Empowered Patient Podcast

Haitham Ayad, CEO of SPIMA Therapeutics, has secured a global licensing agreement for its lead peptide-based immunotherapy candidate, which targets the Myddosome complex involved in inflammation.  This approach aims to target undruggable protein-protein interactions, leveraging the advantages of peptides over small molecules and antibodies.  In addition to inflammatory diseases like acute pancreatitis, SPIMA is also exploring the potential in certain cancers with mutations in the Myddosome complex.   Haitham explains, "In fact, what happened is that the four scientific co-founders worked together for long years to develop and to bring them to the clinical phase and to secure a global patent for that. So, at one point, the technology transfer office of the university, which is called SATT, decided that it was the appropriate moment to create a spin-off of the company so that the company could continue the work and take the lead candidate further to the clinical phase. And I joined at that point as a co-founde

This is a conversation with Nicole Andrews, a patient with LGSOC and STAAR Ovarian Cancer Foundation Board Chairperson, and Dan Paterson, President and CEO of Verastem Oncology. Low-grade serous ovarian cancer is a rare and slow-growing ovarian cancer that is often misdiagnosed. Verastem Oncology is developing a targeted treatment for LGSOC and working with the STAAR Foundation to inform researchers about the disease and ways to improve treatments. Nicole was finally diagnosed with LGSOC after 18 months of unexplained symptoms, and her role at the STAAR Foundation is to raise awareness and funds to support research. Nicole explains, "I have since learned that low-grade is difficult for pathologists who aren't used to seeing it and don't know the intricacies of diagnosing. My surgeon finally said I have to get this right because it changes treatment." "So, she asked permission to send this to a specialty cancer center. And we did. Once that happened, they came back pretty quickly and said this was low-grade se

Maria Perrin, President and Chief Strategy Officer at PPL, is focused on expanding access to self-directed and whole person care allowing people to stay in their homes and receive the services they need to maintain a good quality of life. Consumer-directed care programs funded by Medicaid allows disabled and the aged populations to choose their own caregivers they know and trust to provide personal services like meals, dressing, and transportation. PPL provides training, technology, quality assurance, and other support to help consumers and their caregivers participate in these programs. Maria explains, "So the programs differ from state to state. If someone needs care in their home, say they had an injury or they need help because of a disability or certain access, they can get help for people to, for example, come in, prepare meals, help them get dressed, and for bathing. Or if they're relatively healthy and can do that themselves, some programs support things like meal services, transportation, occupation

James Grover, President of Vyne Dental, addresses the friction and inefficiencies in the dental healthcare system to facilitate payments and improve patient outcomes. The dental care environment is fragmented and lacks coordination between patients, dentists, and payers. Vyne Dental works with dental practices to streamline the revenue cycle management process, improve patient communication, and ensure timely and accurate payments.   James explains, "We sit at the commerce crossroads between patients, practices, and payers, basically helping patients to pay, helping payers to pay, and helping practices to get paid for the services that they’re rendering." "Then in the payer space, they’re trying to avoid fraud. They also have certain places where there are plans that approve certain things but don’t allow for others, and they need to do their work. Unfortunately, there’s a tremendous amount of waste between all three constituents. That waste results in higher prices for patients and less business success for

Professor Piotr Trzonkowski, CEO of PolTREG, is focused on developing cell therapies for autoimmune diseases like type-1 diabetes and multiple sclerosis using polyclonal T-regulatory cell therapy. Treg cells are key in regulating the immune system and preventing autoimmune diseases. Clinical trials are showing promise for safe and effective treatments for preventing type-1 diabetes in pre-symptomatic patients and maintaining insulin production for years after treatment in those with this form of diabetes.   Piotr explains, "My initial research subject was vaccination in the elderly, and I was looking for the reasons they did not respond to the vaccine. It was initially on the flu vaccine. The same is valuable, for example, for the COVID-19 vaccine. What we found is that elderly people do not respond to the vaccines because of the high level of accumulation of T-regulatory cells. T-regulatory cells can suppress immune responses, which is bad for the elderly." "A very simple answer would be if you compare the

Cecil Pineda, Senior VP and Chief Information Security Officer at R1 RCM, is focused on integrating robust cybersecurity into the revenue cycle management process. When healthcare organizations are hit with ransomware attacks, they must respond rapidly and accurately communicate with internal and external partners.  Long-term strategies include controlling network access, backup/recovery testing and educating personnel in order to limit damage from attempts to invade the network.   Cecil explains, "I think most organizations, not just R1, many organizations have made that decision beforehand whether to pay or not. And that decision is not easy. That’s something that takes into account several factors, starting from patient safety to protecting customer data and being able to go back into operations. So there are a lot of things that they can do, the analysis before making that call. So, beforehand, a lot of organizations have their stance on payments." "Another key area besides speed is communications. This

This is a conversation with Dr. David Amaral, a distinguished professor at the MIND Institute and scientific director of Autism BrainNet, and Dorothy Frisch, an activist and supporter of the program. Autism BrainNet is funded by the Simons Foundation to collect and study postmortem brain samples from individuals with autism to understand the neurological basis of the disorder better. Currently, there are no biomarkers for autism, so studying the brains and accomplishments of those who had autism can lead to a better understanding of the abilities and challenges seen on the autism spectrum. David explains, "We went to the Simons Foundation and, with their support, have established a network in the United States. We have three collection sites: one at the UC Davis Mind Institute in Sacramento, one at UT Southwestern in Dallas, Texas, and one at the Mass General Hospital in Boston, where a postmortem brain donation can be sent. Those brains are then prepared in ways that will facilitate all kinds of research bot

Dr. Jose Luchsinger, Vice Chair for Clinical and Epidemiologic Research at Columbia University, is leading a phase 2 clinical trial of a prodrug Benfo that aims to raise the level of thiamine in the brain to improve memory and function in people with early Alzheimer's disease. This effort is based on research showing that Alzheimer's is associated with impaired thiamine processing in the brain, even if thiamine levels in the blood are normal. The phase 2 clinical trial for the drug is testing the ability to overcome the mishandling of thiamine in the brain by patients with mild cognitive impairment or mild dementia with evidence of amyloid.   Jose explains, "So this approach is based on decades of study by Dr. Gary Gibson, who’s at the Burke Institute in New York and Cornell University in New York. What he has found, particularly in animal models of Alzheimer’s disease, is that these animals have memory problems that are related to the ability to process thiamine in the brain, which is a key vitamin that is

Dr. Michael Sherling, Co-Founder, Chief Medical Officer, and Strategy Officer at ModMed, aims to save time for physicians and patients by reducing administrative burden through technology. Their AI-based solutions focus on automating mundane tasks like fax routing and documentation and can passively transcribe doctor-patient conversations to generate structured notes. The interface is designed to be simple and unobtrusive, minimizing extra clicks or steps for the doctors to review and accept the AI's recommendations. Michael explains, "Our approach to AI is focused on curing the drudgery of healthcare. What I mean by that is using any kind of tool to reduce the burden of documentation for staff, providers, and people in the back office. That's really what we're focused on. We're not so focused on how to improve diagnoses or any of the clinical aspects of healthcare but more on the administrative burden." "We're still in the development phase of our AI strategy, but there are two products that we're pretty

Dr. Eric Siemers, Medical Officer at Acumen Pharma, is developing a monoclonal antibody called sabirnetug that targets a specific toxic form of amyloid beta, Aβ oligomers. These oligomers are now believed to be a key driver of neuronal damage in Alzheimer's disease. The drug is in phase 2 clinical trials to evaluate its ability to slow cognitive decline in early-stage Alzheimer's patients and demonstrate the accuracy of biomarkers in identifying pathology before symptoms appear.   Eric explains, "We've identified, and this is a monoclonal antibody, a monoclonal antibody with a unique mechanism of action in that it targets what are called Aβ oligomers. And without going into all the details, these Aβ oligomers are now really felt to be the toxic species, the ones that cause the neurons to die, and the two drugs that have recently gotten approval sort of indirectly get at those toxic species, maybe one more than the other. But in our case, we're directly targeting what we think is the most toxic species. And

Rob Abbott, CEO and Executive Director at ISPOR, the Professional Society for Health Economics and Outcomes Research, focuses on defining and measuring value in healthcare, including accessibility, affordability, effectiveness, and patient outcomes. HEOR (health economics and outcomes research) can provide data-driven insights to guide healthcare decision-making, reduce bias in research, and consider a broader range of factors like social determinants of health. This can improve treatment adherence, align therapies with what matters most to patients, and support the evaluation of technology used for treatments and predictive analysis of new therapies.   Rob explains, "I'm excited at both the legacy of work that health economics and outcomes research has contributed to, but I'm particularly excited about the extent to which health economics and outcomes research can provide data-driven insights to highlight health interventions that provide the best health outcomes for the investment made. This is good for m

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 genot

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

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

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 pro

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

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