Empowered Patient Podcast

Tony Goodman is the Chief Operating Officer at Adial Pharmaceuticals, which is developing a personalized therapy for alcohol use disorder based on a genetic biomarker. This unique approach combines the therapeutic AD04 with the biomarker AG Plus to identify a specific AUD patient population that responds well to this drug. Insights from this work could potentially lead to a broader understanding of the genetic and neurobiological connection underlying addiction. Tony explains, "What makes us unique is that we're out in front of where the current prevailing wisdom of science is going in the addiction space. There's a renewed interest in personalized medicine or genetics, the study of genetic biomarkers, and things of that sort in addiction. As you know, we've been doing this for a long time. And so I think the uniqueness comes into the fact that we've coupled a therapeutic with a genetic biomarker, in this case, known as AG Plus, which we believe can produce results for patients that have this specific genotype. And you may recall that there's a lot of individual variability in addiction, and particularly at AUD, you have gender and genetic differences. You have sort of history of genetic patient history, differences, environmental factors, comorbid conditions including major depression, and you have trauma." "A lot of patients in the AUD space have a history of PTSD or negative experiences. There's a lot of variation in severity levels, which is something else we find unique about our program because we have stratified patients into less than ten drinks per drinking day and greater than ten drinks per drinking day. We know there is a difference in the responder analysis of the patients who fall into the less than ten drinks per drinking day. And a lot of theories have been postulated as to why that may be the case." #Adial #AlcoholUseDisorder #AUD #HealthcareInnovations #AddictionTreatment #BiotechSolutions #GeneticBiomarkers #PrecisionMedicine adial.com Download the transcript here

Shai Shen-Orr, the Co-Founder and Chief Scientist of CytoReason, is developing computational disease models powered by AI to improve the probability of success in phase 2 clinical trials. Their goal is to more precisely develop drugs using AI to analyze large amounts of biological and clinical data and overcome the challenges of the complexity and uncertainty in medical information. Working with large pharmaceutical companies, CytoReason is supporting companies in their drug development efforts and helping them choose the right drug target and patient populations to study. Shai explains, "There are many challenges. I would say that CytoReason right now isn't tackling images. And there are certainly companies in the field that have been doing this. We've been focused more on the molecular side of the data, the genes, the proteins, the cells, the genetics. But the challenge is that when you work in this field and try to do AI in biology, it's very difficult for us to know the ground truth. We don't know when we're wrong or when we're right." "We strive to support as many diseases as we can. Where we've placed the focus now has been immunology and oncology and, particularly, immuno-oncology. We kind of grew up as a company that really can specialize in the immune system. While the immune system plays a role in almost every disease, there are particular diseases, autoimmune diseases, and oncology, where it plays a very large role." "So now when we develop drugs, drug developers are thinking very much across the board, they're thinking about the mechanisms of the disease. They keep asking themselves where are there similar mechanisms that are triggering diseases that may be ultimately, from a physiological perspective, from a disease perspective, the patients may look very different, they may even have a different disease. Yet, from the drug perspective, what the drug is hitting, the mechanisms are similar. And so we need to support that. We need to support the ability of drug developers to think across the board. That also plays into the role of which models we prioritize." #CytoReason #PharmaAI #AI #DrugDiscovery #DrugDevelopment #ClinicalTrials cytoreason.com Download the transcript here

Josh Hix, the CEO of Season Health, has developed a food as medicine platform that combines registered dietitian services, food delivery, and medical nutrition therapy. This makes it easier for patients to access food benefits and eat healthier. The rise of GLP-1 agonist medications for weight management has highlighted the need to develop personalized nutrition plans to help patients maintain a healthy lifestyle. There is growing interest in food as medicine as it is increasingly recognized that improving nutrition can help prevent and manage many chronic health conditions. Josh explains, "I think many people, if not most, do better with a GLP-1 and some form of medical nutrition therapy, dietician services, etc. We hear from a lot of folks that GLP-1 helps turn down the cravings and the food noise. While they're on the drug, whether that's for a month or a year, that's the best time to start to figure out how to eat better and to form some new habits, to eat more whole foods, to find things that they like in the absence of some of the cravings for more processed foods or otherwise. And start building habits around these new choices." "What we hear from a lot of people, both patients and doctors, is that many folks are not able to stay on GLP-1s for all that long. Sometimes, their insurance coverage is short, and the insurance company will only pay for a certain period of time. Sometimes, folks are non-responders. I'm not sure that there are more studies on seniors than others that don't respond to the drugs. Some people have side effects, and some don't want to be on them forever. So, the number that I've heard most frequently cited is that only about 25% of people who start on a GLP-1 are still on it a year later. So I think that it may turn out that these are very, very powerful interventions for a quarter of patients or so, but that many people need more. It's either GLP-1 and a lifestyle intervention, some other form of therapy, or just something altogether different." #SeasonHealth #FoodasMedicine #ChronicDiseases #Nutrition #NutritionTherapy #GLP1 #GLP1Agonist seasonhealth.com Download the transcript here

Dr. Philip Räth, Managing Director at Palleos, discusses the advantages of a mid-size contract research organization compared to a large CRO. Customized solutions, strong cross-departmental cooperation, and fast decision-making are key to addressing the most significant unmet needs of clinical trial sponsors. This nimble clinical trial model, supported by machine learning, emphasizes collaboration and transparency. Philip explains, "In the end, we are a service industry, so it's always about time, costs, and quality. So, certain structures have been established in terms of project management and how you set up trials. We have regulations in place that are very clear on how things should get done. So, I think what collaboration enables is getting something done together. Collaboration between sponsors and CROs can transform the landscape and situation where collaboration enables trust and, therefore, change is possible." "I think that's always the biggest challenge for collaboration. You have change in the project, you have change in the clinical trial landscape in terms of maybe IT or information systems which become more prominent, or there are changes in regulation. So tackling these changes is mostly done through collaboration with a big foundation and trust so people can make bigger jumps and quicker decisions instead of just looking at what's on the contract regarding the deliverables." #Palleos #ClinicalTrials #CRO #ContractResearchOrganization palleos.com Download the transcript here

Dr. Kristin MacGregor, a clinical psychologist and senior clinical director of Integrated Behavioral Health at LifeStance Health, the largest outpatient mental health practice in the U.S., employing nearly 7,000 clinicians across 33 states to provide therapy, psychiatry, and psychological/neuropsychological services both in-person and virtually. They work with large medical practices and health systems to help build integrated behavioral health programs using the collaborative care model. Integrating mental health into primary care settings can help address early warning signs of cognitive decline, reduce stigma, and improve collaboration between providers to address both mental and physical health needs better and manage chronic diseases. Kristin explains, "I think anything that removes barriers to people accessing mental health care when they actually need it is a positive thing. The research shows that it takes 11 years, on average, between the time someone experiences a mental health symptom and the time that they get connected to care. And that is just far, far too long. There are, of course, many reasons for this. Still, one of them is that the longer time a person has to wait between the time they get referred to a mental health provider to the time that they have an appointment, the longer that time, the more likely it is the patient might actually talk themselves out of the appointment." "It's very challenging to do that in the way that the physical healthcare system and the mental healthcare system are currently set up. We're very siloed. There's not a lot of shared data that goes back and forth between PCP and mental health providers. However, in these integrated care settings, which I feel very strongly about, collaboration is incredibly important because there is something to learn. There's something to learn as a mental health provider about how physical symptoms can manifest themselves and about how chronic conditions can impact a patient." "But, bi-directionally, PCPs also really need to understand how mental health symptoms can present in different age groups and different cultures and ethnicities, and things like that. And when you're working side by side together on shared treatment plans, it's just so much easier to learn those things from one another as opposed to continuing to perpetuate these sorts of silos that we currently operate in with very little to no collaboration between the two parties." #LifeStanceHealth #MentalHealthMatters #LFST #MentalHealth lifestance.com Download the transcript here

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 clinical trials is worse. Still, they have to wait longer and ultimately pay more for new treatments as the cost of those clinical trials is ultimately passed on to patients." "So essentially, we're responsible for running the entire clinical trial end to end, but we do that in a very different way and with a very different business model from that of industry incumbents. On the business model front, we provide completely fixed costs for everything and our customers, the companies developing the drugs, only pay us when we hit milestones. In other words, our compensation is tied to the actual trial outcomes, moving the trial along, et cetera. The second difference is under the hood, we have the same level of concierge service - folks who oversee and design the clinical trials, medics and clinicians who are looking after patients. We also have our technology platform to help us find the right patients, get them enrolled in the right trial quickly, and monitor and capture the data as we go – leading to higher quality data." #LindusHealth #ClinicalResearch #CRO #ClinicalTrialRecruitment #DrugDevelopment lindushealth.com Download the transcript here

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 cancer. And so the pathologist will send a report back to the oncologist at that point saying, yes, your patient has cancer." "Now, once the pathologist has diagnosed the cancer, they can just scan that slide or take a picture of the slide and upload it to our cloud-based software. They get an immediate result on the presence or absence of the particular biomarker." "For instance, like ovarian cancer in the guidelines in ovarian cancer, if the patient is positive for ovarian cancer, she's supposed to get a biomarker test for a biomarker called HRD. Now, we can do that immediately. When that pathologist gives the report back to the oncologist, now it can say your patient has ovarian cancer, she's stage three, and she's positive or negative for HRD. And the oncologist, on the day they tell the patient that they have cancer, can also tell them, you have this biomarker, and based on the guidelines, here's the treatment we're going to start you on tomorrow. In essence, we can get the patient on the appropriate frontline therapy weeks ahead of time. And at the end of the day, cancer is a race against time." #PrecisionOncology #PrecisionMedicine #AI #Cancer #BioMarker #Pathologists #Oncologists #Tumors io9.ai Download the transcript here

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 lower cost of goods since you are only expressing or producing one single drug molecule. So, the way we look at bispecific and the real advantage is not just the additive effect. It's not even the synergistic effect, which means we would like our bispecific antibodies to do something combination therapy cannot do. And that's the value of our bispecific antibodies." "Basically, we have two technology platforms. The first one is an antibody phage display library. We call it Omni-mAb. This library is a live library, which means it has more than 100 billion antibody sequences. That's a collection of the 100 billion sequences. And whatever antigen, whatever conformation of the structure of antigens you have, you could isolate a very high-affinity antibody from the library in probably 4-6 weeks." #APBiosciences #Antibody #Biotech #Bispecific #ImmunoOncology #Cancer #SolidTumors APBioInc.com Download the transcript here

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 information that needs to be submitted on an ongoing basis. So, the industry is starting to recognize what it takes to maintain documentation, specifically detailing post-market surveillance activities, which is required to be compliant with the regulations worldwide." "When you think about how medical devices are evolving, you get a sense of the growing complexity. For instance, there is now software that serves as a medical device. You also have AI being embedded into medical devices. But ultimately, it's about ensuring that the products placed on the market are safe and efficacious. The ability to prove that via proper documentation is important. That, in turn, enables different regulatory authorities to feel comfortable with the products that are being approved and being marketed in each region." #Celegence #RegulatoryAffairs #RegTech #RegulatoryStrategy #Pharmaceuticals celegence.com Download the transcript here

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-threatening ischemia. And ultimately, that can put people at risk for amputation." "A lot of people aren't aware of how common it is, and a lot of people aren't attuned to the symptoms of it. People just sort of slow down. They do less and less, and they wind up being limited in their activities, and that really affects their health and their life, and ultimately, that can threaten their limbs. One of the things that Abbott is emphatic about is spreading awareness of the disease, trying to educate patients, trying to educate families, and trying to educate physicians so that people are more on guard for looking out for the signs and symptoms of the disease." "We have been working at Abbott for many years on techniques to help open up these blockages in the arteries of the legs. They start at about the belly button and go all the way down to the toes. At the belly button, the iliac arteries are quite large. They are about a half an inch in diameter. And then, as they go down all the way to the toes, they get narrower and narrower so that they're about a quarter of an inch to an eighth of an inch in diameter. There are a variety of different techniques to get through those blockages, such as using catheters, and wires balloons, and stents and scaffolds to help open up those arteries and change people's lives. One of the biggest challenges in this space has been those smaller arteries below the knee." #Abbott #AbbottVascular #PeripheralArteryDisease #PAD #DissolvableStentTechnology abbott.com PAD-info.com Download the transcript here