Podcasts about Cell therapy

Join us on Coffee & Compatibility as Dr. Medhat Askar discusses the urgent need to investigate the role of HLA in cell therapy and how laboratories can support this rapidly growing treatment strategy. The conversation also highlights ongoing global efforts to advance transplantation and cell therapy initiatives.Learn more about The Transplantation Society's activities during the World Health Assembly here: https://www.linkedin.com/posts/medhataskar_the-transplantation-society-advances-the-activity-7464104308314173440-J-Kn?utm_source=share&utm_medium=member_desktop&rcm=ACoAABF2FhwB2SQa9yztxvbubR246ItZX1ub52kCoffee & Compatibility is the official podcast of ASHI, featuring discussions on current topics, expert insights, and emerging trends in transplantation, histocompatibility, and immunogenetics.#CoffeeAndCompatibility #ASHIHLA #CellTherapy #HLA #Transplantation #Immunogenetics #Histocompatibility #TransplantImmunology #StemCellTherapy #LaboratoryMedicine #HealthcareEducation #MedicalPodcast #HLAResearch #CellularTherapy #TransplantScience

Support the Institute today. https://givenow.nova.edu/the-institute-for-neuro-immune-medicine-inim-2025   In today's episode, Haylie Pomroy talks with Dr. Rafael Gonzalez, a PhD immunologist from UC Irvine and founder of ReStem, for a conversation that brings cutting-edge cell therapy research directly to the chronic illness community.   Dr. Gonzalez breaks down the science of immune exhaustion, explaining why so many patients with ME/CFS, long COVID, POTS, and autoimmune disorders are stuck in a state of dysfunction that conventional labs and appointments often fail to capture. He introduces the concept of senescent cells, what he calls zombie cells, and explains the specific role natural killer cells play in clearing viral burden and restoring immune balance.   Together, Haylie and Dr. Gonzalez explore how cell therapies, specifically quality-cultivated umbilical cord lining stem cells and activated natural killer cells, are being used in clinical studies to re-regulate immune systems that have gone into either hyper-inflammatory overdrive or complete exhaustion. Dr. Gonzalez also clarifies the significant difference between legitimate, rigorously tested cell therapies and the inconsistent products flooding the market under the stem cell label.   Dr. Rafael Gonzalez, PhD is a regenerative medicine expert and researcher with over 20 years of experience in cell biology, stem cell science, and immune health. He earned his PhD and BS from the University of California, Irvine, where his research focused on immune system interactions following spinal cord injury. Known for his work in regenerative medicine, longevity, and cell therapeutics, Dr. Gonzalez has authored scientific publications, holds multiple patents in the field, and frequently teaches and speaks internationally on stem cell biology, immune health, and anti-aging science. LinkedIn: https://www.linkedin.com/in/rafael-gonzalez-6026672a/  Instagram: https://www.instagram.com/drgonzalezphd/  Haylie Pomroy, Founder and CEO of The Haylie Pomroy Group, is a leading health strategist specializing in metabolism, weight loss, and integrative wellness. With over 25 years of experience, she has worked with top medical institutions and high-profile clients, developing targeted programs and supplements rooted in the "Food is Medicine" philosophy. Inspired by her own autoimmune journey, she combines expertise in nutrition, biochemistry, and patient advocacy to help others reclaim their health. She is a New York Times bestselling author of The Fast Metabolism Diet.   Learn more about Haylie Pomroy's approach to wellness through her website: https://hayliepomroy.com   Instagram: https://www.instagram.com/hayliepomroy  Facebook: https://www.facebook.com/hayliepomroy  YouTube: https://www.youtube.com/@hayliepomroy/videos  LinkedIn: https://www.linkedin.com/in/hayliepomroy/  X: https://x.com/hayliepomroy    Thank you for tuning in to the Hope and Help For Fatigue and Chronic Illness Podcast. Sign up today for our newsletter.

Can aging be fundamentally slowed or even reversed—not by science fiction, but by harnessing the unassuming power of super-early stem cells?In Part 1, Yuta Lee, Founder and CEO of Accelerated Bio, walked through the biology, ethical sourcing, and manufacturing profile of human trophoblast stem cells. In Part 2, the conversation shifts to the larger ambition: using those cells not just to treat disease, but to slow, stop, or reverse biological aging itself. The evidence starts with a striking finding from the National Institute on Aging, and it builds from there.Topics discussed:The science and ethics of sourcing stem cells from ectopic pregnancies (03:02)Differences in differentiation potential between very early-stage cells and traditional MSCs or iPSCs (05:09)The origins of the research focus, driven by NIH/NIA inquiry and lessons from Stanford parabiosis studies (07:27)Explanation of senescent cells, inflammation, and disease connections (08:51)Potential therapeutic scope, from neurodegeneration to autoimmune diseases, and systemic anti-inflammatory applications (09:26)Vision for aging prevention—possibility of maintaining young biological age through regular secretome therapy (10:21)Challenges and global differences in regulation, access, and clinical adoption (12:05)The realistic limits and potential for reversing versus preventing age-related damage (13:20)The future landscape of cell and gene therapy in medicine (14:20)Why more investment is needed in longevity science and therapeutics (16:25)Practical takeaways for listeners about improving healthspan and longevity today (18:07)Smart insight:Prevention is becoming the new frontier of medicine, shifting from treating disease to preserving long-term biological function. Yuta Lee highlights a future where proactive longevity strategies, from lifestyle choices to emerging biotech, could keep us healthier for longer and push toward “escape velocity” against aging.If you're interested in how we turn living biology into scalable, reliable, off-the-shelf therapies without losing control of the system, explore these episodes:Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 147 - 148: Lab-Grown Blood: How Stem Cells Transform Transfusions with Ari GargirEpisodes 179 - 180: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay DaviesEpisodes 211 - 212: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús ZurdoConnect with Yuta Lee:LinkedIn: www.linkedin.com/in/yuta10Accelerated Bio website: www.acceleratedbio.comNext:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

What if the key to scalable, off-the-shelf cell therapy was hiding in tissue that surgeons discard every day?Yuta Lee, Founder and CEO of Accelerated Bio, has spent two decades building a cell therapy platform on exactly that insight. Human trophoblast stem cells, sourced from ectopic pregnancy tissue that is otherwise discarded, sit at a unique biological intersection: earlier than MSCs, free from the ethical barriers of embryonic stem cells, expandable to 85 population doublings, and naturally equipped with HLA-G immune modulation that opens the door to allogeneic, off-the-shelf therapy at scale.Topics discussedCommon misconceptions and challenges in bioprocess development for biological therapeutics (02:45)The origin story behind Yuta Lee's interest in stem cells, including his father's surgical discovery (04:15)A look at the intellectual property strategy that protected and enabled Yuta Lee's company to develop its platform (07:26)A clear explanation of different stem cell types (embryonic, trophoblast, mesenchymal, adult, and induced pluripotent) and their sources (09:37)Ethical and regulatory issues involved in sourcing stem cells, and how trophoblast cells offer a unique alternative (10:59)Discussion of stem cell differentiation, population doubling, and scalability for manufacturing purposes (17:03)Importance of immune privilege and HLA-G expression in pre-placental cells for off-the-shelf therapies (20:20)Shifts in the industry from autologous to allogeneic therapies, and the role trophoblast cells may play in future treatments (22:00)In Part 2, Yuta Lee goes into the science of biological aging, the senescent cell secretome findings from the National Institute on Aging, and what a prevention-first therapeutic approach to healthspan extension could look like in practice.Smart insight:The scalability ceiling of MSCs is not just a manufacturing inconvenience, it is a strategic constraint. At 25 to 30 population doublings from birth-derived donors, every new donor batch requires revalidation as a distinct biological starting material. Trophoblast stem cells at 85 doublings from a single donor change that equation fundamentally, making true allogeneic scale not just biologically possible but manufacturable.If you're interested in how we turn living biology into scalable, reliable, off-the-shelf therapies without losing control of the system, explore these episodes:Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 147 - 148: Lab-Grown Blood: How Stem Cells Transform Transfusions with Ari GargirEpisodes 179 - 180: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay DaviesEpisodes 211 - 212: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús ZurdoConnect with Yuta Lee:LinkedIn: www.linkedin.com/in/yuta10Accelerated Bio website: www.acceleratedbio.comNext:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

Today, we're digging into a topic that's getting a lot more attention lately, how early decisions in cell therapy end up shaping or complicating everything that comes later. Our episode today is Freeze Variability, Not Progress, How to Strengthen Your Cell Therapy Supply Chain from the Start, and we're going to challenge a few long-held beliefs about how starting material should be handled. My guest today is Dominic Clarke, Vice President of Technical Operations for IntegriCell at Cryoport Systems. Dominic has spent years in the trenches building and scaling cell therapy processes from early development through commercialization. So, he's seen where things break and what actually works. I hope you enjoy my conversation with Dominic Clark.01:07    Meet Dominic Clarke and Cryoport Systems06:24   Fresh cells versus frozen cells08:21    Why teams switch to cryopreservation late12:37    The challenge of variability16:47    IntegriCell when you already have a process in place22:17    An argument for cryopreservation based on data25:56   The future of IntegriCell and Cryoport SystemsThis episode is brought to you with the support of Cryoport Systems.Interested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletterTo dive deeper into the topic: IntegriCell® CryopreservationCryoport Systems on the state of the ATMP market and the importance of supply chain resilienceCracking the code: Delivering biotherapeutics successfully across EMEA

In this episode of Denatured, you'll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and John Ellis, co-founder & CEO of Trenchant Bios, speaking live from the ISCT annual meeting. We dive into mesenchymal stem cells and induced pluripotent stem cells, exploring the science behind them, the manufacturing challenges, and the potential for scalable, engineered next-generation therapies.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsJon Ellis, Co-founder & CEO, Trenchant BioMiguel Forte, President, International Society for Cell & Gene TherapyDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Marty Makary's hold on the top job at FDA is slipping, with White House leaks about President Donald Trump's displeasure with the FDA commissioner shifting the question from whether he will be fired to when. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin discusses the pressures on Makary, how long he will hold onto his post, and the leading candidates to succeed him.BioCentury's analysts then discuss solutions to AAV's redosing problem, which could reignite industry interest in a modality that has fallen out of favor, and other topics in the spotlight at this week's American Society of Gene and Cell Therapy annual meeting. The analysts also discuss opportunities to attend and present academic posters at the third BioCentury Grand Rounds U.S. conference June 3-5 in Seattle. This episode of the BioCentury This Week podcast has been brought to you by Jeito Capital.View full story: https://www.biocentury.com/article/659426#FDA #GeneTherapy #AAV #CellTherapy #Biopharma00:01 - Sponsor Message: Jeito Capital01:43 - Bio€quity Europe Prague Highlights04:54 - Makary on Thin Ice14:37 - Grand Rounds Poster Pitch16:40 - AAVs at ASGCTTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/ZWS865. CME/AAPA credit will be available until April 23, 2027.An Immune Reset for AlloHCT Recipients: Updates on Engineered Cell Therapy for Improving Transplant Outcomes and Reducing GVHD In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Orca Bio.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/ZWS865. CME/AAPA credit will be available until April 23, 2027.An Immune Reset for AlloHCT Recipients: Updates on Engineered Cell Therapy for Improving Transplant Outcomes and Reducing GVHD In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Orca Bio.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/ZWS865. CME/AAPA credit will be available until April 23, 2027.An Immune Reset for AlloHCT Recipients: Updates on Engineered Cell Therapy for Improving Transplant Outcomes and Reducing GVHD In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Orca Bio.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/AAPA information, and to apply for credit, please visit us at PeerView.com/ZWS865. CME/AAPA credit will be available until April 23, 2027.An Immune Reset for AlloHCT Recipients: Updates on Engineered Cell Therapy for Improving Transplant Outcomes and Reducing GVHD In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Orca Bio.Disclosure information is available at the beginning of the video presentation.

Send us Fan MailToday's conversation sits at the intersection of one of the most ambitious - and most challenging - frontiers in modern medicine: regenerative cell therapy.For decades, the vision has been incredibly compelling - replace damaged or dying cells with healthy ones, and you could potentially restore function in diseases like macular degeneration, spinal cord injury, hearing loss, and even Type 1 diabetes. But while the science has advanced, the field has consistently run into a different kind of barrier: how do you actually manufacture living cells as consistent, scalable, affordable therapies?That's not just a biology problem - it's an engineering, manufacturing, and business problem.And it's one that today's guest has spent his entire career navigating.Brian Culley brings more than three decades of experience across the life sciences industry, spanning drug development, business development, and executive leadership. From early work in neuropharmacology at Neurocrine Biosciences, to technology transfer at University of California, San Diego, to building and leading public biotech companies like Mast Therapeutics, he's seen the industry from nearly every angle - science, capital markets, partnerships, and operations.Today, as CEO of Lineage Cell Therapeutics ( https://lineagecell.com/ ), Brian is applying that full spectrum of experience to one of the hardest problems in medicine: how to turn the promise of regenerative cell therapy into something that can actually reach patients at scale.Under his leadership, Lineage has taken a manufacturing-first approach - building an integrated platform designed to deliver high-quality, ‘off-the-shelf' cell therapies - and in the process has secured major partnerships with companies like Genentech and William Demant.Today, we're going to explore not just the promise of cell therapy - but what it really takes to make it real.#CellTherapy #RegenerativeMedicine #Biotech #StemCells #Longevity #FutureOfMedicine #HealthcareInnovation #Biotechnology #GeneTherapy #MedicalBreakthrough #DrugDevelopment #PrecisionMedicine #LifeSciences #Pharma #BiotechCEO #StartupBiotech #Innovation #SciencePodcast #Healthcare #AgingResearch #VisionRestoration #HearingLoss #SpinalCordInjury #Type1Diabetes #Genentech #LineageCellTherapeuticsSupport the show

Researchers are exploring whether cell therapy—including stem cells and stem cell–derived treatments—could help repair or replace damaged retinal cells in macular degeneration and geographic atrophy. In this episode, we explain how these therapies are intended to work, how the cells may be delivered to the eye, and the potential risks.

Send us Fan MailDr. Atul Malhotra, neonatologist and researcher at Monash University in Melbourne, Australia, makes the case that cell therapy for neonatal brain injury is a slow burn that is finally gaining momentum. He shares why tempering expectations doesn't mean losing hope, how regulatory complexity sets stem cells apart from conventional therapies, and why cell therapy may look different for preterm infants with white matter injury versus term infants with HIE.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!

From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear.In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb.I really wanted to speak to Mike because his career is one of the more fascinating journeys I have come across in quality leadership. He has spent nearly two decades within what is effectively the same organisation, yet has lived through multiple acquisitions, spin-offs and complete pivots in therapeutic modality - each time emerging in a stronger, more interesting role than before.Mike began his career at APP Pharmaceuticals on a midnight QC shift, testing in-process samples on a graveyard schedule. From there, he followed the Abraxane asset into aBraxis Bioscience, built out supplier quality relationships across Central and South America, and eventually relocated from Chicago to New Jersey when Celgene consolidated its operations.That move opened the door to something entirely new - a CAR-T therapy program called BB2121 - a field Mike had never worked in and knew little about. Eight years later, he is now heading quality for in vivo CAR-T, one of the most cutting-edge modalities in all of biopharma.What makes Mike Ruane such a compelling guest is not just the breadth of his experience but his philosophy. He is a first-principles thinker who has thrived precisely because he never assumed the existing process was the right one. He asks the uncomfortable questions, encourages his team to do the same, and believes deeply that curiosity is the most underrated skill in quality.We talk about the following:How working in a lean generic drug environment early in his career shaped his mindset foreverNavigating multiple acquisitions and spin-offs within a single career arcWhat it takes to step into an entirely new therapeutic modality with no prior experienceWhy curiosity and asking the right questions is the real engine of career growth in qualityHow he interviews candidates and what most people get wrong when they are being interviewedMike Ruane is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.Thank you Mike Ruane for sharing your incredible journey.Hope everyone enjoys the show.

Five years ago, The Stem Cell Report set out with a simple goal: to bring the science, the people, and the stories behind stem cell research into one conversation. Since then, the field has advanced at an extraordinary pace—transforming our understanding of development, disease, and regenerative medicine.To celebrate, we're doing something special. In this anniversary episode, we welcome back past guests—scientists, clinicians, and authors—to revisit where their work began, explore how it's evolved, and look ahead to what's next.GuestsLawrence Goldstein, PhD, University of California San Diego (Emeritus), USA Charles Murry, MD, PhD, Keck School of Medicine, University of Southern California, USA Clare Parish, PhD, The Florey Institute of Neuroscience and Mental Health and University of Melbourne, Australia Martin Pera, PhD, The Jackson Laboratory, USA HostJanet Rossant, Editor-in-Chief, Stem Cell Reports and The Gairdner FoundationPrevious Podcasts Parkinson's Disease, Cell Therapy, and Exercise Human Fetal Tissue: A Legacy of Biomedical Research Contributions Mending a Broken Heart About Stem Cell ReportsStem Cell Reports is the open access, peer-reviewed journal of the International Society for Stem Cell Research (ISSCR) for communicating basic discoveries in stem cell research, in addition to translational and clinical studies. Stem Cell Reports focuses on original research with conceptual or practical advances that are of broad interest to stem cell biologists and clinicians. X: @StemCellReportsAbout ISSCRAcross more than 80 countries, the International Society for Stem Cell Research (@ISSCR) is the preeminent global, cross-disciplinary, science-based organization dedicated to advancing stem cell research and its translation to medicine.ISSCR StaffKeith Alm, Shuangshuang Du, Kym Kilbourne, Megan Koch, Jack Mosher, and Hunter Reed

What if the solution to cell therapy's biggest cold-chain challenge comes from the biology of Arctic fish?This conversation features Steve Oh, a leader in advanced bioprocessing, whose career has placed him at the intersection of stem cell biology, process engineering, and clinical translation. Steve Oh joins David Brühlmann to share how XT Thrive®—a next-generation cryopreservation solution drawing from nature's antifreeze proteins—lets cells survive, thrive, and simplify manufacturing from the bench to the clinic.Episode highlights:Biological insights from Arctic fish and their translation into synthetic peptide chemistry for cell preservation (00:23)The effect of ice crystal formation on cellular damage, and how XT Thrive® minimizes this compared to DMSO (05:32)Simplified logistics: reduced risk of contamination, elimination of post-thaw wash steps, and implications for therapy delivery to remote locations (07:23)Applicability beyond single cells—preserving organoids and potential implications for tissue engineering (09:50)The ease of transitioning from DMSO to the new solution in established lab protocols (10:49)Broader industry challenges: maintaining purity, process optimization, and reducing cost of goods in cell therapy manufacturing (12:03)Promising innovations in rapid cell type differentiation and barriers to scaling transformative biotech (12:50)The importance of supporting innovative therapies beyond short-term ROI (14:17)Smart insight:Next-generation cryopreservation solutions address more than just viability—they simplify transport, reduce costs, lower hands-on time, and help ensure therapy reaches patients in remote locations in optimal condition. As Steve Oh observes, these advances are critical for reducing the cost of goods, improving consistency, and enabling truly scalable cell therapy manufacturing.If you're interested in this topic, check out these episodes, where we explore how Minnesota's frozen forests inspired a new wave of biotech innovation—transforming how life-saving cells are frozen, stored, and shipped.Episodes 161 - 162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey AllenThis is Steve's second appearance on the podcast. You can also catch his earlier conversation with David, where they explored the challenges and opportunities of cell and gene therapy.Episodes 11 - 12: From Lab to Patient: Steve Oh's Guide to Mastering Cell Therapy Process Development.Connect with Steve Oh:Email: skwohso@gmail.comLinkedIn: www.linkedin.com/in/steve-oh-4946261/Support the show

Discusses the regulation of cell therapy products and the importance of training on this topic.  Our guests today are Kathy Loper and Jared Schuster.  Kathy serves as the Director of Regulatory Affairs for NMDP, a nonprofit providing life-saving cellular therapies to patients. Kathy has extensive experience in biological product manufacturing and works closely with regulatory agencies, professionals, and other organizations to move the industry forward. Jared also has extensive experience in biotech, specializing in cell therapy CMC, regulatory strategy, and analytical development. He has held scientific, quality, and regulatory roles throughout his career, and is clinically certified as a Histotechnologist and Advanced BioTherapies Professional. At NMDP, he oversees regulatory CMC and strategy functions for cell and gene therapy programs, focusing on procurement of cellular starting materials.  Additional resources: NMDP: https://www.nmdp.org/ Regulation of Cell Therapy course: https://about.citiprogram.org/course/regulation-of-cell-therapy-products/ CITI Program's course catalog: https://about.citiprogram.org/course-catalog 

Arctic fish survive in waters that would freeze most life solid. Not because they tolerate ice, but because their biology prevents crystals from forming in the first place. That same principle, translated into synthetic peptide chemistry, is now showing performance data that DMSO cannot match. Part 2 is where the science becomes practical.Steve Oh spent 22 years at Singapore's A*STAR accumulating 43 patents across stem cell bioprocessing, microcarrier technologies, and serum-free media. He now advises XTherma, where he has been stress-testing their DMSO-free cryopreservation solution across T cells, MSCs, organoids, and beyond. In Part 2, he brings the data.Key topics discussed:How antifreeze protein-inspired peptide chemistry reduces ice crystal size and protects cells during freezing and thawing (00:23)T cell and MSC performance data comparing XT Thrive to DMSO and CryoStor CS10, including a 2.5-fold increase in cell yield on microcarriers post-thaw (02:23-05:00)Why ice crystal formation causes more damage during thawing than freezing, and how XT Thrive addresses this (05:32)Elimination of the post-thaw wash step and what that means for contamination risk and manufacturing simplicity (07:00)Hold time extended to 24 hours and storage performance across 4°C, -80°C, and -196°C (08:01)Applicability beyond single cells: organoids, islets, and potential implications for organ preservation (09:50)How to transition from DMSO to XT Thrive: GMP grade, Drug Master File, same concentration, no protocol overhaul required (10:49)Broader cell therapy challenges: differentiation time, cell population consistency, and cost of goods (12:03)Smart insight:The transition away from DMSO is more accessible than most scientists assume. XT Thrive is GMP-grade, carries a Drug Master File, and is used at the same 5-10% concentration as DMSO, making it a plug-and-play substitution for most cell types. The manufacturing implications go further: no wash step, extended hold times, and storage stability across all standard temperature ranges simplify both production workflows and cold-chain logistics to remote treatment sites.If you're interested in this topic, check out these episodes, where we explore how Minnesota's frozen forests inspired a new wave of biotech innovation, transforming how life-saving cells are frozen, stored, and shipped.Episodes 161 - 162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey AllenThis is Steve's second appearance on the podcast. You can also catch his earlier conversation with David, where they explored the challenges and opportunities of cell and gene therapy.Episodes 11 - 12: From Lab to Patient: Steve Oh's Guide to Mastering Cell Therapy Process Development.Connect with Steve Oh:Email: skwohso@gmail.comLinkedIn: www.linkedin.com/in/steve-oh-4946261/Support the show

Dendritic cells have been known for decades to play a key role in the immune system, but early medical failures led many to believe they couldn't handle complex diseases like cancer. New research shows the problem wasn't the cells themselves, but a misunderstanding of how they work and recognize threats. When dendritic cells are used the right way, studies and patient results suggest the immune system may be far more powerful than we once thought.   Key Takeaways To Tune In For:(03:13) – The Two-Factor Authentication for Immune Cells (10:38) – Activating Dendritic Cells to Fight Cancer (14:16) – Dendritic Cell Therapy vs Checkpoint Inhibitors (21:22) – Strategic Immunization and Immune Guidance (24:45) – Clinical Success Across Multiple Cancer Types (35:55) – Personalized Treatment and Adjunct Therapies   Resources talked about in this episode:Website: immunocine.com  Social media handles: @matthalperphd  

Season 10, Episode 7: Scaling Hope: The Future of Cell Therapy Access   In this episode of the PQI Podcast, Fabian Gerlinghaus, Co-founder and CEO of Cellares, shares insights into the evolving landscape of cell therapy manufacturing and its impact on patient access. Fabian discusses his background as an aerospace engineer turned biotech innovator and the inspiration behind founding Cellares, a company focused on transforming how cell therapies are developed and manufactured. The conversation walks through how CAR T therapies are created, from cell collection to reinfusion, and highlights the operational and logistical challenges that continue to limit scalability and access today. A central theme is the complexity of current manufacturing processes, many of which remain highly manual, contributing to delays, variability, and cost. Fabian shares how automation and new manufacturing models, including the Cell Shuttle platform, aim to address these barriers by improving consistency, reducing turnaround times, and supporting broader access to these therapies. The discussion also connects these advancements back to the oncology care team, exploring what more efficient manufacturing could mean in practice for pharmacists, nurses, physicians, and ultimately, for patients waiting on therapy. Looking ahead, the episode offers a forward-thinking perspective on how cell therapy may evolve over the next five years, with a focus on scalability, innovation, and the opportunity to reach more patients in need.

In this episode, we discuss the pathbreaking use of an encapsulated cell therapy that produces CNTF for the successful treatment of MacTel with Roger Goldberg, MD, from Walnut Creek, CA.

Off-the-shelf immune cell therapies using engineered T cells represent an important direction in cancer treatment. Lili Yang, Ph.D., at UCLA develops an off-the-shelf platform based on invariant natural killer T (iNKT) cells generated from hematopoietic stem cells, often sourced from cord blood. Yang programs these stem cells with iNKT cell receptors, chimeric antigen receptors (CARs), and genes such as IL-15 to create pure, expandable iNKT products that recognize lipid antigens presented by non polymorphic CD1d molecules. These cells combine multiple killing mechanisms, infiltrate tissues, target tumor cells and immunosuppressive myeloid cells, and show reduced risk of graft versus host disease and cytokine release syndrome in preclinical models. Yang's group tests this strategy in models of blood cancers and solid tumors, aiming to generate many therapeutic doses from a single donor. Series: "Stem Cell Channel" [Health and Medicine] [Show ID: 40846]

Off-the-shelf immune cell therapies using engineered T cells represent an important direction in cancer treatment. Lili Yang, Ph.D., at UCLA develops an off-the-shelf platform based on invariant natural killer T (iNKT) cells generated from hematopoietic stem cells, often sourced from cord blood. Yang programs these stem cells with iNKT cell receptors, chimeric antigen receptors (CARs), and genes such as IL-15 to create pure, expandable iNKT products that recognize lipid antigens presented by non polymorphic CD1d molecules. These cells combine multiple killing mechanisms, infiltrate tissues, target tumor cells and immunosuppressive myeloid cells, and show reduced risk of graft versus host disease and cytokine release syndrome in preclinical models. Yang's group tests this strategy in models of blood cancers and solid tumors, aiming to generate many therapeutic doses from a single donor. Series: "Stem Cell Channel" [Health and Medicine] [Show ID: 40846]

Off-the-shelf immune cell therapies using engineered T cells represent an important direction in cancer treatment. Lili Yang, Ph.D., at UCLA develops an off-the-shelf platform based on invariant natural killer T (iNKT) cells generated from hematopoietic stem cells, often sourced from cord blood. Yang programs these stem cells with iNKT cell receptors, chimeric antigen receptors (CARs), and genes such as IL-15 to create pure, expandable iNKT products that recognize lipid antigens presented by non polymorphic CD1d molecules. These cells combine multiple killing mechanisms, infiltrate tissues, target tumor cells and immunosuppressive myeloid cells, and show reduced risk of graft versus host disease and cytokine release syndrome in preclinical models. Yang's group tests this strategy in models of blood cancers and solid tumors, aiming to generate many therapeutic doses from a single donor. Series: "Stem Cell Channel" [Health and Medicine] [Show ID: 40846]

Off-the-shelf immune cell therapies using engineered T cells represent an important direction in cancer treatment. Lili Yang, Ph.D., at UCLA develops an off-the-shelf platform based on invariant natural killer T (iNKT) cells generated from hematopoietic stem cells, often sourced from cord blood. Yang programs these stem cells with iNKT cell receptors, chimeric antigen receptors (CARs), and genes such as IL-15 to create pure, expandable iNKT products that recognize lipid antigens presented by non polymorphic CD1d molecules. These cells combine multiple killing mechanisms, infiltrate tissues, target tumor cells and immunosuppressive myeloid cells, and show reduced risk of graft versus host disease and cytokine release syndrome in preclinical models. Yang's group tests this strategy in models of blood cancers and solid tumors, aiming to generate many therapeutic doses from a single donor. Series: "Stem Cell Channel" [Health and Medicine] [Show ID: 40846]

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the rapidly evolving landscape of biotech and pharmaceuticals, recent events have highlighted significant advancements in scientific research, regulatory landscapes, and strategic industry maneuvers. These stories illustrate a sector characterized by innovation, adaptability, and a relentless drive to improve patient care.One of the standout stories is AstraZeneca's bold move into the cell therapy arena, marked by a substantial $15 billion investment in China. The company is constructing a state-of-the-art cell therapy manufacturing hub and research and development center in Shanghai. This initiative underscores AstraZeneca's commitment to advancing cell therapy as a therapeutic modality. Such an investment could potentially revolutionize patient care, particularly in areas where conventional treatments have limited efficacy, offering new hope in regenerative medicine and personalized therapeutic approaches.Meanwhile, Pfizer is making strategic strides with its PARP inhibitor, Talzenna. Following successful Phase 3 trial results in metastatic hormone-sensitive prostate cancer, Pfizer is advocating for its earlier use. After a previous setback with the FDA regarding broader indications, this development could significantly alter treatment landscapes by targeting earlier stages of the disease. This shift may herald improved patient outcomes and provide fresh hope for those battling this challenging cancer type.In regulatory news, the FDA has granted approval to Lynavoy for treating cholestatic pruritus in patients with primary biliary cholangitis. This marks a significant milestone as it is the first approved therapy for this rare liver disease. It highlights ongoing efforts to address unmet medical needs within niche patient populations and reflects a broader push to expand therapeutic options across rare diseases, reinforcing the importance of tailored therapies.Turning to financial maneuvers within the industry, Collegium Pharmaceutical's acquisition of ADHD drug Azstarys from Corium Therapeutics for $650 million illustrates strategies to bolster product portfolios amid increasing competition and pricing pressures. This acquisition is part of a broader trend where companies seek diversification to maintain their competitive edge in an ever-evolving market landscape.On the economic front, HSBC's recent downgrade of Eli Lilly over concerns about pricing pressures and competition in the obesity market provides insight into the financial challenges pharmaceutical companies face today. Despite Eli Lilly's impressive results with its triple agonist retatrutide, which significantly lowers blood sugar levels and induces weight loss in type 2 diabetes patients, market dynamics continue to exert pressure on pricing strategies across the sector.Eli Lilly's promising phase 3 trial results for retatrutide mark a significant milestone in diabetes care. The experimental triple agonist has shown remarkable efficacy in managing type 2 diabetes by significantly reducing blood sugar levels while inducing substantial weight loss among participants. Such dual-benefit approaches could revolutionize treatment options for these interrelated conditions, offering improved quality of life for millions affected by chronic ailments like diabetes and obesity.Legislative changes are also shaping industry practices. A Maryland bill calling for greater transparency in pharmaceutical disease awareness campaigns highlights growing scrutiny from regulators and policymakers regarding industry practices. This legislative push aims to ensure that campaigns are more informative about brand affiliations, promoting accountability and potentially reshaping how companies communicate with healthcare providers and patients.In manufacturing developments, Axplora's Support the show

Dr. Mike McCullar, CEO of RegCell, is developing a novel cell therapy to treat autoimmune diseases that specifically addresses the loss of tolerance, in which the immune system mistakenly attacks the body's own tissues. This approach contrasts with current treatments, which broadly suppress the immune system and may cause side effects. The key goals of the therapy are to achieve long-term disease control and restore the immune system's natural balance. The company's manufacturing process is designed to simplify cell therapies, making them more affordable and accessible to a broader population of autoimmune patients. Mike explains, "The real driver of immunity, we believe, is what's called loss of tolerance, which is a system in our bodies that protects us from bad immune cells that attack our tissues. So that's a fundamental limitation in biology, and there really is not a curated treatment at this point. So our view has really been to try to restore the natural balance of our immune system by regulatory T cells, which are an indispensable non-redundant cell type to maintain tolerance against our autoimmune disorders. So we think the current treatments really don't address these challenges. They are broadly suppressing the immune system, and they don't offer curative potential."   "We've been using the same kinds of drugs for the immune disease for about three to five years, and they will broadly suppress the immune system. They are really unable to distinguish between a good immune cell and a bad immune cell. And I think that's the fundamental limitation of how these drugs work. They could be very affected, but they do really broadly suppress the immune system in an indiscriminate way." #RegCell #AutoimmuneHepatitis  #Biotechnology #MedicalResearch#AutoimmuneDiseases #CellTherapy #PrecisionMedicine #Immunology #Biotech #RegulatoryTCells #Innovation #HealthcareTechnology #ClinicalTrials regcellbio.com Listen to the podcast here

Dr. Mike McCullar, CEO of RegCell, is developing a novel cell therapy to treat autoimmune diseases that specifically addresses the loss of tolerance, in which the immune system mistakenly attacks the body's own tissues. This approach contrasts with current treatments, which broadly suppress the immune system and may cause side effects. The key goals of the therapy are to achieve long-term disease control and restore the immune system's natural balance. The company's manufacturing process is designed to simplify cell therapies, making them more affordable and accessible to a broader population of autoimmune patients. Mike explains, "The real driver of immunity, we believe, is what's called loss of tolerance, which is a system in our bodies that protects us from bad immune cells that attack our tissues. So that's a fundamental limitation in biology, and there really is not a curated treatment at this point. So our view has really been to try to restore the natural balance of our immune system by regulatory T cells, which are an indispensable non-redundant cell type to maintain tolerance against our autoimmune disorders. So we think the current treatments really don't address these challenges. They are broadly suppressing the immune system, and they don't offer curative potential."   "We've been using the same kinds of drugs for the immune disease for about three to five years, and they will broadly suppress the immune system. They are really unable to distinguish between a good immune cell and a bad immune cell. And I think that's the fundamental limitation of how these drugs work. They could be very affected, but they do really broadly suppress the immune system in an indiscriminate way." #RegCell #AutoimmuneHepatitis  #Biotechnology #MedicalResearch#AutoimmuneDiseases #CellTherapy #PrecisionMedicine #Immunology #Biotech #RegulatoryTCells #Innovation #HealthcareTechnology #ClinicalTrials regcellbio.com Download the transcript here

Maybe you've heard of CAR-T cells, a type of cell you have in your body that is supercharged in a lab and put back in to fight things like cancer. Biomedical engineering expert Jeremy Green at Johns Hopkins and colleagues … There's a new technique that may revolutionize one type of T cell therapy, Elizabeth Tracey reports Read More »

Stylus Medicine CEO Emile Nuwaysir and Chief Scientific Officer Jason Fontenot speak with BioSpace about the biotech's work on next-generation genetic medicines—and why they think it's the perfect time to be in the cell therapy game. Stylus Medicine is featured in BioSpace's  list, the top startups to watch in the U.S.HostAnnalee Armstrong, Senior Editor, BioSpaceGuestsEmile Nuwaysir, CEO, Stylus MedicineJason Fontenot, Chief Scientific Officer, Stylus MedicineDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Tumor-infiltrating lymphocyte (TIL) cell therapy is a promising option for patients with advanced melanoma, but logistical and referral challenges can be a barrier to care. In this episode, CANCER BUZZ speaks with Lilit Karapetyan, MD, MS, FACP, medical oncologist at Moffit Cancer Center and Research Institute, an authorized treatment center (ATC) for TIL cell therapy, and Raju Vaddepally, MD, hematologist-oncologist at Florida Cancer Specialists, a non-ATC, about the referral process. Both guests discuss the relationship between their cancer programs, offering actionable tips on how to streamline the identification and referral of melanoma patients for TIL therapy across institutions. Guests:  Lilit Karapetyan, MD, MS, FACP Medical Oncologist Moffitt Cancer Center and Research Institute Tampa, FL Raju Vaddepally, MD   Hematologist-Oncologist Florida Cancer Specialists Naples, FL  "It is extremely important that providers think about this earlier, because the huge issue that we have with TIL therapy is that we get a lot of patients referred but unfortunately, they are no longer fit to proceed with the therapy." - Lilit Karapetyan, MD, MS, FACP "Cancer care can be so fragmented and always requires multidisciplinary input, whether it be within the town or going to an academic center, so we do have a specialized department in which they handle all these referrals." - Raju Vaddepally, MD Resources ACCC TIL Therapy Resources ACCCBuzz Blog: Streamlining TIL Cell Therapy: ACCC Resources to Improve Referral Pathways and Academic–Community Coordination CANCER BUZZ: Developments in TIL Cell Therapy  

We love to hear from our listeners. Send us a message.In episode 123 of Cell & Gene: The Podcast, Host Erin Harris talks to Dr. Panteli Theocharous, FIBMS, M.S., Ph.D., FRCPath, about the patient journey in cell therapy trials. They pinpoint key friction points, such as delayed referrals, unpredictable vein-to-vein timelines, and burdensome long-term follow-up, while sharing actionable strategies for simplification. These strategies range from upstream trial design and streamlined consent processes to standardized logistics, hybrid monitoring models, honest risk communication, and engaging patients as true partners in real-world evidence generation.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a compelling array of advancements and strategic shifts that are shaping the healthcare landscape across the globe.In recent times, the pharmaceutical and biotech sectors have showcased remarkable resilience and innovation, driving forward with significant scientific breakthroughs and clinical trial results. A standout achievement comes from Novo Nordisk, whose recent Phase 2 trial results for its triple agonist targeting obesity reported a remarkable weight loss of up to 19.7% in patients over 24 weeks. This promising development positions Novo Nordisk as a formidable contender in the obesity treatment market, potentially affecting giants like Eli Lilly. With obesity being a significant global health challenge, these findings underscore the potential of multi-targeted approaches in managing this complex condition.Regulatory landscapes continue to evolve, with pivotal approvals marking milestones for therapies targeting rare diseases. Immedica Pharma's Loargys received FDA approval for treating hyperargininemia associated with arginase 1 deficiency, highlighting perseverance in overcoming regulatory hurdles after a prior rejection. Additionally, Sanofi and Regeneron's Dupixent achieved its ninth FDA approval, underscoring its versatile potential across multiple indications. These approvals not only reflect regulatory progress but also emphasize the critical role of persistence in drug development.Ethical considerations remain at the forefront of industry discussions, particularly highlighted by Novartis' settlement in a lawsuit concerning the use of Henrietta Lacks' cells without consent. This resolution underscores ongoing ethical challenges within biomedical research, emphasizing the need for ethical vigilance as companies increasingly rely on human-derived materials.Significant business trends are shaping strategic directions within the industry. Pfizer's acquisition of marketing rights for Sciwind's GLP-1 receptor agonist in China exemplifies a calculated move to dominate the obesity treatment market. This strategic acquisition allows Pfizer to leverage China's vast market potential for type 2 diabetes medications and positions it favorably for future weight loss treatments.On the manufacturing front, AbbVie has made substantial investments in U.S. infrastructure, committing $380 million to new North Chicago API plants as part of a decade-long strategy to inject $100 billion into U.S. operations. This initiative highlights a commitment to bolstering domestic production capabilities amidst global supply chain uncertainties.The complexities of drug development are further illustrated by Roche's decision to halt the development of Enspryng for Duchenne muscular dystrophy due to unsatisfactory progress. This shift in focus reflects the inherent challenges of drug repurposing and the necessity of robust clinical evidence to support new indications.Geopolitical factors also play a significant role in shaping industry dynamics, with recent U.S. Supreme Court decisions impacting international trade agreements. Such geopolitical influences can significantly affect pharmaceutical companies' operations and strategic planning.The collaboration between Astellas and Vir Biotechnology reflects another significant trend in strategic partnerships within the industry. Their $1.7 billion deal centered on a novel bispecific T-cell engager for prostate cancer underscores the growing importance of immuno-oncology and innovative approaches to targeting hard-to-treat cancers.The regulatory front continues to see transformative changes with the FDA unveiling draft guidance for a new approval pathway tailored for bespoke gene-editing therapies. This initiative could expedite personalized genetic treatments and transform patSupport the show

Today, Ivelisse talks with Dr. Dan Rubin, a naturopathic oncologist and co-founder of Naturopathic Specialists in Scottsdale, Arizona, about an emerging cancer treatment called dendritic cell therapy.Dr. Rubin explains in simple terms how dendritic cells act like “generals” of the immune system—gathering information about a tumor and teaching the body's T cells how to recognize and attack cancer. He discusses Immunocine's “double-loaded” dendritic cell therapy, which uses information from a patient's own tumor to help train the immune system in a more personalized way. This treatment is currently offered in Cancun and is also being studied in U.S. clinical trials for certain cancers, including glioblastoma and pancreatic cancer.They walk through what the process looks like for patients—from application and medical record review, to traveling for tumor sampling, collecting immune cells, and receiving a series of injections. Dr. Rubin also shares how tumor tissue can be stored for possible future use and talks honestly about outcomes, cost, and the importance of ongoing testing to determine who may benefit most.This episode provides hope-filled, easy-to-understand insight into a personalized, immune-based approach to cancer care for patients and caregivers alike.Learn more about Dr. Dan Rubin. Suggested Resources:Naturopathic Specialists in Scottsdale, AZAiresTech Products for EMF protectionHAVN by Lambs - EMF defracting productsImmunocine (Cancun)Immunocine Preserve (Biobank in Scottsdale)Send us Fan Mail! Click here >Your donations power our podcast's mission to support cancer patients with hope, insights, and resources. Every contribution fuels our ability to uplift and empower. Join us in making a lasting impact. Donate now!

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a wide array of topics, from groundbreaking therapies and strategic corporate moves to regulatory shifts and industry trends shaping the future of healthcare.We begin with Eli Lilly, which is making significant strides with its combined Zepbound and Taltz therapy, showing promising results in the treatment of psoriasis and obesity. This combination therapy, initially successful in psoriatic arthritis, is set to transform treatment protocols by bridging gaps between psoriasis and obesity. This dual-targeting approach highlights a burgeoning trend in the industry: the use of combination therapies to enhance patient outcomes while streamlining treatment regimens. This strategy not only promises better management of interconnected conditions but also reflects a broader industry goal of maximizing therapeutic reach with existing drugs.Novartis is advancing its portfolio with the oral BTK inhibitor, Rhapsido, following a successful Phase 3 trial for a new chronic hives subtype. This development underscores Novartis's commitment to addressing niche markets and unmet medical needs, emphasizing the pharmaceutical industry's focus on expanding the utility of existing drugs. Additionally, Novartis has entered into a notable partnership with Macrocycle Biotech for cardiovascular drug development. This collaboration represents a broader trend where large pharmaceutical companies seek innovative partnerships to expand their therapeutic portfolios through cutting-edge biotech solutions.Meanwhile, Moderna's influenza vaccine submission has been accepted by the FDA after an initial rejection, illustrating a responsive regulatory environment crucial for timely access to vaccines amid potential flu outbreaks.Johnson & Johnson's $1 billion investment plan in the U.S., focusing on cell therapy, aligns with broader industry trends towards personalized medicine and advanced therapeutic approaches. This investment is part of a strategic pivot towards cell and gene therapies that promise to redefine treatment pathways for complex diseases. Similarly, Bayer's $7.25 billion settlement over Roundup litigation shows an industry keen on resolving legal challenges swiftly to refocus efforts on innovation.Regulatory reforms are also gaining attention, with proposals aimed at streamlining FDA processes to enhance drug access and reduce burdens. These reforms could significantly impact drug development timelines and market entry strategies, reflecting an ongoing discourse on balancing regulation with fostering innovation.On a global scale, Stada's €85 million investment in Saudi Arabia points to a strategic move towards enhancing supply chain resilience in the Middle East and North Africa. This aligns with industry trends focusing on regional manufacturing capabilities to ensure drug availability while reducing logistical complexities.A notable example of strategic resource allocation is Eli Lilly's $100 million upfront payment for CSL's IL-6 antibody development rights. This reflects an adaptive approach where initial clinical setbacks are seen as opportunities for new therapeutic ventures rather than dead ends.Turning our attention to Alzheimer's research, Korsana Biosciences has emerged from stealth mode with substantial funding aimed at developing an anti-amyloid antibody capable of crossing the blood-brain barrier. This effort addresses a critical need within Alzheimer's disease treatment—a field marked by intense competition and scientific challenge. Parallelly, IQVIA Biotech highlights the importance of accelerating early-stage interventions for Alzheimer's through data analytics and optimized clinical trials. Such efforts aim to expedite regulatory approvals and bring new therapies to market faster—a trend indicative of leveragSupport the show

At the 2026 Tandem Meetings, CancerNetwork® spoke with a variety of experts who presented on key developments and advancements across hematologic oncology. As part of different oral presentations and poster sessions, researchers and clinicians shared updated findings that may influence the management of myelodysplastic syndromes (MDS), leukemia, lymphoma, and other blood cancer types.First, Fernando Duarte, head of the Bone Marrow Transplant Service at Walter Cantídio University Hospital (HUWC), hematologist and professor at the Federal University of Ceará, and president of the Brazilian Society of Cell Therapy and Bone Marrow Transplant, highlighted his presentation analyzing trends associated with allogenic hematopoietic cell transplantation (allo-HCT) among patients with MDS or myeloproliferative neoplasms (MPN) and other types of MDS. Data from the Brazillian SBTMO and CIBMTR registry revealed that patients receiving allo-HCT for MDS/MPN were typically older with worse performance statuses. Additionally, MDS/MPN independently predicted worse overall survival (OS) and relapse-free survival outcomes.Next, Alfonso Molina, MD, MPH, a third-year Hematology and Medical Oncology fellow at Stanford University, detailed results from a phase 1 trial (NCT05507827) assessing Orca-T, an investigational allogeneic T-cell immunotherapy, among those with high-risk B-cell acute lymphoblastic leukemia (B-ALL). Treatment with Orca-T yielded disease-free survival and OS in all (100%) 18 evaluable patients after a median follow-up of 14 months (range, 3-35), which occurred without graft failure, significant graft-versus-host-disease, or severe CAR-mediated toxicity.Finally, Irtiza N. Sheikh, DO, an assistant professor in the Department of Pediatrics - Patient Care, Stem Cell Transplantation and Cellular Therapy Section of the Division of Pediatrics at The University of Texas MD Anderson Cancer Center, discussed his presentation exploring differences in outcomes with lisocabtagene maraleucel (Breyanzi; liso-cel) across various treatment settings and patient populations with large B-cell lymphoma. Data demonstrated that among patients younger than 50 years old, liso-cel produced enduring responses across real-world and clinical trial settings, which were comparable to outcomes in overall populations. References Duarte FB, Garcia YDO, Hamerschlak N, et al. Comparative outcomes of allogeneic hematopoietic cell transplantation in myelodysplastic/myeloproliferative neoplasms and other myelodysplastic syndromes: Brazilian Sbtmo/CIBMTR registry analysis. Presented at: 2026 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR; February 4-7, 2026; Salt Lake City, UT. Presentation 63. Molina A, Shiraz A, Kanegai A, et al. Mature outcomes from the phase I trial of Orca-T and allogeneic CD19/CD22 CAR-T cells for adults with high-risk B-ALL. Presented at: 2026 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR; February 4-7, 2026; Salt Lake City, UT. Presentation 31. Sheikh IN, Patel K, Perales MA, et al. Clinical outcomes of lisocabtagene maraleucel (liso-cel) in YOUNGER PATIENTS (Pts) with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). Presented at: 2026 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR; February 4-7, 2026; Salt Lake City, UT. Poster 210.

In this episode of Plugged Into Public Health, Lauren speaks with Dr. Jill Kolesar about ovarian cancer, precision medicine, and the challenges of translating scientific discovery into real-world care. Dr. Kolesar explains why ovarian cancer remains difficult to treat, including late-stage diagnosis and limited response to immunotherapy. She shares her team's work on a novel cell-based therapy designed to convert “cold” tumors into ones the immune system can attack, with the goal of improving effectiveness while reducing toxicity. The conversation also explores molecular tumor boards, the role of pharmacists in precision oncology, and how collaboration and data sharing help bring innovation to community and rural settings. This episode highlights not only cutting-edge science, but the systems required to ensure that breakthroughs actually reach patients. A transcript of this episode will be available here soon. Have a question for our podcast crew or an idea for an episode? You can email them at CPH-GradAmbassador@uiowa.edu You can also support Plugged in to Public Health by sharing this episode and others with your friends, colleagues, and social networks. #publichealth #cancer #cancercare #ovariancancer #precisionmedicine #immunotherapy #healthcare #pharmacology #medicaltechnology #iowacity

 Ryan Clarke, Co-Founder, CEO, and CTO of Syntax Bio, is focused on solving manufacturing challenges in producing stem cell-derived therapies, specifically the process of stem cell differentiation. The Cellgorithm platform was designed to make differentiation an engineering problem by using a modified form of CRISPR to turn genes on and off in a specific, controlled sequence, reducing processing time from months to days and resulting in cost savings. One goal is to use AI and machine learning to build models capable of predicting optimal gene regulation sequences accelerating the discovery of new differentiation protocols and treatments for degenerative diseases. Ryan explains, "The key problem that we are focused on applies to stem cell-derived cell therapies. And so, just for a little bit of context setting, we use induced pluripotent stem cells or IPS cells. And about 20 years ago, when these were first derived, everybody was very excited because this is the platform where you could then have an infinite supply of stem cells to then make any tissue-specific cell type at will, theoretically. Fast forward 20 years, and there are finally some cell therapies in phase three clinical trials, but none are approved yet. And that just tells you that the development cycle for this modality is actually slower than the other modalities, like biologics or small molecules. And the problem is manufacturing in particular, or how do you convert the stem cell into the target tissue cell type for the process of stem cell differentiation? And so we are solely focused on making stem cell differentiation an engineering problem rather than a kind of dark art."   "We have a program for type one diabetes that is making pancreatic beta cells from IPS cells. And we have also done some work in the musculoskeletal system. So these other cell types we focus on are more demonstrations of the platform technology, but we are interested in possibly co-developing those with other pharmaceutical partners, and that's the musculoskeletal cells of the hematopoietic system. And we've done some work on retinal cells as well, but we endeavor to make many other cell types. And our goal is to partner with the therapeutic experts in the area to develop these." #SyntaxBio #CellTherapy #CRISPR #StemCells #Biotech #RegenerativeMedicine #Diabetes #Manufacturing #Innovation #GeneTherapy #LifeSciences #Bioengineering #SyntheticBiology #CellProgramming syntax-bio.com Listen to the podcast here

 Ryan Clarke, Co-Founder, CEO, and CTO of Syntax Bio, is focused on solving manufacturing challenges in producing stem cell-derived therapies, specifically the process of stem cell differentiation. The Cellgorithm platform was designed to make differentiation an engineering problem by using a modified form of CRISPR to turn genes on and off in a specific, controlled sequence, reducing processing time from months to days and resulting in cost savings. One goal is to use AI and machine learning to build models capable of predicting optimal gene regulation sequences accelerating the discovery of new differentiation protocols and treatments for degenerative diseases. Ryan explains, "The key problem that we are focused on applies to stem cell-derived cell therapies. And so, just for a little bit of context setting, we use induced pluripotent stem cells or IPS cells. And about 20 years ago, when these were first derived, everybody was very excited because this is the platform where you could then have an infinite supply of stem cells to then make any tissue-specific cell type at will, theoretically. Fast forward 20 years, and there are finally some cell therapies in phase three clinical trials, but none are approved yet. And that just tells you that the development cycle for this modality is actually slower than the other modalities, like biologics or small molecules. And the problem is manufacturing in particular, or how do you convert the stem cell into the target tissue cell type for the process of stem cell differentiation? And so we are solely focused on making stem cell differentiation an engineering problem rather than a kind of dark art."   "We have a program for type one diabetes that is making pancreatic beta cells from IPS cells. And we have also done some work in the musculoskeletal system. So these other cell types we focus on are more demonstrations of the platform technology, but we are interested in possibly co-developing those with other pharmaceutical partners, and that's the musculoskeletal cells of the hematopoietic system. And we've done some work on retinal cells as well, but we endeavor to make many other cell types. And our goal is to partner with the therapeutic experts in the area to develop these." #SyntaxBio #CellTherapy #CRISPR #StemCells #Biotech #RegenerativeMedicine #Diabetes #Manufacturing #Innovation #GeneTherapy #LifeSciences #Bioengineering #SyntheticBiology #CellProgramming syntax-bio.com Download the transcript here

Synopsis: At the heart of JPM 2026's biotech buzz, Alok Tayi sits down with Fred Aslan, CEO of Artiva, to explore how bold platform bets, scalable cell therapies, and autoimmune breakthroughs could reshape medicine. Fred traces his journey from medical school in Brazil to consulting at BCG, venture capital, and ultimately founding multiple companies—sharing why following curiosity, not rigid career ladders, shaped his path. Fred dives deep into the bottlenecks holding back traditional CAR-T therapies—manufacturing complexity, cost, hospitalization, and toxicity—and explains how Artiva's off-the-shelf NK-cell platform aims to change the paradigm. The discussion explores why rheumatoid arthritis became Artiva's lead indication, how immune “resets” could redefine autoimmune care, and what's ahead in 2026 as the company prepares registrational trials and expands its basket studies across lupus, myositis, scleroderma, and more. The episode closes with rapid-fire takes on AI in drug development, China's accelerating biotech engine, rare disease trial models, and the strategic principles founders should follow when choosing indications and building durable platforms. Biography: Fred Aslan, M.D., has a 20-year track record as an executive and investor in the life sciences industry. He was most recently President and CBO at Vividion Therapeutics, where he was responsible for business development, finance, alliance and project management, and operations. Dr. Aslan had the opportunity to lead Vividion's Series B financing and $135M-upfront collaboration with Roche. Prior to Vividion, Dr. Aslan had a 12-year affiliation with Venrock. Initially he was an investor from 2006 to 2013, when he cofounded and served as a board member of Receptos Pharmaceuticals (acquired by Celgene for more than $7 billion). Dr. Aslan led Venrock's investment in Zeltiq (acquired by Allergan for more than $2 billion) and was involved in the early formation of Fate Therapeutics. Subsequently as an entrepreneur from 2013 to 2018, he was CEO of Adavium Medical, a Brazilian medical device company, which he grew from zero to 350 employees, sales of over US$40 million, and fully integrated R&D, manufacturing, and commercial capabilities. Prior to Venrock, Dr. Aslan was Director of Business Development and Head of Investor Relations for CuraGen, a Nasdaq-listed oncology-focused biotech company. Prior to CuraGen, he was a consultant at Boston Consulting Group (BCG). Dr. Aslan holds a B.S. in biology from Duke University, an M.D. from Yale School of Medicine, and an MBA from Harvard Business School.

How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands.A few of Nelly's key takeaways:Resilience is adaptability—build organizations that absorb and anticipate change rather than resist itSeparate innovation from execution with intentional gates for when new approaches are ready to implementDocument your assumptions so you can revisit decisions effectively when circumstances changeFailure is a process problem, not a personal one—root cause analysis should improve systems, not assign blameData is the common language that aligns scientists, regulators, and stakeholdersEveryone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their handsAbout Nelly ViseuxNelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/

Tim Lu, CEO of Senti Bio, joins In Vivo to discuss how programmable cell therapies are solving oncology's targeting problem. Lu explains the logic-gated approach behind SENTI-202, an allogeneic CAR-NK therapy for relapsed/refractory AML that achieved 50% response rates in Phase 1 while avoiding the dose-limiting toxicities that have plagued other AML cell therapies. We cover the Phase 1 ASH 2025 data showing 39% complete remission rates (all MRD-negative) with 7.6-month median duration, the rationale for using NK cells over T cells, and why synthetic biology's three-target logic gates can distinguish cancer from healthy bone marrow cells. Lu also discusses plans for pivotal trials following RMAT designation, expansion into solid tumors, and where biotech innovation is accelerating versus where clinical translation bottlenecks remain. For biopharma professionals tracking cell therapy innovation, synthetic biology applications, and AML treatment advances.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. This morning, we're diving into a series of fascinating updates that underline the vibrant and ever-changing landscape of our industry.The J.P. Morgan Healthcare Conference recently set the stage for some intriguing discussions, particularly from Novo Nordisk. The company is diversifying its metabolic drug development portfolio by exploring innovative avenues, reflecting a broader industry trend where firms seek to balance their core expertise with novel therapeutic areas. This strategic diversification is crucial as companies aim to address complex health issues with an expansive approach to innovation. Novo Nordisk's leadership emphasized this strategic pivot towards diversifying their innovation pipeline beyond traditional metabolic disorders, aiming to keep the company at the forefront of pharmaceutical advancements.Meanwhile, Takeda's R&D head, Andy Plump, brought attention to some challenges currently facing U.S. innovation. Despite a sluggish start at the conference, recent months have been buzzing with significant deal-making activities. This scenario highlights the delicate dance between maintaining steady innovation and navigating regulatory hurdles and economic pressures. However, optimism remains high, with strategic investments and collaborations seen as potential catalysts for rejuvenation in research.Amgen made waves by presenting promising results from an exploratory study of Maritide in weight loss maintenance. The study's outcomes signal a significant milestone in obesity management and set the stage for further clinical trials and potential approval processes. This advancement offers hope in addressing what remains a critical public health issue worldwide.A significant development at the National Institutes of Health (NIH) is the leadership change as Dr. Gary Gibbons steps down as Director of the Heart, Lung, and Blood Institute. This shift adds to a growing list of interim leadership roles across NIH's 27 institutes and centers, which could impact continuity in critical research projects and funding initiatives.On the corporate front, Sonoma Pharmaceuticals announced notable workforce reductions due to financial challenges, while Lyra Therapeutics decided to abandon its rhinosinusitis treatment project alongside laying off its entire team. These decisions highlight the financial volatility that smaller biotech firms face amid competitive pressures and regulatory complexities. In contrast, Pretzel Therapeutics has emerged successfully from turbulent times, demonstrating resilience and adaptability within the biotech sector. Strategic restructuring and leadership realignment have positioned Pretzel Therapeutics for future growth in therapeutic development.A major highlight involves AbbVie entering into an agreement with the White House to reduce Medicaid drug prices while committing a substantial $100 billion investment in U.S. R&D over the next decade. This aligns with broader efforts to make healthcare more affordable while encouraging domestic pharmaceutical investment. AbbVie's substantial commitment towards U.S. R&D speaks volumes about their strategy within TrumpRx program contexts that aim at enhancing market penetration while balancing innovation investment against cost management pressures.Medtronic has expressed readiness to engage in mergers and acquisitions, indicating that medtech companies are poised for expansion through strategic buyouts. This move reflects an industry-wide capacity for growth through consolidation and collaboration. As we look towards mergers and acquisitions within medtech highlighted by Medtronic's intentions, it's clear that strategic M&A activities remain vital for companies seeking to expand capabilities and market presence in this competitive landscape.The FDA has aSupport the show

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Nick Manusos, CEO at Kenai Therapeutics, talks about his experiences building cell therapy spinouts from FujiFilm Cellular Dynamics, learning from big pharma decision-making processes, and dosing the first patient with Kenai's allogeneic neuron replacement cell therapy for Parkinson's disease. Nick also talks about funding an early-stage cell therapy company and forging key manufacturing and therapy administration partnerships. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message.Episode 115 of Cell & Gene: The Podcast features Host Erin Harris' talk with Aliya Omer, Vice President and Global Head of Hematology and Cell Therapy at AstraZeneca. Omer shares valuable insights from her rich experience leading cell therapy development across multiple top companies. She highlights the critical importance of collaboration by breaking down silos across research, manufacturing, regulatory, and commercial teams to deliver innovative therapies efficiently. She also discusses AZ's diverse and ambitious cell therapy portfolio, encompassing autologous CAR-T, TCR-T, in vivo gene therapies, and regulatory T-cell therapies. She candidly addresses current challenges in manufacturing scalability, patient access, and healthcare system readiness and describes how AZ is prioritizing fast manufacturing platforms and ecosystem-wide partnerships to surmount these hurdles. Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

We love to hear from our listeners. Send us a message.On episode 114 of Cell & Gene: The Podcast, Host Erin Harris talks to Brian Culley, CEO of Lineage Cell Therapeutics, about advancing cell therapy beyond oncology and into transformative treatments for conditions such as spinal cord injury and blindness. Culley shares how Lineage's allogeneic, off-the-shelf approach, anchored by its OPC1 program, aims to replace lost or damaged cells to restore function, starting with patients who have plateaued after chronic spinal cord injury. He details the DOSED study's innovative delivery device and thaw-and-inject formulation, both designed to simplify administration, enhance safety, and improve patient access. Harris and Culley also explore Lineage's broader vision for commercial viability in cell transplantation and its collaborative work with the Christopher & Dana Reeve Foundation to drive awareness, research, and investment in spinal cord injury therapies.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

Viral pneumonia can cause severe lung damage and make recovery long and life-threatening for patients. Current treatments only provide support, not repair, but Northwestern Medicine scientist Benjamin Singer, MD, wants to change that. In this episode, he details a recent discovery from his team that found laboratory-modified T-cells or induced regulatory T-cells (iTregs), can promote lung tissue repair in mice with severe influenza pneumonia. Singer discusses this breakthrough and how it could lead to an effective cellular therapy for patients with severe viral pneumonia and acute respiratory distress syndrome in the future. 

It's been a tough year for cell and gene therapy — patient deaths, high-profile companies pulling out of the space, and sour investment sentiment. But the field has had some promising readouts in the clinic recently, and it continues to mature, showing steady progress despite challenging market conditions. On the latest BioCentury This Week podcast, Evotec's Bernd Mühlenweg joins BioCentury's analysts to give his view of the field and offer takeaways from this month's Cell & Gene Meeting on the Mesa in Phoenix. This episode of BioCentury This Week is sponsored by Evotec. View full story: https://www.biocentury.com/article/657278To submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Cell therapy holds immense potential to transform the way we treat conditions in oncology, ophthalmology, autoimmune disorders, and a wide range of other therapeutic areas. But how do these engineered cells work, and how do scientists ensure they are safe and function as intended? In this episode, co-host Danielle Mandikian sits down with Todd McDevitt, Head of Cell Therapy, to discuss how cell therapies operate within the body, the challenges researchers face in this field, and the advancements needed to unlock their full potential for patients. Read the full text transcript at www.gene.com/stories/cells-at-work