Empowered Patient Podcast

Dr. Lishan Aklog, CEO of Lucid Diagnostics, discusses the current diagnostic landscape for esophageal cancer and the need for early detection. The current diagnostic tool, an upper endoscopy, is an invasive procedure requiring anesthesia.  The EsoGuard, a noninvasive simple cell collection procedure, uses molecular diagnostics to detect pre-cancerous cells within minutes. This test is particularly beneficial for screening those with risk factors such as chronic heartburn, being male, a smoker, or obese.   Lishan explains, "To prevent it, you have to pick it up at the pre-cancer stage because, unlike many other cancers where detecting earlier stage cancer, stage one cancer is a victory with a real potential for a cure, such as in breast cancer and colon and others, that's not the case here. You have about a 50% likelihood of dying even if you pick up esophageal cancer at the earliest stages. So, our mission and the opportunity here is to prevent about 16,000 cancer deaths a year by detecting the pre-cancerous

David Young, President of R&D at Processa Pharmaceuticals, talks about the FDA's Project Optimus draft guidance on optimal dosage regimens for specific patients. Processa is modifying existing cancer-killing molecules to improve efficacy and decrease side effects by taking into account genetic factors and the benefit-risk profile of each patient. This precision medicine approach will inform clinical trial recruitment, dosing regimens and the number of patients who can be effectively helped.   David explains, "There are a couple of things that make us unique. One is that we're taking the active cancer-killing molecules on the market. It's a given drug that's approved by the FDA, and we know it kills cancer. We've taken that molecule and either changed it slightly or administered it with another drug in some way to decrease or change the drug’s metabolism and then to distribute more drug to the cancer cell."   "So, we started to learn how they look at the benefit-risk profile, and we started to develop our

Dr. Juan Vera, CEO of Marker Therapeutics, a clinical-stage immuno-oncology company, is developing next-generation immunotherapy with a multi-tumor-specific T-cell platform to overcome limitations of current T-cell therapies with narrow target recognition. This approach, which recognizes multiple antigens within the tumor, helps prevent tumor resistance and adaptation. Marker is participating in the APOLLO trial testing this broad spectrum of target recognition in lymphoma patients who have relapsed after CAR-T CD19 therapy while also exploring acute myeloid leukemia and pancreatic cancer.   Juan explains, "Without a doubt, the earlier products that have been approved, such as mainly chimeric T-cell receptors, have validated the clinical power of T-cells in their ability to recognize and kill cancer cells. I think that no one will argue that, and this has been something that has been well evaluated, particularly in hematologic malignancies and particularly in lymphoma." "However, there are limitations with

Andreas Grill, President and CEO of DepYmed, discusses protein tyrosine phosphatase-targeted drugs, a new class of drugs. With a focus on the specific enzyme PTP1B, DepYmed discovered orally bioavailable molecules that inhibit PTP1B, targeting the signal transaction pathway. They are initially testing to treat Rett syndrome, a rare disease with no current therapy while exploring the use of PTP1B inhibitors to treat inflammatory diseases, cancer, diabetes, and neurological diseases.   Andreas elaborates, "In DepYmed, we're focused on a specific enzyme. It's PTP1B. It's part of a family of enzymes called protein tyrosine phosphatases, and, in particular, we're looking at PTP1B. It's a metabolic regulatory enzyme that regulates signal transduction between cells and how cells communicate with each other. It's been worked on in the '90s and early 2000s. A couple of companies were working on the target, and they failed in the target, mainly because they couldn't create an orally bioavailable compound that would inh

Vin Singh, Founder and CEO of Bullfrog AI, discusses how AI is being used to improve the drug development process through a precision medicine approach that looks at a combination of genetic and non-genetic attributes to predict patient response to drugs.  Bullfrog AI aims to reduce the failure rate in late-stage trials by enrolling the right patients in clinical trials. Through their partnership with the Johns Hopkins Lieber Institute for Brain Development, they use AI to analyze a unique dataset of post-mortem brains to discover new drug targets and improve clinical trial design. Vin explains, "Bullfrog is a technology-enabled drug development company. And what we're doing is using a proprietary AI to improve the drug development process, reduce development times and costs for development, and increase access, which benefits the world."   "The pharmaceutical industry is plagued with inefficiencies. It takes 10 to 15 years and one to two billion dollars to develop drugs, and the failure rates in that drug d

Melinda Thomas, the COO and Co-Founder of Octave Bioscience is focused on delivering a new standard of care for multiple sclerosis and other neurodegenerative diseases.  The company aims to address the unmet needs of people living with MS using blood-based biomarkers, expanded imaging, and a clinical insights program. The solution includes an app, wearable sensors, and a nurse care partner to help patients and neurologists make better-informed treatment decisions.   Melinda elaborates, "What we learned when we did about 150 interviews before we even started developing anything was, in MS specifically, there was no way to see what was going on beneath the surface. You didn't have a blood test that told you what was going on in the biology. So, we developed a blood test, 18 biomarkers analytically validated, that reveal underlying activated pathways and mechanisms that allow for accurate measurement of what's going on with their disease activity."   "The tool used today is an MRI, which shows new or worsening l

Cheryl Cheng, Founder and CEO of Vive Collective, discusses the unique business model of their investment platform, which focuses on digital health and health tech addressing large problems in healthcare, such as chronic conditions and complex workflows. Cheryl emphasizes the need for seamless integration of digital health solutions into existing healthcare systems and the importance of user interface. While excited about the potential of AI and robotics in healthcare, Cheryl highlights the need to include humans in decision-making while leveraging technology to improve access and quality of care. Cheryl explains, "We're excited to have launched this investment platform a couple of years ago, and the thesis behind it is to be very flexible in the type of capital we can deploy in the types of businesses we can invest in and build. However, they all need to stay within digital health and health tech. The idea was to give us the flexibility to add value to companies along their lifecycle. We can be a continuous

Dejan Nenov, Founder and Chairman of Panaton Software, highlights the importance of integrating healthcare data for such purposes as ordering medical tests and recruiting patients for clinical trials. The Panaton simple integration service for healthcare services uses AI to help streamline workflow, break down data silos, and provide seamless data exchange. While standardization is desirable, flexibility is essential when creating workflows that allow people to be more efficient. Dejan explains, "Imagine that you have just invented a fantastic new medical test, spent years doing the science and the research, and then millions of dollars doing your studies and FDA approval. So now you have a test and a lab that can perform it. Suddenly, you need to be able to offer that test to 100 different health systems, including the ability to get paid for it, either through private or insurance or Medicare." "You realize you have to move information just to order your tests. You have to move information from your lab to

Brian Smith, Chief Pharmacy Officer at Shields Health Solutions, addresses the challenges patients experience receiving specialty drugs by working with health systems to simplify the process. With a focus on measuring outcomes and improving patient care, Shields has seen a significant cure rate for hepatitis C, driven by attention to medication adherence and tracking outcomes. Recognizing the need to treat the multiple conditions patients often experience, Shields takes a patient-centric view to help these high-risk patients keep their conditions under control.   Brian explains, "We started in the areas of what people would call specialty pharmacy, such as oncology medications that people take at home, oral medications for people who have had a transplant, and injections like Humira for rheumatoid arthritis." "But I'd say what we found over the last 12 years is a lot of medications can be challenging and difficult, and a lot of patients need help. While we focus on specialty pharmacy, I'd say we have broaden

Shelly Hoffman, Partner and Executive VP at Marbury Creative Group emphasizes that branding and messaging in the healthcare industry increasingly focus on problem-solving and emotional messaging. She highlights the value of leveraging written content, audio, video, and podcasts to disseminate information to target audiences. COVID-19 has also changed healthcare and pharma messaging to physicians and patients with a shift to safety, population health, and social determinants of health.  Shelly elaborates, "We're a brand-building marketing agency on a mission to simplify things for our clients. So whether that's from a messaging and positioning standpoint, trying to make things that can be complicated simple, or from a media and campaign standpoint, trying to make sure our clients understand results and everything from an ROI standpoint. So we do work across a lot of different services, including branding, strategy and insights, digital, social, experiential, video, and photography." "Often, on the healthcare s

Dr. Margie Balfour, a psychiatrist and Chief Clinical Quality Officer at Connections Health Solutions, discusses the challenges and demand for behavioral health crisis care.  She highlights the implementation of the 988 Suicide and Crisis National Lifeline, which allows individuals to access mental health support by phone, text, or chat. With a focus on crisis stabilization, help from peer specialists, and face-to-face interventions, Margie emphasizes the importance of teamwork in crisis management.   Margie explains, "What 988 does is, now anyone from your phone, just like you could dial 911, you can dial 988. That connects to what used to be called the National Suicide Prevention Lifeline. And that is a network of about 200 call centers around the country that are staffed with trained mental health counselors who can help. For a lot of crises, having someone to talk to can make people's symptoms decrease and get people connected to the care they need and help that crisis in the moment without having to sen

Chris Sullens, CEO of CentralReach, offers a range of technology solutions to support providers, therapists, educators, and parents working with individuals with autism and intellectual and developmental disabilities. The goal is to streamline administrative tasks, replacing paper-based procedures with digital tools and allowing professionals to spend more in-person time with clients. The digital CR Care Coordinator helps train parents to reinforce the work of the therapists, which leads to better outcomes for the child and the behavior technician.   Chris explains, "At CentralReach, our focus is providing technology and associated services to providers, therapists, special educators, and others who are working with primarily the autistic community and those with broader intellectual and developmental disabilities (IDDs). That technology spans everything from patient-provider management systems, practice management systems, data collection on the clinical side, curriculum content assessments, as well as a ho

Brian Strem, President and CEO of Kiora Pharmaceuticals, is developing a small molecule drug to treat orphan retinal diseases. Their drug KIO-301 restores vision in patients with inherited retinal disease. By giving retinal ganglion cells the ability to sense light, signals can be sent to the brain to effectively see using cells that are not normally light-sensitive.  These molecular photoswitches can change shape based on the presence or absence of light and allow a patient to see the direction and movement of light. Brian explains, "It is dependent on the specific mutation. So, we know that there are certain gene mutations that a child will literally be born with immediate signs and symptoms of that disease. Whether that is immediately being blind, so being born blind, versus some of the other ones where you don't tend to get the onset of disease symptoms until the second, or third decade of life when you have difficulty seeing in the dark. Then all of a sudden, that progresses to losing peripheral vision a

Mark Litton, President and CEO of Athira Pharma, discusses advancements in treating neurodegenerative diseases, highlighting the challenges in treating these diseases. Athira's approach uses the body's natural repair mechanism to enhance the repair and protection of nerve cells.  Their lead molecule, fosgonimeton, enhances the hepatocyte growth factor (HGF) and crosses the blood-brain barrier to effectively target neurodegeneration. Mark explains, "At Athira, we're taking a completely novel approach where we're using the body's natural repair mechanism to help repair. We have spent many years designing molecules that enhance this mechanism. This is what we call the HGF/MET biology. This is a biology that has been known for over 30 years. It was originally discovered coming from the liver. What we know about it is that it's important in repairing, protecting, healing, and developing nerve cells." "What we found in a lot of neurodegenerative diseases is that this repair mechanism is impaired, or it slows down

Jim Murphy, CEO of Greenphire, discusses the company's role in addressing the financial lifecycle of clinical trials.  Greenphire works with sponsors, CROs, and research sites to automate and simplify payment processes, provide patient services, and remove burdens for patients and site personnel.  The aim is to improve patient retention and accelerate clinical development by streamlining processes from traditional manual methods to digital solutions that address budgeting, grant payments, and patient reimbursements.   Jim explains, "There are so many solutions that address data collection points in clinical trials. We're not one of those. We're a company focused on solving more of the business problems of clinical research. For example, we provide workflows that automate and simplify the payment processes from sponsors or CROs to investigative research sites. We provide patient convenience services that enable and support participants to maintain their journey on a clinical trial, giving them reimbursements,

Julia Regan, CEO and Co-Founder of RxLightning discussed the company's platform for streamlining the process of accessing specialty medications. The traditional process of getting the necessary consent and shipment of these drugs involves a significant amount of paperwork and delays in delivery. RxLightning aims to digitize and automate this process by removing the need for physical paper by using digital tools to connect all parties to ensure fast and affordable access to care. By eliminating paper-based processes, they have achieved a completion rate of 85% of applications within 24 hours.   Julia explains, "Specialty medications are always an interesting topic because, over the last 15 years, the definition of a specialty med has evolved with the new medications and molecules coming to market. So when we define specialty meds, we're talking about the high-cost medications that could treat rare diseases. Still, they also treat things like oncology, dermatology issues, GI, RA, and even allergy immunology. S

Mike Pattwell, principal business advisor at Edifecs and Chair of the WEDI payment models work group, emphasizes the pandemic's impact on moving away from the fee-for-service model towards a value-based care model. Improving the administration of healthcare requires automation, new workflow solutions, and better data exchange to improve patient health.  He mentions three organizations, including CMMI, WEDI, and CAQH, working towards creating interoperability and seamless communication between payers and providers.   Mike explains, "We've been around for 26 years, and we've been developing solutions to help our clients, mostly payers and providers, and health systems, to operationalize and automate workflows to improve the administration side of healthcare so that they can focus on doing what they do well, which is taking care of members and patients." "Starting at the top, it would be The Center for Medicare and Medicaid Innovation (CMS) and the innovation center called CMMI. They're paving the future of hea

Tim Moran, President and CEO of Avertix, discusses the company's mission to revolutionize how heart attack survivors are cared for and supported. Targeting patients who have had one prior heart attack or instance of a prior acute coronary syndrome, this first-of-its-kind technology is implanted in patients to monitor for the onset of another heart attack. The device notifies the patient in real-time so they can seek care and minimize the effects of the attack.  Work is underway for providing cloud connectivity to the device, allowing data to be shared with physicians and family members.   Tim explains, "So in our study, patients that had The Guardian product implanted, we were able to reduce their time to care from the onset of symptoms by almost eight times. So we got the time down on average to 1.6 hours from the onset of symptoms where they arrived at an emergency room and then ultimately could have therapeutic intervention like a stent put in, which ultimately would reperfuse them and get blood flowing a

Jason Bock, Co-Founder and CEO of CTMC, and Dr. Chris Flowers, Division Head of Cancer Medicine and Chair of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, are collaborating to accelerate the development of cancer cell therapies and manufacturing innovative cell therapies for cancer patients. CTMC is a joint venture between MD Anderson Cancer Center and National Resilience created to address the challenges of delivering autologous cell therapies at a scalable level. Jason and Chris highlight the value of face-to-face interaction in solving the complex logistics of getting a drug from the research into the clinic.   Jason explains, "We created CTMC to address the challenges of delivering autologous cell therapies to treat cancer patients. This modality is unique in that the starting material for each batch of product comes from the patient. And so, the actual manufacturing supply chain starts with the patient. We bring that into the manufacturing facility, engineer the cells, expan

Jay Srinivasan, CEO of Truvian Health, is on a mission to disrupt the blood testing model by making routine testing readily available and affordable with a platform that provides appropriate information for patients and physicians. The current blood testing process involves multiple tubes of blood being drawn, transportation of the blood to a lab, and waiting days for results.  Truvian aims to streamline the process by placing its platform in retail clinics and physician offices where a single tube of blood can be processed on-site with results available in minutes. Jay explains, "Our goal is to have our platform exist wherever you go. So, it could be in a retail or a corporate clinic, it could be in your physician's office labs, it could be in retail pharmacies, it could be in an arena, it could be in a mall, in a school, in a university setting, anywhere you go." "This platform can take one tube of blood, not multiple tubes of blood because it has integrated multiple technologies that allow us to process a