Empowered Patient Podcast

Ashley Perry is the Chief Strategy and Solutions Officer at Socially Determined, a social risk analytics and solutions company working with payers, providers, and life science companies. Their Socialscope risk and data analytics platform helps organizations understand social determinants of health, identify and manage risk and advance equity for the populations they serve. These organizations are able to be data-driven and action-oriented to mitigate community and individual-level risk.

Ashley explains, "The evidence is very clear from a multitude of sources that up to 80% of healthcare utilization, cost, outcomes, and, importantly also, equity are driven by non-clinical factors or non-medical cost drivers. That includes all aspects of everyday life. So, you think about factors like food insecurity and housing instability, transportation barriers, and health literacy challenges. We see consistently in the data that we look at every day the impact these factors have on those utilization costs and outcome measures. Our customers are ultimately focused on population health and the overall health and well-being of the communities and populations they serve."

"Socialscape is a platform that assesses both community-level SDOH risk exposure for the entire United States as well as individual-level social risk factor scores for millions of adult Americans. Importantly, we do that across different domains. For example, on the community side, we look at factors like the economic climate, the housing environment, and the digital landscape. On the individual patient or member side, we look at factors like food insecurity, housing instability, and transportation barriers."

"Across all of those different domains, we're able to quantify risk using a standardized one-to-five scale. One indicates little to no risk, five indicates severe risk. It empowers the organizations that we work with to be able to identify the contours and concentration of community-level risk for the markets that they're serving. As well as identify the segments of their overall population that they bear the risk for that face elevated risk across those different social domains."

@SocDetermined #SDOH #SocialDeterminantsofHealth #ACOREACH #HealthEquity #SocialRisk #Data #DataAnalytics

sociallydetermined.com

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Ashley Perry is the Chief Strategy and Solutions Officer at Socially Determined, a social risk analytics and solutions company working with payers, providers, and life science companies. Their Socialscope risk and data analytics platform helps organizations understand social determinants of health, identify and manage risk and advance equity for the populations they serve. These organizations are able to be data-driven and action-oriented to mitigate community and individual-level risk.

Ashley explains, "The evidence is very clear from a multitude of sources that up to 80% of healthcare utilization, cost, outcomes, and, importantly also, equity are driven by non-clinical factors or non-medical cost drivers. That includes all aspects of everyday life. So, you think about factors like food insecurity and housing instability, transportation barriers, and health literacy challenges. We see consistently in the data that we look at every day the impact these factors have on those utilization costs and outcome measures. Our customers are ultimately focused on population health and the overall health and well-being of the communities and populations they serve."

"Socialscape is a platform that assesses both community-level SDOH risk exposure for the entire United States as well as individual-level social risk factor scores for millions of adult Americans. Importantly, we do that across different domains. For example, on the community side, we look at factors like the economic climate, the housing environment, and the digital landscape. On the individual patient or member side, we look at factors like food insecurity, housing instability, and transportation barriers."

"Across all of those different domains, we're able to quantify risk using a standardized one-to-five scale. One indicates little to no risk, five indicates severe risk. It empowers the organizations that we work with to be able to identify the contours and concentration of community-level risk for the markets that they're serving. As well as identify the segments of their overall population that they bear the risk for that face elevated risk across those different social domains."

@SocDetermined #SDOH #SocialDeterminantsofHealth #ACOREACH #HealthEquity #SocialRisk #Data #DataAnalytics

sociallydetermined.com

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Rich Pascoe, CEO of Zevra Therapeutics, is working with a team with deep experience developing drugs and getting them approved by the FDA. Having developed multiple prodrugs for pain and ADHD, Zevra is now developing rare disease therapies with an initial focus on Niemann Pick Disease Type C and idiopathic hypersomnia.

Rich explains, "Our lead product is a drug called arimoclomol. It's intended for the treatment of Niemann Pick Type C disease, or NPC for short. Niemann Pick primarily affects children. It's a lysosomal storage disorder condition, meaning patients lack the ability to break down certain things, including cholesterol. As a result, they develop a myriad of symptoms that ultimately lead to, in most cases, the patient's death. The issues they deal with revolve around loss of ambulation and the ability to swallow, and it affects their cognitive function. It's a progressive disease, and oftentimes, it can advance very rapidly."

"A little history on arimoclomol. The drug was previously in the hands of a company out of Denmark. We acquired the asset last year from that company along with some of the individuals at the company that are critical for the success of the product going forward."

"In that setting, Orphazyme, the company that had the drug before us, had submitted it for approval here in the US with the FDA. The FDA rejected that approval request based on a number of factors that we have subsequently been working to address. We believe that given our track record as a company of being able to work with the FDA to get drugs approved, in some cases under some very challenging circumstances, that we are well-equipped to handle and manage this submission."

@Zevratx #ZevraTherapeutics #RareDisease #RareSleepDisorders #NiemannPickDiseaseC #IdiopathicHypersomnia

zevra.com

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Rich Pascoe, CEO of Zevra Therapeutics, is working with a team with deep experience developing drugs and getting them approved by the FDA. Having developed multiple prodrugs for pain and ADHD, Zevra is now developing rare disease therapies with an initial focus on Niemann Pick Disease Type C and idiopathic hypersomnia.

Rich explains, "Our lead product is a drug called arimoclomol. It's intended for the treatment of Niemann Pick Type C disease, or NPC for short. Niemann Pick primarily affects children. It's a lysosomal storage disorder condition, meaning patients lack the ability to break down certain things, including cholesterol. As a result, they develop a myriad of symptoms that ultimately lead to, in most cases, the patient's death. The issues they deal with revolve around loss of ambulation and the ability to swallow, and it affects their cognitive function. It's a progressive disease, and oftentimes, it can advance very rapidly."

"A little history on arimoclomol. The drug was previously in the hands of a company out of Denmark. We acquired the asset last year from that company along with some of the individuals at the company that are critical for the success of the product going forward."

"In that setting, Orphazyme, the company that had the drug before us, had submitted it for approval here in the US with the FDA. The FDA rejected that approval request based on a number of factors that we have subsequently been working to address. We believe that given our track record as a company of being able to work with the FDA to get drugs approved, in some cases under some very challenging circumstances, that we are well-equipped to handle and manage this submission."

@Zevratx #ZevraTherapeutics #RareDisease #RareSleepDisorders #NiemannPickDiseaseC #IdiopathicHypersomnia

zevra.com

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Steve Reed, Co-Founder, President, and CEO of HDT Bio, has spent his life focusing on tropical diseases and points out how the cost of developing and manufacturing vaccines determines access for a global population. HDT Bio was founded to develop more cost-effective technology to induce broader immune responses to various diseases. Their advanced RNA platform AMPLIFY is a technology applied to developing mRNA vaccines for infectious diseases and a therapeutic vaccine to help prevent recurrence and prolong survival from cancer.

Steve elaborates, "COVID was something that came up right after we founded the company, and so the National Institute of Health asked us and funded us to develop a novel platform that could complement the platforms already in place for mRNA vaccines. Other indications that are incredibly important include other viruses. They're always coming up, and they're always mutating. But you probably read in the news about fungal infections on the increase in the United States and other countries."

"The AMPLIFY technology is an RNA platform that expands in a limited way once it's introduced into the cell and then enables you to use a much lower amount of RNA. So that's significant in terms of cost, as well as safety. And then to be able to deliver the RNA, you have to protect it into a formulation, and the formulation we've developed is one that can be mass-produced at low cost and is very safe."

"Back in the '90s and 2000s, when molecular biology, and monoclonal antibodies, those technologies became widely used and understood, we all naively thought that the road to a parasitic disease vaccine would be relatively straightforward. And in some ways, while the technology has enabled such vaccines, the practical limitations have stopped progress or severely limited it."

#Vaccination #Vaccines #HealthForAll #COVID #mRNA #RNA #InfectiousDiseases #Cancer

HDT.bio

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Steve Reed, Co-Founder, President, and CEO of HDT Bio, has spent his life focusing on tropical diseases and points out how the cost of developing and manufacturing vaccines determines access for a global population. HDT Bio was founded to develop more cost-effective technology to induce broader immune responses to various diseases. Their advanced RNA platform AMPLIFY is a technology applied to developing mRNA vaccines for infectious diseases and a therapeutic vaccine to help prevent recurrence and prolong survival from cancer.

Steve elaborates, "COVID was something that came up right after we founded the company, and so the National Institute of Health asked us and funded us to develop a novel platform that could complement the platforms already in place for mRNA vaccines. Other indications that are incredibly important include other viruses. They're always coming up, and they're always mutating. But you probably read in the news about fungal infections on the increase in the United States and other countries."

"The AMPLIFY technology is an RNA platform that expands in a limited way once it's introduced into the cell and then enables you to use a much lower amount of RNA. So that's significant in terms of cost, as well as safety. And then to be able to deliver the RNA, you have to protect it into a formulation, and the formulation we've developed is one that can be mass-produced at low cost and is very safe."

"Back in the '90s and 2000s, when molecular biology, and monoclonal antibodies, those technologies became widely used and understood, we all naively thought that the road to a parasitic disease vaccine would be relatively straightforward. And in some ways, while the technology has enabled such vaccines, the practical limitations have stopped progress or severely limited it."

#Vaccination #Vaccines #HealthForAll #COVID #mRNA #RNA #InfectiousDiseases #Cancer

HDT.bio

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Jeff Liter is the CEO and Founder of Luminary Therapeutics, which is using gamma delta cells in their approach to CART-T cell therapy because of the ability of these cells to infiltrate solid tumors. With a multi-targeting system, Luminary has demonstrated promise treating multiple types of solid tumors, blood tumors, and autoimmune diseases. Their goal is to create a scalable model to manufacture allogeneic cells to drive down the cost and availability of effective cell therapies.

Jeff explains, "We're focused primarily on three big challenges in the CAR-T industry. The first is the overall manufacturing approach and cost. The second is why do CAR-Ts, to date, not work in solid tumors. And then finally, the third is antigen escape and relapse of patients currently being treated by CAR-T therapies."

"We have moved into coming back to the manufacturing area. We have moved into an allogeneic platform, which for your listeners, if they're not familiar with that term, means that we can make multiple products from one healthy donor. And we do that in a very special way, using gamma delta cells and preserving both subsets of the gamma delta cells. Then we also add some immune cloaking with our non-viral gene engineering, and that makes us very unique on the allogeneic front."

"If you look at those 800 companies, probably 80, 85% of them use what's called alpha beta normal white blood T cells. A fair number of companies, maybe 7% to 8%, use NK cells. And then there's a new group using a different kind of subset of cells called IPSC. But in the gamma delta, there are only 12 to maybe 15 companies. So we're very differentiated on that front from the 800. And then, as I noted, we are the only company to have both Vdelta1 and Vdelta2 subsets in our final product."

#LuminaryTherapeutics #CARTCellTherapy #CARTTherapies #Allogeneic #Autologous #CellTherapy #GammaDeltaCells #SolidTumors #Cancer #BloodCancers #AutoimmuneDiseases

luminarytx.com

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Jeff Liter is the CEO and Founder of Luminary Therapeutics, which is using gamma delta cells in their approach to CART-T cell therapy because of the ability of these cells to infiltrate solid tumors. With a multi-targeting system, Luminary has demonstrated promise treating multiple types of solid tumors, blood tumors, and autoimmune diseases. Their goal is to create a scalable model to manufacture allogeneic cells to drive down the cost and availability of effective cell therapies.

Jeff explains, "We're focused primarily on three big challenges in the CAR-T industry. The first is the overall manufacturing approach and cost. The second is why do CAR-Ts, to date, not work in solid tumors. And then finally, the third is antigen escape and relapse of patients currently being treated by CAR-T therapies."

"We have moved into coming back to the manufacturing area. We have moved into an allogeneic platform, which for your listeners, if they're not familiar with that term, means that we can make multiple products from one healthy donor. And we do that in a very special way, using gamma delta cells and preserving both subsets of the gamma delta cells. Then we also add some immune cloaking with our non-viral gene engineering, and that makes us very unique on the allogeneic front."

"If you look at those 800 companies, probably 80, 85% of them use what's called alpha beta normal white blood T cells. A fair number of companies, maybe 7% to 8%, use NK cells. And then there's a new group using a different kind of subset of cells called IPSC. But in the gamma delta, there are only 12 to maybe 15 companies. So we're very differentiated on that front from the 800. And then, as I noted, we are the only company to have both Vdelta1 and Vdelta2 subsets in our final product."

#LuminaryTherapeutics #CARTCellTherapy #CARTTherapies #Allogeneic #Autologous #CellTherapy #GammaDeltaCells #SolidTumors #Cancer #BloodCancers #AutoimmuneDiseases

luminarytx.com

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Joe Tucker, the CEO of Enveric Biosciences, is discovering, developing and testing psychedelic-inspired therapies for the treatment of depression, anxiety, and PTSD. Current treatments target receptors in the brain to increase the concentration of serotonin in the brain by going through classic neurotransmitter pathways. The Enveric Psybrary portfolio and PsyAI drive drug discovery to create new molecules that synthesize chemistry and how nature makes molecules to target new receptors.

Joe elaborates, "This one's completely different. This one is actually going through a receptor that's never been targeted before, 5-HT2A. And it's an adjunct to psychotherapy at this point. The leading molecules are an adjunct to psychotherapy. Although there's some interesting new work, including stuff that we're working on, no one has yet been able to separate those two in humans. But that's where we'd like to go next, is to separate them. But right now, it's really this 5-HT2A receptor, this induction of hallucination. No one else is doing that. No other molecules out there do that as part of a treatment program."

"The issues with those classic psychedelics are, as you can imagine, they weren't designed as mental health treatment molecules. They came about for other reasons. And so they have a lot of side effects or safety issues that really make them suboptimal for patient use. So psychedelic-inspired says, let's take what we can learn from here. If you target the 5-HT2A receptor, you can induce some interesting effects in the patient, but can we then modify the molecules so they have better attributes?"

"And in doing so, we also realized we're breaking new ground. I mean, we're making hundreds and hundreds of new molecules in an area where a handful of molecules had existed before. Five molecules, ten molecules, is what everyone else has looked at. We realized we were in this completely new field, and we had to come up with a way to identify prospectively which of these new molecules were going to be likely good drug candidates for various mental health indications."

@Enveric_Bio #EnvericBiosciences #MentalHealth #Psilocybin #Anxiety #Depression #PsychedelicInspiredTherapeutic #PsychedelicBasedTherapeutic #Psychedelics

enveric.com

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Joe Tucker, the CEO of Enveric Biosciences, is discovering, developing and testing psychedelic-inspired therapies for the treatment of depression, anxiety, and PTSD. Current treatments target receptors in the brain to increase the concentration of serotonin in the brain by going through classic neurotransmitter pathways. The Enveric Psybrary portfolio and PsyAI drive drug discovery to create new molecules that synthesize chemistry and how nature makes molecules to target new receptors.

Joe elaborates, "This one's completely different. This one is actually going through a receptor that's never been targeted before, 5-HT2A. And it's an adjunct to psychotherapy at this point. The leading molecules are an adjunct to psychotherapy. Although there's some interesting new work, including stuff that we're working on, no one has yet been able to separate those two in humans. But that's where we'd like to go next, is to separate them. But right now, it's really this 5-HT2A receptor, this induction of hallucination. No one else is doing that. No other molecules out there do that as part of a treatment program."

"The issues with those classic psychedelics are, as you can imagine, they weren't designed as mental health treatment molecules. They came about for other reasons. And so they have a lot of side effects or safety issues that really make them suboptimal for patient use. So psychedelic-inspired says, let's take what we can learn from here. If you target the 5-HT2A receptor, you can induce some interesting effects in the patient, but can we then modify the molecules so they have better attributes?"

"And in doing so, we also realized we're breaking new ground. I mean, we're making hundreds and hundreds of new molecules in an area where a handful of molecules had existed before. Five molecules, ten molecules, is what everyone else has looked at. We realized we were in this completely new field, and we had to come up with a way to identify prospectively which of these new molecules were going to be likely good drug candidates for various mental health indications."

@Enveric_Bio #EnvericBiosciences #MentalHealth #Psilocybin #Anxiety #Depression #PsychedelicInspiredTherapeutic #PsychedelicBasedTherapeutic #Psychedelics

enveric.com

Download the transcript here