Podcasts about Drug development

“They say it takes a village to raise a child. I really think it takes a village to treat a patient,” says Dr. Lanae Mullane, a naturopathic doctor and clinical strategist who has spent years at the forefront of bridging functional medicine, nutraceutical development, and digital health. In this episode of Raise the Line, host Lindsey Smith explores Dr. Mullane's view that naturopathic medicine complements conventional care by expanding -- not replacing -- the clinical toolkit, and that collaboration should be the future of medicine. “At the end of the day, collaboration and connection create the best outcomes for the people we serve,” she says. Their in-depth conversation also spans the shifting landscape of women's hormone health, including the perimenopausal transition and long-overdue calls for research equity. “We're not just smaller versions of men. We need to have dedicated research for us.” Tune in to learn about the importance of grounding health in sustainable habits, rethinking midlife care for women, and how to help patients take ownership of their health.Mentioned in this episode:Joi + BlokesSuppCoDr. Mullane's Clinical Website 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

“It's kind of a miracle, frankly,” says Dr. John Buse, a distinguished professor at the University of North Carolina School of Medicine, referring to the effectiveness of GLP-1 receptor agonist medications such as Ozempic in treating type 2 diabetes, promoting significant weight loss, and reducing cardiovascular risk. As a physician scientist for the last three decades at UNC, Dr. Buse has played a key role in ushering in this new era of diabetes care, leading or participating in over 200 clinical studies on this class of drugs and others. “Nothing has impacted diabetes care like the GLP-1 receptor agonists. I have lots of patients whose diabetes was never well controlled who have seen all their metabolic problems essentially resolved.”  In this fascinating conversation with Raise the Line host Lindsey Smith, Dr. Buse not only explains how these drugs work, but also provides a clear-eyed look at side effects, and addresses issues of cost and access. Join us for the remarkable story – including the role played by Gila monsters -- behind one of the biggest developments in medicine over the past several years from a world renowned diabetes researcher and clinician. Mentioned in this episode:UNC School of Medicine 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

In this episode of Project Synapse, we explore the innovative use of AI in veterinary oncology with Dr. Christopher Pinard. Dr. Pinard, a veterinary oncologist, discusses his journey from coding HTML in grade school to developing AI-driven solutions for cancer in pets. He shares insights on the challenges and opportunities within veterinary medicine, the impact of AI on clinical efficiency, and the future of personalized medicine for pets. We also delve into issues like regulatory challenges, the importance of context in AI models, and the potential of federated learning. If you're interested in the intersection of AI and veterinary medicine, this episode is a must-watch! 00:00 Introduction to Project Synapse 01:12 Meet Christopher Pinard: Veterinary Oncologist 01:27 The Evolution of Veterinary Specialties 02:02 Training and Clinical Trials in Veterinary Oncology 03:21 AI in Veterinary Medicine 03:48 The Intersection of Veterinary and Human Medicine 04:34 Challenges in Veterinary Medicine 05:19 Cancer Statistics in Pets 09:12 Protein Folding and AI in Drug Development 23:48 AI Scribes and Summarization in Veterinary Medicine 35:43 Guardrails to Prevent Hallucinations 36:57 Embedding Models and Knowledge Graphs 37:49 Introducing Hero: The Rationalization Engine 38:11 Grading Methodology for AI Outputs 39:18 Using Multiple Models for Fact-Checking 43:54 Extracting Data from Clinical Records 45:45 The Future of Domain-Specific AI Models 48:16 Challenges and Opportunities in Veterinary AI 50:55 Federated Learning and Bias Mitigation 55:03 The Importance of Regulation and Education 01:01:50 Starting a Veterinary AI Business in Canada 01:08:00 Future Directions in Veterinary Oncology 01:08:58 Conclusion and Farewell

“It wasn't a profession, it was a way of life,” observes internationally respected psychiatrist Dr. Nasser Loza, reflecting on a century-long family legacy in mental health care that began when his grandfather founded The Behman Hospital in Cairo. In this candid Raise the Line conversation with host Michael Carrese, Dr. Loza traces the transformation of psychiatry he's witnessed in his long career as increases in classifications, payment bureaucracy, reliance on pharmaceuticals, and technological disruption have each left their mark. The cumulative costs associated with these changes have, he laments, pushed care out of reach for many and hindered the human connection that is key to the discipline. He describes his prescription for countering these trends as a focus on effective and modest aims. “Rather than saying, come and see me in therapy for five years and I will make a better person out of you, I think focusing on symptom-targeted help is going to be what is needed.”  In this wide-ranging interview, you'll also learn about progress on advancing the rights of mental health patients and lowering stigmas, how to manage the rise of online therapy and use of AI chatbots, and the importance of empathy and transparency in mental health counseling. Don't miss this valuable perspective on a critically important dimension of healthcare that's informed by decades of experience as a clinician, government official and global advocate. Mentioned in this episode:The Behman HospitalMaadi Psychology Center 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

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Binodh DeSilva, Senior Vice President of Bioanalysis at Ultragenyx Pharmaceutical, to explore the science and soul behind rare-disease drug development.From her early days studying electrochemistry at the University of Kansas to leading cutting-edge bioanalytical programs at Ultragenyx, Dr. DeSilva shares how curiosity and community shaped her four-decade career. She discusses the profound responsibility of working with limited, often irreplaceable patient samples with care.A special thanks to AAPS (https://www.aaps.org/) for their help and support of this episode.The conversation dives into:Balancing rigor and agility in small-population clinical studiesLeveraging entrepreneurial mindsets from biotech within big pharma frameworksThe promise of dried blood spots (DBS) and patient-centric samplingMentorship, curiosity, and the future of scientific leadershipHer return to Sri Lanka with KU faculty to recruit the next generation of scientistsThroughout the discussion, DeSilva underscores a recurring theme: science thrives when curiosity meets compassion. This episode is a masterclass in both.Guest LinksDr. Binodh DeSilvahttps://www.linkedin.com/in/binodh-desilva/ Ultragenyx Pharmaceuticals - https://www.ultragenyx.com/ HostsDr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Keywords: BioTalk Unzipped, Binodh DeSilva, Ultragenyx, rare disease research, bioanalysis, dynamic drug development, dried blood spots, DBS sampling, biologics, AAPS NBC 2025, Gregory Austin, Chad Briscoe, Celerion, scientific leadership, mentorship in science, biopharma innovation, curiosity in research, Sri Lanka scientists, analytical chemistry, pharma innovation, drug development ethics.

What if drug development could be faster, more efficient, and centered on what matters most to patients? In this episode, host Elaine Hamm, PhD, sits down with Klaus Romero, MD, CEO of the Critical Path Institute (C-Path), to explore how two decades of global collaboration have reshaped the way we bring new medicines to life. From redefining clinical endpoints to accelerating treatments for complex diseases like Alzheimer's and tuberculosis, C-Path is leading a movement to remove bottlenecks in drug development through data, regulatory science, and partnership. In this episode, you'll discover: How C-Path's collaborative model helps de-risk and speed up the drug development process. Why patient-focused science is so essential for meaningful innovation. How data sharing, trust-building, and regulatory transparency drive real-world impact. Tune in to learn how C-Path is bridging science, regulation, and patient need—transforming the future of drug development through collaboration. Links: Connect with Klaus Romero, MD, and check out Critical Path Institute. Connect with Elaine Hamm, PhD, and learn about Tulane Medicine Business Development and the School of Medicine. Learn more about Cadenza Bio and the FDA's Critical Path Initiative. Connect with Ian McLachlan, BIO from the BAYOU producer. Check out BIO on the BAYOU and make plans to attend October 28 & 29, 2025. Learn more about BIO from the BAYOU - the podcast. Bio from the Bayou is a podcast that explores biotech innovation, business development, and healthcare outcomes in New Orleans & The Gulf South, connecting biotech companies, investors, and key opinion leaders to advance medicine, technology, and startup opportunities in the region.

“When I was in medical school, no one had even heard of mitochondrial disease. Today, every student who graduates here knows what it is and has seen a patient with it,” says Dr. Mary Kay Koenig, director of the Center for the Treatment of Pediatric Neurodegenerative Disease at UTHealth Houston McGovern Medical School. That remarkable change in awareness has been accompanied by advances in genetic sequencing, the development of clinical guidelines, and the emergence of potential treatments in some forms of mitochondrial disease. In fact, Dr. Koenig's multidisciplinary team at UTHealth's Mitochondrial Center of Excellence has been a key player in clinical trials that may yield the first FDA-approved treatments for it. As you'll learn in this Year of the Zebra conversation with host Michael Carrese, her work in neurodegenerative diseases also includes tuberous sclerosis, where advanced therapies have replaced the need for repeated surgeries, and Leigh Syndrome, which has seen improvements in diagnoses and supportive therapies leading to better quality of life for patients.  Tune in as Dr. Koenig reflects on an era of progress in the space, the rewards of balancing research, teaching and patient care, and the need for more clinicians to center listening, humility and honesty in their approach to caring for rare disease patients and their  families.Mentioned in this episode:Mitochondrial Center of ExcellenceCenter for the Treatment of Pediatric Neurodegenerative Disease 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

How do you design a physical space that matches the lightning-fast pace of modern scientific discovery? This episode explores the new paradigm for innovation districts with Professor Dame Kay Davies and Victoria Collett of Thomas White Oxford, the development company of St. John's College. The conversation covers the critical transition from academic lab work, where Professor Davies has spent 30 years researching Duchenne Muscular Dystrophy, to the intense, milestone-driven world of biotech spin-outs. Victoria Collett, Development Director for the £1.2  billion Oxford North project, explains how its mixed-use, master-planned environment—complete with flexible lab spaces, public art, and community areas—is specifically engineered to foster the "serendipitous moments" crucial for breakthroughs. Kay and Victoria also discuss the vital importance of connectivity, noting that the UK's life sciences VC investment has been selective recently, making integrated innovation clusters like Oxford North, which is positioned on the East West Rail corridor, essential for capturing future talent and growth. (00:00) - Welcome to Oxford+ (01:10) - Kay Davies' Journey in Medical Research (02:10) - Challenges and Innovations in Drug Development (03:11) - The Role of Oxford North in Scientific Advancements (06:39) - Victoria Collett on Developing Oxford North (08:06) - Designing Spaces for Innovation and Collaboration (11:54) - Integrating Science, Art, and Community (18:56) - The Importance of Connectivity and Accessibility (26:26) - Long-Term Vision and Investment in Oxford North (30:10) - Historical Significance and Future Aspirations Professor Dame Kay Davies: An acclaimed academic and innovator, she is Emeritus Dr Lee's Professor of Anatomy at the University of Oxford and a Fellow of Hertford College. Her research group has an international reputation for work on Duchenne Muscular Dystrophy, an effort that has driven her journey from the academic lab to founding biotech spin-out companies to deliver effective treatments to patients. Her insights provide a critical 'user perspective' on the needs of a pioneering science ecosystem. Connect with Kay on LinkedInVictoria Collett: Development Director at Thomas White Oxford, the development company of St. John's College, where she led the creation of Oxford North. A chartered surveyor with over 20 years of experience in development and regeneration, Victoria specialises in large-scale mixed-use masterplans, bringing a unique perspective on community, placemaking, and commercial flexibility to the £1.2 billion global innovation district.Connect with Victoria on LinkedInSusannah de Jager: Susannah is a seasoned professional with over 15 years of experience in UK asset management. She has worked closely with industry experts, entrepreneurs, and government officials to shape the conversation around domestic scale-up capital.Connect with Susannah on LinkedIn / Subscribe to the Oxford+ Newsletter for exclusive contentOxford+ is hosted by Susannah de Jager and supported by Mishcon de Reya and Oxford North.Produced and edited by Story Ninety-Four in Oxford.

“Giving learners options gives them a better learning experience. It's more holistic and more comprehensive,” says Sean Moloney, CEO and founder of EmbodyXR, an extended reality platform focused on the use of immersive technologies in medical education. In this eye-opening Raise the Line conversation, Moloney explains how AI-powered extended reality (XR) --which integrates augmented, virtual, and simulation-based environments -- allows learners to interact with patients, explore multiple diagnostic choices, and experience varied outcomes based on their decisions. The result, he notes, is not only stronger engagement in learning, but a measurable improvement in understanding. Despite these gains, Moloney is quick to point out that he sees these technologies as complements to traditional training, not substitutes for it. “We'll never replace in-person teaching,” he says, “but we can make learners even better.” Beyond training future clinicians, the EmbodyXR platform is also offering new modes of patient and caregiver education, such as augmented reality guidance for using medical devices at home. Join host Lindsey Smith as she explores how EmbodyXR achieves and maintains clinical accuracy, the connectivity it offers between headsets, personal computers and mobile devices, and other capabilities that are shaping the future of how healthcare professionals and patients will learn. Mentioned in this episode:EmbodyXR 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

Chuck Scheper, Board Chair at Bexion Pharmaceuticals, shares how a stage IV non-Hodgkin lymphoma diagnosis at age 39 and a life-saving clinical trial led to his lifelong commitment to cancer research. He joins Tim Schroeder, CEO and Chairman of CTI, to discuss the founding of VaxCella, the evolution of cancer therapies, the importance of patient-centered research, and the role of collaboration in advancing drug development, highlighting resilience, innovation, and the impact of clinical trials. 

Why has America struggled so much to effectively manage the opioid use crisis? One of the answers, as you'll learn in this eye-opening episode of Raise the Line, is rooted in laws and attitudes from the early 20th century that removed addiction from the realm of medicine and defined it as a moral failing.  “The federal Harrison Act of 1914 forbade any physician from prescribing opioids to people with addiction, so it became more the purview of law enforcement or behavioral health or religion,” says Dr. Melody Glenn, who regularly confronts the consequences of this history during shifts in the emergency department at Banner-University Medical Center in Tucson, Arizona. And as Glenn explains to host Caleb Furnas, the resulting stigma associated with addiction has extended to the treatments for it as well, especially methadone, despite its effectiveness. Drawing on her dual expertise in emergency and addiction medicine, Glenn dispels misconceptions that medication-assisted treatment merely replaces one addiction with another, and emphasizes that harm reduction is critical to saving lives. Her desire to break prevailing stigmas led her to discover the story of Dr. Marie Nyswander, who pioneered methadone maintenance therapy in the 1960s and is featured in Dr. Glenn's new book, Mother of Methadone: A Doctor's Quest, a Forgotten History, and a Modern-Day Crisis. You'll leave this instructive interview understanding the roots of our flawed approach to addiction treatment, meeting an overlooked pioneer in the field, and admiring a devoted and compassionate physician who is following in her footsteps.  Mentioned in this episode:Banner-University Medical CenterMother of Methadone book 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

Trân Lê, Co-Founder and CEO of Grove AI,  was founded to automate the manual and inefficient workflows in clinical trial recruitment, patient engagement, and support. The company's AI agent, Grace, is trained on specific trial protocols and approved scripts to respond to patient questions about pre-screening, logistics, and scheduling appointments. This platform aims to increase speed and quality of participant recruitment, improve representation, and expand accessibility to clinical trials by offering support in over 19 languages and providing access to information on demand. Trân explains, "The birth of Grove really came from my co-founder, Sohit, and his experience working in the hospital. We were working at Stanford, and there we were, computer scientists building a lot of internal tools for clinical trials, clinical research, as well as for the greater healthcare patient services. And that, combined with my experience trying to enroll in a clinical trial, really set us off to think deeply about how we can automate a lot of the manual workflows that exist today for patients and for providers, as well as for pharma in taking new drugs to market. Specifically, within that, we identified patient engagement and support, and prescreening to be an important part of ensuring that patients know where they're going and what to do when they're participating in these trials. And so we decided to really step out into the industry and change this process and make it an easier and more accessible experience for patients."   "I would say that having worked inside a hospital and seeing all of this lead generation or getting people educated about the trial is an important aspect, and it's being done by a lot of the recruitment vendors as well as in-house teams out there. In addition to that, a bottleneck that previously has always been there now is possible to automate with agentic AI is actually doing the work of taking all the interest from different potential patients and helping them prescreen and understand the requirements of the trials, getting them to the right site, booking their transportation, reminding them about the appointments, and scheduling that appointment."   "I would say that Grace, as we call her, is a digital staff or an AI agent - both are comparable terms to describe Grace. The difference is that Grace is trained on the trial, the requirements, and the IRB-approved script of that trial. So she really has the knowledge to be able to respond spontaneously in real time to any questions that the participant may have about the trial." #GroveAI #ClinicalTrials #PatientRecruitment #Pharma #HealthTech #DigitalHealth #AI #AgenticAI grovetrials.com Download the transcript here

Trân Lê, Co-Founder and CEO of Grove AI,  was founded to automate the manual and inefficient workflows in clinical trial recruitment, patient engagement, and support. The company's AI agent, Grace, is trained on specific trial protocols and approved scripts to respond to patient questions about pre-screening, logistics, and scheduling appointments. This platform aims to increase speed and quality of participant recruitment, improve representation, and expand accessibility to clinical trials by offering support in over 19 languages and providing access to information on demand. Trân explains, "The birth of Grove really came from my co-founder, Sohit, and his experience working in the hospital. We were working at Stanford, and there we were, computer scientists building a lot of internal tools for clinical trials, clinical research, as well as for the greater healthcare patient services. And that, combined with my experience trying to enroll in a clinical trial, really set us off to think deeply about how we can automate a lot of the manual workflows that exist today for patients and for providers, as well as for pharma in taking new drugs to market. Specifically, within that, we identified patient engagement and support, and prescreening to be an important part of ensuring that patients know where they're going and what to do when they're participating in these trials. And so we decided to really step out into the industry and change this process and make it an easier and more accessible experience for patients."   "I would say that having worked inside a hospital and seeing all of this lead generation or getting people educated about the trial is an important aspect, and it's being done by a lot of the recruitment vendors as well as in-house teams out there. In addition to that, a bottleneck that previously has always been there now is possible to automate with agentic AI is actually doing the work of taking all the interest from different potential patients and helping them prescreen and understand the requirements of the trials, getting them to the right site, booking their transportation, reminding them about the appointments, and scheduling that appointment."   "I would say that Grace, as we call her, is a digital staff or an AI agent - both are comparable terms to describe Grace. The difference is that Grace is trained on the trial, the requirements, and the IRB-approved script of that trial. So she really has the knowledge to be able to respond spontaneously in real time to any questions that the participant may have about the trial." #GroveAI #ClinicalTrials #PatientRecruitment #Pharma #HealthTech #DigitalHealth #AI #AgenticAI grovetrials.com Listen to the podcast here

CEO of Vistagen, Shawn Singh, returns to Inside Biotech to discuss groundbreaking developments in intranasal therapeutics. Shawn shares exciting results from Vistagen's fast-track phase 3 trials, explains how intranasal drug delivery bypasses limitations of traditional therapeutics relying on systemic absorption, and reflects on telehealth's role in accessibility. This conversation spotlights a transformative moment in neuroscience, drug development and mental health innovation.Learn more about Vistagen: https://www.vistagen.com/Listen to our previous episode with Shawn to learn more about social anxiety disorder and the earlier days of Vistagen: https://inside-biotech.simplecast.com/episodes/shawn-singh-ceo-of-vistagen-mental-health-biopharmaceuticals Follow our Instagram @insidebiotech for updates about episodes and upcoming guests!To learn more about BCLA's events and consulting visit our website.Follow BCLA on LinkedIn

“We don't view a person with chronic pain as someone who has a chronic illness and the effect of that is we can't follow patients continuously over prolonged periods of time,” says Dr. Jacob Hascalovici, a neurologist and pain specialist based in New York City.  In co-founding Bliss Health, Dr. Jacob, as he is known, has set out to create a continuous care model for chronic pain treatment that matches the approach taken for patients with diabetes or high blood pressure. The Bliss Health formula includes an initial meeting with a physician that produces a care plan; remote therapeutic monitoring on an ongoing basis; and a monthly meeting with a nurse to review data and determine next steps, including additional appointments with physicians as needed.  All of this occurs via a digital platform which provides a welcome option for patients with mobility issues and can fill gaps in access to specialists, especially in rural areas. Dr. Jacob is also hoping to make chronic pain patents feel respected, which is not always the case in their encounters with the healthcare system. “Because pain is not something that can be seen or measured, oftentimes patients feel marginalized, dismissed and disempowered by providers.” Join Raise the Line host Lindsey Smith for a valuable conversation that also touches on policy changes that could strengthen telemedicine, and has details on the first non-opioid based pain medication to receive FDA approval in over 20 years.Mentioned in this episode:Bliss Health 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

In recent months, public health advocates in the United States have raised concerns about proposed changes to vaccine policy, cuts to food assistance programs, rollbacks of environmental protections and reductions in public health staffing. Chief among them has been Dr. Georges Benjamin who, as executive director of the American Public Health Association (APHA) since 2002, has led national efforts to create a healthier America. Raise the Line host Lindsey Smith recently sat down with Dr. Benjamin to understand more about the current state of public health and explore the path forward, and learned that a top priority for APHA is battling the misinformation that Dr. Benjamin believes is fueling support for many of these changes. “The challenge we have right now is that as a society, we've gone into our little corners and live in our own ecosystems. More people are getting their information from a single source and they're not validating that information to make sure that it's true.” Tune into this thoughtful and timely conversation to hear Dr. Benjamin's advice for curbing the spread of misinformation, how APHA is trying to help people understand the value of public health initiatives, and what the U.S. can learn from other countries about improving public health. Mentioned in this episode:American Public Health Association 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 textIn June, the Fatty Liver Foundation officially launched the Stephen A. Harrison Patient Advocacy program and announced its first class of 20 Fellows. In today's conversation, the program's organizers, Fatty Liver Foundation President Wayne Eskridge and Program Co-ordinator Elena Samsonova, share the program's goals and objectives with Louise Campbell and Roger Green. The bulk of this conversation focuses on the program's goals and scope for its first year. First, though, Harrison Fellow Julie Peyout from Canada describes what it means to her to be part of the program. (Julie's connection was interrupted while her colleagues were answering this question earlier in the roundtable.)Wayne points out that, while the FLF originally focused on NAFLD and NASH, the new nomenclature has led them to broaden their focus to all forms of SLD. (He plans to rebrand as the Steatotic Liver Foundation.)Elena describes the program's four "pillars": Mentorship - Having an experienced advocate guide each Fellow as they pursue the next steps in their advocacy.Education - Learning more about SLD.Networking - Connecting with other advocates and industry decision-makers at conferences.Fellowship - Supporting each other as they grow new skills and have new experiences. Wayne elaborates on some of the "robust flow of information" the Fellows will receive. He focuses on three areas: what he calls "the nuts and bolts of the regulatory process", clinical trials from the researcher and trialist perspectives and more general information about how different functions inside a pharmaceutical company work. As the conversation winds down, Roger cites this podcast's mission to "make a big fat dent in MASH" and asks the Fellows about the dent they anticipate making. Elena responds with a story from the previous week's meetings, during which another Fellow stated that when she has participated in trials, she has never received information on what the trial results and learnings actually showed. Elena describes watching clinicians and trialists respond by discussing ways participants could receive such information in the future. 

“Probably the most exciting thing I've seen in gene therapy over the last ten years is we now have a lot of tools for selective delivery, which will hopefully make treatments more safe and a lot more successful,” says Dr. Jessica Duis, a geneticist and pediatrician focused on the management of individuals with complex, rare disorders. Dr. Duis, who has worked on several gene therapies that are now approved or progressing through the accelerated approval pathway, is currently VP of Clinical Development at GondolaBio, a clinical-stage biopharmaceutical company focused on developing therapeutics for genetic diseases. As you'll learn in this Year of the Zebra episode with host Lindsey Smith, Dr. Duis is encouraged by other recent advances in genetic technology as well, and thinks momentum will grow as breakthrough treatments emerge. “I think we're hopefully going to continue to see companies that are working in rare disease be more successful and really drive how regulators think about making decisions in terms of bringing treatments to patients. I think we're at the tip of the iceberg in terms of the future of truly transformational therapies.”  This wide ranging conversation also explores Dr. Duis' team approach to patient care, her work on clinical endpoints, the importance of patient communities, and her book series, Rare Siblings Stories.Mentioned in this episode:GondolaBioRareDiseaseDocElsevier Healthcare Hub on Rare DiseasesRare Sibling Stories 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

Join Drs. William Petros and Bob Powell as they share advice on pursuing a sustainable career in the pharmaceutical industry. Hosted by Dr. Robbie Parker, they reflect on their professional journeys and the changes that have occurred, especially related to the depth of scientific and researchskill training. This podcast and article are a call to action to provide direction and support for pharmacists seeking successful careers in Pharma. Read the full text review at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.70105.

In 1856, after yet another day of disappointing experiments, a chemist named William Henry Perkin was cleaning up his glassware when he made a discovery that would harken a new — and colorful — era of science and industry. Just 18 years old, Perkin was a promising young student in a prestigious lab at the Royal College of Chemistry in London and he was supposed to be figuring out a way to make a chemical compound called quinine. Despite his best efforts, Perkin was coming up empty — or rather — producing a lot of dirty dishes with little to show for it. But he did notice that there was a curious goop in one of his flasks, and it turned a brilliant shade of purple in the wash. Intrigued, Perkin decided to try dyeing a swatch of silk with his serendipitous solution. Although he had failed yet again to produce quinine, Perkin had created the very first synthetic dye and launched a scientific industry that is still bringing new drugs and dyes to market today.Send us your science facts, news, or other stories for a chance to be featured on an upcoming Tiny Show and Tell Us bonus episode. And, while you're at it, subscribe to our newsletter!Links to the Tiny Show and Tell stories are here and here. All Tiny Matters transcripts and references are available here.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

During episode #93 of The Weekly Bioanalysis, John and Dom welcome guest Chris Crean, founder/CEO of Xyzagen, who reflects on three decades in drug development and how the field has shifted from small molecules to today's complex biologics, gene editing, and beyond. Chris explains how Xyzagen helps small, science-driven teams move faster by uniting early discovery “back-office” needs so studies are right-sized and decision-ready. He dives into modern PK design, showing how advances in LC-MS and immunoassays slash sample volumes and enable smarter rodent studies while preserving animal welfare. The conversation covers non-compartmental vs. modeling/simulation approaches and the practical toolset teams actually use plus when tissue distribution and ocular/CNS models matter. Chris also shares collaboration advice and highlights Xyzagen's strengths in ophthalmology, neurology, and specialized routes like intrathecal or intravitreal dosing.“The Weekly Bioanalysis” is a podcast dedicated to discussing bioanalytical news, tools and services related to the pharmaceutical, biopharmaceutical and biomarker industries. Every month, KCAS Bio will bring you another 60 minutes (or so) of friendly banter between our two finest Senior Scientific Advisors as they chat over coffee and discuss what they've learned about the bioanalytical world the past couple of weeks. “The Weekly Bioanalysis” is brought to you by KCAS Bio.KCAS Bio is a progressive growing contract research organization of well over 250 talented and dedicated individuals with growing operations in Kansas City, Doylestown, PA, and Lyon, France, where we are committed to serving our clients and improving health worldwide. Our experienced scientists provide stand-alone bioanalytical services to the pharmaceutical, biopharmaceutical, animal health and medical device industries.

With nearly one in ten newborns in the US requiring care in a Neonatal Intensive Care Unit, the importance of NICUs has never been more clear. On today's episode of Raise the Line, we're shining a light on the extraordinary world of NICUs with Lindsay Howard, a veteran nurse with over 17 years of experience caring for premature and critically ill infants. She currently works in a Level IV NICU at Children's Memorial Hermann Hospital in Houston, one of the most advanced neonatal units in the country. “We call ourselves ‘the ER of the neonate world' because we're never full. We have to make space no matter what comes in off the street, and at the biggest medical center in the world, we see all the things,” she explains. In this enlightening conversation with host Lindsey Smith, Howard describes how advances in medicine have made it possible to provide more types of care for younger and smaller babies, creating a need for NICU nurses to develop subspecialties. In her case, Howard is on a dedicated team that handles the placement and maintenance of all central line IVs, and has earned certifications in neonatal and pediatric chemotherapy and biotherapies. “We see babies that we may not have seen before being born with cancerous tumors who need chemotherapy to try and eliminate it, or just give them more time with their family.” This is a revealing look inside the workings of a top tier NICU where you'll learn about approaches to care that support healthy neurodevelopment, how clinical staff handle the emotional challenges of the job, and how her own experience as a mother with twins needing NICU care impacted her work.  Mentioned in this episode:Children's Memorial Hermann Hospital 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/raisethelinepodcast

The race to harness AI in biopharma is on, with billions invested to unlock faster, smarter drug discovery and development.In this episode of Straight Out of Health IT, Matthew Studney, SVP, Global R&D IT & Partnerships at Merck, shares how his team is strengthening foundational platforms, upgrading systems, and driving digital transformation across discovery, development, clinical research, and pharmacovigilance. He explains how Merck is reimagining the flow of data, ensuring access for scientists, and piloting machine learning and generative AI solutions to accelerate research and deliver treatments more effectively.Matt highlights how deep learning models are shortening drug development cycles, how pharmacovigilance safeguards patient safety, and why ensuring representative clinical trial data is critical for global equity. He emphasizes that while innovation creates headlines, scaling is what creates true value, and success depends on building strong foundations that support researchers worldwide.Matt also shares his insights on the future of AI in biopharma, busts myths about hype versus impact, points to challenges of change, and offers advice for early-career professionals: build depth, embrace AI, and be useful.Tune in to hear how AI and data science are transforming the future of drug discovery at Merck!

In this episode of IDEA Collider, we are joined by Alex Telford, a biotech founder, writer, and thinker based in the San Francisco Bay Area. As the co-founder of Convoke Bio, Alex discusses his journey from studying biochemistry at UCL to founding a company that develops software tools for streamlining biopharmaceutical workflows.The conversation dives into the impact of AI and language models on the biotech industry, addressing inefficiencies in drug development, and exploring the potential of synthetic biology and personalized medicine. The discussion also touches on the future of drug discovery, China's role in biotech, and the challenges of understanding neuroscience and consciousness. Don't miss this insightful discussion on the future of biopharma innovation! 00:00 Welcome to Idea Collider00:04 Introducing Alex Telford01:59 Alex's Journey from UCL to Convoke Bio05:29 The Mission and Work of Convoke Bio07:57 Challenges in Pharma Decision Making14:05 The Role of AI in Pharma18:26 Knowledge Management and AI27:58 Staying Updated in the Fast-Moving AI Field30:25 AI's Impact on Industry Economics31:38 AI in Clinical Trials and Drug Development35:56 China's Role in Drug Discovery39:24 Neuroscience and AI: Blurring the Lines46:05 Future Predictions in Pharma51:20 Addressing Cognitive Bias in Pharma53:13 Concluding Thoughts and Future Directions Keep up with Alex Telford;LinkedIn: https://www.linkedin.com/in/alexander-telford/Website: atelfo.github.ioX: https://twitter.com/atelfoSubstack: atelfo.substack.com Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

“When you think about where we were as a country before Medicare and Medicaid were created and where we are now, it's an incredible story,” says Chiquita Brooks-LaSure, who until earlier this year was the administrator for the Centers for Medicare and Medicaid Services (CMS). In a recent essay for The Century Foundation, where she is now a senior fellow, Brooks-LaSure used the 60th anniversary of enactment of those foundational insurance programs to help put their impact on individual Americans, the healthcare system and society at large in perspective. One prominent example is the desegregation of hospitals, which was achieved in part by withholding reimbursements for care unless facilities served Blacks as well as whites. Another is making it possible for more people with disabilities to live at home instead of in institutional settings. But as you'll hear in this probing Raise the Line conversation with host Lindsey Smith, Brooks-LaSure worries that many gains in coverage and other progress made over the years through Medicare, Medicaid and the Child Health Insurance Program (CHIP) are at risk because of a new federal law that calls for a trillion dollar decrease in spending, resulting in potentially millions of people losing their coverage, cuts to clinical staff and medical services, and the closure of hospitals and clinics, especially in rural areas. “Most rural hospitals in this country are incredibly dependent on both Medicare and Medicaid to keep their doors open and there's an estimate that over 300 hospitals will close as a result of this legislation, so that, I think, is a place of incredible nervousness.” Whether you are a patient, provider, policymaker or health system leader, this is a great opportunity to learn from an expert source about the range of potential impacts that will flow from changes to critically important insurance programs that provide coverage to 40% of adults and nearly 50% of children in the U.S. Mentioned in this episode:The Century FoundationEssay on 60th Anniversary of Medicare & Medicaid 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/raisethelinepodcast

What does it take to lead successful drug development—whether at a global pharma giant or a small biotech start-up?In this episode of SNiPs, Dr. David Krause joins Bracken CEO Dr. Colin Miller to reflect on three decades of experience spanning large organizations like GSK to fast-moving start-ups. From aligning clinical development with medical affairs to serving “many masters” in drug development, patients, regulators, providers, and marketers, Dr. Krause shares insights on how to keep the patient at the center while driving innovation forward.Topics include:Lessons learned moving from big pharma to start-upsThe evolving relationship between medical affairs and clinical developmentBalancing regulatory, commercial, and patient prioritiesWhy knowing what you don't know is key to success in smaller companiesListen to this episode of Fractals: Life Science Conversations wherever you get your podcasts—and connect with Bracken to learn how we support drug development from concept to approval.

It seems there are news stories every week about the accelerating pace of innovation in gene therapy, but only about 50 therapies have been approved so far by the US Food and Drug Administration. Our guest today, Dr. Bobby Gaspar, leads a UK-based biotech company, Orchard Therapeutics, that developed one of those treatments using gene-modified stem cells in your blood that self-renew, so a single administration can give you potentially a lifelong effect. “Our approach is about correcting those hematopoietic stem cells and allowing them to give rise to cells that can then correct the disease,” explains Dr. Gaspar.  The therapy in focus is lenmeldy, the first approved treatment for metachromatic leukodystrophy, also known as MLD, a devastating inherited disorder that affects roughly 600 children worldwide. But Dr. Gaspar is optimistic that learnings from Orchard's work on MLD could be useful in treating much more common disorders including frontotemporal dementia, Crohn's disease and others. This highly informative conversation with host Lindsey Smith also explores the importance of newborn screening, community collaboration in advancing clinical trials for rare diseases, and a future in which each gene therapy will be used as a tool for specific applications.  “There will be many gene therapies available, some of which will become the standard of care for certain diseases, but it won't be for every disease.”Mentioned in this episode:Orchard Therapeutics 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/raisethelinepodcast

The FDA has endorsed vibration-controlled transient elastography as a surrogate endpoint for MASH trials, marking the first non-invasive alternative to liver biopsy. A Japanese cohort study linked breakfast skipping and late dinners to higher fracture risk, with combined habits raising risk by nearly 25%. Finally, a global meta-analysis suggests shingles vaccination reduces major cardiovascular events by ~16–18%, though most evidence is observational.

Send us a textThis discussion on ways to improve MASH patient management comes from the early July roundtable on "Major Issues of the First Six Months of 2025." As a reminder, that roundtable included the three co-hosts (Louise, Jörn Schattenberg and Roger Green) Roger drives this conversation, focusing on two very different, yet very important issues: the first is the increasing dynamism of the in-office scanning market, with leader Echosens developing new products and services, while companies like e-Scopics, Sonic Incytes, and Mindray (Hepatus) are introducing new devices with competing profiles. Roger discusses the idea that some scanners keep all data resident in the machine, while others send it immediately to the cloud. Louise suggests that while we should welcome any reliable scanning device to the market, Echosens has a significant advantage in terms of data richness and depth when compared to all competitors. (NOTE: This benefit became clearer when Echosens submitted a Letter of Intent to the FDA to qualify liver stiffness measurement (LSM) using VCTE, as found in FibroScan, as a reasonably likely surrogate endpoint in clinical trials for MASH.Separately, he lists some concerns about how the Trump Administration's focus on cutting services to the poor, coupled with Robert F. Kennedy Jr.'s distrust of pharmaceuticals and mainstream health research, might limit the number of Americans with access to healthcare and the kinds of care they can access. At the end of this conversation, Roger asks Jörn and Louise what they consider major issues for the next six months.

Gene Mack, CEO and President of Gain Therapeutics, is combining AI-powered drug discovery with the development of allosteric modulators, drugs that bind to unique sites on proteins. The company's AI platform, Magellan, is crucial for accelerating drug discovery by reducing the time for computational screening of potential drug compounds.  Their lead compound is showing promising results as a potential disease-modifying therapy for Parkinson's disease, aiming to halt the progression of the disease rather than just treating symptoms. Gene explains, "So allosteric modulators of protein, it's a bit of a word salad, but what we're trying to achieve here is finding unique binding sites on proteins that are sort of away from the active site of that protein." "So, a lot of physics calculations go into these binding site calculations. The idea is to complete these quickly during the screening of hundreds or thousands of compounds. This process takes 10 to 15 minutes to run a set of computations and determine if a particular molecule is a fit for a specific protein. If that takes 10 or 15 minutes per compound, it's not a very big deal to go to that library if you need to get through billions, trillions of those compounds, and you need that computational speed to really fire up." "We are able to speed up those calculations from, let's say, 10 minutes to milliseconds. You can screen through much larger numbers of compounds and potentially even construct new molecules that are not known to the public domain, which would be a real key innovation." "What we think we have in our lead program, which is GT-02287, another molecule that was discovered through our application of Magellan. What we hope we have in GT-02287 is a disease-modifying approach to Parkinson's. Up until now, the only available treatments for Parkinson's are really just focused on the symptoms and allaying the severity of the symptoms." #Parkinsons #ParkinsonsDisease #AI #DrugDiscovery #GAINtherapeutics #DiseaseModification gaintherapeutics.com Download the transcript here

Gene Mack, CEO and President of Gain Therapeutics, is combining AI-powered drug discovery with the development of allosteric modulators, drugs that bind to unique sites on proteins. The company's AI platform, Magellan, is crucial for accelerating drug discovery by reducing the time for computational screening of potential drug compounds.  Their lead compound is showing promising results as a potential disease-modifying therapy for Parkinson's disease, aiming to halt the progression of the disease rather than just treating symptoms. Gene explains, "So allosteric modulators of protein, it's a bit of a word salad, but what we're trying to achieve here is finding unique binding sites on proteins that are sort of away from the active site of that protein." "So, a lot of physics calculations go into these binding site calculations. The idea is to complete these quickly during the screening of hundreds or thousands of compounds. This process takes 10 to 15 minutes to run a set of computations and determine if a particular molecule is a fit for a specific protein. If that takes 10 or 15 minutes per compound, it's not a very big deal to go to that library if you need to get through billions, trillions of those compounds, and you need that computational speed to really fire up." "We are able to speed up those calculations from, let's say, 10 minutes to milliseconds. You can screen through much larger numbers of compounds and potentially even construct new molecules that are not known to the public domain, which would be a real key innovation." "What we think we have in our lead program, which is GT-02287, another molecule that was discovered through our application of Magellan. What we hope we have in GT-02287 is a disease-modifying approach to Parkinson's. Up until now, the only available treatments for Parkinson's are really just focused on the symptoms and allaying the severity of the symptoms." #Parkinsons #ParkinsonsDisease #AI #DrugDiscovery #GAINtherapeutics #DiseaseModification gaintherapeutics.com  Listen to the podcast here

Join us this week for The Tech Leaders Podcast, where Gareth sits down with Chris Moore, European President at Veeva Systems. Chris talks about the impact AI will have on software development and data security, how technology has transformed the life sciences industry, and the long-term implications of Covid on drug development.On this episode, Chris and Gareth discuss how Chris helped make Veeva Europe more European, the importance of understanding the opportunities and threats associated with new technologies, and why the Y2K bug was a beautiful anti-climax.Timestamps:ICI, Kinesis and PWC (3:40)IBM, EY and living abroad (10:28)Making Veeva Europe more European (17:30)The impact of Covid on drug development (29:05)The evolution of the CIO (33:00)AI: Hopes, fears and the impact on software development and pharma (36:33)Advice for 21-year-old Chris (51:46)https://www.bedigitaluk.com/

In this episode of Idea Collider, host Mike Rea interviews Dr. Christian Rommel from Bayer. Dr. Rommel discusses his journey in molecular oncology from the Max Planck Institute, through roles at Roche, to overseeing global R&D at Bayer. He shares insights on turning scientific discovery into novel medicines, collaboration between scientists and commercial teams, and the importance of maintaining scientific integrity. Dr. Rommel also delves into the impact of AI in drug development, the potential of genetic medicines, and the complexities of launching new medicines on a global scale. The conversation also touches on embracing failure, internal and external partnerships, and the evolving landscape of clinical translation. 00:00 Introduction and Guest Welcome00:25 Christian Rommel's Journey in Oncology03:02 The Importance of Collaboration in Innovation05:16 Balancing Risk and Reward in Drug Development18:07 The Role of AI and Data in Modern R&D22:33 Partnerships and External Learning26:16 Balancing Legacy and Innovation in Biotech27:18 Global Expansion and Leadership Diversity27:27 Courage in Biotech Management27:54 Inspiration from Roche Genentech30:26 Commitment to Product Supply and Market Readiness32:23 Challenges of Global Launches35:53 Emerging Trends in Pharma: AI and Genetic Medicines42:20 Decision-Making in Pharma47:30 Reflections on Academic and Professional Journey Don't forget to Like, Share, Subscribe, Rate, and Review! Keep up with Christian Rommel;LinkedIn: https://www.linkedin.com/in/christian-rommel/Website: https://www.bayer.com/en/innovation/science-research-and-innovation Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

Lindsay Mateo is the Chief Commercial Officer at Weave. This company has developed a platform to automate and streamline the regulatory documentation process for FDA submission for pharmaceutical and biotech companies.  The regulatory lifecycle for drug development currently involves data from various sources in digital and paper formats. Weave Bio's tools are designed to automate and streamline administrative aspects of the regulatory process and create a living digital record of the development of the drug, which supports collaboration and saves time. Lindsay explains, "I look at the regulatory life cycle for any given drug program, and experts are at the core of that. Those experts, who are scientists, strategists, and project managers, essentially put all the work into the documentation that goes to regulators like the FDA here in the US. And that information goes on to allow this drug to continue through various stages of development to ultimately get to market and obviously help patients." "That is everything from early studies looking at how drugs are being handled in animals, in mice and rats, all the way through to clinical development. We start to get into humans and then again out through what gets drugs to market and even post-market expansion of various labels. So this is critical to getting any therapy to any patient with any condition. The process itself, the challenge with the process is that it's manual."  #Weave #WeaveBio #Pharma #Biopharma #WeavePlatform #AINative #AutoCT #AutoND #FDASubmission #RegulatoryDocumentation Weave.bio Listen to the podcast here  

Lindsay Mateo is the Chief Commercial Officer at Weave. This company has developed a platform to automate and streamline the regulatory documentation process for FDA submission for pharmaceutical and biotech companies.  The regulatory lifecycle for drug development currently involves data from various sources in digital and paper formats. Weave Bio's tools are designed to automate and streamline administrative aspects of the regulatory process and create a living digital record of the development of the drug, which supports collaboration and saves time. Lindsay explains, "I look at the regulatory life cycle for any given drug program, and experts are at the core of that. Those experts, who are scientists, strategists, and project managers, essentially put all the work into the documentation that goes to regulators like the FDA here in the US. And that information goes on to allow this drug to continue through various stages of development to ultimately get to market and obviously help patients." "That is everything from early studies looking at how drugs are being handled in animals, in mice and rats, all the way through to clinical development. We start to get into humans and then again out through what gets drugs to market and even post-market expansion of various labels. So this is critical to getting any therapy to any patient with any condition. The process itself, the challenge with the process is that it's manual."  #Weave #WeaveBio #Pharma #Biopharma #WeavePlatform #AINative #AutoCT #AutoND #FDASubmission #RegulatoryDocumentation Weave.bio Download the transcript here  

You are in for a dose of inspiration in this episode of Raise the Line as we introduce you to a rare disease patient who was a leading force in establishing the diagnosis for her own condition, who played a key role in launching the first phase three clinical trials for it, and who is now coordinating research into the disease and related disorders at one of the nation's top hospitals. Rebecca Salky, RN, was first afflicted at the age of four with MOGAD, an autoimmune disorder of the central nervous system that can cause paralysis, vision loss and seizures. In this fascinating conversation with host Lindsey Smith, Rebecca describes her long and challenging journey with MOGAD, her work at the Neuroimmunology Clinic and Research Lab at Massachusetts General Hospital, and the importance of finding a MOGAD community in her early twenties. “There's a sense of power and security when you have others on your side. You're not alone in this journey of the rare disease,” she explains. Be sure to stay tuned to learn about Rebecca's work in patient advocacy, her experience as a nurse, and the three things she thinks are missing in the care of rare disease patients as our Year of the Zebra series continues.Mentioned in this episode:The MOG ProjectNeuroimmunology Clinic & Research Lab at Mass General 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/raisethelinepodcast

BUFFALO, NY — September 4, 2025 — A new #research perspective was #published in Volume 17, Issue 8 of Aging (Aging-US) on August 16, 2025, titled “Age-related diseases as a testbed for anti-aging therapeutics: the case of idiopathic pulmonary fibrosis.” In this research perspective, Alex Zhavoronkov, Dominika Wilczok, Feng Ren, and Fedor Galkin, from Insilico Medicine, Buck Institute for Research on Aging, and Duke University, propose a new method to evaluate age-related diseases based on how closely they align with the biological processes of aging. Their analysis shows that idiopathic pulmonary fibrosis (IPF), a progressive lung condition, is one of the diseases most strongly associated with aging. This makes IPF a promising model for testing new anti-aging therapies with the potential to treat multiple age-related conditions. “This perspective explores how aging-related diseases (ARDs) can serve as experimental platforms for discovering new geroprotective interventions.” While many age-related diseases are used as models for aging research, not all accurately reflect the biology of aging. To address this, the authors developed a scoring system that measures how closely a disease is connected to the key hallmarks of aging, such as inflammation, genetic instability, and impaired cellular repair. Using this system, they evaluated 13 common age-related diseases and found that IPF had a particularly high overlap with aging biology. IPF is a chronic disease that causes scarring in the lungs and a rapid decline in lung function. In contrast to the gradual loss of function seen in normal aging, IPF progresses more than five times faster. The authors highlight that IPF shares nearly all of the biological features associated with aging. These similarities make IPF a strong candidate for studying aging and testing therapies that target its underlying causes. The authors also discuss different therapies currently being developed for IPF that are also designed to address aging itself. These include drugs that clear senescent cells, activate telomerase to maintain chromosome health, or repair damaged signaling between cells. Some of these treatments, such as senolytic combinations and AI-discovered compounds like rentosertib, are already showing early promise in preclinical or clinical trials. In addition, the authors point out that IPF's fast progression and clearly measurable outcomes offer an advantage for clinical testing. If a therapy proves effective in IPF, it may also be useful for other conditions that share similar aging-related mechanisms, including diabetes, arthritis, and heart disease. This approach could accelerate drug development and reduce costs by focusing on therapies that target shared biological pathways. Overall, this perspective supports a shift in pharmaceutical research toward treating aging as an underlying cause of many chronic diseases. By positioning IPF as a model for aging-related drug development, the authors propose a strategic pathway for testing and expanding anti-aging therapies across a wide range of health conditions. DOI - https://doi.org/10.18632/aging.206301 Corresponding author - Alex Zhavoronkov – alex@insilico.com Video short - https://www.youtube.com/watch?v=p5ur7itzvSI Subscribe for free publication alerts from Aging - https://www.aging-us.com/subscribe-to-toc-alerts To learn more about the journal, please visit our website at https://www.Aging-US.com​​ and connect with us on social media at: Facebook - https://www.facebook.com/AgingUS/ X - https://twitter.com/AgingJrnl Instagram - https://www.instagram.com/agingjrnl/ YouTube - https://www.youtube.com/@AgingJournal LinkedIn - https://www.linkedin.com/company/aging/ Bluesky - https://bsky.app/profile/aging-us.bsky.social Pinterest - https://www.pinterest.com/AgingUS/ Spotify - https://open.spotify.com/show/1X4HQQgegjReaf6Mozn6Mc MEDIA@IMPACTJOURNALS.COM

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo Nordisk's drug Wegovy has successfully reduced cardiovascular risk by 57% compared to tirzepatide. Eli Lilly has terminated two mid-stage trials for a second obesity asset, while Vertex Pharmaceuticals and Enlaza Therapeutics have formed a potential $2 billion partnership to develop drugs for autoimmune diseases. Biogen and Eisai have received FDA approval for the subcutaneous maintenance formulation of Leqvembi. Arrowhead Pharmaceuticals has secured a commitment of up to $2 billion from Novartis for an siRNA Parkinson's program. The FDA's new radiopharma guidance is expected to accelerate the space, and Teva has launched the first generic version of Novo Nordisk's obesity drug Saxenda. The pharmaceutical industry is navigating uncertainty during turbulent times, with companies focusing on innovation and new partnerships to drive progress.The FDA has issued new radiopharma guidance, which former FDA Commissioner Stephen Hahn believes is crucial for cancer therapy. Despite recent investments in radiopharmaceutical therapeutics by big pharma, the FDA's approval of updated COVID-19 vaccines with restrictions contradicts the medical freedom promised by health secretary Robert F. Kennedy Jr. Rare diseases secured four FDA firsts in August, including a win for Novo Nordisk's glp-1 drug WeGovy. Investment in new ALS therapies signals progress after setbacks, with new biotechs and collaborative initiatives showing promise at Bio2025. Other news includes the closure of Appia, Senate summons of Kennedy, updates on COVID-19 vaccines, and Lilly's obesity pill heading to the FDA. Thank you for listening to Pharma and Biotech daily.

In this episode of Sounds of Science, learn how the Retrogenix® platform is reshaping drug development by identifying off-target risks earlier, reducing animal use, and gaining traction with regulators—now as part of the FDA's ISTAND pilot program. Guests Nick Brown and Mark Aspinall-O'Dea from Charles River Discovery Services share real-world insights on their role in advancing NAMs and supporting safer, faster therapeutic development.Show Notes Maximize Safer, Targeted Biologic Development with Smarter NAMs-Based Off-Target Screening Paving the Way for Enhanced Drug Development A Status Report on Cell-Based Protein Arrays Retrogenix® Human Protein Library Retrogenix®: The Screen Door of Drug Development Retrogenix® CAR Specificity Testing Charles River Launched New Retrogenix Non-Human Protein Library 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ##FDA approves new drug for rare genetic disorderThe FDA has recently approved a new drug for the treatment of a rare genetic disorder. This drug has shown promising results in clinical trials and is expected to provide much-needed relief for patients suffering from this condition. ##Major pharmaceutical company announces mergerA major pharmaceutical company has announced plans to merge with another company in the industry. This merger is expected to create a powerhouse in the pharmaceutical world, with the potential for significant growth and innovation. ##Biotech startup secures funding for groundbreaking researchA biotech startup has recently secured a substantial amount of funding to support their groundbreaking research in a new area of biotechnology. This funding will allow the company to further develop their technology and bring it to market in the near future. ##FDA issues warning about potential side effects of popular medicationThe FDA has issued a warning about potential side effects of a popular medication that is commonly used to treat a variety of conditions. Patients are advised to speak with their healthcare provider if they have any concerns about taking this medication. ##Pharma company announces breakthrough in cancer treatmentA pharmaceutical company has announced a major breakthrough in the treatment of cancer. Their new therapy has shown promising results in clinical trials and has the potential to significantly improve outcomes for cancer patients. ##Biotech firm partners with university on new drug developmentA biotech firm has partnered with a university on a new drug development project. This collaboration brings together the expertise of both organizations to advance research and bring new treatments to market. ##FDA approves expanded use of existing medicationThe FDA has approved the expanded use of an existing medication for the treatment of a different condition. This decision is based on new research showing the effectiveness of this medication in treating this additional condition.

As global regulatory expectations evolve, biotech sponsors face growing pressure to make smarter, earlier decisions about where and how to run their trials. In this episode, Novotech experts Renita Hite (Director of Regulatory Affairs, Drug Development Consulting) and Scott Schliebner (Global Head of Drug Development Consulting) join moderator Meredith Landry to discuss how early-stage sponsors can adapt to shifting FDA initiatives, accelerated global pathways, and increasing demands for regulatory flexibility. They explore: How new FDA initiatives—like AI-driven reviews, user fee changes, and the National Priority Voucher—are reshaping IND strategy Why sponsors should design trials with global data packages in mind from day one Accelerated and early access pathways that can speed startup and market entry How CROs are evolving to help sponsors prioritize markets and build regulatory flexibility If you're planning trials for 2025 and beyond, this conversation will help you prepare for what's next—and position your program for long-term success. About This Episode This episode is the final installment (4 of 4) in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Catch up on earlier episodes: [Part 1: Navigating Regulatory Changes & Market Dynamics] [Part 2: Navigating Regulatory & Market Shifts] [Part 3: Navigating Regulatory Changes & Market Dynamics]

“You have to love what you do, especially in healthcare, and the earlier you find that, the better. So that's why I love to see HOSA helping young people find what it is that they want to do,” says Dr. David Kelly, a fellow in oculofacial surgery at University of California San Francisco and HOSA's board chair. You can still hear the excitement in Dr. Kelly's voice describing his earliest experiences with HOSA -- a student led organization with 300,000 plus members that prepares future health professionals to become leaders in international health – even though they happened sixteen years ago when he was a sophomore in highschool. Through hundreds of competitive events and hands-on projects, HOSA creates a framework for developing skills in communication, professionalism and leadership starting in middle school. Programs are offered throughout highschool and college as well, which Dr. Kelly took advantage of before becoming an active alumnus and joining the HOSA board as a way of giving back to an organization that has given so much to him. Since taking the reins as board chair last year, one key focus has been preparing to mark HOSA's 50th anniversary in 2026. Dr. Kelly sees the occasion as not only an opportunity to celebrate what HOSA has accomplished, but to ensure it is positioned to continue helping the healthcare industry tackle important challenges in the future. Examples include chronic workforce shortages and improving how clinicians communicate with patients and team members.  Join host Lindsey Smith on this uplifting Raise the Line episode for an optimistic look at the next generation of healthcare leaders.Mentioned in this episode:HOSAHOSA Alumni Registration 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/raisethelinepodcast

How can biotech leaders navigate the complexities of neurodegenerative research while tackling today's funding challenges? In this episode, host Elaine Hamm, PhD, welcomes Vikas Sharma, PhD, Chief Business Officer at QurAlis, for an insightful conversation on innovation, leadership, and fundraising in the biotech sector. Drawing from his extensive experience with ALS and neurodegeneration research, Vikas shares lessons on balancing science with business, navigating board dynamics, and finding creative approaches to raise capital. In this episode, you'll discover: Why genetic insights are reshaping neurodegenerative research. How to creatively approach funding when investors are focused on lower-risk, later-stage opportunities. Practical strategies for balancing science, investors, and board relationships to drive biotech success. Tune in to gain actionable strategies and leadership lessons that can help you move your biotech forward with confidence. Links: Connect with Vikas Sharma, PhD, and check out QurAlis. Connect with Elaine Hamm, PhD, and learn about Tulane Medicine Business Development and the School of Medicine. Connect with Jason Adair, MBA, and Kevin Eggan, PhD. Connect with Ian McLachlan, BIO from the BAYOU producer. Check out BIO on the BAYOU and make plans to attend October 28 & 29, 2025. Learn more about BIO from the BAYOU - the podcast. Bio from the Bayou is a podcast that explores biotech innovation, business development, and healthcare outcomes in New Orleans & The Gulf South, connecting biotech companies, investors, and key opinion leaders to advance medicine, technology, and startup opportunities in the region.

Alzheimer's is not inevitable—and it may even be optional. In this groundbreaking episode, you'll learn how to prevent, slow, and in some cases reverse cognitive decline using strategies that also enhance brain optimization, metabolism, and longevity. Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR Host Dave Asprey is joined by Dr. Dale Bredesen, a world-renowned neurologist and leading Alzheimer's researcher who has published over 240 peer-reviewed papers. Dr. Bredesen has spent decades proving that Alzheimer's is not a one-pathway disease but a network failure driven by inflammation, toxins, and mitochondrial dysfunction. His protocol has helped thousands of patients regain memory, extend healthspan, and reclaim brain performance. Together, they unpack how biohacking tools like fasting, ketosis, supplements, sleep optimization, cold therapy, and functional medicine can rewire neuroplasticity, protect mitochondria, and keep the brain in “connection mode” instead of decline. You'll hear why the pharmaceutical industry resists these solutions, how toxins like Paraquat and mold fuel cognitive decline, and what young people can do right now to bulletproof their brains for life. This episode is essential listening if you care about hacking human performance, upgrading metabolism, or extending longevity. You'll walk away with practical strategies you can use today—whether that means optimizing your mitochondria with nootropics, strengthening resilience with smarter not harder recovery, or fueling your brain with Danger Coffee. You'll Learn: • Why Alzheimer's can begin as early as your 20s and what biomarkers to track • The seven major drivers of Alzheimer's and how to reverse them with biohacking strategies • How APOE4 genetics, toxins, and inflammation accelerate brain aging—and what to do about it • The role of mitochondria, ketosis, and fasting in restoring brain optimization and neuroplasticity • Why prevention is exponentially easier than reversal and the top three actions you should start in your 20s • How to avoid “learned helplessness” in medicine and reclaim control over your brain span and longevity Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade is the top podcast for people who want to take control of their biology, extend their longevity, and optimize every system in the body and mind. Each episode features cutting-edge insights in health, performance, neuroscience, supplements, nutrition, hacking, emotional intelligence, and conscious living. Episodes are released every Tuesday, Thursday, and Friday (audio-only) where Dave asks the questions no one else dares, and brings you real tools to become more resilient, aware, and high performing. Keywords: Alzheimer's prevention biohacking, APOE4 genetics risk, mitochondrial dysfunction brain, network insufficiency model, cognitive decline reversal protocol, neuroplasticity longevity strategies, mild cognitive impairment treatment, subjective cognitive impairment biomarkers, ketoflex 12/3 diet, mycotoxins and Alzheimer's, Paraquat Parkinson's risk, mitochondrial transfusion therapy, fasting neuroprotection, ketosis brain optimization, natokinase soft plaque removal, sleep apnea cognitive decline, functional medicine Alzheimer's, hippocampal volume preservation, nootropics cognitive resilience, learned helplessness medicine Thank you to our sponsors! EMR-Tek | Go to https://www.emr-tek.com/DAVE and use code DAVE for 40% off.fatty15 | Go to https://fatty15.com/dave and save an extra $15 when you subscribe with code DAVE. OneSkin | Get 15% off your first purchase at https://oneskin.co/ASPREY with code ASPREY. Resources: • Dale's Website: https://www.apollohealthco.com/dr-bredesen/ • Danger Coffee: https://dangercoffee.com/DAVE15 • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Upgrade Collective: https://www.ourupgradecollective.com • Upgrade Labs: https://upgradelabs.com • 40 Years of Zen: https://40yearsofzen.com Timestamps: 0:00 — Trailer 1:10 — Introduction 2:43 — Personal Story 7:52 — APOE4, Genetics, and Drug Development 11:37 — Pharma, Media, and Pushback 17:13 — Prevention, Stages, and Biomarkers 23:34 — Causes and Mechanisms 30:24 — Parkinson's, Toxins, and Mitochondria 37:17 — Longevity, Biohacking, and Protocols 44:11 — AI, Data, and Future Treatments 54:11 — Case Studies and Success Stories 1:03:00 — Detox, Mold, and Environmental Triggers 1:12:00 — Neuroplasticity and Brain Regeneration 1:20:00 — Hormones, Supplements, and Personalized Hacks 1:29:00 — Cortisol, Addison's, and AI Protocols 1:38:00 — Large-Scale Trials and Global Impact 1:45:00 — Final Takeaways See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

“We've been able to show that even by 30 days of age, we can predict with some accuracy if a child is going to have a diagnosis of autism,” says Dr. Geraldine Dawson, sharing one of the recent advancements in early diagnosis being aided by artificial intelligence.  Dr. Dawson -- a leading scholar in the field and founding director of the Duke Center for Autism and Brain Development – explains that an AI examination of a child's pattern of visits to medical specialists in its very early life is an objective diagnostic tool that can supplement the current subjective reports from parents which vary in reliability. Another objective diagnostic tool in development uses a smartphone app developed at Duke that takes video of babies watching images and applies AI-aided Computer Vision Analysis to measure for signs of autism. This enlightening Raise the Line conversation with host Lindsey Smith is loaded with the latest understandings about Autism Spectrum Disorder including advancements in early therapeutic interventions, the interplay of genetic and environmental factors, and the role of the mother's health and exposures during pregnancy. You'll learn as well about what Dawson sees as necessary societal shifts in how autism is perceived, the numerous factors contributing to a near tripling of diagnoses over the past two decades, and how early intervention and informed advocacy can make a meaningful difference in the lives of countless families.Mentioned in this episode:Duke Center for Autism and Brain Development 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/raisethelinepodcast

From TV production to trailblazing in generative AI, Jennifer Bittinger's journey is anything but ordinary. In this episode of Inside Biotech, Jennifer shares how her non-linear career path–from helping launch Hulu to leading Narrativa–prepared her to bring AI innovation into the life sciences. She reveals how Narrativa became the first company to have FDA-approved, AI-generated clinical trial documentation, cutting years of “white space” in the drug-development process. Along the way, she tackles fears about AI replacing jobs, explaining how it can instead give scientists and medical writers their time back for high-value work. Today's episode is a masterclass in how relationships, curiosity, and a little bit of courage can transform entire industries. Follow our Instagram @insidebiotech for updates about episodes and upcoming guests! To learn more about BCLA's events and consulting visit our website.Follow BCLA on LinkedIn

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Claire Riches, Vice President, Clinical Solutions at Citeline. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Claire, covering: Being involved in the clinical development and commercial launch of a little mega-blockbuster, called... Viagra. Her first exposure to outsourcing at a small biotech, and the importance of partnerships in progressing the pipeline. Ignoring the pharma industry snobbery, and opting to move into the fast and varied world of CROs. Timeless sponsor and provider partnership tips, including the importance of aligned intentions, especially with biotechs. How are the tailwinds for rare diseases, meeting unmet patient needs, AI/data, and personalised medicines driving demand at Citeline? With over 30 years' experience in the life science sector, Claire is a passionate advocate of bringing drug development to life. Having worked in large pharma, biotech and the CRO space, Claire uses her platform to raise awareness of the challenges the industry is facing, and how as a collective voice, we can solve big, challenging questions. She believes strongly in the need to ask questions of the industry to drive change, which in turn drives innovation and growth. Claire speaks regularly through various forums on the topics of Women in Science, Impacts of Politics and Economics on Drug Development and Drug Access, and Evolution and Efficiency of Drug Development pathways. She is currently focused on levelling the playing field for the Biotech industry via her podcast Small Biotech, Big Decisions | Citeline   Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!

Try OCI for free at http://oracle.com/eyeonai This episode is sponsored by Oracle. OCI is the next-generation cloud designed for every workload – where you can run any application, including any AI projects, faster and more securely for less. On average, OCI costs 50% less for compute, 70% less for storage, and 80% less for networking. Join Modal, Skydance Animation, and today's innovative AI tech companies who upgraded to OCI…and saved.  Matthew Carroll, CEO and co-founder of Immuta, joins the Eye on AI podcast to explore how data access governance is evolving in the age of generative AI.  As AI drives a surge in both human and non-human data consumers, traditional security models are no longer enough. Matthew explains how Immuta automates compliance, enforces policies across global jurisdictions, and scales secure access for enterprises—from blinded clinical trials in pharma to cross-border data sharing.  Discover why AI-powered governance agents, risk-based access controls, and native cloud integration are the future of compliant, scalable data use. Stay Updated: Craig Smith on X: https://x.com/craigss Eye on A.I. on X: https://x.com/EyeOn_AI (00:00) How Immuta Governs Data in the AI Era   (02:59) Security Alone Isn't Enough in AI   (05:24) From U.S. Intel Roots to Immuta's Platform   (07:38) Pharma Trials: Protecting Billions in Drug Development   (12:58) The Data Marketplace & Access Negotiations   (16:07) Why Native Integration Beats Proxy Models   (20:33) Managing Data Across Borders & Sovereignty Laws   (25:33) The Data Governor Bottleneck (and AI Solution)   (31:05) Inside Immuta's SaaS Model & User Roles   (33:26) Big Data Lessons Driving AI ROI   (41:05) The Growing Data Governance Market   (45:48) Storage Portability & Apache Iceberg Explained   (48:32) Future Shift to Risk-Based, AI-Driven Access

“Seeing that you can get through the most difficult times in life, succeed, and then also return to your community and work in service to your community was a lesson that has stuck with me,” says Dr. Uche Blackstock, the Founder and CEO of Advancing Health Equity and our guest on this inspiring episode of Raise the Line with Osmosis from Elsevier. It was a lesson the Harvard-trained physician learned from her own mother – also a Harvard trained physician – who overcame poverty, sexism and racial bias to forge an inspiring path.  In her bestselling book, Legacy: A Black Physician Reckons with Racism in Medicine, Dr. Blackstock weaves her mother's remarkable story with her own and argues for systemic change in a healthcare system riddled with racially-biased practices and policies that impact patient outcomes. As she explains to host Lindsey Smith, Advancing Health Equity's work to drive measurable and sustainable change is focused on embedding equity as a core value in the leadership, strategy, and organizational practice of health systems. “We exist to challenge inequities, empower underrepresented communities, and help build a healthcare system where everyone can thrive.” Don't miss a thought-provoking conversation with a nationally respected voice that also addresses race correction factors that impact the care of Black patients, and the work required of health institutions to build trust in effected communities.Mentioned in this episode:Advancing Health EquityLegacy: A Black Physician Reckons with Racism in Medicine 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/raisethelinepodcast

“Pandemics are a political choice. We will not be able to prevent every disease outbreak or epidemic but we can prevent an epidemic from becoming a pandemic,” says Dr. Joanne Liu, the former International President of Médecins Sans Frontières/Doctors Without Borders and a professor in the School of Population and Global Health at McGill University. You are in for a lot of that sort of frank and clear-eyed analysis in this episode of Raise the Line from Dr. Liu, whose perspective is rooted in decades of experience providing medical care on the frontlines of major humanitarian and health crises across the globe, as well as wrangling with world leaders to produce more effective responses to those crises and to stop attacks on medical facilities and aid workers in conflict zones. Firsthand accounts from the bedside to the halls of power are captured in her new book Ebola, Bombs and Migrants, which focuses on the most significant issues during her tenure leading MSF from 2013-2019.  The book also contains insights about the geopolitical realities that hamper this work, including lax enforcement of international humanitarian law, and a focus on national security that erodes global solidarity. Join host Lindsey Smith as she interviews this leading voice on our preparedness to meet the needs of those impacted by violent conflict, forced migration, natural disasters, disease outbreaks and other grave challenges. 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/raisethelinepodcast