with pharmaceutical companies who are sponsoring these trials or running them directly, 70% of trials don't meet their recruitment targets. And that's profoundly problematic for them."

"So, we do not just work with the patient to get them into the trial. We will continue to advocate for them. And as we use the term, we'll hold their hand through the entire trial process. Then, we even have some post-trial services and some work we do with them after the trial. So we have found that because we don't just work with them in one kind of component of the life cycle of the trial, our retention rates are much higher as well. "

#ClinConnect #ClinicalTrials #TrialRetention #TrialRecruitment #DigitalHealth #PatientAdvocacy

clinconnect.io

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