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“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
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.
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
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/
Over 90% of drugs fail during clinical development, costing billions and leaving patients without life-saving treatments. Why does the pharmaceutical industry face such a high drug development failure rate, and how can artificial intelligence change the story?In this episode, Vitalay Fomin, CEO and co-founder of Numenos AI, reveals how his team is rethinking clinical trials, biomarker discovery, and drug development with advanced AI technologies designed to predict patient response, reduce late-stage trial failures, and accelerate medicines to market.Vitalay shares:Why traditional clinical trial design contributes to such high failure ratesHow AI can predict drug response across different cancers and diseasesThe importance of moving beyond binary “responder / non-responder” modelsHow Numenos AI uses cross-disease data to uncover hidden treatment insightsThe role of AI in drug toxicity prediction and improving patient safetyWhy the pharma industry needs a mindset shift toward embracing novel technologiesThe potential of AI to reduce Phase 2 and Phase 3 clinical trial failuresA case study: how Numenos AI predicted the failure of a major immunotherapy target (TIGIT)This episode is essential listening for:Pharma executives and biotech leaders looking to cut R&D costsClinical trial designers and data scientists in life sciencesHealthcare innovators and AI in medicine researchersInvestors in biotech, healthtech, and AI-driven drug discoveryPatients and advocates who want to understand how AI can accelerate safe, effective treatmentsAbout the PodcastAI for Pharma Growth is a podcast focused on exploring how artificial intelligence can revolutionise healthcare by addressing disparities and creating equitable systems. Join us as we unpack groundbreaking technologies, real-world applications, and expert insights to inspire a healthier, more equitable future.This show brings together leading experts and changemakers to demystify AI and show how it's being used to transform healthcare. Whether you're in the medical field, technology sector, or just curious about AI's role in social good, this podcast offers valuable insights.AI For Pharma Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr. Andree Bates created to help organisations understand how the use of AI based technologies can easily save them time and grow their brands and business. This show blends deep experience in the sector with demystifying AI for all pharma people, from start up biotech right through to Big Pharma. In this podcast Dr Andree will teach you the tried and true secrets to building a pharma company using AI that anyone can use, at any budget. As the author of many peer-reviewed journals and having addressed over 500 industry conferences across the globe, Dr Andree Bates uses her obsession with all things AI and futuretech to help you to navigate through the, sometimes confusing but, magical world of AI powered tools to grow pharma businesses. This podcast features many experts who have developed powerful AI powered tools that are the secret behind some time saving and supercharged revenue generating business results. Those who share their stories and expertise show how AI can be applied to sales, marketing, production, social media, psychology, customer insights and so much more. Dr. Andree Bates LinkedIn | Facebook | Twitter
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
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
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.
In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Hilary Eaton, a rare disease advocate and chief business officer at Profluent about AI-first protein design and its part in accelerating biomedicine. Eaton discusses her advocacy, gene editing, and how real-world evidence shows that AI scaling laws – which predict model performance based on size and computing power – apply to biology. You can also listen to episode 202a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.
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
In this episode, we invite Access Infinity Partner, Isabel Rubio back to the podcast to explore the unique challenges and innovative solutions reshaping market access and pricing within rare disease. Isabel shares insights from her extensive experience with due diligence assessments in orphan drug development, discussing three transformative strategies that are revolutionising how companies prove value in ultra-rare diseases. From multi-domain endpoints and visual evidence to payment-by-results models, this episode reveals why traditional HTA frameworks fall short for orphan drugs and how early collaboration between pricing, market access, and clinical teams is essential for success. Isabel has authored a blog on this topic, which you can read here: accessinfinity.com/blogs/breaking-through-barriers-how-innovation-is-revolutionising-orphan-drug-development. Send us a text
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.
Send us a textCloud computing is transforming biotech by offering purpose-built infrastructure that supports AI-driven drug discovery and development while meeting strict regulatory requirements. Dr. Ilya Burkov explains how Nebius provides full-stack solutions that democratize access to powerful technology, enabling researchers to achieve breakthroughs that previously required generations.• Cloud computing market was built for general purpose workloads but biotech needs specialized infrastructure for sensitive data and AI models• GPUs enable parallel processing that accelerates AI applications—like "a whole classroom solving math problems at once" versus CPUs solving one at a time• Applications include drug discovery, genomics, protein structure modeling, quantum chemistry, and single-cell modeling for cancer treatment• Nebius provides full-stack solutions with hardware and software layers, working with NVIDIA to offer specialized packages• Democratizing access to AI infrastructure is leveling the playing field between small biotechs and large pharmaceutical companies• Scientists can now accomplish in their lifetime what previously would have taken multiple generations of researchers• Breaking down silos between data teams and institutions is crucial for accelerating healthcare innovationSupport the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page
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.
In this special episode of Conversations in Drug Development, host Harriet Edwards sits down with Professor Alan Boyd, founder and CEO of Boyds, to reflect on the company's remarkable 20-year journey in drug development. Professor Boyd shares his experiences from pioneering work in gene therapy, the challenges of bringing innovative medicines forward, and the value of projects that helped pave the way for future innovation. He also highlights the importance of maintaining a patient-centric vision and the role this has played in Boyds' success on a global scale. With stories from Boyds' involvement in pivotal projects - from the early work on the first gene therapy developed for brain cancer to contributions to the Covid-19 vaccine - the conversation offers a rare, behind-the-scenes look at how scientific innovation and evolving regulation have shaped modern medicine. Whether you're closely involved in drug development or simply interested in how new medicines reach patients, this episode offers unique insights and reflections from someone who has spent a lifetime at the forefront of the industry. 00:00:13 – Introduction to Conversations in Drug Development 00:00:30 – Welcoming Professor Alan Boyd Back 00:01:43 – Reflecting on 20 Years of Boyds 00:02:49 – The Journey to Founding Boyds 00:06:05 – Early Challenges in Gene Therapy 00:07:26 – Manufacturing Gene Therapy Products 00:10:35 – Achievements in Cell and Gene Therapy 00:15:39 – Highlights from Two Decades 00:19:46 – Changes in Drug Development 00:23:32 – Evolution of Clinical Trials 00:28:17 – The Role of the Team at Boyds 00:31:43 – Personal Interests Beyond Medicine 00:38:12 – Future of Drug Development 00:38:42 – Closing Thoughts and Reflections
“The greatest opportunity at Teva is our innovative pipeline. We're really leaning in on our innovative pipeline as an integral part of our pivot to growth strategy.”This is the ambitious vision of Dr Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva Pharmaceuticals.He speaks about the company's strategic transformation from generics powerhouse to innovative biopharmaceutical leader - including how strategic partnerships and a matrix organisational approach are driving Teva's remarkable 10 consecutive quarters of growth. He shares best practices on leveraging generics expertise for innovation, building successful partnerships across multiple therapeutic areas, and creating synergies between different business portfolios.Full article here
“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
Just over two years ago, the FDA issued its first draft guidance on clinical trials with psychedelic drugs. Now, HHS has hired a dedicated psychedelics advisor. This week, Reunion Neuroscience reported a mid-stage success with its short-acting psychedelic drug in postpartum depression.At a moment of increasing momentum – both in terms of research, funding and commercial promise – behind psychedelics, it's worth checking in with one of the leaders in the space: Cybin, a clinical-stage biopharma.In November, Cybin reported positive Phase 2 data for its major depressive disorder drug and has its sights set on next steps in the regulatory approval process.Pharma Editor Lecia Bushak brings us a conversation with Cybin CEO Doug Drysdale about "second-generation" psychedelics and how they are impacting the mental health treatment space.For our Trends segment, we're talking about recent updates to health data sharing on the federal level. Step into the future of health media at the MM+M Media Summit on October 30th, 2025 live in NYC! Join top voices in pharma marketing for a full day of forward-thinking discussions on AI, streaming, retail media, and more. Explore the latest in omnichannel strategy, personalization, media trust, and data privacy—all under one roof. Don't wait—use promo code PODCAST for $100 off your individual ticket. Click here to register! AI Deciphered is back—live in New York City this November 13th.Join leaders from brands, agencies, and platforms for a future-focused conversation on how AI is transforming media, marketing, and the retail experience. Ready to future-proof your strategy? Secure your spot now at aidecipheredsummit.com. Use code POD at check out for $100 your ticket! Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music.
With more than 30 years of experience spanning global pharma, emerging biotech, and the evolving field of personalized medicine, Bracken Senior Partner Dr. David Krause has helped shape the clinical and regulatory landscape across therapeutic areas—from vaccines and anti-infectives to neuropsychiatry and oncology.As a physician, former Chief Medical Officer, and trusted development advisor, David brings a uniquely humanist and interdisciplinary lens to the science and strategy of drug development.In this episode of Fractals: Life Science Conversations, David and host Colin Miller explore:How leadership style must evolve from large pharma to small biotech—and why succession planning matters more than you think.The future of personalized medicine in CNS and oncology—and how AI, genetics, and neuroplasticity are reshaping treatment paradigms.What pharma can learn from infectious disease: why psychiatry is just now catching up to decades-old precision strategies in anti-infectives.Reflections on partnering with the FDA, lessons learned from vaccine development, and the clinical promise of psychedelics.Listen to Fractals on your favorite podcast platform, and contact Bracken to learn how our cross-functional teams can support your clinical, medical, and regulatory strategy.
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
In this episode of Onc Now, host Jonathan Sackier is joined by Simon Lord, Associate Professor in Experimental Cancer Therapeutics, University of Oxford, UK, to discuss translating scientific breakthroughs into real-world treatments. With deep expertise in precision medicine and a passion for innovation in oncology, Lord brings a unique perspective on how the future of cancer therapy is being shaped today. Timestamps 01:04 – Quickfire question 11:26 – Metabolic imaging 15:26 – Insulin resistance 18:04 – Patient-specific biology 20:35 – Tamoxifen risks 21:57 – Metabolic interventions 24:46 – Lifestyle changes 27:04 – Clinical trials 00:00 – Wishes for healthcare
Send us a text00:00:00 - Surf's Up: Episode 6.9This conversation covers three topics. The first discusses the challenges of behavior change in dietary habits and ways governments can help, the second looks at what one can learn from wearing a CGM for 30 days, and the third celebrates the late Stephen Harrison while looking into the future of clinical trials and medical education. 00:06:12 - Global Think-Tank on SLD Roundtable, Part 3Behavior consultant Dr. Kristina Curtis joins Jörn Schattenberg, Louise Campbell and Roger Green to discuss issues related to patient-centered care. This conversation starts by focusing on the unique challenges that come with changing dietary habits. Changing this behavior is so challenging because the issues are so complex. People lack education about healthy eating habits. Even when they do, the high-pressure world in which we live often makes it easier simply to offer children fast food. Even parents who know better might allow their children (or spouses, or selves) not to eat vegetables after a trying day. The panel proceeds to discuss steps politicians can take to encourage healthier living and lifestyles if they wish, and why some are easier to execute than others. Finally, the group shares why they felt "enlightened" when leaving the SLD, and perhaps a little less alone. 00:21:34 - Newsmaker: Fatty Liver Alliance President Mike BetelThis interview with Fatty Liver Alliance President Mike Betel focuses on Year 3 of his 30-day Glucose Challenge. Mike wears a continuous glucose monitor (CGM) for the entire month of July and provides daily videos on LinkedIn and the Fatty Liver Alliance website discussing what he learned. The first year was dedicated to teaching the impact of eating badly and the second year was similar, but less egregious. This year, Mike, who is pre-diabetic, set the goal of keeping his glucose in a "normal" range of 70-140 mg/dl. He did so successfully 97-98% of the time over the month, and discusses some of the tricks he learned that help keep glucose in range over that time (HINT: walking 10-15 minutes after meals helps a lot!). He also shares hints about how to look at overall weight (it's the fat that matters, not simple weight), why it is not healthy to believe you must finish every bite of food put in front of you, and how all this relates to sleep and overall health. He also provides seeds for thought about ways manufacturers and providers might educate patients effectively on these issues. 00:53:11 - Expert: Summit Clinical Research Chief Academic Officer Naim AlkhouriThis interview occurred in late April during our episode celebrating Stephen Harrison. Naim chose this interview to annouce that he was joining Summit as Chief Academic Officer. The first part of this discussion focuses on Stephen on two levels: the personal history between Naim and Stephen and the nature of the contributions Stephen has made to the science of MASH, and particularly clinical trial design. The second part of the interview discusses Naim's new role, the diffrent kinds of teaching, training and medical education he sees as pivotal to the future of MASLD and MASH therapies, and the other elements of his new role. While discuss the role, he shares several bright, challenging insights about when MASH-ville is heading. 01:15:09 - ConclusionThe business report discusses vacations on the SurfingMASH team, upcoming episodes, and grateful notes from Ukrainian listeners.
“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
Send us a textThis conversation is the fourth and final segment of SurfingMASH's April discussion of drug development in memory of Stephen A. Harrison. In addition to co-hosts Jörn Schattenberg, Louise Campbell and Roger Green, panelists include hepatologist and key opinion leader Sven Francque. The discussion focuses on PPARs, genetic medicines, and other emerging drug classes while considering the idea that drug therapies can have an impact on the liver independent of their effect on fibrosis regression. It begins with Sven discussing his experience as a lead investigator in clinical trials for the pan-PPAR agonist lanifibranor, whose Phase 3 trial is now fully recruited. Sven states that in addition to fibrosis regression, lanifibranor is likely to exhibit other pleiotropic effects, and notes that vascular changes start early in the fibrotic progression process. After Sven elaborates on these effects, Louise asks about the SCD-1 agent Aramchol. This leads to a discussion about the idea that over time, therapy will probably come to incorporate two separate modes of action, with one to treat the metabolic dysfunction and the other to treat specific effects in the liver or, as Jörn puts it, "combining weight-neutral and weight-reducing drugs." This evolves into a discussion of what Louise terms "personal-centric" medicine, or what patient advocate Mike Betel has previously described on SurfingMASH as "tailored medicine."The rest of the conversation predominantly lists other classes of drugs, "safe" mitochondrial uncouplers, genetic medicines, and others. Roger inquires about the FASN inhibitors, which are entering Phase 3 clinical trials. Jörn says that the data appears positive and unique. That said, he and Sven agree we need more data.Louise sounds the closing note for this roundtable by discussing our co-founder, Stephen Harrison, and the energy and enthusiasm he brought to the entire drug development process. The group agrees that Stephen's impact continues to be felt through the MASLD community, even as he is missed by us all.
In this week's episode of the BroadEYE Podcast, hosts Dr. Shawn Maloney and Dr. Carlos Quezada-Ruiz sit down with Dr. Wiley Chambers, recently retired Deputy Director of the Division of Ophthalmology at the U.S. Food and Drug Administration (FDA). With over 36 years at the FDA, Dr. Chambers offers a rare insider's perspective on regulatory science, ophthalmic drug development, and the evolution of clinical trial oversight. This episode explores: How ophthalmology regulation has changed over the decades Common pitfalls in pre-IND meetings and what smart innovators do differently Lessons learned from reviewing countless drug and biologic applications The future of FDA guidance in areas like rare disease, gene therapy, and digital endpoints Dr. Chambers also shares personal reflections on mentorship, scientific integrity, and his transition out of federal service after a distinguished career. About Our Guest Dr. Wiley Chambers served as a lead ophthalmic reviewer at the U.S. FDA from 1987 until his retirement in 2023. As Deputy Director of the Division of Ophthal
Send us a text00:00 - Surf's Up, Season 6 Episode 8The conversation addresses three issues that are distinct, yet each is pivotal to the future of MASLD and MASH therapies. The first, from the Global Think-Tank on Steatotic Liver Disease, considers how personal and digital approaches can be combined to form the most effective strategy for patient management. In the second, Global Liver Institute President and CEO Larry Holden joins Roger Green to discuss the new challenges in Washington stemming from the Trump Administration and RFK Jr. The final section is the conclusion of our recent drug development roundtable, examining drug classes we did not previously discuss, along with a thought on where combination therapy is likely to lead. 00:04:57 - Global Think-Tank on SLD Roundtable, Part 2Behavior consultant Dr. Kristina Curtis joins Jörn Schattenberg, Louise Campbell and Roger Green to discuss issues related to patient-centered care. This discussion focuses on the elements of successful behavior change and the importance of real-time, actionable feedback. The group discusses the interplay of diagnostic test feedback, real-time personal exchanges and AI-based algorithms in what Kristina terms a "hybrid therapy."00:18:39 - Newsmaker: Larry HoldenGLI President and CEO Larry Holden addresses two issues related to current goings-on in Washington. First, he acknowledges that we are in for "dark times" under the current administration, and describes some of the decisions and challenges we face. Second, he suggests what individuals and organizations can do to create the best possible situation -- and even some "wins" -- for people living with liver disease. These suggestions reflect his experiences during a 30-year career on Capitol Hill, prior to his joining GLI.00:46:15 - Drug Development Roundtable, Part 4Sven Francque joins Jörn, Louise and Roger to share an up-to-date look at drug development. This discussion focuses on PPARs, genetic medicines, and other emerging drug classes. Sven uses the example of the pan-PPAR lanifibranor to explore the idea that drug therapies can have an impact on the liver independent of their effect on fibrosis regression. The group proceeds to discuss other emerging drugs in development and their modes of action. One theme: over time, we may see prescribers consider using different therapies to address metabolic vs. liver-specific effects, often in combination.01:00:47 - Business ReportThanks to our listeners, Jörn's vacation, Welcome Regeneron
Send us a textThis conversation is the third segment of SurfingMASH's April discussion of drug development in memory of Stephen A. Harrison. In addition to co-hosts Jörn Schattenberg, Louise Campbell and Roger Green, panelists include hepatologists and key opinion leaders Sven Francque and Naim Alkhouri. Louise starts the discussion by asking when a patient is metabolically and hepatically healthy instead of merely driving weight loss. She notes that basing therapy entirely on weight loss goals will breed failure and frustration while failing to address the actual pivotal goal of metabolic health. Sven agrees and notes how important this point is. Roger suggests that the benefit of weight loss is likely to become limited over time, which is why there is such excitement about GLP-glucagon combination therapies. Again, Sven concurs, noting that such knowledge and increasing drug class diversity will allow researchers to look at true, basic differences between agents instead of "small numerical differences."Jörn notes the importance of NITs in addressing these kinds of issues. Scanning is an effective method for measuring changes in liver fat; however, the academic community has developed surrogate NITs for specific physiological activities. As Sven notes, there is still a great deal of work to do here. That said, Jörn cites examples of large, NIT-based projects like the VCTE Study Group that have sufficient sample size to start building definitions around kilopascal levels. Louise shares her strong concern that many TE operators are not trained adequately to appreciate subtle clues that would tell an expert how an individual scan was providing misleading results. She notes that the increased demand for scanning, in this case TE, is going to drive a watering down of the qualifications and the skill of the user and the supervision level..." The discussion winds down with Sven agreeing with Louise and stating the need for sequential testing and Jörn citing EASL guidelines in stating that practices should provide and manage high-quality care to the best of their abilities.
“As parents dedicated to getting a treatment for our children in their lifetimes, we have turned the rare disease drug development landscape upside down and created a new model,” says Nicole Johnson, co-founder and executive director of the FOXG1 Research Foundation. That's not an exaggeration, as the foundation is on track to make history as it begins patient clinical trials on a gene replacement therapy next year. The former TV news producer and media executive unexpectedly entered the world of patient advocacy and drug research after her daughter, Josie, was born with FOXG1, a genetic disorder which causes severe seizures and impedes normal movement, speech, and sleep among other problems. Johnson is also making an impact in another important dimension of the rare disease space in her efforts to educate parents, teachers, and students about disability inclusion through her Joyfully Josie book series and “Live Joyfully” education programs. Tune-in to this fascinating Year of the Zebra conversation with host Lindsey Smith to find out how the foundation is aiming to bring a drug to market in less than half the time and at a fraction of the cost than the industry standard, and how this model might impact research on other rare disorders. Mentioned in this episode:FOXG1 Research FoundationJoyfully Josie 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/raisethelinepodcast
In this episode, Eunice Wang, MD and Eytan Stein, MD explore the latest key clinical updates on menin inhibitors in AML. This episode unpacks evolving treatment strategies and what these developments mean for patient care.Presenters:Eytan M. Stein, MDChief, Leukemia ServiceDirector, Program for Drug Development in LeukemiaAssociate Attending PhysicianLeukemia Service, Department of MedicineMemorial Sloan Kettering Cancer CenterNew York, New YorkEunice S. Wang, MDChief, Leukemia ServiceProfessor of OncologyDepartment of MedicineRoswell Park Comprehensive Cancer CenterBuffalo, New YorkLink to full program: https://bit.ly/4f4an0O
On this episode of Chit Chat Stocks, we speak with Leandro from the Best Anchor Stocks newsletter on a biopharma stock he recently researched. We discussed:(00:00) Introduction and history(04:31) Understanding the Pharmaceutical Supply Chain(07:30) Exploring Business Segments(12:06) High Value Products vs. Bulk Products(14:24) The Impact of AI on Drug Development(17:17) Current Industry Cycles and Demand Dynamics(21:24) CapEx Expansion and Future Capacity(24:04) Drivers of Demand for Products(26:33) The Impact of GLP-1s on Business Dynamics(29:27) Navigating Tariff Impacts in the Pharmaceutical Supply Chain(32:21) Understanding Competition in the Pharmaceutical Packaging Industry(36:45) The Advantages of Vertical Integration(41:41) Valuation Insights and Market Perception(47:38) Identifying Risks and Challenges Ahead(51:54) Exploring Best Anchor Stocks and Investment StrategiesLeandro's Twitter: https://x.com/InvesquotesBest Anchor Stocks: https://www.bestanchorstocks.com/*****************************************************JOIN OUR NEWSLETTER AND FREE CHAT COMMUNITY: https://chitchatstocks.substack.com/ *********************************************************************Chit Chat Stocks is presented by TSOH Investing Research. Long-term equity research with 100% portfolio transparency. Subscribe Today: https://thescienceofhitting.com/ *********************************************************************Chit Chat Stocks is presented by Interactive Brokers. Get professional pricing, global access, and premier technology with the best brokerage for investors today: https://www.interactivebrokers.com/ Interactive Brokers is a member of SIPC. *********************************************************************Fiscal.ai is building the future of financial data.With custom charts, AI-generated research reports, and endless analytical tools, you can get up to speed on any stock around the globe. All for a reasonable price. Use our LINK and get 15% off any premium plan: https://fiscal.ai/chitchat *********************************************************************Disclosure: Chit Chat Stocks hosts and guests are not financial advisors, and nothing they say on this show is formal advice or a recommendation.
Today on Raise the Line, we bring you the unlikely and inspiring story of a woman who was afraid of blood as a child but became an accomplished nurse; who struggled with learning disabilities but became an effective educator; and who, despite lacking business experience or knowledge of graphics, built a successful company that produces visually rich educational materials for nurses and other providers. “I think the theme of my life has been I have struggled with learning, and I didn't want other people to struggle,” says Jennifer Zahourek, RN, the founder and CEO of RekMed which has developed a sequential, interactive learning system that includes illustrated planners, books, and videos used by millions of students and providers. The initial focus was to provide nurses with everything they needed to know from “the basics to the bedside” but RekMed now offers content for medics, respiratory therapists, medical assistants, and veterinarians as well. Driven by her belief in the power of visual learning and her “just freakin' do it” attitude, Jennifer overcame her fear of launching a business and quickly realized just how well nursing had prepared her for the hard work and unpredictability of entrepreneurship. “Nursing teaches you how to just be resilient, to pivot, to delegate, to work on a team and to handle high stress. I think nurses could literally be some of the best entrepreneurs on the planet,” she tells host Lindsey Smith. Tune in to this lively and valuable conversation as Jennifer shares lessons from bootstrapping a publishing company, insights on the evolving landscape of healthcare education, and advice on embracing change in nursing, especially with the expanding role of AI. Mentioned in this episode:RekMed 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
00:00:00 - Surf's Up: Season 6 Episode 7Host Roger Green explains our recent vacation from publishing episodes, assures the audience that the podcast will continue weekly for months and years ahead, and discusses the episode's sections, covering the Global Think-Tank on Steatotic Liver Disease (SLD), the EASL patient screening activity and the increasing role of NITs in drug development. While introducing roundtable guests, he introduces first-time Surfer Dr. Kristina Curtis of the UK-based consultancy, Applied Behaviour Change.00:09:11 - Roundtable I: From the Global Think-Tank on SLDThis discussion starts with co-host Jörn Schattenberg discussing the history and evolution of the first four Global Think-Tanks as the focus shifts from educating medical professionals about liver disease to incorporating a broader group of stakeholders, including politicians and non-hepatologist MDs, to break down siloes and create wider awareness. Co-host Louise Campbell describes the breadth of stakeholders necessary to address this pandemic fully. She explains how her work with transient elastography and the MyLife365.me app constitutes a form of behavioral therapy. Jörn describes the test as a diagnostic and comments that the treatment is what health professionals do with the results. Kristina says that the behavioral change that results comes from well-delivered feedback. She describes "hybrid interventions, digital interventions with a human in the loop." Louise discusses results from the EASL late-breaker that support these findings and goes on to discuss the role AI can play in medical practices.00:23:50 - Newsmaker: Jose Willemse, Dutch Liver Patients Association This discussion covers two primary topics: (1) the Amsterdam screening activity that took place during EASL. Jose describes the phenomenal level of interest in this activity, in which hepatologists and APPs scanned 400 people per day for MASLD and MASH. Boosted by significant mass publicity in Amsterdam, the number of people seeking screening exceeded the 400/day quota, with some arriving in line hours before the scheduled start time and others traveling for hours to reach the site. Jose believes that with adequate publicity, efforts like these could be replicated around the world, but that the healthcare system lacks the necessary resources to do so. In terms of patient care, Jose emphasized the importance of sensitive yet frank conversations and helping patients appreciate the successes they are achieving. 00:53:45 - Roundtable II: NITs Increasing Role in Drug Development Sven Francque and Naim Alhouri joined Louise, Jörn and Roger for this roundtable, although Naim had dropped off by this time. The conversation starts with Louise noting that the goal of therapy is not simply to treat MASLD, but to achieve overall metabolic health, of which MASLD is a key component. Jörn states that we are on the path toward conducting clinical trials entirely with NITs as disease markers, which he describes as a "game changer" and Louise terms "exciting." She asks whether NITs can serve as the only trial surrogate. Jörn and Sven agree that we are not at that point yet, but we are headed in that direction. Jörn asserts that "nothing" will replace outcomes as the prerequisite for full approval and mentions the VCTE study group as demonstrating that a large NIT-based trial can prove effects on disease. Louise cautions that operator competency is a key, if overlooked, criterion for this kind of activity. Sven concurs and states that repeat measures are crucial in managing disease. Jörn notes that practices can serve as centers of care, but will need support from nutritionists and other professionals. 01:06:08 - Business ReportRoger highlights special September programming, indicates that new sponsors are on the way, and asks how many listeners find SurfingMASH on YouTube.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Takeda has taken the lead in the race for a narcolepsy treatment with back-to-back phase III wins for their drug Oveporexton. Investors are eagerly awaiting breakthroughs in using psychedelics to treat depression. Ultragenyx faced a setback as the FDA rejected their gene therapy for Sanfilippo syndrome, citing manufacturing issues. The FDA is considering speeding up reviews for companies that promise to lower drug costs. Market reaction to recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression shows the challenges psychedelic therapies must overcome for commercial viability. Rainin Micropro offers a solution to streamline NGS preparation with their 96-channel pipettor. The industry is also focused on precision diagnostics to support precision therapeutics in the future. AstraZeneca's Baxdrostat showed promising results in lowering blood pressure in a phase III trial. The ADA revealed R&D priorities for potential blockbuster obesity treatments. Relmada has abandoned development of a depression drug after three failed attempts.The challenges faced by psychedelic therapies in the treatment of depression are discussed, as recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression have left investors wanting more. The market reaction highlights the hurdles psychedelic therapies must overcome to prove their commercial viability. Additionally, the importance of precision diagnostics in the development of next-generation precision oncology therapies is emphasized, stating that only with the adoption of digital imaging and AI-powered analysis will these therapies reach their full potential. The FDA has several important decisions lined up, including applications in lymphoma, rare diseases, and hormone deficiency, while the American Diabetes Association's annual meeting reveals R&D priorities for weight loss medicines. Topics discussed include Capricor's FDA rejection of a DMD cell therapy, the ALS community petitioning the FDA to reconsider Brainstorm's Nurown, and updates on COVID-19 vaccines and Alzheimer's drugs. Upcoming webinars and job opportunities in the biopharma industry are also included.
“Very often, doctors try to suppress what they feel or don't even have the vocabulary to describe their emotions,” says Professor Alicja Galazka of the University of Silesia, an observation based on decades of work with physicians to enhance their emotional intelligence and resilience. Galazka, a psychotherapist, psychologist, lecturer and coach, believes this deficit is rooted in part in a lack of instruction in the internal and external psychological dimensions of being a medical provider. “There is not enough space created in medical school for teaching and training students about how to deal with their own stress and all of the skills connected to building relationships with patients,” she tells host Michael Carrese. Those same skills are also critical to working effectively as a member of a care team, which is an increasingly common arrangement in hospitals and clinics. Galazka employs simulations, dramatic role-playing, mindfulness, Acceptance and Commitment Therapy and other methods in her work with an eye on increasing the emotional agility and sensitivity of her trainees and clients. Tune in to this thoughtful episode of Raise the Line to hear Galazka's ideas on how to reshape medical training, why she is a proponent of narrative medicine, and the merits of embedding psychologists on care teams as a resource for both patients and providers. Mentioned in this episode:University of SilesiaInternational Association of Coaching Institutes 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
In this episode, host Zac Lloyd engages with expert in the field Colleen Johnson to discuss critical considerations in designing in vivo nonclinical programs for dermal and topical products. Through this conversation we aim to enhance understanding of key aspects in this specialized area of toxicology. This podcast is designed to offer listeners an introduction to dermal product drug development.
Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode. Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency. So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated. Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations. And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers: Dr. Diwakar Davar @diwakardavar Dr. Jason Luke @jasonlukemd Follow ASCO on social media: @ASCO on Twitter ASCO on Bluesky ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Diwakar Davar: Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences Consulting or Advisory Role: Instil Bio, Vedanta Biosciences Consulting or Advisory Role (Immediate family member): Shionogi Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences Research Funding (Inst.): Zucero Therapeutics Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy Dr. Jason Luke: Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof) Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio
"Older adults have this special clarity about who they are and what they want, which is incredibly inspiring," says Dr. Julia Hiner, explaining, in part, why she loves her work as a geriatrician in Houston, Texas. She also enjoys the challenge of the medical complexity these patients present and the opportunity it creates to see the patient as a whole person. In fact, as you'll hear in this upbeat conversation with Raise the Line host Lindsey Smith, there's almost nothing about geriatrics that Dr. Hiner does not enjoy, which explains her passion for teaching the subject at McGovern Medical School at the University of Texas Health Science Center in Houston and trying to convince more students to pursue it as their specialty. The need is great, given that there are only 8,000 geriatricians in the US despite a rapidly growing senior population. Tune in to learn why Dr. Hiner thinks clinicians avoid the field and the steps that can be taken to improve the situation, including requiring courses in geriatrics. You'll also learn about the importance of capacity assessments, the troubling, and under-reported, problem of elder mistreatment, ageism among health professionals and much more in this super informative episode. Mentioned in this episode:University of Texas Health Science Center at Houston McGovern Medical School 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
In this episode, we speak with Jean-Philippe Therrien, a senior director of R&D, to discuss critical considerations in designing nonclinical programs for dermal and topical products. Through this conversation, we aim to enhance understanding of key aspects in this specialized area of toxicology. This podcast offers listeners an introduction to dermal product drug development.
My guest today is Dinakar Singh. Dinakar is the founder and CEO of Axon, the family office successor to TPG-Axon, which was a successful global long-short hedge fund. We wanted to share his story on Father's Day to honor the person and the dad that Dinakar is. He shares one of the most extraordinary stories at the intersection of finance and medicine I've ever encountered. This conversation explores the highest-stakes investment themes—timing, concentrated conviction, exceptional team building, and deploying resources toward outcomes that matter most. I will let him tell you his story. Please enjoy my conversation with Dinakar Singh. For the full show notes, transcript, and links to mentioned content, check out the episode page here. ----- This episode is brought to you by Ramp. Ramp's mission is to help companies manage their spend in a way that reduces expenses and frees up time for teams to work on more valuable projects. Go to Ramp.com/invest to sign up for free and get a $250 welcome bonus. – This episode is brought to you by Ridgeline. Ridgeline has built a complete, real-time, modern operating system for investment managers. It handles trading, portfolio management, compliance, customer reporting, and much more through an all-in-one real-time cloud platform. Head to ridgelineapps.com to learn more about the platform. – This episode is brought to you by AlphaSense. AlphaSense has completely transformed the research process with cutting-edge AI technology and a vast collection of top-tier, reliable business content. Invest Like the Best listeners can get a free trial now at Alpha-Sense.com/Invest and experience firsthand how AlphaSense and Tegus help you make smarter decisions faster. ----- Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com). Show Notes: (00:00:00) Welcome to Invest Like the Best (00:06:17) The Diagnosis and Initial Reactions (00:07:29) Understanding SMA and the Scientific Challenge (00:09:15) The Drive to Fund Research and Find a Cure (00:14:10) Building a Virtual Company for Drug Development (00:19:02) Breakthroughs and the First Approved Drugs (00:24:16) Personal Reflections and the Impact of the Journey (00:40:25) Challenges in the Biotech Industry and Future Hopes (00:46:43) The Kindest Thing Anyone Has Ever Done For Dinakar
"It was pretty apparent to me that something was going on with him," says Kristi Levine, describing the realization that, based on her experience as a Montessori teacher, her infant son, Trey, was missing developmental milestones. Unfortunately, Kristi's hunch turned out to be correct and Trey was later diagnosed with a rare genetic mutation called CACNA1A which is impacting his motor skills, balance, coordination and speech. Kristi and her husband, Eric, join host Michael Carrese on this installment in our Year of the Zebraseries to help us understand the disorder and its implications for Trey and their family, which includes Trey's older sister Stella. “There's a lot of guilt involved in being a parent of a child who has a disability because you never feel like you're doing enough,” shares Eric, even though they both work full time and have becoming experts at juggling work, caregiving, advocating, and volunteering with the CACNA1A Foundation. In this candid interview, Eric and Kristi discuss the challenges of parenting a child with complex medical needs, the importance of community support, the ongoing search for treatment options, and share some advice for clinicians caring for patients and families living with rare disorders. “We just want medical professionals to respect and understand what we're dealing with on a day-to-day basis and to see our kids holistically, and not just try to fix the problem medically. Understand that for us, the biggest thing that we want for our kids is just their quality of life.”Mentioned in this episode:CACNA1A Foundation 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
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