Podcasts about clinical trials

Misinformation still finds its way into the conversation. Dorothy Gibbons and Dr. Raz dive into breast cancer myths, mammogram safety, risk factors, and common social media claims. They sort through concerns about bras, deodorants, cell phones, diet, and trauma. Evidence and screening guidelines guide the facts during this episode. Please consider sharing this episode, or making a donation at therose.org so more women receive breast cancer screening and care. Subscribe to Let’s Talk About Your Breasts on Apple Podcasts, Spotify, iHeart, and wherever you get your podcasts. Key Questions Answered 1. Does getting a mammogram increase your risk of developing breast cancer due to radiation exposure? 2. Why is there so much controversy and skepticism surrounding mammograms and breast cancer screening, especially compared to other screenings? 3. Is breast cancer only a concern for women with a family history of the disease? 4. Is breast cancer purely an older woman’s disease, or can younger women get it too? 5. Does wearing an underwire bra or any bra cause breast cancer? 6. Can deodorant use (especially with aluminum) lead to breast cancer? 7. Is carrying a cell phone in your bra (or close to your body) a cause of breast cancer? 8. Does hair dye or using plastic water bottles increase breast cancer risk? 9. Does hormone replacement therapy (HRT) increase breast cancer risk? 10. Can breast injury or trauma cause breast cancer? 11. Does obesity relate to breast cancer risk? 12. Can animals sense breast cancer in humans? 13. Are alternative treatments or internet trends (like ivermectin or bee venom) effective against breast cancer? 14. Is it important for patients to trust their doctor and treatment process? Timestamped Overview 00:00 Mammogram Radiation: Safe and Essential 04:22 Annual Screening Controversy Explained 08:28 Breast Cancer: Risks and Incidence 11:14 Impact of Treating Women's Diseases 13:52 Aluminum in Deodorant Safe 18:29 HRT Risks and Tapering Explained 25:52 Ivermectin Misuse and Clinical Trials 28:51 Health's Role in Cancer Prevention 29:47 Poison Necessary to Fight CancerSee omnystudio.com/listener for privacy information.

Marking an important milestone for this rare form of retinitis pigmentosa (RP)

Shannon Burkett has lived about six lives. Broadway actor. SNL alum. Nurse. Filmmaker. Advocate. Cancer survivor. And the kind of person who makes you question what you've done with your day. She wrote and produced My Vagina—the stop-motion musical kind, not the cry-for-help kind—and built a global movement after her son was poisoned by lead dust in their New York apartment. Out of that came LEAD: How This Story Ends Is Up to Us, a documentary born from rage, science, and maternal defiance. We talked about everything from The Goonies to Patrick Stewart to the quiet rage of parenting in a country that treats public health like a hobby. This episode is about art, anger, resilience, and what happens when an unstoppable theater nerd turned science geek Jersey girl collides with an immovable healthcare system.RELATED LINKSShannon Burkett Official SiteLEAD: How This Story Ends Is Up to UsEnd Lead PoisoningLinkedIn: Shannon BurkettBroadwayWorld ProfileFEEDBACKLike this episode? Rate and review Out of Patients on your favorite podcast platform. For guest suggestions or sponsorship email podcasts@matthewzachary.com.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

The treatment landscape for melanoma continues to evolve at a rapid pace, with new clinical trial data and therapeutic modalities refining how clinicians approach both early-stage and advanced disease. Michael A. Davies, MD, PhD, Professor and Chairman of the Department of Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, recently chaired i3 Health's CME/NCPD/AAPA activity, "Melanoma in Minutes: Evidence-Driven Care for Improved Patient Outcomes." With numerous new developments in melanoma treatment over recent months, Dr. Davies sat down again to share these critical updates that are impacting practice. After the interview, stay tuned to hear module 1 of the full podcast activity. Click the link to complete module 1 and claim your free credit: bit.ly/4iYmYD2

The treatment landscape for melanoma continues to evolve at a rapid pace, with new clinical trial data and therapeutic modalities refining how clinicians approach both early-stage and advanced disease. Michael A. Davies, MD, PhD, Professor and Chairman of the Department of Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, recently chaired i3 Health's CME/NCPD/AAPA activity, "Melanoma in Minutes: Evidence-Driven Care for Improved Patient Outcomes." With numerous new developments in melanoma treatment over recent months, Dr. Davies sat down again to share these critical updates that are impacting practice. After the interview, stay tuned to hear module 2 of the full podcast activity. Click the link to complete module 2 and claim your free credit: bit.ly/44yO9RB

In the third installment of the Skin Anarchy and Timeline Masterclass, Dr. Ekta Yadav sits down with Dr. Brad Currier, Manager of Clinical Trials at Timeline, for a behind-the-scenes look at what real evidence in longevity science and skincare actually requires.With a foundation in muscle physiology, exercise science, and aging research, Dr. Currier brings a performance-driven lens to longevity — reframing skin not as a cosmetic surface, but as a mitochondria-dense longevity organ, biologically linked to muscle health, metabolic resilience, and cellular energy. The episode explores why mitochondrial function may be one of the most underappreciated drivers of how both skin and the body age.At the center of the conversation is Timeline's research on urolithin A, a postbiotic shown to support mitochondrial renewal. Rather than relying on marketing narratives, Timeline has built its platform on mechanism-first science, translating years of cellular research into human clinical trials — including biopsy-based studies that reveal measurable changes in collagen synthesis and skin structure.Dr. Currier also pulls back the curtain on the truth about clinical claims in beauty — explaining why many “clinically tested” labels lack rigor, how underpowered or biased studies distort results, and what separates meaningful, published human data from perception-based marketing. From wrinkle depth to hydration to barrier function, he outlines how Timeline measures outcomes that reflect real biological change — not just surface-level improvement.The episode ultimately reframes longevity as precision science, not hype — emphasizing the importance of human trials, mitochondrial health, and transparent evidence in an industry flooded with buzzwords.Listen to the full episode of Skin Anarchy to hear Dr. Brad Currier unpack what clinical validation should look like — and why the future of longevity skincare depends on measurable biology, not marketing promises.SHOP TIMELINEDon't forget to subscribe to Skin Anarchy on Apple Podcasts, Spotify, or your preferred platform.Reach out to us through email with any questions.Sign up for our newsletter!Shop all our episodes and products mentioned through our ShopMy Shelf!Support the show

The first coordinated global research strategy to prevent MS has been announced. This week, Dr. Bruce Bebo, the National MS Society's Executive Vice President and Chief Research & Medical Affairs Officer, joins me to explain what MS prevention looks like and how experts plan to achieve this remarkable goal. We'll also tell you who won the 2025 Barancik Prize for Innovation in MS Research, and we'll explain how their groundbreaking research impacts MS care. We're sharing the details of a newly announced partnership designed to reduce delays in getting an MS diagnosis and expand access to MS care in Wisconsin. We'll tell you how an international drug discovery network found that a drug already approved for another condition could also protect nerve cells and promote remyelination. And we'll share research that shows that AI can accurately predict whether someone newly diagnosed with MS will experience progression independent of relapse activity (PIRA) in the three years following their diagnosis. We have a lot to talk about! Are you ready for RealTalk MS??! I'm asking for your support:  :22 This Week: Preventing MS  1:47 Dr. Manuel Friese is the winner of the 2025 Barancik Prize for Innovation in MS Research  2:41 National MS Society announces a partnership to improve time to MS diagnosis and access to MS care in Wisconsin  6:26 An international drug discovery network identifies a drug that protects nerve cells and promotes remyelination  8:05 STUDY: AI accurately predicts progression independent of relapse activity in individuals who are newly diagnosed with MS  10:51 Dr. Bruce Bebo explains the strategy behind the global research initiative to prevent MS  14:48 Share this episode  31:31 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/439 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Support Jon at WALK MS https://realtalkms.com/walkms RealTalk MS Episode 424: I'm a Participant in a Clinical Trial for CAR T-Cell Therapy for MS with Jan Janisch-Hanzlik https://realtalkms.com/424 STUDY: In Silico Screening and Preclinical Validation Identify Bavisant as a Therapeutic Candidate for Multiple Sclerosis https://science.org/doi/10.1126/scitranslmed.ads0633 STUDY: Machine Learning Analysis Applied to Prediction of Early Progression Independent of Relapse Activity in Multiple Sclerosis Patients https://onlinelibrary.wiley.com/doi/10.1111/ene.70417 Find out about ABLEnow Accounts https://ablenow.com JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 439 Guests: Dr. Bruce Bebo Privacy Policy

Send us a textDr. Michael Koren joins Kevin Geddings to offer the solace of taking control of your medical future in these uncertain times. The doctor reminds listeners that when news is stressful and chaotic, doing things that impact you and your life can help reduce anxiety. He suggests that taking advantage of free screening exams at clinical research sites may help people make sense of the otherwise mysterious and can help find solutions to problems they weren't even aware of.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!

Sarah Smith, Qualitative Specialist and Global Behavioral Science Strategy Lead at Oracle Life Sciences, is focused on the critical role of behavioral science in improving recruitment and retention in clinical trials.  Oracle Life Sciences is working to address historical underrepresentation in clinical trials by combining behavioral insights with integrated technologies to identify at-risk populations and understand barriers to participation. Using nudges to encourage trial participation, conducting decentralized trials, and applying AI to reshape patient engagement are strong tools for building trust and improving accessibility. Sarah explains, "Behavioral science is about understanding behavior. It draws from a number of disciplines like psychology, anthropology, and behavioral economics. But what it tells us is that people aren't rational. They don't always do the things that we expect them to do. So if we want to engage people, if we want to engage them properly, if we want to ensure that all the things we do are equitable and have an equal playing field, then we need to really understand why people do the things they do and to try and help us make sense of that in a way that encompasses everybody."   "We see treatment and technology advancing, but there are many communities that aren't part of that still, that are underrepresented. Factors like gender, ethnicity, culture, conditions that carry a stigma, socioeconomic issues, and geographic limitations - all of these things can limit the opportunity, ability, and willingness of individuals to participate in clinical trials. And that means the impact of those trials is less generalizable because those people are not represented. They're just simply not there. So the treatment that is aimed at these people is not measured in those groups. Oracle is working to address this by combining a deeper understanding of behavior with integrated technology to try to close this gap in representation to give more inclusive patient-centered care that unifies clinical, behavioral, and safety data across settings. To give a more holistic view, to give more coordinated care, to identify risks earlier, to identify patients that perhaps just need a bit more attention - a more personalized engagement."   #OracleLifeSciences #lifesciences #ClinicalResearch #PatientCentricity #PatientEngagement #ClinicalTrials #Healthliteracy #BehavioralScience #HealthEquity #AI #Healthcare #Diversity #Inclusion #MedicalResearch #Innovation Oracle.com/life-sciences  Listen to the podcast here  

Sarah Smith, Qualitative Specialist and Global Behavioral Science Strategy Lead at Oracle Life Sciences, is focused on the critical role of behavioral science in improving recruitment and retention in clinical trials.  Oracle Life Sciences is working to address historical underrepresentation in clinical trials by combining behavioral insights with integrated technologies to identify at-risk populations and understand barriers to participation. Using nudges to encourage trial participation, conducting decentralized trials, and applying AI to reshape patient engagement are strong tools for building trust and improving accessibility. Sarah explains, "Behavioral science is about understanding behavior. It draws from a number of disciplines like psychology, anthropology, and behavioral economics. But what it tells us is that people aren't rational. They don't always do the things that we expect them to do. So if we want to engage people, if we want to engage them properly, if we want to ensure that all the things we do are equitable and have an equal playing field, then we need to really understand why people do the things they do and to try and help us make sense of that in a way that encompasses everybody."   "We see treatment and technology advancing, but there are many communities that aren't part of that still, that are underrepresented. Factors like gender, ethnicity, culture, conditions that carry a stigma, socioeconomic issues, and geographic limitations - all of these things can limit the opportunity, ability, and willingness of individuals to participate in clinical trials. And that means the impact of those trials is less generalizable because those people are not represented. They're just simply not there. So the treatment that is aimed at these people is not measured in those groups. Oracle is working to address this by combining a deeper understanding of behavior with integrated technology to try to close this gap in representation to give more inclusive patient-centered care that unifies clinical, behavioral, and safety data across settings. To give a more holistic view, to give more coordinated care, to identify risks earlier, to identify patients that perhaps just need a bit more attention - a more personalized engagement."   #OracleLifeSciences #lifesciences #ClinicalResearch #PatientCentricity #PatientEngagement #ClinicalTrials #Healthliteracy #BehavioralScience #HealthEquity #AI #Healthcare #Diversity #Inclusion #MedicalResearch #Innovation Oracle.com/life-sciences  Download the transcript here  

What happens when decades of clinical research experience collide with a regulatory environment that is changing faster than ever? In this episode of Tech Talks Daily, I sat down with Dr Werner Engelbrecht, Senior Director of Strategy at Veeva Systems, for a wide-ranging conversation that explores how life sciences organizations across Europe are responding to mounting regulatory pressure, rapid advances in AI, and growing expectations around transparency and patient trust. Werner brings a rare perspective to this discussion. His career spans clinical research, pharmaceutical development, health authorities, and technology strategy, shaped by firsthand experience as an investigator and later as a senior industry leader.  That background gives him a grounded, practical view of what is actually changing inside pharma and biotech organizations, beyond the headlines around AI Acts, data rules, and compliance frameworks. We talk openly about why regulations such as GDPR, the EU AI Act, and ACT-EU are creating real pressure for organizations that are already operating in highly controlled environments. But rather than framing compliance as a blocker, Werner explains why this moment presents an opening for better collaboration, stronger data foundations, and more consistent ways of working across internal teams. According to him, the real challenge is less about technology and more about how companies manage data quality, align processes, and break down silos that slow everything from trial setup to regulatory response times. Our conversation also digs into where AI is genuinely making progress today in life sciences and where caution still matters. Werner shares why drug discovery and non-patient-facing use cases are moving faster, while areas like trial execution and real-world patient data still demand stronger evidence, cleaner datasets, and clearer governance. His perspective cuts through hype and focuses on what is realistic in an industry where patient safety remains the defining responsibility. We also explore patient recruitment, decentralized trials, and the growing complexity of diseases themselves. Advances in genomics and diagnostics are reshaping how trials are designed, which in turn raises questions about access to electronic health records, data harmonization across Europe, and the safeguards regulators care about most. Werner connects these dots in a way that highlights both the operational strain and the long-term upside. Toward the end, we look ahead at emerging technologies such as blockchain and connected devices, and how they could strengthen data integrity, monitoring, and regulatory confidence over time. It is a thoughtful discussion that reflects both optimism and realism, rooted in lived experience rather than theory. If you are working anywhere near clinical research, regulatory affairs, or digital transformation in life sciences, this episode offers a clear-eyed view of where the industry stands today and where it may be heading next. How should organizations turn regulation into momentum instead of resistance, and what will it take to earn lasting trust from patients, partners, and regulators alike? Useful Links Connect with Dr Werner Engelbrecht Learn more about Veeva Systems Viva Summit Europe and Viva Summit USA Follow on LinkedIn Thanks to our sponsors, Alcor, for supporting the show.

Send us a textDr. A. Mark Fendrick joins Dr. Michael Koren to discuss his life and legacy promoting value-based insurance design (VBID). VBID is the idea is that procedures which are neccecary should cost patients less than thsoe that are optional, and is seen in the US with many insurance plans offering 100% coverage of preventative services. Dr. Fendrick recounts his career and how he managed to get VBID language in healthcare laws under both Republican and Democratic legislatures, and that focusing on out-of-pocket patient costs has proved a beneficial strategy to getting policy passed. Dr. Fendrick closes the discussion talking about the future of healthcare in America, from the devestating loss of coverage due to changing administrations to the promise and danger of AI in the healthcare space.Visit Dr. Fendrick at Vbidcenter.orgBe 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!

Dr. Eugene Manley, biomedical scientist turned social impact leader and Founder and CEO of the STEMM & Cancer Health Equity Foundation,  is focused on increasing STEMM workforce diversity and improving outcomes for underserved cancer patients. He highlights the lack of diversity in foundational lung cancer research and the need to expand the number of cell lines being included to develop more effective therapies. Eugene also raises concerns about barriers to clinical trial participation and the need to engage local community partners and AI to raise awareness and improve accessibility. Eugene explains, "The SCHEQ Foundation, which is a short name for STEMM and Cancer Health Equity, is tasked with working to increase STEMM workforce diversity and improve outcomes for underserved patients navigating the cancer care continuum. This is done broadly through trying to increase STEMM access and exposure, mentorship and training programs to help students navigate career transitions, and providing information and resources to underserved patients to help them navigate and access the care they're entitled to." "There are many paths into the medical field now. If you're trying to do particularly applied research or do things that directly impact patient outcomes, then yes, you might want to go more of a technical path. But as we mentioned, AI is the new thing on the block. It's a lot of looking at trends, variances, and differences in data, and then you can use that to predict how things may act or behave. However, the downside of this is that the data is often based on one population, one race, or ethnicity, which makes it harder to broadly generalize these results. So that's a lot of the challenges that we're seeing right now." #SCHEQ #HealthEquity #STEMM #CancerResearch #DiversityInScience #BiomedicalResearch #ClinicalTrials #LungCancer #HealthDisparities #MedicalInnovation #SocialImpact #HealthcareAccess #PrecisionMedicine scheq.org Download the transcript here  

Dr. Eugene Manley, biomedical scientist turned social impact leader and Founder and CEO of the STEMM & Cancer Health Equity Foundation,  is focused on increasing STEMM workforce diversity and improving outcomes for underserved cancer patients. He highlights the lack of diversity in foundational lung cancer research and the need to expand the number of cell lines being included to develop more effective therapies. Eugene also raises concerns about barriers to clinical trial participation and the need to engage local community partners and AI to raise awareness and improve accessibility. Eugene explains, "The SCHEQ Foundation, which is a short name for STEMM and Cancer Health Equity, is tasked with working to increase STEMM workforce diversity and improve outcomes for underserved patients navigating the cancer care continuum. This is done broadly through trying to increase STEMM access and exposure, mentorship and training programs to help students navigate career transitions, and providing information and resources to underserved patients to help them navigate and access the care they're entitled to." "There are many paths into the medical field now. If you're trying to do particularly applied research or do things that directly impact patient outcomes, then yes, you might want to go more of a technical path. But as we mentioned, AI is the new thing on the block. It's a lot of looking at trends, variances, and differences in data, and then you can use that to predict how things may act or behave. However, the downside of this is that the data is often based on one population, one race, or ethnicity, which makes it harder to broadly generalize these results. So that's a lot of the challenges that we're seeing right now." #SCHEQ #HealthEquity #STEMM #CancerResearch #DiversityInScience #BiomedicalResearch #ClinicalTrials #LungCancer #HealthDisparities #MedicalInnovation #SocialImpact #HealthcareAccess #PrecisionMedicine scheq.org Listen to the podcast here  

Michael Kramer was 19 when cancer ambushed his life. He went from surfing Florida beaches to chemo, radiation, and a bone marrow transplant that left him alive but carrying a chronic disease. He had necrosis in his knees and elbows, lost his ability to surf for years, and found himself stuck in hospitals instead of the ocean. Yet he adapted. Michael picked up a guitar, built Lego sets, led support groups, and started sharing his story on Instagram and TikTok.We talk about masculinity, identity, and what happens when the thing that defines you gets stripped away. He opens up about dating in Miami, freezing sperm at a children's hospital, awkward Uber-for-sperm moments with his brother, and how meditation became survival. Michael lost his father to cancer when he was a teen, and that grief shaped how he lives and advocates today. He is funny, grounded, and honest about the realities of survivorship in your twenties. This episode shows what resilience looks like when you refuse to walk it off and choose to speak it out loud instead.RELATED LINKSMichael Kramer on InstagramMichael Kramer on TikTokMichael and Mom Inspire on YouTubeAshlee Cramer's BookUniversity of Miami Sylvester Comprehensive Cancer CenterStupid Cancer FEEDBACKLike this episode? Rate and review Walk It Off on your favorite podcast platform. For guest suggestions or sponsorship inquiries, email podcast@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Hosts Heather and Lauren sit down with Patrick McCarthy, CEO of Validcare, to discuss how technology is reshaping the future of clinical research. Patrick shares how Validcare is re‑engineering the traditional CRO model, known for its complexity, by creating a unified, tech-enabled approach that simplifies workflows, increases data quality, reduces costs, and expands access for patients and investigators alike. Patrick also breaks down the disruption facing biopharma and biotech companies, how evolving investor expectations are influencing emerging life sciences companies, and more. Tune in now!

Move beyond the hype in this episode as we explore how Agentic AI is actively reshaping clinical research by moving from theoretical concepts to real-world autonomous deployments. Tune in to discover how intelligent agents are accelerating trials today and exactly what this shift means for the future of your work.In this episode, host Sandy Vance is behind the mic with Michelle Longmire, the co-founder and Chief Executive Officer of Medable. Together they dive into what Medable is actually building and why it matters. They break down real examples of trials happening now, the evolving role of Clinical Research Associates, and how ambient and agentic AI are taking on the repetitive work that slows teams down. In this episode, they talk about:Medable's mission and long-term vision for clinical researchA pilot clinical trial Sandy participated in and what it revealedReal-world examples of clinical trials Medable is supporting todayThe evolving role of Clinical Research Associates in AI-enabled trialsKey use cases where Medable delivers the most impactHow ambient AI handles repetitive operational workWhy humans do their best work when focused on complex, meaningful challengesUsing generative and agentic AI in safe, deterministic waysCommon misconceptions about the risks of generative AIEmerging clinical research use cases expected in 2026A Little About Michelle:As the co-founder and Chief Executive Officer of Medable, Dr. Michelle Longmire is mission-driven to accelerate the development of new therapies for disease. A Stanford-trained physician-scientist, Dr. Longmire witnessed firsthand the critical barriers to drug development – including the time and costs associated with clinical trial participation. She founded Medable to pioneer a new category of clinical trial technologies that remove traditional roadblocks to participation and radically accelerate the research process. Medable is now the industry leader in decentralized and direct-to-patient research, with the ability to serve patients in over 120 languages, 60 countries, and across all therapeutic areas. In addition to having raised over $500M in venture capital and driving Medable to an industry-leading position, Dr. Longmire has received recognition as a leading innovator and businesswoman, including being named as one of the 100 most creative people in business by Fast Company.

Ro Wickramasinghe, Vice President and Head of Global Business at Pi Health, identifies fundamental problems plaguing clinical trials, including operational inefficiencies and limited access to trials. Pi Health is addressing these challenges by developing an integrated software platform for clinical trial sponsors, sites, and patients and partnering with community-based cancer treatment centers worldwide.  The company has built a hospital in India to serve as a living laboratory to test and refine its model to democratize access and increase the ethnic diversity of trial participants.  Ro explains, "I think the challenge has always been, from a pharma-biotech perspective, is to find patients, but, from the other perspective, its patients participating in trials and being able to find clinical trials. So a lot of stats get bandied around, but despite many eligible patients, the percentage of eligible patients who actually end up in a clinical trial is really small. It's like 5% to 8%, so not a huge amount. I think that's kind of one problem."  "So we have it in chicken and egg scenario where we as a company develop clinical trial software, but when ultimately the vision for us is for that to really become the standard of care and really make trials more efficient for the clinicians that treat the patients and run the trials for these pharma companies and biotech companies that develop the drugs and sponsor the study."  "But having said that, I think to run lots of studies, what we decided to do was to build our own cancer hospital in India. And the beauty of that is that it is fully vertically integrated at the point of care. So the data gets captured on those patients in FICS, which is the software we've developed and then we can run trials. We have run trials for pharma and biotech at that site using our software. So it was, I guess, one of the quicker ways to test the software in a real-world environment and also getting lots of data on FICS and how it can benefit patients from the point of care to being on trials."  #PiHealth #ClinicalTrials #HealthTech #CancerResearch #Innovation #DigitalHealth #PharmaTech #PatientAccess #MedTech #Healthcare #ClinicalResearch #GlobalHealth #HealthcareInnovation #India Pihealth.ai Download the transcript here

Ro Wickramasinghe, Vice President and Head of Global Business at Pi Health, identifies fundamental problems plaguing clinical trials, including operational inefficiencies and limited access to trials. Pi Health is addressing these challenges by developing an integrated software platform for clinical trial sponsors, sites, and patients and partnering with community-based cancer treatment centers worldwide.  The company has built a hospital in India to serve as a living laboratory to test and refine its model to democratize access and increase the ethnic diversity of trial participants.  Ro explains, "I think the challenge has always been, from a pharma-biotech perspective, is to find patients, but, from the other perspective, its patients participating in trials and being able to find clinical trials. So a lot of stats get bandied around, but despite many eligible patients, the percentage of eligible patients who actually end up in a clinical trial is really small. It's like 5% to 8%, so not a huge amount. I think that's kind of one problem."  "So we have it in chicken and egg scenario where we as a company develop clinical trial software, but when ultimately the vision for us is for that to really become the standard of care and really make trials more efficient for the clinicians that treat the patients and run the trials for these pharma companies and biotech companies that develop the drugs and sponsor the study."  "But having said that, I think to run lots of studies, what we decided to do was to build our own cancer hospital in India. And the beauty of that is that it is fully vertically integrated at the point of care. So the data gets captured on those patients in FICS, which is the software we've developed and then we can run trials. We have run trials for pharma and biotech at that site using our software. So it was, I guess, one of the quicker ways to test the software in a real-world environment and also getting lots of data on FICS and how it can benefit patients from the point of care to being on trials."  #PiHealth #ClinicalTrials #HealthTech #CancerResearch #Innovation #DigitalHealth #PharmaTech #PatientAccess #MedTech #Healthcare #ClinicalResearch #GlobalHealth #HealthcareInnovation #India Pihealth.ai Listen to the podcast here

Clinical trial budgeting remains one of the biggest bottlenecks in study startups, driving delays, rework, and frustration across sponsors, CROs, and research sites. In this episode of the Clinical Trial Podcast, recorded live at Research Revolution, a clinical research conference hosted by Florence Healthcare, we take a hard look at why clinical trial budget negotiations continue to break down—and what experienced operators are doing differently. This conversation brings together sponsor, site, and consultant perspectives to unpack the real drivers of delay, including slow escalation pathways, unclear or inconsistent budget justifications, misaligned expectations, and communication gaps between stakeholders. Rather than rehashing theory, this episode focuses on practical, experience-driven insights you can actually apply. In this episode, you'll learn: The most common causes of delays during clinical trial budget negotiations How sites can create clear, defensible budget justifications without triggering endless revision cycles What sponsors look for when approving higher-than-expected line items Best practices for internal rate cards, fee schedules, and budgeting templates How improved communication and transparency can reduce negotiation friction and speed study startup This episode features insights from: Kristen McKenna, Senior Manager and Investigator Contracts Lead at Pfizer Heidi Castle, Director of Business Development at Mercy Research Matt Lowery, CEO and Principal Consultant at The Pathways Group If you're involved in clinical trial budgeting, contracting, or study startup - whether at a sponsor, CRO, or research site - this episode offers practical insights to help you navigate negotiations more effectively and avoid common pitfalls. Listen to the episode to hear how sponsor, site, and consultant leaders approach clinical trial budgeting and study startup.

New research is transforming the outlook for cervical and uterine cancers -- two of the most serious gynecologic malignancies worldwide – and we'll be hearing from one of the people shaping that progress, Dr. Mary McCormack, on this episode of Raise the Line. From her perch as the senior clinical oncologist for gynecological cancer at University College London Hospitals, Dr. McCormack has been a driving force in clinical research in the field, most notably as leader of the influential INTERLACE study, which changed global practice in the treatment of locally advanced cervical cancer, a key reason she was named to Time Magazine's 2025 list of the 100 most influential people in health. “In general, the protocol has been well received and it was adopted into the National Comprehensive Cancer Network guidelines which is a really big deal because lots of centers, particularly in South and Central America and Southeast Asia, follow the NCCN's lead.”In this conversation with host Michael Carrese, you'll learn about how Dr. McCormack overcame recruitment and funding challenges, the need for greater access to and affordability of treatments, and what lies ahead for women's cancer treatment worldwide. Mentioned in this episode:INTERLACE Cervical Cancer Trial If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/podcast

Send us a textDr. Noelle Pomeroy, PhD, joins Dr. Erich Schramm to discuss mental health, particularly from the perspective of relationships. The two discuss the value of therapy and the importance of talking with an expert in areas that are new to us, and then get into sexual health and relationships. They talk through the changes that happen as people age, the challenges that pornography can create for chronic users, and how intimacy can change over the life of a relationship. Dr. Pomeroy then gives practical advice for couples on sex, nonsexual intimacy, and the importance of communication.Visit Noelle Pomeroy on the web at https://jax-therapy.com/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!

Brenda Davis opens with powerful evidence that type 2 diabetes is not a life sentence—covering remission data, the Twin Cycles hypothesis, and groundbreaking trials showing reversal with diet. #DiabetesReversal #PlantBasedHealth #TwinCycles

Daniel Garza had momentum. Acting roles, directing gigs, national tours lined up. Then anal cancer stopped everything. Radiation wrecked his body, stripped him of control, and left him in diapers, staring down despair. His partner, Christian Ramirez, carried him through the darkest nights, changed his wounds, fought hospitals, and paid the price with his own health. Christian still lives with permanent damage from caregiving, but he stayed anyway.Together they talk with me about masculinity, sex, shame, friendship, and survival. They describe the friendships that vanished, the laughter that kept them alive, and the brutal reality of caregiving no one prepares you for. We get into survivor guilt, PTSD, and why even rocks need rocks. Daniel is now an actor, director, and comedian living with HIV. Christian continues to tell the unfiltered truth about what it takes to be a caregiver and stay whole. This episode gives voice to both sides of the cancer experience, the survivor and the one who stands guard. RELATED LINKSDaniel Garza IMDbDaniel Garza on InstagramDaniel Garza on FacebookChristian Ramirez on LinkedInLilmesican Productions Inc (Daniel & Christian)Stupid Cancer FEEDBACKLike this episode? Rate and review Walk It Off on your favorite podcast platform. For guest suggestions or sponsorship inquiries, email podcast@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

First patient treated in Part B of ASTRA trial evaluating SB-007.

In this episode of Parts and Labor, Angela Chaudhari, MD, hosts a panel of experts from Northwestern Medicine's Division of Gynecologic Oncology to discuss the groundbreaking research and clinical trials shaping the future of gynecologic cancer care. The panel explores innovations in immunotherapy, investigator-initiated trials, survivorship and symptom science, while highlighting efforts to expand access and diversity in clinical research across Chicago and the surrounding suburbs.This episode's panel of guests includes:• Emma L. Barber, MD, John and Ruth Brewer Professor of Gynecology and Cancer Research, Division Chief of Gynecologic Oncology and Director of Robotic Surgery• Daniela E. Matei, MD, Diana, Princess of Wales Professor of Cancer Research and Chief of Reproductive Science in the Departments of Obstetrics and Gynecology and Hematology and Oncology• Dario R. Roque, MD, Associate Professor of Gynecologic Oncology and Fellowship Program Director• Emily M. Hinchcliff, MD, Assistant Professor of Gynecologic Oncology and Program Director of the OB-GYN Residency Program

Skin Deep: How Melanin Impacts Your Body's Response To DrugsScientific research is becoming more inclusive, but one area that's still lacking this diversity is pre-clinical research. Without knowing how medications will react to different ancestries and skin tones, millions of people are being put at risk. Our experts discuss the effect melanin has on a drug's efficacy and changes the industry can implement right now that will make a big difference.  Does Birth Control Cause PCOS? Facts And Misconceptions Of The Disorder  Polycystic ovarian syndrome affects at least one in ten women – probably more since it's so underdiagnosed. Sadly, many women are told that having PCOS means they'll never become pregnant. However, our expert this week dispels this and other misinformation that's widespread about PCOS.  Medical Notes: Robots Are Outperforming Doctors, The Dangerous Additives In Ultra-Processed Foods, And How Happiness Supports Your Brain HealthHow scientists could catch Schizophrenia sooner than ever before. Ultra-processed foods may be raising your blood sugar levels. How happiness supports your brain health. Are robots better doctors? Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Send us a textDr. Michael Koren joins Kevin Geddings to discuss atrial fibrillation. This heart condition is caused by rapid, irregular heartbeats originating in the upper chambers and is a critical risk factor for strokes. Dr. Koren talks about the current standard-of-care medicines for atrial fibrillation, blood thinners, and  their shortcomings. He finishes with an explanation of how clinical trials are looking for new ways to lower the risk of stroke in those with atrial fibrillation with a better side effect profile than current blood thinners.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!

In this episode of From Lab To Launch, Meg is joined by Dr. Les Enterline, Senior VP and Global Head of Functional Service Partnerships at PPD, part of Thermo Fisher Scientific.With decades of experience across clinical research, Les is helping redefine how biopharma companies structure and scale their development teams through what's known as the FSP model: a flexible outsourcing approach that's gaining traction as sponsors face increasing pressure to deliver trials faster, more efficiently, and with more adaptive designs.As clinical complexity grows and internal teams get stretched thin, FSPs are helping organizations scale specialized expertise while maintaining oversight, quality, and operational control. Under Les' leadership, PPD has become one of the industry leaders in offering hybrid and fit-for-purpose models that blend the best of traditional CRO services with strategic resourcing.In today's conversation, we'll explore how functional partnerships are evolving, how sponsors are rethinking outsourcing to meet modern challenges, and where the future of trial delivery is headed. Qualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Dr. Hope Rugo and Dr. Vivek Subbiah discuss innovative trial designs to enable robust studies for smaller patient populations, as well as the promise of precision medicine, novel therapeutic approaches, and global partnerships to advance rare cancer research and improve patient outcomes. TRANSCRIPT  Dr. Hope Rugo: Hello and welcome to By the Book, a podcast series from ASCO that features engaging conversations between editors and authors of the ASCO Educational Book. I am your host, Dr. Hope Rugo. I am the director of the Women's Cancers Program and division chief of breast medical oncology at the City of Hope Cancer Center [in Los Angeles]. The field of rare cancer research is rapidly transforming thanks to progress in clinical trials and treatment strategies, as well as improvements in precision medicine and next-generation sequencing that enable biomarker identification. According to the National Cancer Institute, rare cancers occur in fewer than 150 cases per million each year, but collectively, they represent a significant portion of all cancer diagnoses. And we struggle with the appropriate treatment for these rare cancers in clinical practice. Today, I am delighted to be joined by Dr. Vivek Subbiah, a medical oncologist and the chief of early-phase drug development at the Sarah Cannon Research Institute in Nashville, Tennessee. Dr. Subbiah is the lead author of a paper in the ASCO Educational Book titled "Designing Clinical Trials for Patients with Rare Cancers: Connecting the Zebras," a great title for this topic. He will be telling us about innovative trial designs to enable robust studies for small patient populations, the promise of precision medicine, and novel therapeutic approaches to improve outcomes, and how we can leverage AI now to enroll more patients with rare cancers in clinical trials. Our full disclosures are available in the transcript of this episode.  Dr. Subbiah, it is great to have you on the podcast today. Thanks so much for being here. Dr. Vivek Subbiah: Thank you so much, Dr. Rugo, and it is an honor and pleasure being here. And thank you for doing this podcast for rare cancers. Dr. Hope Rugo: Absolutely. We are excited to talk to you. And congratulations on this fantastic paper. It is such a great resource for our community to better understand what is new in the field of rare cancer research. Of course, rare cancers are complex and multifaceted diseases. And this is a huge challenge for clinical oncologists. You know, our clinics, of course, cannot be designed as we are being very uni-cancer focused to just be for one cancer that is very rare. So, oncologists have to be a jack of all trades in this area. Your paper notes that there are approximately 200 distinct types of rare and ultra-rare cancers. And, by definition, all pediatric cancers are rare cancers. Of course, clinical trials are essential for developing new treatment strategies and improving patient outcomes, and in your paper, you highlight some unique challenges in conducting trials in this rare cancer space. Can you tell us about the challenges and how really innovative trial designs, I think a key issue, are being tailored to the specific needs of patients with rare cancer and, importantly, for these trials? Dr. Vivek Subbiah: Rare cancers present a perfect storm of challenges. First, the patient populations are very small, which makes it really hard to recruit enough participants for traditional type trials. Second, these patients are often geographically dispersed across multiple cities, across multiple states, across multiple countries, across multiple zip codes. So, logistics become complicated. Third, there is often limited awareness among clinicians, which delays referrals and diagnosis. Add to that regulatory hurdles, funding constraints, and you can see why rare cancer trials are so tough to execute. To overcome these barriers, we are seeing some really creative novel trial designs. And there are four different types of trial designs that are helping with enrolling patients with rare cancers. The first one is the basket trial. So let us talk about what basket studies are. Basket studies group patients based on shared genetic biomarkers or shared genetic mutations rather than tumor type. So instead of running separate 20 to 30 to 40 trials, you can study one therapy across multiple cancers. The second type of trial is the umbrella trial. The umbrella trials flip that concept of basket studies. They focus on one cancer type but test multiple targeted therapies within it. The third category of innovative trials are the platform studies. Platform trials are another exciting innovation. They allow new treatment arms to be added or removed as the data matures and as the data evolves, making trials more adaptive and efficient. The final category are decentralized tools in traditional trials, which are helping patients participate closer to where they are so that they can sleep in their own bed, which is, I think, a game changer for accessibility.  These designs maximize efficiency and feasibility for rare cancer research and rare cancer clinical trials. Dr. Hope Rugo: I love the idea of the platform trials that are decentralized. And I know that there is a trial being worked on with ARPA-H (Advanced Research Projects Agency for Health) funding in triple-negative breast cancer as well as in lung cancer, I think, and others with this idea of a platform trial. But it is challenged, I think, by precision medicine and next-generation sequencing where some patients do not have targetable markers, or there isn't a drug to target the marker. I think those are almost the same thing. We have really seen that these precision medicine ideas and NGS have moved the needle in helping to identify genetic alterations. This helps us to be more personalized. It actually helps with platform studies to customize trial enrollment. And we hope that this will result in better outcomes. It also allows us, I think, to study drugs even in the early stage setting more effectively. How can these advances be best applied to the future of rare cancers, as well as the challenges of not finding a marker or not having a drug? Dr. Vivek Subbiah: Thank you so much for that question. I think precision medicine and next-gen sequencing, or NGS, are truly the backbone of modern precision oncology. They have transformed how we think about cancer treatment. Instead of treating based on where the tumor originated or where the tumor started, we now look at the genetic blueprint of cancer. The NGS or next-gen sequencing allows us to sequence millions of DNA fragments quickly. Twenty, 30 years ago, they said we cannot sequence a human genome. Then it took almost a decade to sequence the first human genome. Right now, we have academic centers and commercial sequencing companies that are really democratizing NGS across all sites, not just in academic centers, across all the community sites, so that NGS is now accessible. This means that we can identify these actionable alterations like picking needles in haystacks, like NTRK fusions, RET fusions, or BRAF V600E alterations, high tumor mutational burden. This might occur across not one tumor type, across several different tumor types. So for rare cancers, this is critical because some of these mutations often define the best treatment option. Here is why this matters. Personalized therapy, right? Instead of a one-size-fits-all approach, we can tailor treatment to the patient's unique molecular profile. For trial enrollment, this can definitely help because patients can join biomarker-driven trials even if their cancer type is rare or ultra-rare. NGS technology has also helped us in designing rational studies. Many times monotherapy does not work in these cancers. So we are thinking about rational combination strategies. So NGS technology is helping us. Looking ahead, I see NGS becoming routine in clinical practice, not just at major niche academic centers, but everywhere. We will see more tumor-agnostic approvals, more molecular tumor boards guiding treatment decisions in real time. And I think we are seeing an expanded biomarker setup. Previously, we used to have only a few drugs and a handful of mutations. Now with homologous recombination defects, BRCA1/2 mutation, and expanding the HRD and also immunohistochemistry, we are expanding the biomarker portfolio. So again, I personally believe that the future is precision. What I mean by precision is delivering the right drug to the right patient at the right time. And for rare cancers, this isn't just progress. It is survival. And it is maybe the only way that they can have access to these cutting-edge precision medicines. Dr. Hope Rugo: That is so important. You mentioned an important area we will get to in a moment, the tumor-agnostic therapies. But as part of talking about that, do you think that the trials should also include just standard therapies? You know, who do you give an ADC to and when with these rare cancers? Because some of them do not have biomarkers to target and it is so disappointing for patients and providers where you are trying to screen a patient for a trial or a platform trial where you have one arm with this mutation, one arm with that, and they do not qualify because they only have a p53 loss, you know? They just do not have the marker that helps them. But we see this in breast cancer all the time. And it is tough because we don't have good information on the sequencing. So I wonder, you know, just because for some of these rare cancers it is not even clear what to use when with standard treatments. And then that kind of gets into this idea of the tumor-agnostic therapies that you mentioned. There are a lot of new treatments that are being evaluated. We have seen approval of some treatments in the last few years that are tumor-agnostic and based on a biomarker. Is that the best approach as we go forward for rare cancers? And what new treatment options are most exciting to you right now? Dr. Vivek Subbiah: Tumor-agnostic therapies, really close to my heart, are real breakthrough therapies and represent a major paradigm shift in oncology. Traditionally, for the broad listeners here, we are used to thinking about designing clinical trials and therapy like where the cancer originated, breast cancer, kidney cancer, prostate cancer, lung cancer. A tumor-agnostic therapy flips that model. Instead of focusing on the organ, they target the specific genetic alteration or biomarker that drives cancer growth regardless of where the tumor started, regardless of the location of the tumor, regardless of the zip code of the tumor. So why is this so important for rare cancers? Because many rare cancers share molecular features with more common cancers. For instance, NTRK fusion might occur in pediatric sarcoma, a salivary gland tumor, or a thyroid cancer. Historically, each of these would require separate trials, which is nearly impossible, unfeasible to conduct in these ultra-rare cancers like salivary gland cancer or pediatric sarcomas. Tumor-agnostic therapies allow us to treat all those cancers with the same targeted drug if they share that biomarker. Again, we are in 2025. The first tissue-agnostic approval, the historic precedent, was in fact an immunotherapy. Pembrolizumab was approved in 2017, May 2017, as the first immunotherapy to be approved in a tumor-agnostic way for a genomic biomarker, for MSI-High and dMMR cancers. Then came the NTRK inhibitors. So today we have not one, not two, but three different NTRK inhibitors: larotrectinib, entrectinib, and repotrectinib, which show response rates of nearly more than 60 to 75% across a handful of dozens and dozens of cancer types. Then, of course, we have RET inhibitors like selpercatinib, which is approved tissue-agnostic, and pralsetinib, which also shows tissue-agnostic activity across multiple cancers. And more recently, combination therapy with a BRAF and MEK combination, dabrafenib and trametinib, received tumor-agnostic approval for all BRAF V600E tumors with the exception of colorectal cancer. And even recently, you mentioned about antibody drug conjugates. Again, I think we live in an era of antibody drug conjugates. And Enhertu, trastuzumab deruxtecan, which was used first in breast cancer, now it is approved in a histology-agnostic manner for all HER2-positive tumors defined by immunohistochemistry 3+. So again, beyond NGS, now immunohistochemistry for HER2 is also becoming a biomarker. So again, for the broad listeners here, in addition to comprehensive NGS that may allow patients to find treatment options for these rare cancers for NTRK, RET, and BRAF, immunohistochemistry for HER2 positivity is also emerging as a biomarker given that we have a new FDA approval for this. So I would say personally that these therapies are game changers because they open doors for patients who previously had no options. Instead of waiting for years for a trial in their specific cancer type, they can access a treatment based on their molecular profile. I think it is precision medicine at its finest and best. Looking ahead, the third question you asked me is what is exciting going on? I think we will see more of these approvals. My hope is that today, I think we have nine to ten approvals. My hope is that within the next 25 to 50 years, we will have at least 50 to 100 drugs approved in this space based on a biomarker, not based on a location of the tumor type. Drug targeting rare alterations like FGFR2 fusions, FGFR amplifications, ALK fusions, and even complex signatures like high tumor mutational burden. I think we will be seeing hopefully more and more drugs approved. And as sequencing becomes routine, we will identify more patients for these therapies. I think for rare cancers, this is not just innovative approach. This is essential for them to access these novel precision medicines. Dr. Hope Rugo: Yeah, that is such a good point. I do think it is critical. Interestingly in breast cancer, it hasn't been, you know, there is always like two patients in these tumor-agnostic trials, or if that. You know, I think I have seen one NTRK fusion ever. I think that highlights the importance for rare cancers. And you know, I am hoping that that will translate into some new directions for some of our rarer and impossible-to-treat subtypes of breast cancer. It is this kind of research that is really going to make a difference. But what about those people who do not have biomarkers? What if you do not fit into that? Do you think there is a possibility of trying to do treatments for rare cancers in some prospective way that would help with that? You know, it is really a huge challenge. Dr. Vivek Subbiah: Absolutely. I think, you know, you're right, usually many of these rare cancers are driven by specific biomarkers. And again, some of the pediatric salivary gland tumors or pediatric sarcomas like fibrosarcomas, they are pathognomonic with NTRK fusions. And again, given that we have a tumor-agnostic approval, now these patients have access to these therapies. And I do not think that we would have had a trial just for pediatric fibrosarcomas with NTRK fusions. So that is one way. Another way is SWOG, right? The SWOG DART [1609] had this combination dual checkpoint, it was called the DART study dual combination chemotherapy with ipi/nivo. Now here the rare cancer subtype itself becomes a biomarker and they showed activity across multiple rare cancer subtypes. They didn't require a biomarker. As long as it was a rare or ultra-rare cancer, these patients were enrolled into the SWOG DART trial and multiple arms have read out. Angiosarcoma, Kaposi sarcoma, even gestational trophoblastic disease. Again, they have shown responses in these ultra-rare, rare cancers. Sometimes they might be seeing one or two cases a whole year. And I think this SWOG effort, this cooperative group effort, really highlighted the need for such studies without biomarkers as well. Dr. Hope Rugo: That is such a fantastic example of how to try and treat patients in a collaborative way. And in the paper, you also emphasize the need for collaborative research efforts, you know, uniting resource expertise across different ways of doing research. So cooperative groups, advocacy organizations that can really help advance rare cancer research, improve access to new therapies, and I think importantly influence policy changes. I think this already happened with the agnostic approvals. Could you tell us more about that? How can we move forward with this most effectively? Dr. Vivek Subbiah: Personally, I believe that collaboration is absolutely critical and essential for rare cancer research. No single institution, no single individual, or no single state or entity can tackle these challenges alone. The patient populations are small and dispersed. So pooling resources is the only way to run these meaningful trials. Again, it is not like singing, it is like putting a huge, huge, I would say, an opera piece together. It is not a solo, vocal therapy, but rather putting a huge opera piece like Turandot. You know, you mentioned cooperative groups. Cooperative groups, as I mentioned earlier, the SWOG DART program, the ASCO [TAPUR study]. ASCO is doing a phenomenal work of the TAPUR study. Again, this ASCO TAPUR program has enrolled so many patients with rare cancers who otherwise would not have treatment options. NCI-MATCH, the global effort, right? NCI-MATCH and the ComboMATCH are great examples. They bring together hundreds of sites, thousands of clinicians to run large-scale trials that would be impossible for any individual center or institution. These trials have already changed practice. For instance, the DART demonstrated the power of immunotherapy in rare cancers and influenced NCCN guidelines. One of the arms of the NCI-MATCH study from the BRAF V600E arm contributed towards the BRAF V600E tissue-agnostic approval. So, the BRAF V600E tissue-agnostic approval was by a pooled analysis of several studies. The ROAR study, the Rare Oncology Agnostic Research study, the NCI-MATCH dataset of tumor-agnostic cohort, and another pediatric trial, and also evidence from literature and evidence of case reports. And all this pooled analysis contributed to the tissue-agnostic approval of BRAF V600E across multiple rare cancers. There are several patient advocacy organizations which are the real unsung heroes here. Groups like, for instance, we mentioned in the paper, Target Cancer Foundation, don't just raise awareness for rare cancer research, they actively connect patients to trials providing financial, emotional support, and even run their own studies like the TRACK trial. They also influence policy to make access easier. On a global scale, initiatives like DRUP in the Netherlands, the ROME study in Italy, the PCM4EU in Europe are expanding precision medicine across these borders. These collaborations accelerate research, improve trial enrollment, and ensure patients everywhere can have access to these cutting-edge therapies. Again, it is truly a team effort, right? It is a multi-stakeholder approach. Researchers, clinicians, investigators, industry, regulators, academia, patients, patient advocates, and their caregivers all working together. And it takes a village. Dr. Hope Rugo: Absolutely. I mean, what a nice response to that. And I think really exciting and it is great to see your passion about this as well. But it helps all of us, I think, getting discouraged in treating these cancers to understand what is happening moving forward. And I think it is also a fabulous opportunity for our junior colleagues as they rise up in academics to be involved in these international collaborative efforts which are further expanding. One of the things that comes up for clinical trials for patients, and I think it is highlighted with rare cancers because, as you mentioned, people are all over the place, you know, they are so rare. They are all far away. Our patients are always saying to us, "Should I go here for a phase 1 trial?" Can you talk a little bit about how we can overcome these financial and geographic burdens for the patients? You talked about having trials locally, but it is a big financial and just social burden for patients. Dr. Vivek Subbiah: Great point. Financial cost is a major barrier in rare cancer clinical trials. It is a major barrier not just in rare cancer clinical trials, but in clinical trials in general. The economics of rare cancer research are one of the toughest challenges we face. Developing a new drug is already expensive, often billions of dollars. On an average, it takes 2 billion dollars or 2.8 billion dollars according to some data from drug discovery to approval. For rare cancers, the market is tiny, which means the pharmaceutical companies have really little financial incentive to invest. That is why initiatives like the Orphan Drug Act were created to provide tax credits, grants, and market exclusivity to encourage development for rare diseases. Clinical trials themselves are expensive because the small patient populations mean longer recruitment times and higher per-patient costs. Geographic dispersion, as you mentioned, for the patients adds travel, coordination. That is why we need to think out of the box about decentralized trial infrastructure so that we can mitigate some of these expenses. Complex trial designs like basket or platform trials sometimes require sophisticated data systems and regulatory oversight. That is a challenge. And I think some of the pragmatic studies like ASCO TAPUR have overcome those challenges. Advanced technologies like next-gen sequencing and molecular profiling also add significant upfront cost to this. Funding is also limited because rare cancers receive less attention compared to common cancers. Public funding and cooperative group trials help a lot, but I think they cannot cover everything. Patient advocacy organizations sometimes step in to bridge these gaps, but sustainable financing remains a huge challenge. So, the bottom line is without financial incentives and collaborating funding models, many promising therapies for rare cancers would never make it to patients. That is why we need system-wide policy changes, global partnerships, and innovative, effective, seamless trial designs which are so critical so that they can help reduce the cost and make research feasible so that we can deliver the right drug to the right patient at the right time. Dr. Hope Rugo: There is a lot of excitement about the future integration of AI in screening. Just at the San Antonio Breast Cancer meetings, we have a number of different presentations about AI to find markers, even like HER2, and using AI where you would screen and then match patients to clinical trials. Do you have any guidance for the rare cancer community on how to leverage this technology in order to optimize patient enrollment and, I think, identification of the best treatment matches? Dr. Vivek Subbiah: I think artificial intelligence, AI, is a game-changer in the making. Right now, clinical trial is clunky. Matching patients to trial is often manual, time consuming, laborious. You need a lot of personnel to do that. AI can automate this process by analyzing genomic data, medical records, and trial eligibility criteria to find the best matches quickly, accurately, and effectively. For the community, the key is to invest in data standardization and interoperability because AI needs clean, structured data to work effectively. Dr. Hope Rugo: Thank you so much, Dr. Subbiah, for sharing these fantastic insights with us on the podcast today and for your excellent article. Dr. Vivek Subbiah: Thank you so much. Dr. Hope Rugo: We thank you, our listeners, for joining us today. You will find a link to Dr. Subbiah's Educational Book article in the transcript of this episode. And please join us again next month on By the Book for more insightful views on key issues and innovations that are shaping modern oncology.  Thank you. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:        Dr. Hope Rugo   @hoperugo   Dr. Vivek Subbiah @VivekSubbiah Follow ASCO on social media:        ASCO on X  ASCO on Bluesky       ASCO on Facebook        ASCO on LinkedIn        Disclosures:       Dr. Hope Rugo:    Honoraria: Mylan/Viatris, Chugai Pharma   Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer   Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx   Dr. Vivek Subbiah: Consulting/Advisory Role: Loxo/Lilly, Illumina, AADI, Foundation Medicine, Relay Therapeutics, Pfizer, Roche, Bayer, Incyte, Novartis, Pheon Therapeutics, Abbvie Research Funding (Inst.): Novartis, GlaxoSmithKline, NanoCarrier, Northwest Biotherapeutics, Genentech/Roche, Berg Pharma, Bayer, Incyte, Fujifilm, PharmaMar, D3 Oncology Solutions, Pfizer, Amgen, Abbvie, Mutlivir, Blueprint Medicines, Loxo, Vegenics, Takeda, Alfasigma, Agensys, Idera, Boston Biomedical, Inhibrx, Exelixis, Amgen, Turningpoint Therapeutics, Relay Therapeutics Other Relationship: Medscape, Clinical Care Options

Skin Deep: How Melanin Impacts Your Body's Response To DrugsScientific research is becoming more inclusive, but one area that's still lacking this diversity is pre-clinical research. Without knowing how medications will react to different ancestries and skin tones, millions of people are being put at risk. Our experts discuss the effect melanin has on a drug's efficacy and changes the industry can implement right now that will make a big difference.  Host: Elizabeth Westfield.  Producer: Kristen Farrah.  Guests: Sophie Zaaijer, Molecular Biologist, Consultant for Diversity, Equity, and Inclusion and Clinical Trials; Simon Groen, Assistant Professor of Evolutionary Systems Biology, University of California at Riverside Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

This podcast is brought to you by Outcomes Rocket, your exclusive healthcare marketing agency. Learn how to accelerate your growth by going to⁠ outcomesrocket.com Accelerating drug development from ten years to one is possible when data, technology, and clinical trial design finally work together. In this episode, Bari Kowal, Senior Vice President of Development Operations & Portfolio Management for Regeneron, discusses how modernizing clinical trials, strengthening data infrastructure, and using AI responsibly can expand patient access and accelerate development. She emphasizes that education is a significant missing link in clinical research and that true progress depends on interoperability rather than flashy standalone tools. Bari highlights the need for clean, structured data and strong partnerships with health systems to integrate genetics, EMRs, and real-world information for more personalized and preventive medicine. She also explores the future of drug development, emphasising the importance of reducing cycle time, fostering regulatory collaboration, streamlining protocols, ensuring site readiness, and simplifying trial complexity while leveraging digital biomarkers effectively. Tune in and learn how thoughtful trial design, better data, and smarter collaboration can reinvent the path from discovery to patient impact! Resources Connect with and follow Bari Kowal on LinkedIn. Follow Regeneron on LinkedIn and visit their website!

In this episode of Disruption/Interruption, host KJ sits down with Jurek Kozyra, founder and CEO of Nanovery, to explore how DNA nanotechnology and AI are revolutionizing molecular medicine. Discover how tiny nanorobots made from DNA could dramatically accelerate drug development, make diagnostics faster and more affordable, and potentially cure diseases that were previously untreatable. From detecting diseases in hours instead of days to cutting years off the drug development process, this conversation reveals the cutting-edge science that's transforming healthcare. Four Key Takeaways: The Promise of Oligonucleotide Therapeutics (9:06) Traditional medicine targets defective proteins, but many diseases can't be cured because we can't find the right molecule. Oligonucleotide therapeutics target mRNA—the underlying mechanism of disease—meaning you could potentially cure all diseases since all proteins come from mRNA. DNA Nanorobots for Rapid Detection (14:12) Nanovery's DNA nanorobots can detect diseases in blood samples within 2-4 hours compared to traditional lab tests that take two days. These self-assembling machines produce fluorescent signals when they find specific DNA or RNA molecules, enabling point-of-care diagnostics. Accelerating Drug Development (17:13) Pharmaceutical companies race against 20-year patents while drugs take 10+ years to develop. Nanovery's technology provides more accurate data at lower cost and time, potentially shaving years off the development process and helping more drugs successfully reach the market. Real-World Clinical Validation (20:26) In a hospital study with 170 patient samples, Nanovery's technology delivered same or better results than traditional tests in just two hours instead of two days—a game-changer for emergency situations like drug overdoses where immediate answers are critical. Quote of the Show (9:05):"If you can target mRNA very specifically, that means that in theory you could potentially cure all diseases. That's why this area is so exciting right now." – Jurek Kozyra Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Jurek Kozyra: LinkedIn: https://www.linkedin.com/in/j3ny/ Company Website: https://nanovery.co.uk How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

Join podcast host Takanori Yamaguchi, MD, PhD, and his guests Koichi Magashina, MD, PhD, and Michifumi Tokuda, MD, PhD for this week's Lead episode. This episode was recorded LIVE at APHRS 2025 in Yokohama, Japan. This episode is recorded entirely in Japanese. The DECAF trial investigated whether continuing regular caffeinated coffee consumption versus complete abstinence affected the recurrence of atrial fibrillation (AF) or atrial flutter in patients after successful cardioversion. Over six months in this randomized study of 200 adults, those who drank at least one cup of caffeinated coffee daily had a significantly lower rate of AF or flutter recurrence compared to those who abstained (47% vs. 64%), suggesting moderate coffee intake may be safe and potentially beneficial for rhythm stability in this setting.    Learning Objectives Evaluate the impact of caffeinated coffee consumption versus abstinence on atrial fibrillation recurrence following cardioversion. Interpret the design and key outcomes of the DECAF randomized clinical trial and their relevance to clinical practice. Apply the trial findings to patient counseling regarding caffeine intake and atrial fibrillation management.   Article Authors Christopher X. Wong, MBBS, MPH, PhD; Christopher C. Cheung, MD, MPH; Gabrielle Montenegro, BA, Hannah H. Oo, BS; Isabella J. Peña, BA; Janet J. Tang, MPH, PhD; Samuel J. Tu, MBBS; Grace Wall, BA1; Thomas A. Dewland, MD; Joshua D. Moss, MD; Edward P. Gerstenfeld, MD; Zian H. Tseng, MD, MAS; Henry H. Hsia, MD; Randall J. Lee, MD, PhD; Jeffrey E. Olgin, MD; Vasanth Vedantham, MD; Melvin M. Scheinman, MD; Catherine Lee, PhD; Prashanthan Sanders, MBBS, PhD; Gregory M. Marcus, MD, MAS Podcast Contributors Takanori Yamaguchi, MD, PhD Koichi Magashina, MD, PhD Michifumi Tokuda, MD, PhD   Link to article Host and Contributor Disclosure(s): T. Yamaguchi Honoraria/Speaking/Teaching/Consulting: Abbott Japan, Japan Medtronic, Inc., Daiichi Sankyo, Boehringer Ingelheim, Bayer Healthcare Pharmaceutical, Japan, Nihon Kohden, Japan Lifeline, Novartis K. Nagashina   Nothing to disclose M. Tokuda   Honoraria/Speaking/Consulting: Medtronic Japan   Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner): S. Sailor: No relevant financial relationships with ineligible companies to disclose.

Join Digital Education Committee Member and podcast host Melissa E. Middeldorp, MPH, PhD, and her guests Eue-Keun Choi, MD, PhD, and Sandeep Prabhu, MBBS, PhD for this week's Lead episode. This episode was recorded LIVE at APHRS 2025 in Yokohama, Japan. The DECAF trial investigated whether continuing regular caffeinated coffee consumption versus complete abstinence affected the recurrence of atrial fibrillation (AF) or atrial flutter in patients after successful cardioversion. Over six months in this randomized study of 200 adults, those who drank at least one cup of caffeinated coffee daily had a significantly lower rate of AF or flutter recurrence compared to those who abstained (47% vs. 64%), suggesting moderate coffee intake may be safe and potentially beneficial for rhythm stability in this setting.    Learning Objectives Evaluate the impact of caffeinated coffee consumption versus abstinence on atrial fibrillation recurrence following cardioversion. Interpret the design and key outcomes of the DECAF randomized clinical trial and their relevance to clinical practice. Apply the trial findings to patient counseling regarding caffeine intake and atrial fibrillation management.   Article Authors Christopher X. Wong, MBBS, MPH, PhD; Christopher C. Cheung, MD, MPH; Gabrielle Montenegro, BA, Hannah H. Oo, BS; Isabella J. Peña, BA; Janet J. Tang, MPH, PhD; Samuel J. Tu, MBBS; Grace Wall, BA1; Thomas A. Dewland, MD; Joshua D. Moss, MD; Edward P. Gerstenfeld, MD; Zian H. Tseng, MD, MAS; Henry H. Hsia, MD; Randall J. Lee, MD, PhD; Jeffrey E. Olgin, MD; Vasanth Vedantham, MD; Melvin M. Scheinman, MD; Catherine Lee, PhD; Prashanthan Sanders, MBBS, PhD; Gregory M. Marcus, MD, MAS Podcast Contributors Melissa E. Middeldorp, MPH, PhD Eue-Keun Choi, MD, PhD Sandeep Prabhu, MBBS, PhD   Link to article Host and Contributor Disclosure(s): E.K. Choi •Honoraria/Speaking/Teaching/Consulting: Daiichi •Stock Options, Privately Held: DeepQure •Research: Biosense Webster, Inc., Bristol-Meyers Squibb, Bayer Healthcare Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp., Jeil Pharmaceutical Co, Medtronic, Inc., Samjinpharm, Seers Technology, Skylabs, Genome Opinion Inc S. Prabhu   •Honoraria/Speaking/Consulting: Biosense Webster •Research: National Health and Medical Research •Fellowship Support: St. Jude Medical Center, Boston Scientific   M. Middeldorp   •Nothing to disclose.   Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner): S. Sailor: No relevant financial relationships with ineligible companies to disclose.

Dr. Elinor Ben-Menachem, epileptologist, researcher and professor at Sweden's University of Gothenburg, shares insights and experiences from her 40-plus years working with clinical trials and providing care to refractory epilepsy patients.

Doctors Lisa and Sara are back with Consultant Neurologist Dr Antonella Macerollo for this episode about Parkinson's disease.  We look at a typical case and discuss what Parkinson's is, the differentials, the need for time to discern between these, and the options for treatment. Links include information on Clinical Trials and Parkinson's UK which is an active Charity linking resources together for patients and professionals. Thanks to Alison Day at Parkinson's UK for making the connection between ourselves and Antonella to make these episodes possible. You can use these podcasts as part of your CPD - we don't do certificates but they still count :)   Resources: Parkinson's UK: https://www.parkinsons.org.uk/ The epidemiological link between Essential Tremor and Parkinson's Disease: https://www.nature.com/articles/s41531-023-00577-y PD Frontline (clinical trial in Parkinson's disease): https://pdfrontline.com/en Cure Parkinson's: https://cureparkinsons.org.uk/ Parkinson's Europe Charity (good resources): https://parkinsonseurope.org/ ___ We really want to make these episodes relevant and helpful: if you have any questions or want any particular areas covered then contact us on Twitter @PCKBpodcast, or leave a comment on our quick anonymous survey here: https://pckb.org/feedback Email us at: primarycarepodcasts@gmail.com ___ This podcast has been made with the support of GP Excellence and Greater Manchester Integrated Care Board. Given that it is recorded with Greater Manchester clinicians, the information discussed may not be applicable elsewhere and it is important to consult local guidelines before making any treatment decisions.  The information presented is the personal opinion of the healthcare professional interviewed and might not be representative to all clinicians. It is based on their interpretation of current best practice and guidelines when the episode was recorded. Guidelines can change; To the best of our knowledge the information in this episode is up to date as of it's release but it is the listeners responsibility to review the information and make sure it is still up to date when they listen. Dr Lisa Adams, Dr Sara MacDermott and their interviewees are not liable for any advice, investigations, course of treatment, diagnosis or any other information, services or products listeners might pursue as a result of listening to this podcast - it is the clinicians responsibility to appraise the information given and review local and national guidelines before making treatment decisions. Reliance on information provided in this podcast is solely at the listeners risk. The podcast is designed to be used by trained healthcare professionals for education only. We do not recommend these for patients or the general public and they are not to be used as a method of diagnosis, opinion, treatment or medical advice for the general public. Do not delay seeking medical advice based on the information contained in this podcast. If you have questions regarding your health or feel you may have a medical condition then promptly seek the opinion of a trained healthcare professional.

Trevor Maxwell lived the archetype of masculinity in rural Maine. Big, strong, splitting wood, raising kids, and carrying the load. Then cancer ripped that script apart. In 2018 he was bedridden, emasculated, ashamed, and convinced his family would be better off without him. His wife refused to let him disappear. That moment forced Trevor to face his depression, get help, and rebuild himself. Out of that came Man Up To Cancer, now the largest community for men with cancer, a place where men stop pretending they are bulletproof and start being honest with each other.Eric Charsky joins the conversation. A veteran with five cancers, forty-nine surgeries, and the scars to prove it, Eric lays out what happens when the military's invincible mindset collides with mortality. Together, we talk masculinity, vulnerability, sex, shame, and survival. This episode is blunt, raw, and overdue.RELATED LINKSMan Up To CancerTrevor Maxwell on LinkedInDempsey CenterEric Charsky on LinkedInStupid Cancer FEEDBACKLike this episode? Rate and review Walk It Off on your favorite podcast platform. For guest suggestions or sponsorship inquiries, email podcast@matthewzachary.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

This podcast is brought to you by Outcomes Rocket, your exclusive healthcare marketing agency. Learn how to accelerate your growth by going to⁠ outcomesrocket.com Clinical trials fail far more often due to flawed operations and unusable data than because of poor science. In this episode, Heather Grey, Senior Vice President and General Manager of Real World Data, Clinical Trials, and Registry at Omega Healthcare, explains why clinical research continues to stall despite scientific breakthroughs and growing excitement around AI. She details how messy data, underprepared sites, missed timelines, and gaps in education across patients, providers, and pharma create systemic delays that limit patient access and slow drug development. Heather shows how pairing clinical expertise with AI-driven data curation can produce FDA-grade data, keep trials on track, and enable more health systems to participate in research. She concludes by emphasizing that AI alone is insufficient, and that strong infrastructure, human quality assurance, and operational discipline are essential for expanding trial access and diversity. Tune in and learn how fixing execution, not chasing hype, is the real key to accelerating clinical trials! Resources: Connect with and follow Heather Grey on LinkedIn. Follow Omega Healthcare on LinkedIn and visit their website! Email Heather directly here.

Omega-3 supplements are at the center of a controversy regarding their oxidation levels and potential harm. This presentation addresses the gap between claims of harm and the available human data, explaining how oxidation is measured and interpreted. 00:00 Introduction to Omega-3 Supplements00:49 Understanding Oxidation in Fish Oil01:10 Measuring Oxidation: Peroxide, Anisidine, and Totox Values01:50 The Flavoring Problem in Oxidation Testing02:46 Market Surveys and Oxidation Failures04:08 Do Oxidation Standards Correlate with Human Harm?04:30 Clinical Trials on Oxidized Fish Oil06:54 Regulatory Perspectives on Oxidation and Safety07:57 Summary and Takeaways09:08 Conclusion and References

Send us a textDr. Michael Koren joins Kevin Geddings to give some advice on easy-to-accomplish resolutions for the new year. The doctor gives three resolutions:Get an advanced cholesterol Lp(a) checkGet a fatty liver testDo an Alzheimer's screeningThese are easy resolutions that can help guide health decisions for the year and beyond.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!

Risk-based monitoring has been discussed in clinical research for more than a decade, yet many organizations still struggle to implement it in a meaningful and effective way. In this episode of the Clinical Trial Podcast, we sit down with Dr. Artem Andrianov, a leading expert in clinical data quality and risk-based quality management, to unpack what risk-based monitoring really means in today's regulatory landscape.  Artem has over 25 years of experience in the pharmaceutical industry and is the CEO and cofounder of Cyntegrity a company that specializes in data driven risk management in clinical trials. Together, they explore how the industry has evolved from traditional monitoring approaches to a more holistic model centered on risk-based quality management and quality by design.  Dr. Andrianov shares practical insights on common misconceptions, why simply reducing monitoring is not a strategy, and how technology and analytics can be used to proactively manage risk. The conversation also examines the changing role of CRAs, and the growing expectations from regulators and inspectors.   

Send us a textJavonte Maynor joins Dr. Erich Schramm to talk about Mr. Maynor's journey from Division I basketball to starting and running a clinical research site. The entrepreneur talks about his passion for clinical research, representation, and how historically low representation of minorities is a design choice which can be remedied. The duo discusses methods of increasing diversity, trust, and good patient outcomes and how those three ideas are intrinsically linked. They finish the conversation by talking about a shared interest, medical cannabis and the slow movement towards more natural medicines.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!

The most anticipated annual tradition on Out of Patients returns with the 2025 Holiday Podcast Spectacular starring Matthew's twins Koby and Hannah. Now 15 and a half and deep into sophomore year, the twins deliver another unfiltered year end recap that longtime listeners wait for every December. What began as a novelty in 2018 has become a time capsule of adolescence, parenting, and how fast childhood burns off.This year's recap covers real moments from 2025 A subway ride home with a bloodied face after running full speed into that tree that grows in Brooklyn. Broadway obsessions fueled by James Madison High School's Roundabout Youth Ensemble access, including Chess, & Juliet, Good Night and Good Luck, and Pirates of Penzance holding court on Broadway. A Disneylanmd trip where the Millennium Falcon triggered a full system reboot. A New York Auto Show pilgrimage capped by a Bugatti sighting. All the things.The twins talk school pressure, AP classes, learner permit anxiety, pop culture fixation, musical theater devotion, and the strange clarity that comes with turning 15. The humor stays sharp, the details stay specific, and the passage of time stays undefeated. This episode lands where the show works best: family, honesty, and letting young people speak for themselves.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.

Today from SDPB - a look at funds helping the Rapid City solid water infrastructure and a study on a common type of cancer.

Graham Rigby is the President and CEO of the American Herbal Products Association (AHPA), the leading trade association for the herbal products industry. With 20 years of experience across startups and industry leadership—including serving as Chief Innovation Officer at Care/of—Graham has helped shape how modern supplement brands navigate regulation, formulation, and go-to-market strategy.In this episode of DTC Pod, Graham shares what it actually takes to launch and scale a supplement brand without getting burned by regulators. He breaks down exactly where the line is between claims that sell and claims that get you in trouble, why so many founders get blindsided by FDA and FTC enforcement, and how to work with contract manufacturers when you're just starting out. Graham also gets into the real opportunity in supplements right now—why clinical trials cost 90% less than they did two decades ago, how AI is changing the formulation game, and why a $70 billion market growing at 6.5% still has plenty of room for new entrants. Plus, his take on the brands that are doing it right, from AG1 to Ritual, and what founders can learn from their playbooks.Episode brought to you by StordInteract with other DTC experts and access our monthly fireside chats with industry leaders on DTC Pod Slack.On this episode of DTC Pod, we cover:1. The evolution and growth of the herbal supplement industry2. Key regulatory milestones: DSHEA, GMPs, and FDA compliance for supplements3. What founders must do to stay compliant when launching a supplement brand4. The distinction between pharmaceuticals, dietary supplements, and nutraceuticals5. Marketing, claims, and the importance of substantiation6. Emerging opportunities with clinical trials and claim innovation7. DTC, Amazon, TikTok, and brick-and-mortar distribution channels for wellness brands8. The practicalities and risks of supplement retail (and when to scale beyond DTC)9. Practitioner and non-traditional channels for supplement sales10. How Ingredient AI, Infinite Garden, and other platforms are applying AI to supplements11. Content creators, credentialed doctors, and the new face of trusted health advice12. The role of diagnostics, wearables, and personalization in driving supplement trends13. Growth outlook: Why the supplement market is just getting startedTimestamps00:00 Intro to DTC POD and Graham Rigby02:25 20 years of supplements: Startup vs. regulatory side03:00 The exponential growth of the herbal products market04:44 Regulatory basics: DSHEA, FDA oversight, and GMPs explained07:14 How AHPA helps brands navigate compliance and education08:03 Launching a supplement brand: Key compliance steps and best practices10:00 FDA's post-market regulatory process and founder responsibilities13:04 Supplements vs. pharmaceuticals: Safety, claims, and approvals17:32 Telling stories and using clinical research for marketing claims20:00 What marketers can and cannot say: Health vs. disease claims22:04 Substantiating claims and the importance of compliance for growth24:31 Label vs. online claims: How rules apply to different channels27:02 DTC vs. Amazon, TikTok, and expanding to retail and practitioner channels30:19 The risks and rewards of brick-and-mortar expansion35:14 AI and technology's role in supplement industry efficiency and safety40:47 The rise of content creators and doctors shaping supplement education46:34 Diagnostics, wearables, and the future of personalized wellness51:13 Supplement industry outlook and advice for emerging brands52:25 How to connect with Graham and AHPA, and upcoming founder programsShow notes powered by CastmagicPast guests & brands on DTC Pod include Gilt, PopSugar, Glossier, MadeIN, Prose, Bala, P.volve, Ritual, Bite, Oura, Levels, General Mills, Mid Day Squares, Prose, Arrae, Olipop, Ghia, Rosaluna, Form, Uncle Studios & many more.  Additional episodes you might like:• #175 Ariel Vaisbort - How OLIPOP Runs Influencer, Community, & Affiliate Growth• #184 Jake Karls, Midday Squares - Turning Your Brand Into The Influencer With Content• #205 Kasey Stewart: Suckerz- - Powering Your Launch With 300 Million Organic Views• #219 JT Barnett: The TikTok Masterclass For Brands• #223 Lauren Kleinman: The PR & Affiliate Marketing Playbook• ​​​​#243 Kian Golzari - Source & Develop Products Like The World's Best Brands-----Have any questions about the show or topics you'd like us to explore further?Shoot us a DM; we'd love to hear from you.Want the weekly TL;DR of tips delivered to your mailbox?Check out our newsletter here.Projects the DTC Pod team is working on:DTCetc - all our favorite brands on the internetOlivea - the extra virgin olive oil & hydroxytyrosol supplementCastmagic - AI Workspace for ContentFollow us for content, clips, giveaways, & updates!DTCPod InstagramDTCPod TwitterDTCPod TikTokGraham Rigby - President & CEO of American Herbal Products Association (AHPA)Blaine Bolus - Co-Founder of CastmagicRamon Berrios - Co-Founder of Castmagic

Jason Gilley walked into adulthood with a fastball, a college roster spot, and a head of curls that deserved its own agent. Cancer crashed that party and took him on a tour of chemo chairs, pediatric wards, metal taste, numb legs, PTSD, and the kind of late night panic that rewires a kid before he even knows who he is.I sat with him in the studio and heard a story I know in my bones. He grew up fast. He learned how to stare down mortality at nineteen. He found anchors in baseball, therapy, and the strange friendships cancer hands you when it tears your plans apart. He owns the fear and the humor without slogans or shortcuts. Listeners will meet a young man who refuses to let cancer shrink his world. He fights for the life he wants. He names the truth without apology. He reminds us that survivorship stays messy and sacred at the same time. This conversation will stay with you.RELATED LINKS• Jason Gilley on IG• Athletek Baseball Podcast• EMDR information• Children's Healthcare of AtlantaFEEDBACKLike 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.

Send us a textTreatment of Hypotension of Prematurity: a randomised trial.Alderliesten T, Arasteh E, van Alphen A, Groenendaal F, Dudink J, Benders MJ, van Bel F, Lemmers P. Arch Dis Child Fetal Neonatal Ed. 2025 Dec 15;111(1):F60-F66. doi: 10.1136/archdischild-2024-328253.PMID: 40413017 Clinical Trial.Support the showAs always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!

Send us a textFull exclusively enteral fluids from day 1 versus gradual feeding in preterm infants (FEED1): a open-label, parallel-group, multicentre, randomised, superiority trial.Ojha S, Mitchell EJ, Johnson MJ, Gale C, McGuire W, Oddie S, Hall SS, Meakin G, Anderson J, Partlet C, Su Y, Johnson S, Walker KF, Ogollah R, Mistry H, Naghdi S, Montgomery A, Dorling J; FEED1 collaborative.Lancet Child Adolesc Health. 2025 Dec;9(12):827-836. doi: 10.1016/S2352-4642(25)00271-8. Epub 2025 Oct 17.PMID: 41115446 Free article. Clinical Trial.Support the showAs always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!

Dr. Martin Picard, PhD, is a professor of behavioral medicine at Columbia University and an expert on how our behaviors and psychology shape cellular energy production and rates of aging. He explains that your mitochondria don't just “make energy”; they translate what you do—your mindset and your relationships—into the energy you experience as vitality or lack thereof. He explains how exercise, nutrition, sleep, meditation, and even certain thought patterns and our sense of purpose can charge our cells like batteries. He also shares findings that hair greying is the result of cellular stress and is reversible. This episode links physical and mental ‘energy' with cellular energy and provides science-supported tools to improve your physical and mental health. Read the episode show notes at hubermanlab.com. Thank you to our sponsors AG1: https://drinkag1.com/huberman Helix: https://helixsleep.com/huberman Lingo: https://hellolingo.com/huberman Function: https://functionhealth.com/huberman Waking Up: https://wakingup.com/huberman Timestamps (00:00:00) Martin Picard (00:03:50) What is Energy?, Energy Flow & Transformation (00:07:53) Energy, Vitality, Emotions, Sensory Perception (00:14:18) Sponsors: Helix Sleep & Lingo (00:17:19) “Mito-Centric” View of World, Mitochondrial Energy & Information Patterns (00:25:26) Organelles, Mitochondria & Energy Transformation; Maternal Genes (00:31:12) Mitotypes & Differentiation, Mitochondria as “Social Organisms” (00:36:52) Food & Dysfunctional Energy Transformation (00:40:02) Lifestyle Choices & Interests, Physiological Growth (00:46:39) Pregnancy, Amenorrhea; Illness & Tiredness (00:51:07) Sponsor: AG1 (00:52:29) Energy Transformation & Distribution; Body's Wisdom, Feeling Sick (00:56:27) Tool: Feel Your Energy; Breath & Energy (01:02:31) Flow of Energy; Trade-Offs, Life Purpose & Enjoyment (01:10:15) Biology, Meaningful Experiences & Energy Flow (01:16:27) Sponsor: Function (00:18:15) Inflammation, Energetic Flow (01:20:43) Child Prodigies, Species Lifespan & Mitochondrial Metabolism; Aging (01:28:56) Lifestyle & Aging: Exercise, Fasting; Inflammation, Sleep, Stimulants (01:37:06) Energetic Stress Signals, GDF-15, Cancer, Heart Failure (01:42:18) Genes, Lifestyle & Aging (01:47:54) Gray Hair Reversal, Stress; Inflammation & Aging (01:57:37) Energy Recovery, Sleep & Mitochondrial Function, Stress, Meditation (02:05:16) Tools: Yoga Nidra, NSDR; Pre-Sleep Relaxation, Energy & Restorative Sleep (02:10:58) Diet & Individualization, Clinical Trials; Mitochondria & Nutrition, Keto (02:20:14) Alcohol & Energy Budget; Stress (02:25:02) Exercise, Increase Mitochondria, Overtraining; Resistance & Growth (02:33:06) Sponsor: Waking Up (02:34:41) Supplements & Mitochondria Health, Deficiencies, SS31, Methylene Blue (02:41:31) Energy Flow & Experiences, Balance (02:49:13) Transform Through Resistance, Energetic Awareness, Connection (02:56:05) Food Overconsumption & Mitochondria Disruption; Tissues & Mitochondria (03:01:02) Mitochondrial Health Test; Tool: Ways to Increase Energy; Meditation (03:06:10) Peptides; Fertility Supplements, Urolithin A; Electromagnetic Fields (03:12:16) Acknowledgements (03:14:15) Zero-Cost Support, YouTube, Spotify & Apple Follow, Reviews & Feedback, Sponsors, Protocols Book, Social Media, Neural Network Newsletter Learn more about your ad choices. Visit megaphone.fm/adchoices