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At 20 years old, newly arrived from Puerto Rico and trying to build a future in science, Benjamin Suarez Jimenez found himself sitting in front of two senior faculty members accused of plagiarism. He knew the material. He had done the work. His mistake came from failing to cite class notes during an exam because nobody had told him that was expected. In a matter of minutes, he watched what felt like his entire career flash before him.On this episode of Standard Deviation, host Oliver Bogler examines the hidden architecture of academic science through the experiences of Dr. Benjamin Suarez Jimenez, Assistant Professor at the University of Rochester and a neuroscientist studying PTSD, anxiety, trauma, and spatial cognition through virtual reality and video game environments.Benjamin traces his path from Puerto Rico to the mainland United States, through the NIH, Columbia University, and eventually to leading his own laboratory. Along the way, he encountered a series of barriers that had little to do with scientific ability and everything to do with access to unwritten rules. From academic gatekeeping to grant writing expectations, he learned that success in biomedical research often depends on knowledge that never appears in a textbook.Oliver explores how those invisible obstacles shape careers, influence research funding, and determine who gains access to opportunity. The conversation also examines the Justice, Equity, Diversity, and Inclusion Program at the Life Science Editors Foundation, which pairs scientists from underrepresented backgrounds with experienced scientific editors. Through that mentorship, Benjamin transformed a critical grant proposal into a successful pilot award that helped launch an NIH R01 application.The discussion extends beyond one scientist's experience. Benjamin describes helping a former mentee navigate dissertation roadblocks that threatened her graduation, illustrating how institutional bureaucracy can delay careers and discourage talented researchers. Together, they explore the hidden administrative burden, cultural barriers, and bias that many scientists carry alongside their research, and what happens when someone who receives support turns around and opens the door for others.RELATED LINKSLife Science Editors FoundationBenjamin Suarez Jimenez LabDr. Benjamin Suarez JimenezBenjamin Suarez JimenezFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
STRONGER BONES LIFESTYLE: REVERSING THE COURSE OF OSTEOPOROSIS NATURALLY
In this eye-opening conversation, Debi Robinson and Dr. John Neustadt expose a fundamental flaw in how we approach bone health: we've been focusing on bone density instead of actual fracture risk.Drawing from 20+ years of research and clinical practice, Dr. Neustadt reveals that only four nutrients have been proven in clinical trials to reduce fractures—calcium, vitamin D, vitamin K2 (MK-4 specifically), and magnesium. He challenges the one-size-fits-all approach to supplementation and explains why popular supplements like MK-7 and strontium fall short of their marketing claims.The episode deep-dives into why bone density tests are poor predictors of fracture risk, how supplement companies mislead consumers with marketing claims that don't align with clinical data, and the critical role of gut health, sleep, hormones, and lifestyle in fracture prevention.Most importantly, Debi and Dr. Neustadt provide actionable, evidence-based strategies that women can implement immediately to actually protect their bones—without fear-based messaging.WHAT YOU'LL LEARN✓ Why bone density scores are not reliable predictors of fracture risk✓ The 4 nutrients with clinical trial evidence for fracture reduction (and the doses that actually work)✓ Why MK-7 vitamin K2 doesn't improve bone strength (and why MK-4 does)✓ How to assess YOUR individual calcium needs (most women are over-supplementing)✓ The vitamin D target range for optimal fracture protection✓ Why strontium supplements mislead consumers (and the hidden risks)✓ The role of melatonin receptors in bone health and sleep deprivation's link to fractures✓ How gut health directly impacts bone strength✓ The importance of serotonin, melatonin, and the gut-bone axis✓ HRT and testosterone replacement as part of a comprehensive bone health strategy✓ How to evaluate supplement companies and ensure they have fracture outcome data✓ Red flags when choosing bone health supplements✓ The gap between conventional medicine's approach (DEXA + medication) and integrative bone health✓ Why doctors are confused about osteoporosis (and how to advocate for yourself)ACTION STEPSGet your vitamin D tested. Aim for 30–44 ng/mL for optimal fracture protection (different from immune health recommendations).Assess your dietary calcium intake before adding supplements. If you're eating well, you may only need 400 mg as a supplement, not the standard 1,200 mg recommendation.Switch MK-7 supplements to MK-4. If you're taking a vitamin K2 supplement, verify it's MK-4 at 45 mg per day in divided doses. MK-7 doesn't reduce fractures.Check your supplement labels for strontium. If it's there, especially if the company markets it as "proven to improve bone density," consider switching to a formula without it.Prioritize gut health. Work with a practitioner to run stool tests if you have bloating, constipation, postnasal drip, or other GI symptoms. Gut inflammation accelerates bone loss.Track your sleep quality. Sleep deprivation is linked to 17% of fractures. If you're sleeping less than 6 hours nightly, prioritize this.Ask supplement companies the right questions:"Do you have fracture outcome data from clinical trials?""Will you provide a certificate of analysis showing purity and potency?""What guarantee do you offer?"Evaluate your medications. Check with your doctor: Are any of your current prescriptions contributing to bone loss? (SSRIs, certain blood pressure meds, proton pump inhibitors, corticosteroids, etc.)Consider HRT or bioidentical hormone replacement, especially if you're post-menopausal. Research shows a 40% reduction in osteoporotic fracture risk with appropriate hormone therapy.Build lifestyle foundations: Prioritize whole-food nutrition, strength training, stress management, and community connection. Oxytocin (released through physical contact) supports bone health.RESOURCES & LINKSDr. John Neustadt's Website: nbihealth.com and book Fracture-Proof Your Bones: A Comprehensive Guide to OsteoporosisDebi's website: https://debirobinson.comHealthy Gut Healty Bones Program: https://debirobinson.com/healthy-gut-healthy-bones-program-v2/Join the Community: https://debirobinson.com/the-stronger-bones-lifestyle-community/Yoga Therapy MasterClass: https://debirobinson.com/yoga-therapy-for-bones-health-mc/28-Day Stronger Bones Method: https://debirobinson.com/28-day-stronger-bonesmorning-method/Instagram: https://www.instagram.com/debirobinsonwellness/Youtube Channel: https://www.youtube.com/@debirobinsonwellness/DEBI'S TAKEAWAY"Fracture-proofing your bones isn't about chasing a higher DEXA score. It's about building the internal biochemical balance that actually prevents fractures. You have the research, you have the tools, and you have the power to take control of your bone health naturally. Use that power."
In this episode of SurgOnc Today, Dr. Christina Angeles, surgical oncologist and Chair of the SSO Research Committee, sits down with two experienced surgical investigators, Dr. Andrew Lowy and Dr. Craig Slingluff, to discuss one of the most challenging steps in advancing surgical research: securing funding for pilot clinical trials. Drawing from their real-world experience designing and running surgical trials, our guests share practical strategies for identifying funding sources, building a competitive application, and navigating setbacks along the way. Whether you are a junior faculty member with your first research idea or a mid-career surgeon looking to expand your trials program, this episode delivers actionable advice to help you turn your clinical observations into funded research.
What does it really take to thrive as a first-time fund manager in today's challenging investment landscape, especially when you're building a venture fund from scratch while championing diversity and innovation? This episode delves into the real experiences behind the headlines, inviting listeners to consider the often unseen hurdles and triumphs that define entrepreneurial journeys. Our guest, Laurel Mintz, is the founder of Fabric VC—a new venture capital fund spun out of her extensive 17-year run as the leader of a successful marketing agency. With a background that includes corporate M&A law, entrepreneurship, and marketing, Laurel Mintz brings a unique and practical perspective to the venture capital world. Her approach blends deep sector knowledge with a commitment to supporting underrepresented founders and championing women's health, fintech, and consumer tech sectors. In this update, listeners get an inside look at the nuts and bolts of raising and deploying Fabric VC's first fund—just under $8 million, already largely deployed across 23 portfolio companies. Laurel Mintz shares candid insights on the emotional rollercoaster of fundraising, the critical importance of diversity, and the creative approaches to supporting women-led companies, such as accepting investments via donor-advised funds and retirement accounts. This episode is a must-listen for aspiring investors, founders, or anyone interested in how real change is being made within venture capital. It's raw, motivating, and packed with unfiltered advice on how to show up, take risks, and put capital to work for the next generation. To get the latest from Laurel Mintz, you can follow her below! LinkedIn - https://www.linkedin.com/in/laurel-mintz/ https://www.fabricvc.com/ Laurel's first appearance on The Angel Next Door Sign up for Marcia's newsletter to receive tips and the latest on Angel Investing! Website: www.marciadawood.com Learn more about the documentary Show Her the Money: www.showherthemoneymovie.com And don't forget to follow us wherever you are! Apple Podcasts: https://pod.link/1586445642.apple Spotify: https://pod.link/1586445642.spotify LinkedIn: https://www.linkedin.com/company/angel-next-door-podcast/ Instagram: https://www.instagram.com/theangelnextdoorpodcast/ TikTok: https://www.tiktok.com/@marciadawood
Two recent studies have shown remarkable advances in HIV cure research: (1) a Norwegian man who achieved long-term HIV remission after a stem cell transplant from his brother and (2) a Phase 1 trial testing CAR-T cell therapy. On this episode, Antonio Urbina, MD, Medical Director for CEI's HIV Primary Care and Prevention Center of Excellence, dives into these studies and puts them into clinical context, including how to discuss cure research with patients. Related Content: CEI Line: 1-866-637-2342 https://ceitraining.org/ Clinicaltrials.gov
Why do two people with Parkinson's experience the disease so differently?In this episode, we sit down with researchers Patrik Verstreken and Natalie Kaempf to explore groundbreaking work that may help answer that question. Using advanced biology, biomarkers, and artificial intelligence, their team has identified what could be five distinct biological subtypes of Parkinson's disease.We discuss what these findings mean for people living with Parkinson's today, how genetics and environmental factors may influence disease progression, and why understanding the biology behind Parkinson's could lead to more personalized treatments, better clinical trials, and earlier diagnosis in the future.Chapters00:00 Introduction to Parkinson's Disease Research02:54 Understanding the Variability of Parkinson's Disease06:07 Symptomatic Treatments vs. Underlying Causes08:57 Subtypes of Parkinson's Disease11:51 The Role of Biomarkers in Early Diagnosis14:46 AI's Impact on Parkinson's Research18:10 Clinical Trials and Treatment Stratification20:59 Future Directions in Parkinson's Disease Treatment23:55 The Importance of Community and Hope
Dr. Sarah Matt trained as a burn surgeon, working in a field where patients arrive with catastrophic injuries and survival depends on speed, skill, and resources. She left the bedside after confronting a limit that medicine does not like to admit. One physician can only see so many people in a day. The system surrounding those patients decides the rest. She moved into health technology, held leadership roles in startups, and built global infrastructure at Oracle to scale care across populations. Then she watched billions of dollars in digital health and AI initiatives stall out when they hit real clinical environments.This episode follows that pivot from surgeon to strategist and back into direct patient care in rural New York, where she now treats uninsured patients, migrant workers, and communities pushed to the margins. The conversation centers on a persistent failure across healthcare systems. Products get built for regulators, executives, and investors instead of the people who use them. The result shows up in failed adoption, broken workflows, prior authorization delays, and rising physician burnout.The discussion cuts through health policy language and lands on lived consequence. The system rewards speed over usability, scale over trust, and compliance over care. Patients absorb the fallout. Physicians carry the liability. The incentives remain intact.RELATED LINKSDr. Sarah MattThe Borderless Healthcare RevolutionThe Clinical RealistJessica FedererSovatoFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Clinical Trial Shows Effectiveness of Silver Diamine Fluoride for School-based CariesBy Today's RDH ResearchOriginal article published on Today's RDH: https://www.todaysrdh.com/clinical-trial-shows-effectiveness-of-silver-diamine-fluoride-for-school-based-caries/Need CE? Start earning CE credits today at https://rdh.tv/ce Get daily dental hygiene articles at https://www.todaysrdh.com Follow Today's RDH on Facebook: https://www.facebook.com/TodaysRDH/Follow Kara RDH on Facebook: https://www.facebook.com/DentalHygieneKaraRDH/Follow Kara RDH on Instagram: https://www.instagram.com/kara_rdh/
If you experience severe, sharp burning at the vaginal opening, you know how frustrating the journey to a clear diagnosis can be. In this episode, world-renowned pelvic pain expert Dr. Jill Krapf joins Dr. Rachel Pope to share a massive milestone in neuroinflammatory vulvar pain research: a gold-standard, 3-month clinical trial testing a brand-new topical Ketotifen cream.Ketotifen is a mast cell stabilizer historically used for allergies, but it has never before been formulated into a topical cream for pelvic pain. This breakthrough treatment directly targets the "neuroinflammatory zone," calming hyper-reactive mast cells and hypersensitive nerve endings.Key Takeaways: The Clinical Protocol: To track improvement, the trial uses two precise baseline tests: a specialized Q-Tip pressure monitor at the vestibule (requiring a 5/10 pain score to qualify) and a gentle dilator insertion test. Patient comfort is the absolute priority; tests stop immediately if pain thresholds are hit. A Pure Passion Project: Funding for localized vulvar pain is notoriously low. Backed by a small grant from the National Vulvodynia Association (NVA), this trial is a true labor of love by Dr. Krapf, Dr. Andrew Goldstein, and Dr. Chailee Moss to provide a non-surgical alternative for patients. How to Get Screened: Active trials are currently recruiting. Reach out directly to the site closest to you:The Centers for Vulvovaginal Disorders Research Details & Locations: Duration: Approximately 3 months (only 4 short in-person study visits). Locations: Tampa (FL), Washington D.C., and New York City.Tampa, (FL): donyaresearch1@gmail.com Lichen Scelorus research: researchjkmd@gmail.comVulvodynia Research: Washington, DC- research.cvvd@gmail.com New York City, NY- research.cvvd@gmail.comExclusion Criteria: Individuals with active pudendal neuralgia or a diagnosed vulvar dermatosis (such as Lichen Sclerosus or Lichen Planus) are unfortunately excluded.How to Get Screened: If you are interested in participating or traveling to one of the three sites, check the screening contacts listed. Even if you can't participate, sharing this study on social platforms helps show investors and pharmaceutical companies that women's health research is highly valued and desperately needs funding!
External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations. In this episode, I speak with Ben Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges. If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.
Send us Fan MailS4E4 The Oncology Journal Club Podcast In this special ASCO 2026 edition of The Oncology Journal Club, Craig Underhill, Chris Jackson and Kate Clarke unpack some of the meeting's most talked-about studies and discuss what they could mean for clinical practice.From the PROTEUS trial in high-risk prostate cancer and promising advances in RET fusion-positive lung cancer, to a rare sarcoma study demonstrating the potential of CDK4 inhibition, the team explores the data behind the headlines and highlights the challenges of translating trial results into real-world care.The episode also dives into what many are calling the breakthrough study of the meeting – the RESOLUTE-302 trial of daraxonrasib in previously treated pancreatic cancer. With a striking overall survival benefit in a disease that has seen few meaningful advances, the results sparked excitement throughout the oncology community.Along the way, the panel reflects on the atmosphere at ASCO, emerging trends in precision oncology, and how new therapeutic approaches such as KRAS inhibitors, bispecific antibodies and antibody-drug conjugates are reshaping the future of cancer treatment.The Oncology Journal Club Podcast is hosted by Professor Craig Underhill, Dr Kate Clarke and Professor Chris Jackson, and proudly produced by The Oncology NetworkVisit oncologynetwork.com.au for Show Notes, to send us Voice Notes and more information. And to download your bingo card if you'd like to play along with the team!
Developing a cancer drug is one of the most expensive, slow, and failure-prone processes in modern science. PharosAI is trying to change that – by building multimodal, AI-ready datasets from donated cancer tissue samples and making them available to researchers, biotech companies, and clinicians.In this episode, Technical Director Adrian La Porta speaks with PharosAI's Dr Lucie Burgess (COO) and Dr Emma Colliver (Research Fellow) about what it takes to curate cancer data at scale, why federated learning matters for patient privacy, where AI is already transforming diagnostics, and what synthetic patients could mean for clinical trials.Whether you work in life sciences, pharma manufacturing, digital health, or clinical data governance, understanding how AI is reshaping the drug discovery pipeline has direct implications for how and when new facilities will need to be built. This one is worth your time.Topics covered:00:00 Introduction00:01 What is PharosAI?00:06 Why AI can fundamentally change cancer care00:08 The venture behind the mission00:12 Lowering the barrier for UK biotech00:16 Are we at an inflection point?00:20 AI in diagnostics – what's already working00:24 Misconceptions about AI in biotech00:30 Data – acquiring, cleaning, and structuring00:34 Patient privacy, consent, and NHS data00:37 What cancer care could look like in 10 years00:40 Why this work matters personallySend us Fan MailTo learn more about Bryden Wood's Design to Value philosophy, visit www.brydenwood.com. You can also follow Bryden Wood on LinkedIn.
A headline like “weight loss drugs may reduce breast cancer risk” grabs attention fast, but the real story lives in the fine print. We take you through a new Penn Medicine study that observed lower breast cancer rates among women with overweight or obesity who used GLP-1 medications, then we translate what that finding actually means in plain language. Observational data can reveal a signal worth studying, but it cannot prove the medication caused the outcome, and that distinction matters for your decisions and your expectations. We also zoom out to the bigger why: obesity is not just about body size. Fat tissue is biologically active, shaping chronic inflammation, estrogen exposure after menopause, insulin resistance, and even how well the immune system spots abnormal cells. Those pathways help explain why obesity is linked to many cancers, including postmenopausal breast cancer, and why researchers are curious whether effective obesity treatment could shift risk over time. Then we get practical. We review what stronger evidence from randomized controlled trials says so far: GLP-1 drugs like Ozempic, Wegovy, Mounjaro, and Zepbound do not appear to increase breast cancer risk in the available trial data, even though most trials were not designed to study cancer outcomes for many years. We also discuss why newer studies seem most suggestive for hormone receptor positive breast cancer, along with the leading theories: weight loss itself, improved metabolic health and insulin signaling, reduced inflammation, and the still-unclear possibility of direct GLP-1 effects in cancer biology. If you like evidence-based medicine with real-world context (and a little Philly-life banter), subscribe, share this episode with a friend, and leave a review so more people can find the show. What question do you want answered next about GLP-1s, obesity treatment, or cancer risk?ReferencesRisk for Cancer With Glucagon-Like Peptide-1 Receptor Agonists and Dual Agonists : A Systematic Review and Meta-Analysis. Ko A, Chang YC, Bahar F, et al. Annals of Internal Medicine. 2025;. doi:10.7326/ANNALS-25-02237.Do GLP-1 Receptor Agonists Increase the Risk of Breast Cancer? A Systematic Review and Meta-Analysis. Piccoli GF, Mesquita LA, Stein C, et al. The Journal of Clinical Endocrinology and Metabolism. 2021;106(3):912-921. doi:10.1210/clinem/dgaa891.Glucagon-Like Peptide 1 Receptor Agonists and Cancer Risk: The Good, the Bad and the Unknown. Mannucci E, Dicembrini I. Nature Reviews. Clinical Oncology. 2026;23(6):459-470. doi:10.1038/s41571-026-01135-0.GLP-1 Agonists Are Associated With a Significant Reduction in Breast Cancer Incidence in Women. McDonald ES, Gillis LB, Gabriel P, et al. JCO Oncology Practice. 2026;:101200OP2600485. doi:10.1200/OP-26-00485.GLP-1 therapy and hormone receptor–positive breast cancer risk and survival: A real-world analysis.. Shah Z, Hundal J, Afridi S, et al. Journal of Clinical Oncology. 2026;44(Suppl 16):10548. doi:10.1200/JCO.2026.44.16_suppl.10548.Survival and Recurrence With GLP-1 Receptor Agonists in Breast Cancer. Tatum KL, Dahman B, Stevenson A, et al. JAMA Network Open. 2026;9(5):e2612133. doi:10.1001/jamanetworkopen.2026.12133.Association of Glucagon-Like Peptide-1 Receptor Agonists With Risk of Cancers-Evidence From a Drug Target Mendelian Randomization and Clinical Trials. Sun Y, Liu Y, Dian Y, et al. International Journal of Surgery (London, England). 2024;110(8):4688-4694. doi:10.1097/JS9.0000000000001514.GLP-1 receptor agonists and breast cancer risk in type 2 diabetes.. Guo Cheng and Amanda Ward. Journal of Clinical Oncology. 2025;43(Suppl 16):10557. doi:10.1200/JCO.2025.43.16_suppl.10557.Glucagon-Like Peptide-1 Analogues and Risk of Breast Cancer in Women With Type 2 Diabetes: Population Based Cohort Study Using the UK Clinical Practice Research Datalink. Hicks BM, Yin H, Yu OH, et al. BMJ (Clinical Research Ed.). 2016;355:i5340. doi:10.1136/bmj.i5340.GLP-1 Receptor Agonists and Cancer: Current Clinical Evidence and Translational Opportunities for Preclinical Research. Valencia-Rincón E, Rai R, Chandra V, Wellberg EA. The Journal of Clinical Investigation. 2025;135(21):e194743. doi:10.1172/JCI194743.Send us a (voice ) message with this link, we would love to hear from you. Standard message rates may apply.Support the showProduction and Content: Edward Delesky, MD, DABOM & Nicole Aruffo, RNArtwork Rebrand and Avatars:Vantage Design Works (Vanessa Jones) Website: https://www.vantagedesignworks.com/Instagram: https://www.instagram.com/vantagedesignworks?igsh=aHRuOW93dmxuOG9m&utm_source=qrOriginal Artwork Concept: Olivia Pawlowski
What does it take to run successful clinical trials across borders? Tune in as Chris Boone (Group VP, Research, Health & Life Sciences at Oracle) and Alicia Baker McDowell (VP & Head of Global Regulatory Strategy at Fortrea) explore the shift from transactional outsourcing to truly co-created partnerships.They discuss how sponsors, CROs, and tech partners are redefining collaboration, tackling data fragmentation, and striking the right balance between global consistency and local execution to deliver more effective clinical trials worldwide.
What happens when a research site gets so frustrated with disconnected systems that they decide to build their own? In this episode, Jimmy Bechtel sits down with Brian Hunter, COO, and Florin Petrutiu, CIO of Site Centric, to hear exactly that story. Born out of CNS Healthcare over 18 years ago, Site Centric has evolved from an internal workaround into a full CTMS platform now available to sites everywhere. Brian and Florin share how their hands-on site experience shaped every corner of the platform, how they're integrating AI tools without adding operational burden, and why becoming an SCRS Global Impact Partner felt like a natural next step.
Drs. Saver and Sanossian discuss ISC 2026 data highlighting neurologists' frequent inaction on markedly uncontrolled hypertension in high‑risk stroke patients and the need for specialists to “own” blood pressure management at every visit. They also review refinements in patent foramen ovale (PFO) risk stratification, including Pascal algorithm-defined “possible” PFO cases, and explore how a “clinical trial effect” may lower stroke risk through greater patient engagement.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the evolving landscape of the pharmaceutical and biotechnology industries, where scientific advancements, regulatory updates, and strategic business decisions are reshaping the future. A significant development in this dynamic arena is the strategic withdrawal by Eli Lilly and Boehringer Ingelheim from planned investments in Germany. Both companies have decided to cut at least $1 billion each from their investments, a direct response to Germany's healthcare reforms targeting reduced branded drug prices. This decision highlights how governmental policy can significantly influence pharmaceutical investment strategies, prompting companies to be more cautious in markets with strict pricing controls. Another critical area of focus is clinical trials, where ADC Therapeutics has encountered a significant challenge. The company's antibody-drug conjugate, Zynlonta, which was granted accelerated FDA approval in 2021, recently reported three times as many deaths in its study arm compared to the control group. This raises important questions about the safety profile of antibody-drug conjugates, a class of drugs celebrated for their potential in targeted cancer therapy. The situation underscores the ongoing struggle to balance efficacy with safety in innovative cancer treatments. Regulatory oversight remains a pivotal aspect of the industry. The FDA recently issued a warning letter to Medline over recurring issues with toxic bacteria in finished products, emphasizing the critical need for compliance and safety within the medical device sector. Additionally, an untitled letter was sent to QOL Medical for potentially misleading promotional communications regarding Sucraid. Such actions demonstrate the FDA's vigilance in monitoring marketing practices that could mislead healthcare providers or patients. In drug approval news, AbbVie's Qulipta and Amgen's Imdelltra have secured approvals in Europe. These milestones are part of a broader strategy by pharmaceutical companies to expand geographically and enhance product portfolios through new indications. Meanwhile, Axsome Therapeutics successfully defended its narcolepsy medication Sunosi against generic competition until 2040 by settling patent litigation with a prospective generic manufacturer. This move reflects the intense patent battles common in the industry to extend product lifecycles and maintain market exclusivity. Turning to geopolitical influences, there is heightened scrutiny on China's biotech sector following calls from U.S. lawmakers for increased oversight. The potential application of the Comprehensive Outbound Investment National Security Act to Chinese biotech investments signals escalating tensions and could significantly impact international collaborations and investments. This reflects growing concerns over intellectual property protection and biotechnological advancements within international trade dynamics. In financial developments, Parabilis Medicines is preparing for an IPO with aims to raise $476 million to fund Phase 3 trials of its desmoid tumor drug candidate. This move illustrates continued investor interest in oncology innovations despite broader economic uncertainties. On the scientific front, Autobahn Therapeutics is making strides with its thyroid hormone receptor stimulator, showing efficacy in reducing depression symptoms in bipolar disorder during Phase 2 trials. This success paves the way for pivotal trials and highlights how hormone mimics can offer new therapeutic avenues for neuropsychiatric disorders. Meanwhile, Alnylam Pharmaceuticals has entered into a groundbreaking $2 billion agreement with Inceptive Nucleics to incorporate artificial intelligence into small interfering RNA design. By leveraging AI-driven methodologies, Alnylam aims to enhance precision and efficacy in siRNA therapies, potentially speeding up drug discovery processes. Operational challenges are also evident as companies navigate complex markets like Japan, underscoring the importance of integrating regulatory and strategic planning early on to mitigate risks and ensure market feasibility. These developments paint a vivid picture of a vibrant pharmaceutical and biotech landscape where scientific innovation is rapidly advancing alongside strategic partnerships and regulatory oversight. Breakthrough technologies such as AI-driven drug design hold promise for more targeted therapies while emphasizing personalized medicine approaches. However, these advancements come with challenges like safety concerns and regulatory compliance that demand constant vigilance and adaptability from industry stakeholders. The implications for patient care are significant as these scientific breakthroughs promise new treatment avenues for complex diseases while highlighting personalized medicine approaches. As these industries continue to evolve, staying informed about scientific innovations and regulatory landscapes will be crucial for stakeholders aiming to drive future growth and improve global health outcomes. Thank you for tuning into Pharma Daily. Stay informed and stay ahead with us as we continue to bring you the latest insights from around the pharmaceutical and biotech world.Support the show
Kert Viele, PhD, director and senior statistical scientist at Berry Consultants, discusses "Interpretation of Clinical Trials That Stopped Early" with JAMA Statistical Editor Roger J. Lewis, MD, PhD. Related Content: Interpretation of Clinical Trials That Stopped Early
Can turmeric really sharpen memory within hours?
In the late 1980s, a child exposed to fallout from the Chernobyl disaster lay in a hospital bed while doctors told his family there were no clear answers and no reliable path forward. Decades later, that same child, Yan Leyfman, walks into exam rooms as a hematology oncology fellow, expected to deliver clarity inside a system that still runs on delay, uncertainty, and institutional self preservation.This episode traces the throughline from early life shaped by radiation exposure and hospice level uncertainty to a career inside academic medicine, translational research, and oncology media. Yan built his identity around survival and usefulness, moving from patient to physician while carrying the memory of what it feels like to sit on the other side of the table. He helped launch MedNews Week during the COVID crisis to push back on misinformation and expand access to medical knowledge, stepping into a public role while still in training.The conversation stays grounded in the friction between personal narrative and system reality. Clinical training demands efficiency, hierarchy, and emotional distance. Cancer care demands time, clarity, and human connection. Those forces collide in real patient encounters where prior authorization delays, insurance barriers, and fragmented care pathways shape outcomes as much as any treatment protocol.Yan speaks openly about mentorship, belonging, and the drive to make meaning out of survival. The discussion pushes further into what the healthcare system actually rewards, what it quietly strips away, and how quickly empathy can erode under institutional pressure. The episode also examines the role of medical media, where education, industry influence, and narrative control often blur together.This is a conversation about identity under construction, about what happens when someone who remembers powerlessness steps into a role that carries authority, and about whether that memory can survive long enough to change anything.RELATED LINKSYan Leyfman on LinkedInYan Leyfman on InstagramSurviving ChernobylFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Contrary to historical processes, clinical trials do not have to be limited to large academic centers or homogeneous populations. On this episode, host Alex Maiersperger speaks with Dr. Mimi Fenton, CEO of Cedar Health Research, a community based clinical research organization using AI to bring trials into trusted local care settings.Drawing on her experience across academia, pharma, CROs and retail health, Dr. Fenton explains why access, education and patient support remain major barriers to participation. She discusses how Cedar embeds research into trusted community settings. The conversation also explores how AI and large language models help connect the right patients to the right trials while preserving the human relationships that drive trust and retention.
Dr. Abud Bakri, MD, is a board-certified internal medicine physician and expert in the science and clinical use of peptides. We discuss the history, uses, sourcing and safety of BPC-157, GHK-Cu, pinealon, epithalon, GLP-1s, retatrutide, melanotan and growth hormone-promoting peptides. We discuss the gap that exists between animal and human data and meaningful differences in the sources for different peptides. For those interested in peptides, Dr. Bakri provides a grounded look at the science, risks and uncertainties shaping the field today. Read the show notes at hubermanlab.com. Thank you to our sponsors AG1: https://drinkag1.com/huberman Eight Sleep: https://eightsleep.com/huberman Lingo: https://hellolingo.com/huberman Function: https://functionhealth.com/huberman LMNT: https://drinklmnt.com/huberman Timestamps (00:00:00) Abud Bakri (00:03:33) What are Peptides?, Receptors (00:06:26) BPC-157, Discovery, Animal Proteins (00:11:19) BPC-157, Animal Data, Regeneration (00:12:27) Sponsors: Eight Sleep & Lingo (00:14:51) BPC-157, Regeneration & Healing, Neurological Effects (00:19:27) Adverse Events, Clinical Trials & Legality of BPC-157 (00:29:41) GLPs & Compounding Pharmacy; Peptides & Gray Market (00:35:25) Manufacturing, Compounding Pharmacies, Gray Market, Black Market (00:41:32) Peptides & Tumor Growth?; Angiogenesis (00:45:17) Sponsor: AG1 (00:47:01) Pharmaceutical Patents, Clinical Trials for BPC-157, Potential Outcomes (00:54:19) BPC-157 Healing, Patient Experiences (01:01:22) Physician Counsel, FDA Legality, Malpractice (01:07:25) Pinealon, Epithalon, Discovery; Sleep & Cognitive Performance, Risks (01:18:17) Sponsor: Function (01:19:55) Pineal Age Deterioration, Epithalon, Eye Health (01:29:38) Thymus, Age Shrinkage; Thymosin Alpha-1, Immune Function (01:38:13) TB-500; Pet Health; Thymic Peptide Doses, Thymulin, Zinc (01:49:13) Sponsor: LMNT (01:50:33) GHK-Cu (Copper GHK), Collagen (01:55:32) Illness Recovery, Thymic Score, Tool: Blood Test & Immune Cell Counts (02:04:01) Growth Hormone Secretagogues, Age Decline, Cancer Risk, Insulin (02:15:36) GHK-Cu, Topical Cream, Red Light Therapy (02:20:25) GLPs, Discovery, Physical & Cognitive Long-Term Effects, Fertility (02:33:53) Retatrutide; Drug Patents & Nomenclature (02:39:03) Peptides: Women Reproductive Disorders; TBI, Neurologic Effect; Safe Sources (02:45:34) Zero-Cost Support, YouTube, Spotify & Apple Follow, Reviews & Feedback, Sponsors, Protocols Book, Social Media, Neural Network Newsletter Disclaimer & Disclosures Learn more about your ad choices. Visit megaphone.fm/adchoices
Artificial intelligence is rapidly reshaping the landscape of rare disease research -- but how close are we to realizing its full potential? In this episode, Tanya Binette (Director of Therapeutic Expertise, Rare Disease at ICON plc) and Roz Round (SVP of Operational Strategy, Patient and Site Engagement at Precision for Medicine) explore how AI is being applied across the rare disease clinical trial lifecycle, from drug discovery and protocol design to patient identification and engagement.The discussion highlights both the promise and complexity of using AI in a research space defined by small patient populations, fragmented data, and unique ethical considerations. Guests emphasize the importance of patient trust, regulatory alignment, and responsible innovation, while also identifying opportunities to accelerate trials, improve access, and empower patients through AI-enabled tools.
“Behind every breakthrough are countless failures no one ever sees—but that's exactly what makes progress possible.” Dr. Thomas Kaiser. When I have scientists on the podcast: they're some of the coolest, smartest, funniest people, and they're always willing (and excited) to explain what they do in ways you can actually understand. Dr. Tom Kaiser is no exception. He lives and works in Durham, North Carolina, and brings together an impressive mix of scientist, physician, and entrepreneur. His work focuses on designing better medicines using cutting-edge technology. He began his career at Emory University in Dennis Liotta's lab, working on antiviral drug discovery, and later helped pioneer early machine learning approaches in drug design. His research spans RSV, cancer, and neurodegenerative diseases, and he went on to earn his medical degree from the University of Oxford. Tom is now the co-founder and Chief Scientific Officer of Avicenna Biosciences, where he's leading the development of innovative therapies aimed at improving and saving lives. And my favorite detail from his bio? He ends it by mentioning the love of his life, his wife. I'll be honest, when I first met him, I told Dr. Kaiser he seemed like someone who must have been in a movie. He's just that cool. His Company: Dr. Thomas Kaiser shares the story behind his company's name, Ibn Sina, also known as Avicenna a true Renaissance figure of the Islamic Golden Age. A physician, philosopher, and scientist, Ibn Sina embodied the kind of multidisciplinary thinking that still drives innovation today. It's a powerful reminder that the roots of modern medicine, and the spirit of discovery stretch back centuries. The Part We Don't Talk About Enough Science is not a straight line. Not even close. Experiments fail. Clinical trials don't work. Hypotheses fall apart after years of effort. Funding can disappear. Progress can stall in ways that are frustrating and sometimes heartbreaking especially when patients are waiting. Dr. Kaiser speaks about this with a clarity and calm that really stayed with me. Because the truth is: scientists have to keep going anyway. They carry the weight of those disappointments and start again. They adjust, rethink, rebuild, and try again. Over and over. And that persistence? That's where breakthroughs come from. From the outside, it's easy to celebrate the wins ... the new drug, the successful trial, the headlines. But behind every one of those moments are countless failures no one ever sees. For families like ours, waiting, hoping, advocating it matters to understand that this difficult process is also what makes progress possible. Living the Dream What if you actually got to live the dream you had as a kid? In this conversation, Dr. Thomas Kaiser shares something surprisingly personal: he feels lucky to be doing exactly what he dreamed of as a child. That early curiosity grew into a career designing new medicines and pushing the boundaries of science. From imagination to impact, his journey is a reminder that sometimes those childhood passions really can shape the future. Go to Dr. Kaisers website: https://www.avicenna-bio.com Like, subscribe, and comment on our podcasts!Please consider making a donation: https://thebonnellfoundation.org/donate/The Bonnell Foundation website:https://thebonnellfoundation.orgEmail us at: thebonnellfoundation@gmail.com Watch our podcasts on YouTube: https://www.youtube.com/@laurabonnell1136/featuredNew: Shop our merchandise! https://thebonnellfoundation.org/product-shop/Thanks to our sponsors:Vertex: https://www.vrtx.comViatris: https://www.viatris.com/enRead us on Substack: https://substack.com/@lstb?utm_campaign=profile&utm_medium=profile-pageWatch our trailer of Embracing Egypt: https://youtu.be/RYjlB25Cr9Y
What does it take to prepare statisticians for the realities of modern clinical trials? This month, “Practical Significance” cohosts Donna LaLonde and Ron Wasserstein are joined by Ji-Hyun Lee (University of Florida) and Nolan Wages (Virginia Commonwealth University) to discuss the new ASA Clinical Trials Certificate Program. Lee and Wages explore the gap between traditional […]
At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Megan-Claire Chase, known as Warrior Megsie on social media, was one of the speakers at the ASCO Voices session. In her talk, she explained how her views on clinical trials shifted after she was diagnosed with breast cancer. Listen to the episode to hear Megsie explain: some of the reasons why the Black community distrusts the medical system why she didn't want to be part of a clinical trial how her feelings changed after she suffered rare, debilitating side effects from treatment why she became an outspoken advocate
Matthew Zachary is a brain cancer survivor, healthcare advocate, founder of Stupid Cancer and We the Patients, and host of Out of Patients. In April 2026, he returned to the stage at Merkin Hall near Lincoln Center for his first solo public piano concert in almost 22 years while launching his debut book, We the Patients: Understanding, Navigating, and Surviving America's Healthcare Nightmare.What unfolded became far larger than a concert.Over 2 hours, survivors, clinicians, advocates, nonprofit founders, journalists, pharmaceutical sponsors, and healthcare insiders gathered in one room to reflect on 30 years of survivorship, institutional failure, accidental advocacy, and the emotional afterlife of cancer. The evening moved through original piano performances, live chapter readings, and deeply personal conversations about infertility, disability, financial toxicity, insurance denials, grief, burnout, and what happens when patients spend decades navigating systems designed around transactions instead of continuity.Guests including Wendell Potter, Maimah Karmo, Craig Lustig, Shelly Fuld Nasso, Tamika Felder, and others reflected on how the modern cancer advocacy movement emerged largely because patients built parallel systems where healthcare infrastructure failed to meet human needs. The conversation explored how prior authorization, reimbursement incentives, administrative fragmentation, and institutional distrust continue shaping the patient experience across oncology and survivorship.The performance also marked a deeply personal milestone. After brain cancer compromised his left hand at age 21, Zachary spent 6 months rehabilitating both hands to return to public performance for the first time in over 2 decades. The result became part concert, part civic gathering, and part historical record of a generation of survivors who refused to disappear quietly.RELATED LINKSMZLIVE Official WebsiteMZLIVE YouTube VideoFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Dr. Gregg Day and Drs. Sonia Vallabh and Eric Minikel discuss scientific insights and the future of prion disease treatment, highlighting the importance of early diagnosis, personalized medicine, and hope for affected families. Learn about the clinical trial. Learn more about the Prion Alliance. Show transcript: Dr. Gregg Day: This is Gregg Day with Neurology Minute. I've just been speaking with Eric Minikel and Sonia Vallabh, a husband and wife team at the heart of the PRiSM trial, a first-in-human study of a prion protein-lowering, divalent, small-interfering RNA for patients with symptomatic prion disease. Eric and Sonia, could you provide us with a brief overview of the PRiSM trial and what this first-in-human study seeks to accomplish? Dr. Eric Minikel: The PRiSM trial is testing a short interfering RNA designed to bind the RNA that encodes the prion protein. That is the protein that causes Prion disease. We are at the heart of what causes this disease. Through doing this, we hope to make prion disease a treatable and preventable condition. We both want to stabilize symptomatic patients and prevent the disease in people who are at genetic risk. This is a personal mission for us. Sonia is a carrier of a prion disease mutation that she inherited from her mother who died of prion disease, and we, along the way, aspire to be a different kind of sponsor. We want to create our own clinical data that are shareable learnings for the entire field. Dr. Gregg Day: This is Gregg Day with Neurology Minute. Thanks for listening.
In this episode of Beyond The Abstract, Dr. Manish Jha stops by to talk about his new article Craving, Impulsivity, and Subsequent Methamphetamine Use With Naltrexone-Bupropion Versus Placebo: Findings From a Randomized Clinical Trial featured in the March/April issue of the Journal of Addiction Medicine. Article Link: Craving, Impulsivity, and Subsequent Methamphetamine Use With Naltrexone-Bupropion Versus Placebo: Findings From a Randomized Clinical Trial
Dr. Gregg Day talks with Drs. Sonia Vallabh and Eric Minikel about scientific insights and the future of prion disease treatment, highlighting the importance of early diagnosis, personalized medicine, and hope for affected families. Learn about the clinical trial. Learn more about the Prion Alliance. Disclosures can be found at Neurology.org.
Clinical trials are research projects that study the effects of new medical interventions, like drugs, devices, vaccines or behavioral therapies, to determine if they are safe and effective for humans. Only 5% of clinical trial participants are African American. What makes Black people so reluctant to participate in the trials? Why is Black representation important? And what can be done to increase trust? We explore those questions during Another View on Health.
If Part 1 was about the field of sexual medicine, Part 2 is about the marriage at the center of it. Dr. Jenni Skyler and Daniel Lebowitz return to their conversation with Dr. Irwin and Sue Goldstein, and this time, the questions get more personal. How do you stay married for fifty years? What does great sex actually look like across the decades? And what happens when a woman who has spent her career in sexual medicine starts experiencing low desire herself? Sue Goldstein opens up about her own journey through peri-menopause and the slow erosion of her libido- what she calls "duty sex", and the medications that brought not just her sex drive back, but a playfulness in her marriage she hadn't realized had gone missing. She walks listeners through her menopause toolbox of five treatments, explains why she's "76 and feels like she's in her 50s", and dismantles the lingering fears from the Women's Health Initiative that have kept generations of women in what she calls hormone prison. Dr. Irwin shares his own daily protocols for sexual health, why he believes most older men are leaving capacity on the table, and the surprising data from their own clinic- that more than half the Vyleesi prescriptions they write are off-label for men. They explore why dopamine is dopamine, regardless of gender. The reality of persistent genital arousal disorder. And a remarkable story of a teenage horseback rider whose chronic arousal turned out to be a herniated disc. This episode is full of practical wisdom, clinical innovation, and one of the most real conversations about long-term love you'll hear all year. The Goldsteins' secret to fifty years of marriage? Best friends, good sex, and the willingness to keep trying new things — including a chocolate sauce on the day before you change the sheets. Irwin Goldstein, MD, IF (he/him/his). Director, San Diego Sexual Medicine 5555 Reservoir Drive, Suite 300, San Diego, CA 92120, Director, Sexual Medicine, UC San Diego Health East Campus, San Diego, CA. Clinical Professor of Urology, University of California at San Diego. Voluntary Clinical Professor of Obstetrics, Gynecology and Reproductive Services Past President, International Society for the Study of Women’s Sexual Health. Past President, Sexual Medicine Society of North America. Editor Emeritus, Sexual Medicine Reviews, The Journal of Sexual Medicine, International Journal of Impotence Research. Phone: 619 265-8865 - Mobile: 619 987-7432. Email: dr.irwingoldstein@gmail.com. http://www.sandiegosexualmedicine.com. Like us on Facebook: https://www.facebook.com/SDSexMed. X: http://twitter.com/SDSexualMedSee omnystudio.com/listener for privacy information.
Clinical trials are essential to advancing care for age‑related macular degeneration (AMD) and geographic atrophy (GA). In this episode, Mathew MacCumber, MD, PhD, explains how clinical trials work, the potential benefits and challenges of participation, and key factors to consider when deciding whether a trial may be right for you. The discussion will also include a high-level overview of the GALLOP clinical trial for GA and what current research means for the future of vision health.
In December 1996, a 37 year old pharmaceutical executive sat in a Borders bookstore reading medical textbooks on the floor, trying to understand a disease she had never heard of. Multiple myeloma carried a three year prognosis. Her daughter was 18 months old. Her father had just died of cancer. Within weeks, she pushed her doctors to say the quiet part clearly. This would likely end her life before her child entered kindergarten.Kathy Giusti refused to accept passive survival. She built a plan while the system offered fragments. She interviewed oncologists and fertility specialists at the same time. She pursued IVF to have a second child while preparing for treatment. She stayed employed to keep insurance coverage. Every decision carried financial, medical, and emotional risk.That same urgency exposed a deeper failure. Cancer research moved slowly. Academic centers guarded data. Clinical trials lacked coordination. Patients entered a system that demanded compliance without providing clarity. Giusti responded by building the Multiple Myeloma Research Foundation, not as a support group, but as an operating engine to accelerate drug development, fund research, and force collaboration across institutions.This episode tracks the tension between individual agency and systemic failure. Giusti describes how patients navigate diagnosis, insurance barriers, and fragmented care in real time. She explains how data, genomics, and clinical trials reshape cancer treatment while still leaving patients responsible for decisions they are not trained to make. She addresses disparities in access, the limits of early detection, and the reality that progress in oncology often depends on speed, funding, and alignment of incentives.The conversation moves between lived experience and structural critique. It names the cost of delay, the burden placed on patients to act as their own advocate, and the tradeoffs required to push a system forward that still protects itself first.⸻RELATED LINKSKathy GiustiMultiple Myeloma Research FoundationFatal to FearlessAmerican Society of Hematology⸻FEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Site feasibility remains a critical yet complex component of clinical trial startup. In this episode, listen as Andrea Bastek (VP, Market Strategy at Florence Healthcare), Christine Senn (SVP, Site-Sponsor Innovation at Advarra), and Ashley Davidson (SVP, Head of Product at Advarra) unpack the persistent challenges in feasibility -- from manual, time-intensive processes and data trust gaps to misaligned timelines and limited transparency between stakeholders.The conversation explores how collaboration, smarter process design, and emerging technologies like AI and real-time data integration can reduce burden on sites and improve study startup timelines. Guests also share practical recommendations, including simplifying CDA processes, improving communication between sponsors and sites, and leveraging data more effectively to move forward toward a more efficient and connected feasibility model.Resources:- Advarra CDA Template - Advarra Site ID Feasibility Solution- Paper from Florence Healthcare's Site Enablement League
In this episode of The Effective Statistician, I speak with Andrew (Andy) York about the evolving world of programming validation, traceability, and quality assurance in clinical trials. Andy has decades of experience in statistical programming, leadership roles across pharma and CROs, and now works with AI-driven solutions focused on improving validation and traceability.
Show Notes: Peter Schmidt talks about his senior year during the Iraq War, and how the news on the problem of jobless recovery led him to consider graduate school. The Journey from Student to Dean Peter studied biomechanics at Cornell, focusing on the mathematics of biological systems and modeling clinical trials in orthopedics. He was admitted into a fellowship program in New York at an orthopedic hospital where he worked on total joint replacement. His career path led him to neuroscience, where he led clinical research and worked for a nonprofit before becoming the vice dean of a medical school. He then moved on to running clinical trials and drug development. A Focus on Parkinson's Disease Pete shares his interest in Parkinson's disease and explains that Parkinson's affects a tractable part of the brain, the basal ganglia, which is easier to model mathematically. He enjoys thinking about neuronal signaling and the microstructure of the brain, which helps in understanding the macro structure. Pete's PhD work involved modeling bone at the cellular level, and he applies similar thinking to the basal ganglia in Parkinson's disease. Research on Neurodegenerative Diseases Pete discusses the challenges in determining whether a question in neurodegenerative diseases is a question of science or engineering. He explains the historical focus on stem cells and extracellular proteins as solutions for diseases like Alzheimer's and Parkinson's. Pete emphasizes the need to understand the role of extracellular proteins and the importance of scientific inquiry. He mentions the Nobel Prize-winning discovery of prion diseases and the subsequent focus on characteristic proteins in neurodegenerative diseases, which led to initiatives focused on proteins. The Brain's Micro and Macro Structures Pete discusses the current focus on extracellular proteins and the challenges in proving their role in diseases like Parkinson's. He mentions the drug Lecanemab for Alzheimer's, which slows the disease but does not reverse it. Pete predicts that future research will focus on intracellular proteins and the need to restore lost cells in the brain. He highlights the importance of understanding the microstructure to inform the macro structure of the brain. The Logistics of Running Clinical Trials Pete explains that success in clinical trials is more about logistics than science, with 90-95% of the work being logistical. He discusses the challenges of recruiting subjects and the importance of working with academic medical centers that have a high volume of patients. Pete emphasizes the need for fast-moving ethics boards and efficient contracting to ensure the success of clinical trials. Incentives for Physicians When asked about the incentives for physicians to participate in clinical trials, Pete explains that most physicians are driven by scientific interest rather than financial incentives. He mentions the importance of academic leaders who can influence the participation of residents and fellows in trials. Pete highlights the passion of physicians in diseases like Huntington's and cystic fibrosis, which drives their engagement in research. The Role of Pharma Companies in Clinical Trials Pete talks about his role at East Carolina University where he oversaw clinical care and research at the medical school. He discusses the changing role of pharma companies in running clinical trials. He explains that many drugs are now discovered in labs, leading to a shift in the need for pharma companies to own their data. Pete mentions the issue of trial fraud, where fake patients are used to inflate data, and the importance of tighter control over trial data. He shares his experience of rescuing a trial from fraudulent data and the challenges of identifying such issues. Life on the Family Farm The conversation turns to Pete's family life, and Pete shares that his youngest child recently went to college, and he inherited a family farm that has been in his wife's family for 200 years. He enjoys working with his hands, doing woodworking, and using a skid steer for various tasks on the farm. Pete describes his role as the farm handyman, fixing things and maintaining the farm equipment. Harvard Reflections Pete mentions taking a quantum mechanics course and a material science class with X-ray interferometry. He highlights the impact of a physics class on fits and tolerances, which taught him about the importance of clearance and interference fits. Pete also shares his experience taking a folklore course with his roommate, which was his only pass/fail course at Harvard. Pete explains the concept of fits and tolerances in engineering. He discusses the importance of understanding whether a fit needs to be tight or loose and planning accordingly. Pete uses examples from finance to illustrate the principle of having a cushion in budgeting. He emphasizes the need to know the target fit (tight or loose) to optimize engineering and design solutions. This episode on The 92 Report:https://92report.com/podcast/168-peter-schmidt-from-math-to-neuroscience/ Timestamps: 02:40: A focus on Parkinson's Disease 05:10: Challenges in Neurodegenerative Disease Research 09:50: The Role of Extracellular Proteins and Future Directions 17:34: Running Clinical Trials and Logistics 27:58: Incentives for Physicians to Participate in Clinical Trials 32:16: Pharma Companies and Clinical Trial Data 38:53: Personal Life and Farming 42:30: Reflections on Harvard Courses 46:23: Fits and Tolerances in Engineering Links: https://www.linkedin.com/in/pnschmidt https://www.instagram.com/pnschmidt
Building on the concepts introduced in the previous episode Rethinking the Design and Conduct of Kidney Trials, this episode explores how innovative ideas in nephrology research can be translated into practical trial strategies. Experts discuss novel approaches to trial design, evolving endpoint selection, and the importance of engaging patients, clinicians, regulators, and other stakeholders throughout the research process. Drawing on insights from the ISN Consensus Meeting on Changing Paradigms of Studies in CKD (Vancouver, Nov 22-23, 2024), the discussion highlights how more pragmatic and implementation-focused trials can help generate evidence that is meaningful for clinical practice and patient care worldwide. Speakers Adeera Levin Professor of Medicine, University of British Columbia, Canada, and Past-President of the International Society of Nephrology (ISN). Dr. Levin is a global leader in kidney health research, with extensive experience in chronic kidney disease (CKD) management, clinical trials, and international health system strengthening. David Wheeler Professor of Kidney Medicine at University College London, UK and Honorary Consultant Nephrologist at the Royal Free Hospital. His research focuses on the management of chronic kidney disease and the evaluation of therapies through large-scale clinical trials. He was co-principal investigator of the landmark DAPA-CKD trial and served as Co-Chair of KDIGO from 2012–2019. Kevin Weinfurt Professor and Vice Chair of Faculty, Department of Population Health Sciences, Duke University School of Medicine, USA. Dr. Weinfurt is a behavioural scientist specializing in patient-reported outcomes (PROMs), ethical aspects of research participation, and improving the relevance of clinical trials to patients lived experiences. Hiddo J. Lambers Heerspink Professor of Clinical Trials and Personalized Medicine, University Medical Center Groningen, The Netherlands. Dr. Heerspink's work bridges pharmacology, nephrology, and precision medicine, focusing on optimizing kidney and cardiovascular outcomes through innovative clinical trial design and biomarker discovery. To read more, explore the related paper Changing Paradigms of Studies in Kidney Diseases published in Kidney International.
We recently got a call from a SciFri listener in Florida who has autoimmune arthritis. He told us that over the years he'd taken 10 drugs, and each out eventually stopped working. He then tried to enroll in a clinical trial for a new drug for his condition, but he was rejected specifically because he was on his 10th drug. Today we're digging into clinical trials and how they work. Are there incentives for drug developers to leave out “problem children”? Or is it more complicated than that? Flora talks with lawyer and bioethicist Holly Fernandez Lynch about what clinical trials are designed to do, how participants are chosen, and where FDA regulation comes into play. Guest: Dr. Holly Fernandez Lynch is an associate professor of medical ethics and health policy at the University of Pennsylvania. Other episodes you may enjoy: Why so many studies can't be replicatedCan ‘Suggestion-Box Science' Make Public Health More Useful? Transcripts for each episode are available within 1-3 days at sciencefriday.com. Subscribe to this podcast. Follow our show on Instagram, TikTok, Facebook, and Bluesky @scifri and sign up for our newsletters. Got a science question that's keeping you up at night? Call us: 877-4-SCIFRI Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
What if the anxiety, overthinking, people pleasing, emotional shutdown, hypervigilance, burnout, and relationship struggles you experience today… were never actually "you" to begin with? In this deeply personal and profoundly eye-opening solo episode, Darin Olien dives into the hidden nervous system programming formed between the ages of 0 and 8 that silently shapes our adult lives. Drawing from neuroscience, trauma research, attachment theory, epigenetics, somatic healing, and his own emotional breakthroughs, Darin explores how childhood experiences become subconscious operating systems that influence everything from relationships and stress responses to chronic disease and self-worth. This episode is a powerful roadmap toward healing. Darin breaks down the science behind trauma, the ACE study, nervous system dysregulation, emotional patterning, and neuroplasticity, while also sharing practical tools like somatic experiencing, expressive writing, EMDR, and Internal Family Systems to help listeners begin rewiring their emotional lives from the inside out. What You'll Learn How childhood experiences program the nervous system Why most adult emotional reactions are subconscious survival patterns The connection between trauma, stress hormones, and chronic disease How the nervous system stores emotional experiences in the body Why people pleasing, hypervigilance, burnout, and emotional shutdown develop The science behind neuroplasticity and rewiring the brain What the ACE Study revealed about childhood trauma and adult health How trauma impacts the amygdala, hippocampus, and stress-response systems Why emotional patterns are adaptations, not character flaws How epigenetics can pass trauma responses across generations The role of somatic experiencing in trauma healing Practical tools for emotional regulation and nervous system repair Chapters 00:00:03 – Welcome to SuperLife 00:00:32 – Sponsor: Bite Toothpaste and eliminating toxic plastic exposure 00:02:47 – Darin introduces emotional reactions and nervous system triggers 00:03:15 – A personal story about reacting vs responding in conflict 00:03:50 – Emotional shutdowns, rage, withdrawal, people pleasing, and overcorrection 00:04:19 – Darin's physical pain journey and emotional discoveries in 2025 00:04:42 – Birth trauma, childhood conditioning, and nervous system programming 00:05:04 – Why the ages of 0–8 are the most neurologically influential years 00:05:18 – Theta and delta brainwave states during childhood 00:05:55 – How children absorb emotional patterns without filters 00:06:22 – Childhood experiences becoming subconscious operating systems 00:06:44 – Adults unknowingly living through a 5-year-old nervous system 00:07:12 – Why this episode became deeply personal for Darin 00:07:35 – The neuroscience behind stress responses and emotional conditioning 00:08:17 – Brain development, neuroplasticity, and subconscious programming 00:09:13 – How the HPA axis, amygdala, and prefrontal cortex are shaped early in life 00:09:45 – Core childhood questions that program the nervous system 00:10:29 – Why adult stress responses originate in childhood environments 00:11:05 – Research showing childhood adversity alters brain structure and chemistry 00:11:18 – The ACE Study explained 00:11:49 – Why patients losing weight became emotionally overwhelmed 00:12:18 – The ten categories of adverse childhood experiences 00:13:02 – "The health crisis of America begins in childhood" 00:13:36 – How adverse childhood experiences increase disease risk 00:14:03 – Suicide, alcoholism, autoimmune disease, depression, and trauma correlations 00:14:37 – Chronic disease as a nervous system issue 00:15:04 – Survival mode, inflammation, hormonal dysregulation, and emotional scarcity 00:15:42 – Self-sabotage and emotional coping patterns explained 00:16:02 – Why your emotional patterns are not character flaws 00:16:22 – Childhood survival adaptations and nervous system intelligence 00:16:52 – Hypervigilance, people pleasing, rage, emotional shutdown, and fear 00:17:05 – Sponsor: Manna Vitality and frequency-based wellness 00:18:59 – Epigenetics and inherited trauma responses 00:19:22 – Cortisol regulation genes and hyperactive stress responses 00:19:51 – Holocaust survivors, inherited trauma, and generational nervous systems 00:20:19 – Why healing requires nervous system awareness—not just intellectual understanding 00:20:45 – "You were never supposed to get over it—you were supposed to heal from it" 00:21:01 – Real-life examples of subconscious nervous system programming 00:21:16 – Why receiving compliments can feel unsafe 00:21:30 – Darin's personal struggle with overachievement and scarcity programming 00:22:03 – Emotional neglect, chronic striving, and feeling "not enough" 00:22:16 – The nervous system roots of burnout and exhaustion 00:22:23 – Hair-trigger emotional reactions and hyperactive amygdala responses 00:22:38 – Chronic self-abandonment and losing personal boundaries 00:22:52 – Fear of intimacy, trust issues, and emotional safety 00:23:02 – "The body keeps the score" explained 00:23:22 – Trauma stored in posture, breath, digestion, immunity, and emotional regulation 00:23:43 – Harvard research on trauma-related brain changes 00:24:19 – The radical power of neuroplasticity and nervous system rewiring 00:24:48 – Why healing requires conscious participation 00:25:01 – Darin shares how healing changed decades of emotional pain 00:25:33 – Somatic Experiencing and Peter Levine's trauma work 00:25:57 – How animals discharge stress naturally 00:26:23 – Trauma as incomplete physiological responses frozen in the body 00:26:42 – Why humans suppress emotional discharge 00:27:16 – PTSD research and the effectiveness of somatic experiencing 00:27:41 – A step-by-step somatic grounding practice 00:28:14 – Why healing is more powerful with a regulated person beside you 00:28:38 – EMDR and reprocessing traumatic experiences 00:28:55 – Internal Family Systems and the "parts" inside the psyche 00:29:13 – Inner critics, overachievers, and nervous system adaptations 00:29:39 – Compassionately listening to emotional parts instead of suppressing them 00:29:51 – Expressive writing as a trauma healing practice 00:30:22 – The neuroscience behind emotional journaling 00:30:48 – A four-day expressive writing protocol for healing 00:31:05 – "You are not broken" 00:31:16 – Reprogramming the nervous system through love and safety 00:31:37 – Why deep healing happens in the presence of another regulated person 00:31:52 – Darin considers creating a future healing workshop 00:32:04 – Final reflections: "You are not what happened to you" 00:32:12 – Peace. Love. SuperLife. Thank You to Our Sponsors Bite Toothpaste: Go to trybite.com/DARIN20 or use code DARIN20 for 20% off your first order Manna Vitality: Go to mannavitality.com/ and use code DARIN12 for 12% off your order. Join the SuperLife Patreon: This is where Darin now shares the deeper work: - weekly voice notes - ingredient trackers - wellness challenges - extended conversations - community accountability - sovereignty practices Join now for only $7.49/month at https://patreon.com/darinolien Connect with Darin Olien: Website: darinolien.com Instagram: @darinolien Book: Fatal Conveniences Platform & Products: superlife.com New Show: Roadmap to Happiness Key Takeaway "The emotional patterns, fears, reactions, and coping mechanisms that run your adult life are often survival adaptations created by your nervous system during childhood. They are not your identity. They are not permanent. And through awareness, somatic healing, emotional processing, nervous system regulation, and conscious repetition, those deeply rooted patterns can be rewritten into something healthier, freer, and more aligned with who you truly are." Bibliography/Sources Neuroscience & Early Programming Agorastos, A., Pervanidou, P., Chrousos, G. P., & Baker, D. G. (2019). Developmental trajectories of early life stress and trauma: A narrative review on neurobiological aspects beyond stress system dysregulation. Frontiers in Psychiatry, 10, Article 118. https://doi.org/10.3389/fpsyt.2019.00118 Bolton, J. L., Short, A. K., Simeone, K. A., Daglian, J., & Baram, T. Z. (2019). Programming of stress-sensitive neurons and circuits by early-life experiences. Frontiers in Behavioral Neuroscience, 13, Article 30. https://doi.org/10.3389/fnbeh.2019.00030 Shonkoff, J. P., & Boyce, W. T. (2024). Toxic stress and developmental programming of the HPA axis. Annual Review of Developmental Psychology. https://www.annualreviews.org/journal/devpsych Teicher, M. H., & Ohashi, K. (2023). Childhood trauma and reduced hippocampal, anterior cingulate, and corpus callosum volumes. JAMA Psychiatry. https://jamanetwork.com/journals/jamapsychiatry van der Kolk, B. A. (2014). The body keeps the score: Brain, mind, and body in the healing of trauma. Viking / Penguin. https://www.penguinrandomhouse.com/books/313183/the-body-keeps-the-score-by-bessel-van-der-kolk-md/ ACE Study & Adverse Childhood Experiences Felitti, V. J. (2002). The relation between adverse childhood experiences and adult health: Turning gold into lead. The Permanente Journal, 6(1), 44–47. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112216/ Felitti, V. J., & Anda, R. F. (2010). The relationship of adverse childhood experiences to adult health, well-being, social function, and healthcare. In R. Lanius, E. Vermetten, & C. Pain (Eds.), The impact of early life trauma on health and disease (pp. 77–87). Cambridge University Press. https://doi.org/10.1017/CBO9780511777042 Hillis, S., Mercy, J., Amobi, A., & Kress, H. (2023). Economic burden of health conditions associated with adverse childhood experiences among U.S. adults. JAMA Network Open, 6(12). https://jamanetwork.com/journals/jamanetworkopen Liu, Y., Croft, J. B., Chapman, D. P., et al. (2013). Associations between adverse childhood experiences and health outcomes in adults aged 18–59 years. PLOS ONE, 8(3), e58625. https://doi.org/10.1371/journal.pone.0058625 Epigenetics & Trauma Baratta, M. V., et al. (2021). Epigenetics of childhood trauma: Long term sequelae and potential for treatment. Neuroscience & Biobehavioral Reviews, 132, 1049–1063. https://doi.org/10.1016/j.neubiorev.2021.09.043 Jiang, S., Postovit, L., Cattaneo, A., Binder, E. B., & Aitchison, K. J. (2019). Epigenetic modifications in stress response genes associated with childhood trauma. Frontiers in Psychiatry, 10, Article 808. https://doi.org/10.3389/fpsyt.2019.00808 Provençal, N., & Binder, E. B. (2015). The effects of early life stress on the epigenome: From the womb to adulthood and even before. Experimental Neurology, 268, 10–20. https://doi.org/10.1016/j.expneurol.2014.12.001 Healing Modalities — Research Brom, D., Stokar, Y., Lawi, C., et al. (2017). Somatic experiencing for posttraumatic stress disorder: A randomized controlled outcome study. Journal of Traumatic Stress, 30(3), 304–312. https://doi.org/10.1002/jts.22189 Fratarolli, J. (2006). Experimental disclosure and its moderators: A meta-analysis. Psychological Bulletin, 132(6), 823–865. https://doi.org/10.1037/0033-2909.132.6.823 Gilbert, P. (2009). The compassionate mind: A new approach to life's challenges. New Harbinger Publications. https://www.newharbinger.com/9781572248403/the-compassionate-mind/ Justice Resource Institute. (2022). Evaluation of the efficacy of Internal Family Systems (IFS) therapy for trauma-related symptoms among complexly traumatized adults. ClinicalTrials.gov Identifier: NCT05155930. https://clinicaltrials.gov/ct2/show/NCT05155930 Kuhfuß, M., Maldei, T., Hetmanek, A., & Baumann, N. (2021). Somatic experiencing — effectiveness and key factors of a body-oriented trauma therapy. European Journal of Psychotraumatology, 12(1), Article 1929023. https://doi.org/10.1080/20008198.2021.1929023 Levine, P. A. (2010). In an unspoken voice: How the body releases trauma and restores goodness. North Atlantic Books. https://www.northatlanticbooks.com/shop/in-an-unspoken-voice/ Neff, K. D., & Germer, C. K. (2013). A pilot study and randomized controlled trial of the Mindful Self-Compassion Program. Journal of Clinical Psychology, 69(1), 28–44. https://doi.org/10.1002/jclp.21923 Pennebaker, J. W. (1997). Writing about emotional experiences as a therapeutic process. Psychological Science, 8(3), 162–166. https://doi.org/10.1111/j.1467-9280.1997.tb00403.x Rodenburg, R., Benjamin, A., de Roos, C., Meijer, A. M., & Stams, G. J. (2009). Efficacy of EMDR in children: A meta-analysis. Clinical Psychology Review, 29(7), 599–606. https://doi.org/10.1016/j.cpr.2009.06.008 Schwartz, R. C. (2021). No bad parts: Healing trauma and restoring wholeness with the Internal Family Systems model. Sounds True. https://www.soundstrue.com/products/no-bad-parts Shapiro, F. (2017). Eye movement desensitization and reprocessing (EMDR) therapy: Basic principles, protocols, and procedures (3rd ed.). Guilford Press. https://www.guilford.com/books/Eye-Movement-Desensitization-and-Reprocessing/Francine-Shapiro/9781462532766
This April 2026 Heart Rhythm Journal publication reports a sub-analysis of the CHAMPION-AF trial evaluating left atrial appendage closure (LAAC) versus oral anticoagulation in patients with atrial fibrillation who previously underwent catheter ablation. The analysis demonstrated that LAAC with the WATCHMAN FLX device provided comparable protection against stroke, systemic embolism, and cardiovascular death when compared with NOAC therapy, while also reducing long-term non-procedural bleeding events. These findings support consideration of LAAC as an alternative stroke prevention strategy in selected post-ablation AF patients through individualized, shared decision-making. Digital Education Committee Member Danesh Kella, MBBS, FHRS discusses this article from the Heart Rhythm Journal that preceded the Heart Rhythm 2026 Late-Breaking Clinical Trial. He is joined in the conversation by Jason T. Jacobson, MD, FHRS, Ammar M. Killu, MBBS, and Gregory M. Marcus, MD, FHRS. Learning Objectives Describe the rationale for left atrial appendage closure as an alternative to chronic oral anticoagulation in patients with atrial fibrillation after catheter ablation. Review the efficacy and safety outcomes from the CHAMPION-AF sub-analysis comparing LAAC and NOAC therapy in post-ablation AF patients. Discuss patient selection considerations and the role of shared decision-making when choosing stroke prevention strategies following AF ablation. Podcast Contributors Danesh Kella, MBBS, FHRS Jason T. Jacobson, MD, FHRS Ammar M. Killu, MBBS Gregory M. Marcus, MD, FHRS Host and Contributor Disclosure(s): J.T. Jacobson •Board/Advisory Committee Membership: Abbott Medical •Honoraria/Speaking/Teaching/Consulting: Zoll Medical Corporation, Vektor Medical, Inc. •Research: CardioFocus, Inc., Johnson and Johnson •Stocks, Privately Held: Atlas 5D D. Kella •Honoraria/Speaking/Teaching/Consulting: Zoll Medical Corporation, MBW Spectrum A. Killu •Board/Advisory Committee Membership: Boston Scientific •Honoraria/Speaking/Teaching/Consulting: AtriCure, Inc., Abbott, Biosense Webster, Inc., Siemans Healthineers •Research: Boston Scientific, Access Point Technologies G.M. Marcus •Honoraria/Speaking/Teaching/Consulting: InCarda Therapeutics •Research: NIH, PCORI, TRDRP •Stocks, Publicly Traded: InCarda Therapeutics
This late-breaking sub-analysis from the CHAMPION-AF trial evaluated outcomes of left atrial appendage closure (LAAC) with the WATCHMAN FLX device versus oral anticoagulation in patients with atrial fibrillation who had previously undergone catheter ablation. Investigators found that LAAC provided similar protection against stroke, cardiovascular death, and systemic embolism compared with non-vitamin K oral anticoagulants (NOACs), while significantly reducing non-procedural bleeding events, regardless of prior ablation status. These findings suggest LAAC may be a viable alternative to long-term anticoagulation in select post-ablation AF patients through a shared decision-making approach. Join Digital Education Committee member Sandeep A. Saha, MD, MS, FHRS and his colleagues Scott C. Brancato, MD, FHRS and Rakesh Gopinathannair, MBA, MD, FHRS for this late-breaking coverage from Heart Rhythm 2026 in Chicago! Learning Objectives Review the rationale for left atrial appendage closure as an alternative to long-term oral anticoagulation in patients with atrial fibrillation following catheter ablation. Analyze the CHAMPION-AF sub-analysis outcomes comparing LAAC and NOAC therapy with respect to stroke prevention, cardiovascular outcomes, and bleeding risk. Discuss how these findings may influence patient selection and shared decision-making for stroke prevention strategies in post-ablation atrial fibrillation care. Podcast Contributors Sandeep A. Saha, MD, MS, FHRS Scott C. Brancato, MD, FHRS Rakesh Gopinathannair, MBA, MD, FHRS Host and Contributor Disclosure(s): S. Brancato Nothing to disclose. R. Gopinathannair Board/Advisory Committee Membership: Heart Rhythm Society, AltaThera Pharmaceuticals Honoraria/Speaking/Teaching/Consulting: Abbott, Johnson and Johnson, Boston Scientific, Sanofi S. Saha Board/Advisory Committee Membership: Medtronic Honoraria/Speaking/Teaching/Consulting: Medtronic
Send us Fan MailWhen T.J. Sharpe was diagnosed with stage 4 melanoma at just 37 years old, the statistics were devastating. With a newborn son, a two-year-old daughter, and limited treatment options available at the time, he faced a life-changing decision: pursue standard chemotherapy or take a chance on early immunotherapy clinical trials.In this powerful episode of the MedEvidence Podcast, cardiologist and medical researcher Michael Koren sits down with T.J. to discuss his remarkable journey from cancer recurrence and uncertainty to becoming a long-term survivor through groundbreaking clinical research.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!
At 19, Shlomit woke up unable to speak. The right side of her body went numb. An emergency room sent her home and called it stress. That moment did not end in a diagnosis that changed policy or triggered reform. It sent her into a decade long pursuit of understanding how the brain fails language and how the healthcare system fails patients who cannot advocate for themselves.Shlomit trained as a speech language pathologist and spent years inside acute care hospitals and ICUs, performing endoscopies and treating patients with brain injury, stroke, and dysphagia. She watched medical teams rotate in and out, deliver dense updates, and leave families nodding without comprehension. She stayed behind and translated. Every day, patients told her she was the only one who explained what was happening. That gap is not an accident. Hospital systems optimize for throughput, not understanding. Patients move through beds based on cost, not readiness. Discharge planning becomes a financial decision wrapped in clinical language. A stay under 48 hours can shift the insurance burden dramatically, leaving patients exposed to higher out of pocket costs. Shlomit left the system and built Patient Path NYC, a private patient advocacy service. She now spends 15 to 20 hours a week per client reading charts, coordinating care teams, and translating medical decisions into plain language. Her work sits in the uncomfortable space between healthcare policy and lived experience. Families pay out of pocket to understand their own care. Hospitals benefit from the clarity she provides while maintaining the same structural incentives that created the confusion.This conversation tracks the human cost of fragmented care, the economics behind discharge decisions, and the quiet reality that patients who cannot communicate clearly often lose control of their own outcomes.RELATED LINKSShlomit LibertyShlomit Liberty on LinkedInPatient Path NYCBoard Certified Patient AdvocateFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Keeping patients on PARP inhibitors long enough to see real benefit often comes down to proactive side effect management. In this episode of BackTable Urology, Dr. Neeraj Agarwal and Dr. Arun Azad join host Dr. Alan Tan to discuss practical, evidence-based strategies for managing hematologic and GI toxicities in advanced prostate cancer patients receiving PARP inhibitors. --- Get the BackTable apphttps://www.backtable.com/app --- This podcast is supported by an educational grant from Pfizer. --- Timestamps 00:00 - Introduction06:17 - Managing Anemia11:12 - Side Effect Profiles19:33 - Transfusions vs ESAs26:43 - Docetaxel vs PARP Inhibitors30:27 - Side Effect Management Pearls40:18 - Team Based Monitoring52:27 - Tissue Versus Liquid01:01:24 - Genetic Counseling Workflow01:07:07 - Trial Equity and Access --- More about this episode The doctors discuss the importance of close anemia monitoring during the critical first 3 to 4 months of therapy, maintaining dose intensity, proactive antiemetic use, and the role of exercise and resistance training in combating fatigue. The conversation also covers differences in toxicity profiles between PARP agents, the value of multidisciplinary care teams, molecular advances in molecular and germline testing, and the evolving landscape of emerging therapies in prostate care. --- Resources Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trialhttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00684-1/abstract BRCAAway: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) bearing homologous recombination-repair mutations (HRRm).https://ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.19 --- BackTable Urology is the go-to podcast for urologists, urologic oncologists, and urogynecologists. Download the free BackTable app to get early access to new episodes, cases, and courses curated by physicians in your specialty. ► https://www.backtable.com/app
On this episode of the Medical Alley Podcast, host Ben Wagner sits down with the leaders of Mobius Medical — co-founder Stefan Czyniewski and VP of clinical operations David Pomfret — for a behind-the-scenes look at the regulatory and clinical strategies shaping the future of medtech innovation. From early feasibility studies in Australia, to scaling operating in the United States, the conversation explores the realities of clinical research, the biggest mistakes founders make when building regulatory strategies, and why bringing medical technology to market is "not just hard — it's really, really, hard." Send us a message! Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram.
Learn how clinical trials in optometry are advancing eye care through AI, myopia control, dry eye innovation, and personalized medicine.
On the May 18th edition: The temporary suspension of Georgia's gas tax has been extended; Two Georgia Supreme Court candidates have been accused of misconduct; And Emory University's School of Medicine is expanding access to clinical trials.
In 2020, developmental biologist Dr. Crystal Rogers drove the country roads outside Davis, California crying between grant rejections, wondering whether she was about to lose her lab, her career, and the scientific future she had spent years building. She had already done what academia tells young scientists to do. She earned the credentials. She landed a faculty position at UC Davis. She built a lab. Then the real test began.On this episode of Standard Deviation, Dr. Oliver Bogler examines the unspoken rules that determine which scientists survive academic research and which quietly disappear from it. The conversation follows Crystal Rogers and cancer biologist Dr. Michelle Mendoza as they collide with the “Hidden Curriculum” of biomedical science: the unwritten rhetoric, institutional signaling, and grant writing strategies that often decide who receives funding, tenure, and long term stability.Michelle Mendoza entered a tenure track position at the Huntsman Cancer Institute while raising 3 children, navigating a divorce, and trying to secure major NIH funding during COVID. What looked like objective scientific review turned out to depend heavily on persuasion, presentation, and insider fluency. Established researchers could promise massive research agendas based on reputation alone. Junior investigators faced a completely different standard.Oliver traces how the Life Science Editors Foundation and its JEDI program intervened by pairing scientists with former editors from journals including Cell and Nature. The work had little to do with commas or grammar. Editors challenged logic, structure, and scientific framing before grant reviewers could destroy an application in public.Both researchers eventually secured career defining grants. One realized she would keep her job and not have to move her family. The other celebrated by ordering a personalized “DEV BIO” license plate and driving through Davis blasting nineties hip hop and Beyoncé.The episode exposes how biomedical research funding rewards institutional fluency as much as scientific talent, and how hidden systems inside academic medicine continue shaping who gets to stay in science long enough to make discoveries.RELATED LINKSDr. Crystal Rogers LinkedInDr. Crystal Rogers Faculty PageDr. Crystal Rogers LabDr. Michelle Mendoza LinkedInDr. Michelle Mendoza Faculty PageHuntsman Cancer Institute Mendoza LabLife Science Editors FoundationFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
For decades, a tight carotid stenosis felt like a ticking time bomb — a plaque waiting to throw an embolus and cause the next stroke. We were taught that severe narrowing meant surgery, and trials like ACAS and ACST-1 seemed to prove it. But medicine has changed. Statins, antiplatelets, tighter blood pressure control, even PCSK9 and GLP-1 therapies have quietly slashed stroke risk, and now newer data from CREST-2 suggest that for many asymptomatic patients, the knife — or the stent — may not add much at all. So if modern medical therapy works better than ever… who actually benefits from intervention anymore? Today, we unpack the evidence, the controversies, and how to counsel the patient who feels perfectly fine but has high-grade stenosis.Hosts: Carolyn Judge, Andrew Huang, Luciano Delbono, Frank Davis, Robert BeaulieuInstitution: University of Michigan, Department of Surgery, Section of Vascular SurgeryLearning objectives: Describe how modern intensive medical therapy has transformed the natural history of asymptomatic carotid stenosis and explain why contemporary patients experience substantially lower annual stroke risk than those in earlier eras. Interpret and compare the results of landmark trials—including ACAS, ACST-1, and CREST-2—to assess the relative benefits of medical therapy, endarterectomy, and stenting. Apply current evidence and guideline recommendations to patient care by selecting which asymptomatic patients are most likely to benefit from carotid revascularization versus optimized medical therapy alone. References:SVS Guidelines:Brook, R. D., et al. (2022). Society for Vascular Surgery clinical practice guidelines for management of extracranial carotid artery disease. Journal of Vascular Surgery, 75(1), e1–e67. https://doi.org/10.1016/j.jvs.2021.09.031CREST (1)Brott, T. G., Hobson, R. W., Howard, G., et al. (2010). Stenting versus endarterectomy for treatment of carotid-artery stenosis. New England Journal of Medicine, 363(1), 11–23. https://doi.org/10.1056/NEJMoa0912321CREST-2Brott, T. G., Howard, G., Fong, P., et al. (2024). Randomized trial of carotid artery stenting or carotid endarterectomy vs best medical therapy for asymptomatic carotid stenosis: CREST-2 results. [Manuscript in preparation]. ClinicalTrials.gov Identifier: NCT02089217. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02089217ACST-1Halliday, A., Mansfield, A., Marro, J., et al. (2004). Randomised trial of carotid artery surgery for asymptomatic stenosis. Lancet, 363(9420), 1491–1502. https://doi.org/10.1016/S0140-6736(04)16153-1ACST-2Halliday, A., Bulbulia, R., Bonati, L. H., et al. (2021). Carotid artery stenting versus carotid endarterectomy in patients with asymptomatic carotid stenosis (ACST-2): A randomised trial. Lancet, 398(10291), 1065–1073. https://doi.org/10.1016/S0140-6736(21)01980-1ACASExecutive Committee for the Asymptomatic Carotid Atherosclerosis Study. (1995). Endarterectomy for asymptomatic carotid stenosis. JAMA, 273(18), 1421–1428. https://doi.org/10.1001/jama.1995.03520420033036Sponsor URL: https://www.goremedical.com/Please visit https://behindtheknife.org to access other high-yield surgical education podcasts, videos and more. If you liked this episode, check out our recent episodes here: https://behindtheknife.org/listenBehind the Knife Premium: https://behindtheknife.org/premiumOral Board Review: https://behindtheknife.org/oral-boardOral Board Simulator: https://behindtheknife.org/oral-board/simulatorGeneral Surgery Oral Board Review Course: https://behindtheknife.org/premium/general-surgery-oral-board-reviewTrauma Surgery Video Atlas: https://behindtheknife.org/premium/trauma-surgery-video-atlasDominate Surgery: A High-Yield Guide to Your Surgery Clerkship: https://behindtheknife.org/premium/dominate-surgery-a-high-yield-guide-to-your-surgery-clerkshipDominate Surgery for APPs: A High-Yield Guide to Your Surgery Rotation: https://behindtheknife.org/premium/dominate-surgery-for-apps-a-high-yield-guide-to-your-surgery-rotationVascular Surgery Oral Board Review Course: https://behindtheknife.org/premium/vascular-surgery-oral-board-audio-reviewColorectal Surgery Oral Board Review Course: https://behindtheknife.org/premium/colorectal-surgery-oral-board-audio-reviewSurgical Oncology Oral Board Review Course: https://behindtheknife.org/premium/surgical-oncology-oral-board-audio-reviewCardiothoracic Oral Board Review Course: https://behindtheknife.org/premium/cardiothoracic-surgery-oral-board-audio-reviewDownload our App:Apple App Store: https://apps.apple.com/us/app/behind-the-knife/id1672420049Android/Google Play: https://play.google.com/store/apps/details?id=com.btk.app&hl=en_US