Empowered Patient Podcast

Meri Beckwith, Co-Founder of Lindus Health, aims to transform clinical trials by changing the CRO model to leverage technology to improve patient recruitment, retention, and the experience of the sponsors and trial participants. While the compensation model for contract research organizations is often not aligned with trial outcomes, Lindus ties compensation to hitting milestones and outcomes. They emphasize the need for more flexible trial design and a decentralized and hybrid approach to reduce participant burden and bring drugs to market sooner.   Meri explains, "This comes back to how contract research organizations are paid and compensated where they're typically paid per hour of input, and it's not at all tied to the outputs being speed, patient experience, or quality of data. And so we've created this monster over the last 10 or 20 years where the cost of clinical trials keeps going up. Patient experience certainly seems to be getting worse. Above all, patients suffer because the direct experience in

Greg Hamilton, CEO of io9, aims to enable precision oncology treatments for patients globally.  The company has developed an AI-powered biomarker analysis platform called OncoGaze that can rapidly analyze digital pathology images to identify cancer biomarkers. This enables pathologists to efficiently and quickly digitize and analyze tumor samples and oncologists to start patients on the appropriate targeted therapy much faster.   Greg explains, "For many of these cancers, determining the right cancer treatment is the difference between life and death. When we look at how we treat cancer today, what hasn't changed is that there'll be a biopsy. So, they take a piece of the tumor out and send that tumor to a pathologist. Pathologists will take that tumor and put it in a glass slide. They usually use what's called H&E, they kind of stain it to read it better. But basically, a pathologist is looking under a microscope at the cells, and that's how we diagnose cancer. That's the formal way that we diagnose can

Dr. Jeng Her, Founder and CEO of AP Biosciences, is developing T-Cube bispecific antibodies that can target cancer cells and engage T-cells to kill them more effectively and safely than existing treatments. The company is focused on treating hard-to-treat cancers such as HER2-positive breast cancer, lung cancer, head and neck cancer, and pancreatic cancer. The T-Cube bispecific antibodies use CD137 instead of CD3 to activate T-cells, which can lead to better efficacy and safety compared to other T-cell engager antibodies. Jeng explains, "So why not just take two, let's say, monospecific antibodies and then put them together and give them to the patient in the combination therapy? Instead, we wanted to develop bispecific antibodies by fusing two antibodies together into one single molecule. So what's the advantage? Eventually, what it comes down to is the therapeutic window of bispecific antibodies. This means you want your antibodies, your bispecific, to have better efficacy, better safety, and sometimes low

Sonia Veluchamy, CEO and Co-founder of Celegence discusses the increasing regulatory requirements and complexities faced by the medical device industry. Celegence works with companies to streamline their regulatory data management processes and adopt advanced technology solutions to manage compliance efficiently. Medical device companies are often slower than pharmaceutical companies to recognize the need to invest in data governance and process optimization to maintain compliance and avoid fines, delays in product approval, and loss of market access. Sonia explains, "The awareness is there, but medical device companies have traditionally been a bit slower in adapting and bringing in consultancy, expertise, and technology. That is partly because the sector's regulations have not evolved at the same pace as in the pharmaceutical industry. More recently, though, the regulations have become more complex. For instance, the requirements under the EU MDR- Medical Device Regulation – are very heavy in terms of the

Dr. Ethan Korngold is the chief medical officer and divisional vice president of medical affairs at Abbott's vascular business, which has developed a dissolvable stent technology to treat peripheral artery disease. PAD disproportionately affects Black and Hispanic communities and is often overlooked because early symptoms can be mistaken for other conditions. The Esprit BTK stent can help open up the smaller arteries below the knee and improve blood flow to the legs and feet to treat PAD and prevent severe complications and amputations. Ethan explains, "So peripheral artery disease refers to blockages in the arteries to the legs. When those blockages build up, it's because of cholesterol typically that builds up in the walls of the artery and causes limited blood flow. Initially, people can have cramping or soreness in their legs when they walk. That gets better with rest. As the blockages get worse, people can develop infections, ulcers, or non-healing wounds of their legs with what we call chronic limb-thre

Dr. Jonathon Hill, VP of Science and Technology and Co-Founder of Wasatch Bio Labs has developed the Next-Generation Sequencing 3.0, NESSI-Seq platform, which can analyze blood to detect epigenetic changes and provide insights into current health and predisposition for diseases. This native-read third-generation sequencing tool can provide longer sequence reads and analyze epigenetic modifications to DNA. Epigenetics can change over time in response to diet, environment, and lifestyle. Advanced genetic testing has the potential to provide biomarkers to support personalized medicine for earlier detection and tailored interventions. Jonathon explains, "The biggest limitation with the Illumina sequencing was that it was only short sequences, so you had to get a lot of them to stitch them together and figure out what the human genome looked like. With this third-generation sequencing, we can get much longer reads, sometimes to the order of a hundred thousand nucleotide bases at a time. So we get these big comple

Bob Zemke, Director at Extreme Networks, provides network infrastructure and security solutions to help hospitals build resilient and secure networks. Critical security challenges hospitals face in managing networks include the proliferation of connected devices and the vulnerability of medical devices to cyber threats. In addition to education and collaboration between stakeholders, strategies for reducing security risks include network segmentation, AI-powered monitoring, and behavior analysis to help hospitals proactively address possible threats. Bob explains, "There are multiple factors that we take into play. First, how do we build a resilient network that can handle the amount of devices and traffic types? How do we prioritize the type of traffic flowing through, like the wires of the infrastructure and the wireless connectivity? And then how do we understand through analytics the behavior of those applications so that the healthcare organization, the security team can understand what is standard traf

Wardah Inam is the CEO of Overjet, which uses AI to analyze dental X-rays to help dentists provide more comprehensive and objective diagnoses and treatment recommendations for patients. The Overjet platform can quantify dental disease progression and provide visualizations to help patients better understand their oral health. The use of AI in dentistry can improve patient outcomes, practice workflows, and the ability of dentists to communicate with patients about personalized data-driven care. Wardah explains, "One of our main challenges is that the dentist and the patients speak different languages when talking to each other. For example, a dentist licenses dental X-rays to communicate. Patients don't read X-rays, so they do not understand what the dentist says. So, for example, they might say, Hey, I see a radiolucency on tooth number four. The patient doesn't know what tooth number four is, and they don't know what atypical radiolucency is. And then they're squinting and trying to see what the dentist see

Dan Gallagher, Vice President for Strategy and Partnerships at Lyric, describes how Lyric uses advanced analytics to improve the coordination of benefits by proactively identifying coverage changes, verifying eligibility at the time of service, and transitioning patients to the correct payer. Coordination of benefits can be complex due to job changes, data lags, and situations like workplace accidents where multiple payers may be involved. Improving coordination of benefits can reduce patients' out-of-pocket costs and get providers paid faster.   Dan explains, "Simply stated, coordination of benefits is determining who or what entity has financial responsibility for an individual during a course of treatment. So, for a large portion of the population, it's pretty straightforward. You may have commercial insurance, and you may have one insurance card for your family, but there's not a lot to coordinate for other members of the population. You may have Medicare and you're still working over the age of 65. You

Yoona Kim, CEO of Arine,  a medication intelligence company, works with health plans and payers to ensure safe and effective medication therapy for patients. The Arine platform addresses polypharmacy, medication mismanagement, drug interactions, and proper dosing. Using AI and integrated databases, Arine is identifying patients who would benefit from medication management and shifting from reactive to proactive and preventative care. Yoona explains, "Our clients are health plans and risk-bearing providers. So these are the payers of the healthcare system, those who bear the financial burden of healthcare costs because medications can be very powerful, they can cure, or they can lead to detrimental consequences and even unnecessary fatalities and high-cost events like hospitalizations. So it's important to these customers to make sure that their members are on the right medications to avoid these unnecessary clinical and financial outcomes."  "I think it pertains to all of these situations. One of our bigge

Andrew Spier is the Vice President of Advanced Cyber Solutions and Commercial Services at Core4ce, a company specializing in protecting healthcare organizations and critical infrastructure from cyber threats. The healthcare environment has outdated software, weak access controls, insecure network connectivity, and a large Internet of Things network with many connected medical devices vulnerable to cyberattacks. Core4ce provides cybersecurity services, risk assessment, and education so that healthcare organizations can be more proactive in recognizing vulnerabilities and protecting against cyber criminals.  Andrew explains, "Core4ce is a data-centric national and enterprise security organization primarily specializing in protecting the nation and healthcare organizations. Critical infrastructure is mostly from cyber threats, which could be insider threats, cybersecurity or cyber criminals, or adversarial nation-states. We also provide a full suite of cybersecurity solutions in support of those customers." "I t

Dr. Sam Lee, Co-CEO of Cocrystal Pharma, is an expert in developing small-molecule antiviral drugs to treat COVID-19, Norovirus, influenza, avian flu, West Nile virus, Dengue, Zika, and other RNA viruses. Cocrystal uses its structure-based drug discovery platform to identify promising drug targets for potent broad-spectrum oral and inhaled antiviral therapeutics. The COVID-19 pandemic highlighted the need for vaccines and effective therapeutics to respond to viral outbreaks and prevent further transmission. Sam elaborates, "Before we talk about avian flu, let's just step back up about the strains. Influenza, as you know, includes influenza A strains, influenza B, and the C. But the public health point of view is the influenza A strains are important. These cause the pandemic flu, as well as the seasonal flu. Influenza B is roughly less than 20% of flu patients that have this influenza B. It's seasonal. It doesn't cause a pandemic influenza infection." "So we're talking about avian flu. Avian flu is mostly a

Dr. Mark Campbell, Chief Pharmacy Officer at RxBenefits, a prescription benefit optimizer that works with self-funded employers to help them get the best clinical and economic value from their pharmacy benefit manager relationships. As the healthcare landscape has become more complex with the rise of specialty and high-cost drugs, a significant portion of an employer's pharmacy costs can be impacted by a small population. A key challenge is managing the volatility introduced each year by changes in the health of employees and their families while also managing costs for the broader covered population. Mark explains, "The landscape for prescription benefits has shifted a lot over the course of my career. In 1998, for example, 35% of the prescriptions were generic, and 65% were branded. There was no appreciable amount of specialties at that time. And the average cost for a plan was probably in the mid-thirties per member per month. But with the shift we've seen where generics have grown to roughly 88% of the p

Dr. Vicky Demas, CEO of identifeye HEALTH, is using AI-powered diagnostic algorithms and automation to improve the accessibility and quality of retinal imaging, focusing on the early detection of diabetic retinopathy. The identifeye technology makes it easier for patients to get screened for eye conditions in primary care or retail settings. The goal is to leverage the information from retinal scans to detect other eye conditions and identify biomarkers for other systematic diseases.   Vicky explains, "In general, we leverage AI and automation to solve workflow problems to make, first and foremost the capturing of good-quality retinal imaging. It's really easy to make sure that, for example, we can remove the barriers and access for that. We don't need to be at a specialist office for a lot of the screening conditions. Very specifically too, for our first application, we're focusing on diabetic retinopathy, which is a huge problem and one where accessibility to good quality screenings and early detection or

Felicia Janovich is a founding member of the American IV Association, which advocates for safe and effective IV therapies, including hydration, vitamin infusions, and treatments to support patients with chronic conditions or undergoing chemotherapy. While there is limited research on the effectiveness of these IV therapies, AIVA is working to collect and analyze clinical data to understand better the impact these therapies might have on individuals to help with recovery and overall health. Felicia explains, "Right now, in our space, we struggle with clear guidelines. And there's kind of misunderstanding that there's a bunch of IV cowboys out there, and they're just starting IVs, and they don't have regulations. It's just entirely untrue. The IV Association and its members bring in this amazing opportunity to collaborate, not compete, which is huge within this IV industry because it is relatively new, so we need all the data, all the information, and all the science to back it up. What AIVA has done is welcom

Michael McFadden is the CEO of Alpha Cognition, a biopharmaceutical company focused on developing treatments for brain diseases such as Alzheimer's, ALS, and traumatic brain injury. Their drug ZUNVEYL, recently approved by the FDA, is an oral treatment for mild to moderate Alzheimer's that improves symptoms such as memory loss, mental processing speed, and mood changes. A key feature of the drug is fewer gastrointestinal side effects compared to other Alzheimer's drugs coming onto the market.   Michael explains, "ZUNVEYL is a class of medications known as acetylcholinesterase inhibitors. It's the second oral compound approved by the FDA to treat Alzheimer's disease in the last decade. So, it is a momentous accomplishment by our company, and it is an accomplishment that will serve patients and physicians well. It's designed to treat symptoms of mild to moderate Alzheimer's disease that many patients suffer from. These are things like memory loss, mental health processing speed, ability to solve problems or re

George Pappas, CEO of Intraprise Health, works with various healthcare organizations across the healthcare industry and healthcare ecosystem to help address cybersecurity risks. While recent cyber attacks have raised awareness about the need for better cybersecurity measures, the complexity of healthcare IT systems creates significant challenges for comprehensive risk management. Proactive measures, including employee training, enhanced identity confirmation, and limiting access, are critical to mitigating the risk of cyber attacks.   George explains, "The net situation is that these large technology companies that serve healthcare and hospital systems and large medical practices change are clearinghouses, revenue cycle managers, and manage real-time price transparency. What medication management companies manage is so complicated, and they have so many ways that something can be attacked. As you mentioned at the beginning, the attackers are getting very clever and sharing a lot of their methods, so you have

Ketan Mehta, Founder and CEO of Tris Pharma, is focused on developing non-addictive pain medication. Their lead drug candidate is designed to be an effective pain drug without the respiratory-depressive and addictive side effects of traditional opioid drugs. This drug works by targeting the nociceptin receptor and has also shown promise to help curb cravings and dependence on opioids. The goal is to provide doctors and patients with a non-opioid pain medication option that can help reduce reliance on highly addictive prescription opioids.  Ketan explains, "Tris is focused on neuroscience-based products, especially CNS, at a high level. More specifically, we focused on ADHD and neurodevelopmental disorders and the products that treat them. And also, more recently, we have been more active in the pain space." "We're developing a drug, which is currently an investigational drug in Phase three clinical trials. It's called cebranopadol. And what we have seen is that it has an efficacy just on par with your typica

Beth Houck, Chief Executive Officer at SonarMD, works with payers and physician practices to provide proactive, value-based care for patients with chronic GI conditions. They use a digital platform to monitor self-reported patient symptoms and enable physicians to identify those patients that need attention. This approach aims to improve patient outcomes and reduce emergency room visits and hospitalizations.   Beth explains, "SonarMD manages patients with chronic gut health conditions, and specifically, we started with something called inflammatory bowel disease, which is the encompassing word for patients with Crohn's and ulcerative colitis. We develop a value-based contract with a payer, so somebody at risk for the cost of care of a patient, and then we bring that cost of care program to a physician's office. In collaboration with that physician, we manage a population of patients to have better outcomes for their chronic GI conditions." "We just talk about this as a shift to proactive care from reactive c

Dr. Chris Bouton, the Senior VP and Head of Artificial Intelligence at Certara, is exploring applying generative AI to drug discovery and development to improve efficiency and identify novel therapeutics across various use cases. The focus is on developing specialized secure AI models to integrate internal data with the Certara platform. Generative AI is particularly useful in areas with high specificity, such as antibody design and mRNA therapeutics, where modeling the underlying biology is crucial.  Chris explains, "Certara helps pharmaceutical and biotech companies throughout their process, from early basic research to regulatory filing and beyond. And we're quite a unique company in that we are not developing our own drugs but instead helping companies develop their drugs. And it's something like over 90% of all FDA approvals are projects that, in some way, shape, or form, Certara has helped with." "Our philosophy is to start with the use case. Generative AI is an incredible novel technology. There are m