Empowered Patient Podcast

Dr. Jennifer Jones-McMeans is a Divisional Vice President of Global Clinical Affairs at Abbott Vascular Business and she sheds light on the FDA guidance to encourage sponsors of clinical trials to include all genders, ethnicities, and under-represented patients to participate. New guidelines are more organized and provide better guidance for what sponsors of clinical trials should consider during their submissions to the FDA. Jennifer explains, "If you think about where clinical trials sit, clinical trials are part of the overall healthcare ecosystem. And if we consider that the healthcare ecosystem is to be inclusive, it is to make sure that there are appropriate treatments for women and different ethnic groups. Also understanding that possibly there could be differences in maybe therapeutic responses, or even considering access too. Clinical trials have to then move forward as the medical ecosystem is moving forward to ensure that there's treatment available for all patients. And so this is where again, this guidance is just a guideline to help support that pathway for clinical trials." "We do know that there are specific populations that, based on their access to health and lack of trust that can occur with the healthcare system, when it comes to clinical trials, they may actually not know and have an awareness of the clinical trial. But they also may not be connected with the appropriate medical system or within a medical system to even have that access. So that's some of the work that we know that the sponsors can do in reaching out." @AbbottCardio #ClinicalTrials #FDAGuidance #UnderservedPatients #UnderrepresentedPatients #MinorityPatients abbott.com Listen to the podcast here

Dr. Jennifer Jones-McMeans is a Divisional Vice President of Global Clinical Affairs at Abbott Vascular Business and she sheds light on the FDA guidance to encourage sponsors of clinical trials to include all genders, ethnicities, and under-represented patients to participate. New guidelines are more organized and provide better guidance for what sponsors of clinical trials should consider during their submissions to the FDA. Jennifer explains, "If you think about where clinical trials sit, clinical trials are part of the overall healthcare ecosystem. And if we consider that the healthcare ecosystem is to be inclusive, it is to make sure that there are appropriate treatments for women and different ethnic groups. Also understanding that possibly there could be differences in maybe therapeutic responses, or even considering access too. Clinical trials have to then move forward as the medical ecosystem is moving forward to ensure that there's treatment available for all patients. And so this is where again, this guidance is just a guideline to help support that pathway for clinical trials." "We do know that there are specific populations that, based on their access to health and lack of trust that can occur with the healthcare system, when it comes to clinical trials, they may actually not know and have an awareness of the clinical trial. But they also may not be connected with the appropriate medical system or within a medical system to even have that access. So that's some of the work that we know that the sponsors can do in reaching out." @AbbottCardio #ClinicalTrials #FDAGuidance #UnderservedPatients #UnderrepresentedPatients #MinorityPatients abbott.com Download the transcript here

Kathleen Aller is the Director of Market Strategy for Healthcare at InterSystems, a software company that focuses on high-volume data management and mobile applications to manage healthcare data. By taking advantage of the InterSystems capabilities on the AWS platform, young startup companies can use its technology to help them cost-effectively build interoperable applications or data-intensive applications and scale up as needed. Kathleen explains, "In fact, there are more than a billion records managed in our technology. One of the groups we've been working with a lot in the last few years are payer organizations who are responding to government regulation that says you have to make the information you hold about patients available to them. You need to do it using a standard called FHIR, Fast Health Interoperability Resources. They have to be able, then, to import that data into applications so that they can do things with it." "We've been involved in digital health practically since its inception. Some of that is managed in applications built by partners like Epic, like 3M, who use our data management platform at the center of what they do. Some of that is in applications that we build on our own platform, so our HealthShare Interoperability engine connects up records for citizens around the world and gives a seamless longitudinal record. Our TrakCare EHR is used outside the US to document and deliver care." @InterSystems #AWS #DigitalHealth #Healthcare #MedicalApps #HealthcareApps #FHIR InterSystems.com Listen to the podcast here

Kathleen Aller is the Director of Market Strategy for Healthcare at InterSystems, a software company that focuses on high-volume data management and mobile applications to manage healthcare data. By taking advantage of the InterSystems capabilities on the AWS platform, young startup companies can use its technology to help them cost-effectively build interoperable applications or data-intensive applications and scale up as needed. Kathleen explains, "In fact, there are more than a billion records managed in our technology. One of the groups we've been working with a lot in the last few years are payer organizations who are responding to government regulation that says you have to make the information you hold about patients available to them. You need to do it using a standard called FHIR, Fast Health Interoperability Resources. They have to be able, then, to import that data into applications so that they can do things with it." "We've been involved in digital health practically since its inception. Some of that is managed in applications built by partners like Epic, like 3M, who use our data management platform at the center of what they do. Some of that is in applications that we build on our own platform, so our HealthShare Interoperability engine connects up records for citizens around the world and gives a seamless longitudinal record. Our TrakCare EHR is used outside the US to document and deliver care." @InterSystems #AWS #DigitalHealth #Healthcare #MedicalApps #HealthcareApps #FHIR InterSystems.com Download the transcript here

Keith Palmer is the Worldwide Vice President for Hip Reconstruction at DePuy Synthes, which is the orthopedic company of Johnson & Johnson. DePuy Synthes is focused on adapting their technology, techniques, and implants to provide stability, flexibility, and durability to an ever more active patient population. Keith reports, "When we think about our surgeons and our patients and keep them in mind, we have solutions that address unmet needs in patients that lead to improved outcomes. So, through our anterior advantage, our portfolio solutions, in particular, patients benefit from shorter hospital stays, quicker recovery times, and reduced use of pain medication when they're surgeon implants or comprehensive systems for hip replacement surgeries." "Our patients today are highly educated on different surgical technique offerings. They even think about what's best in terms of meeting their needs, the quicker recovery, and even going to outpatient surgery centers and ensuring that the time is reduced to help them get back to their active lifestyle quicker. But they're continuously involved in goal planning with the surgeon to be able to address some of these needs." @DePuySynthes #HipReplacement #HipReplacementSurgery jnjmedtech.com Listen to the podcast here

Keith Palmer is the Worldwide Vice President for Hip Reconstruction at DePuy Synthes, which is the orthopedic company of Johnson & Johnson. DePuy Synthes is focused on adapting their technology, techniques, and implants to provide stability, flexibility, and durability to an ever more active patient population. Keith reports, "When we think about our surgeons and our patients and keep them in mind, we have solutions that address unmet needs in patients that lead to improved outcomes. So, through our anterior advantage, our portfolio solutions, in particular, patients benefit from shorter hospital stays, quicker recovery times, and reduced use of pain medication when they're surgeon implants or comprehensive systems for hip replacement surgeries." "Our patients today are highly educated on different surgical technique offerings. They even think about what's best in terms of meeting their needs, the quicker recovery, and even going to outpatient surgery centers and ensuring that the time is reduced to help them get back to their active lifestyle quicker. But they're continuously involved in goal planning with the surgeon to be able to address some of these needs." @DePuySynthes #HipReplacement #HipReplacementSurgery jnjmedtech.com Download the transcript here

Javier Szwarcberg, CEO of Spruce Biosciences, is developing a compound to address the needs of patients with classic congenital adrenal hyperplasia, CAH, a rare disease first diagnosed at birth. Only recently have companies started to explore innovative therapies to improve the standard of care discovered in the early 1960s. Currently, patients manage their conditions with glucocorticoids but often suffer from steroid-related complications. Javier explains, "What we're trying to do with our drug is to treat the disease. The compound is a small molecule that binds to a receptor in the pituitary and blocks the release of a hormone called ACTH or adrenal corticotropin hormone. By blocking that hormone, you reduce the amount, the stimulation on the adrenals, and the buildup of precursors that are going to lead to a hyperandrogenic state. So our drug treats the disease. Patients, of course, will still need to get steroids daily to supplement the missing cortisol. But the CAH piece of the disease will be well managed. That's the hope." "The whole pharmaceutical industry and academic community are starting to pay more attention to rare diseases. And back when I started my career in industry, it was all about addressing the totality of a population with, say, hypertension or diabetes or cancer, for that matter. Now there's a realization that companies ought to be more thoughtful, and research ought to be more thoughtful and address the needs of a subset of patients with rare diseases with more kinds of patient-targeted therapies." @Spruce_Bio #RareDisease #CAH #CongenitalAdrenalHyperplasia #Glucocorticoids SpruceBiosciences.com Download the transcript here

Javier Szwarcberg, CEO of Spruce Biosciences, is developing a compound to address the needs of patients with classic congenital adrenal hyperplasia, CAH, a rare disease first diagnosed at birth. Only recently have companies started to explore innovative therapies to improve the standard of care discovered in the early 1960s. Currently, patients manage their conditions with glucocorticoids but often suffer from steroid-related complications. Javier explains, "What we're trying to do with our drug is to treat the disease. The compound is a small molecule that binds to a receptor in the pituitary and blocks the release of a hormone called ACTH or adrenal corticotropin hormone. By blocking that hormone, you reduce the amount, the stimulation on the adrenals, and the buildup of precursors that are going to lead to a hyperandrogenic state. So our drug treats the disease. Patients, of course, will still need to get steroids daily to supplement the missing cortisol. But the CAH piece of the disease will be well managed. That's the hope." "The whole pharmaceutical industry and academic community are starting to pay more attention to rare diseases. And back when I started my career in industry, it was all about addressing the totality of a population with, say, hypertension or diabetes or cancer, for that matter. Now there's a realization that companies ought to be more thoughtful, and research ought to be more thoughtful and address the needs of a subset of patients with rare diseases with more kinds of patient-targeted therapies." @Spruce_Bio #RareDisease #CAH #CongenitalAdrenalHyperplasia #Glucocorticoids SpruceBiosciences.com Listen to the podcast here

Richard Hague is the CEO and President of PolarityTE, creating a paste-like substance containing multicellular skin segments that can be spread on the patient's wound bed and engrafts into the wound. This stimulates healing from the inside out with wounds created by diabetic foot ulcer and venous leg ulcer. Richard elaborates, "We're very excited about our SkinTE platform. It's a very unique and novel approach for treating wounds. The goal here is to use the patient's own cells so that there's no risk of rejection of any kind, no introduction of anything foreign to the body." "The first thing that happens is a physician takes a very small, full thickness harvest from the patient's body, usually somewhere in the proximal calf area. So this is healthy tissue. It's a small harvest that's easily stitched up and closed. And that tissue is sent back to our facility in Salt Lake City. We have a proprietary process for processing that skin that allows us to utilize all aspects of that harvest. So we're using all layers of the cells and all the extracellular material that's in that full thickness skin." @PolarityTE #PolarityTE #SkinTE #DiabeticFootUlcers #Diabetes #PressureUlcers PolarityTE.com Listen to the podcast here

Richard Hague is the CEO and President of PolarityTE, creating a paste-like substance containing multicellular skin segments that can be spread on the patient's wound bed and engrafts into the wound. This stimulates healing from the inside out with wounds created by diabetic foot ulcer and venous leg ulcer. Richard elaborates, "We're very excited about our SkinTE platform. It's a very unique and novel approach for treating wounds. The goal here is to use the patient's own cells so that there's no risk of rejection of any kind, no introduction of anything foreign to the body." "The first thing that happens is a physician takes a very small, full thickness harvest from the patient's body, usually somewhere in the proximal calf area. So this is healthy tissue. It's a small harvest that's easily stitched up and closed. And that tissue is sent back to our facility in Salt Lake City. We have a proprietary process for processing that skin that allows us to utilize all aspects of that harvest. So we're using all layers of the cells and all the extracellular material that's in that full thickness skin." @PolarityTE #PolarityTE #SkinTE #DiabeticFootUlcers #Diabetes #PressureUlcers PolarityTE.com Download the transcript here

Greg Sturmer is the Co-Founder and CEO of Elysium Therapeutics and rethinking how to overcome the challenges of opioid abuse and addiction by reformulating the drug itself. Blending an understanding of chemistry and human behavior, Elysium questions why it takes 70 years for an opioid to lose half its potency and what would discourage patients from taking more opioids than their prescribed treatment plan. Greg explains, "When you look at Elysium's mission, just to step back briefly, it's all about relieving suffering from acute pain, from opioid use disorder, and from an opioid overdose. And our objective is to save thousands of lives each year and reduce the next generation of opioid use disorder sufferers while still providing patients with highly effective, proven pain relief." "O2P, again, which stands for Oral Overdose Protection, is expected to be the first-in-class immediate-release opioid that eliminates that incentive to take more. And it protects against fatal overdose, not only orally but also via injection and inhalation. So, it's a way that Tom has done using chemistry, has created a way to limit, self-limit, the amount of opioid that actually becomes activated. So regardless of how many you swallow, we're limiting the amount of opioid that will actually be active. And that'll protect, one, from incentivizing an individual to take more and, two, preventing an overdose." #Elysium #ElysiumRX #OpioidAbuse #OpioidOverdose #Opioids elysiumrx.com Download the transcript here

Greg Sturmer is the Co-Founder and CEO of Elysium Therapeutics and rethinking how to overcome the challenges of opioid abuse and addiction by reformulating the drug itself. Blending an understanding of chemistry and human behavior, Elysium questions why it takes 70 years for an opioid to lose half its potency and what would discourage patients from taking more opioids than their prescribed treatment plan. Greg explains, "When you look at Elysium's mission, just to step back briefly, it's all about relieving suffering from acute pain, from opioid use disorder, and from an opioid overdose. And our objective is to save thousands of lives each year and reduce the next generation of opioid use disorder sufferers while still providing patients with highly effective, proven pain relief." "O2P, again, which stands for Oral Overdose Protection, is expected to be the first-in-class immediate-release opioid that eliminates that incentive to take more. And it protects against fatal overdose, not only orally but also via injection and inhalation. So, it's a way that Tom has done using chemistry, has created a way to limit, self-limit, the amount of opioid that actually becomes activated. So regardless of how many you swallow, we're limiting the amount of opioid that will actually be active. And that'll protect, one, from incentivizing an individual to take more and, two, preventing an overdose." #Elysium #ElysiumRX #OpioidAbuse #OpioidOverdose #Opioids elysiumrx.com Listen to the podcast here

Dr. Alice Martin is the Co-Founder of Dermanostic, the largest teledermatology resource in Europe. Their vision is to give access to a dermatologist to everyone worldwide with a rapid diagnosis and suggested therapy, including prescriptions. While many skin conditions are not life-threatening and are often seen as unimportant by physicians, they impact the quality of life and are treatable. Alice explains, "We have a lot of patients with skin cancer, white and also black skin cancer melanoma, for example, and it's so easy to just make the pictures because we can see the criteria for malignancy. The patients don't want to go to the appointment because they don't have any symptoms. It's just skin, the area that is growing, and by having such easy access, they are sending the pictures. They are getting the diagnosis before it's starting to make any metastases." "So the application is available, for example, on the Apple Play Store or Google Play Store, and you can download it in your language. It's also available in English and after you are downloaded that application, you can just take three pictures of the area, for example, something on your skin or your hair and also on your nail. Afterward, you're getting a very small questionnaire, like since when do you have this problem? Does it hurt? And do you have any allergies or something like that? And then you are making the registration process, and afterward, you are making the payment process." "And normally it takes two to four hours and that time you can just enjoy your free time and our physicians are getting the pictures and the questionnaire, and on this basis, they are making the diagnosis, and the treatment and they are sending back a doctor's letter in PDF. Also, the prescription and the patient can get the prescription by just clicking on the button. So in Europe, it's working all over all European countries. Of course, we are also working on the other countries to get good access to the pharmacist and so on, but for the first step here in Europe it's working quite well." #Dermanostic #DermatologistApp #Teledermatology #Dermatology #Dermatologist #DigitalHealth #Germany dermanostic.com Listen to the podcast here

Dr. Alice Martin is the Co-Founder of Dermanostic, the largest teledermatology resource in Europe. Their vision is to give access to a dermatologist to everyone worldwide with a rapid diagnosis and suggested therapy, including prescriptions. While many skin conditions are not life-threatening and are often seen as unimportant by physicians, they impact the quality of life and are treatable. Alice explains, "We have a lot of patients with skin cancer, white and also black skin cancer melanoma, for example, and it's so easy to just make the pictures because we can see the criteria for malignancy. The patients don't want to go to the appointment because they don't have any symptoms. It's just skin, the area that is growing, and by having such easy access, they are sending the pictures. They are getting the diagnosis before it's starting to make any metastases." "So the application is available, for example, on the Apple Play Store or Google Play Store, and you can download it in your language. It's also available in English and after you are downloaded that application, you can just take three pictures of the area, for example, something on your skin or your hair and also on your nail. Afterward, you're getting a very small questionnaire, like since when do you have this problem? Does it hurt? And do you have any allergies or something like that? And then you are making the registration process, and afterward, you are making the payment process." "And normally it takes two to four hours and that time you can just enjoy your free time and our physicians are getting the pictures and the questionnaire, and on this basis, they are making the diagnosis, and the treatment and they are sending back a doctor's letter in PDF. Also, the prescription and the patient can get the prescription by just clicking on the button. So in Europe, it's working all over all European countries. Of course, we are also working on the other countries to get good access to the pharmacist and so on, but for the first step here in Europe it's working quite well." #Dermanostic #DermatologistApp #Teledermatology #Dermatology #Dermatologist #DigitalHealth #Germany dermanostic.com Download the transcript here

Patty Hayward is the Vice President of Industry Strategy for Healthcare and Life Sciences at Talkdesk which is working with payer and provider organizations, life sciences companies, and other clients in the healthcare and life sciences areas.  Its mission is to synchronize data streams so that there is a convenient way for care providers and patients to receive healthcare information and services using their channel of choice. Patty elaborates, "People are really looking for that kind of convenience, and I think that's a radical shift from where we've been in the provider space, where it's really, you hang a sign outside and people came to you. You didn't do as much of the big outreach and marketing unless you were in really congested marketplaces. Even then it was very traditional in how you went about marketing." "I think today that's really shifted. A lot of folks that we're talking to are really looking to digitize their contact centers, digitize their patient experience, and trying to look at things in a very different way to allow different kinds of conversations and communication styles." #Talkdesk #ContactCenter #DigitalHealth #Healthcare #HealthcareInnovation #HealthcareIT #PatientExperience Talkdesk.com Listen to the podcast here

Patty Hayward is the Vice President of Industry Strategy for Healthcare and Life Sciences at Talkdesk which is working with payer and provider organizations, life sciences companies, and other clients in the healthcare and life sciences areas.  Its mission is to synchronize data streams so that there is a convenient way for care providers and patients to receive healthcare information and services using their channel of choice. Patty elaborates, "People are really looking for that kind of convenience, and I think that's a radical shift from where we've been in the provider space, where it's really, you hang a sign outside and people came to you. You didn't do as much of the big outreach and marketing unless you were in really congested marketplaces. Even then it was very traditional in how you went about marketing." "I think today that's really shifted. A lot of folks that we're talking to are really looking to digitize their contact centers, digitize their patient experience, and trying to look at things in a very different way to allow different kinds of conversations and communication styles." #Talkdesk #ContactCenter #DigitalHealth #Healthcare #HealthcareInnovation #HealthcareIT #PatientExperience Talkdesk.com Download the transcript here

Terry Weber is the CEO of BioTE and is on a mission to educate medical professionals about the need to address the hormone levels in patients as they age. With a personalized approach, BioTE focuses on providing hormone therapy to help patients maintain their quality of life and not just be dismissed as getting old when they report discomfort, sexual dysfunction, and loss of muscle mass.   Terry explains, "At BioTE we don't just do hormone treatment. We try to optimize the individual's hormones, and that would be estrogen and testosterone, both for men and women. Testosterone's very important for women. Also, looking at the thyroid and adrenals. What we look to see is how do we balance those hormones in the individuals so that they really feel their absolute best. We take blood tests, and we have very in-depth questionnaires because everyone's reaction to hormone levels is very personal." "BioTE's history has been to focus on putting a light on testosterone for women because it's such a critical hormone. Most people assume that testosterone is just for men, and that's not true at all. What BioTE has brought to the market is a real focus on women's needs and the need for testosterone in women's bodies and how important that is in the long run for their general health. We've been disruptive in that way." #BioTE #HealthyAging #WomensHealth #HormoneTherapy #Hormones #HormonalInbalance #Testosterone #Estrogen BioTE.com Listen to the podcast here

Terry Weber is the CEO of BioTE and is on a mission to educate medical professionals about the need to address the hormone levels in patients as they age. With a personalized approach, BioTE focuses on providing hormone therapy to help patients maintain their quality of life and not just be dismissed as getting old when they report discomfort, sexual dysfunction, and loss of muscle mass.   Terry explains, "At BioTE we don't just do hormone treatment. We try to optimize the individual's hormones, and that would be estrogen and testosterone, both for men and women. Testosterone's very important for women. Also, looking at the thyroid and adrenals. What we look to see is how do we balance those hormones in the individuals so that they really feel their absolute best. We take blood tests, and we have very in-depth questionnaires because everyone's reaction to hormone levels is very personal." "BioTE's history has been to focus on putting a light on testosterone for women because it's such a critical hormone. Most people assume that testosterone is just for men, and that's not true at all. What BioTE has brought to the market is a real focus on women's needs and the need for testosterone in women's bodies and how important that is in the long run for their general health. We've been disruptive in that way." #BioTE #HealthyAging #WomensHealth #HormoneTherapy #Hormones #HormonalInbalance #Testosterone #Estrogen BioTE.com Download the transcript here

Dr. Diem Nguyen is the CEO of Xalud Therapeutics, a DNA delivery gene therapy company striving to develop and deliver medicines for large, broad-based disease indications like chronic inflammatory diseases, particularly musculoskeletal diseases like osteoarthritis of the knee and as well as neurodegenerative diseases like MS and ALS. Earlier in her career, Diem was the global President of Pfizer, covering multiple therapeutic areas, and has joined Xalud because of their ground-breaking DNA delivery platform. Diem explains, "Gene therapy means a lot of things to a lot of people. And the first, I would say, is most people, when they think about gene therapies, think about viral AAV gene therapy. And a lot of promise is associated with that type of platform because you're seeing this potential, particularly in rare diseases. The challenges associated with AAV sometimes are the safety profile associated with that product. Our particular gene therapy is DNA gene therapy, so we do not have the challenges with genome integration, which allows us to have a potentially stronger safety profile." "I want to be very clear when I say disease modification because it can mean many things from a definition perspective to different audiences. What I want to say specifically about our product, XT-150, is we're not looking to treat pain associated with osteoarthritis of the knee by just blocking the pain or masking the pain. What we're trying to do is help your body restore homeostasis." "What we're saying is we're supplementing your body with interleukin-10, which then allows you to have your body naturally reduce pro-inflammatory cytokines, which then reduces the inflammation." #XaludTherapeutics #GeneTherapy #InflammatoryDiseases #Cytokines #Inflammation #Osteoarthritis #NeurodegenerativeDiseases #ALS #MS XaludThera.com Listen to the podcast here

Dr. Diem Nguyen is the CEO of Xalud Therapeutics, a DNA delivery gene therapy company striving to develop and deliver medicines for large, broad-based disease indications like chronic inflammatory diseases, particularly musculoskeletal diseases like osteoarthritis of the knee and as well as neurodegenerative diseases like MS and ALS. Earlier in her career, Diem was the global President of Pfizer, covering multiple therapeutic areas, and has joined Xalud because of their ground-breaking DNA delivery platform. Diem explains, "Gene therapy means a lot of things to a lot of people. And the first, I would say, is most people, when they think about gene therapies, think about viral AAV gene therapy. And a lot of promise is associated with that type of platform because you're seeing this potential, particularly in rare diseases. The challenges associated with AAV sometimes are the safety profile associated with that product. Our particular gene therapy is DNA gene therapy, so we do not have the challenges with genome integration, which allows us to have a potentially stronger safety profile." "I want to be very clear when I say disease modification because it can mean many things from a definition perspective to different audiences. What I want to say specifically about our product, XT-150, is we're not looking to treat pain associated with osteoarthritis of the knee by just blocking the pain or masking the pain. What we're trying to do is help your body restore homeostasis." "What we're saying is we're supplementing your body with interleukin-10, which then allows you to have your body naturally reduce pro-inflammatory cytokines, which then reduces the inflammation." #XaludTherapeutics #GeneTherapy #InflammatoryDiseases #Cytokines #Inflammation #Osteoarthritis #NeurodegenerativeDiseases #ALS #MS XaludThera.com Download the transcript here

Sabrina Johnson is the Founder, President, and CEO of Daré Bioscience. Sabrina points out that there are several unmet needs in women's health and that many of the indications or conditions that women are dealing with are not life-threatening but affect their quality of life. Applying technologies created by smaller companies and academic institutions, Daré aims to become a pipeline for companies that have a global commitment to improving women's health. Sabrina explains, "Our business model is to really be that innovation accelerator that starts with finding and identifying that persistent unmet need. And that's where we start. What is that condition that is not adequately addressed today for her? Developing a target product profile, what would the product look like that might be best suited to address that condition for her? We then go out and look for a technology that has a proof of concept that it should address that and hit that target product profile. We bring that into Daré into our portfolio. We advance it through development, and then ultimately, we seek to bring that product to market in whatever way makes the most sense for that product. And sometimes that's going to be by being that pipeline resource to companies like Bayer and Organon. And I mentioned both of those because we have a collaboration with each of them now." @DareBioscience #WomensHealth #GenderInequality #Healthcare #ReproductiveHealth #SexualHealth #Biotech #DrugDevelopment darebioscience.com Listen to the podcast here

Sabrina Johnson is the Founder, President, and CEO of Daré Bioscience. Sabrina points out that there are several unmet needs in women's health and that many of the indications or conditions that women are dealing with are not life-threatening but affect their quality of life. Applying technologies created by smaller companies and academic institutions, Daré aims to become a pipeline for companies that have a global commitment to improving women's health. Sabrina explains, "Our business model is to really be that innovation accelerator that starts with finding and identifying that persistent unmet need. And that's where we start. What is that condition that is not adequately addressed today for her? Developing a target product profile, what would the product look like that might be best suited to address that condition for her? We then go out and look for a technology that has a proof of concept that it should address that and hit that target product profile. We bring that into Daré into our portfolio. We advance it through development, and then ultimately, we seek to bring that product to market in whatever way makes the most sense for that product. And sometimes that's going to be by being that pipeline resource to companies like Bayer and Organon. And I mentioned both of those because we have a collaboration with each of them now." @DareBioscience #WomensHealth #GenderInequality #Healthcare #ReproductiveHealth #SexualHealth #Biotech #DrugDevelopment darebioscience.com Download the transcript here

Dr. Kimberly Kilby is the Vice-President and Medical Director of Health and Wellbeing at MVP Health Care. Trained as a family and preventive physician, Kimberly is focused on the patient journey and expanding the options for virtual care. MVP collaborates with virtual care providers and other digital health solutions, supporting virtual primary care, urgent care, chronic care management, and specialty care. Kimberly explains, "We want to be sure that patients are finding options for virtual care that are actually high-quality medicine but also thoughtfully integrated into the rest of their care continuum. That's part of the professional reason why a physician is dedicated to that key customer experience as you expand options in the virtual care space." "A lot of the data is showing that patient and consumer preferences within healthcare have obviously changed dramatically, and patients are looking for more convenience and availability. And I'm really charged with determining which of the innovative options people are migrating to are actually high value and improve care and don't really add waste to the system." @MVPHealthCare #DigitalHealth #Telemedicine #VirtualPrimaryCare #VirtualUrgentCare MVPHealthCare.com Listen to the podcast here

Dr. Kimberly Kilby is the Vice-President and Medical Director of Health and Wellbeing at MVP Health Care. Trained as a family and preventive physician, Kimberly is focused on the patient journey and expanding the options for virtual care. MVP collaborates with virtual care providers and other digital health solutions, supporting virtual primary care, urgent care, chronic care management, and specialty care. Kimberly explains, "We want to be sure that patients are finding options for virtual care that are actually high-quality medicine but also thoughtfully integrated into the rest of their care continuum. That's part of the professional reason why a physician is dedicated to that key customer experience as you expand options in the virtual care space." "A lot of the data is showing that patient and consumer preferences within healthcare have obviously changed dramatically, and patients are looking for more convenience and availability. And I'm really charged with determining which of the innovative options people are migrating to are actually high value and improve care and don't really add waste to the system." @MVPHealthCare #DigitalHealth #Telemedicine #VirtualPrimaryCare #VirtualUrgentCare MVPHealthCare.com Download the transcript here

Mai-Britt Zocca is the Founder, CEO, and President of IO Biotech, a clinical stage biopharmaceutical company headquartered in Denmark. They are developing immune modeling cancer therapies based on their T-win technology. Using these cancer vaccines, pre-existing T-cells are being directed in patients to attack and eliminate solid tumors. Mai-Britt explains, "Currently, we have a leading program that is in Phase 3. So, this is in first-line advanced melanoma. We have a breakthrough therapy designation granted by the FDA, based on the earlier data that we have seen in melanoma. Our targets also are able to be used in other cancer indications. We are not melanoma per se. We are already running trials in first-line solid tumors where we are including also lung, head, neck, and bladder cancer." "What we do is vaccinate, as I mentioned before, and the vaccination process is a combination of first a booster program, where we give vaccination or injections several times. Then we have a maintenance phase after that. This is where we see that after these vaccinations, where we vaccinate against the tumor environment, we generate the T-cells that can react towards the immune suppressive mechanisms that we know are hindering the effect of the T-cells in these patients." #IOBiotech #Melanoma #CancerVaccine #Immunotherapy #Cancer #ImmunoOncology IOBiotech.com Listen to the podcast here

Mai-Britt Zocca is the Founder, CEO, and President of IO Biotech, a clinical stage biopharmaceutical company headquartered in Denmark. They are developing immune modeling cancer therapies based on their T-win technology. Using these cancer vaccines, pre-existing T-cells are being directed in patients to attack and eliminate solid tumors. Mai-Britt explains, "Currently, we have a leading program that is in Phase 3. So, this is in first-line advanced melanoma. We have a breakthrough therapy designation granted by the FDA, based on the earlier data that we have seen in melanoma. Our targets also are able to be used in other cancer indications. We are not melanoma per se. We are already running trials in first-line solid tumors where we are including also lung, head, neck, and bladder cancer." "What we do is vaccinate, as I mentioned before, and the vaccination process is a combination of first a booster program, where we give vaccination or injections several times. Then we have a maintenance phase after that. This is where we see that after these vaccinations, where we vaccinate against the tumor environment, we generate the T-cells that can react towards the immune suppressive mechanisms that we know are hindering the effect of the T-cells in these patients." #IOBiotech #Melanoma #CancerVaccine #Immunotherapy #Cancer #ImmunoOncology IOBiotech.com Download the transcript here

Dr. Hernan Bazan is the CEO and Co-Founder of South Rampart Pharma and focuses on finding a new way to treat acute and chronic pain with a drug that has no expectation for abuse and is not toxic to the liver, kidneys, or cardiovascular system. Hernan explains, "This is a tremendous unmet need in that there really has been no innovation in the pain space for over 50 years. Tylenol itself, acetaminophen, Tylenol was born in the '40s and the early '50s and worked by actually someone that was at the NIH that came to visit us a few times, a very well renowned neuroscientist. And he really discovered it incidentally, looking for another pathway, but we won't go into that. And that was adopted by McNeil Laboratories, and then eventually Johnson & Johnson." "And then, in the '60s and '70s, non-steroidals, non NSAIDs, were marketed as Advil and ibuprofen, and a bunch of NSAIDs were derived. And these are very good medicines for preventing inflammation and treating pain in the short term. The challenge with both of these classes of pain meds is that they have risks." "And then the third class, obviously, everybody knows about opioids and how they were marketed in the '90s." @SR_Pharma #Pain #AcutePain #Analgesic #Acetaminophen #Opioid #NSAID #Nontoxic #NonOpioid #NewOrleans southrampartpharma.com Listen to the podcast here

Dr. Hernan Bazan is the CEO and Co-Founder of South Rampart Pharma and focuses on finding a new way to treat acute and chronic pain with a drug that has no expectation for abuse and is not toxic to the liver, kidneys, or cardiovascular system. Hernan explains, "This is a tremendous unmet need in that there really has been no innovation in the pain space for over 50 years. Tylenol itself, acetaminophen, Tylenol was born in the '40s and the early '50s and worked by actually someone that was at the NIH that came to visit us a few times, a very well renowned neuroscientist. And he really discovered it incidentally, looking for another pathway, but we won't go into that. And that was adopted by McNeil Laboratories, and then eventually Johnson & Johnson." "And then, in the '60s and '70s, non-steroidals, non NSAIDs, were marketed as Advil and ibuprofen, and a bunch of NSAIDs were derived. And these are very good medicines for preventing inflammation and treating pain in the short term. The challenge with both of these classes of pain meds is that they have risks." "And then the third class, obviously, everybody knows about opioids and how they were marketed in the '90s." @SR_Pharma #Pain #AcutePain #Analgesic #Acetaminophen #Opioid #NSAID #Nontoxic #NonOpioid #NewOrleans southrampartpharma.com Download the transcript here

Sheila Frame is the President for the Americas at Amryt Pharma, founded on the belief that rare and ultra-rare diseases were an opportunity to support underserved patients differently than the big pharmaceutical companies could. With the acquisition of Mycapssa, Amryt is changing the treatment for the rare disease acromegaly from painful injections to the first and only twice-daily oral medication. Shelia explains, "We're currently commercially, at least, in three different areas. So lipodystrophy is a pretty significant leptin deficiency for people who suffer from that. It's a fairly rare disease, with about 300 patients roughly in the US. The second one is in homozygous familial hypercholesterolemia, and again, a very rare genetic disease, probably even fewer patients than what we see in lipodystrophy. And then the third area, of course, is acromegaly with Mycapssa, where we actually have products in the market." "I think what's interesting about not only the technology that we have with Mycapssa but also the impact of taking a pill twice a day means that you have this sustained control of the drug in your system. I think patients are finding that that really helps them. And so beyond just the convenience of not having to go through monthly objections, but also just the way they feel by having that sustained control and the drug in their system." @AmrytPharma #Amryt #Acromegaly #Endocrinology #RareDisease #Mycapssa Acromegalycommunity.org Amrytpharma.com Download the transcript here

Sheila Frame is the President for the Americas at Amryt Pharma, founded on the belief that rare and ultra-rare diseases were an opportunity to support underserved patients differently than the big pharmaceutical companies could. With the acquisition of Mycapssa, Amryt is changing the treatment for the rare disease acromegaly from painful injections to the first and only twice-daily oral medication. Shelia explains, "We're currently commercially, at least, in three different areas. So lipodystrophy is a pretty significant leptin deficiency for people who suffer from that. It's a fairly rare disease, with about 300 patients roughly in the US. The second one is in homozygous familial hypercholesterolemia, and again, a very rare genetic disease, probably even fewer patients than what we see in lipodystrophy. And then the third area, of course, is acromegaly with Mycapssa, where we actually have products in the market." "I think what's interesting about not only the technology that we have with Mycapssa but also the impact of taking a pill twice a day means that you have this sustained control of the drug in your system. I think patients are finding that that really helps them. And so beyond just the convenience of not having to go through monthly objections, but also just the way they feel by having that sustained control and the drug in their system." @AmrytPharma #Amryt #Acromegaly #Endocrinology #RareDisease #Mycapssa Acromegalycommunity.org Amrytpharma.com Download the transcript here

Allison London Brown is the CEO of LUMINELLE, inventors of an advanced endoscopic system with a camera and biopsy device that allows physicians to perform gynecological procedures in their offices more safely, more efficiently, and with better reimbursement. Being able to look inside the uterus and bladder and perform operations that in the past would have required a hospital outpatient visit means that women and their doctors are more likely to identify problems sooner and get a prompt diagnosis of cancerous tissues. Allison elaborates, "If you have problems, it can also help with things like drug delivery for overactive bladder. And it can be used for fertility, both treatments, as well as trying to prevent pregnancy. So it's a pretty versatile system. It's very low cost, and it's really so that women can have procedures done in the comfort of their physician's office with less anesthesia and certainly less cost." "And for the payers, if you're catching things sooner, you're not incurring all these costs that you might in a hospital, like the anesthesiologist and all the nurses and all the different things that go along with the hospital outpatient procedure. It's much more beneficial for them as well. So it's really a nice move to try to get people care the first time at the first place they should be going." #LUMINELLE #Endoscopy #MedicalDevice #WomensHealth #UterineCancer LUMINELLE360.com Listen to the podcast here

Allison London Brown is the CEO of LUMINELLE, inventors of an advanced endoscopic system with a camera and biopsy device that allows physicians to perform gynecological procedures in their offices more safely, more efficiently, and with better reimbursement. Being able to look inside the uterus and bladder and perform operations that in the past would have required a hospital outpatient visit means that women and their doctors are more likely to identify problems sooner and get a prompt diagnosis of cancerous tissues. Allison elaborates, "If you have problems, it can also help with things like drug delivery for overactive bladder. And it can be used for fertility, both treatments, as well as trying to prevent pregnancy. So it's a pretty versatile system. It's very low cost, and it's really so that women can have procedures done in the comfort of their physician's office with less anesthesia and certainly less cost." "And for the payers, if you're catching things sooner, you're not incurring all these costs that you might in a hospital, like the anesthesiologist and all the nurses and all the different things that go along with the hospital outpatient procedure. It's much more beneficial for them as well. So it's really a nice move to try to get people care the first time at the first place they should be going." #LUMINELLE #Endoscopy #MedicalDevice #WomensHealth #UterineCancer LUMINELLE360.com Download the transcript here

Dr. Emily Hamilton is the Senior Vice President of Clinical Research at PeriGen, which is applying artificial intelligence and machine learning to early warning and clinical decision support in healthcare.  With a focus on labor and delivery, PeriGen is providing real-time information to clinicians to drive down the likelihood of birth-related brain injury. Emily explains, "So, what we have developed is an AI machine learning-based way of looking at the tracing to identify contractions, to notify nurses and doctors that there are excessive contractions, and that's gone on for a while. We've also used that to recognize patterns in the fetal heart rate, which indicate that the baby's not responding well to labor and to notify them of that so that they can intervene and prevent the adverse outcome." "Likewise, we can look at the labor, and we can compare a patient's labor to a group of similar women who are having the same frequency of contractions, a number of other variables, and indicate whether or not this labor is on course or whether or not it's slower or perhaps faster. It's all done in a very consistent, quantifiable way." @PeriGen #AI #ArtificialIntelligence #MachineLearning #ML #WomensHealth #LaborandDelivery #BirthRelatedBrainInjury Perigen.com Listen to the podcast here

Dr. Emily Hamilton is the Senior Vice President of Clinical Research at PeriGen, which is applying artificial intelligence and machine learning to early warning and clinical decision support in healthcare.  With a focus on labor and delivery, PeriGen is providing real-time information to clinicians to drive down the likelihood of birth-related brain injury. Emily explains, "So, what we have developed is an AI machine learning-based way of looking at the tracing to identify contractions, to notify nurses and doctors that there are excessive contractions, and that's gone on for a while. We've also used that to recognize patterns in the fetal heart rate, which indicate that the baby's not responding well to labor and to notify them of that so that they can intervene and prevent the adverse outcome." "Likewise, we can look at the labor, and we can compare a patient's labor to a group of similar women who are having the same frequency of contractions, a number of other variables, and indicate whether or not this labor is on course or whether or not it's slower or perhaps faster. It's all done in a very consistent, quantifiable way." @PeriGen #AI #ArtificialIntelligence #MachineLearning #ML #WomensHealth #LaborandDelivery #BirthRelatedBrainInjury Perigen.com Download the transcript here

Arjan Haverhals is the CEO and President of Milestone Scientific, which is exploring how to modernize hypodermic syringe use. One application of their injection technology is for women during labor and delivery to inject the epidural needle more accurately and control the pain. Milestone is also looking at dentistry, chronic pain, neuro-surgery, and cosmetic medicine as additional opportunities to deliver more efficient, precise, and safer injections. Arjan provides a historical perspective, "Just to give you some background information from a study from last year. It was found that even when male and female patients expressed the same amount of pain, female patients' pain is often seen as less intense and more likely to benefit from psychotherapy versus medication as compared to men's pain. And I do believe that this gender gap in healthcare could lead to bias diagnoses related to chronic pain for women and may also explain why very little has changed in the field of epidural delivery. And any way we can aid in closing that gap is a win-win." "Now, if women go for labor and delivery these days, it is still a technology that is used stemming from the 1860s, and it is nothing more or less than a hypodermic syringe, later positioned in the medical field as the loss of resistance technique, which is a very manual, subjective way of placing the epidural needle in the epidural space. And the reason why we entered this field is a strong belief that we can solve the problems, and the associated risk factors, with this high-risk epidural analgesia procedure." @MilestoneSciInc #CompuFlov#WomensHealth #Pregnancy #LaborandDelivery #Epidural #DuralPuncture #MedicalDevice #MedTech MilestoneScientific.com Listen to the podcast here

Arjan Haverhals is the CEO and President of Milestone Scientific, which is exploring how to modernize hypodermic syringe use. One application of their injection technology is for women during labor and delivery to inject the epidural needle more accurately and control the pain. Milestone is also looking at dentistry, chronic pain, neuro-surgery, and cosmetic medicine as additional opportunities to deliver more efficient, precise, and safer injections. Arjan provides a historical perspective, "Just to give you some background information from a study from last year. It was found that even when male and female patients expressed the same amount of pain, female patients' pain is often seen as less intense and more likely to benefit from psychotherapy versus medication as compared to men's pain. And I do believe that this gender gap in healthcare could lead to bias diagnoses related to chronic pain for women and may also explain why very little has changed in the field of epidural delivery. And any way we can aid in closing that gap is a win-win." "Now, if women go for labor and delivery these days, it is still a technology that is used stemming from the 1860s, and it is nothing more or less than a hypodermic syringe, later positioned in the medical field as the loss of resistance technique, which is a very manual, subjective way of placing the epidural needle in the epidural space. And the reason why we entered this field is a strong belief that we can solve the problems, and the associated risk factors, with this high-risk epidural analgesia procedure." @MilestoneSciInc #CompuFlov#WomensHealth #Pregnancy #LaborandDelivery #Epidural #DuralPuncture #MedicalDevice #MedTech MilestoneScientific.com Download the transcript here

Daniel Teper is the CEO and Founder of Cytovia Therapeutics and talks about using natural killer, NK, cells as an alternative to T-cells in immuno-oncology. He shares insights about the development of induced pluripotent stem cells, IPSC-derived NK cells, iNK cells, used by themselves or using their Flex-NK cell Engagers or in combination to address the challenges cancer patients face. Daniel elaborates, "That's also where the NK cells may have advantages over T-cells, in that it hasn't been reported that they cause CRS, GBHD, or other side effects that would require the patients to be kept in the hospital. Now, if we say the first iteration was derived from the patient's own blood, the second iteration is donor, the third generation, which we are one of a handful of companies to pursue and master, is the production of immune cells, including NK cells, from induced pluripotent stem cells." "We see also that you can direct the cells in two ways. You can direct the cells by inserting what's called a CAR, or chimeric antigen receptor, that's like a GPS on the cell. But alternatively, we can redirect the NK cells to kill the tumor cells by combining them with antibodies, and particularly with what we call NK engager antibodies. So our brand of NK engager antibodies is called Flex-NK cell engager antibodies. And what they do is that they have one arm that binds and activates the NK cell, and another arm that binds into the tumor cell, and the NK cells are redirected to kill the tumor cells." @Cytovia #CytoviaTX #Oncology #ImmunoOncology #Cancer #CancerTherapeutics #CellTherapeutics #NKCells #iNKCells #NaturalKillerCells CytoviaTX.com Listen to the podcast here

Daniel Teper is the CEO and Founder of Cytovia Therapeutics and talks about using natural killer, NK, cells as an alternative to T-cells in immuno-oncology. He shares insights about the development of induced pluripotent stem cells, IPSC-derived NK cells, iNK cells, used by themselves or using their Flex-NK cell Engagers or in combination to address the challenges cancer patients face. Daniel elaborates, "That's also where the NK cells may have advantages over T-cells, in that it hasn't been reported that they cause CRS, GBHD, or other side effects that would require the patients to be kept in the hospital. Now, if we say the first iteration was derived from the patient's own blood, the second iteration is donor, the third generation, which we are one of a handful of companies to pursue and master, is the production of immune cells, including NK cells, from induced pluripotent stem cells." "We see also that you can direct the cells in two ways. You can direct the cells by inserting what's called a CAR, or chimeric antigen receptor, that's like a GPS on the cell. But alternatively, we can redirect the NK cells to kill the tumor cells by combining them with antibodies, and particularly with what we call NK engager antibodies. So our brand of NK engager antibodies is called Flex-NK cell engager antibodies. And what they do is that they have one arm that binds and activates the NK cell, and another arm that binds into the tumor cell, and the NK cells are redirected to kill the tumor cells." @Cytovia #CytoviaTX #Oncology #ImmunoOncology #Cancer #CancerTherapeutics #CellTherapeutics #NKCells #iNKCells #NaturalKillerCells CytoviaTX.com Download the transcript here

Dr. Phil Kantoff is the CEO and Co-Founder and Alex Brown is the COO of Convergent Therapeutics which is developing the next generation of targeted therapies to treat cancer. Drawing on insights from developments in radiopharmaceuticals, Convergent focuses on radioantibodies that are radioisotopes attached to antibodies directed to treat prostate cancer. Phil explains, "Antibodies will recognize surface molecules on cancer cells and they can be linked to radioisotopes. We are focused on an isotope known as Actinium-225, which is an important radioisotope because it's different than isotopes that have been previously used, it's an alpha-emitting radiopharmaceutical. Alpha particles are much larger, they're much more powerful, and they travel a shorter distance. You can deliver a very powerful, very targeted therapy to cancer." "We have clinical trials that are taking place right now that are showing remarkable activity using the combination of the directed antibody against prostate cancer cells, specifically prostate-specific membrane antigen coupled to this isotope, Actinium-225." Alex continues, "Our radioantibodies, which is what we're talking about here, are novel enough that there are few if any, examples of marketed products out there. It's a field that's emerging, so aside from having the experience in antibody development and commercialization, some of this is new to our team as well as to others." @ConvergentRx @DrPhilKantoff #ProstateCancer #Radiopharmaceuticals #PSMA #Radioantibody #RadioLingandTherapy #Oncology #Biotechnology ConvergentRx.com Listen to the podcast here

Dr. Phil Kantoff is the CEO and Co-Founder and Alex Brown is the COO of Convergent Therapeutics which is developing the next generation of targeted therapies to treat cancer. Drawing on insights from developments in radiopharmaceuticals, Convergent focuses on radioantibodies that are radioisotopes attached to antibodies directed to treat prostate cancer. Phil explains, "Antibodies will recognize surface molecules on cancer cells and they can be linked to radioisotopes. We are focused on an isotope known as Actinium-225, which is an important radioisotope because it's different than isotopes that have been previously used, it's an alpha-emitting radiopharmaceutical. Alpha particles are much larger, they're much more powerful, and they travel a shorter distance. You can deliver a very powerful, very targeted therapy to cancer." "We have clinical trials that are taking place right now that are showing remarkable activity using the combination of the directed antibody against prostate cancer cells, specifically prostate-specific membrane antigen coupled to this isotope, Actinium-225." Alex continues, "Our radioantibodies, which is what we're talking about here, are novel enough that there are few if any, examples of marketed products out there. It's a field that's emerging, so aside from having the experience in antibody development and commercialization, some of this is new to our team as well as to others." @ConvergentRx @DrPhilKantoff #ProstateCancer #Radiopharmaceuticals #PSMA #Radioantibody #RadioLingandTherapy #Oncology #Biotechnology ConvergentRx.com Download the transcript here

Dr. Eric Brouwer is the Chief Scientific Officer for SQI Diagnostics, which believes that lung health is human health.  Their focus is on the lung and ranges from COVID PCR, antigen, and antibody tests, across the spectrum to assessing lung transplant donors. With demand going up for lung transplants and new protocols for COVID screening of donors, diagnostic tests help better identify good candidates for organ donors. Eric elaborates, "We're a Canadian-based company, and we have the distribution rights in Canada for a technology that was developed by the US military. The product is called Biomeme, and it's a portable PCR analyzer. So it does very rapid thermocycling that will enable the results to be delivered in just over two hours." "This is deployed in mines and remote locations, on TV and film crew sets, and so that technology exists. We're using it, and that really makes that testing cycle reduced, so we can get same-morning tests, same-day testing, versus sending it in to a central lab which has the travel time, which has the review time, which has the execution time, that's pushing four to eight, sometimes 24 hours, before those results can get back. So the technology is out there, and it's becoming more widely available." #SQI #COVID #COVIDTesting #PCRTest #Lungs #LungTransplants #Antibodies #Inflammation #LungDiagnostics #TransplantDiagnostics #PrecisionMedicine SQIDiagnostics.com Listen to the podcast here

Dr. Eric Brouwer is the Chief Scientific Officer for SQI Diagnostics, which believes that lung health is human health.  Their focus is on the lung and ranges from COVID PCR, antigen, and antibody tests, across the spectrum to assessing lung transplant donors. With demand going up for lung transplants and new protocols for COVID screening of donors, diagnostic tests help better identify good candidates for organ donors. Eric elaborates, "We're a Canadian-based company, and we have the distribution rights in Canada for a technology that was developed by the US military. The product is called Biomeme, and it's a portable PCR analyzer. So it does very rapid thermocycling that will enable the results to be delivered in just over two hours." "This is deployed in mines and remote locations, on TV and film crew sets, and so that technology exists. We're using it, and that really makes that testing cycle reduced, so we can get same-morning tests, same-day testing, versus sending it in to a central lab which has the travel time, which has the review time, which has the execution time, that's pushing four to eight, sometimes 24 hours, before those results can get back. So the technology is out there, and it's becoming more widely available." #SQI #COVID #COVIDTesting #PCRTest #Lungs #LungTransplants #Antibodies #Inflammation #LungDiagnostics #TransplantDiagnostics #PrecisionMedicine SQIDiagnostics.com Download the transcript here

Dave Lareau is the CEO of Medicomp Systems, which has spent 44 years working with providers to understand better the kinds of information that is most relevant to a diagnosis and therapeutic approach.  With 400,000 concepts and tens of millions of relevancy links and mappings to data, Medicomp is prepared to handle the flood of information expected with the standardization of person-centered care. Just finalized in January, TEFCA, the Trusted Exchange Framework, and Common Agreement is expected to provide an infrastructure for sharing information. Dave explains, "So there's a new era starting in healthcare, which is the data belongs to the patient. It doesn't belong to the provider or the organization. And now there's a framework in place for sharing it, a trusted framework. It's right in the name, TEFCA. And I think it's going to open up new possibilities, new opportunities, new challenges. And for the first time, the patient will be able to participate in the viewing and managing of their own care. It will radically change the way that people interact with information all along the continuum of care." @MedicompSys #TEFCA #ElectronicHealthRecords #EHR #DataExchange #Interoperability Medicomp.com Listen to the podcast here

Dave Lareau is the CEO of Medicomp Systems, which has spent 44 years working with providers to understand better the kinds of information that is most relevant to a diagnosis and therapeutic approach.  With 400,000 concepts and tens of millions of relevancy links and mappings to data, Medicomp is prepared to handle the flood of information expected with the standardization of person-centered care. Just finalized in January, TEFCA, the Trusted Exchange Framework, and Common Agreement is expected to provide an infrastructure for sharing information. Dave explains, "So there's a new era starting in healthcare, which is the data belongs to the patient. It doesn't belong to the provider or the organization. And now there's a framework in place for sharing it, a trusted framework. It's right in the name, TEFCA. And I think it's going to open up new possibilities, new opportunities, new challenges. And for the first time, the patient will be able to participate in the viewing and managing of their own care. It will radically change the way that people interact with information all along the continuum of care." @MedicompSys #TEFCA #ElectronicHealthRecords #EHR #DataExchange #Interoperability Medicomp.com Download the transcript

Wei Escala is the founder and CEO of Eggschain, the first biotech on the Bitcoin blockchain. This blockchain-integrated approach brings order to the management of tracking patient  and biospecimen information. Their goal is to bring the healthcare industry to Web3 through decentralization. Wei explains, "We're the first blockchain-enabled and blockchain-integrated inventory management and chain-of-custody solution for tracking all biospecimens. When I say all biospecimens, I mean sperm, eggs, embryos, genome, stem cells, tissues, organs, DNA and RNA, and more. So, essentially, we are the bridge between biology and blockchain. And our goal is to bring the healthcare industry to Web3 through decentralization." "Yes, a blockchain-integrated platform helps tackle the problem of centralized records. Let me talk about what might be some of the issues of centralized records. Centralized records can be lost or can become inaccessible in times of need. And we all have heard that centralized records can be corrupted and can also be hacked. So, a blockchain approach, through decentralization, brings an added layer of security or backup to the current system." @Eggschain #Eggschain #Blockchain #DigitalHealth #HealthRecords #Web3 Eggschain.com Listen to the podcast here

Wei Escala is the founder and CEO of Eggschain, the first biotech on the Bitcoin blockchain. This blockchain-integrated approach brings order to the management of tracking patient  and biospecimen information. Their goal is to bring the healthcare industry to Web3 through decentralization. Wei explains, "We're the first blockchain-enabled and blockchain-integrated inventory management and chain-of-custody solution for tracking all biospecimens. When I say all biospecimens, I mean sperm, eggs, embryos, genome, stem cells, tissues, organs, DNA and RNA, and more. So, essentially, we are the bridge between biology and blockchain. And our goal is to bring the healthcare industry to Web3 through decentralization." "Yes, a blockchain-integrated platform helps tackle the problem of centralized records. Let me talk about what might be some of the issues of centralized records. Centralized records can be lost or can become inaccessible in times of need. And we all have heard that centralized records can be corrupted and can also be hacked. So, a blockchain approach, through decentralization, brings an added layer of security or backup to the current system." @Eggschain #Eggschain #Blockchain #DigitalHealth #HealthRecords #Web3 Eggschain.com Download the transcript here

Bill Stilley is the CEO and President of Adial Pharmaceuticals, which is focused on developing medicinal therapies for the treatment and prevention of addiction.  Their first drug is a genetically targeted drug to treat alcohol use disorder, otherwise known as alcoholism. Bill explains, "Yes, in the end, a lot of diseases are based on our genetics, and addiction seems to have some genetic components. I mean, for decades, it's been known that people that have had family members with an alcohol use problem have a much higher rate, and the numbers thrown around a lot are a nine times greater likelihood to have the problem themselves. Of course, some of that's going to be due to an environment, but it's clear that there's a genetic component." "So, we believe that we have identified some defects in the serotonin system of certain patients which will allow them to respond to treatment with our drug, which is a serotonin-3 receptor blocker. By that, I mean what it seems to indicate in clinical trials to date, is that we can reduce the craving that these patients have that's driven through their serotonin system to encourage them where they have a need to drink, rather than just a desire to drink." "In our phase 2 study, which is a 283 patient clinical trial that was run with our drug, patients that were on the drug that had the right genetics reduced the frequency of their drinking by almost 50%. When they drank, they reduced the amount they drank by almost 60%. So they picked up the bottle less often, and when they picked it up, they could put it back down. We think this is a really meaningful result for these people." @AdialPharma #Addiction #AlcoholUseDisorder #Alcoholism #AddictionTreatment #MentalHealth adialpharma.com Listen to the podcast here  

Bill Stilley is the CEO and President of Adial Pharmaceuticals, which is focused on developing medicinal therapies for the treatment and prevention of addiction.  Their first drug is a genetically targeted drug to treat alcohol use disorder, otherwise known as alcoholism. Bill explains, "Yes, in the end, a lot of diseases are based on our genetics, and addiction seems to have some genetic components. I mean, for decades, it's been known that people that have had family members with an alcohol use problem have a much higher rate, and the numbers thrown around a lot are a nine times greater likelihood to have the problem themselves. Of course, some of that's going to be due to an environment, but it's clear that there's a genetic component." "So, we believe that we have identified some defects in the serotonin system of certain patients which will allow them to respond to treatment with our drug, which is a serotonin-3 receptor blocker. By that, I mean what it seems to indicate in clinical trials to date, is that we can reduce the craving that these patients have that's driven through their serotonin system to encourage them where they have a need to drink, rather than just a desire to drink." "In our phase 2 study, which is a 283 patient clinical trial that was run with our drug, patients that were on the drug that had the right genetics reduced the frequency of their drinking by almost 50%. When they drank, they reduced the amount they drank by almost 60%. So they picked up the bottle less often, and when they picked it up, they could put it back down. We think this is a really meaningful result for these people." @AdialPharma #Addiction #AlcoholUseDisorder #Alcoholism #AddictionTreatment #MentalHealth adialpharma.com Download the transcript here  

Dr. Mark Berman is the Chief Medical Officer at Better Therapeutics, using a prescription digital therapeutic to treat diseases caused by human behavior, particularly type II diabetes. While PDT model might be expected to be effective with younger patients, clinical trial data is revealing that older patients 60+ are getting the most benefit in blood sugar reduction from this approach. Mark elaborates, "We are, at Better Therapeutics, trying to pioneer a prescription digital therapeutics platform with the intent of treating a whole host of cardiometabolic conditions, starting first with type II diabetes. Then moving on to other related cardiometabolic conditions that all share their roots in health behaviors that really drive the pandemic of disease that we're seeing in cardiometabolic health. And so, at Better Therapeutics, we're bringing about this platform to enable scalable means of treating those root causes of cardiometabolic conditions." "The notion of prescription digital therapeutic is that instead of prescribing yet another drug to help those types of patients, they're going to prescribe an FDA regulated mobile medical app, a prescription digital therapeutic, which is easy to fill, and it comes directly onto the patient's smartphone. And from there, it's the job of the digital therapeutic to really personalize the therapy for the patient. We don't believe that the providers have the time or the ability to really get very granular into the nature of the behavioral therapy. We really need to rely on the digital therapeutic to do that personalized work about what behaviors to target and how to be effective in each patient." @Better_TX #DigitalTherapeutics #DigitalHealth #PDT  #PrescriptionDigitalTherapeutic #Type2Diabetes #MobileHealth BetterTX.com Listen to the podcast here      

Dr. Mark Berman is the Chief Medical Officer at Better Therapeutics, using a prescription digital therapeutic to treat diseases caused by human behavior, particularly type II diabetes. While PDT model might be expected to be effective with younger patients, clinical trial data is revealing that older patients 60+ are getting the most benefit in blood sugar reduction from this approach. Mark elaborates, "We are, at Better Therapeutics, trying to pioneer a prescription digital therapeutics platform with the intent of treating a whole host of cardiometabolic conditions, starting first with type II diabetes. Then moving on to other related cardiometabolic conditions that all share their roots in health behaviors that really drive the pandemic of disease that we're seeing in cardiometabolic health. And so, at Better Therapeutics, we're bringing about this platform to enable scalable means of treating those root causes of cardiometabolic conditions." "The notion of prescription digital therapeutic is that instead of prescribing yet another drug to help those types of patients, they're going to prescribe an FDA regulated mobile medical app, a prescription digital therapeutic, which is easy to fill, and it comes directly onto the patient's smartphone. And from there, it's the job of the digital therapeutic to really personalize the therapy for the patient. We don't believe that the providers have the time or the ability to really get very granular into the nature of the behavioral therapy. We really need to rely on the digital therapeutic to do that personalized work about what behaviors to target and how to be effective in each patient." @Better_TX #DigitalTherapeutics #DigitalHealth #PDT  #PrescriptionDigitalTherapeutic #Type2Diabetes #MobileHealth BetterTX.com Download the transcript here      

Dr. Tom Lendvay is the Chief Medical Officer of Tend, which addresses the gut microbiome of the severe intestinal infection Clostridium difficile CDIF. Currently, recurrent Clostridium difficile is the only FDA-regulated disease for the use of microbiome transplants outside of a clinical trial. Clinical trials are also underway applying microbiome transplants to intestinal diseases such as inflammatory bowel diseases, irritable bowel syndrome, and other diseases outside of the gut. Tom explains, "Tend is focused on two types of offerings. One is a device called the CAP device, a collection processing device that allows a clinician or a researcher to collect a sample and process it, mix it, filter it and encapsulate it into orally ingestible capsules that can be stored in a freezer." "The other side is the data side, which is understanding. So, doing microbiome analyses on the donors, on the recipient ill patients and seeing how their microbiome changes over time and learning who's the best donor for the best recipient. Those two offerings do not exist today, and right now, the process for a clinician, for a researcher to provide microbiome transplants to their patients is extremely onerous and laborious." @Tend_Health #FMT #CDIF #Microbiome #GutMicrobiome #MedicalDevice #Healthcare #Patient tend-health.com Listen to the podcast here