Empowered Patient Podcast

Ryan Mooney is the Executive VP and General Manager of Burgess Source, the payment integrity business unit of HealthEdge. Ryan sheds light on the root causes that lead to waste and errors in the process of providing and paying for healthcare. He points out the need for better data management and clear lines of communication for all participants in the system, including patients, providers, and payers. Ryan says, "I spent 23-plus years working in strict payment integrity. That is a kind of gain share model and contingency where you go, and you identify issues, and you recover them, or you prevent them from happening. The outside vendor keeps a percentage of that recovery and so on. And that way of thinking goes directly to the way that your question was asked, which is, where's the most waste? And I spent over two decades thinking in that same way." "But another way of framing that question is, what is leading to all of these downstream issues? And in the current project with Burgess Source and HealthEdge, we'

Michael Schrader is CEO and Co-Founder of Vaxess Technologies, which is transforming vaccine delivery from needles and syringes to a skin patch delivery system. Their solution reduces the need to have mass vaccination sites, makes vaccines easier and cheaper to transport, and addresses the reluctance of patients to get a shot in the arm.  Using the protein polymer from silk, Vaxess is making patches with tiny protrusions that pierce the skin and allow the large molecule vaccines into the skin. Michael explains, "I think what COVID really brought to the forefront and highlighted for all of us was that the needle and syringe has a lot of drawbacks. The first being that these COVID vaccines required refrigeration or freezing temperatures, which made storage very challenging. In order to get these vaccines to people, we actually had to ask them to congregate. So we came to mass vaccination sites, whether at hospitals or places like Gillette Stadium or Fenway park here in Boston. In the event of a pandemic outbrea

Gabriele Brambilla is the CEO and Executive VP of AliraHealth and is looking for ways to humanize healthcare and involve patients in the entire drug development continuum. They deliver services to drug developers, medical device developers, and digital health solution providers. Gabriele explains, "We call it democratization of life sciences research, the ability to use our technology to directly involve patients, in different phases of development of a drug or a device, in a very active partnership, not just a passive collection of data." "So AliraHealth provides a continuum of services that starts from the very early phases of development of a drug or a device. And a drug would be for us the CMC, which is chemistry manufacturing control. It would go then to regulatory, so we help our clients to interact with the FDA, or EMA for Europe, and then register the drugs. And we run clinical trials for our clients and market access. Also the ability to deliver value and effectiveness in front of payers so that they

Dr. Matt Wilson is the Founder and CEO of uMEd, bringing together healthcare providers and researchers to reach out to patients to participate in clinical trials.  Using health data, uMed facilitates targeting good candidates for trials and helps the care provider educate patients about the value of participating in one or multiple clinical trials. In a very repeatable and scalable environment, uMed can match patients to specific study opportunities based on standardized queries. Matt explains, "A lot of other organizations in the clinical study space that are looking at using health record data are using it in a very different way because they're generally focused on bringing together existing EMR data or claims data from lots of different healthcare providers and using that in of itself to identify trends and value for researchers. Whereas uMed is taking a different approach, saying, "Well, actually, their health record data is incredibly useful as a starting point to be able to identify potential study par

Andrew Hall is the CEO of IMV Inc, which has developed a platform based on a lipid-in-oil technology that encapsulates the therapeutic.  When injected subcutaneously, the drug remains in a specific location to reinvigorate the immune system to overcome the tumor surveillance that allows cancer to grow. Andrew explains, "There is a checkered history in oncology drug development that is known as vaccines in oncology. For the longest period of time, they were so exciting and, unfortunately, so disappointing in the way they performed clinically. We believe with the technology that we've created at IMV, that we can make vaccines in oncology cool again. We are creating an ability to educate the immune system in a prolonged way, in a way that may present a historical retraction of why things failed before, or maybe it wasn't the targets that made them fail. Maybe it was the way in which the targets were delivered in a meaningful way." "The initial clinical trials are around a lead product, maveropepimut-S. So the ta

Clark Lagemann is the CEO of Avidon Health which is helping organizations support employees as they recover from the disruption of COVID and adjust to the reconfiguration of the workplace. While many people are leaving their jobs for more income, Avidon is finding that employees are also seeking resources to address substance abuse, stress, and pain. Clark explains, "The kinds of substances really expanded so significantly prior to COVID then post-COVID. Before COVID, we could talk about one in 10 adults who reported anxiety and depressive disorder. Since COVID and in 2020, that shot up to four in 10, so nearly 40% of American workers suffer from mental health issues." "So things that they're going to rely on to help them get through this, alcohol, a substance, pills. Opioids are very common, then you can go into more illicit drugs. So, the most common things that we see in the workplace that we're doing for large organizations are alcohol addiction and typically some sort of prescribed medications." "Substan

Matthew Robinson is the Senior Vice President of R&D at Immunome, which is leveraging the information in memory B cells to target antibody therapeutics to kill tumor cells. Matthew explains, "At Immunome, we believe that the antibodies that these B cells are making have an ability to see the different types of tumor antigens, or the specific epitopes on infectious disease. Our platform allows us to see that disease through the lens of the human B cell. We can interrogate what those antibodies are binding to, and we can use that information to help other patients." "Right now, we have a couple of programs ongoing that are either in the clinic or moving towards the clinic. We have a program in infectious disease and COVID that is currently in phase 1b trials. It's a three-antibody cocktail. Those were isolated from patients who made a very robust antibody response to the disease and fought it off very effectively. Each of those antibodies was selected because they have different mechanisms of action." "Our

Dr. Michael Racke is the Medical Director at Quest Advanced Neurology, which is extending the options for neurologic diagnoses by looking for biomarkers in blood tests. Michael explains, "And now, we're very much involved in developing plasma-based biomarkers to help diagnose Alzheimer's disease. Alzheimer's disease was a disorder that was initially diagnosed pathologically. You had to find the plaque and tangles in the brain at autopsy. Over the last 20 years, they've been able to show that with spinal fluid testing, you're able to identify changes in the cerebral spinal fluid suggestive of Alzheimer's disease. And now, we're also able to do that with a blood test." "And for example, one of the ways that people were first able to do an evaluation for Alzheimer's disease in living people was to do a PET scan and actually demonstrate that you could do an imaging test that would show the beta amyloid plaques."  "So, Alzheimer's disease was diagnosed by finding these plaques. The plaques are caused by aggregatio

Dr. Guenther Koehne is the Deputy Director and Chief of Blood and Marrow Transplant and Hematologic Oncology at the Baptist Health South Florida Miami Cancer Institute. They are part of a clinical trial for an approach that protects healthy cells from the toxic side-effects of targeted blood cancer treatments with a focus on acute myeloid leukemia (AML). Guenther explains," And then, we have the opportunity to administer medications or CAR-T cells, for example, post transplantation, that are specifically targeting CD33, which then presumably allows us to specifically target residual leukemia cells." "So, my institution, Miami Cancer Institute, and before that, I was at Memorial Sloan Kettering Cancer Center, where I implemented the purification of stem cells from the stem cell product, from the donor stem cell product, allowing to deplete the T cells and other cells that were not necessarily needed for a successful transplant while we have a purified stem cell population. And on this clinical trial, we can no

Dr. Judy Chou is the President and CEO of AltruBio which is developing novel immunomodulators to treat immunological diseases such as autoimmune and inflammatory diseases. Their first-in-class agnostic antibody has a unique mechanism to regulate T cell homeostasis. Currently, there is a clinical trial for SR-aGVHD, steroid-refractory acute graft-host disease and an investigation is underway into using their second-generation molecule to treat ulcerative colitis. Judy explains, "So we have this specific approach, only targeting those activated or the so-called over-activated T cell. So when the T cell is supposed to come down to quieten and to bring back to homeostasis, go back to balance, it did not. It keeps going and going and going. And we have identified the key target to turn it down to the balance point to tell those T cells it's time to rest, to downregulate this group of T cells. And that's the approach you are taking. That's why AltruBio is so unique in addressing immunological diseases." #AltruBio #

Jeff Cleland is the Chairman, President, and CEO of Ashvattha Therapeutics, initially focusing on demonstrating the ability to deliver drugs that cross tissue barriers like the blood-brain barrier and the blood-retinal barrier to attack inflammation. The company is part of the emerging era of Hydroxyl Dendrimer Therapeutics, HDTs. While starting with ophthalmology and treating wet age-related macular degeneration and diabetic macular edema, they are also running trials with long haul COVID patients. In addition, they are investigating neurological diseases like Alzheimer's and Parkinson's with the ability to measure the amount of the drug that gets into the brain. Jeff explains, "The secret is the platform that was developed by our founders at Johns Hopkins. It's a husband and wife team that really focused on trying to figure out how to get across tissue barriers. So, they empirically went about looking at different nanomedicine platforms, and they came across what's called a hydroxyl dendrimer platform." "Wh

Dr. Todd Johnson is the Chief Growth Officer at M2GEN an oncology-focused health informatics company. Its mission is to connect cancer patients to a precise cure using its data platform to analyze longitudinal clinical and genomic data. With a permission-based approach to data collection, M2GEN looks at the information related to the patient and from a tumor biopsy. This data analysis allows M2GEN to understand how patients respond to existing cancer treatments and gain more knowledge about the science behind cancer so that innovations and new precision medicines can be developed. Todd elaborates, "Let's call the first the natural genome or the normal genome of a patient, also often called the germline genome. We provide information on germline as well as on the genome of the cancer. The reason why that's really important is that cancer is a disease of DNA, and it's a disease of how DNA changes over time or mutates. Those mutations are what cause a cancer to actually occur in the first place, for it to be abl

Laurent Levy is the CEO of Nanobiotix, which is applying nanophysics to direct radiation therapy more efficiently to cancerous tumors while reducing the side effects of damage to surrounding tissue. This intratumoral injection of nanoparticles maximizes the concentration in the tumor and minimizes the rest of the body exposure. Starting with soft tissue sarcoma, they are expanding to head and neck cancer with plans for other indications like pancreatic, liver, and breast cancer. Laurent explains, "We thought, at Nanobiotix, that we may find something different. Rather than making better radiation therapy equipment, we thought about the problem in a different way. We did develop a product that is an injectable that you will inject directly into the tumor. And, when the product is in the tumor -- they are based on nanoparticles, tiny objects -- these objects will go into the cell, and they will sit there. They'll do nothing until the patient is getting the usual radiation therapy." "And we've been designing tho

Dr. Jacob Donoghue is the CEO and Co-Founder of Beacon Biosignals, a computational neurobiomarker discovery and deployment platform taking EEG readings and applying their algorithms to identify novel neurobiomarkers that might be related to a disease that can be modulated by a new therapy.  Jacob drills down, "We anchor these biomarkers that we are able to identify off the world's largest annotated EEG database, which we have at Beacon, to be able to really put things into context. When we make a discovery, we can really see, even in a small cohort of patients, how does that relate to both other patients with that related disease or also healthy normal patients? "Beacon was born by looking at the massive opportunity and unmet need in patients with neurological and psychiatric diseases and to take in all these long data sets of electrical brain activity, EEG data, to be able to provide the same types of tools that were transforming digital pathology, radiology, and GI to better characterize diseases of the bra

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, thi

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

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

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 manag

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 laye

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