Empowered Patient Podcast

Gene Mack, CEO and President of Gain Therapeutics, is combining AI-powered drug discovery with the development of allosteric modulators, drugs that bind to unique sites on proteins. The company's AI platform, Magellan, is crucial for accelerating drug discovery by reducing the time for computational screening of potential drug compounds.  Their lead compound is showing promising results as a potential disease-modifying therapy for Parkinson's disease, aiming to halt the progression of the disease rather than just treating symptoms. Gene explains, "So allosteric modulators of protein, it's a bit of a word salad, but what we're trying to achieve here is finding unique binding sites on proteins that are sort of away from the active site of that protein." "So, a lot of physics calculations go into these binding site calculations. The idea is to complete these quickly during the screening of hundreds or thousands of compounds. This process takes 10 to 15 minutes to run a set of computations and determine if a par

Paul Howe, COO of Protega Pharmaceuticals, is focused on how abuse-deterrent technology can address the opioid crisis and the need for mandates for insurance coverage of safer abuse-deterrent formulations. The SentryBond technology was specifically designed for immediate-release opioids to make it difficult to manipulate pills for abuse via crushing, inhaling, or injecting. Protega partnered with software company Opus to offer a program that helps educate chronic pain patients, manage their treatment, and provides physicians with risk stratification data to improve care and reduce the likelihood of abuse. Paul explains, "Most importantly from our standpoint is to protect from the risk of misuse, abuse, and diversion, which is escalation from orally taking medications to crushing, inhaling, injecting, or smoking. Unfortunately, when that escalation happens, many times patients end up on illicit fentanyl and heroin through the black market. So what we're trying to do is stop that escalation through our abuse d

Dr. George Magrath, CEO of Opus Genetics, discusses the company's experience in obtaining non-dilutive funding for its ultra-rare inherited retinal disease program. He highlights the challenges and advantages of this funding source, as well as the importance of establishing relationships with patient advocacy groups and foundations to mitigate risk and increase their attractiveness to traditional investors. The drive for non-dilutive funding for ultra-rare diseases is expected to become increasingly important in helping to get drugs to clinical trials. George explains, "Opus Genetics is a gene therapy company for eye disorders that occur in children. And these disorders are ultra-rare. It's 200 patients, a thousand patients per indication, and it's really good science. It's from Gene Bennett, who was the inventor of Luxturna, which was the first approved genetic medicine. And it does require some non-conventional thought on the financing, though, because these are so rare. And what we've done at Opus Genetic

Lindsay Mateo is the Chief Commercial Officer at Weave. This company has developed a platform to automate and streamline the regulatory documentation process for FDA submission for pharmaceutical and biotech companies.  The regulatory lifecycle for drug development currently involves data from various sources in digital and paper formats. Weave Bio's tools are designed to automate and streamline administrative aspects of the regulatory process and create a living digital record of the development of the drug, which supports collaboration and saves time. Lindsay explains, "I look at the regulatory life cycle for any given drug program, and experts are at the core of that. Those experts, who are scientists, strategists, and project managers, essentially put all the work into the documentation that goes to regulators like the FDA here in the US. And that information goes on to allow this drug to continue through various stages of development to ultimately get to market and obviously help patients." "That is eve

Aspen Noonan, CEO of Elevate Holistics, a company that helps patients obtain medical marijuana cards through a telehealth consultation with licensed doctors. The qualifications for obtaining a medical marijuana card vary by state, and Elevate Holistics helps patients navigate the regulatory landscape. Many doctors are hesitant to recommend cannabis due to the federal illegality and restrictions from employers, and Elevate Holistics is filling the gaps by connecting patients looking for alternative treatments for conditions such as anxiety, depression, PTSD, and chronic pain. Aspen explains, "We are a one-stop shop for getting your online medical marijuana card. We connect doctors with patients 100% online in over 18 states to go through the process, which basically means book your appointment, fill out forms, join a video chat, call, and check for your emails because it's a hands-off experience. We really help people. I say A to Z, we don't just see you and get out. We ensure that your state application is f

Mark Goddard, Vice President of Clinical Services at Infobionic.AI,  describes the remote cardiac monitoring system that provides near real-time monitoring of patients with potential cardiac irregularities.  The benefit of continuous monitoring allows for early detection of arrhythmias like atrial fibrillation, a growing concern driven by an aging population and factors like obesity and high blood pressure. AI-driven algorithms are used to analyze ECG data and identify potential issues, enabling proactive treatment and prevention of complications like stroke.    Mark explains, "The focus of our monitoring system is to provide near real-time monitoring of patients who are reporting maybe cardiac irregularities. The whole idea is to provide that near-real-time access to cardiac information so that arrhythmias can be identified relatively quickly. Additionally, the treatments for those arrhythmias are relatively quick as well, providing better patient outcomes. Just related to the fact that the data is always t

Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics, is dedicated to addressing unmet needs in breast cancer prevention and treatment. Dense breasts are a significant risk factor for breast cancer, and Atossa's lead drug candidate has shown effectiveness in reducing breast density and lowering the risk of cancer. This dual-action drug blocks estrogen receptor signaling and induces programmed cell death in cancer cells, potentially offering a more effective and more tolerable treatment option. Steven explains, "So we are very focused on breast cancer to the point that Princess of Atossa, the company is named after, was the first woman in recorded history with breast cancer about four 50 BC. She was the wife of Darius the Great, who had the Persian Empire, the largest piece of real estate before the Roman Empire. And she had a breast lesion. It was documented that her slave cauterized it with a hot poker from the fire. We didn't get a follow-up from that, but anyway, we are dedicated to all the women, inc

Dr. Alex Meves, distinguished dermatologist at the Mayo Clinic and a spokesperson for SkylineDx, discusses the challenges in diagnosing and treating melanoma and how a new molecular test called Merlin can help improve risk stratification and treatment decisions for patients with early-stage melanoma. Diagnosis and treatment have traditionally used tumor thickness as a primary risk factor. This molecular test measures the expression of genes in the tumor biopsy and can help determine the extent of surgery needed and whether additional therapies may be beneficial. Alex explains, "My department, when I started to work here at Mayo, wanted me to do some translational research, and I had just come back from a postdoc in Germany, at the Max Planck Institute, and I was tasked to get some research going. And so I focused on melanoma because I thought at the time there wasn't a lot of molecular research going on in melanoma that could be translated to patients. And so we started to develop biomarkers, sort of molecul

Elaina McMillan, a director of product marketing at Edifecs,  describes the challenges and opportunities around healthcare data interoperability with a focus on prior authorization. Standardizing prior authorization workflows and data submissions across payers is a major focus to reduce delays and errors. Ensuring data security and patient consent are critical concerns, especially for smaller payers with limited resources to comply with mandates.  Elaina explains, "Primarily, what I work on and what Edifecs is most known for is our healthcare data interoperability platform, which includes EDI standards and the new-ish since 2020 FHIR standards. So we're really focused on that. How I would explain it is the data engine that helps payers get things done with quality data through the standardization of that. In addition, we have a whole set of what we call workflow solutions or applications that you can actually build on top of the data platform. So it helps to do things like claims correction, enrollment manag

Anmy Mayfield, Vice President and Dean for the Western Governors University College of Nursing in the Michael O. Leavitt School of Health, discusses the university's mission to provide accessible, online nursing education to address the nursing workforce shortage and encourage a more diverse population of nurses. The ReNEW Fund, a collaborative initiative with Social Finance, provides zero-interest, forgivable loans to nursing students. This model appeals to a diverse student population, including working adults and career-changers, by offering flexibility and employment opportunities for graduates. Anmy explains, "The ReNEW Fund is a collaboration with Social Finance, another nonprofit organization. And we have a shared goal of tackling the nursing shortage that is estimated to be about 30,000 to 40,000 fewer RNs entering the field compared to what's open to RNs. And there are a lot of barriers that can keep someone from becoming a nurse. And one of those is the cost of nursing school."   "We want to make s

Dr. Frank Bedu-Addo, President and CEO of PDS Biotechnology, focuses on the challenge of cancer recurrence and the development of a targeted immunotherapy approach using nanoparticle technology. Their lead immunotherapy candidate is designed to train the immune system to detect and attack microscopic or undetectable cancer cells, prolonging survival by preventing recurrence. Early clinical results in cervical, head and neck, and other HPV 16-positive cancers have been promising, showing sustained immune response leading to long-lasting T cell memory.  Frank explains, "Recurrence of cancer after treatment is actually one of the bigger hurdles we face in successfully treating cancer. So, PDS Biotechnology, as you know, we have a sharp focus on advancing our targeted immunotherapy platforms to address significant unmet needs in treating cancer. And this is actually one of those key unmet needs in cancer today. The prevailing hypothesis on knowledge is that cancer treatment, whether it's done using radiation the

Paul Romness, Chairman, CEO, and President of OS Therapies, and Olivia Egge, a member of the Board of Directors of OS Therapies, discuss osteosarcoma, a rare and aggressive form of bone cancer that primarily affects teenagers. OS Therapies is developing an immunotherapy that utilizes a weakened form of the listeria bacteria to stimulate the immune system and prevent the spread of cancer cells to the lungs and brain. Olivia's experience as a patient has motivated her to advocate for better treatment options and join the board of OS Therapeutics. Paul explains, "So osteosarcoma is quite literally bone cancer. It happens in teenagers like Olivia, after the growth comes together in the long bones, and there's some sort of miscalculation, and a very aggressive and very deadly cancer develops from that of the growth. And as a result, the cancer can usually spread to the lungs and then the brain. And that's where it gets very, very deadly. And our approach is to stimulate the immune system with a weakened or attenu

Dan Schmitt, President and CEO of Actuate Therapeutics, is developing a cancer therapy that inhibits GSK3β, a key enzyme that is hijacked in cancer cells to drive tumor growth. Inhibiting this enzyme can impact the cancer cells and stimulate an immune response against the tumor. Actuate selected metastatic pancreatic cancer as their first target due to unmet need and promising data for their lead drug candidate. This could represent a significant advancement in the treatment of metastatic pancreatic cancer, offering a new standard-of-care option.   Dan explains, "So, GSK-3β is a known quantity across a number of inflammatory diseases. It was understood when we first started the company that, particularly in cancer cells, GSK is hijacked in its activity. Basically it's been shown that in normal cells, GSK-3β sits in the cytoplasmic domain and there it's involved in multiple paths, basically in glucose metabolism. But in cancer cells, it translocates into the nuclear compartment, and there it's accumulated at

Andrea James, Chief Financial Officer at iMDx, is focused on expanding access to innovative molecular diagnostic testing staring with a test for monitoring transplanted organ health.  The test measures the donor-derived cell-free DNA which can indicate the need for drugs to target organ rejection before invasive procedures are required. The company is developing a kit-based version of the test that can be run by hospitals rather than relying on centralized labs, to increase access to this diagnostic and improve transplant outcomes. Andrea explains, "We changed our name on June 17th from OncoCyte, as you had just referenced, to Insight Molecular Diagnostics Inc. We're now going by iMDx, and our mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes." "We actually have three pieces of IP, intellectual property, and we are initially commercializing in transplant. So we measure a biomarker called donor-derived cell-free DNA, don't get too hung up on it. That's a lot of

James Hereford, President and CEO of Fairview Health Services, describes this Minnesota-based healthcare system's $600 million turnaround and the importance of focusing on people and processes, not just technology changes. Addressing staff shortages, quality of care, and patient experience led to finding a holistic approach that improved financial outcomes and changed the culture in a sustainable way. Investments have been made in community programs like food access and vaccination events, recognizing the impact of social determinants of health on patient outcomes. James explains, "When doing this, we have to think about sustainability, and there are things that you can do, like mass layoffs, that can change the short-term economics of an organization. They're just not sustainable. The work hasn't gone away. You haven't changed the nature of work, and we really tried to focus on the people in the process side of this and really make our focus on our processes." "The other problem with thinking only about th

Steve Butts, Co-Founder and CEO of Arrivo BioVentures, is a biopharmaceutical company focused on developing therapies that target the root causes of disease rather than just treating the symptoms. Their drugs treat major depressive disorder and acute pancreatitis through novel epigenetic mechanisms of action. Sex-based differences were observed in clinical trials where the drug SP-624 showed efficacy in females but not in males, which could lead to a paradigm shift in how depression is treated in men and women. Steve explains, "We've evolved over time at Arrivo and with our previous companies. What we're excited about right now is the fact that we have two drugs. One called SP-624 or Forvisirvat is the generic name, and the other one is code-named RABI-767. And as we've gotten into the science behind these drugs, what we're finding is that we're not just treating the symptoms of a disease, but we're really trying to get at what's causing the disease fundamentally and trying to make an impact there. And I thi

Daniel Blumenthal, VP of Strategy at MDClone, is building synthetic data models to mimic real patient data without the need to protect the identity of individuals. This type of data is being utilized in drug discovery and development, building predictive tools and new care models, and to better understand biases in clinical trials making them more representative. AI tools play an essential role in generating and validating synthetic data as well as integrating it into various processes and environments. Daniel explains, "Synthetic data means different things to different people. So I definitely would want to start with sharing what it usually means to MDClone, which is creating data based on real populations of patients, real patient data. Learning from that real patient data, extracting essentially the statistics from that data, understanding the relevant patterns that exist inside that data, and then, based on the statistics alone, generating a brand-new set of data, a brand-new set of people, and the synt

Rick Geoffrion, Founder and CEO of Cyrano Therapeutics, is developing a drug to restore olfactory function due to post-viral loss of smell and taste. As a result of COVID-19, there has been a significant increase in the number of people affected by long-term smell and taste loss, with no effective pharmaceutical options previously available. Smell loss can also be an early indicator of neurodegenerative conditions, suggesting future applications of the intranasal spray that aims to directly restore function to the olfactory receptor neurons. Rick explains, "Taste and smell have a really strong connection, actually. First of all, they're two out of the five basic senses that we have as human beings. When you lose your sense of smell, people actually perceive that they've lost about 80% of their sense of taste. Now, technically, you're not losing your sense of taste. We actually just give our tongue too much credit. Our tongue is able to detect sweet, sour, salty, bitter, and umami. That's all it detects, and

Loren Larsen, CEO and Co-Founder of Videra Health, is using AI-powered technology to improve the patient-provider connection and monitor patient health, particularly mental health, in an empathetic and conversational way. The video-based AI platform engages patients in regular check-ins to assess mental and physical conditions and detect subtle changes in behavior, tone, or language that could indicate issues like suicidal ideation or movement disorders. Data from patient encounters is also providing insights to clinicians and helping patients and providers better understand the connection between mental health and chronic conditions. Loren explains, "We started Videra Health recognizing this challenge that when a patient isn't with their doctor, they lose connection. You go to your doctor, you get good care, you leave. There's never been a good way to follow up or check in with patients to see how they're doing. And so we've really applied AI to this for the last six years since we started the company to ch

David Fischel, CEO and Chairman of the Board of Stereotaxis, is advancing the ability of surgical robotics, particularly in the field of minimally invasive catheter-based procedures. Stereotaxis is developing the use of robotic technology to improve precision and accessibility in endovascular surgeries with a unique mechanism that allows surgeons to control the tip of the catheter. The adoption of surgical robotics for endovascular procedures will expand as remote access is made available and safety concerns are addressed for previously impossible-to-treat conditions.  David explains, "We build advanced robots that allow physicians to do minimally invasive catheter-based procedures with greater precision and safety. We're kind of pioneering that area of robotic surgery. We've seen other areas of medicine benefit significantly over the last decade or two from advanced robotic technologies. And there's a whole field of catheter-based endovascular cardiovascular procedures where we're still using handheld cathe