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Dr. Anne Marie Morse walks into the studio like a one-woman Jersey Broadway show and leaves behind the best damn TED Talk you've never heard. She's a neurologist, sleep medicine doc, narcolepsy expert, founder of D.A.M.M. Good Sleep, and full-time myth buster in a white coat. We talk about why sleep isn't a luxury, why your mattress does matter, and how melatonin is the new Flintstones vitamin with a marketing budget. We unpack the BS around sleep hygiene, blow up the medical gaslighting around “disorders,” and dig into how a former aspiring butterfly became one of the loudest voices for patient-centered science. Also: naps, kids, burnout, CPAPs, co-sleeping, airport pods, the DeLorean, and Carl Sagan. If you think you're getting by on five hours of sleep and vibes, you're not. This episode will make you want to take a nap—and then call your doctor.RELATED LINKSdammgoodsleep.com: https://www.dammgoodsleep.comLinkedIn: https://www.linkedin.com/in/anne-marie-morse-753b2821/Instagram: https://www.instagram.com/dammgoodsleepDocWire News Author Page: https://www.docwirenews.com/author/anne-marie-morseSleep Review Interview: https://sleepreviewmag.com/practice-management/marketing/word-of-mouth/sleep-advocacy-anne-marie-morse/Geisinger Bio: https://providers.geisinger.org/provider/anne-marie-morse/756868SWHR Profile: https://swhr.org/team/anne-marie-morse-do-faasm/FEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship inquiries, email podcast@matthewzachary.com.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Dr. Tijana Milinic and Lia Barros, DNP, from the University of Washington take a deep dive into the world of pulmonary arterial hypertension (PAH) clinical trials and discuss why diversity and inclusion matter. They explore the hidden biases in medical research and the real-world consequences of exclusion. Learn more about pulmonary hypertension trials at www.phaware.global/clinicaltrials. Engage for a cure: www.phaware.global/donate #phaware Share your story: info@phaware.com Like, Subscribe and Follow us: www.phawarepodcast.com. @uwepidemiology #phawareMD
Clinical trial transparency is a delicate balance of getting the right data to the right resources at the right time. Senior Partner Lisa Chamberlain James sits down with the President of Holtzople Consulting, Julie Holtzople, to discuss how to do just that. They discuss standardizing information for researchers, building trust, advice for best practices, and whether all this transparency is legally mandated – or simply the right thing to do.
Dr. Justin Abbatemarco talks with Dr. Eric L. Voorn about the efficacy of combined personalized home-based aerobic exercise and coaching on physical fitness in people with neuromuscular diseases, compared with usual care. Read the related article in Neurology®. Read the additional article that was referenced. Disclosures can be found at Neurology.org.
Back in Episode #401, we reported promising results from a Phase 2 clinical trial for vidofludimus calcium and its impact on progressive MS. This therapy is being developed by Immunic Therapeutics, and this week, Jason Tardio, Immunic's President and Chief Operating Officer, joins me to share some of the specifics of that clinical trial. Jason will also shed light on why Immunic believes that vidofludimus calcium goes beyond merely slowing disability, potentially offering vital neuroprotection for MS patients, making it a potential game-changer. We're also sharing the encouraging results from a study that focused on the efficacy of neural stem cell transplantation as a remyelination therapy. We'll tell you about a study in the U.K. that measured disability progression among people with MS five years after undergoing autologous hematopoietic stem cell transplantation (aHSCT). You'll learn about an AI tool that can predict whether someone living with MS is likely to experience progression independent of relapse activity (PIRA) with a high degree of accuracy. We'll tell you where you can catch the International Progressive MS Alliance webcast featuring a panel of experts discussing the future role of digital tools in MS research. We'll explain how one of the less publicized aspects of the One Big Beautiful Bill Act will impact future MS care. And Crush MS is less than two weeks away! We're sharing all the details! We have a lot to talk about! Are you ready for RealTalk MS??! This Week: Encouraging results from a clinical trial for progressive MS. :22 How a less-publicized aspect of the One Big Beautiful Bill Act will impact future MS patient care 1:18 A study looked at the efficacy of neural stem cell transplantation as a remyelination therapy 4:31 A study in the U.K. analyzed disability progression among people with MS five years after receiving autologous hematopoietic stem cell therapy (aHSCT) 7:42 Can AI accurately predict who will experience progression independent of relapse activity (PIRA)? 10:45 Don't miss the International Progressive MS Alliance webcast featuring experts discussing the future role of digital tools in MS research 12:40 Are you ready to support MS research while spending the afternoon in a Napa Valley vineyard? Get all the details to attend Crush MS 13:45 Jason Tardio, President and Chief Operating Officer of Immunic Therapeutics, discusses the recent Phase 2 clinical trial for vidofludimus calcium as a therapy for progressive MS 15:03 Share this episode 30:03 Have you downloaded the free RealTalk MS app? 30:23 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/411 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Become an MS Activist https://nationalmssociety.org/advocacy STUDY: Remyelination of Chronic Demyelinated Lesions With Directly Induced Neural Stem Cells https://academic.oup.com/brain/advance-article/doi/10.1093/brain/awaf208/8185601 STUDY: Autologous Haemotopoietic Stem Cell Transplantation in the U.K.: A 20-Year Retrospective Analysis of Activity Haematological Outcomes from the British Society of Blood And Marrow Transplantation and Cellular Therapy https://onlinelibrary.wiley.com/doi/epdf/10.1111/bjh.20199 STUDY: Deep Learning to Predict Progression Independent of Relapse Activity at a First Demyelinating Event https://academic.oup.com/braincomms/article/7/4/fcaf243/8185588 WEBCAST: A Discussion From the International Progressive MS Alliance's Digital Tools Workshop https://msif.org/news/2025/07/08/webcast-digital-tools EVENT: Crush MS https://crushms.org Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 411 Guest: Jason Tardio Privacy Policy
Axel Bex joins the show to discuss trials that he thinks have impacted RCC. We also discuss consolidative approaches, neoadjuvant trials and what can impact an academic career.
Thought leader Julio G. Martinez-Clark shares how his company in helping to bring medical innovation to the market sooner by conducting clinic trials in Latin America. About Julio: Julio G. Martinez-Clark stands at the forefront of clinical research transformation as the Ambassador of IAOCR/GCSA in the Americas and CEO of bioaccess®, where he bridges global quality standards with the world's growing MedTech, BioPharma, and Radiopharmaceutical ecosystems. With over two decades of cross-industry leadership spanning healthcare, telecommunications, and venture capital, Martinez-Clark has become the trusted partner for 100+ companies seeking accelerated regulatory approvals and cost-effective clinical trials worldwide. His unique fusion of technical expertise from Johns Hopkins Hospital infrastructure projects, regulatory acumen honed through UNESCO-aligned accreditations, and operational mastery of diverse global clinical trial landscapes positions him as the definitive authority on risk-mitigated medical innovation in emerging markets. Resources: Products discussed in the podcast: ReGelTec: https://regeltec.com/regeltec-chooses-colombia-bioacce-for-first-in-human-clinical-trial-of-hydrafil-system/ Spine Stabilization Technologies (SST): https://thespinemarketgroup.com/spinal-stabilization-technologies-ltd-announces-start-of-lopain-2-clinical-trial-in-south-america-for-lumbar-degenerative-disc-disease/ bioaccessla.com Show sponsor: The Cox 8 Table by Haven Medical
Dr. Arif Ali is a board-certified radiation oncologist at Peeples Cancer Institute at Hamilton Medical Center in Dalton, Georgia.For more information about Peeples Cancer Institute, call 844-PCI-HOPE or visit VitruvianHealth.com/cancer.This program in no way seeks to diagnose or treat illness or to replace professional medical care. Please see your healthcare provider if you have a health problem.
Send us a textOver the past 100 years, the poorest Americans have shifted from being underweight to becoming the group most likely to be overweight. Dr. Michael Koren joins Kevin Geddings to explore some of the social determinants of health underlying this trend. They touch on the complex biological, economic, and environmental factors contributing to higher obesity rates among economically disadvantaged Americans.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!
What if one prayer could change everything? In this episode of Behind the Human, Marc sits down with Matt Potter—co-founder of Pray.com—to unpack an extraordinary life story that began with a near-abortion and grew into one of the most influential faith-based platforms in the world. They explore how spiritual practice, digital innovation, and how a personal relationship with God are reshaping how we approach mental and emotional health. Whether you're religious, spiritual, or simply curious about how ancient rituals are finding new life through technology, this conversation will stretch your mind and open your heart. **** Release details for the NEW BOOK. Get your copy of Personal Socrates: Better Questions, Better Life Connect with Marc >>> Website | LinkedIn | Instagram | Drop a review and let me know what resonates with you about the show! Thanks as always for listening and have the best day yet! * A special thanks to MONOS, our official travel partner for Behind the Human! Use MONOSBTH10 at check-out for savings on your next purchase. ✈️ * Special props
From Episode 195 with Archana SahIn this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials—from phase one focusing on safety to phase three assessing effectiveness in diverse populations. Key aspects include the importance of the trial design, the role of comparator arms, regulatory requirements, patient recruitment, and the cultural preferences that influence trial protocols. The episode provides an in-depth look at how data is collected and analyzed to ensure the safety and efficacy of new drugs.00:00 Introduction to Clinical Trials00:26 Phases of Clinical Trials02:09 Designing Oncology Trials04:00 Protocol Design and Regulatory Approval05:27 Patient-Centric Considerations06:25 Vendor Roles and Statistical Analysis
In this explosive and highly anticipated episode, Dr. Roger McFillin hosts Dr. Ragy Girgis, a Columbia University Professor of Psychiatry and researcher, for a no-holds-barred confrontation that exposes the shocking divisions tearing apart the mental health field. What begins as a conversation about mass violence research rapidly explodes into a devastating examination of psychiatric medicine's crumbling foundations, questionable effectiveness, and devastating potential harms. The two clash in fierce, unrelenting disagreements over fundamental issues including the validity of DSM diagnoses, the debunked "chemical imbalance" theory of depression, dangerous SSRI safety cover-ups and black box warnings, corrupted research quality and pharmaceutical industry manipulation, and the catastrophic crisis of psychiatric drug overprescription poisoning 1 in 4-5 Americans. Dr. Girgis desperately defends traditional academic psychiatry and current treatment approaches, while Dr. McFillin ruthlessly dismantles the entire paradigm, arguing that the current system is systematically creating chronic mental illness rather than healing it. Buckle up for this brutal intellectual warfare.___________________________________________________________________________________________________________________________________________________Throughout the interview, Dr. Girgis repeatedly stated that "the data is clear" while dismissing contradictory evidence that challenges his conclusions. For our listeners' benefit, I have compiled research and documentation that directly disputes several of Dr. Girgis's key claims.Serotonin Hypothesis of Depression1. The serotonin theory of depression: a systematic umbrella review of the evidence (Moncrieff et al.)Conclusions: "This review suggests that the huge research effort based on the serotonin hypothesis has NOT produced convincing evidence of a biochemical basis to depression. This is consistent with research on many other biological markers . We suggest it is time to acknowledge that the serotonin theory of depression is NOT empirically substantiated."2.What has serotonin to do with depression?Conclusions: "Simple biochemical theories that link low levels of serotonin with depressed mood are no longer tenable."3. Is the chemical imbalance an ‘urban legend'? An exploration of the status of the serotonin theory of depression in the scientific literatureViolence & Suicide Associated with SSRI's 1. Precursors to suicidality and violence on antidepressants: systematic review of trials in adult healthy volunteers2. Prescription Drugs Associated with Reports of Violence Towards Others3. Antidepressant-induced akathisia-related homicides associated with diminishing mutations in metabolizing genes of the CYP450 family4. Lexapro Approved for Pediatric Use Despite the 6-Fold Increase in Suicide Risk5. McFillin Substack Review on Lexapro approved despite Suicide Risk6. Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports7. Antidepressants Increase Suicide Attempts in Youth; No Preventative Effect8. Effect of selective serotonin reuptake inhibitor treatment following diagnosis of depression on suicidal behaviour risk:9. FDA Warning: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents10. Suicide Mortality in the United States, 2001–2021 CDC documentation11. US suicide rate reaches highest point in more than 80 years: See what latest data shows12. CNN article reporting Eli Lilly Internal Documents"An internal document purportedly from Eli Lilly and Co. made public Monday appears to show that the drug maker had data more than 15 years ago showing that patients on its antidepressant Prozac were far more likely to attempt suicide and show hostility than were patients on other antidepressants and that the company attempted to minimize public awareness of the side effects. The 1988 document indicated that 3.7 percent of patients attempted suicide while on the blockbuster drug, a rate more than 12 times that cited for any of four other commonly used antidepressants.In addition, the paper said that 1.6 percent of patients reported incidents of hostility -- more than double the rate reported by patients on any of four other commonly used antidepressants."Examples of Violence after Prescription in legal system (Sample)January 24, 2020 – Newcastle, South Dublin, Ireland: Deirdre Morley, 44, smothered and killed her two sons Conor, 9, and Darragh, 7, and her three-year-old daughter Carla McGinley in their family home. She had been taking antidepressants since October 2018 and was admitted to St. Patrick's Mental Health Services on July 6, 2019, but was discharged after a short period, but was put on a combination of two antidepressants and a sedativeMay 11, 2018 – Osmington, Western Australia: Peter Miles, 61, shot his 35-year-old daughter and four grandchildren, aged 8 through 13, while they slept in their beds, in a shed that had been converted to a second house on the property. He then turned the gun on his 58-year-old wife in the living room of their house, before placing a call to police alerting them to his crimes. When they arrived, Miles was also found dead from a gunshot wound. Miles had started taking antidepressant medication just weeks before.April 6, 2018 – Wadsworth, Ohio: Gavon Ramsay, 17, strangled his neighbor, 98-year-old Margaret Douglas in her own home. His parents blame his actions on his having been misprescribed Zoloft. After a report by his school principal that the teen was depressed and might harm himself, he “returned to therapy,” and after a recommendation by a psychologist, the family's pediatrician prescribed the antidepressant Zoloft. From January through March leading up to the incident, the dosages were increased. During this time, his mother said she observed her son's behavior change—becoming increasingly irritable and hostile and saying bizarre things.October 21, 2013 – Sparks, Nevada: 12-year-old Jose Reyes opened fire at Sparks Middle School, killing a teacher and wounding two classmates be...
Dr. Paul Hanona and Dr. Arturo Loaiza-Bonilla discuss how to safely and smartly integrate AI into the clinical workflow and tap its potential to improve patient-centered care, drug development, and access to clinical trials. TRANSCRIPT Dr. Paul Hanona: Hello, I'm Dr. Paul Hanona, your guest host of the ASCO Daily News Podcast today. I am a medical oncologist as well as a content creator @DoctorDiscover, and I'm delighted to be joined today by Dr. Arturo Loaiza-Bonilla, the chief of hematology and oncology at St. Luke's University Health Network. Dr. Bonilla is also the co-founder and chief medical officer at Massive Bio, an AI-driven platform that matches patients with clinical trials and novel therapies. Dr. Loaiza-Bonilla will share his unique perspective on the potential of artificial intelligence to advance precision oncology, especially through clinical trials and research, and other key advancements in AI that are transforming the oncology field. Our full disclosures are available in the transcript of the episode. Dr. Bonilla, it's great to be speaking with you today. Thanks for being here. Dr. Arturo Loaiza-Bonilla: Oh, thank you so much, Dr. Hanona. Paul, it's always great to have a conversation. Looking forward to a great one today. Dr. Paul Hanona: Absolutely. Let's just jump right into it. Let's talk about the way that we see AI being embedded in our clinical workflow as oncologists. What are some practical ways to use AI? Dr. Arturo Loaiza-Bonilla: To me, responsible AI integration in oncology is one of those that's focused on one principle to me, which is clinical purpose is first, instead of the algorithm or whatever technology we're going to be using. If we look at the best models in the world, they're really irrelevant unless we really solve a real day-to-day challenge, either when we're talking to patients in the clinic or in the infusion chair or making decision support. Currently, what I'm doing the most is focusing on solutions that are saving us time to be more productive and spend more time with our patients. So, for example, we're using ambient AI for appropriate documentation in real time with our patients. We're leveraging certain tools to assess for potential admission or readmission of patients who have certain conditions as well. And it's all about combining the listening of physicians like ourselves who are end users, those who create those algorithms, data scientists, and patient advocates, and even regulators, before they even write any single line of code. I felt that on my own, you know, entrepreneurial aspects, but I think it's an ethos that we should all follow. And I think that AI shouldn't be just bolted on later. We always have to look at workflows and try to look, for example, at clinical trial matching, which is something I'm very passionate about. We need to make sure that first, it's easier to access for patients, that oncologists like myself can go into the interface and be able to pull the data in real time when you really need it, and you don't get all this fatigue alerts. To me, that's the responsible way of doing so. Those are like the opportunities, right? So, the challenge is how we can make this happen in a meaningful way – we're just not reacting to like a black box suggestion or something that we have no idea why it came up to be. So, in terms of success – and I can tell you probably two stories of things that we know we're seeing successful – we all work closely with radiation oncologists, right? So, there are now these tools, for example, of automated contouring in radiation oncology, and some of these solutions were brought up in different meetings, including the last ASCO meeting. But overall, we know that transformer-based segmentation tools; transformer is just the specific architecture of the machine learning algorithm that has been able to dramatically reduce the time for colleagues to spend allotting targets for radiation oncology. So, comparing the target versus the normal tissue, which sometimes it takes many hours, now we can optimize things over 60%, sometimes even in minutes. So, this is not just responsible, but it's also an efficiency win, it's a precision win, and we're using it to adapt even mid-course in response to tumor shrinkage. Another success that I think is relevant is, for example, on the clinical trial matching side. We've been working on that and, you know, I don't want to preach to the choir here, but having the ability for us to structure data in real time using these tools, being able to extract information on biomarkers, and then show that multi-agentic AI is superior to what we call zero-shot or just throwing it into ChatGPT or any other algorithm, but using the same tools but just fine-tuned to the point that we can be very efficient and actually reliable to the level of almost like a research coordinator, is not just theory. Now, it can change lives because we can get patients enrolled in clinical trials and be activated in different places wherever the patient may be. I know it's like a long answer on that, but, you know, as we talk about responsible AI, that's important. And in terms of what keeps me up at night on this: data drift and biases, right? So, imaging protocols, all these things change, the lab switch between different vendors, or a patient has issues with new emerging data points. And health systems serve vastly different populations. So, if our models are trained in one context and deployed in another, then the output can be really inaccurate. So, the idea is to become a collaborative approach where we can use federated learning and patient-centricity so we can be much more efficient in developing those models that account for all the populations, and any retraining that is used based on data can be diverse enough that it represents all of us and we can be treated in a very good, appropriate way. So, if a clinician doesn't understand why a recommendation is made, as you probably know, you probably don't trust it, and we shouldn't expect them to. So, I think this is the next wave of the future. We need to make sure that we account for all those things. Dr. Paul Hanona: Absolutely. And even the part about the clinical trials, I want to dive a little bit more into in a few questions. I just kind of wanted to make a quick comment. Like you said, some of the prevalent things that I see are the ambient scribes. It seems like that's really taken off in the last year, and it seems like it's improving at a pretty dramatic speed as well. I wonder how quickly that'll get adopted by the majority of physicians or practitioners in general throughout the country. And you also mentioned things with AI tools regarding helping regulators move things quicker, even the radiation oncologist, helping them in their workflow with contouring and what else they might have to do. And again, the clinical trials thing will be quite interesting to get into. The first question I had subsequent to that is just more so when you have large datasets. And this pertains to two things: the paper that you published recently regarding different ways to use AI in the space of oncology referred to drug development, the way that we look at how we design drugs, specifically anticancer drugs, is pretty cumbersome. The steps that you have to take to design something, to make sure that one chemical will fit into the right chemical or the structure of the molecule, that takes a lot of time to tinker with. What are your thoughts on AI tools to help accelerate drug development? Dr. Arturo Loaiza-Bonilla: Yes, that's the Holy Grail and something that I feel we should dedicate as much time and effort as possible because it relies on multimodality. It cannot be solved by just looking at patient histories. It cannot be solved by just looking at the tissue alone. It's combining all these different datasets and being able to understand the microenvironment, the patient condition and prior treatments, and how dynamic changes that we do through interventions and also exposome – the things that happen outside of the patient's own control – can be leveraged to determine like what's the best next step in terms of drugs. So, the ones that we heard the news the most is, for example, the Nobel Prize-winning [for Chemistry awarded to Demis Hassabis and John Jumper for] AlphaFold, an AI system that predicts protein structures right? So, we solved this very interesting concept of protein folding where, in the past, it would take the history of the known universe, basically – what's called the Levinthal's paradox – to be able to just predict on amino acid structure alone or the sequence alone, the way that three-dimensionally the proteins will fold. So, with that problem being solved and the Nobel Prize being won, the next step is, “Okay, now we know how this protein is there and just by sequence, how can we really understand any new drug that can be used as a candidate and leverage all the data that has been done for many years of testing against a specific protein or a specific gene or knockouts and what not?” So, this is the future of oncology and where we're probably seeing a lot of investments on that. The key challenge here is mostly working on the side of not just looking at pathology, but leveraging this digital pathology with whole slide imaging and identifying the microenvironment of that specific tissue. There's a number of efforts currently being done. One isn't just H&E, like hematoxylin and eosin, slides alone, but with whole imaging, now we can use expression profiles, spatial transcriptomics, and gene whole exome sequencing in the same space and use this transformer technology in a multimodality approach that we know already the slide or the pathology, but can we use that to understand, like, if I knock out this gene, how is the microenvironment going to change to see if an immunotherapy may work better, right? If we can make a microenvironment more reactive towards a cytotoxic T cell profile, for example. So, that is the way where we're really seeing the field moving forward, using multimodality for drug discovery. So, the FDA now seems to be very eager to support those initiatives, so that's of course welcome. And now the key thing is the investment to do this in a meaningful way so we can see those candidates that we're seeing from different companies now being leveraged for rare disease, for things that are going to be almost impossible to collect enough data, and make it efficient by using these algorithms that sometimes, just with multiple masking – basically, what they do is they mask all the features and force the algorithm to find solutions based on the specific inputs or prompts we're doing. So, I'm very excited about that, and I think we're going to be seeing that in the future. Dr. Paul Hanona: So, essentially, in a nutshell, we're saying we have the cancer, which is maybe a dandelion in a field of grass, and we want to see the grass that's surrounding the dandelion, which is the pathology slides. The problem is, to the human eye, it's almost impossible to look at every single piece of grass that's surrounding the dandelion. And so, with tools like AI, we can greatly accelerate our study of the microenvironment or the grass that's surrounding the dandelion and better tailor therapy, come up with therapy. Otherwise, like you said, to truly generate a drug, this would take years and years. We just don't have the throughput to get to answers like that unless we have something like AI to help us. Dr. Arturo Loaiza-Bonilla: Correct. Dr. Paul Hanona: And then, clinical trials. Now, this is an interesting conversation because if you ever look up our national guidelines as oncologists, there's always a mention of, if treatment fails, consider clinical trials. Or in the really aggressive cancers, sometimes you might just start out with clinical trials. You don't even give the standard first-line therapy because of how ineffective it is. There are a few issues with clinical trials that people might not be aware of, but the fact that the majority of patients who should be on clinical trials are never given the chance to be on clinical trials, whether that's because of proximity, right, they might live somewhere that's far from the institution, or for whatever reason, they don't qualify for the clinical trial, they don't meet the strict inclusion criteria. But a reason you mentioned early on is that it's simply impossible for someone to be aware of every single clinical trial that's out there. And then even if you are aware of those clinical trials, to actually find the sites and put in the time could take hours. And so, how is AI going to revolutionize that? Because in my mind, it's not that we're inventing a new tool. Clinical trials have always been available. We just can't access them. So, if we have a tool that helps with access, wouldn't that be huge? Dr. Arturo Loaiza-Bonilla: Correct. And that has been one of my passions. And for those who know me and follow me and we've spoke about it in different settings, that's something that I think we can solve. This other paradox, which is the clinical trial enrollment paradox, right? We have tens of thousands of clinical trials available with millions of patients eager to learn about trials, but we don't enroll enough and many trials close to accrual because of lack of enrollment. It is completely paradoxical and it's because of that misalignment because patients don't know where to go for trials and sites don't know what patients they can help because they haven't reached their doors yet. So, the solution has to be patient-centric, right? We have to put the patient at the center of the equation. And that was precisely what we had been discussing during the ASCO meeting. There was an ASCO Education Session where we talked about digital prescreening hubs, where we, in a patient-centric manner, the same way we look for Uber, Instacart, any solution that you may think of that you want something that can be leveraged in real time, we can use these real-world data streams from the patient directly, from hospitals, from pathology labs, from genomics companies, to continuously screen patients who can match to the inclusion/exclusion criteria of unique trials. So, when the patient walks into the clinic, the system already knows if there's a trial and alerts the site proactively. The patient can actually also do decentralization. So, there's a number of decentralized clinical trial solutions that are using what I call the “click and mortar” approach, which is basically the patient is checking digitally and then goes to the site to activate. We can also have the click and mortar in the bidirectional way where the patient is engaged in person and then you give the solution like the ones that are being offered on things that we're doing at Massive Bio and beyond, which is having the patient to access all that information and then they make decisions and enroll when the time is right. As I mentioned earlier, there is this concept drift where clinical trials open and close, the patient line of therapy changes, new approvals come in and out, and sites may not be available at a given time but may be later. So, having that real-time alerts using tools that are able already to extract data from summarization that we already have in different settings and doing this natural language ingestion, we can not only solve this issue with manual chart review, which is extremely cumbersome and takes forever and takes to a lot of one-time assessments with very high screen failures, to a real-time dynamic approach where the patient, as they get closer to that eligibility criteria, they get engaged. And those tools can be built to activate trials, audit trials, and make them better and accessible to patients. And something that we know is, for example, 91%-plus of Americans live close to either a pharmacy or an imaging center. So, imagine that we can potentially activate certain of those trials in those locations. So, there's a number of pharmacies, special pharmacies, Walgreens, and sometimes CVS trying to do some of those efforts. So, I think the sky's the limit in terms of us working together. And we've been talking with corporate groups, they're all interested in those efforts as well, to getting patients digitally enabled and then activate the same way we activate the NCTN network of the corporate groups, that are almost just-in-time. You can activate a trial the patient is eligible for and we get all these breakthroughs from the NIH and NCI, just activate it in my site within a week or so, as long as we have the understanding of the protocol. So, using clinical trial matching in a digitally enabled way and then activate in that same fashion, but not only for NCTN studies, but all the studies that we have available will be the key of the future through those prescreening hubs. So, I think now we're at this very important time where collaboration is the important part and having this silo-breaking approach with interoperability where we can leverage data from any data source and from any electronic medical records and whatnot is going to be essential for us to move forward because now we have the tools to do so with our phones, with our interests, and with the multiple clinical trials that are coming into the pipelines. Dr. Paul Hanona: I just want to point out that the way you described the process involves several variables that practitioners often don't think about. We don't realize the 15 steps that are happening in the background. But just as a clarifier, how much time is it taking now to get one patient enrolled on a clinical trial? Is it on the order of maybe 5 to 10 hours for one patient by the time the manual chart review happens, by the time the matching happens, the calls go out, the sign-up, all this? And how much time do you think a tool that could match those trials quicker and get you enrolled quicker could save? Would it be maybe an hour instead of 15 hours? What's your thought process on that? Dr. Arturo Loaiza-Bonilla: Yeah, exactly. So one is the matching, the other one is the enrollment, which, as you mentioned, is very important. So, it can take, from, as you said, probably between 4 days to sometimes 30 days. Sometimes that's how long it takes for all the things to be parsed out in terms of logistics and things that could be done now agentically. So, we can use agents to solve those different steps that may take multiple individuals. We can just do it as a supply chain approach where all those different steps can be done by a single agent in a simultaneous fashion and then we can get things much faster. With an AI-based solution using these frontier models and multi-agentic AI – and we presented some of this data in ASCO as well – you can do 5,000 patients in an hour, right? So, just enrolling is going to be between an hour and maximum enrollment, it could be 7 days for those 5,000 patients if it was done at scale in a multi-level approach where we have all the trials available. Dr. Paul Hanona: No, definitely a very exciting aspect of our future as oncologists. It's one thing to have really neat, novel mechanisms of treatment, but what good is it if we can't actually get it to people who need it? I'm very much looking for the future of that. One of the last questions I want to ask you is another prevalent way that people use AI is just simply looking up questions, right? So, traditionally, the workflow for oncologists is maybe going on national guidelines and looking up the stage of the cancer and seeing what treatments are available and then referencing the papers and looking at who was included, who wasn't included, the side effects to be aware of, and sort of coming up with a decision as to how to treat a cancer patient. But now, just in the last few years, we've had several tools become available that make getting questions easier, make getting answers easier, whether that's something like OpenAI's tools or Perplexity or Doximity or OpenEvidence or even ASCO has a Guidelines Assistant as well that is drawing from their own guidelines as to how to treat different cancers. Do you see these replacing traditional sources? Do you see them saving us a lot more time so that we can be more productive in clinic? What do you think is the role that they're going to play with patient care? Dr. Arturo Loaiza-Bonilla: Such a relevant question, particularly at this time, because these AI-enabled query tools, they're coming left and right and becoming increasingly common in our daily workflows and things that we're doing. So, traditionally, when we go and we look for national guidelines, we try to understand the context ourselves and then we make treatment decisions accordingly. But that is a lot of a process that now AI is helping us to solve. So, at face value, it seems like an efficiency win, but in many cases, I personally evaluate platforms as the chief of hem/onc at St. Luke's and also having led the digital engagement things through Massive Bio and trying to put things together, I can tell you this: not all tools are created equal. In cancer care, each data point can mean the difference between cure and progression, so we cannot really take a lot of shortcuts in this case or have unverified output. So, the tools are helpful, but it has to be grounded in truth, in trusted data sources, and they need to be continuously updated with, like, ASCO and NCCN and others. So, the reason why the ASCO Guidelines Assistant, for instance, works is because it builds on all these recommendations, is assessed by end users like ourselves. So, that kind of verification is critical, right? We're entering a phase where even the source material may be AI-generated. So, the role of human expert validation is really actually more important, not less important. You know, generalist LLMs, even when fine-tuned, they may not be enough. You can pull a few API calls from PubMed, etc., but what we need now is specialized, context-aware, agentic tools that can interpret multimodal and real-time clinical inputs. So, something that we are continuing to check on and very relevant to have entities and bodies like ASCO looking into this so they can help us to be really efficient and really help our patients. Dr. Paul Hanona: Dr. Bonilla, what do you want to leave the listener with in terms of the future direction of AI, things that we should be cautious about, and things that we should be optimistic about? Dr. Arturo Loaiza-Bonilla: Looking 5 years ahead, I think there's enormous promise. As you know, I'm an AI enthusiast, but always, there's a few priorities that I think – 3 of them, I think – we need to tackle head-on. First is algorithmic equity. So, most AI tools today are trained on data from academic medical centers but not necessarily from community practices or underrepresented populations, particularly when you're looking at radiology, pathology, and what not. So, those blind spots, they need to be filled, and we can eliminate a lot of disparities in cancer care. So, those frameworks to incentivize while keeping the data sharing using federated models and things that we can optimize is key. The second one is the governance on the lifecycle. So, you know, AI is not really static. So, unlike a drug that is approved and it just, you know, works always, AI changes. So, we need to make sure that we have tools that are able to retrain and recall when things degrade or models drift. So, we need to use up-to-date AI for clinical practice, so we are going to be in constant revalidation and make it really easy to do. And lastly, the human-AI interface. You know, clinicians don't need more noise or we don't need more black boxes. We need decision support that is clear, that we can interpret, and that is actionable. “Why are you using this? Why did we choose this drug? Why this dose? Why now?” So, all these things are going to help us and that allows us to trace evidence with a single click. So, I always call it back to the Moravec's paradox where we say, you know, evolution gave us so much energy to discern in the sensory-neural and dexterity. That's what we're going to be taking care of patients. We can use AI to really be a force to help us to be better clinicians and not to really replace us. So, if we get this right and we decide for transparency with trust, inclusion, etc., it will never replace any of our work, which is so important, as much as we want, we can actually take care of patients and be personalized, timely, and equitable. So, all those things are what get me excited every single day about these conversations on AI. Dr. Paul Hanona: All great thoughts, Dr. Bonilla. I'm very excited to see how this field evolves. I'm excited to see how oncologists really come to this field. I think with technology, there's always a bit of a lag in adopting it, but I think if we jump on board and grow with it, we can do amazing things for the field of oncology in general. Thank you for the advancements that you've made in your own career in the field of AI and oncology and just ultimately with the hopeful outcomes of improving patient care, especially cancer patients. Dr. Arturo Loaiza-Bonilla: Thank you so much, Dr. Hanona. Dr. Paul Hanona: Thanks to our listeners for your time today. If you value the insights that you hear on ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers: Dr. Arturo Loaiza-Bonilla @DrBonillaOnc Dr. Paul Hanona @DoctorDiscover on YouTube Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn ASCO on BlueSky Disclosures: Paul Hanona: No relationships to disclose. Dr. Arturo-Loaiza-Bonilla: Leadership: Massive Bio Stock & Other Ownership Interests: Massive Bio Consulting or Advisory Role: Massive Bio, Bayer, PSI, BrightInsight, CardinalHealth, Pfizer, AstraZeneca, Medscape Speakers' Bureau: Guardant Health, Ipsen, AstraZeneca/Daiichi Sankyo, Natera
In this episode of TOGA's Conversations in Lung Cancer Research, A/Prof Mel Moore speaks with Prof Shankar Siva about his groundbreaking work in radiation oncology, particularly focusing on the PRIME Lung study. They discuss the journey from concept to large clinical trials, the challenges of grant applications, the importance of controversial ideas in research, and the role of industry funding. Shankar also shares insights into his interest in genitourinary cancers and the future of radiation therapy, emphasising the significance of mentorship and practical advice for junior radiation oncologists.00:00 Welcome and Introduction00:33 Meet Professor Shankar Siva01:26 Prime Lung Study Overview02:32 Building on Previous Research04:00 From Concept to Large Trial06:11 International Collaborations07:16 Tips for Clinician Researchers12:11 Industry Funding in Radiation Oncology14:33 Interest in Genitourinary Cancers19:34 The Role of Mentorship25:09 Advice for Junior Colleagues28:25 Conclusion and Final Thoughts
Send us a textIn this special episode of The Just MS Show, we explore the groundbreaking advancements in Multiple Sclerosis (MS) research that are changing lives and redefining what's possible.We cover:The paradigm shift: How B-cells—not T-cells—are the true culprits behind MS, and how this discovery has led to life-changing treatments like Ocrevus and Kesimpta.The EBV connection: Why Epstein-Barr Virus is now considered the leading cause of MS, and how this could lead to a preventative vaccine.Myelin repair therapies: From over-the-counter drugs like clemastine to next-gen breakthroughs like PIPE-307, stem cell grafts, and microglia modulation.Disease-modifying therapies (DMTs): New drugs like Tolebrutinib and CNM-Au8 that are slowing or reversing MS progression.Emerging trends: Using fMRI to track cognitive decline, the impact of mental health on fatigue, and how GLP-1 weight-loss drugs could reduce MS risk.Patient-focused care: Insights on treatment preferences, postpartum considerations, and financial relief through Medicare changes.This isn't just another research update—it's a roadmap to what may soon be a world where MS is preventable, treatable, and even curable.This episode was made with A.I. to help
Today's guest is Michael Zaiac, Head of Medical Oncology for Europe and Canada at Daiichi Sankyo. Michael joins the platform in a special episode focused on how AI is driving measurable ROI in clinical trials—particularly in patient recruitment and eligibility. Their conversation explores how life sciences teams are applying advanced analytics to accelerate enrollment, improve diversity in study populations, and reduce time to trial completion. Michael also shares where generative AI is beginning to play a role in patient-facing materials, including simplified consent forms and study summaries. Throughout the episode, Michael emphasizes the importance of early stakeholder alignment, regulatory transparency, and the discipline required to deploy AI responsibly in high-risk clinical environments. This episode is sponsored by Medable. Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast!
In this episode of the Diabetes Innovators Series, Rob interviews Jonathan Rigby, CEO of Sernova Biotherapeutics, about the innovative approaches to treating type 1 diabetes, particularly through the development of a biohybrid organ known as the cell pouch. Jonathan shares his personal journey as a type 1 diabetic and discusses the clinical trials, patient selection, and the future of diabetes treatment, including the challenges of immunosuppression and the complexities of daily diabetes management. The conversation emphasizes the importance of innovation in diabetes care and the hope for a future where patients can achieve insulin independence. Chapters 00:00 Introduction to Diabetes and Innovation 02:51 The Cell Pouch Biohybrid Organ 05:53 Clinical Trials and Patient Selection 08:48 Living with Type 1 Diabetes 11:51 Future of Diabetes Treatment 14:47 Immunosuppressants and Cell Acceptance 17:48 The Complexity of Diabetes Management 20:44 Conclusion and Future Outlook Resources: Sernova Jonathan Rigby LinkedIn
The expanded Phase 1/2/3 shortens time to potential FDA approval.
Send us a textDr. Michael Koren sits down with Dr. Allan Rosenfeld, a Canadian physician specializing in occupational medicine. The two doctors explore some of the realities of Canadian healthcare by moving through Dr. Rosenfeld's career in family practice, occupational medicine, and his personal use of the healthcare system. Dr. Rosenfeld offers candid insights that challenge common perceptions by discussing wait times, physician compensation challenges, and some differences between the US and Canadian healthcare models.Contact Dr. Rosenfeld at occdocc@rogers.com or (905) 828-6016. His book is titled "Holocaust Lumber" and is available on lulu.comBe a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!
Send us a textThe larger the country, the longer it takes to get trials approved. In this episode, Captain Integrity Bob Wade explores how compliance works for national & international clinical trials with Julio Martinez-Clark, CEO of bioaccess. Hear how clinical research is global, why some countries approve trials quicker, why patients in developing economies need to have access to these trials, how countries differ with their regulatory requirements, and the hottest topics in compliance. Learn more at CaptainIntegrity.com
Inato: https://go.inato.com/3VnSro6CRIO: http://www.clinicalresearch.ioMy PatientACE recruitment company: https://patientace.com/Join me at my conference! http://www.saveoursites.comText Me: (949) 415-6256Listen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7aGET THE BOOK! https://www.amazon.com/Comprehensive-Guide-Clinical-Research-Practical/dp/1090349521/ref=sr_1_1?keywords=Dan+Sfera&qid=1691974540&s=audible&sr=1-1-catcorrText "guru" to 855-942-5288 to join VIP list!My blog: http://www.TheClinicalTrialsGuru.comMy CRO and Site Network: http://www.DSCScro.comMy CRA Academy: http://www.TheCRAacademy.comMy CRC Academy: http://www.TheCRCacademy.comLatinos In Clinical Research: http://www.LatinosinClinicalResearch.comThe University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/My TikTok: DanSfera
Gigi Robinson grew up with Ehlers-Danlos syndrome, a disease that turns your joints into overcooked spaghetti. Instead of letting it sideline her, she built a career out of telling the truth about invisible illness. We talk about what it takes to grow up faster than you should, why chronic illness is the worst unpaid internship, and how she turned her story into a business. You'll hear about her days schlepping to physical therapy before sunrise, documenting the sterile absurdity of waiting rooms, and finding purpose in the mess. Gigi's not interested in pity or polished narratives. She wants you to see what resilience really looks like, even when it's ugly. If you think you know what an influencer does, think again. This conversation will challenge your assumptions about work, health, and what it means to be seen.RELATED LINKSGigi Robinson Website: https://www.gigirobinson.comLinkedIn: https://www.linkedin.com/in/gigirobinsonInstagram: https://www.instagram.com/itsgigirobinsonTikTok: @itsgigirobinsonA Kids Book About Chronic Illness: https://akidsco.com/products/a-kids-book-about-chronic-illnessFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship inquiries, email podcast@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Dr. Lana Melendres-Groves dives into her research on racial and ethnic disparities in PAH treatment. From differences in medication access to the role of social determinants of health, she explores how systemic barriers impact care and what steps can be taken to ensure equity and inclusivity in PAH management. Learn more about pulmonary hypertension trials at www.phaware.global/clinicaltrials. Engage for a cure: www.phaware.global/donate #phaware Share your story: info@phaware.com Like, Subscribe and Follow us: www.phawarepodcast.com. @UNMHSC #phawareMD
Clinical trials are the future of medicine, to borrow a phrase. Every medication on the market right now was at one point in time subject to a clinical trial. Our guest for this episode, Jennifer Kesey, Ph.D., associate managing director for the Clinical Research Institute at TTUHSC, explains to us what a clinical trial is, the different types of trials and how to participate in one. For more information on how to volunteer for a clinical trial visit: https://app4.ttuhsc.edu/CRIVolunteer/
Dr. Arif Ali is a board-certified radiation oncologist at Peeples Cancer Institute at Hamilton Medical Center in Dalton, Georgia.For more information about Peeples Cancer Institute, call 844-PCI-HOPE or visit VitruvianHealth.com/cancer.This program in no way seeks to diagnose or treat illness or to replace professional medical care. Please see your healthcare provider if you have a health problem.
Originally aired in 2023, Molly Jacobson interviews Dr. Kim Agnew about the groundbreaking trials of Monepantel, a sheep dewormer repurposed as a potential treatment for canine lymphoma. Discover the science behind this innovative therapy, its potential to stabilize lymphoma, and how it compares to traditional treatments like chemotherapy and prednisone. Key Topics: What is Monepantel, and how was it discovered? The mechanism behind Monepantel's ability to target cancer cells. Early trial results: Quality of life and stability for dogs with B-cell lymphoma. How Monepantel compares to prednisone and chemotherapy. Insights into ongoing and future clinical trials. How dog lovers can participate in studies. Your Voice Matters! If you have a question for our team, or if you want to share your own hopeful dog cancer story, we want to hear from you! Go to https://www.dogcancer.com/ask to submit your question or story, or call our Listener Line at +1 808-868-3200 to leave a question. Related Videos: https://www.youtube.com/watch?v=_92w6TTXM5c https://www.youtube.com/watch?v=uAZrPM1X8ww Related Links: PharmAust Dog Lymphoma Clinical Trial: https://www.pharmaust.com/petdogtrial/ Chapters: 00:00 Introduction 00:30 Meet Dr. Kim Agnew and Monepantel Overview 01:15 The Origin of Monepantel: From Dewormer to Cancer Fighter 03:30 How Monepantel Targets Cancer Cells 07:00 Insights on Clinical Trials for Canine Lymphoma 09:30 Benefits of Monepantel: A Daily Pill for Dogs 12:00 Comparing Monepantel to Chemotherapy and Prednisone 14:45 Early Trial Results: Stabilizing Lymphoma in Dogs 18:30 Why Lymphoma Was Chosen for Trials 20:00 Potential for Treating Other Cancers in Dogs 23:15 How to Enroll Dogs in Clinical Trials 26:45 Side Effects and Safety of Monepantel 31:00 Future Trials and Research Goals 34:30 Closing Thoughts and Resources 33:55 Closing Remarks and Resources Get to know Kim Agnew, BVSc: https://www.dogcancer.com/people/kim-agnew-bvsc/ For more details, articles, podcast episodes, and quality education, go to the episode page: https://www.dogcancer.com/podcast/ Learn more about your ad choices. Visit megaphone.fm/adchoices
Send us a textDr. Michael Koren joins Kevin Geddings to introduce the concept of "scienceploitation." He explains that many marketing tactics in the health and supplement industry are disguised as scientific claims. For example, phrases like "supports immune health" often sound convincing but are meaningless without specific, evidence-based backing from rigorous clinical trials. Dr. Koren also highlights the benefits of participating in clinical trials, noting that involvement gives a behind-the-scenes look into how the healthcare industry works.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!
Send us a textThe path to FDA approved prescribable medicine has been a long and precarious one for psychedelics. However, recent reports by some of the major players in the psychedelic medicine space show promising results from clinical trials involving psilocybin and 5-MeO-DMT. In today's episode of the Psychedelic Therapy Frontiers podcast, we review the topline data from these recent reports and explore what the future of psychedelic therapies might look like for people struggling with mental health conditions. For those of you who are new to the show, welcome! Psychedelic Therapy Frontiers is brought to you by Numinus Network and is hosted by Dr. Steve Thayer and Dr. Reid Robison.Learn more about our podcast at https://numinusnetwork.com/learn/podcast/Learn more about psychedelic therapy training opportunities at https://numinusnetwork.com/training/Learn more about our clinical trials at https://www.numinusnetwork.com/researchLearn more about Numinus at https://numinusnetwork.com/Email us at ptfpodcast@numinus.com Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/numinushealth/
Send us a textWhen people talk about clinical trials, they usually think of drugs, but what about the tools that deliver, diagnose, and detect? Medical device Innovation often flies under the radar despite being essential to modern care. In this episode of the HealthBiz Podcast, Jason Monteleone, CEO of Avania, discusses how his firm helps medtech, diagnostics, and digital health companies navigate clinical trials and regulatory hurdles.
Maria Mori Brooks, PhD, University of Pittsburgh School of Public Health, discusses "Assessing Unexpected Circumstances That Lead to Modifications in Clinical Trial Design, Conduct, or Analysis" in the JAMA Guide to Statistics and Methods series, with JAMA Statistical Editor Roger J. Lewis, MD, PhD. Related Content: Assessing Unexpected Circumstances That Lead to Modifications in Clinical Trial Design, Conduct, or Analysis
Text Dr. Lenz any feedback or questions In this episode, Dr. Michael, a pediatrician and author of 'Conquering Your Fibromyalgia,' discusses the connections between ADHD, chronic fatigue syndrome, and fibromyalgia with Dr. Joel Young, a psychiatrist and head of the Rochester Center for Behavioral Medicine. The conversation delves into their shared experiences and research on treating these overlapping conditions, highlighting findings from clinical trials on LDX (Vyvanse) and Sorial (Armodafinil) as treatments for chronic fatigue syndrome. They explore the prevalence of ADHD in patients with chronic fatigue and discuss the limitations of traditional neuropsychological testing in diagnosing ADHD. Dr. Young shares insights on the effectiveness of targeted interventions and presents his clinic's innovative diagnostic tool, Mind Metrics, which aids in identifying psychiatric disorders in patients.00:00 Introduction and Background01:17 Guest Introduction: Dr. Joel Young02:02 Dr. Young's Journey and ADHD Focus04:03 Exploring ADHD and Chronic Fatigue Syndrome07:00 Clinical Trials and Findings09:47 Patient Experiences and Qualitative Insights10:11 Ongoing Research and Future Directions17:05 Challenges in Diagnosing Chronic Fatigue Syndrome24:16 Discussion on Neuropsychological Testing International Conference on ADHD in November 2025 where Dr. Lenz will be one of the speakers. Support the showWhen I started this podcast—and the book that came before it—I had my patients in mind. Office visits are short, but understanding complex, often misunderstood conditions like fibromyalgia takes time. That's why I created this space: to offer education, validation, and hope. If you've been told fibromyalgia “isn't real” or that it's “all in your head,” know this—I see you. I believe you. You're not alone. This podcast aims to affirm your experience and explain the science behind it. Whether you live with fibromyalgia, care for someone who does, or are a healthcare professional looking to better support patients, you'll find trusted, evidence-based insights here, drawn from my 28+ years as an MD. Please remember to talk with your doctor about your symptoms and care. This content doesn't replace personal medical advice.* ...
In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She also discusses the importance of patient diversity, the ethical considerations in clinical research, and the future of clinical trials, including decentralized trials and the use of advanced technologies. The conversation highlights the intricate balance between maintaining rigorous scientific standards and adapting to new methodologies to enhance patient recruitment and data integrity. Time Stamps: 00:00 Welcome and Introduction 00:28 Understanding Clinical Trial Design 00:58 Phases of Clinical Trials 02:27 Oncology Trials and Patient Pathways 05:00 Protocol Design and Regulatory Considerations 08:40 Patient Preferences and Vendor Selection 18:53 Types of Clinical Trials 23:01 Understanding BA and BE Studies 24:39 Clinical Coordination of BA/BE Studies 25:15 Infrastructure and Emergency Management in Clinical Trials 26:19 Addressing Mistrust in Clinical Trials 29:54 Ensuring Diversity in Clinical Trials 32:41 The Rise of Decentralized Clinical Trials 39:06 Challenges and Solutions in Decentralized Trials 42:49 Technology and Regulation in Clinical Trials 47:28 Final Thoughts and Contact InformationArchana Sah is a Clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals including Tecentriq® in multiple indications and combinations, Alecensa®, Polivy®, Hemlibra®, Gazyva®, Pixuvri®. She has held various global positions within Biotech, Big pharma, CRO including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two Oncology biotech start up companies. She has also worked in healthcare technology as the Senior Vice President of Digital and Decentralized Solutions at Medable Inc. She is now an independent strategy consultant and Board Advisor and provides strategic advisory services to pharma, biotechs, digital healthtech software companies, venture firms in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development and featured in PharmaFEATURES on Oncology drug development and Digital Health technology.She has routinely led several industry collaboration consortiums. She is the co-founding chair and member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She is a current Mentor for the CancerX Moonshot program dedicated to revolutionizing advancements in cancer care, clinical trials, patient support, biotech & pharma and drive integration of digital tools in oncology. She serves on the Leadership Council for Decentralized Trials and Research Alliance(DTRA) and as their Evidence/Publications Librarian. She also serves as an Advisor to American Cancer Society Cancer Action Network (ACS CAN) and is a reviewer for the international Journal of the American Cancer Society "Cancer". Invited advisor and keynote/speaker at several industry conferences.Contact: archana.sah@aspharmaadvisors.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.
Episode Description:If you've ever wondered what happens when a Bronx-born pediatric nurse with stage 4 colon cancer survives, raises a kid, becomes a policy shark, and fights like hell for the ignored, meet Vanessa Ghigliotty. She's not inspirational. She's a bulldozer. We go way back—like pre-Stupid Cancer back—when there was no “young adult cancer movement,” just a handful of pissed-off survivors building something out of nothing. This episode is personal. Vanessa and I built the plane while flying it. She fought to be heard, showed up in chemo dragging her kid to IEP meetings, and never stopped screaming for the rest of us to get what we needed. We talk war stories, progress, side-eyeing advocacy fads, TikTok activism, gatekeeping, policy wins, and why being loud is still necessary. And yeah—she's a damn good mom. Probably a better one than you. You'll laugh. You'll cry. You'll want to scream into a pillow. Come for the nostalgia. Stay for the righteous anger and iced coffee.RELATED LINKSVanessa on LinkedInColorectal Cancer Alliance: Vanessa's StoryZenOnco Interview with VanessaFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship inquiries, email podcast@matthewzachary.com.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
On this edition of the ATS Breathe Easy: The Latest, host Patti Tripathi and Foundation for Sarcoidosis Research President and CEO Mary McGowan discuss sarcoidosis research and the Champions for Change movement to encourage companies to allow employees to use paid time off to enroll in clinical trials. To learn more, go to ignorenomore.org. Did you miss the ATS 2025 International Conference? Or were you unable to attend some key sessions? Go to conference.thoracic.org/program/conference-highlights/ to purchase your ATS Conference Highlight Package. Be sure to check out the Out of the Blue podcast from the American Journal of Respiratory and Critical Care Medicine, which takes you out of the pages of the Blue Journal and into the minds of the most brilliant researchers in the fields of respiratory, critical care, and sleep medicine. Tune in wherever you listen to podcasts!
Dr. Arif Ali is a board-certified radiation oncologist at Peeples Cancer Institute at Hamilton Medical Center in Dalton, Georgia.For more information about Peeples Cancer Institute, call 844-PCI-HOPE or visit VitruvianHealth.com/cancer.This program in no way seeks to diagnose or treat illness or to replace professional medical care. Please see your healthcare provider if you have a health problem.
In this podcast, expert clinicians and a patient with IBD outline actionable strategies to enhance diversity in clinical trial recruitment and retention.
Send us a textCardiologist Michael Koren joins Kevin Geddings to discuss how kidney disease can offect other body systems, including the heart. The doctor explains that people with kidney dysfunction have significantly higher risks for cardiovascular problems including heart attacks, heart failure, and strokes. Dr. Koren differentiates between typical, insurance-driven care and the attentive clinical research experience, noting that the clnical research model may be better for many kidney disease patients.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!
Join Michael and mom Ashlee as they talk to Michael Canney, Ph.D., who is leading an exciting Phase 3 clinical trial that holds the promise of reshaping brain cancer treatment in particular in glioblastoma. This trial is testing a new surgical implant using ultrasound to enhance chemotherapy effectiveness against brain tumors, in particular because of the blood/brain barrier. Mike is at the forefront of efforts at 40 clinical sites worldwide, 20 in the US, working to push the boundaries in brain cancer treatments. The conversation takes a personal turn, as always with Michael and mom :)find out more about this phase 3 clinical trial for Glioblastoma:https://sonobird.eu/More info about Carthera:https://carthera.eu/More about Michael Canney on Linked In:https://www.linkedin.com/in/michael-canney-ph-d-42457b5/
Marianna Fontana, MD, PhD / Julian Gillmore, MD, PhD, FRCP, FRCPath - Identifying Outcomes That Matter in ATTR-CM: Critical Considerations in the Interpretation of Contemporary Clinical Trials
Send us a textProphylactic hydrocortisone and the risk of sepsis in neonates born extremely preterm.Baud O, Lehert P; PREMILOC study group.Eur J Pediatr. 2025 Jun 14;184(7):419. doi: 10.1007/s00431-025-06248-9.PMID: 40515786 Clinical Trial.As always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!
Send us a textFrom Warm to Cold: Feeding Cold Milk to Preterm Infants with Uncoordinated Oral Feeding Patterns.Ferrara-Gonzalez L, Kamity R, Htun Z, Dumpa V, Islam S, Hanna N.Nutrients. 2025 Apr 26;17(9):1457. doi: 10.3390/nu17091457.PMID: 40362766 Free PMC article. Clinical Trial.As always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!
Send us a textNorepinephrine versus Dopamine for Septic Shock in Neonates: A Randomized Controlled Trial.Mazhari MYA, Priyadarshi M, Singh P, Chaurasia S, Basu S.J Pediatr. 2025 Jul;282:114599. doi: 10.1016/j.jpeds.2025.114599. Epub 2025 Apr 17.PMID: 40252959 Clinical Trial.As always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!
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Attention: The first clinical trial testing creatine for Alzheimer's just dropped, and the results are absolutely mind-blowing. In this episode, I've sat down with Max Lugavere at The White House to discuss the new research on creatine. This pilot study gave 20 Alzheimer's patients 20 grams of creatine daily for 8 weeks. The results? Statistically significant improvements across nearly every cognitive measurement. Join the Ultimate Human VIP community and gain exclusive access to Gary Brecka's proven wellness protocols today!: https://bit.ly/4ai0Xwg Get Max Lugavere book, “Genius Foods”: https://theultimatehuman.com/book-recs Want to dive deeper into brain health? Watch Max's documentary "Little Empty Boxes" here: https://bit.ly/47Qf8Y9 Listen to Max Lugavere's "The Genius Life" podcast weekly on all your favorite platforms: https://bit.ly/47MyoWK Connect with Max Lugavere: Website: https://bit.ly/3XLOGdN YouTube: https://bit.ly/4eJc6r7 Instagram: https://bit.ly/3BsEf7y Facebook: https://bit.ly/3Y4QkZr TikTok: https://bit.ly/3Y8ov2w X.com: https://bit.ly/3ZMQgPk LinkedIn: https://bit.ly/4eGVrEw Thank you to our partners: H2TABS - USE CODE “ULTIMATE10” FOR 10% OFF: https://bit.ly/4hMNdgg BODYHEALTH - USE CODE “ULTIMATE20” FOR 20% OFF: http://bit.ly/4e5IjsV BAJA GOLD - USE CODE "ULTIMATE10" FOR 10% OFF: https://bit.ly/3WSBqUa EIGHT SLEEP - SAVE $350 ON THE POD 4 ULTRA WITH CODE “GARY”: https://bit.ly/3WkLd6E COLD LIFE - THE ULTIMATE HUMAN PLUNGE: https://bit.ly/4eULUKp WHOOP - GET 1 FREE MONTH WHEN YOU JOIN!: https://bit.ly/3VQ0nzW MASA CHIPS - GET 20% OFF YOUR FIRST ORDER: https://bit.ly/40LVY4y VANDY - USE CODE “ULTIMATE20” FOR 20% OFF: https://bit.ly/49Qr7WE AION - USE CODE “ULTIMATE10” FOR 10% OFF: https://bit.ly/4h6KHAD HAPBEE - FEEL BETTER & PERFORM AT YOUR BEST: https://bit.ly/4a6glfo CARAWAY - USE CODE “ULTIMATE” FOR 10% OFF: https://bit.ly/3Q1VmkC HEALF - GET 10% OFF YOUR ORDER: https://bit.ly/41HJg6S BIOPTIMIZERS - USE CODE “ULTIMATE” FOR 10% OFF: https://bit.ly/4inFfd7 RHO NUTRITION - USE CODE “ULTIMATE15” FOR 15% OFF: https://bit.ly/44fFza0 GENETIC TEST: https://bit.ly/3Yg1Uk9 Watch the “Ultimate Human Podcast” every Tuesday & Thursday at 9AM EST: YouTube: https://bit.ly/3RPQYX8 Podcasts: https://bit.ly/3RQftU0 Connect with Gary Brecka: Instagram: https://bit.ly/3RPpnFs TikTok: https://bit.ly/4coJ8fo X.com: https://bit.ly/3Opc8tf Facebook: https://bit.ly/464VA1H LinkedIn: https://bit.ly/4hH7Ri2 Website: https://bit.ly/4eLDbdU Merch: https://bit.ly/4aBpOM1 Newsletter: https://bit.ly/47ejrws Ask Gary: https://bit.ly/3PEAJuG Timestamps: 00:00 Intro 01:30 Getting Back to the Basics 02:17 Clinical Trial on Creatine 05:57 Impact of Creatine on Health 11:26 Spreading Awareness on Positive Healthcare Choices The Ultimate Human with Gary Brecka Podcast is for general informational purposes only and does not constitute the practice of medicine, nursing or other professional health care services, including the giving of medical advice, and no doctor/patient relationship is formed. The use of information on this podcast or materials linked from this podcast is at the user's own risk. The Content of this podcast is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard or delay in obtaining medical advice for any medical condition they may have and should seek the assistance of their health care professionals for any such conditions. Learn more about your ad choices. Visit megaphone.fm/adchoices
UCSF's Dr. Rahul Aggarwal explains the role of clinical trials in advancing prostate cancer treatment and how trial design is evolving to match today's more personalized approaches. He highlights how UCSF has contributed to major prostate cancer therapies and emphasizes the importance of genetic and genomic testing in identifying suitable trials for each patient. Dr. Aggarwal explains the different trial phases, clarifies common myths—such as concerns about placebos—and stresses that trials are considered at every stage of disease. He also discusses efforts to improve access, affordability, and diversity in trial participation, including regional partnerships and digital matching tools. The talk encourages patients to be informed and proactive when considering clinical trials as part of their treatment plan. Series: "Prostate Cancer Patient Conference" [Health and Medicine] [Show ID: 40800]
Host Melissa Berry sits down with LaToya Bolds-Johnson — Physician Associate, triple negative breast cancer survivor, and passionate clinical trials advocate. With her experience as both a healthcare provider and a patient, Latoya offers a meaningful and insightful perspective on clinical trials and how they can transform cancer treatment. In this episode, LaToya shares her personal journey navigating breast cancer treatment and the challenges of finding the right clinical trial. They discuss the critical need for greater diversity in clinical trial participation, and how her involvement created a “medical trust fund” for her daughters' futures. LaToya also discusses how we can shift the mindset around clinical trials from being seen as a last resort to a standard of care, helping patients advocate for themselves and make informed choices. If you're newly diagnosed, considering treatment options, or want to learn how clinical trials can offer hope and opportunity, this episode is a must-listen!
Send us a textDr. Mitchell Rothstein joins Dr. Michael Koren to wake us up to the dangers of insomnia. Insomnia is a common sleep disorder affecting approximately 30% of adults and is characterized by poor sleep on at least three nights a week for three months or more. Dr. Rothstein reviews what insomnia is, what is happening in the brain, and what sufferers can do about it. He explains how lifestyle changes can make a big difference, especially in our digital world. Dr. Rothstein then reviews the effectiveness of cognitive behavior therapy, common over-the-counter treatments, prescription medicines, and when it's time to see a sleep specialist.Be a part of advancing science by participating in clinical research.Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.comListen on SpotifyListen on Apple PodcastsWatch on YouTubeShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramX (Formerly Twitter)LinkedInWant to learn more? Checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.comMusic: Storyblocks - Corporate InspiredThank you for listening!
Risa Arin doesn't just talk about health literacy. She built the damn platform. As founder and CEO of XpertPatient.com (yes, expert with no E), Risa's taking a wrecking ball to how cancer education is delivered. A Cornell alum, cancer caregiver, and ex-agency insider who once sold Doritos to teens, she now applies that same marketing muscle to helping patients actually understand the garbage fire that is our healthcare system. We talk about why she left the “complacent social safety” of agency life, how her mom unknowingly used her own site during treatment, what it's like to pitch cancer education after someone pitches warm cookies, and why healthcare should come with a map, a translator, and a refund policy. Risa brings data, chutzpah, and Murphy Brown energy to the conversation—and you'll leave smarter, angrier, and maybe even a little more hopeful.RELATED LINKS• XpertPatient.com• Risa Arin on LinkedIn• XpertPatient & Antidote Partnership• XpertPatient Featured on KTLA• 2024 Health Award BioFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship inquiries, email podcast@matthewzachary.com.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
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