Podcasts about regeneron

Send us Fan MailCAR-T therapy can be extraordinarily powerful against cancer - but there's a catch. We currently have to take a patient's T cells out of their body, genetically engineer them in a laboratory, manufacture billions of cells, and then put them back. But what if we could skip the factory entirely - and genetically program the T cells inside the patient's body?Dr. Luke Russell, Ph.D. is President of Vyriad ( https://vyriad.com/ ), a biotechnology company developing viral therapies designed to deliver genetic payloads directly to cells in the body.Dr. Russell has spent much of his career at the intersection of cancer immunotherapy, oncolytic virotherapy, gene delivery, and biotechnology strategy. Before moving into executive leadership, his research focused on using viruses to attack tumors and stimulate antitumor immunity. He earned his PhD in Neuroscience from The Ohio State University, where his work included developing an immunostimulatory oncolytic herpesvirus for brain cancer, and later earned an MBA in Finance and Strategy from Carnegie Mellon University's Tepper School of Business.Dr. Russell joined Vyriad in 2018 and has held increasingly senior roles spanning research, alliance management, business development, operations and corporate strategy. During that time, he has helped build strategic relationships with major pharmaceutical companies including Novartis, Regeneron and Merck KGaA.And now, as President, Dr. Russell is helping lead Vyriad's effort to develop a new generation of viral medicines - including VV169, the company's third clinical program, and its G-Link platform, which is designed to give viral vectors a modular, “plug-and-play” ability to retarget which cells they deliver their genetic payloads to.At the center of today's conversation is a particularly provocative possibility: in-vivo CAR-T - using a targeted viral vector to genetically reprogram a patient's own T cells inside the body.#CAR T #CAR TCellTherapy #Cancer #CancerResearch #Immunotherapy #ImmunoOncology #GeneTherapy #GeneDelivery #CellTherapy #InVivoCAR T #CAR TResearch #TCells #ViralVectors #OncolyticVirotherapy #Biotechnology #Biotech #PrecisionMedicine #MedicalInnovation #DrugDevelopment #FutureOfMedicine #Vyriad #LukeRussell #ProgressPotentialAndPossibilities #PPPSupport the show

Listen in as our expert panel breaks down what clinicians need to know about the 2026 dyslipidemia guidelines, such as the role of lipoprotein a, apolipoprotein B, and coronary artery calcium scoring. Plus, you'll walk away with practical takeaways to optimize lipid management including when to add non-statin therapies like PCSK9 inhibitors and ezetimibe for your patients.Special guests:Mary Katherine Cheeley, PharmD, BCPS, CLS, FNLAExecutive Director, Ambulatory Pharmacy ServicesGrady Health SystemJoel C. Marrs, PharmD, MPH, BCACP, BCCP, BCPS, CLS, FAHA, FASHP, FCCP, FNLACardiology Ambulatory Clinical PharmacistCheyenne Regional Medical Group Heart & Vascular InstituteAdjoint Associate ProfessorUniversity of Colorado School of MedicineYou'll also hear practical advice from panelists on TRC's Editorial Advisory Board:Stephen Carek, MD, CAQSM, DipABLMClinical Associate Professor of Family MedicinePrisma Health/USC-SOMG Family Medicine Residency ProgramUSC School of Medicine GreenvilleAndrea Darby-Stewart, MDAssociate Director, Honor Health Family Medicine Residency ProgramClinical Professor of Family, Community & Occupational MedicineThe University of Arizona College of Medicine - PhoenixCraig D. Williams, PharmD, FNLA, BCPSClinical Professor of Pharmacy PracticeOregon Health and Science UniversityFor the purposes of disclosure, Dr. Cheeley reports relevant financial relationships with [lipids] Novartis, Regeneron (honorarium). The other speakers have nothing to disclose.  All relevant financial relationships have been mitigated.This podcast is an excerpt from one of TRC's monthly live CE webinars, the full webinar originally aired in July 2026.

Therapeutics, vaccines, Regeneron, will therapeutics replace vaccines?, the biotechnology industry, genetic engineering, Stanford, University of California at San Francisco (UCSF), the roll of the Bay area in biotech, advances in gene editing during the 1990s, mRNA and its links to therapeutics, Jesse Gelsinger, Bush II and bans on research, lipid nanoparticles (LNPs), the advent of synthetic biology, cell therapy, stem cells, embryonic stem cell controversy, CRISPR, CRISPR CaS9, Jennifer Dounda, Emmanuelle Cherpentier, Feng Zhang, Broad Institute, UC Berkeley, Intellia Therapeutics, CRISPR Therapeutics, Operation Warp Speed, Editas Medicine, Innovative Genomics Institute (IGI), Covid vaccines, why the Covid vaccines are more like a therapeutic, AI biotech, AlphaFold2, tech money piles into biotech post pandemic, Arc Institute, Vitalik Buterin, Big Pharma and its lack of involvement in therapeutics, Big Tech's entry into defense and healthcare, Peter Thiel, Thiel as the catalyst for modern therapeutic research, life-extension, Thiel's extensive investment in therapeutics and biotech, Jason Camm, Jim Mellon, Brexit, Thiel's lack of investment in CRISPRResourcesTrump on "miracle drugs":https://www.yahoo.com/news/article/trump-coronavirus-twitter-video-234914108.html?guccounter=1On the links between therapeutics and the Covid vaccineshttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02444-3/fulltexthttps://pmc.ncbi.nlm.nih.gov/articles/PMC12179814/AI Biotechhttps://whatisbiotechnology.org/index.php/science/summary/aiBig Tech and AI biotechhttps://www.forbes.com/sites/richardnieva/2024/03/13/why-nvidia-google-and-microsoft-are-betting-billions-on-biotechs-ai-future/How funding for biotech has unfolded since the 2010shttps://www.fiercebiotech.com/biotech/how-healthy-exchange-ideas-rfk-jr-kicked-fdas-gene-therapy-pushThiel's Links to Biotechhttps://www.technologyreview.com/2015/03/16/168909/a-contrarian-in-biotech/https://sociallifemagazine.com/celebrities/bezos-thiel-longevity-investments/https://www.inc.com/jeff-bercovici/emerald-therapeutics-peter-thiel.htmlhttps://www.fiercebiotech.com/biotech/thiel-s-breakout-labs-fuels-four-new-life-science-companieshttps://alloytx.com/42-million-series-d-financing/https://www.wholesaleinvestor.com/epiaxis-therapeutics-peter-thiel-backed-peptilogics-enter-strategic-partnership/https://www.businessinsider.com/peter-thiel-funded-de-extinction-animal-resurrection-woolly-mammoth-2017-6https://www.sfgate.com/tech/article/synthego-after-raising-forced-bankrupcty-20331773.phpJason Camm's biohttps://www.berentx.com/companyMusic by: Keith Allen Dennishttps://keithallendennis.bandcamp.com/ Hosted on Acast. See acast.com/privacy for more information.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore groundbreaking advancements, regulatory updates, and strategic partnerships shaping the future of patient care and drug development. Revolution Medicines has achieved a significant milestone with the FDA approval of its RAS inhibitor, daraxonrasib, for metastatic pancreatic cancer treatment. This approval follows an impressive presentation at the American Society of Clinical Oncology meeting that garnered widespread acclaim. Targeting one of the most challenging cancers, this advancement offers renewed hope for patients with limited treatment options and sets a potential new standard in pancreatic cancer therapy. In another promising development, Amgen and AstraZeneca have successfully completed a Phase 3 trial for their drug Tezspire in eosinophilic esophagitis. This success positions Tezspire as a formidable contender in the competitive landscape of inflammatory disease treatments, directly challenging Sanofi and Regeneron's Dupixent. The focus on biologics targeting specific inflammatory pathways underscores ongoing innovation in this area, offering enhanced treatment options for patients. On the regulatory front, the FDA has expanded its authorization for Tivicay, an HIV medication, to include newborns. This move aligns with global efforts to advance pediatric HIV treatment and address public health challenges. Additionally, Roche has secured further FDA approval for diagnostic tests linked to Jazz Pharmaceuticals' oncology drug Ziihera, emphasizing the critical role of companion diagnostics in personalized medicine. Meanwhile, strategic initiatives are also taking shape in pricing agreements. The Trump administration is preparing to announce "most favored nation" pricing agreements with mid-sized biopharma companies as part of ongoing efforts to tackle drug pricing issues. Although these arrangements could lead to lower drug prices, they may also face industry resistance due to potential impacts on revenue. Flagship Pioneering's Profound Therapeutics has partnered with the Gates Foundation in a $35 million effort to discover new drug targets for preeclampsia—a dangerous pregnancy complication. Such collaborations are vital in accelerating research and offering innovative solutions to complex health problems. Artis Biosolutions is expanding its synthetic DNA and mRNA production capabilities with a new facility in Spain. This development highlights the growing importance of genetic medicines and reflects an industry shift towards next-generation therapies like gene editing and RNA-based treatments. On a global scale, CEPI is supporting Minapharm's Ebola vaccine candidate advancement into clinical trials amid a growing outbreak. This initiative is part of a broader strategy to enhance epidemic preparedness through rapid vaccine development and deployment. Another significant move comes from McKesson's $2.25 billion acquisition of Precision Medicine Group. This acquisition aims to strengthen McKesson's oncology and biopharma segments, emphasizing precision medicine's growing role in personalized cancer treatment. In the context of geopolitical dynamics, concerns about Chinese dominance in clinical trials and supply chains have been raised by Congressman Nathaniel Moran. This highlights strategic dependencies and underscores the need for robust domestic capabilities in biopharmaceutical research and manufacturing. In clinical developments, Bausch + Lomb faced setbacks with its phase 2 trial combining dry-eye disease drugs Xiidra and Miebo but remains optimistic as it advances to phase 3 trials. Conversely, Spyre Therapeutics is deprioritizing its anti-TL1A antibody approach following underwhelming phase 2 results for rheumatoid arthritis—a testament to the rigorous validation process required before new therapies can reach patients. Akeso's success with its PD-1xVEGF bispecific antibody ivonescimab in biliary tract cancer demonstrates innovative biologics' potential to expand treatment options beyond traditional indications. In regulatory news concerning Capricor Therapeutics' Duchenne muscular dystrophy therapy, an extended FDA review period reflects careful regulatory evaluation following additional data submissions. These developments paint a picture of a dynamic landscape where scientific innovation is paralleled by regulatory challenges and strategic partnerships aimed at addressing both market demands and pressing health issues. The continued focus on personalized medicine, competitive dynamics in biologics, and global collaboration efforts underscores a transformative period for pharmaceuticals and biotech industries. As these sectors evolve, they hold the promise of delivering more effective treatments worldwide while addressing unmet medical needs across various domains.Support the show

Hear from Dr. April McCullough of Regeneron and Katherine Freund of Independent Transportation Network of America about the real-world barriers that prevent people with vision loss from accessing timely eye care. Together, they'll explore how social determinants of health—specifically transportation—affect vision outcomes, and highlight innovative efforts such as Rides in Sight, a free national service helping connect people with reliable transportation to sight-saving medical appointments.

Science is, in a word, complicated. Fortunately, there's a drugmaker out there utilizing immersive audio and visual elements to break down some pretty heady concepts in a digestible, yet engaging way. Earlier this month, Regeneron debuted Science Illuminated, which is now available on Spotify.  The series is borne out of the work the New York-based drugmaker has undertaken across a range of therapies, with audio narration and scientific imagery produced by the company's employees.  Reporter Bella Czajkowski brings us a conversation with Regeneron's head of research communications Ella Campbell about Science Illuminated, including the drugmaker's reasoning for producing the series, how it was developed and what the company learned from experimenting with new approaches to science communication. For our Trends segment, executive editor Jack O'Brien is joined by Bella and pharma editor Lecia Bushak for thoughts about Rep. Alexandria Ocasio-Cortez's decision to publicly document freezing her eggs, the backlash to it as well as how this is a watershed moment for discussions around fertility treatments in America. 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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Co-hosts Ryan Piansky, a patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Science Advisory Council, interview Timothy Buckey, MD, MBE, an allergy and immunology attending physician with a joint faculty position at the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [00:48] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of APFED's Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda.   [1:04] Ryan introduces co-host Holly Knotowicz. Ryan just returned from APFED's 24th Annual EOS Connection Patient Education Conference. It was a wonderful time. Listeners can still check out the resources on demand online.   [1:26] Ryan mentions that a handful of people came up to him at the conference to say how much they appreciate the Real Talk podcast. It was wonderful to hear how impactful the podcast has been for them.   [1:53] Holly introduces today's topic: how parents and caregivers can help children and teens with eosinophilic disorders build the skills and confidence they need to manage their health as they grow and navigate transitions from pediatric to adult care teams.   [2:06] Holly introduces and welcomes today's guest, Dr. Timothy Buckey, an allergist and immunologist at the University of Pennsylvania and the Children's Hospital of Philadelphia.   [2:14] Dr. Buckey's research interests include eosinophilic esophagitis, food allergy, medical ethics, and improving access to medical care for vulnerable populations.   [2:24] Dr. Buckey thanks Ryan and Holly for having him on the program. He's a long-time listener and is looking forward to the conversation on this important topic.   [2:32] Holly comments on Dr. Buckey working with children and adults. Dr. Buckey says he sees patients of all ages, from a few days old at the Children's Hospital through the end of life at the adult hospital. He loves that there's no patient he cannot see.   [3:10] Dr. Buckey says, in addition to seeing patients as an allergist/immunologist, he is also a medical ethicist or bioethicist. He is trained in medical ethics, and he utilizes that approach in shared decision-making, trying to understand his patients' goals and values for their health, and making a plan that works for them.   [3:31] Holly says her allergist/immunologist at Massachusetts General also sees teens and adults.    [3:53] Dr. Buckey says a special aspect of the relationship he has with his patients is that he has been in a fairly similar position, as someone who has dealt with many different allergic or atopic conditions for his whole life.   [4:08] Dr. Buckey says his conditions started with asthma as a young child, which he still manages, allergic rhinitis, and environmental allergies. He has been on allergy shots. He deals with atopic dermatitis, or eczema. He has seen an allergist/immunologist his whole life. It feels like full circle to be one now.   [4:29] Ryan feels like it's easier from a patient perspective if your physician gets it and can understand what you're going through.   [4:41] Ryan says that eosinophilic disorders generally require lifelong management, especially when diagnosed in children. Over time, a patient may need to transition from being treated by a pediatric care team to an adult care team.   [4:57] Ryan says that Dr. Buckey, through his work with the University of Pennsylvania, provides a lot of support for young adults going through that transition. Ryan asks Dr. Buckey to explain the importance of transition of care.   [5:14] Dr. Buckey breaks down the term into its two words: transition and care.   [5:24] Transition of care is a process in which we are shifting from a pediatric health model, in which a parent or guardian is the primary historian, or person managing the patient's care, to one in which the patient becomes the primary point of contact.   [5:49] Dr. Buckey says that during this process, our overarching goal is for an individual to begin to develop ownership of their health so that they can take care of their medications, schedule appointments, and know their bodies.   [6:05] Dr. Buckey says the second part is care. Not only medical care, but it is a period of life of going through a lot of personal growth. Dr. Buckey's goal is for patients to know themselves and learn to support themselves as independent individuals.   [6:30] Holly appreciates that Dr. Buckey talked about the transition at that age when there are so many things going on with becoming an adult.   [6:40] Holly says when she worked at the Children's Hospital of Colorado, we thought about this a lot.   [7:00] Holly said that when she interacted with patients, she tried to look at them, even if they were little. If they were three or four, she asked them what their favorite foods were.   [7:17] Holly says she was trying, as young as possible, to have them feel that they have some say and control over their health, and they can start developing how to be a historian of their medical journey.   [7:36] Dr. Buckey says every person matures or develops at different times. Having a strict age cutoff may ignore the unique aspects of each person and their history. Dr. Buckey generally begins that conversation in the teenage years through the early 20s.   [8:02] Dr. Buckey says that with some kids, he will introduce the idea earlier than a teenager, based on how much they understand about their health. As they start to switch to adult care, he emphasizes that the transition process is not over at their first adult visit.   [8:24] Dr. Buckey says it takes additional visits for that person to understand themselves, to know how to request a refill of their medication, to know how to make the appointment, and to know how to contact Dr. Buckey if they have questions.    [8:38] Dr. Buckey says it is a continual process, and it doesn't just stop at that first visit with an adult doctor.   [8:45] Holly agrees that people reach maturity at different ages. Holly remembers that when she was in college, she asked her mom to schedule her dentist and doctor appointments.    [9:17] Dr. Buckey says it's overwhelming and it can be quite scary. It takes a team.   [9:30] Holly notes there are age ranges on the Healthcare Transition Timeline Toolkit for what the provider should be doing to help the patient get ready for transition, and what the caregiver and the patient should be doing. She invites listeners to check it out at eoscare.apfed.org.   [9:45] Holly asks about ages when a child would meet alone with their physician for part of the appointment to talk about things they don't want to say in front of their parent.   [10:18] Dr. Buckey says it depends on age and individual factors. He says he has met some very mature 10-year-olds and some not-as-mature 17-year-olds.   [10:38] Dr. Buckey says he understands how it might be nerve-wracking for parents to ask them to step out, but it is an important part of that person starting to know their own body.   [10:50] Dr. Buckey says if he's seeing an individual with asthma, he will have the parents step out briefly from the clinic room so he can have a conversation about possible triggers they may not be comfortable talking to their parents about, such as vaping or cigarette use, and if they have tried them or friends have tried them.   [11:20] Dr. Buckey says they will discuss that, and that's not something they always feel comfortable sharing with their parents because they feel like they may be disappointing them. The doctor needs to know it to keep them healthy.   [11:44] Holly says in her practice, a lot of teenagers will ask to meet with her if they have IgE-mediated food allergies on top of eosinophilic-related disease.   [11:51] They want to know if it's safe to kiss a person if they've eaten this or what to do to protect themselves. If they get this symptom, what should they do? They feel comfortable asking Holly. She's trying to coach them to feel confident in their bodies.   [12:22] Ryan comments that he's gone through the transition of care process relatively recently. The conversation has touched on so many things he remembers from the last 10 years of trying to transition.   [12:28] Even before that, at eight or nine, when the doctor asked what medications Ryan was on, his mother looked at him and said, You should know this; you take them every day. What medications are you on?   [12:43] Ryan says that was super helpful to him, as a young patient, that his parents supported him in making sure he was aware of his health, his treatment options, and was able to guide his own medical appointments, with supervision.   [12:57] Ryan had had no idea that he was choking on food or taking extra time to chew. It felt normal, so it was helpful to have a caregiver in the office. His caregiver would say it takes him half an hour to have a handful of crackers. That should not be happening.   [13:20] Ryan asked about caregivers helping with appointment management and prescription management. Until recently, Ryan's parents helped him.    [13:50] Ryan says, even into your 20s, that transition process is still happening. Ryan asks Dr. Buckey for advice on teens and young adults making their own appointments and dealing with healthcare systems.   [14:04] Dr. Buckey says it's difficult to navigate our healthcare system. There are questions about insurance and what is in-network vs. out-of-network. How do you get prescriptions filled? What's covered? Cost? So it's complicated.   [14:21] Dr. Buckey emphasizes that when we're talking about this transition process, sometimes a part can get misconstrued: that we don't want parents or caregivers involved. We do.   [14:35] Dr. Buckey says his goal is for people to have the community, however they define that, to still be a part of their healthcare. What he is aiming for with this transition is that the individual starts to take control of their own health.   [14:50] If making appointments is something they still need some help from their parents, that is them recognizing what they need. [14:57] If they want to come to the visit but have Mom or Dad or their significant other on the phone, because that is the support that they need, then absolutely do that.    [15:08] Dr. Buckey says, as we are generally switching over, at 18 into our early 20s, recognizing the support you need is an important part of knowing your own body.   [15:20] Holly says that's an important stage, and she got there later. She needed help when she was younger; then, in her teens, she said, "No, I've got it." Now, in her 40s, she would like some help again.   [15:37] Holly says it's OK to ask for help when you're feeling overwhelmed, and you can't navigate all these chronic diseases on your own.   [15:42] Ryan says this is a topic we're both passionate about. At APFED, we see younger patients stop seeing their care team when they get to their college years.   [15:54] Ryan says part of it is they get busy and are not able to engage with the patient advocacy community as much, and part of it is they drop out of care. It's important to have caregivers or your community to support you through that process.   [16:07] Ryan says, whatever it takes to stay in care and make sure you're healthy is super important.   [16:14] Ryan brings up legal age cutoffs. In his 20s, he has access to his medical records; his parents don't. He still wants their take on some stuff. After he gets an endoscopy, he pulls up MyChart to show his parents his results.   [16:38] Dr. Buckey says once we turn 18, we are legally adults. At that point, the patient is the owner of their health and their information. They have to provide access to their parents to be able to see it. That can be done in several different ways.   [16:55] If you have an electronic health record, sometimes you can add a proxy, or you can just pull up the results and choose to show your parents.   [17:05] Dr. Buckey says if he is seeing an 18-, 19-, or 20-year-old at the Children's Hospital, he will tell them that once they turn 18, he only communicates results to them.   [17:16] Of course, they can have their parents, caregiver, or significant other present. That is their choice to invite them into that conversation. That is very helpful for many people.   [17:30] Dr. Buckey is a proxy for his parents. Holly is also a proxy for her parents.   [17:41] Holly says that having somebody who is in your corner to talk about your results with and talk about the next stages of treatment is always important because it can be overwhelming.   [17:51] Dr. Buckey gives kudos to pediatric providers. They are so wonderful, and they build such a great relationship that it makes it hard for us to want to leave.   [18:03] When Dr. Buckey was at the point of applying to medical school, his pediatrician told him they needed to have him see an adult doctor. He was reluctant to transition. His pediatrician inspired Dr. Buckey to go into medicine.   [18:25] Ryan says it can be a hard transition, with so much else going on that you want to stay in that familiar environment.   [18:31] Ryan shares how he recently dealt with transitioning insurance plans.   [18:55] Dr. Buckey says the general rule is that you can stay on your parents' health insurance until you are 26. There are caveats for individual persons and individual insurance plans.   [19:05] Some people start working and may get health insurance through their job, so you may have your own health insurance at 18 and no longer be on your parents' insurance.   [19:16] When you're 16 or 17, it's an important time to talk to your parents, or whoever's insurance you are on, about what's going to happen when you turn 18.   [19:26] Ryan says it's specific to each medical plan. He says when he went to college, he was offered a student health insurance plan, but his specialty medications, like biologics, were not covered, only hospitalizations.   [20:00] Ryan says it's always good to double-check what your plan options are and what those plans cover, to make sure that you're able to maintain the care you need.   [20:12] Holly says that something really helpful is to sit down with the family and help them identify an adult care team that will fit them best as they transition.   [20:33] Dr. Buckey says sitting down and having that conversation is an important part of the visit. Talk to patients about where they will live. If you're living away at college or moving away for a job, what geographic area are you moving to?   [20:53] If you're going to be on a different coast or city, do you want to switch your care over to that area? Or do you want to keep your care in the area where your parents live and come back during your breaks and see your physician?   [21:09] Dr. Buckey says it's also important to have a local provider to go to if something comes up. Talk to your pediatric provider about whether they know adult clinicians who care for the condition that you have in the area where you will be living.   [21:30] Dr. Buckey says another important thing to think about is,  when we are in pediatric care, we are often follow-up or return patients. Visits may be of a different duration. Sometimes it's easier to schedule a follow-up visit than a new patient visit.   [21:48] Planning that new patient visit in your new area, sometimes weeks or months ahead, is an important part of this transition process to ensure that there are no gaps in the care you're going to be having.   [22:08] Holly mentions the APFED Specialist Finder on the APFED website. It's a tool for when you are not part of a multidisciplinary setting or wherever you're going, no one knows who they would recommend in that part of the country.   [22:25] There are a lot of good people listed on the APFED Specialist Finder if you are going to be moving somewhere else or getting your care in another place. Dr. Buckey proudly shared that he is on that Specialist Finder. So is Holly.   [22:51] Ryan recently moved to California, and he is trying to find care teams there that specialize in EoE.   [23:12] Ryan asks if patients transitioning to a new doctor typically need a referral from their existing physician, or do you chat with your insurance company first to help find new care teams?   [23:25] Dr. Buckey says some insurance policies do require a referral for each visit you are going to have with your provider. For many policies, you can look online to see who is in-network vs. out-of-network.   [23:52] Sometimes there are different costs to see someone who is in-network vs. out-of-network. The differences can be dramatic. Discuss it with your physician or clinician, but also with your insurance company.   [24:13] Dr. Buckey says make sure there's no lapse in care. We don't want someone to go without their medication. If you're no longer seeing your pediatric provider, make plans to see an adult provider who can continue your prescriptions.   [24:45] Ryan says we see a lot of patients who have an EGID and also other conditions. We see a lot of comorbidities within our community. We have multiple things going on, which can make this transition process especially complicated.   [25:15] Dr. Buckey says many people are experiencing different things and may need to see more than one clinician. They probably also have a primary care doctor. They are going to have to switch from each of those clinicians to an adult provider.   [25:38] That transition takes time and effort. It can sometimes be a long wait. Beginning that process early will only set you up for success. Dr. Buckey says different health systems will accept different insurances.   [26:01] Dr. Buckey says sometimes for specialty medicines, when you switch health systems, the specialty medication may be provided by a different specialty pharmacy than it was when you were seeing a pediatric healthcare team.   [26:13] How you schedule appointments, how you speak to someone if you're having new symptoms, all changes as you're switching to adult care. Dr. Buckey says because this is complicated, we do worry that sometimes things can get lost during the transition.   [26:37] Planning will only set you up for success, so that nothing gets missed in the switchover process; you have no lapse in medications or procedures that you need, and you can continue to see the clinicians you need to keep you healthy for your best life.   [27:03] Holly has learned from her healthcare and working in different hospitals to ask, before picking a specialist, what electronic medical records (EMR) the practice uses. Some can communicate with each other, and it makes the transition smoother.   [27:25] Holly says some places have EMRs that don't communicate with other places, and that makes sharing information tricky. Holly has experience dealing with EMRs that do not talk to each other at all.   [28:05] Dr. Buckey says if you use an EMR that communicates with others, your care can easily be accessed at different institutions. Dr. Buckey explains how that helps make the transition smooth if transferring to adult care or switching healthcare systems.   [28:56] Dr. Buckey says things you need for a helpful transition are to know your medical history, your diagnoses and how they were made, your current medications and dosing, and medications or therapies you tried before that weren't successful for you.   [29:31] Dr. Buckey says, as we approach the era of precision medicine where we are treating each person in a different way, knowing what did or did not work for you is so helpful for your clinician so they can continue to help you feel good.   [29:49] Holly suggests a role-play. For example, if she's going to see Dr. Buckey with her records from Maine, which do not communicate with his EMR. What should she physically bring to the visit?   [30:23] Dr. Buckey says to know what health conditions she is being treated for. In Holly's case, they will talk about asthma and EoE.   [30:33] Dr. Buckey would like to know if Holly has ever been hospitalized for asthma, what inhalers she takes, what inhalers she tried before, and if she is on any biologic medicines, the doses and the frequency, and what she tried in the past.   [30:53] Dr. Buckey would ask if she's ever had breathing tests, called spirometry or pulmonary function tests.   [30:58] Having paper copies is wonderful. You can bring them in, and he will review them at the visit. Dr. Buckey always appreciates it when patients send them to him ahead of time, so he can review them and prepare for a successful first visit for both of them.   [31:18] Dr. Buckey says if we're talking about EoE, he will ask when the diagnosis was made, what symptoms led her or her parents to do that first endoscopy or see an allergist, immunologist, or gastroenterologist, when the most recent endoscopy was, and what medications she was on when she had her different endoscopies.   [31:40] Dr. Buckey says usually clinicians are keeping track of this, so Holly could ask them for copies of procedures she has had, the last two or three office visits, which are usually pretty comprehensive, and a list of any medications Holly takes.   [32:00] Holly appreciates having the ability to send paper records in advance. When Holly sets an appointment, she will fax Dr. Buckey some of her tests and important facts to look at before her appointment.   [32:20] Holly says some places won't look at the reports in advance, so she brings a bullet list with her of all the things Dr. Buckey listed for them to look at when she checks in to the appointment.   [32:39] Dr. Buckey responds that healthcare is very busy and some clinicians don't have the time to look at reports ahead of the visit, but can take five or ten minutes to look at them at the start of the visit to be successful and have a comprehensive visit.   [32:59] Ryan appreciates Holly's point to bring a bulleted list to the visit. Ryan is grateful that his parents kept his records organized throughout his life. For any caregivers listening, set your patients up for success by keeping track of these things over time.   [33:24] Ryan has a one-page summary he gives to all new providers of all his hospitalizations over the last 20 years, the medications he has been on, with date ranges, his diagnoses with dates, and different procedures and endoscopies.   [33:46] Ryan says that one-page summary is in 6-point font to squish it down to one page. It's helpful to have all that information organized together.   [33:55] Ryan invites caregivers: If you have a young patient and you're starting to think about the transition process, start keeping track of all that if you haven't before.   [34:03] Dr. Buckey says our health can be complicated. We can have periods when we're feeling great and periods when we're having more symptoms. Having it written down is an easy way to keep track so things don't get forgotten or lost.   [34:22] Dr. Buckey often says he appreciates when patients come in with that sort of list of their history because it shows how invested you are in your health and keeping yourself healthy. It's a wonderful way that you can be proactive.   [34:40] Ryan says it can feel like a big undertaking if you start now and you're in your 20s. Whenever you can start keeping track of how you're feeling and why, what treatment and symptoms you're having, it's good to have more information than less.   [34:58] Dr. Buckey says there's never a period when it's too late. If you are in your 30s or 40s and just starting out, it's very helpful. The provider can prompt you with questions that will help you recall things you had in the past and add them to the document.   [35:21] Ryan says it's a very collaborative process. Discuss it with your clinician, who may point out symptoms you should note.   [35:40] Ryan asks, when you are transitioning from pediatric to adult care, is it typical for an adult care provider to call a pediatric care provider with questions? Dr. Buckey says in his system, doctors have those conversations, which is a great asset to patients.   [36:33] Dr. Buckey says, for example, if I were not their pediatric allergist, but I would become their adult allergist, I would reach out to their pediatric allergist and ask details about their history. I would also reach out to their dermatologist and gastroenterologist.   [36:59] It's helpful to ask each other questions, know things to look out for, or things in a person's history that might be helpful as therapies and medications continue to advance that might be a good fit. It helps us to have a good comprehensive plan in place.   [37:26] Dr. Buckey says talking to each other helps to provide good longitudinal care.    [37:39] Ryan asks about having procedures and allergy testing in a pediatric setting and switching to a new provider. Do adult providers typically want to repeat testing?   [38:04] Dr. Buckey says it will depend on each person, when they were performed, and what was performed. If Dr. Buckey is seeing someone for food allergies, was skin or blood testing done last year or 10 or 20 years ago? Last year is pretty current. If it was 20 years ago and you're 22, your body is very different from when you were two.   [38:40] Dr. Buckey says if you have asthma and you had a breathing test two weeks ago, that's very recent. If you have not had a breathing test done in 10 years, I probably would repeat it on your first or second visit.   [38:56] Dr. Buckey says, for endoscopies, if you have EoE of another EGID, it would depend on timing. Was this done recently or in the remote past? Was it done on the current regimen you are on? Was it done on a different regimen?   [39:14] Dr. Buckey says I'm going to ask you if you're having any changes in symptoms recently. If anything has changed how you're feeling, it's probably going to prompt me to do a new set of testing and not just rely on the ones you had before.   [39:31] Dr. Buckey says, if you could bring the previous tests to me, I can compare. I can see what your endoscopy looks like now vs. two years ago. It's helpful to have that baseline to compare to.   [39:48] Dr. Buckey adds that knowing how you're feeling, or what's been done before, or your medical history, helps clinicians to take care of you as best we can.   [40:15] Holly says this is such a needed conversation. It will be helpful for our listeners, both practicing physicians and patients.   [40:37] Holly asks what advice Dr. Buckey gives for navigating challenges during the transition of care.   [40:51] Dr. Buckey says for every new EoE patient visit, he shares a link to the APFED website because there are such wonderful resources and references there. He explains to them what APFED is, and he provides resources to other websites or research that he thinks is helpful for them, depending on what each person is looking for.   [41:31] Talking with your doctor about what you are looking for is very helpful.   [41:38] In terms of the transition process, it's an exciting period. We're often going through a lot of big life changes. It could be our first time living away from our parents, having a job, or going to college.   [42:05] Know your own health. Learn about your body. We are the best advocates for ourselves. Only you know what you are feeling. Only you can tell your doctor what you're feeling. Taking ownership of your health will set you up for success for a healthy, long life, achieving your goals. Holly says that sums it up beautifully.    [42:40] Holly says for listeners who are feeling overwhelmed, unsure, or want to find out more about the transition, eoscare.apfed.org is a great site that helps you navigate healthcare for eosinophilic conditions. It also has a tab for building a care team.   [43:05] Ryan says it's great when the guest plugs APFED resources! For those who are looking to learn more about transition of care, please visit apfed.org and check out the links in the show notes below.   [43:25] If you're looking to find specialists, as you're going through this transition process, who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder, available at apfed.org/specialist.   [43:36] If you would like to hear some recent sessions from the 24th annual Eos Connection conference, we had a session focused on transition of care. Those are available on demand online.    [43:50] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [44:00] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experiences, please check out apfed.org/shareyourstory.   [44:09] Ryan thanks Dr. Buckey for joining us today. It was such a great conversation. This will be so helpful for the community. Dr. Buckey says the work of this podcast and of APFED as a whole is so important.   [44:36] Dr. Buckey thanks all the patients and colleagues that he has. He has a job where he walks with a smile on his face every day. It's a privilege to take care of his patients and work with his colleagues. Thank you all for listening today.   [44:56] Holly thanks APFED's Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.orgapfed.org/specialist apfed.org/connections eoscare.apfed.org Eos Connection 2026 Timothy Buckey, MD, MBE Hospital of the University of Pennsylvania Children's Hospital of Philadelphia Department of Medical Ethics and Health Policy Healthcare Transition Timeline Toolkit Education Partners: This episode of APFED's podcast is brought to you thanks to the support of AstraZeneca, GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I am trained in medical ethics, and I utilize that approach, particularly in shared decision-making, trying to understand my patients' goals and values for their health, … and making a plan that works for them." — Timothy Buckey, MD, MBE   "During this [transition] process, our overarching goal is for an individual to begin to develop ownership of their health so that they can take care of their medications, schedule appointments, and know their bodies." — Timothy Buckey, MD, MBE   "Having a strict age cutoff may ignore the unique aspects of each person and their history. I generally begin that conversation [about transition of care] in the teenage years through the early 20s." — Timothy Buckey, MD, MBE   "Healthcare is very busy, and some clinicians don't have the time to look [at reports] ahead of time, but often, we can take five or ten minutes to look at them at the start of the visit … to be successful and have a comprehensive visit." — Timothy Buckey, MD, MBE   "We are the best advocates for ourselves. Only you know what you are feeling inside. Only you can tell your doctor what you're feeling. Taking ownership of your health will set you up for success for a healthy long life, achieving your goals." — Timothy Buckey, MD, MBE   Guest Bio: Timothy Buckey, MD, MBE, is an allergy and immunology attending physician with a joint faculty position at the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia, and a secondary academic appointment in the Department of Medical Ethics and Health Policy. Dr. Buckey completed his allergy and immunology fellowship training at the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia. He attended Georgetown University School of Medicine. He also received a Master of Bioethics from the Perelman School of Medicine at the University of Pennsylvania.   Several of Dr. Buckey's research interests include eosinophilic esophagitis, food allergy, medical ethics, and improving access to medical care for vulnerable populations. He was the lead author on one of the largest studies evaluating the rate of eosinophilic esophagitis during food allergy oral immunotherapy. Dr. Buckey was also the lead author on the pivotal 2024 food allergy study, which utilized allergist-performed oral food challenges to demonstrate there are no differences in food allergy outcomes based on race or ethnicity. Dr Buckey has also become a pioneer in investigating the intersection of medical ethics with allergy and immunology. Dr. Buckey developed the first comprehensive ethical framework for the specialty of allergy and immunology to assist clinicians with navigating ethically complex decisions in their clinical practices. He utilizes this patient-centered approach in the clinic when caring for patients with allergic and immunologic conditions of all ages.   Website profile: pennmedicine.org/providers/timothy-buckey

Earnings calls are a chance to catch up with the latest developments across Big Pharma and beyond, and last quarter was no different. From the rollout of AI to the oral GLP-1 battle between Novo Nordisk and Eli Lilly and new leadership at Sarepta and Sanofi, it feels like the opportunities and challenges for biopharma have never been greater. In this week’s episode of "The Top Line," Fierce Pharma Senior Editor Fraiser Kansteiner and Fierce Biotech Senior Editor James Waldron share their takeaways from another whirlwind season of earnings calls. Alongside a Q2 scorecard breakdown, the Fierce editors discuss how several new CEOs are finding their footing, which drugs appear poised to cross the $1 billion sales threshold in 2026 and more. To learn more about the topics in this episode: Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow Sarepta’s new CEO Michael Severino faces critical milestones to prove growth See omnystudio.com/listener for privacy information.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the latest advancements and achievements across this dynamic industry, where innovation is reaching new heights and regulatory landscapes are continuously evolving. In a groundbreaking moment for gene therapy, Ultragenyx has secured the first FDA approval for its gene therapy product, Genglycos (DTX401), aimed at treating Glycogen Storage Disease Type Ia. This rare metabolic disorder has long posed significant challenges due to the body's inability to convert glycogen into glucose. Using an adeno-associated virus vector to deliver the therapeutic gene, Genglycos has shown significant clinical efficacy in Phase 3 studies, offering new hope for patients with limited options. This achievement underscores gene therapy's potential to transform the management of metabolic diseases and sets a precedent for future innovations in treating genetic disorders. Shifting focus to monoclonal antibodies, Regeneron has received FDA approval for Pasatru (Garetosmab), a treatment for Fibrodysplasia Ossificans Progressiva (FOP), a rare and debilitating bone disease. Pasatru targets Activin A to reduce unwanted bone formation outside the normal skeleton, marking a strategic use of monoclonal antibodies in managing rare conditions. This approval provides another therapeutic avenue for FOP patients and highlights the critical role monoclonal antibodies play in addressing complex medical challenges. On the technological front, Vitestro's Aletta has become the first FDA-approved robotic blood draw device. This innovation addresses the current shortage of phlebotomists and promises enhanced efficiency in healthcare settings. The integration of robotics into routine medical procedures exemplifies how technological advancements can optimize healthcare delivery, improving patient experiences and operational workflows. In regulatory news from the UK, NICE's endorsement of Eli Lilly's once-weekly insulin Onswik for NHS coverage marks a significant step forward in diabetes management. By facilitating access to innovative treatments with more convenient dosing regimens, this approval aims to enhance patient compliance and outcomes significantly. Business development continues to drive innovation across various therapeutic areas. Eli Lilly's collaboration with Amplitude Therapeutics on an RNA vaccine platform signifies a focused effort to harness cutting-edge technologies against infectious diseases. Similarly, Chai Discovery's partnership with Bristol Myers Squibb leverages AI and machine learning to accelerate antibody discovery, showcasing how AI is reshaping drug discovery paradigms. Funding initiatives further reveal industry trends. Kynexis's successful EUR97 million Series A raise will advance its cognitive impairment schizophrenia drug toward registrational development. Such investments underscore confidence in neuroscience therapeutics and emphasize a growing focus on addressing cognitive disorders through novel small molecules. Despite these advancements, challenges persist. Amgen's decision to terminate its collaboration with TScan Therapeutics on a Crohn's disease project due to strategic realignments highlights ongoing industry shifts. Moreover, regulatory recalls impacting product safety continue to underscore the importance of maintaining rigorous standards. In other significant developments, Novo Nordisk is exploring smaller doses of its weight management drug Wegovy through a Phase 3 trial. This study reflects an industry trend towards optimizing drug formulations for enhanced efficacy and patient compliance. On the legal front, Aurinia Pharmaceuticals reached a settlement with Teva Pharmaceuticals to delay a generic version of its lupus drug Lupkynis until late 2036. This agreement secures Aurinia's market position while providing a buffer period to maximize revenue from its patented formulation. Amid geopolitical tensions, Chinese biotech companies remain confident in navigating international markets, reflecting resilience and underscoring China's growing influence in global biotech innovation. The field also observes notable movements such as Boehringer Ingelheim's improved standing in rare disease reputation rankings and B. Braun Medical's IV solution recall due to contamination concerns—highlighting ongoing challenges in product safety and quality assurance. As we wrap up, these discussions showcase an industry rapidly evolving through scientific breakthroughs, strategic collaborations, and regulatory successes. The implications are profound: from more effective therapies for rare conditions to leveraging technological advances for streamlined R&D processes. The pharmaceutical and biotech sectors are on a promising trajectory that could redefine patient care and drug development paradigms globally. Thank you for tuning into Pharma Daily; stay informed about the latest developments shaping our industry.Support the show

What can pharmacovigilance data tell us about the post-marketing safety profiles of anti-VEGF agents, and where do those signals fall short? In this episode of New Retina Radio Journal Club with VBS, Katherine Talcott, MD, moderates a discussion with Akshay Thomas, MD, and Nita Valikodath, MD, MS, on a 2026 study comparing ocular adverse event reporting for aflibercept 2 mg (Eylea, Regeneron), aflibercept 8 mg (Eylea HD, Regeneron), and faricimab (Vabysmo, Genentech/Roche) using the FDA Adverse Event Reporting System. The group examines distinct signal profiles for each agent and makes the case for why these findings should be viewed as hypothesis-generating rather than evidence of causality.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of updates that underscore the dynamism and complexity of these industries, marked by breakthroughs, strategic shifts, and regulatory hurdles. A notable scientific advancement comes from Biokin Pharma, where their bispecific antibody-drug conjugate, Iza-Bren, has achieved its primary endpoint in a Phase 3 trial focused on lung cancer. This success underscores the promise of ADCs in oncology, particularly their ability to target cancer cells while minimizing damage to healthy tissues. This approach not only enhances the efficacy of cancer therapies but also reduces side effects, providing a compelling argument for Bristol Myers Squibb's global testing initiatives in this domain. Such advancements are pivotal as they represent a significant leap toward more personalized cancer treatments. In regulatory and corporate news, Sanofi's recent restructuring following its acquisition of Blueprint Medicines has been significant. The integration process involves laying off 229 employees and closing operations in Cambridge. This move highlights a broader trend of consolidation within the biotech sector as companies seek to streamline operations and optimize resources amid an increasingly competitive market. Meanwhile, CSL Behring, an Australian company specializing in plasma and vaccines, anticipates mid-single-digit growth by fiscal year 2027. This optimistic outlook follows a period of challenges, including impairments and leadership changes. The company attributes its recovery largely to advancements in immunoglobulin therapies, which play a critical role in treating immune deficiencies and autoimmune diseases, highlighting the importance of innovation in sustaining growth. On the clinical trial front, Amylyx Pharmaceuticals is making waves with its GLP-1 receptor antagonist Avexitide. The drug has shown promising Phase 3 results by significantly reducing hypoglycemic episodes in patients with a rare endocrine disorder. This finding could revolutionize treatment protocols for endocrine disorders beyond traditional diabetes management, emphasizing the potential of GLP-1 inhibitors to enhance patient outcomes across various conditions. The latest updates from Amylyx Pharmaceuticals further showcase these industry dynamics as they prepare for an FDA filing for Avexitide following successful trial outcomes. The drug addresses post-bariatric hypoglycemia—a critical gap in metabolic disorder management—highlighting its potential impact on patient care and market dynamics with an anticipated $1.7 billion peak sales forecast. However, not all developments have been positive. EyePoint Pharmaceuticals faced setbacks with Duravyu, their AMD drug-device combo, which did not meet expectations in a Phase 3 trial. This highlights the inherent risks of developing drug-device combinations in late-stage trials and underscores the competitive pressures from market leaders like Eylea. In another strategic shift within big pharma, Merck KGaA has laid off 20 staff members from its U.S. research team as part of an ongoing reassessment of research priorities and resource allocations. Similarly, BioMarin Pharmaceutical's $275 million acquisition of Alesta Therapeutics marks an effort to bolster their bone disease portfolio and challenge competitors like AstraZeneca in specialized therapeutic areas. BioMarin's acquisition emphasizes competition within rare diseases—a sector ripe with opportunities for innovative treatments addressing unmet needs. Technological advancements are also reshaping the landscape. Johnson & Johnson MedTech's recent software updates for its Monarch bronchoscopy robot illustrate how digital solutions are enhancing diagnostic capabilities in lung cancer detection. This aligns with industry trends towards leveraging AI and robotics to improve precision medicine. Eurofins CDMO Alphora's expansion to meet the growing demand for high-potency active pharmaceutical ingredients reflects a rising interest in targeted therapies requiring precise dosing and specialized manufacturing processes. Such trends indicate a shift toward more personalized medicine approaches that prioritize efficacy and safety. Despite setbacks faced by companies like Regeneron due to safety concerns halting clinical trials, strategic moves such as GSK's licensing agreement with Chugai Pharmaceutical for an anti-dengue antibody exemplify ongoing efforts to combat infectious diseases through innovative biologics. The collaboration between Evaxion and Duke University on AI-designed glioblastoma vaccines further illustrates how artificial intelligence is becoming integral to next-generation cancer therapies—potentially paving the way for personalized vaccines that optimize antigen selection based on individual tumor profiles. Rigel Pharmaceuticals' launch of Veppanu marks another milestone—the first FDA-approved PROTAC for advanced breast cancer—demonstrating novel mechanisms targeting pathogenic proteins effectively while offering new treatment avenues for molecularly defined cancers. These stories capture the essence of today's pharmaceutical landscape: one where innovation coexists with challenges but holds immense potential to transform healthcare delivery globally. As companies continue pushing boundaries with emerging technologies like AI integration or expanding into niche markets through strategic acquisitions—the future looks promising for delivering more targeted solutions tailored toward specific patient populations worldwide.Support the show

Having spent 14 years building out its capacity, Regeneron Genetics Center—the genomic research branch of the Tarrytown, New York-based pharma—is a pro when it comes to the sort of target validation work central to the field today. Now, as RGC continues the massive expansion of its genetic database, the center’s unique ability to interpret that trove of data could give it an edge in the age of AI-powered drug development. In this week’s episode of "The Top Line," Fierce’s Fraiser Kansteiner sits down with Andy Deubler, chief business and administrative officer at Regeneron Genetics Center, to discuss the role RGC plays in the larger Regeneron model, as well as where the center could be headed as drug development pushes into new technological frontiers. Aside from the data interpretation advantage RGC believes it holds in the AI era, Deubler also discusses how the unit’s ongoing genetic research has helped deliver recent breakthroughs like the hearing loss gene therapy Otarmeni. To learn more about the topics in this episode: Regeneron ushers in new genetic medicine era with groundbreaking gene therapy approval J. Craig Venter launches genomics startup designed to boost diagnostic insights Genomics inks partnership deal with Greywolf to assess gene datasets How a new tool for large-scale gene editing could power novel genetic medicines In global life sciences, insight isn’t the problem—execution is. Disconnected dashboards, siloed teams and fragmented workflows make it harder to act—consistently, compliantly and at scale. ZAIDYN by ZS closes that gap. ZAIDYN is the Life Sciences Intelligence Platform that embeds intelligence in the flow of work, based on domain expertise and agentic AI across commercial, medical, patient and content work. Trusted by more than 150 life sciences organizations across over 100 countries, ZAIDYN is built for global scale, regulatory compliance and trusted AI—so teams act together across brands, markets and channels. ZAIDYN. Move beyond reporting to intelligent action. Learn more at ZAIDYN.aiSee omnystudio.com/listener for privacy information.

"A good way of thinking about this is this is the survival of the fittest clone. There could be a portion of a cancer that naturally has some resistance or ability to survive a particular drug. And over time, as the other cells around it are dying off, that particular clone is able to replicate and continue to survive in the face of that drug therapy and eventually take over as being the fittest clone. At that point, we're often seeing disease progression," Danielle Roman, PharmD, BCOP, manager of clinical pharmacy services at the Allegheny Health Network Cancer Institute in Pittsburgh, PA, told Jaime Weimer, MSN, RN, AGCNS-BS, AOCNS®, manager of oncology nursing practice at ONS, during a conversation about resistance pathways.  Music Credit: "Fireflies and Stardust" by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0  Earn 0.5 contact hours of nursing continuing professional development (NCPD), including 30 minutes of pharmacotherapeutic content, by listening to the full recording and completing an evaluation at courses.ons.org by August 7, 2027. Roman has served on advisory boards for Genetech, Pfizer, Regeneron, and Daiichi Sankyo and received honoraria payments from Pharmacy Times and Decera for faculty lectures. These financial relationships have been mitigated. ONS is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Learners will report increased knowledge related to resistance pathways in oncology care. Episode Notes  Complete this evaluation for free NCPD.  ONS Podcast™ episodes: Pharmacology 101 series Episode 423: Pharmacology 101: Interaction Pathways Episode 406: Drug Resistance Biomarkers and Their Impact on Cancer Treatment Choices ONS Voice articles: Predictive and Diagnostic Biomarkers Scientists Identify Protein Implicated in Tumor Growth, Treatment Resistance ONS book: Guide to Cancer Immunotherapy (second edition) Genomics and Precision Oncology Learning Library ONS Biomarker Database Pharmacogenomics Huddle Card CancerQuest: Cancer Drug Resistance National Comprehensive Cancer Network OncoKB.org Research To Practice To discuss the information in this episode with other oncology nurses, visit the ONS Communities.  To find resources for creating an ONS Podcast club in your chapter or nursing community, visit the ONS Podcast Library. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From This Episode "As we look at drug resistance, this is the concept that cancer cells are no longer able to respond to a cancer treatment. The downstream of this is that we could end up with progression of the disease and need to look at alternative therapies that may be beneficial for the patient. This is unfortunately a very common phenomenon. Drug resistance is a major cause of treatment failure and poor patient outcomes with treatments. Unfortunately, this is an issue we see that increases over time on treatment." TS 2:29 "Genetics play a really big role in drug resistance. We know that drug resistance can be due to different things. It could be epigenetics. It could be the tumor microenvironment factors. But genetics often play a very big role in resistance pathways. It's generally considered to be a critical contributor to resistance, particularly in the way of acquired variants to drug targets or amplifications of certain oncogenes that can lead cancers to have progression. A well-known genetic alteration is the BRCA1/BRCA2 variant that helps to make the cancer more efficient at fixing DNA damage. So we're trying to get DNA damage with chemotherapy, and this particular variant helps at fixing that damage to allow the cancer to progress. So that is one genetic variant we see that plays a big role in a number of different cancers." TS 4:51 "These pathways are not mutually exclusive. Oftentimes we have multiple resistance pathways involved. I think it's important to understand some of those individually, but kind of thinking about this as we might be facing multiple resistance pathways. ... We can see resistance mechanisms that vary based on the type of treatment we use, for example, traditional cytotoxic chemotherapy. We may be more likely to see some resistance mechanisms that are working at DNA: repairing broken DNA or working on those efflux pumps that are being used to push chemotherapy out of cells. If we're talking more about the targeted therapies such as tyrosine kinase inhibitors or monoclonal antibodies, we may be more likely to see resistance mechanisms that are what we discussed with that drug target alteration: changing the way that the target agents are able to bind to the tumor cells to activate or inactivate pathways so we may see some changes there." TS 12:39 "One way to overcome this and to help to decrease the resistance from developing is using combination therapy: drugs that are targeting different pathways at once or potentially using combinations with things like chemotherapy in addition to immunotherapy. In this way, as we're getting these different targets, we can hopefully decrease the mechanism of resistance that may be developing." TS 14:48 "Biomarker testing is an incredibly important part of our practice. In many situations now, we are getting upfront, comprehensive biomarker testing to identify whether the patient may have any of those intrinsic or primary resistance mechanisms that might make it so a patient is never going to respond to a particular type of treatment. And in that case, we can spare the patient from the potential toxicities of that treatment if we don't think that there's going to be benefit there. So I think that that has become a really important way that we can tailor patients for understanding what treatments are going to be more effective. And then after that, there's usually additional biomarker testing that may be warranted at the time of progression in certain types of cancer. And that really helps us to understand that acquired resistance that might be developing." TS 17:32 "Nurses are really helpful with filling in the gaps and bringing back patient concerns that might be shared with them. And these might be early signs of progression. Better understanding how our patients are feeling and what's going on with them may help us to identify a patient that we need to do some additional testing for to understand whether there is drug resistance ongoing and potential progression of disease." TS 21:52

This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits. The speakers were compensated by Sanofi and Regeneron in connection with this program.   COPD trial outcomes are not all equal, yet conventional endpoints can make it difficult to weigh severe events, exacerbations, lung function, and symptom burden within a single clinical picture.   In this AMJ podcast, Sanjay Ramakrishnan and Simon Couillard discuss how win ratio methodology may help capture a broader, more clinically meaningful view of treatment benefit by comparing outcomes across a prespecified hierarchy.   Listen to the full episode to learn:   Why standard COPD endpoints may not tell the full story How win ratio analysis prioritizes outcomes by clinical importance What the pooled BOREAS and NOTUS analysis showed How this approach could shape future respiratory trial design Speakers: Sanjay Ramakrishnan, Clinical Senior Lecturer, UWA Medical School, Centre for Respiratory Health, The University of Western Australia, Perth, Australia Simon Couillard, Professor, Faculty of Medicine and Health, Université de Sherbrooke, Quebec, Canada

I am Rolf Claessen and my co-host Ken Suzan and I are welcoming you to episode 177 of our podcast IP Fridays! Today's interview guest is Dr. Ernst-Peter Heilein, who is a German and European patent attorney, the founder of HEILEIN IP LAW, and a long-time IP leader at BSH Home Appliances. He is the mastermind behind the BSH v. Electrolux decision of the European Court of Justice about long-arm jurisdiction in Europe that has the whole patent world stirring in Europe at the moment! But before we jump into this fascinating interview, I have news for you! Emboline v. AorticLab (UPC Court of Appeal) The UPC Court of Appeal has clarified for the first time how a conditional revocation counterclaim should be handled, in a dispute over Emboline’s embolic protection patent EP 2 129 425 against AorticLab. A defendant can validly make its revocation counterclaim conditional on infringement being found first, meaning no ruling on the counterclaim is needed if the infringement claim fails, as the Munich Local Division had held. The Court of Appeal also closed a related gap: if the claimant appeals a non-infringement finding, the counterclaimant may conditionally appeal the unresolved counterclaim too. AorticLab missed its own appeal deadline and can now at best seek re-establishment of rights, while Emboline has already appealed the non-infringement finding. FujiFilm v. Kodak (UPC Court of Appeal) Following the closely watched long-arm jurisdiction ruling of June 2, the UPC Court of Appeal, chaired by Rian Kalden, has now granted FujiFilm an injunction against Kodak in a second proceeding. The Court upheld the limited printing plate patent and found that Kodak’s Sonora XTRA 3 plate infringes it. Kodak can no longer sell or use that plate in Germany. OpenAI v. EUIPO (General Court of the EU, T-555/25) The General Court’s Eighth Chamber dismissed OpenAI’s action against the EUIPO decision to partially cancel the OPENAI trademark. The partial refusal for classes 9, 42, and 45 rests decisively on Article 7(1)(c) EUTMR, the descriptiveness ground. For a significant part of the English-speaking public, “OPENAI” directly conveys that the goods or services are provided using freely accessible artificial intelligence. Dental Monitoring v. Align Technology (CAFC) On July 7, 2026, the Federal Circuit confirmed that AI and deep-learning patent claims covering dental image analysis are not patent-eligible under Section 101. Simply training a “deep learning device” on a specific dataset does not amount to a patent-eligible technical solution. Publisher v. Google (Munich I Regional Court) The Munich I Regional Court issued a preliminary injunction barring Google from spreading false factual claims about a publishing company in its AI Overviews. A search query combining the company’s name with the German term for “fraud scheme” had triggered an AI-generated summary containing entirely fabricated accusations of subscription traps. KPN v. Oppo (Federal Court of Justice, X ZR 103/24) On July 1, the Federal Court of Justice dismissed KPN’s appeal against the revocation of a central claim of its LTE patent EP 2 291 033. Oppo had successfully challenged the claim, leaving KPN’s infringement action against Oppo’s German distribution entity without a legal basis for now. BSH v. Electrolux: What the ECJ Ruling Means for Your Company’s Patent Enforcement Strategy A vacuum cleaner from 2001 has reshaped the European patent landscape. That sounds like an overstatement. It isn’t. For IP Fridays, I spoke with Dr. Ernst-Peter Heilein, founder of HEILEIN IP LAW and long-time Senior IP Leader at BSH Home Appliances. He guided the case BSH v. Electrolux from its first strategic idea all the way to the Grand Chamber of the European Court of Justice, a case that earned the 2025 Managing IP Award as “Europe Impact Case of the Year.” For managing directors, IP heads, and R&D leaders at German Mittelstand companies, this case is not a legal footnote. It changes where you can enforce your patents, and it changes where you yourself can be sued if your company operates across several European markets. That is what this article is about. Background: How a Patent Dispute Became an ECJ Case The invention dates back to 2001 and concerns a new vacuum cleaner technology. In 2006, BSH identified what it believed was an unauthorized use of that invention and contacted Electrolux to clarify the situation. The European patent was granted in 2009 and validated in a number of European countries. Nobody, Heilein says, could have imagined at the time that this matter would eventually reach the Grand Chamber of the European Court of Justice almost twenty years later. In late 2018, BSH successfully defended the patent through opposition and appeal proceedings before the European Patent Office. In 2019, the Higher Regional Court of Düsseldorf found that certain Electrolux vacuum cleaner models infringed the patent. A classic milestone win, the kind that occurs regularly in patent practice. Except the patent had been validated in many countries. Winning in Germany did not solve the enforcement problem everywhere else. Heilein describes the starting point in very concrete terms: how do you enforce a patent that exists in many countries without filing a separate lawsuit in every single one? And how do you prevent claims from becoming time-barred while you work that out? Running parallel proceedings in multiple countries is not just legally complex. It consumes time, personnel, and money that a mid-sized company rarely has in that quantity to spare. This is exactly where the real value of this case for you begins. From the outset, this was never an academic debate about jurisdiction. It was a question that every company holding rights in more than one country eventually faces: how do you enforce your rights efficiently without burning your budget on ten parallel proceedings? Brussels Ia Regulation: The Underrated Article 4 While searching for a solution, the BSH team came across Article 4 of the Brussels Ia Regulation. The underlying idea is simple: a person can generally be sued in the country where that person is based. In the BSH case, that pointed toward the Swedish home court, because Electrolux is headquartered in Stockholm. For a long time, this rule played no real role in patent practice. The widely held view was that cross-border patent litigation in Europe was effectively dead the moment a defendant challenged the validity of the patent. Anyone wanting to enforce a patent across several countries appeared to have no choice but to litigate country by country. Heilein and his team questioned that assumption instead of simply accepting it. This is the point I find most instructive: challenging accepted assumptions in your own field is often the difference between a standard solution and a strategic one. In 2020, the team decided to file the action in Sweden, aware that they were looking at a possibility, not a guarantee. Cross-Border Enforcement: The Three Questions Referred to Luxembourg After Electrolux challenged the validity of the patents, the Swedish home court declared itself not competent to hear the case. BSH appealed, and the Swedish Court of Appeal agreed to refer three questions to the European Court of Justice. The first question addressed the core problem: does a home court that would otherwise have jurisdiction over an infringement claim lose that jurisdiction simply because the defendant argues the patent is invalid? The second question concerned a feature common to many legal systems, including Germany’s, where infringement and validity are decided in separate proceedings. The third question originally concerned Turkey. Today, most people immediately think of the United Kingdom, and some even think of US patents. Originally, the question was simpler: do the same jurisdiction rules apply to patents from countries outside the European Union? The fact that the ECJ first assigned the case to a Chamber of seven judges and later referred it to the Grand Chamber of 15 judges already signaled how much weight the Court placed on these questions. The Judgment: What the ECJ Actually Decided A home court does not automatically lose jurisdiction simply because the defendant argues the patent is invalid. For many years, the opposite was widely assumed to be settled law. The ECJ made clear that this reading was too narrow. The court where the defendant is based can generally continue to hear the infringement case. One point matters for how you read this ruling: questions concerning the validity of a European patent still fall to the national courts of the country for which the patent was granted, as provided in Article 24(4) of the Brussels Ia Regulation. What is new is that the infringement case does not automatically collapse the moment validity is challenged. The home court keeps control of the overall proceeding. For patents from EU Member States, the home court does not automatically lose jurisdiction. It assesses the validity challenge. If it looks strong, the home court may stay the infringement case. If it looks weak, the home court may proceed. For patents from non-EU countries, the home court may stay the case if a validity proceeding is already pending there, drawing on Articles 33 and 34 of the Brussels Ia Regulation. The result is a considerably more flexible system than most observers expected . Patents from Outside the EU: Long-Arm Jurisdiction The part of the judgment with the greatest international reach concerns patents from countries outside the EU. The ECJ ruled that the special jurisdiction rule for patent validity generally does not apply to non-European patents. That means the general rule can apply instead, opening the door for infringement claims based on non-European patents to be brought before a home court where the defendant is based in the EU. Commentators quickly started calling this “long-arm jurisdiction.” One clarification matters here, because it tends to get lost in the public discussion: the ECJ did not say that a European home court can revoke or invalidate a foreign patent. That remains a matter for the authorities and courts of the country that granted it. What the ECJ said is that a European home court may assess the claims between the parties. That distinction is essential to how you should read this ruling. Consequences in Practice: Fujifilm, Regeneron, and Onesta Three recent cases show how quickly practice is already adapting to the new possibilities. Fujifilm v. Kodak: the Düsseldorf Local Division of the Unified Patent Court accepted jurisdiction over the UK part of a European patent even before the ECJ delivered its judgment, building on reasoning the Advocate General had already signaled in the BSH case. In June 2026, the UPC Court of Appeal further developed that approach based on the principles confirmed in BSH. Regeneron v. Formycon: the Munich home court applied the BSH framework and granted a Europe-wide injunction based on a European patent, one of the first examples of a national home court putting the BSH logic into practice. Onesta v. BMW: this case shows the debate has moved well beyond Europe. After Onesta attempted to assert two US patents before the Munich home court, BMW obtained an anti-suit injunction from a Texas federal court. Judge Albright took the view that US patents should generally be decided by US courts. The injunction was directed against Onesta, not against the Munich court, and Onesta has appealed the Texas decision. The Munich home court stayed the proceeding but did not reject its own jurisdiction. Whether a European home court can ultimately decide infringement claims based on US patents remains an open question, one that has turned from a European jurisdiction issue into an international jurisdiction conflict. What This Means for Your Company Heilein sums up twenty years of litigation in three lessons, and I share this assessment without reservation when advising my Mittelstand clients. First: patent enforcement has become more international. National litigation still matters, but companies should think across borders from the very beginning, not only once the first cease-and-desist letter has been sent. Second: choice of forum now carries real strategic weight. Where you bring a case can matter just as much as the legal arguments themselves. Third: long-term commitment pays off. Major developments rarely result from a single filing or a single hearing. They come from pursuing a clear strategy consistently over many years. For you as a managing director, R&D lead, or Head of IP at an innovative Mittelstand company, this translates into two concrete points. First, if you hold rights in several European countries and a competitor infringes them, you no longer necessarily have to fund five or six parallel national proceedings. A single action at the infringer’s home base can be the economically smarter option. Second, and this side of the ruling gets less attention in public discussion, if your company is based in Germany and operates across several countries, you can now be sued at your own home base over patent infringement claims tied to activities in other countries. That risk belongs in every freedom-to-operate analysis and in every assessment tied to acquisitions or market entry. Here is the full transcript of the interview: Host Today's interview guest is Dr. Ernst-Peter Heilein. If you don't know Ernst-Peter, he is a German and European patent attorney, the founder of HEILEIN IP LAW, and a long-time IP leader at BSH Home Appliances. Thank you for being on IP Fridays. Answer Yeah, great to be here! BLOCK 1 – THE PERSON BEHIND THE CASE Host When looking at your career, one thing stands out: you never really followed the traditional path of either private practice or industry. Er, how did your professional journey begin, actually? Answer My professional roots are actually in private practice. After qualifying as a Patent Attorney, I worked in private practice and fairly early founded my own law firm, which later became HEILEIN IP LAW. Host So you never completely left private practice behind? Answer Exactly. In 2005, I had the opportunity to take on additional responsibilities on the BSH side. There, I was able to build and lead a new unit within the IP organization. The team was responsible for patents in the small appliances business, as well as global design and trademark protection. At the same time, I helped build an international network of internal and external IP counsel and coordinated their work. Host That still sounds fairly like traditional IP work. When did international disputes become part of your career? Answer Over time, my focus gradually shifted from traditional IP protection to strategic enforcement. That included anti-counterfeiting activities, global trademark and design matters, and cross-border patent disputes. Host So your work became more about enforcing rights rather than simply obtaining and managing them, right? Answer Exactly. And that development eventually led me to play a strategic role in the case BSH Home Appliances versus Electrolux, a case that still accompanies me today. Host Looking back now — from private practice, to building an international IP organization, and eventually becoming involved in a case before the European Court of Justice — did you ever imagine that path? Answer No, not at all. Looking back, this combination of private practice, responsibilities on the business side, and international enforcement experience turned out to be very useful when our case eventually reached the European Court of Justice. BLOCK 2 – HOW IT ALL STARTED Host Yeah, talking about this case. The case BSH versus Electrolux started long before it reached the European Court of Justice. When did the story actually begin? Answer The story actually begins much earlier than most people would expect. The invention itself dates back to 2001 and concerns a new vacuum cleaner technology. In 2006, we identified what we believed to be an unauthorized use of the invention and contacted Electrolux to clarify the situation. The European patent in suit was granted in 2009 and validated in a number of European countries. At the time, nobody could have imagined that this would eventually lead to a decision of the European Court of Justice almost twenty years later. Host Wow, 20 years! That's a long time. So, at first this was simply a normal patent dispute? Answer Yes, absolutely! After many years of opposition and appeal proceedings before the European Patent Office, we were finally able to defend the patent successfully in late 2018. Less than one year later, in the summer of 2019, the Higher Regional Court of Düsseldorf found that certain Electrolux vacuum cleaner models infringed the patent. Host Er, at that point, one might think, that the patent owner had achieved its goal, right? Answer That is what many people would think. But that judgment did not bring the dispute to an end. A new challenge emerged. The patent had been validated in many European countries. Winning in one country, like Germany, did not automatically solve the enforcement issue in all the other countries. Host What was the practical problem then? Answer We were facing a very simple question: How do we enforce a patent that exists in many countries? And how do we prevent claims from becoming time-barred without filing separate infringement actions in every single country? Doing that would not only be legally complex. It would also require a huge amount of time, effort, and money. Host That sounds less like a major legal question and more like a business problem. Answer Exactly. At the beginning, this was not an academic discussion about jurisdiction. It was a very practical business question. How can we enforce our rights efficiently without running parallel lawsuits all over Europe? That was the real challenge we were trying to solve. BLOCK 3 – THE IDEA OF A CENTRAL ACTION Host So, how did the idea of one central action emerge? Answer While looking for possible solutions, we came across Article 4 of the Brussels Ia Regulation. The idea behind that rule is very simple. In general, a person can be sued in the country where that person is based. In our case, that pointed us toward the Swedish home court because Electrolux is based in Stockholm. Host That sounds like a fairly ordinary jurisdiction rule. Answer Yes. And that was exactly what made it interesting. Article 4 is the general rule. The question was whether that rule could also be used for patent infringement claims covering several countries. Host Was that a common approach at the time? Answer No. Quite the opposite. Many people believed that cross-border patent litigation in Europe was effectively dead. Host That sounds rather dramatic. Why did people think that? Answer Because there was a widely held view that a central patent case could be stopped as soon as the defendant challenged the validity of the patent. As a result, many companies assumed they had no real choice but to litigate country by country. Host Yet you decided to look at the issue differently. Answer Yes. Sometimes it is worth taking a fresh look at accepted assumptions. We felt that Article 4 might play a much more important role than many people believed. Host So at that point, you already saw an opportunity, right? Answer Yes, we saw a possibility! Not a guarantee. But we believed there was a strong legal basis for bringing all claims before the Swedish home court. Host And that eventually led to the lawsuit being filed in Sweden, right? Answer Exactly. In 2020, we decided to file the action in Sweden. That followed our success before the European Patent Office in late 2018 and in the Düsseldorf infringement proceedings in 2019. At that stage, our objective was very practical. We were simply trying to find an efficient way to enforce rights that exist in many countries. Host At that point, you already think the case might end up before the European Court of Justice? Answer No. Not at all. We were focused on solving a business problem. The idea that the case would eventually reach the European Court of Justice came much later. BLOCK 4 – THE OBSTACLE: GAT v. LuK Host You mentioned that, er, many people believed cross-border patent litigation in Europe was no longer a realistic option. Why was that? Answer The main reason was an earlier decision of the European Court of Justice known as GAT versus LuK, decided in 2006. For many years, that decision was understood to mean that a home court could lose its ability to hear a patent infringement case as soon as the defendant challenged the validity of the patent. In practice, that understanding made many cross-border patent cases extremely difficult. As a result, many people believed that cross-border patent litigation was not effective. Host And yet you decided to follow exactly that path, right? Answer Yes. Sometimes it is worth questioning assumptions that have been accepted for many years. We believed that Article 4 of the Brussels Ia Regulation played a more important role than many people thought. That is why, in 2020, we decided to file the case in Sweden. Host And at that point, did you already realize that the case might eventually reach the European Court of Justice? Answer No. Not at all. Our goal was simply to find a practical solution to a real enforcement problem. The idea that this would eventually become a case before the European Court of Justice was far from our minds. BLOCK 5 – THE QUESTIONS REFERRED TO THE EUROPEAN COURT OF JUSTICE Host So, how did the case eventually reach the European Court of Justice then? Answer After we filed the lawsuit in Sweden in 2020, Electrolux challenged the validity of the patents. The Swedish home court then concluded that it could not hear the case and declared itself not competent to proceed. We appealed that decision, because the issues were important and affected far more than just our case. We suggested that several questions should be referred to the European Court of Justice. The Swedish Court of Appeal agreed and sent those questions to Luxembourg. Host So, what were these main questions? Answer At the heart of the case, there were three questions: First: if a home court has jurisdiction over a patent infringement case, does it lose that jurisdiction simply because the defendant argues that the patent is invalid? Second: Does it make a difference if the national legal system requires validity issues to be decided in a separate proceeding? And third: Do this jurisdiction rules also apply to patents from countries outside the European Union? Host The third question sounds particularly interesting. Answer Yes, at the time, the discussion in our case focused on Turkey. Today, many people immediately think about the United Kingdom, and some even think about US patents. But originally, the question was much simpler. We wanted to know, whether the same jurisdiction rules also apply when patents from non-European countries are involved. Host And, did you realize how important that third question might become? Answer No, certainly not to that extent. At the beginning, most of the discussion focused on the relationship between the different jurisdiction rules within Europe. Only later did it become clear that the European Court of Justice’s answers might have consequences far beyond the European Union. Host So, how did the European Court of Justice react then? Answer That was actually quite interesting. The European Court of Justice first heard the case before a Chamber of seven judges. Later, it referred the case to the Grand Chamber of 15 judges. That already showed that the European Court of Justice considered the issues to be important. And when the judgment finally came out, some of the answers were very different from what many observers had expected. BLOCK 6 – THE DECISION OF THE EUROPEAN COURT OF JUSTICE Host Let’s talk about the European Court of Justice’s answers. What was, in your view, the most important part of the decision? Answer The most important point was this: A home court does not automatically lose jurisdiction just because the defendant argues that the patent is invalid. For many years, many people believed exactly the opposite. The European Court of Justice made it clear that this understanding was too narrow. The home court where the defendant is based can generally continue to hear the infringement case. That is really the key message of the decision. Host Why is that so important? Answer Because it gives new momentum to cross-border patent enforcement in Europe. Before this decision, many people assumed that a defendant could effectively stop a central infringement case simply by challenging the validity of the patent. The European Court of Justice made clear that this is not automatically the case. Host Does that mean the home court hearing the infringement case will now also decide whether the patent is valid? Answer No, and that is a very important point. The European Court of Justice confirmed that questions about the validity of a European patent should still be decided by the national courts of the country for which the patent was granted, as provided for in Article 24(4) of the Brussels Ia Regulation. What is new, is that the infringement case does not automatically fall apart because of a validity challenge. The home court can keep control of the overall case. Host So, how does that work in practice? Answer The European Court of Justice gives the home court some flexibility. For patents from Member States of the European Union, the home court does not automatically lose its power if the defendant says the patent is invalid. The home court can look at the validity challenge. If it seems strong, the home court may stay the infringement case. If it seems weak, the home court may continue the infringement case. For patents from countries outside the European Union, the home court may also stay the case if there is already a validity case pending in that country. In such situations, Articles 33 and 34 of the Brussels Ia Regulation may apply. That creates a much more flexible system than many people expected. Host Er, we have discussed the implications for patents from Member States of the European Union, but a lot of attention has been given to another part of the decision, that we already talked about briefly, namely patents from countries outside the European Union. Answer Absolutely, and that may be the part of the judgment with the biggest international impact. Host Why? Answer Because the European Court of Justice decided that the special jurisdiction rule for patent validity does not generally apply to patents from non-European countries. In simple terms, that means the general rule can still apply. And that opens the possibility of bringing infringement cases based on non-European patents before the home court where the defendant is based in the European Union. Host That sounds like a very far-reaching statement. Answer It is. That is why many commentators started talking about what is often called “long-arm jurisdiction.” In other words, a European home court may, under certain circumstances, deal with infringement claims relating to patents from countries outside the European Union. Host So, many listeners may now wonder: Can a Swedish or a German home court really decide a dispute involving a British or Turkish patent? Answer Ah, we need to be careful here. The European Court of Justice did not say that a European home court can cancel or revoke a foreign patent. That remains a matter for the authorities and national courts of the country that granted the patent. What the European Court of Justice said is that a European home court may assess the claims between the parties in a dispute. That is an important distinction. Host Did you realize during the proceedings how important this part of the decision might become? Answer Not to this extent. We started with a very practical enforcement problem. Only later did it become clear that the European Court of Justice’s answers might have consequences far beyond the original case. Today, the decision is discussed not only in connection with Turkish patents, but also British patents and even possible claims involving US patents. Host If you had to summarize the decision in one sentence, and I know, this is a very difficult task, what would that sentence be? Answer The European Court of Justice did not re-invent cross-border patent enforcement in Europe. But after many years, it clearly gave it much more room to develop. BLOCK 7 – THE REACTION OF THE IP COMMUNITY Host So, how was the decision received after it was published? Answer Ah, the reaction was very strong. It quickly became clear that many people saw the decision as much more than just another patent case. Many articles and commentaries described it as an important development in European patent litigation. Host Did that surprise you? Answer To some extent, yes. Of course, we knew that the questions referred to the European Court of Justice were important. But I was surprised by how quickly the decision became a major topic of discussion across the European patent community. Host Er, you later presented the decision at several conferences yourself, right? Answer Yes. The discussion started right away. I had the opportunity to discuss and present the case at several conferences and events, including the annual VPP conference in Germany and the Ingolstadt Patent Symposium. I recently received an invitation to serve as a panel speaker on cross-border litigation at the AIPPI World Congress 2026 in Hamburg. What struck me most was that both internal and external IP counsel were trying to understand the practice consequences of the decision. Host So, what was the question you were asked most often? Answer Almost always the same one: How far does this decision really go? People wanted to know whether this was simply a correction of earlier case law or whether it marked the beginning of a new phase in cross-border patent enforcement. Host And what did you say? Answer I would describe it as: neither a revolution nor a minor adjustment. The European Court of Justice did not rewrite the system. But it clearly changed the balance between the different jurisdiction rules. That is why I believe the decision will continue to be discussed for many years, both in practice and in academia. Host Er, one year later, the case received the Managing IP Award as the “Europe Impact Case of the Year.” What did that recognition mean to you? Answer First of all, it was a great honor for everyone involved. But for me, the most important thing was the message behind the award. The award showed that the decision affects much more than the parties involved in the case. It has an impact on European patent practice as a whole. And it also shows that the underlying jurisdiction questions reach far beyond patent law. They are relevant whenever companies have to enforce rights across borders in an increasing international world. That is what makes this case special. Host You often describe this case as a team effort. Answer Absolutely. A case of this size is never the work of one person. Many people contributed over many years. On the BSH side, team members from different functions played an important role throughout the proceedings. And we worked closely with external advisors in several countries. So I see the award as recognition of a shared achievement rather than an individual success. Host Looking at the discussions today, would you say the debate is over? Answer Not at all. I actually think we are only at the beginning. There are still many practical questions that home courts will have to answer in the coming years. That is exactly why the decision remains so interesting. BLOCK 8 – WHAT DOES THE DECISION MEAN IN PRACTICE? Host Let’s move from legal theory to practical business implications. What does this decision mean for patent owners and companies? Answer In my view, the biggest change is strategic. Patent owners now have better opportunities to bring cross-border disputes together in one central proceeding. At the same time, companies need to be aware that they may face claims at their European headquarters covering activities in several countries. So the decision creates opportunities, but it also creates new risks. Host That sounds really like a significant shift; right? Answer I would call it a rebalancing rather than a revolution. The European Court of Justice did not create a completely new system. But it made clear that the general rule — suing a defendant where it is based — plays a much bigger role than many people had assumed. As a result, the court at the defendant’s home base becomes much more important strategically. Host In the patent community, people often talk about cases such as Fujifilm v. Kodak, or Regeneron v. Formycon or Onesta v. BMW. Why are those cases attracting so much attention now? Answer Because they show how quickly practice is already adapting to the new possibilities. Fujifilm was important because it was one of the first UPC cases to test the logic that was later confirmed in BSH. At that time, the BSH case was already pending before the European Court of Justice, and the Advocate General had expressed a view that pointed in that direction. Against that background, the Düsseldorf Local Division accepted jurisdiction over the UK part of a European patent even before the European Court of Justice delivered its judgment. In June 2026, based on the principles confirmed in BSH, the UPC Court of Appeal further developed that approach. Host And what happened in Regeneron v. Formycon ? Answer In the Regeneron case, the Munich home court applied the approach confirmed in BSH and granted a Europe-wide injunction based on a European patent. That was one of the first examples of a national home court using the BSH framework in practice. That demonstrates that the decision is not just an academic discussion. It already has practical consequences. Host And what about the Onesta case? Answer The Onesta case shows that the debate has moved beyond Europe. After Onesta attempted to assert two U.S. patents before the Munich home court, BMW obtained an anti-suit injunction from a Texas federal court. Judge Albright took the view that U.S. patents should generally be decided by U.S. courts. The Onesta case therefore illustrates that the limits of the BSH logic are now being tested internationally. Host Did that end the proceedings in Munich? Answer Not necessarily. What makes the case interesting is that the Texas injunction was directed against Onesta, not against the Munich home court. At the same time, Onesta appealed Judge Albright’s decision in the United States. The Munich home court therefore decided to stay the case for the time being. Importantly, however, the Munich home court did not reject its own jurisdiction. So, at least for the moment, the underlying question remains open. Host Can a European home court ultimately decide infringement claims based on U.S. patents? Answer That question has not yet been answered. But the case has already shown that such an attempt can trigger strong reactions outside Europe. In that sense, the debate has moved from a European jurisdiction question to an international jurisdiction conflict. Host For our audience of internal and external IP counsel, what are the main lessons from this decision? Answer For me, there are three key takeaways. First: Patent enforcement has become more international. National litigation remains important, but companies should think across borders from the very beginning. Second: The choice of forum is becoming more important. Where you bring a case may be just as important as the legal arguments themselves. And third: Long-term commitment matters. This case shows that major developments rarely happen because of a single filing or a single hearing. They usually result from pursuing a clear strategy consistently over many years. Host Do you think this decision will also influence the Unified Patent Court, the UPC? Answer Yes, I believe so. The decision fits into a broader trend toward more centralized patent litigation. Both, the UPC and the BSH decision are driven by the same idea: Handling cross-border disputes more efficiently and more consistently. What is interesting is that many of the questions were faced in BSH versus Electrolux are now reappearing in a new form before the UPC. Cases like Fujifilm versus Kodak show that the discussion about jurisdiction, scope, and cross-border effects is far from over. Institutions may be new. But the underlying challenge remains the same: How do we enforce patents effectively across borders? Host Some commentators even see this as a step toward a more independent European patent judiciary. Do you agree? Answer To some extent, yes. Professor Hanns Ullrich, who supervised my doctoral studies on the legal protection of a then new semiconductor technology many years ago, recently observed that the UPC is gradually developing its own European case law.[DH1] I think that is — again — a very accurate observation. If you look at the developments since BSH and the first UPC decisions, you can see that European patent litigation is becoming more connected. National courts will remain important. But at the same time, we are seeing a more integrated European patent system taking shape. How far that development will go remains to be seen. Host Looking back on the entire journey — from a vacuum cleaner patent, through litigation in several countries, all the way to the European Court of Justice and an award-winning decision — what is your personal conclusion? Answer My main conclusion is that innovation needs effective legal protection. But it also requires the willingness to challenge established assumptions and explore new approaches. For me, the BSH versus Electrolux case shows that persistence, teamwork, a willingness to challenge accepted assumptions, and a long-term strategic view can sometimes lead to developments that go far beyond the original dispute. BLOCK 9 – THE PERSON BEHIND THE DECISION Host Ernst-Peter, today we have talked a lot about jurisdiction, patent enforcement, and European case law. When you look back at this journey, which has lasted almost twenty years, what impressed you most? Answer Probably the realization that major developments rarely follow a straight line. When we started thinking about the case, we were dealing with a very practical problem. Nobody said: Let’s create a landmark decision of the European Court of Justice. We were simply looking for a reasonable and practical solution for a company. The fact that this would eventually lead to a decision with Europe-wide impact was something nobody could foresee at the time. Host Were there moments when you thought the case might fail? Answer Of course. Whenever a case lasts many years, there will be setbacks, new questions, and unexpected developments. That is exactly why persistence is so important. In the end, success is often not about one filing or one hearing. It is about staying focused on a clear objective over a long period of time. Host You often talk about teamwork. Is that one of the main lessons from this case? Answer Absolutely. A case of this size requires commitment from many people and institutes over many years. On the BSH side, my role was to help maintain the strategic direction and long-term commitment that such a case requires. At the same time, experts from different functions within BSH contributed technical expertise, testing, documentation, and practical support throughout the proceedings. On the legal side, Roman Sedlmaier and his team at IP-Counsels Gigerich & Sedlmaier (IPCGS) helped develop the cross-border litigation strategy and the overall case architecture. Our Swedish litigation team then carried the arguments through all stages of the proceedings. Looking back, it was the combination of institutional commitment, technical expertise, strategic leadership, well-designed case architecture, and consistent execution that made the difference. Host One final question. What advice would you give to young internal or external IP counsel? Answer Stay curious: Don’t be afraid to question accepted assumptions. Be patient: Intellectual property is usually a marathon, not a sprint. And never forget that every patent dispute involves an invention, a business, and many people who have worked hard to bring that innovation to market. For me, that connection between technology, law, and strategy is what still makes this profession so fascinating today. Host Ernst-Peter, thank you very much for joining us today on IP Fridays. Answer Thank you. It was a pleasure to be here.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of events that underscore the dynamic nature of these industries, characterized by scientific advancements, strategic partnerships, and regulatory milestones. Johnson & Johnson has made headlines with its substantial $785 million upfront payment to Sail BioMed for an in vivo CAR-T cell therapy deal. This agreement includes an option for Johnson & Johnson to acquire Sail BioMed for $2.58 billion, underscoring the sustained interest in cell therapies, particularly for autoimmune diseases. In vivo CAR-T therapies represent a significant leap forward by modifying T cells directly within the patient's body. This method offers potential advantages over traditional ex vivo techniques by simplifying the manufacturing process and potentially reducing both costs and time to treatment. Such transactions highlight Johnson & Johnson's commitment to expanding its cell therapy portfolio, which could significantly enhance patient care by making advanced treatments more accessible. Eli Lilly and Resilience have announced a significant $750 million investment aimed at boosting the production of diabetes and obesity medications in the United States. This move comes as a response to the global rise in these conditions, necessitating increased production capacities to meet growing demand. The focus on injectable drug devices emphasizes efforts to improve drug delivery systems, ultimately enhancing patient compliance and therapeutic outcomes. Sanofi's financial outlook for 2026 is promising, driven by robust sales of Dupixent, which exceeded €5 billion in quarterly sales. Dupixent, a monoclonal antibody used for treating atopic dermatitis and other autoimmune conditions, has been a significant revenue driver for Sanofi. The success of Dupixent reflects its effectiveness and strong market adoption, highlighting the potential of monoclonal antibodies as cornerstones of modern pharmacotherapy, particularly for chronic inflammatory diseases. Regeneron and Sanofi's Dupixent continues performing strongly with $6 billion in sales during Q2 2026—marking its largest quarterly revenue since the pandemic began—illustrating robust demand across various indications within both companies' portfolios. On the regulatory front, Alfasigma's Linerixibat (Lynavoy) has received a positive opinion from the CHMP for treating cholestatic pruritus in primary biliary cholangitis following successful Phase 3 trials. As an IBAT inhibitor targeting bile acid metabolism pathways, Lynavoy introduces a novel therapeutic approach for managing symptoms associated with this autoimmune liver disease. Meanwhile, ImmunityBio's Anktiva has gained marketing authorization in the UAE for non-muscle invasive bladder cancer and metastatic non-small cell lung cancer. Anktiva, an IL-15 cytokine-based protein therapy, exemplifies the growing interest in harnessing immune system modulators for cancer treatment. Takeda's recent decision to discontinue its nanoparticle therapy (TAK-101) for celiac disease highlights the inherent challenges in developing new therapies for autoimmune disorders. The disappointing Phase 2 results suggest that achieving immune tolerance to dietary gluten remains a significant scientific hurdle. From a strategic perspective, Sanofi's CEO has emphasized stricter go/no-go decisions during Phase 3 clinical trials amid pipeline cuts and significant impairment losses. This approach could lead to more efficient resource allocation and potentially higher success rates for late-stage drug candidates. The industry is witnessing significant transformations through strategic shifts driven by executives like Sanofi's new CEO Belen Garijo. Her vision includes reversing recent challenges faced by Sanofi by capitalizing on its strengths while addressing setbacks such as discontinuing certain late-stage clinical programs like the joint venture with Regeneron on the IL-33 candidate itepekimab. This strategic pivot mirrors broader industry trends toward optimizing late-stage pipelines to enhance competitive positioning and drive future growth. Advancements in AI-powered drug discovery continue gaining momentum through collaborations like those between GSK and Relation Therapeutics, alongside Causaly and Sage. These partnerships aim to leverage AI and machine learning technologies to accelerate drug discovery processes by integrating vast amounts of scientific literature into data analytics platforms. GlaxoSmithKline's $110 million deal with an AI biotech firm further signals increased integration between artificial intelligence technologies and pharmaceutical research efforts aimed at enhancing dataset quality thereby accelerating innovation throughout drug discovery processes. Bristol Myers Squibb faces further delays regarding its Alzheimer's psychosis treatment Cobenfy—a postponement reflecting ongoing complexities related to neurological drug development which requires overcoming high scientific hurdles alongside regulatory scrutiny. Alnylam Pharmaceuticals recently experienced a 29% drop in stock value following disappointing sales of Amvuttra and a downward revision of its ATTR franchise outlook for 2026. Such fluctuations highlight volatility within biotech investments when market expectations are not met. These collective developments reveal significant trends shaping today's pharmaceutical landscape: strategic pipeline optimization efforts alongside robust investment initiatives targeting high-demand therapeutic areas—all while leveraging technological advancements like AI integration aimed at improving R&D efficiency ultimately impacting patient care worldwide through innovative therapies addressing unmet medical needs globally.Support the show

Join Dr. Kal Patel, CEO and Co-Founder of BrightInsight, for an illuminating masterclass on navigating product-market fit (PMF) inside one of the most complex, highly regulated sectors in global business: healthcare. Every year, life science giants invest billions of dollars developing breakthrough biopharmaceutical therapies, yet nearly 50% of patients with chronic diseases drop off their prescribed medication regimes within the first twelve months. Drawing from his rare vantage point as a physician, former BCG strategist, former head of Amgen's Digital Health unit, and leader of BrightInsight, Dr. Patel breaks down why traditional "direct-to-consumer" wellness apps repeatedly fail, how to build enterprise software that biopharma giants trust to touch regulated therapies.

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Aris Baras, M.D., SVP, Head of Regeneron Genetics Center (RGC) and Co-Head of Regeneron Genetic Medicines, talks about using large-scale human genetics to find better drug targets based on "superhuman" variants. Aris explains how multi-omics, linked health records, and AI are helping developers move faster in the clinic and reduce the odds of failure, while also pushing biotech toward earlier disease prediction and more preventive care. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.  Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

In this episode, hosts Sameer Berry, MD, and William Chey, MD, speak with Sarah Enslin, PA-C, Vivek Kaul, MD, and Amy Stewart, CRNP, about the benefits of introducing advanced practice providers in practice and how to help them succeed. ·       How can advanced practice providers, or APPs, help overcome access barriers in gastroenterology? 6:54 ·       How can we effectively onboard APPs? 10:24 ·       Is ACG's APP Academy for Clinical Excellence accounting for the fact that different specialties and practices have different requirements? 18:21 ·       What models have worked well for deploying APPs into GI practices? 24:32 ·       What strategies are most effective for APP retention? 29:07 ·       How can we improve professional development for APPs? 42:14 We'd love to hear from you! Send your comments/questions to guttalkpodcast@healio.com. Follow us on X @HealioGastro, @sameerkberry and @umfoodoc.  Berry and Chey report no financial disclosures. Stewart reports financial relationships with AbbVie, Ardelyx, Celltrion, Cristcot, Eli Lilly & Co, Exact Sciences, Genentech, Johnson & Johnson, Merck, Mindset Health (Nerva), Nestle Health Science, Pfizer, Phathom Pharmaceuticals, Prometheus Laboratories, Regeneron, Salix Pharmaceuticals, Sanofi and Takeda Pharmaceuticals. Healio could not confirm relevant financial disclosures for Enslin and Kaul at the time of publication.

Co-hosts Ryan Piansky, a patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Science Advisory Council, interview Dr. Claire Beveridge about EoE and dysphagia. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, research on eosinophilic esophagitis (EoE) and dysphagia.   [1:24] Holly introduces and welcomes today's guest, Dr. Claire Beveridge, a gastroenterologist at the Cleveland Clinic. Dr. Beveridge heads the EoE Adult Clinic and the Transition from Pediatric to Adult EoE Clinic.   [1:36] Holly, a speech pathologist, says she is very excited to dive into the research Dr. Beveridge did with EoE and dysphagia. Holly asks Dr. Beveridge to share some of her background.   [1:48] Dr. Beveridge was recruited to the Cleveland Clinic about five years ago to head the EoE Center. She loves the work they have done there.   [1:57] Dr. Beveridge says it's been nice to center everything on their EoE patients and have multidisciplinary care with speech-language pathologists, allergists, dietitians, pulmonologists, and more. It's been a great experience.   [2:15] Dr. Beveridge says the other thing they are really proud of is having a Transition Clinic. It can be tough for patients to transition from pediatric to adult care.   [2:23] Dr. Beveridge says this is something she was inspired to do when she was finishing her training at the University of Pennsylvania, where they had been doing some of that. It was really important to her when she joined Cleveland Clinic.   [2:34] Dr. Beveridge, with her Co-director, Dr. Sophia Patel, helps patients transition from pediatric to adult care.   [2:41] Holly speaks of the challenge of transitioning from pediatric care at a multidisciplinary clinic to adult care.   [3:08] Dr. Beveridge says you can't do any training at Northwestern without loving the esophagus. She did her residency there, got exposed to esophagology, and got to know Dr. Gonsalves and Dr. Hirano really well.   [3:33] Drs. Gonsalves and Hirano are really big names in EoE. Dr. Beveridge was fascinated by the disease. She loved the patients and wanted to help them and make them feel better. It's a burgeoning field.   [3:48] Dr. Beveridge says that it's only in the last few years that we have had FDA-approved medications for it, and that we have been jerry-rigging asthma medications to treat our patients.   [4:03] Dr. Beveridge says it's really exciting to see the treatment options we can offer.   [4:10] Ryan says it's exciting to see how EoE management has changed.   [4:16] Ryan says we see so many patients who are untreated or poorly treated for years, who have restructuring of their esophagus and present with dysphagia, or have strictures and rings leading to food impactions; the long-term effects of untreated EoE.   [4:34] Ryan says it's exciting that now we do have better treatment options for people, right off the bat.   [4:43] Dr. Beveridge conducted some research on EoE and dysphagia and presented a poster at the 2024 Digestive Diseases Week.   [4:51] The poster was titled, "Esophageal Luminal Diameter is Associated with Dysphagia and Eosinophilic Esophagitis: Implications for Endoscopic Dilation Therapy."   [5:11] Dr. Beveridge says dysphagia means issues with swallowing. It's a feeling of something getting stuck or something slowly moving down. There are also subtle symptoms that can happen.   [5:31] Dr. Beveridge says patients who have had EoE for a long time become accustomed to how they swallow. Things a patient may think are normal, like needing water and taking a sip after each bite, are learned accommodating behaviors.   [5:58] Dr. Beveridge says accommodating behaviors are that you're needing to imbibe extra water, you're modifying how you're eating, extra chewing, avoiding pills, avoiding other certain foods, and things like that that can be modifying factors.   [6:19] So, difficulty with swallowing, things getting stuck, slowly moving down, but also keeping in mind some of those modifying behaviors that we may end up using.   [7:23] Dr. Beveridge says her motivation was seeing patients in her clinic who were having persistent symptoms, and getting them into histological remission. The goal of treating your EoE is to get the eosinophils less than 15; close to zero is great.   [7:45] Dr. Beveridge says we have patients who, despite doing their endoscopies and taking biopsies, things look fine; they're still having issues with swallowing. Why is that the case?   [7:58] Dr. Beveridge says in a different research paper she had done, looking at some of the predictors for that, one of them was fibrostenosis. There are also other things that can contribute, like esophageal hypervigilance and a fear of swallowing.   [8:21] If a patient has had a food impaction, it's going to be scary to try to swallow again. Some of it is behavioral, but some of it is structural. At what luminal diameter (the size of the esophagus) is that causing a clinical problem for patients?   [8:45] A normal esophagus is 20 to 24 mm in diameter. Traditionally, around 14 to 16 mm in diameter has been when we say that patients get symptoms or they're feeling the issues with swallowing.   [9:03] Dr. Beveridge says a lot of those studies have never been done specifically for EoE patients.   [9:08] Dr. Beveridge wanted to know, if we exclude cancer, if we exclude acid reflux, and all of these other things, and just look at our EoE patients, what size of the esophagus are we looking at?   [9:20] Dr. Beveridge explained they specifically looked at patients whose histology was under control and then compared those who continued to experience symptoms with those who did not. The goal was to determine the histologic threshold at which patients begin to experience dysphagia.    [9:54] Dr. Beveridge says they saw this threshold at 16 mm (1.6 cm). That's still quite the difference from a normal esophagus of 20 to 24.   [10:08] Dr. Beveridge says our esophagus can definitely handle being smaller, but then, once you get to that 16 mm, for a lot of patients, it really does cause that feeling of things getting stuck or slowly moving down.   [10:20] Holly says what's cool about the retrospective data Dr. Beveridge looked at, and the parameters she placed in the research, is that when a patient goes in for an endoscopy, the doctor can measure and say maybe this is why dysphagia is going on.   [10:48] Holly finds that adult patients with food impactions are scared to eat the same food again. She loves having this data to share with patients and say, let's look at what your esophagus measures at. Let's do a smaller bite. Let's add a dip and liquid.   [11:12] Holly says data can push so much progress. Holly, having multiple chronic illnesses, loves when doctors can say, this is going to be safe. This is the mode that we're going to go with.   [11:30] Dr. Beveridge says in the retrospective study, they were looking at stuff that had already been done. We decided from here to assess patients more prospectively. All of this was based on chart review from when the note said symptoms or no symptoms.   [11:53] Dr. Beveridge says when she started this EoE clinic at the Cleveland Clinic, part of it was to standardize better how we were collecting data from patients to understand their symptoms.   [12:07] Dr. Beveridge has a standardized questionnaire for patients to understand if they are having heartburn and difficulty with swallowing, so she can know that at each point of their endoscopy.   [12:18] Dr. Beveridge says it will be nice, hopefully in the future, when she can give a little more detail and depth in terms of assessing this more prospectively and seeing if that same number holds up or if she needs to tweak it a little bit.   [12:34] Holly thinks it's fascinating. Numbers give us so much information, to know if my mm is this versus this, the next time, or during allergy season or not.   [12:53] Ryan says it's cool that you're able to look back at existing patient records and identify this information. Now we have that 16 mm number in mind to say maybe this is where we'll start to see increased risk of dysphagia in these patients.   [13:28] Dr. Beveridge says, how we had to do it retrospectively was based on the endoscopist estimating what the size is. Gastroenterologists recognize they're not always the best at estimating the size of the esophagus.   [13:50] Dr. Beveridge says, if your endoscope could not pass through, or it was snugly passing through, you know the diameter of the endoscope. If a dilation was done, at what size dilation do we start to see a disruption?   [14:19] Dr. Beveridge says, the goal of a dilation is to get a disruption because there's scar tissue we want to break open. A patient might think disruption means a perforation or something more scary, but that is the goal. We want to break open that scar tissue.   [14:42] Dr. Beveridge says, once we see that scar tissue break open a little bit, then we can estimate what the diameter is, based on the size dilator we used.   [15:10] Dr. Beveridge says for adults, we use a standard adult upper endoscope, and that's about 13 mm. The ones we use for kids are about 6 mm.   [15:35] Dr. Beveridge says the adult endoscope is around 13 mm, and it's around 14 to 16 mm when we start to see the symptoms.   [16:07] Dr. Beveridge says there are two main types of dilation that we do. One is the Savary dilator or wire-guided dilator, a long dilator that stretches the entire esophagus, from the mouth down to the stomach.   [17:20] Dr. Beveridge says another way of doing it is while you have the endoscope in, you thread a catheter. At the end of the endoscope, there's a balloon. You fill the balloon with saline up to different sizes. Typically, they go up by 3 mm, so 12 to 15 mm.   [18:01] Dr. Beveridge says the catheter balloon dilator is good for discrete strictures because the balloon isn't going to do the entire esophagus; it's just going to do one area of the esophagus, and you're watching it the whole time.   [18:19] For the wire dilator, you remove the scope. You're not able to see, so it's important to assess ahead of time how narrow things are, so you start at a safe dilation. You go in each time to see if there's starting to be disruption, and then you can do more.   [18:44] Holly asks if a gastroenterologist doing an upper endoscopy with sedation sees that it's tight, would the gastroenterologist automatically do a dilation? Or, can a patient with dysphagia symptoms request to have a dilation?   [19:28] Dr. Beveridge says, right before an endoscopy, she discusses it with the patient and gets consent. She asks, even if their symptoms are good, but in the endoscopy she sees a narrowing where she would recommend a dilation, if they're OK with that.   [20:05] Dr. Beveridge says, if they're having issues with swallowing, often she will ask if they're OK with her doing a dilation. If she sees a narrowing, she can focus on that area and dilate it.   [20:19] Dr. Beveridge says not everywhere in the esophagus can we see as well. The very beginning of the esophagus is challenging to see and challenging to evaluate on imaging.   [20:32] Dr. Beveridge talks about empiric dilation. You don't see a narrowing, but you want to rule it out, so you do a dilation at a safe size, like 16 or 18 mm, to make sure you're not missing something up high.   [20:58] Dr. Beveridge says she always talks about that with her patients. Most say, go ahead. Some patients definitely want dilation; other patients say no, they really don't.   [21:12] Dr. Beveridge then asks the patient if there's real narrowing that may cause a food impaction, would they want dilation then, or hold off for another day?   [21:30] Dr. Beveridge never wants to do something the patient is not comfortable with. She also doesn't want them to need another endoscopy unnecessarily, if she can avoid that for them in the moment.   [21:46] Dr. Beveridge mentions the BougieCap used in Europe. It's a cap you put at the end of the endoscope. You use your endoscope as the dilator. You watch the whole time. It is hard plastic that causes a nice dilation. We may see it come to the U.S.   [22:37] Dr. Beveridge speaks of the FLIP catheter, which is a catheter with a balloon that doesn't cause dilation but distends and helps measure the diameter.   [23:33] Holly asks if Dr. Beveridge gives tips to patients on how to prepare for dilation and the recovery process.   [23:49] Dr. Beveridge had an upper endoscopy. She says there's nothing like experience to understand it better. She didn't have a dilation, but the biopsies caused discomfort.    [24:21] Dr. Beveridge says a lot of her patients have been through upper endoscopies, so they know how it feels. She warns them that the biopsies and dilation can cause discomfort.   [24:33] What's challenging is that everyone is different. Some patients are going to be more hypersensitive to it, and other patients are going to say they felt nothing and they were fine.   [24:46] Dr. Beveridge says some patients need to modify their diet for a few days to avoid significant chest pain. You never want someone to have to go to the ER for significant chest pain when it will just heal over time, and there's no perforation.   [25:12] Dr. Beveridge says other patients will be like her, eating chips and pretzels and saying they're fine. Dr. Beveridge typically has them start with liquids, nothing too hot or too cold, and advance as tolerated.   [25:28] Dr. Beveridge says patients can always use TylenolⓇ and over-the-counter numbing agents. You'll still have patients who will get significant discomfort. For the most part, starting with liquids has worked for Dr. Beveridge's patients.   [25:44] Holly recommends over-the-counter when her patients call, after she talks to their GI. Holly says after she has an endoscopy, she starts on liquids and shakes. On day three, she's fine. Holly says individualized care is amazing. We all are different.   [26:14] In the pediatric setting, the parents get the counseling, and they have not had sedation, but on the adult side, you're talking with the patient, who had sedation. Sometimes they don't remember.   [26:40] Dr. Beveridge says when possible, she waits for family members to come back and tells them they're going to have to "be the memory" because the patient probably won't remember this conversation.   [26:55] If a patient says no, they don't want them to come back and hear about it, always respect that. But Dr. Beveridge always tells them, you may not remember what we say.   [27:30] Ryan asks about data on how many times someone may need dilations. Dr. Beveridge says it comes down to the patient, but the biggest issue can be uncontrolled inflammation.   [27:44] Dr. Beveridge says if a patient's EoE is not controlled, inflammation leads to continued scarring down. That's why we talk about dilation as being an adjunctive measure, but not a treatment for EoE. It doesn't do anything for the inflammation.   [28:03] Dr. Beveridge says she has patients who ask why she can't just do a dilation every now and then. Dr. Beveridge considers dilation to be safe when needed, but if you can avoid it, that would be nicer for everyone.   [28:21] Dr. Beveridge says there's no great data on whether you only need one, or whether you're going to need 10, but one big theme is just: have we gotten your inflammation under control? That's also true for other conditions, such as acid reflux.   [28:45] Holly wasn't diagnosed until she was in her mid-twenties, and she had several upper endoscopies as a teenager and college student to dilate her, to help the situation.   [29:17] Holly says she had to get more endoscopies to figure out her weird food triggers that are not typical for everybody, so even if she's treated, she still has inflammation. That's why she had so many upper endoscopies.   [29:30] Ryan talks about underlying issues causing inflammation. Dilation is not treating those underlying causes. It's just helping with one symptom of this dysphagia, by expanding the esophagus.   [29:50] Ryan asks, What changes in symptoms should patients expect after the dilation? Dr. Beveridge says, ideally, if there's been a stricture, you're going to start to feel like your swallowing is better. You can get pills and food down better.   [30:07] Dr. Beveridge says, immediately post-dilation, sometimes people feel a little bit worse. Everything you swallow may be uncomfortable for you. But if it's been a successful dilation, hopefully, you're going to feel that things are going down better.   [30:40] Holly says she is so grateful that Dr. Beveridge looked into this, and hopefully, there will be a new protocol in the future. Holly asks what other key takeaways from this research may interest Dr. Beveridge in researching something further.   [31:02] Dr. Beveridge says, making sure that we're not missing scar tissue is big and important. One thing that we're trying to look at with our Pediatric GI colleagues is what threshold we should be looking at for the pediatric patient population.   [31:19] Dr. Beveridge says a pediatric patient's esophagus is a different size than an adult patient's. Understandably, we are more cautious when doing a dilation in the pediatric patient population than we are with adults.   [31:34] Dr. Beveridge may recommend empiric dilation for an adult but will feel more cautious about that with pediatric patients than with adult patients. Understanding what that threshold should be for the pediatrics is going to be really interesting.   [31:57] Dr. Beveridge says the diameter threshold we discussed is going to be important to know about, but everyone is different. You may have a diameter of 14 mm, you feel fine, and you don't want a dilation; you can accommodate OK. That's reasonable.   [32:15] Dr. Beveridge says she has had patients who get up to 18 mm, and that helps them, but they need a little bit more. If someone needs more of a dilation, we do that. Yes, have a threshold to assess, but always assess for what's personal for your patient.   [33:04] Dr. Beveridge says not just to assess the luminal diameter, but a thing that is helpful for gastroenterologists to know will be if there are other factors at play. As in her study of dysphagia predictors, anxiety, depression, and hypervigilance can play roles.   [33:37] Dr. Beveridge has patients who have to have a critical narrowing for them to finally feel an issue. Other patients, if they have the slightest of narrowing, are feeling something. Some patients are just more vigilant of what's happening in their esophagus.   [34:07] Dr. Beveridge says there's definitely a role for asking if your anxiety is under control. If there's feedback in the nerves, should we ask your GI Psychologist to be involved in terms of CBT for your esophagus? Take a look at everything.   [34:27] Dr. Beveridge says another part of the study they looked at was: are there different thresholds of eosinophils that we should be looking at? Is it just less than 15, or do some patients need it to be lower? Less than six? Less than 10?   [34:43] Dr. Beveridge says look at it as a whole for your patient.   [34:53] Dr. Beveridge says next, she will be working on a very long-term project: Can we identify a non-invasive method of screening a patient, diagnosing a patient for EoE, or monitoring a response to therapy?   [35:13] Dr. Beveridge has looked at transnasal endoscopy, which is put into this category of minimally invasive. It's still invasive; you're putting a scope through someone's nose, but it doesn't require sedation, which is a nice thing for some patients.   [35:29] There's the EnteroTrack, which started in Colorado. A patient swallows a string, and it stays in their esophagus for an hour, and we look at the proteins to see if things are active or not active.   [35:45] Dr. Beveridge is also looking at the breath metabolome. If we breathe into a bag and take a look at all the volatile organic compounds that are in our breath, can we find a signature related to EoE?   [36:01] It's assessing about 100 different compounds, not looking at one in particular, but how the whole thing looks. What signature is there, based on looking at all the compounds?   [36:15] Dr. Beveridge presented some of that data at DDW and has a grant from the ACG to look at this and assess patients with and without EoE.   [36:33] Dr. Beveridge says further, doing longitudinal data of looking at patients once they've gotten into remission on treatment and seeing, do we then see a signature change?   [36:47] Dr. Beveridge says no one is under any illusion that endoscopies are going away. They will always be part of what we do in gastroenterology, but there are limitations: sedation, a full day away from work, nothing by mouth, and a driver, etc.   [37:04] If there are alternatives to help supplement that, it would be nice. One of the barriers for patients doing diet elimination is the number of endoscopies that are required. If there's a way to assess by breath if a food is a trigger, that would be good.   [37:32] Dr. Beveridge says that's the big thing she's looking at, but it will take years. It's not going to be a quick, easy one, but it's very interesting to take a look at.   [37:45] Holly speaks of how much treatment has changed since she was diagnosed. She has done all the scopes. She says this sounds amazing. She loves that people like Dr. Beveridge are thinking of how to make testing less invasive and more comfortable.   [38:12] Dr. Beveridge says another thing she is excited about is the transition of care. She recently did a survey and is analyzing the data to assess what the barrier is from the physician perspective in terms of helping our patients transition.   [38:40] Dr. Beveridge is also looking at doing a nice multi-center consensus to help this as well, led by Dr. Sophia Patel and Dr. Emily McGowan, who are fantastic in the EoE world, looking to see how we can make this better for our patients.   [38:58] Ryan says, with so much interesting work coming up, we'll have to have you back to chat about some of these additional projects. Everyone is super interested in less invasive stuff and better treatment pathways. Transition of care is an important part of that.   [39:11] Ryan appreciates Dr. Beveridge for joining the conversation and hopes to have her back on another episode so we can learn more about EoE and these different future research endeavors.   [39:20] For our listeners who would like to learn more about EoE today, you can visit apfed.org/EoE and check out the links in the show notes below. [39:27] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder, available at apfed.org/specialist.   [39:36] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [39:46] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experience, please check out apfed.org/shareyourstory.   [39:55] Ryan thanks Dr. Beveridge for joining us. This was a fun conversation and really insightful. Holly thanks APFED's Education Partners AstraZeneca, GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.orgapfed.org/specialist apfed.org/connections Claire Beveridge, MD Cleveland Clinic Education Partners: This episode of APFED's podcast is brought to you thanks to the support of AstraZeneca, GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I have loved the work that we've done [at the Cleveland Clinic]. It's been really nice to center everything on our EoE patients and have nice multidisciplinary care with speech-language pathologists, allergists, dietitians, pulmonologists, and everyone." — Claire Beveridge, MD   "It's a little crazy to think that it's only in the last few years that we have had FDA-approved medications for [EoE], and that we have been jerry-rigging asthma medications to treat our patients." — Claire Beveridge, MD   "On the whole, dysphagia means issues with swallowing. … It's a feeling of something getting stuck or something slowly moving down. There are also subtle symptoms that can happen." — Claire Beveridge, MD   "The goal of a dilation is to get a disruption because there's scar tissue we want to break open." — Claire Beveridge, MD   "I am looking at the breath metabolome. If we breathe into a bag and take a look at all the volatile organic compounds that are in our breath, can we find a signature related to EoE?" — Claire Beveridge, MD   Guest Bio: Claire Beveridge, MD, is a Staff Member in the Department of Gastroenterology and Hepatology and heads the Eosinophilic Esophagitis (EoE) adult clinic as well as the transition pediatric to adult EoE clinic. Dr. Beveridge's specialty interests include: EoE, Achalasia, Barrett's esophagus, GERD, esophageal swallowing disorders, and esophageal motility disorders.

For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/learn/course/recent-research-into-biologics-in-asthma-10830Program DescriptionThis podcast activity provides an in-depth review of several recent trials in severe asthma management, highlighting the ongoing shift in asthma precision medicine towards identifying the right patients for the right treatments. Clinicians will examine clinical data from the NIMBLE trial (depemokimab), alongside the WAYFINDER trial (tezepelumab), as well ZEPHYR 5 (benralizumab), REMOMEPO (mepolizumab), VESTIGE (dupilumab) and VALLIANT (verekitug). This activity will grant clinicians critical insights to move beyond simple exacerbation reduction and precisely align advanced biologic therapies with the underlying cellular biology driving each patient's symptoms.Educational ObjectiveAt the conclusion of this activity, participants should be better able to:Review recent updates in the asthma literature, including recent guideline revisions and evolving clinical trial data for newer biologic therapies.Accredited ProvidersThe National Association for Continuing Education in partnership with the Association for Pulmonary Advanced Practice Providers (APAPP).The National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.25 Physicians should claim only the credit commensurate with the extent of their participation in the activity. The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.25 contact hours (which includes 0.25 hours of pharmacology).FacultyCedric Rutland, BS, MD, FCCPVolunteer FacultyUniversity of CaliforniaPulmonary Critical Care Internal Medicine, ProducerRutland Medical GroupNewport Critical Care PhysiciansLake Forest, CADr. Rutland has disclosed the following financial relationships:Consultant: Sanofi (asthma, diabetes, NP, RSV, AD), Boehringer Ingelheim (IPF, PPF), Regeneron (asthma, diabetes, NP, RSV, AD), Chiesi (asthma), Baxter (bronchiectasis), Insmed (bronchiectasis), AstraZeneca (asthma, cough)Advisor/Advisory Board: Sanofi (asthma, AD, NP), Regeneron (asthma, AD), Chiesi (asthma), Boehringer Ingelheim (IPF, PPF), AstraZeneca (asthma, cough)Speaker: Sanofi (asthma, NP, AD, AFRS, urticaria, EoE), Regeneron (asthma, NP, AD, AFRS, urticaria, EoE), Boehringer Ingelheim (IPF, PPF), AstraZeneca (asthma, cough), Chiesi (asthma), Baxter (bronchiectasis)These relationships have ended within last 24 months:Consultant: GSK (asthma, cough, RSV)Advisor/Advisory Board: GSK (asthma, cough, RSV)Speaker: GSK (asthma, cough, RSV)Diego J. Maselli, MD, FCCP, ATSFProfessor and ChiefDivision of Pulmonary Diseases & Critical CareUT Health at San AntonioDirector, Respiratory Care, University Health SystemDirector, Severe Asthma Program, University Health SystemSan Antonio, TXDr. Maselli has disclosed the following financial relationships:Consultant: AstraZeneca (asthma, COPD), Sanofi/Regeneron (asthma, COPD), GSK ( asthma, COPD), Amgen (asthma, COPD), Insmed (bronchiectasis)Speaker: GSK (asthma, COPD), AstraZeneca (asthma, COPD), Amgen (asthma, COPD), Sanofi/Regeneron (asthma, COPD)All of the relevant financial relationships listed for these individuals have been mitigated.Nurse Planner and Peer ReviewerMarjorie Crabtree, DNP, FNP, ANPHaymarket Medical EducationSteering CommitteeNurse Practitioner Healthcare FoundationAccredited Provider Program DirectorBellevue, WADr. Crabtree has no relevant conflicts of interest with any ACCME-defined ineligible company.Accredited Provider DisclosureNACE staff has no relevant financial relationships to disclose.Intended AudiencePulmonology, allergy/immunology, and critical care clinicians (physicians, nurse practitioners, and physician associates), as well as primary care and geriatric medicine clinicians caring for patients with asthma.Commercial SupportersThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.Please visit  http://naceonline.com to engage in more live and on demand CME/CE content.

For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/courses/emerging-agents-in-pulmonary-arterial-hypertension-10829Program DescriptionThis enduring educational activity provides a comprehensive update on late stage agents being researched for the management of pulmonary arterial hypertension (PAH). Led by expert faculty, the program shifts the clinical focus from traditional vasodilators to novel investigational therapies that directly target the underlying cellular pathways responsible for pulmonary vascular remodeling and disease progression. Clinicians will gain critical insights into the mechanisms of action, latest clinical trial data, and real-world practice implications of these emerging therapeutic classes to better address unmet needs in contemporary care.At the conclusion of this activity, participants should be better able to:Discuss clinical trial data and potential clinical utility of emerging agents in PAH.Accredited ProvidersThe National Association for Continuing Education in partnership with the Association for Pulmonary Advanced Practice Providers (APAPP).Accreditation StatementThe National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.25 Physicians should claim only the credit commensurate with the extent of their participation in the activity. The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.25 contact hours (which includes 0.25 hours of pharmacology).Intended AudiencePulmonology clinicians (physicians, nurse practitioners, and physician associates), cardiology clinicians, and primary care clinicians caring for patients with or at risk for PAH.FacultyIoana Preston, MDDirector Pulmonary Hypertension CenterLahey Hospital and Medical CenterUMASS Chan Medical SchoolBurlington, MADr. Preston has disclosed the following financial relationships:Consultant: Gossamer Bio, Insmed, Janssen Pharmaceuticals, Keros Therapeutics, Liquidia Technologies, Merck & Co./Acceleron Pharma, Respira Technologies, United Therapeutics CorporationContracted Research: Gossamer, Janssen Pharmaceuticals, Merck & Co./Acceleron Pharma, Novartis, United Therapeutics CorporationData and Safety Monitoring Board (DSMB): Tectonic TherapeuticAll of her disclosures are related to PH.Jean Elwing, MDProfessor of Medicine, University of Cincinnati College of MedicineDirector, Pulmonary Hypertension Program, University of Cincinnati Pulmonary, Critical Care and Sleep MedicineCincinnati, OHDr. Elwing has disclosed the following financial relationships:Consultant: Gossamer Bio (pulmonary hypertension), Insmed (pulmonary hypertension), Liquidia (pulmonary hypertension), United Therapeutics (pulmonary hypertension)Speaker: Merck (pulmonary hypertension)Contracted Research: Acceleron/Merck (pulmonary hypertension), Gossamer Bio (pulmonary hypertension), Inhibikase (pulmonary hypertension), Insmed (pulmonary hypertension), Lung LLC (pulmonary hypertension), Novartis (pulmonary hypertension), NS Pharma (pulmonary hypertension), Pharmosa/Liquidia (pulmonary hypertension), Pulmovant (pulmonary hypertension), Regeneron (pulmonary hypertension), United Therapeutics (pulmonary hypertension)These relationships ended within the last 24 months:Consultant: Inhibikase (pulmonary hypertension), Janssen/Actelion/Johnson & Johnson (pulmonary hypertension), Merck (pulmonary hypertension)Advisor/Advisory Board: Gossamer Bio (pulmonary hypertension), Inhibikase (pulmonary hypertension), Merck (pulmonary hypertension), United Therapeutics (pulmonary hypertension)Speaker: United Therapeutics (pulmonary hypertension)All of the relevant financial relationships listed for these individuals have been mitigated.Nurse Planner and Peer ReviewerMarjorie Crabtree, DNP, FNP, ANPHaymarket Medical EducationSteering CommitteeNurse Practitioner Healthcare FoundationAccredited Provider Program DirectorBellevue, WADr. Crabtree has no relevant conflicts of interest with any ACCME-defined ineligible company.Accredited Provider DisclosureNACE staff have no relevant financial relationships to disclose.Commercial SupportersThis activity is supported by an independent educational grant from Insmed and an independent educational grant from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.Please visit  http://naceonline.com to engage in more live and on demand CME/CE content.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant advancements and strategic shifts reshaping the industry landscape. To begin, the U.S. Food and Drug Administration has taken a noteworthy step by selecting key industry players, including Eli Lilly, Regeneron, Fujifilm, and Kriya Therapeutics, for its PreCheck pilot program. This initiative is designed to enhance U.S. drug manufacturing capabilities, emphasizing the importance of robust domestic production. By reducing dependency on international supply chains, the program aims to expedite the delivery of critical therapies, highlighting a strategic move towards self-reliance in pharmaceutical manufacturing. In oncology news, Beone's Brukinsa (zanubrutinib), a small molecule BTK inhibitor, has demonstrated a remarkable 43% reduction in risk of progression for patients with first-line mantle cell lymphoma in its Phase 3 trial. This breakthrough offers a promising chemotherapy-free option for non-Hodgkin lymphoma treatment, marking significant progress in targeted cancer therapies that could improve patient outcomes in previously underserved areas. Meanwhile, Boulevard Bio and Metis TechBio have sealed a substantial licensing agreement valued at $1.6 billion for MTS-128, a trispecific T-cell engager aimed at autoimmune diseases. This collaboration reflects a broader industry trend towards leveraging advanced AI and machine learning technologies to enhance the development of precision medicine and personalized therapies. Such partnerships indicate a shift towards more innovative approaches to tackling complex disease mechanisms and illustrate burgeoning interest in multispecific biologics within immunotherapy domains—offering new avenues for targeting multiple disease pathways simultaneously. On the regulatory front, Sanofi is advancing efforts to expand the U.S. label for Nexviazyme (avalglucosidase alfa) following successful Phase 3 trials for infantile-onset Pompe disease. As an enzyme replacement therapy targeting GAA enzyme deficiency, Nexviazyme could address a critical gap in treatment options for this debilitating genetic disorder, underlining the importance of regulatory pathways in facilitating access to life-saving therapies. Financially, Beeline Medicines has garnered $126.3 million in Series A extension funding to propel its autoimmune programs originally sourced from Bristol Myers Squibb. Similarly, SmartBax has raised €6.3 million to advance its lead antibiotic program targeting multi-drug resistant infections. These investments underscore an unwavering focus on addressing unmet medical needs through innovative therapeutic solutions. Regulatory challenges persist as well; Unicycive Therapeutics faced FDA rejection due to third-party manufacturing deficiencies surrounding oxylanthanum carbonate. This setback emphasizes the critical importance of maintaining rigorous quality standards throughout drug production processes to secure regulatory approvals and ensure patient safety. Globally, China has achieved a milestone with the approval of the world's first CAR-T therapy for solid tumors—a significant leap forward given the historical challenges of applying CAR-T technology beyond hematological malignancies. This approval could transform cancer treatment paradigms globally and prompt similar regulatory advancements in other regions. In other developments, Abbvie and Genmab's combination therapy involving Epkinly has shown promise in diffuse large B-cell lymphoma (DLBCL) trials following prior challenges with monotherapy approaches. This success story highlights the potential of combination therapies in enhancing outcomes for patients battling complex cancers like DLBCL. From a corporate perspective, Klick Health's acquisition of Oxford Pharmagenesis marks its third purchase in 18 months, expanding its global footprint and scientific capabilities—a testament to ongoing consolidation trends aimed at augmenting expertise and strategic growth within the sector. These developments collectively paint a picture of an industry dynamically evolving amidst scientific breakthroughs and regulatory recalibrations. As companies navigate this transformative landscape, their ability to adapt and innovate remains paramount for sustaining growth and addressing global healthcare challenges effectively. Stakeholders must remain agile to seize opportunities while mitigating inherent risks in this high-stakes environment that increasingly prioritizes patient-centric innovations.Support the show

Ryan Piansky, a patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, interviews Maddie, a young adult living with EoE, about her journey with EoE and navigating an elimination diet. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:51] Host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda.   [1:07] Ryan introduces today's topic, eosinophilic esophagitis (EoE). EoE is a chronic, allergic, inflammatory disease of the esophagus. It occurs when eosinophils, a type of white blood cell, accumulate in the esophagus in elevated numbers, causing inflammation that can make eating or swallowing difficult or uncomfortable.   [1:25] Ryan introduces and welcomes today's guest, Maddie, also known as Eosinophilic Chick on Instagram. She's a patient advocate living with EoE.   [1:38] Maddie was diagnosed with EoE in 2021. She has been symptomatic for 10 to 12 years, but was not familiar with the condition itself until then. In her childhood, she was afraid of the upper endoscopy procedure, so she avoided it as much as she could.   [2:06] Besides the patient advocacy that she does, Maddie is an actuary. Throughout the week, she dedicates time to the healthcare industry space in the Philadelphia area. Maddie is 26, navigating her 20s with EoE.   [2:24] Ryan says he feels like being diagnosed as a young adult can be a very big shift. You're going through a lot of other changes: graduating from college, having to figure out work, and having to start managing a chronic illness like EoE.   [2:46] When Maddie was 12 years old, she would have a blockage in her throat. Typically, she walked away from the dinner table and had to regurgitate the food she had consumed.   [3:02] Since heading into college and becoming aware, with the pandemic, of the symptoms of COVID, shortness of breath is one that she leaned into. When she was 21, she felt like she couldn't breathe. It turned out that she was choking on food.     [3:18] There was an impaction, which Maddie obsessed about over time. In addition, around the time she was 21, her symptoms got the best of her. She wasn't able to keep up with thriving, day to day.   [3:31] As a child, some of her symptoms weren't normal, but they were manageable to adapt to: throwing up after a meal, here and there. Her symptoms started to pick up, and she started to lose a lot of weight in her 20s. That's when she sought a diagnosis.   [4:18] Maddie thought it was related to her lung function. She started to lean toward getting diagnosed with asthma, but after testing, that wasn't clear. Her gynecologist thought it was more of a hormonal conflict. They did a lot of labs but got no diagnosis.   [4:45] Meanwhile, Maddie was getting sick. As a last resort, she headed over to gastro. They didn't find anything initially. They did a barium swallow test, another lung function test, and finally, an upper endoscopy.   [5:04] Maddie had spent most of the summer before her senior year of college just trying to figure out what was going on, doing a multitude of tests, and that upper endoscopy with a biopsy captured the EoE.   [5:17] Maddie was able to get support from a specialist who dedicates all of their day-to-day work to EoE treatments.   [5:25] Ryan says it can be tricky to figure out right away what's going on; there are so many other conditions that could be the answer. Until you get to that final diagnosis, it can be a very long process. He's glad she got an answer, eventually.   [5:53] Maddie says, given the timeline of her life, a lot of people were anxious and worried about her future.    [6:08] Once she was able to get that answer, Maddie noticed a lot of relief from a ton of her symptoms, once she was able to get to work on it. Maddie also had an ulcer from frequent vomiting.   [6:25] Maddie had to slow everything down and be very intentional about the things she ate.   [6:51] Maddie lost 15 pounds that summer, as she was trying to gain weight. Whatever she ate, she still lost weight. She was worrying about that rather than about graduating that year.   [7:08] Maddie wanted to know how to register as a disabled student at her university to make sure she got all the resources she needed to be successful.   [7:18] Maddie was rewiring the things she once was worried about, relative now, to what this condition has packaged with it. It was a difficult time. It taught her a lot about discipline, making sure that hard things don't turn her away from achieving the goal.   [7:46] It taught Maddie about being intentional with her time and energy, what's best for her, what's going to make her succeed with whatever goal she's achieving.   [8:07] Ryan says now that Maddie is properly diagnosed, he hopes she's a little bit more in control of her health. Maddie says, "Answers are the biggest power with this condition."   [8:30] Maddie says that before her condition was managed, she went to the ER three times. The first time she was hospitalized, she could not keep down food for two days, so she had to get IV treatment. It wasn't necessarily an impaction, but she wasn't able to eat.   [9:04] The second and third times Maddie went to the ER were related to throwing up again.    [9:26] Maddie's goal was to stop vomiting altogether. She started to get serious with diet therapy, leaning into her six-food elimination diet.   [9:39] Maddie started the diet the week after she graduated, just to be home and have a lot of variables controlled to try the diet, rather than cutting corners. It was really simple to do at home.   [10:04] Maddie first tried cutting dairy, eggs, and shellfish. Her sister is allergic to those foods and is anaphylactic; Maddie is not. That elimination diet was helpful, but it didn't check all the boxes where all her symptoms were free.   [1024] Maddie tried swallowing medication from an inhaler instead of inhaling it into her lungs, trying to coat her esophagus with it. It was effective in the biopsy results, but she was still getting sick, so she did not feel comfortable proceeding with that treatment.   [10:42] All roads led to the six-food elimination diet that could reveal what the culprits were and what was causing her to be so sick. The results were surprising.   [11:06] Soy was a big trigger that surprised Maddie. She consumed so many soy products. That was quite humbling to hear. That was one of her biggest triggers.   [11:34] Maddie completed the six-food elimination diet with triggers of soy, eggs, dairy, nuts, and shellfish. Because of all those groups, it was really difficult for her to manage her diet effectively when going out to eat.   [11:52] Sometimes soybean oil is in a salad dressing or how foods are fried, to a point where Maddie wasn't able to maintain her EoE count below 15 eosinophils per high-powered field.   [12:08] With that, she started with a biologic, dupilumab. That enables her to eat all her trigger foods. An injectable is tough for Maddie as she's not fond of needles.    [12:36] Now Maddie can eat all of the food groups, which is definitely a huge win in terms of her treatment plan. It lessens the impact of living every day with EoE.    [12:53] Ryan says he is on dupilumab, as well. It works well for him. Maddie says she is not avoiding any food triggers, and that's the best part.   [13:24] Ryan says it takes a huge mental load off when you're not having to think about whether there may be soy in what you order from a restaurant, or having to check all the ingredients at the store to make sure that you're not accidentally being exposed.   [13:53] Maddie says, the best advice I would give [to someone on an elimination diet] is focusing on the perimeter of the grocery store. A lot of those foods are dedicated to being whole foods. So, I found that approach to be the most successful.   [14:12] Maddie says, and still finding things that you love and can find new things to enjoy. You're entitled to absolutely enjoy food. It brings a lot of joy into my life.   [14:23] Maddie says, I would specifically love traveling to a bunch of different grocery stores and exploring the allergy aisle. Everyone had their unique niche for it. So, you'll definitely find ones that are more favorable to your preferences than others.   [14:37] Maddie says, but find things, too, that you still enjoy beyond just feeling fully nutritious, and strong, and equipped. You're entitled to indulge, too, even with all the restrictions that you have.   [15:00] Ryan agrees there are a lot of options out there. Exploring and finding something can be really impactful from a quality-of-life perspective, just to have something new. Sticking to the border of the grocery store is a good way of putting it.   [15:13] Ryan says it's everything in those center aisles that gets so complicated. There are always some good, whole food options on the edges, which is nice.   [15:23] Maddie says read every food label, even if you think that you know what's in the food products. A brand of hummus had soybean oil in it. I had to retest, and it added six additional weeks onto my game plan because of that silly mistake.   [15:40] Read everything, even if you think you know it. Odds are, you don't. Don't trust any label until you've fully read it and are confident.   [15:56] Ryan says one of his trigger foods is rice and it does pop up in weird places. Once he was eating potato chips, but then he looked at the ingredients. Rice flour was the second ingredient!   [16:33] If you're not paying attention, it can catch you by surprise. Definitely read labels. It's time-consuming, but it's always a good idea.   [16:42] Ryan asks what other treatment options Maddie tried besides a swallowed inhaled steroid. When she had GI symptoms, she immediately tried a PPI, but was still symptomatic.    [17:47] Maddie says, facing the hard things, getting in front of a problem, and actually attacking it with the solution, is something she consistently dismissed in her teenage years. It took a lot of effort to find the perfect solution that fit.   [18:06] Maddie says, she'll continue to make sure that this is the best solution for her, as her lifestyle and needs change over time.   [18:14] Maddie says, attacking things that might seem intimidating, like 360-plus days of dieting, and not going out to eat, something that was really isolating for her; it just proved so much value in her journey.   [18:29] Maddie says, she is now equipped with that knowledge to make additional decisions as more treatments hopefully come out for EoE. You never know if there are more resources in the pipeline.   [18:48] Maddie says, with this knowledge that I've had, I think it's equipped me to face anything new, and/or ensure that my disease is managed, ultimately.   [18:57] Ryan says, there's a ton of ongoing research and all sorts of new treatments coming out. Ten years ago, he could not have imagined a treatment option like dupilumab.    [19:08] Ryan says, now that we have that, and it's proving so effective for so many people, he thinks that's so exciting and so wonderful. The fact that there are more treatment options like that coming out is so exciting.   [19:27] Maddie says she thinks accepting the illness, and accepting that she's not normal, and the way she lives comes with complexities, relative to her peers. It's frustrating.   [19:40] Maddie says she would love to just not take my dupilumab dose and eat whatever she wants, and not have an annual visit, not do upper endoscopies, and put all this effort, money, and mind all towards this illness.   [19:56] Maddie says accepting that she is unique and this illness will always be a part of her. Coming to terms with that is something she continues to struggle with, just recognizing her peers are not going through the same thing.   [20:12] Maddie says her peers are supportive, but she wonders why she is different and how she got there. She's still working through that.   [30:21] Ryan talks about all the small details a person living with EoE has to think about when traveling or going out for food after work. It's an extra level of anxiety that other people don't have to worry about.   [20:54] Maddie has suggestions for people living with EoE: Inform your peers about your condition. Share your knowledge with your community. With their understanding, they can empower you in social situations, rather than isolate you.   [21:14] When Maddie was dieting, her closest friend's family made sure she had something to eat rather than asking why she wasn't eating. Once she had to tell friends at a dinner that she wasn't eating, she was there to socialize.   [21:55] The more you work towards your acceptance, the more you inform your community, the more you inform yourself, those situations will come a lot lighter. There's always going to be a new scenario where you have to explain your condition.   [22:15] Maddie says, If you can get everybody to pronounce eosinophilic esophagitis, that's a huge win itself. I typically stop at EoE.   [22:32] Ryan talks about anxiety about not eating at dinner. Everybody's just happy you show up and are willing to socialize. Advocating for yourself is such a good lesson to take away from this.   [23:10] Ryan talks about Maddie's patient advocacy work. He follows her on Instagram. She puts so much great information out there. She also works in a professional career.   [23:30] Maddie talks about balancing her activities and illness. She aligns her content with her passion, so it's a hobby she enjoys. She hopes others find value in it. Outside of work, Maddie likes to advocate for EoE. It's busy, but she's super passionate about it.   [24:08] Ryan engages and advocates mostly through APFED, because they provide a lot of wonderful support. He's glad that Maddie uses her experiences to advocate through Instagram and her day-to-day life.   [24:33] Ryan says it's such a great way to approach living with a chronic illness.   [24:40] Maddie's initial goal was to create content so she could explore her growth in her journey. It was a diary about all the things she had done with EoE.   [24:58] Maddie mentions milestones in the community: dupilumab having FDA approval during that timeline, it was exciting to witness with her community.   [25:12] When Maddie was diagnosed, she found information online. The social media community is very powerful in making it real. Maddie loves APFED's content and the comments of folks impacted by the disease. It adds organic, natural reality.    [25:37] Maddie says she loves sharing her story, and she will continue to share it. This isn't ending yet. It's chronic, so EoE will be with her for quite some time. Hopefully, they'll find a cure, but in the meantime, it's not going anywhere.   [25:59] Maddie started her account when she got diagnosed in the Fall of 2021. She focused on alternative foods in the grocery store and dairy-free and egg-free cooking.   [26:18] When she transitioned to the six-food elimination diet, she focused on recipe creation and innovation. She tried to make a deep-dish Chicago-style pizza that was gluten-free. It was a huge mess! She gives respect to the gluten-free community.   [26:46] Ryan describes a poor experience with a chicken-crust gluten-free pizza.   [27:31] Maddie pushes for awareness because there are more people than you think in your community who have undiagnosed EoE. Some are quiet warriors with the condition, working behind the scenes, managing it, not sharing with their community.   [27:54] Between 2021 and now, Maddie has crossed paths with a lot of individuals, even down to childhood neighbors, who have the condition. It's humbling to know that other individuals are going through the same thing, quietly.   [28:13] Maddie says, being able to connect and unify that community is something she wishes she could promise her 2021 self: There's a community out there waiting for you with open arms that will support you through this journey.   [28:30] There are a lot of great people in this space who are unfortunately impacted by this disease. Knowing the community is there is something I would tell myself.   [29:02] Ryan invites Maddie to share a message of encouragement for people living with eosinophilic-associated diseases.   [29:08] Maddie would say, failure is not always a failure. In this case, it took her four forms of therapy treatments until she found the perfect one for her. Try to keep your mind open on the pathways of managing your symptoms.    [29:30] It may cause you to run into a couple of failures, which is so frustrating. She has been in tears before about this, but sometimes failure brings you one step closer to success, or in this case, relief in managing your symptoms.   [31:04] Maddie and Ryan discuss the string test, relating to upper endoscopies, and the benefits of a shorter test without anesthesia. Maddie is excited by the things in the pipeline for potential treatments or maintenance options.   [32:06] Ryan has talked to people who have had the string test, and it sounds like a much better experience until they have to pull it back up, and then it sounds like maybe you wish you were asleep for that part. Overall, it sounds so much more pleasant.   [32:21] Ryan and Maddie discuss trans-nasal endoscopies, with a thinner tube and no anesthesia. It's on Ryan's radar. Endoscopies are not fun.   [34:37] Maddie is excited that there are commercials starting with EoE, talking about the condition on television.   [35:21] Ryan says, it is exciting that there's so much more understanding about this disorder. There is more public awareness now. Maybe 10 years ago, you never would have known that your neighbor also has EoE.   [35:34] Now people can get these diagnoses, understand what's going on, and talk about it more openly, which is really exciting.    [35:45] Maddie says APFED had a great campaign in May, promoting EoE awareness. The more we do that, the more everybody impacted by this disease will win, for sure.   [36:01] Ryan thanks Maddie for her work promoting EoE awareness. It's great to have people out there pushing advocacy and getting information out there. Ryan thanks Maddie for joining us today for this great conversation.   [35:22] For our listeners who would like to learn more about eosinophilic disorders, please visit apfed.org and check out the links in the show notes. [36:28] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder, available at apfed.org/specialist.   [36:37] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experiences, please check out apfed.org/shareyourstory.   [36:45] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [36:56] Ryan thanks Maddie. Ryan thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.orgEsophageal string test (early research was supported by an APFED grant)  apfed.org/specialist apfed.org/connections Eosinophilic.Chick — Maddie on Instagram Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I have officially been diagnosed with EoE since 2021. So, coming up on fiveish years now with the condition, knowing that I have it. I've been symptomatic for over 10 to 12 years, call it, just not really familiar with the condition itself." — Maddie   "My symptoms started to pick up, and I started to lose a lot of weight in my 20s. That's really when I started to get a lot of attention towards my diagnosis." — Maddie   "I first tried cutting dairy, eggs, and shellfish. My sister has an allergy to those foods and is anaphylactic; I am not. That diet was good, but it didn't check all the boxes where all my symptoms were free." — Maddie   "I completed the six-food elimination diet with triggers of soy, eggs, dairy, nuts, and shellfish. Because of all those groups, it was really difficult for me to manage my diet effectively when going out to eat." — Maddie   "I started my [Instagram] account when I got diagnosed in the Fall of 2021. I focused on alternative foods in the grocery store and dairy-free and egg-free cooking. … When I transitioned to the six-food elimination diet, I focused on recipe creation and innovation." — Maddie   Guest Bio: Maddie is the creator behind Eosinophilic Chick, a platform dedicated to raising awareness about eosinophilic esophagitis (EoE), food allergies, and life with chronic illness. Diagnosed with EoE as a young adult, Maddie shares her experiences navigating elimination diets, medical treatments, endoscopies, and the emotional impact of living with a chronic condition. Through honest storytelling, practical tips, recipes, and advocacy, she aims to help others feel less alone.

This episode covers: Cardiology This Week: A concise summary of recent studies Host: Emer Joyce Guests: Yasmina Bououdina, JP Carpenter, Milton Packer, Lorenz Raeber Want to watch that episode? Go to: https://esc365.escardio.org/event/2558 Want to watch that extended interview on PCI guidance by intracoronary imaging, go to: https://esc365.escardio.org/event/2558?resource=interview   Disclaimer  ESC TV Today is supported by Novartis and Novo Nordisk through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. ESC TV Today uses a range of tools and resources (including AI) to support content production. All content is reviewed and approved by the editorial team. Statements and opinions expressed by guest speakers are their own.   Declarations of interests Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier, Takeda, Tecnimede, Viatris. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. David Duncker has declared to have potential conflicts of interest to report: lecture honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientifics, Bristol Meyers Squibb, CVRx, Daiichi Sankyo, Medtronic, Microport, Pfizer, Sanofi, Zoll. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Milton Packer has declared to have potential conflicts of interest to report: 89bio, Abbvie, Actavis, Altimmune, Alnylam, Amarin, Amgen, Ardelyx, ARMGO, AstraZeneca, Attralus, Biopeutics, Boehringer Ingelheim, Caladrius, Casana, CSL Behring, Cytokinetics, Daiichi Sankyo, Imara, Lilly, Medtronic, Moderna, Novartis, NovoNordisk, Pharmacocosmos, Regeneron, Roche, Salamandra. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Lorenz Raeber has declared to have potential conflicts of interest to report: consultation/speaker fees from Abbott, Boston Scientific, Occlutech, and research grants to the institution by Abbott, Heartflow, Novo Nordisk and Heartflow. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of groundbreaking advancements and strategic shifts that are shaping the future of healthcare. In a remarkable development from China, Carsgen has achieved approval for the world's first CAR-T therapy targeting solid tumors. This therapy focuses on Claudin18.2, marking an unprecedented expansion of CAR-T applications beyond hematologic malignancies. The significance of this breakthrough cannot be overstated, as it opens new avenues for treating cancers resistant to traditional therapies, offering hope to patients worldwide. Meanwhile, in regulatory news, the U.S. is closely examining Germany's proposed drug spending reforms due to concerns over "persistent underpayment" for new medications. This scrutiny highlights the complexities of international pharmaceutical pricing and could have profound implications for drug accessibility and pricing strategies across Europe. Sanofi is undergoing transformative changes under CEO Belen Garijo's leadership. The departure of R&D chief Houman Ashrafian and the appointment of Paulo Fontoura, known for his work at Roche, signal a strategic pivot to rejuvenate Sanofi's research and development pipeline. This move aims to address challenges within Sanofi's pipeline and inject new energy into its R&D initiatives. Reflecting broader industry trends, Eli Lilly is reevaluating its marketing strategies amid increasing emphasis on pharmaceuticals in mainstream health discussions. This introspection aligns with efforts across big pharma to enhance corporate image alongside product portfolios. The Federal Trade Commission recently mandated that Aurobindo divest four drugs as part of its $250 million acquisition of Lannett, addressing antitrust concerns and ensuring competitive balance in the generics market. Pfizer has made headlines with a rapid $10 billion oncology deal with Innovent Biologics. This collaboration underscores an industry trend towards swift, large-scale partnerships aimed at expanding global pharmaceutical ambitions. The deal's finalization in under five months illustrates the increasing pace at which such collaborations are being forged. Moderna continues to expand its mRNA capabilities beyond COVID-19 with unanimous FDA advisory committee support for its influenza vaccine candidate. This advancement signifies Moderna's strategic entry into broader vaccine markets, leveraging its mRNA platform to potentially transform vaccine development for seasonal influenza. AbbVie's acquisition of Apogee Therapeutics for $10.9 billion marks a competitive maneuver in the dermatology space. With a promising late-phase eczema drug candidate, AbbVie positions itself against market leaders like Eli Lilly, Regeneron, and Sanofi. Definium Therapeutics has announced promising phase 3 data for its novel LSD-based treatment for depression. This development has the potential to revolutionize mental health treatment paradigms by demonstrating unprecedented efficacy in psychedelic therapeutics. In an innovative stride forward, Insilico Medicine's collaboration with SK Biopharm on an AI-driven drug discovery initiative highlights the growing reliance on artificial intelligence to accelerate drug development pipelines. Targeting neuroimmune disorders, this partnership could be valued at over $2.5 billion, exemplifying AI's transformative potential in pharmaceutical innovation. These developments collectively highlight an industry characterized by rapid scientific advancements and strategic realignments. By expanding CAR-T therapies to solid tumors and integrating AI-driven drug discovery approaches, alongside significant regulatory updates and strategic collaborations, the pharmaceutical and biotech sectors are poised for continued evolution in patient care and drug development methodologies. As we continue to witness these transformative changes across pharmaceuticals and biotechnology, it remains crucial for stakeholders to adapt swiftly and collaborate effectively. The integration of novel technologies such as mRNA platforms, gene editing advancements, and AI-driven research will undoubtedly shape future healthcare outcomes and redefine traditional approaches to medicine. Thank you for tuning into Pharma Daily. We hope you found today's insights valuable as we navigate these dynamic shifts within the pharmaceutical and biotech landscapes together. Stay informed and join us next time as we continue to explore the cutting-edge developments driving healthcare innovation forward.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some of the most significant advancements in scientific research, clinical trials, and regulatory landscapes within the industry. These developments are shaping the future of patient care and drug development significantly. Starting with Legend Biotech's LB2501, which achieved an impressive 100% response rate in a Phase 1 study for non-Hodgkin lymphoma using in vivo CAR T-cell therapy. This breakthrough highlights the transformative potential of CAR T-cell therapies in oncology, especially for B-cell lymphomas. Such success opens the door for accelerated regulatory pathways, offering hope to patients with limited treatment options. In another key development, JJP Biologics shared positive interim data from its Phase 1b trial of nebaprubart targeting CD89 in linear IgA disease. This monoclonal antibody is promising in treating autoimmune conditions by targeting specific disease mechanisms. Meanwhile, GSK's Velzatinib (IDRX-42) achieved a 61% response rate in Phase 1/1b trials for gastrointestinal stromal tumors, showing efficacy against cases resistant to treatments like imatinib. Johnson & Johnson's Nipocalimab met its primary endpoint in a Phase 2 study for systemic lupus erythematosus, underscoring the potential of FcRn blockade in managing autoimmune diseases. Zenas Biopharma's Phase 3 data for Obexelimab targeting CD19/FcγRIIB in IgG4-related disease further emphasizes the role of targeted therapies in managing complex autoimmune disorders. On the regulatory front, Foundation Medicine's FoundationOne Blood Test received FDA approval as a companion diagnostic for Pfizer's Talzenna (talazoparib) to treat prostate cancer with homologous recombination repair gene mutations. This approval underscores the growing importance of precision medicine and companion diagnostics in tailoring cancer treatments based on genetic profiles. Additionally, Lupin and Natco Pharma secured FDA approval for their generic version of Eribulin Mesylate Injection, essential for reducing healthcare costs and improving patient access to vital therapies. Eli Lilly's collaboration with Ascidian Therapeutics focuses on RNA exon editing for kidney diseases, potentially revolutionizing treatment approaches by correcting genetic errors at the RNA level. This partnership reflects a burgeoning interest in RNA-based therapies and their capacity to address unmet medical needs. Regeneron expanded its pact with CytomX Therapeutics to develop conditionally active bispecific antibodies, emphasizing innovation in oncology drug discovery. Such collaborations combine expertise across companies to expedite cutting-edge therapies' development. In terms of funding, NewLimit's successful $435 million Series C round aims to advance epigenetic reprogramming medicine towards human trials. This initiative highlights the burgeoning field of aging biology and its implications for extending healthy human lifespan through innovative therapeutic approaches. Similarly, Immu Biosciences raised $53 million to enhance its immunology platform using AI/ML technologies, underscoring AI and machine learning's critical role in accelerating drug development processes. Turning our gaze towards China's expanding influence on the global biotech stage, Akeso's presentation at ASCO 2026 marked a significant milestone as it became the first-ever Chinese dataset featured in a plenary session. This achievement underscores China's growing prominence in biotechnology and highlights its commitment to advancing innovative medical solutions globally. Simultaneously, Gilead's strategic partnership with Cencora aims to enhance access to CAR-T therapies like Yescarta and Tecartus by expanding their network of treatment centers. CAR-T therapies represent a paradigm shift in cancer treatment by offering personalized options for certain types of cancer. Despite challenges such as Roche's setbacks with its oral SERD drug giredestrant in breast cancer trials, innovation continues unabated. Zevra Therapeutics' launch of Miplyffa for Niemann-Pick disease type C exemplifies efforts to transform rare disease markets by improving patient outcomes through increased access and tailored treatment strategies. Finally, Eli Lilly's acquisition spree reflects broader trends where pharmaceutical companies increasingly integrate Chinese innovations into their development pipelines. This period marks a transformative phase characterized by collaboration between global pharma giants and Chinese biotechs, signaling an era where innovation is globalized and aimed at addressing critical healthcare challenges worldwide. These advancements reflect a dynamic period of innovation within the pharmaceutical and biotech industries. The focus on personalized medicine, targeted therapies, and groundbreaking technologies like RNA editing indicates a shift towards more precise treatment modalities. As these discoveries transition from research phases to clinical applications, they hold the potential to transform patient care significantly. Strategic partnerships and substantial funding initiatives illustrate a robust ecosystem supporting these innovations' rapid advancement. As regulatory bodies continue approving novel therapeutics and diagnostics, the emphasis on personalized healthcare will likely drive future developments, ultimately leading to improved patient outcomes worldwide. As we continue navigating these developments, it's clear that the pharmaceutical and biotech sectors are on the cusp of transformative breakthroughs that promise to redefine healthcare delivery across multiple domains. Thank you for tuning into Pharma Daily; stay informed and stay ahead.Support the show

Dr. Marty Makary out as FDA Commissioner—was he the victim of a BigPharma purge? Are “liquid biopsies” useful for predicting recurrences, as well as guiding therapy, for cancer? Nighttime smartphone by adolescents surges, eroding kids' sleep needs; Persistent itch may require an “all of the above” approach to break its vicious cycle—could topical vitamin B12 provide an answer? Study critiques research methods that fast-tracked new Alzheimer's drugs.

Change management in manufacturing breaks down at the people layer, not the technology layer. This episode explains how engineering leaders actually drive adoption.Ronald Sherrod is a Staff Automation Engineer at Regeneron deploying a global event based architecture and Unified Namespace rollout across pharmaceutical operations. Ron, Vlad Romanov, and Dave Griffith dig into the parts of change management that rarely make it onto vendor decks. Subscribe to Manufacturing Hub for weekly conversations with industrial automation practitioners.Want to go deeper? Vlad and the team at Joltek have covered related topics here:Digital Transformation in Manufacturing: https://www.joltek.com/blog/digital-transformation-in-manufacturingMastering the Unified Namespace for Manufacturing: https://www.joltek.com/blog/mastering-unified-namespace-uns-a-guide-to-data-driven-manufacturing-transformationRon makes a point that is rarely stated this directly. The organization implementing the change is the one responsible for it. OEMs and system integrators deliver the box. Consultants help interpret it. Auditors do not call the machine builder when something goes wrong on the floor of a regulated pharmaceutical plant. They walk into the manufacturer and ask whether the audit trails hold up, whether the predicate rule was met, and whether the product is safe for patients. That responsibility cannot be outsourced, even when the technical work is.That framing changes how engineering managers should think about RFP scope. If the scope is loose, the integrator absorbs the risk and prices accordingly. If the scope is rigorous, bids come back tight and comparable. Negotiating power changes with the size of the buyer. A large pharmaceutical company can dictate hypercare windows, on site commissioning support, and structured training. A small to mid sized manufacturer often cannot, and the result is the metaphorical Ferrari on the plant floor that only ever gets used for grocery runs. Capital was deployed. The technology works. The operation never adopted it.The episode also goes deep on tribal knowledge and the industrial elder, the technical anchor who carries the institutional history of a unit or process and is often more valuable than the Excel file on a network drive. Senior operators know why a pipe was rerouted fifteen years ago and why a procedure looks irrational on paper but works perfectly in practice. With 59 percent of frontline skilled workers over 55 planning to retire within five years per the Schneider Electric 2024 workforce survey, capturing that knowledge is now a leadership priority, not an engineering task.On planning, Ron walks through how he runs user story workshops with operators, manufacturing leaders, engineers, and developers in the same room, producing a shared data contract that defines what information moves where, who needs it, and why. He cites a successful SCADA deployment that worked because the organization had inertia, operators had asked for the problem to be solved, and the team was closing a real gap rather than chasing a trend.Ronald Sherrod is a Staff Automation Engineer at Regeneron, a chemical engineer by training who moved from oil and gas into pharma and now works on event driven architecture, UNS, and robotics initiatives. Ron: https://www.linkedin.com/in/rdsherrod/Timestamps0:00 Welcome and Episode Intro1:50 Ron's Career: Oil and Gas to Pharma at Regeneron4:30 Defining Change Management and Its KPIs8:30 Change Management vs Operational Excellence11:50 Who Owns Change Management on Industrial Projects17:00 Negotiating Power: Large vs Small Manufacturers20:30 Why Capital Projects End Up Mothballed22:10 Tribal Knowledge and Learning From Operators26:00 Why Industrial Projects Fail29:00 The Industrial Elder and Passing Knowledge Through People31:30 AI Generated Documentation in Manufacturing35:50 Project Planning and the RFP Process47:50 A Successful SCADA Deployment and User Story Workshops54:30 Predictions, Career Advice, and Smart GlassesAbout Your HostsVladimir Romanov is a cohost of The Manufacturing Hub Podcast and the founder of Joltek, an independent manufacturing and industrial automation consulting firm specializing in modernization strategy, digital transformation, and workforce development.Connect with Vlad: https://www.linkedin.com/in/vladromanov/Dave Griffith is a cohost of The Manufacturing Hub Podcast and founder of Capelin Solutions, an industrial automation firm helping manufacturers adopt smart manufacturing technology.Connect with Dave: https://www.linkedin.com/in/davegriffith23/Subscribe to Manufacturing Hub: https://www.manufacturinghub.liveLinkedIn: https://www.linkedin.com/company/manufacturing-hub-networkYouTube: https://www.youtube.com/@ManufacturingHub

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Science Advisory Council, interview Phillip Arceneaux, PhD, on his journey with EoE and balancing his career. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:50] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:12] Holly introduces today's topic. It's May, and each year in May, there are several awareness observances for eosinophilic-associated diseases, including National Eosinophil Awareness Week, World Eosinophilic Diseases Day, and World EoE Day.   [1:29] Throughout May, APFED is sharing stories from individuals and families living with eosinophil-associated diseases to highlight the impact of these chronic conditions.   [1:38] Ryan says, Today, we'll be discussing eosinophilic esophagitis (EoE). EoE is a chronic allergic inflammatory disease of the esophagus. It occurs when eosinophils, a type of white blood cell, accumulate in the esophagus in elevated numbers, causing inflammation that can make eating or swallowing difficult or uncomfortable.   [1:56] Holly introduces today's guest, Dr. Phillip Arceneaux, a patient advocate living with EoE since 2019.   [2:18] Phil is 35. He was born and raised in Lafayette, Louisiana. He received his undergraduate degree there. He worked at the U.S. Naval Academy in Annapolis, Maryland. Then he worked at the University of Oregon.   [2:38] Phil moved to Florida and did his Ph.D. in Mass Communication at the University of Florida. Since 2020, he has been based out of the Cincinnati area, working at Miami University of Ohio.   [3:05] Phil was diagnosed with EoE in March of 2019, while finishing his degree at UF.   [3:12] Phil was eating dinner with his girlfriend. He took a bite of a roast beef sandwich, and it didn't go down smoothly, it became impacted.    [3:56] Phil thought he had food stuck in his windpipe. He was running around banging his chest. He calmed down and was able to get some of the food out, and he was breathing again.   [4:12] Phil thought he was fine. He quickly realized he wasn't. He still had a partial impaction. He didn't know what was going on in his chest. He spent about 30 minutes moving around, coughing, and trying to get his chest to feel right.   [4:44] After about an hour, Phil decided to go to the ER. His girlfriend insisted on driving him to the hospital. It was spring break, so the ER was not busy. It still took a couple of hours to be seen and treated.   [5:25] The doctors assessed him. They gave him medicine to induce vomiting. About 12 hours after the initial choking, his impaction cleared. They kept him overnight and gave him an endoscopy in the morning to check his esophagus and take biopsies.   [6:31] Phil was in the ER for four to six hours before anyone told him what they thought he had. Then the ER doctor told him he was 95% certain Phil had eosinophilic esophagitis. Phil had never heard of it.   [7:04] The ER doctor gave Phil a rundown of EoE. He said Phil would have an endoscopy, and then he would be referred to a GI and set up for treatment. The doctor said he couldn't confirm it before the endoscopy, but he thought it was EoE.   [7:31] Ryan says he's talked to people who have had months-long processes of getting their diagnosis. Phil gives all the credit to the hospital. He was fortunate that his experience was good.   [7:55] Phil says that the staff at the ER and the GI specialist were so knowledgeable about the research and where things were going in this area of medicine. They were very confident about the diagnosis and treatment plan.   [8:11] Dr. Arcenaux gives a shout-out to his GI. He spent well over an hour with him during his initial consult. He explained how EoE would impact him, from diet, grocery shopping, and challenges eating at restaurants, because of cross-contamination.   [8:42] The GI specialist talked him through impacts on dating and dining out  and how to approach social activities.   [9:09] Phil's GI specialist talked to him about employers. He would need employers with health insurance that will cover the endoscopies and treatments for EoE. Phil appreciated the initial onboarding for his EoE diagnosis.   [9:41] Ryan says he needs to discuss this with Phil, as he just finished his Ph.D. a few months ago, and he's looking at insurance for his new job, and how to figure out business lunches.   [9:51] Ryan says Ph.D. students are so motivated by free food. As someone with EoE, that never applied to him. Ryan says shifting from normal eating habits to an EoE diet is a major shift.   [10:27] Phil knows now that there were signs and symptoms, but he had no idea about them before his diagnosis.   [10:33] Phil is on a special diet for his EoE. When he's not great at avoiding his trigger foods, he starts to see dysphagia symptoms in his swallowing, and he has quite a bit of regurgitation. He had been seeing that for months before this initial major food impaction and ER visit.   [10:54] Phil had no idea what was going on. He just thought it was weird that he was regurgitating more than he used to. Sometimes food didn't go down well. Once or twice, he had a small aspiration event. He thought he needed to chew better.   [11:11] He didn't know what those symptoms meant, and he wrote them off. None of it made sense until that diagnosis. Even then, it took a while to wrap his head around it. Years removed, he sees there were so many signs and symptoms he never processed.   [11:28] Holly asks what Phil means by aspiration. He says he means water going down his windpipe, making it hard to breathe, with liquid in his lungs. Holly says that aspiration can be caused by inflammation in people who have EoE.   [12:07] Holly says people with EoE can be sent for a swallow study to look at the anatomy of their swallow function. That's a subject for another episode!   [12:35] Ryan says Phil noticed he was regurgitating more than normal and remarks that people with chronic illnesses don't realize that most people don't normally regurgitate at all. It's a sign that something's wrong.   [13:03] The ER doctor didn't offer Phil any other diagnosis than EoE. The doctor was 95% sure he had EoE, but confirmed it with an endoscopy.   [13:20] Holly asks Phil what food allergies he has. As an infant, he had an egg allergy that limited his vaccines. Now he knows his primary allergen is egg, and it led to his EoE issues.   [13:51] When Phil started his Ph.D. program, he wanted to eat healthier foods. He cut out fast food, and he ate more eggs. He consumed many eggs during his Ph.D. program. A snack was scrambled eggs or something with scrambled eggs.   [14:22] Phil went through a carton of 18 eggs in less than a week. He knew that when he was younger, he'd had egg sensitivity, but as an adult, he'd eaten eggs and nothing happened that registered as an issue. He thought he had outgrown it.   [14:40] Phil says he had outgrown other food allergies. He assumed eggs were fine, so he adopted a heavy egg diet to increase his protein intake and be healthier. Then all these symptoms manifested.   [15:00] Phil never associated the symptoms with eggs. His treatment plan is dieting and minimizing egg as much as possible. That is not easy in the United States, where everything is processed and often contains egg.   [15:19] Holly says she has seen an influx of adult-onset EoE patients with a history of a dairy or egg allergy who were putting cottage cheese and eggs in everything, and all of a sudden, started having regurgitation and food getting stuck.   [15:51] Phil doesn't eat scrambled eggs anymore. One slice of a cake with eggs in it will not send him to the ER. It takes a couple of days of high exposure to reach that point. He knows what he can have daily that will not impact him in the long term.   [16:20] Holly and Ryan agree that it's important to know your limits, and consult with your physicians about foods. Rice is a trigger for Ryan, but if brown rice syrup is about the 20th ingredient, he can have it and be fine. If he were to eat a lot of rice, he will have issues. [17:21] Phil says he recently got married, and his wife is a health nut. She has radically changed his diet. They eat very high-protein, low-fat, and low-carb. It's been easy to manage that without eggs. They eat a lot of chicken, turkey, and fish.   [17:41] Being from Louisiana, Phil says if he had to give up seafood, he doesn't know what he would do. He's a huge craft beer lover. If he had to give up gluten, he doesn't know what he would do. He can manage without eggs.   [18:21] Ryan says dairy was a big trigger for him when he was younger, but now he's on dupilumab, a biologic approved for treating EoE, and that's helped him a lot. He's started to integrate whey protein and milk protein back into his diet.   [18:47] Phil says once he finished with school, he graduated and lost health insurance. He didn't have a source of income or health insurance, so he declined to have dilation therapy. That's also why he deferred to dietary therapy. He removed his allergens one by one.   [19:12] Phil was diagnosed in 2019, not long before the pandemic hit. He lived in a bubble for two to three years and kept to a very regimented diet. That's where he started to find his balance.   [19:30] Phil travels quite a bit as a professor. He goes to international conferences. In 2022, a big annual conference opened in Paris, France. He was living his best life, but didn't register that every pastry he put in his mouth had an egg wash.   [20:14] Phil was there for seven days. On the sixth night, he was eating a tough, dry steak. He had a severe food impaction, worse than the one in 2019. He was with colleagues who didn't know what he had.   [20:40] He paid, excused himself, went to his hotel room, and tried to vomit it up. He couldn't do it. He called an Uber and went to the nearest ER. He had an emergency endoscopy. It's not easy to navigate another country's healthcare system, but he did it.   [21:14] When Phil returned from the conference, he said he needed to get serious. He had a GP, but he needed a GI specialist. Cincinnati has multiple great health systems, so he got a GI specialist and started down a path of treatment.   [21:38] He told his GI specialist, this has happened to me, and I never want it to happen again. What can we do? He started with proton pump inhibitors. No effect. He doesn't have acid reflux. Next was the topical corticosteroid, swallowed budesonide.    [22:22] Phil used a pump for asthma, but this was to swallow. After two weeks, he developed a bad case of thrush that took a long time to get rid of. He had never had thrush and didn't know what it was. It took a couple of rounds of treatment to clear up.   [22:43] After that, in 2022, he moved to dupilumab. The FDA had just approved it as a course of treatment for EoE. Phil did not do well with the treatment, and has since gone back to  back to a diet-only course of treatment.    [24:13] Phil says the dupilumab shots did help. He had been having reactions to some foods for years, and after a couple of weeks on the shot, those reactions went away, and he could eat the foods, like avocado and watermelon, again.   [24:39] The dupilumab did him some good, as he returned to some foods that he loved, but it wasn't a long-term solution for him.   [24:50] Ryan shares that he started his Ph.D. in 2019. He felt great, he had no symptoms, and he was following up with his GI every year. With no symptoms, he wasn't scoped until 2025 for insurance reasons. His scope was horrible.   [25:11] His symptoms were in remission, but his esophagus looked terrible. He had to switch up his treatment plan. Ryan advises all listeners to follow up with their GI.   [26:14] Phil says he thinks he's in a very lucky position that what his allergen is, what his dietary preferences are, and how he manifests symptoms, do not significantly impact his day-to-day.   [26:36] Phil's doctor in 2019 had advised him that EoE would impact his work and his business lunches. With the treatment plan he has opted into, it doesn't impact his day-to-day. He says he is very lucky, compared to what other patients deal with.   [26:50] It hasn't impacted his day-to-day, but the problem is, when it does impact something. It's very big, very noticeable, and it's in front of everyone. He recalls his Paris episode. He's very vocal about it. That's why he reached out to APFED.   [27:13] Phil likes talking about it. The only way we know more about it is when we talk about it and share our stories. His colleagues all know he has EoE. They don't understand exactly what it is, but when he's having trouble, they understand.   [27:44] When Phil has an issue, he doesn't tell anyone; he just gets up and walks out of the room and paces the hall, doing his stretches.   [28:09] Largely, it's just letting people know he has EoE. They recognize that he manages it himself, and he's OK.   [28:24] Phil says figuring out your medical treatment plan and balancing your quality of life is different from having a disease that can eventually be treated.   [28:51] This is something you have to deal with the rest of your life. That's going to fundamentally change things, not drastically, but in fairly subtle ways.    [29:18] No matter how comfortable you get, you have to be diligent. You always have to be cognizant of your symptoms and stay on whatever your treatment plan is, whether that's dieting or medication. This will not go away. You're always going to have it.   [29:37] Phil says you have to frame it as a lifelong marathon and find a very sustainable pace. That's where the quality of life is so important. We're human beings. We have to enjoy life. Settle in for the long haul. That's how it will be sustainable.   [30:18] Ryan thinks self-advocacy is important, whether talking with doctors, co-workers, or friends. Take care of yourself and make sure you're doing OK. Make sure you're putting yourself in a position to stay healthy, especially while balancing a career.   [30:45] Ryan says those are great things for our listeners to keep in mind.   [30:49] For our listeners who do want to learn more about eosinophilic disorders, we encourage you to visit APFED.org and check out the links in the show notes below. [30:55] If you're looking to find a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder. available at APFED.org/specialist.   [31:04] If you have personally been impacted by eosinophilic disorders and are interested in sharing your experience, please check out APFED.org/shareyourstory.   [31:12] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at APFED.org/connections.   [31:23] Ryan thanks Phil for joining us today. This was a super interesting conversation. Phil thanks Ryan and Holly for having him on. He is happy to represent on the podcast.   [31:35] Holly thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast Apfed.org apfed.org/specialist apfed.org/connections Phillip Arceneaux, PhD Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables (Edited):   "I took a bite of a roast beef sandwich, and it wasn't going down smoothly. I drank some water. The bite became an impaction. The water stayed in my esophagus, and I started to aspirate." — Phillip Arceneaux, Ph.D.   "The ER doctor told me he was 95% certain I had eosinophilic esophagitis. I had never heard of it. He gave me a quick rundown of what it was." — Phillip Arceneaux, Ph.D.   "I want to give a shout-out to my GI. He spent well over an hour in my initial consult. He explained how [EoE] would impact me, from diet, grocery shopping, and eating at restaurants, because of cross-contamination." — Phillip Arceneaux, Ph.D.   "I never associated the symptoms with eggs. My treatment plan is diet and minimizing egg as much as possible. That is not easy in the United States." — Phillip Arceneaux, Ph.D.   "This is something you have to deal with the rest of your life. That's going to fundamentally change things, not drastically, but in fairly subtle ways." — Phillip Arceneaux, Ph.D.   "No matter how comfortable you get, you have to be diligent. You always have to be cognizant of your symptoms and stay on whatever your treatment plan is, whether that's dieting or medication. This will not go away. You're always going to have it." — Phillip Arceneaux, Ph.D.   Guest Bio: Dr. Phillip Arceneaux is an Assistant Professor of Strategic Communication at Miami University in Ohio, where he teaches mass communication courses focusing on media psychology and content strategy. Phil was diagnosed with EoE in 2019 following an ER visit to UF Health Shands Hospital that required an emergency endoscopy. A Cajun French native of Lafayette, Louisiana, he earned his Ph.D. from the University of Florida and has resided in Cincinnati since 2020.  

Ohne Aktien-Zugang ist's schwer? Starte jetzt bei unserem Partner Scalable Capital. Mit eigenem KI-Chatbot, der dir alle Fragen rund ums Investieren beantwortet. Alle weiteren Infos gibt's hier: scalable.capital/oaws. Iran-Entspannung drückt Ölpreis kurz. NextEra kauft Dominion Energy. Publicis schnappt sich LiveRamp. Elliott steigt bei Bio-Rad ein. Regeneron scheitert mit Krebsmittel. Uber baut Delivery-Hero-Anteil auf 25% aus. Commerzbank lehnt UniCredit-Angebot ab. Hoka war der Laufschuh-Hype der letzten Jahre. Jetzt flacht das Wachstum ab, die Aktie der Holding Deckers (WKN: 894298) hat 25% verloren. Ist die Skepsis übertrieben oder holt die Konkurrenz von Brooks und New Balance Hoka ein? Glutamat-Hersteller, Autokühler-Bauer, Wafer-Monopolist: Die krassesten KI-Profiteure kennt kaum jemand. Ajinomoto (WKN: 853681), Modine (WKN: 869795), Soitec (WKN: A2DKAC), AT&S (WKN: 922230) und Sivers (WKN: A1W9Z9) bis zu 1.150% Plus in 2026. Diesen Podcast vom 19.05.2026, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung. Learn more about your ad choices. Visit megaphone.fm/adchoices

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. The industry is currently navigating a pivotal era marked by a blend of scientific innovation, regulatory shifts, and intriguing clinical trial results. A key regulatory upheaval unfolds as the FDA faces leadership changes. The recent departures of key figures from both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) underscore a period of uncertainty. With former commissioner Marty Makary stepping down, concerns arise about how these changes might affect drug approvals and regulatory guidance at such a crucial time in the industry. Turning to clinical trials, Regeneron has experienced a setback as its lag-3 inhibitor failed to surpass Merck's Keytruda in phase 3 melanoma studies. This marks Regeneron's second significant late-stage failure within a year, prompting analysts to reassess its strategic direction in oncology. In parallel, Regeneron has inked a $2.3 billion agreement with Parabilis Medicines to develop an advanced antibody-drug conjugate (ADC)-like therapy. The goal is to enhance targeting capabilities by improving binding to complex target sites, which could revolutionize ADC technology. Similarly, BioMarin's substantial investment in Inozyme's enzyme replacement therapy faced hurdles after falling short on one of two primary endpoints in a phase 3 trial for a rare genetic disorder. Such outcomes highlight the inherent risks and high stakes involved in late-stage drug development. Yet, innovation continues to drive progress. Vincentage Pharma's oral GLP-1 agonist has demonstrated a promising mean weight loss of 12.4% over a year, positioning it as a competitor to Eli Lilly's Orforglipron in the burgeoning Chinese market. This reflects the global pursuit to harness GLP-1 receptor agonists in tackling metabolic disorders and obesity. Ipsen has made strides with its long-acting neurotoxin for aesthetic applications, advancing into phase 3 trials following encouraging phase 2 results that showed significant improvements in frown lines lasting up to 24 weeks post-treatment. This progress suggests robust competition against established players like Botox. Meanwhile, Merck and Kelun-Biotech have successfully completed a phase 3 trial with their trop2-directed ADC sacituzumab tirumotecan (SAC-TMT) for endometrial cancer, achieving primary endpoints and paving the way for further regulatory submissions. Such advancements emphasize ADC technology's growing importance in oncology therapeutics. Broad industry trends reflect strategic investments, exemplified by Boston Scientific's $1.5 billion investment in Mirus and an option to acquire its transcatheter aortic valve replacement system—highlighting continued interest in high-growth medtech sectors. In another notable development, Daiichi Sankyo and AstraZeneca have reached a milestone with their ADC Enhertu, securing dual FDA approvals for early breast cancer treatment. These approvals underscore Enhertu's potential to expand treatment options for patients at an early disease stage, potentially altering standard treatment protocols. On the regulatory front, AstraZeneca has secured FDA approval for baxdrostat—an aldosterone synthase inhibitor developed through its acquisition of CinCor Pharma—demonstrating strategic investment in innovative cardiovascular therapies aligned with ambitious revenue goals. However, challenges persist as demonstrated by Amgen's Tavneos being linked to fatalities across Japan and the U.S., raising significant concerns about data integrity and pharmacovigilance. In contrast, Revolution Medicines' RAS inhibitor doubled survival rates in phase 3 pancreatic cancer trials. This breakthrough positions Revolution as an emerging leader in oncology therapeutics amidst fierce competition from companies aiming to improve drug tolerability and extend survival benefits. These narratives paint a picture of an industry poised for transformation—balancing scientific breakthroughs against regulatory challenges and financial pressures. As therapeutic modalities evolve—from oral biologics to advanced ADCs—the sector is set on course for substantial impacts on patient care and drug development pipelines. In summary, the pharmaceutical and biotech industries' focus on advancing therapeutic options through scientific innovation while navigating complex regulatory landscapes underscores an ongoing commitment to addressing unmet medical needs through new drug classes and targeted therapies. These efforts highlight trends toward personalized medicine and precision oncology that are likely to shape future trajectories in these dynamic fields.Support the show

With the S&P 500 and Nasdaq coming off their worst day since March, Carl Quintanilla, Jim Cramer and David Faber kicked off a new week of trading that will include earnings from Nvidia and Walmart. With inflation and Iran war developments on Wall Street's radar, the anchors discussed the recent jump in bond yields and oil prices — and what's at stake for the markets. The biggest power deal on record: NextEra Energy agrees to buy Dominion in an all-stock transaction valued at $66.8 billion. Also in focus: Regeneron shares tumble on melanoma drug trial results, jury set to deliberate at the Elon Musk-OpenAI trial, price target hikes for Nvidia, veteran strategist Ed Yardeni's take on the future for rates once Kevin Warsh leads the Fed.   Squawk on the Street Disclaimer Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Scott Wapner and the Investment Committee debate how to manage your portfolio amid a rising rate environment. Plus, the Committee share their latest portfolio moves. And later, we hit some Committee stocks on the move including Regeneron and Delta Air Lines. Investment Committee Disclosures Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

In this episode of Bowel Sounds, hosts Dr. Temara Hajjat and Dr. Peter Lu talk to Dr. Maureen Leonard, a pediatric gastroenterologist and Associate Professor at Massachusetts General Hospital. Dr. Leonard discusses the latest research on early life factors that can increase celiac disease risk for susceptible children, including potentially modifiable risk factors. Dr. Leonard's disclosures include:  Consultant for Takeda, Chugai, Anokion, Sonoma, and Interlude Biopharma and research support from Takeda, Pfizer, Regeneron, Moderna, and Mead Johnson Nutrition.Learning objectivesUnderstand early life determinants for celiac diseaseUnderstand environmental influences on developing celiac diseaseSend us Fan MailSupport the showThis episode may be eligible for CME credit!  Once you have listened to the episode, click this link to claim your credit.  Credit is available to NASPGHAN members (if you are not a member, you should probably sign up).  And thank you to the NASPGHAN Professional Education Committee for their review!As always, the discussion, views, and recommendations in this podcast are the sole responsibility of the hosts and guests and are subject to change over time with advances in the field.Check out our merch website!Follow us on Bluesky, Twitter, Facebook and Instagram for all the latest news and upcoming episodes.Click here to support the show.

Our Kate Rooney reports on Elon Musk losing his case against Sam Altman and OpenAI. John Belton of Gabelli Funds previews Nvidia's upcoming earnings report and where he is placing his bets. Bank of America reinstates bullish ratings on ServiceNow and Salesforce; the analyst behind the call, Tal Liani, breaks down the competition and where investors should focus. Alan McKnight of Regions and Kevin Gordon of Charles Schwab debate the market outlook and where investors should position from here. Plus, our Angelica Peebles reports on a sharp decline in Regeneron and what it means for biotech investors. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Recorded and published daily during #ASGCT2026, Soundbites of the Annual Meeting captures the energy and breadth of the conference through quick-hit conversations, scientific snapshots, attendee perspectives, and highlights from across the field — offering a daily pulse on what’s happening throughout the meeting. Take a listen from Wednesday, May 13, 2026 as we talk with Jon Whitton, PhD, VP, Global Program Head of Genetics Medicine at Regeneron. This discussion centers around Regeneron's recent approval of Otarmeni and the role the Annual Meeting plays in advancing innovation across the field. This soundbite is hosted by Lynnea Olivarez of the ASGCT Communications Committee. Music: Everything Connected by High Street Music.Show your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Science Advisory Council, interview Dr. Chukwuemeka Oko, MD, MBA, on clinical trials. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:49] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:13] Holly introduces today's topic — clinical trials — and today's guest, Dr. Chukwuemeka Oko, a Clinical Research and Medical Affairs Professional supporting Duke University Hospital's Department of Gastroenterology and Transplant Hepatology.   [1:33] Dr. Oko explains that he is sharing general, educational information from his perspective and experience, not speaking on behalf of Duke University, nor any industry sponsor, nor any company he has worked for.   [1:50] Dr. Oko's goal today is to help the listeners feel clearer, more confident, and more in control when they are thinking about clinical research.   [2:29] Dr. Oko's work sits mainly at the intersection of clinical research and medical affairs. He helps translate evolving science into practical, patient-centered decisions.   [2:40] From an academic standpoint, he supports clinical trials and evidence generation from feasibility through education.   [2:49] Dr. Oko also engages investigators and thought leaders from industry sponsors in scientific exchanges that lead to insights, study design, and real-world care pathways.   [3:03] Dr. Oko had two reasons to study eosinophilic esophagitis and eosinophilic disease. The first is the patient journey and biology.   [3:11] On the patient side, many people spend a long time seeking answers. Sometimes they feel dismissed before they get a clear diagnosis and a plan that fits their life.   [3:24] On the biology side, eosinophilic disease teaches us a lot about how our immune signals can drive information differently across tissues like the esophagus and airways.   [3:40] Dr. Oko supported an EoE study experience with an industry sponsor in the past. The best research doesn't just test; it helps patients and clinicians make clearer decisions.   [4:12] Dr. Oko explains that a clinical trial is a carefully designed, carefully crafted study in people that answers specific medical questions, most often about safety, effectiveness, or dosing of the study drug or how a treatment should be used.   [4:32] A key structure of a study is a written protocol where safety monitoring is in place, and the defined outcome or results are very reliable. The FDA always oversees clinical trials in the U.S.    [4:44] Dr. Oko often describes a trial as a highly-monitored learning system. It's how medicine moves from "We think this might help" to "We know what helps, for whom, and also at what risk."   [5:09] Dr. Oko says clinical trials usually study what improves patient outcomes, for whom, and at what risk, using methods that we can trust. Trials may evaluate new medicines, devices, dosage strategies, or even procedures.   [5:31] Clinical trials can also study non-drug approaches such as diet interventions, symptom tracking, monitoring tools, and education strategies.   [5:44] Many trials have also included biomarkers, or signals in the blood or tissue, helping to support an EoE diagnosis so that the patients can get treated in an early and effective manner.   [6:36] Dr. Oko says patients sometimes ask him if they are guinea pigs. In reality, trials are heavily regulated and closely monitored, with strict safety reporting requirements. Participants are not guinea pigs.   [7:06] Dr. Oko also hears patients ask if they are "stuck" once they join the clinical trial. No, a trial is a completely voluntary participation, and they can withdraw at any time.   [7:25] Other patients ask if trials are only for people who are out of options. Many trials are designed for earlier stages, especially when the goal is to prevent complications or reduce steroid exposure.   [7:46] The last question Dr. Oko hears a lot is "Will I be in the placebo group?" He says it's an understandable fear. They are asking if they will go untreated in the placebo group.   [8:29] In many trials, a placebo is not the same as "no care". Often, the participants continue the standard-of-care treatment, and the study drug or placebo is added to the standard-of-care treatment.   [8:45] Trials typically involve symptom monitoring and a plan for what happens if the symptoms worsen. There are exit criteria.   [9:01] From the pharmaceutical side, it's the end of treatment once you decide to voluntarily exit the study.   [9:10] Dr. Oko's advice is, if you participate, ask the study team physicians to explain in plain language what you'll receive, what you can continue, and what happens if you flare up. Clear answers are always a part of ethical research.   [10:33] Holly asks what it means to participate in a Phase 1, Phase 2, or Phase 3 trial. Dr. Oko says a Phase 1 trial is focused mostly on the safety and the dosing regimen. It's usually a small group of five to 100 or so.   [10:52] A Phase 2 trial always looks for the drug's effectiveness and continues monitoring safety. It's usually a group of 100 to 300 subjects. They look for meaningful signals of the outcomes derived from the trial.   [11:10] A Phase 3 trial is usually large. It's multi-centered. It's called a complementary study. It involves thousands of patients. It can even be across nations and states.   [11:26] This is where they compare new interventions against a placebo or against a standard of treatment to provide clinical benefits and support for regulatory approval.    [12:03] Participating in any phase of a trial includes fitting the eligibility criteria of inclusion for that particular phase. If you are a good match, you can be in either a Phase 1, Phase 2, or Phase 3 trial.   [12:52] Holly says she knows that a lot of people with EoE or EGIDs are very curious about trials and how to participate in them.   [13:00] Ryan says we have a very active patient community, and everyone's looking for ways to get involved in research and new diagnostics or medications to improve their own outcomes and help everyone else.   [13:35] Dr. Oko says the benefits of participating in a clinical trial include access to potentially disease-modifying therapies years before they reach the market.   [13:47] Another benefit is extraordinarily close medical monitoring. When you're in a clinical trial, you have more frequent visits and more frequent labs than usual.   [14:01] Endoscopies are out of the normal standard of care, but will be more frequent than normal to analyze the efficacy of the study drug.   [14:11] Dr. Oko says one of the risks is the unknown side effects the study drug comes with, because we are still understanding the biology.   [14:21] The time commitment for visits can be more than typical for a patient, especially if there is a long travel time involved. Patients may arrive at 7:00 or 8:00 a.m. They may need to find a place to live nearby, depending on the pace of the trial.   [14:57] Holly lives in Maine, and a lot of the trials are in Boston. It's a lot of travel. For people with any kind of chronic illness, all we think about is money. Holly asks if people pay to be part of a clinical trial.   [15:25] Dr. Oko states that the patients do not have to pay anything to be part of a clinical trial. Patients do get compensated by the trial sponsor for travel, accommodation, parking, and a meal for the days they are onsite.   [16:33] Dr. Oko says that patients tend to bring up insurance. It is a misconception that the study will pay for their standard-of-care medication during the study. Patients need to ask the study team what insurance will pay for and what the study will pay for.   [16:59] Dr. Oko says the insurance usually covers the regular standard-of-treatment, but any other additional treatment, procedures, and visits are all covered by the study sponsor.    [17:29] The study sponsor may ask for an endoscopy to be done six months before the study to determine eligibility for the study. If it is done within a year, the study sponsor will determine if you are qualified. That is part of the eligibility criteria in some cases.   [18:26] Dr. Oko tells patients to always ask questions, like what the schedule of events is in the clinical trial.   [18:35] The schedule of events tells you how many visits are required for you to be part of this study. They will list the activities to be done. They will list the labs you will need at what week. They will list when you need endoscopies, at week one and later.   [19:05] If you exit from the study, if you don't want to participate anymore, you are still required to come on site just to make sure that you are in good shape. Those are called formal visits.   [10:29] Dr. Oko explains that formal visits are necessary for the patient's safety and to make sure that the data points collected in the study will be effective.   [20:01] Patients enrolling in a clinical trial can also ask about the known risks of the symptom monitoring plan. They can ask what is covered and what is not covered by insurance, and what will be considered out of pocket.   [20:20] If patients are in the placebo group, what will happen if symptoms worsen? In the protocol, there is always a rescue plan. If a symptom flares up, the Principal Investigator carries out the rescue plan.   [20:58] The study team is available on a 24/7 hotline. The questions you ask are very important. No question is too small to ask. Every question and every symptom you report is important. You can withdraw at any time, and there is always a follow-up.   [22:19] Dr. Oko says the trial data that has already been collected from part of our eosinophilic studies has led to various FDA approvals of the biologics. We are working  to try to transform EoE from a steroid-dependent or diet-only disease into a position of long-term control.   [22:37] Trial findings have shaped care, expanding evidence-based options, clarifying which patients benefit the most, and improving how we measure our outcomes, the symptoms, and quality of life, as measured by patients' quality-of-life surveys.   [23:06] Quality-of-life surveys are very important for the study team. They help to measure safety, too. The evidence generated from this data leads to insights and improves study design, protocol design, and ultimately, improves patient care.   [23:40] Ryan says the community is interested in clinical trials because they benefit patients, researchers, and clinicians. We're thankful for the clinicians and researchers putting in all the work to make these clinical trials happen.   [24:01] Ryan adds, we're also thankful for the patients who are interested in these trials. For patients who are looking to participate, how can they find clinical trials to participate in and join?   [24:15] Dr. Oko says people can find the website ClinicalTrials.gov. It's an important tool in looking for various clinical research. Scientists are recruiting at a given time. You can use the Advanced Search option to narrow the search by state and criteria.   [24:54] You can always discuss clinical trials with your primary care physicians. You can look for major academic medical centers. Most of them always have clinical research studies going on.   [25:07] Dr. Oko says APFED.org is a very good tool. It always maintains up-to-date trial listings and patient-friendly summaries where patients can read about the studies.   [25:30] Ryan says he's very appreciative of the mention of APFED. There is a link on APFED.org so people can find studies. There are clinical trials listed that people can research more and join.   [25:46] Holly asks Dr. Oko to share advice for listeners who are considering participating in a clinical trial. He shares, "I want each one of you to approach the decision with the same care you would with any major medical choice. Review the Informed Consent Form (ICF)."   [26:23] "The word informed means you should be informed. It's your right to get informed with every line, every detail. The Consent Form can be 30 pages long, but please just know that you are not in a rush to answer."   [26:43] "You can take the Consent Form and discuss it with your friends, your family, your primary care physician, your gastroenterologist, and your allergist and get more information."   [27:00] "When you join an interventional trial, or a registry, your contribution accelerates the science and benefits the entire eosinophilic community."   [27:12] "From my years of reviewing medical charts and supporting new recruitments, I feel patients feel most satisfied when they are fully informed and genuinely partnered with the study team. That's how I partner with the patients. I am always there to help."    [27:40] Ryan says that is great advice for patients, and hopefully, some of our listeners to this episode will go out there and look for clinical trials to participate in or ask their physicians, next time they're getting care.   [27:52] For patients who would like to know more about eosinophilic disorders, we encourage you to visit APFED.org and check out the links in the show notes below, specifically to research opportunities listed on APFED.org. [28:08] If you've been personally impacted by eosinophilic disorders and are interested in sharing your experiences, we encourage you to please check out APFED.org/shareyourstory.   [28:17] Ryan thanks Dr.Oko for joining us today. This was really helpful and insightful, and hopefully, we'll have many new patients interested in joining clinical trials. Dr. Oko thanks Ryan and Holly for having him on and thanks every listener who has joined us.   [28:33] Dr. Oko says it has been a genuine pleasure and privilege for him. He has spent years seeing patients, reviewing their charts, and hearing their stories. We see you, we hear you. Science is advancing rapidly and shaping outcomes. You are not alone.   [30:17] Holly thanks Dr. Oko for his research and clinical trials, and thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast Apfed.org apfed.org/specialist apfed.org/connections apfed.org/research/clinical-trials Duke University Hospital's Department of Gastroenterology Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "Many people spend a long time seeking answers. Sometimes they feel dismissed before they get a clear diagnosis and a plan that fits their life." — Chukwuemeka Oko, MD, MBA   "On the biology side, eosinophilic disease teaches us a lot about how our immune signals can drive information differently across tissues like the esophagus and airways." — Chukwuemeka Oko, MD, MBA   "In many trials, a placebo is not the same as no care. Often, the participants continue the standard-of-care treatment, and the study drug or placebo is added to the standard-of-care treatment." — Chukwuemeka Oko, MD, MBA   "I tell patients to always ask questions, like what the schedule of events is in the clinical trial." — Chukwuemeka Oko, MD, MBA   "[If a patient exits the study], formal visits are necessary for the patient's safety and to make sure that the data points collected in the study will be effective." — Chukwuemeka Oko, MD, MBA   "From my years of reviewing medical charts and supporting new recruitments, I feel patients feel most satisfied when they are fully informed and genuinely partnered with the study team." — Chukwuemeka Oko, MD, MBA   Guest Bio: Chukwuemeka Oko, MD, MBA

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a myriad of significant advancements, strategic investments, and regulatory updates reshaping the landscape of drug development and patient care. In a remarkable move, Novartis has announced a $23 billion investment in the U.S., with plans to establish an Active Pharmaceutical Ingredient facility in Morrisville, North Carolina. This venture aims to bolster Novartis' manufacturing capabilities for solid dose tablets, capsules, and RNA therapeutics, marking a critical investment in U.S. pharmaceutical manufacturing. This decision reflects a broader trend of pharmaceutical giants strengthening their domestic production capacities to enhance supply chain resilience and support local economies. Eli Lilly has introduced Foundayo, its oral GLP-1 drug for obesity. Despite not matching the initial sales figures of Novo Nordisk's Wegovy pill, Lilly remains optimistic about capturing a substantial share of the obesity treatment market. The launch highlights the increasing competition and interest in GLP-1 therapies, recognized for their effectiveness in managing weight and metabolic disorders. This growing focus on obesity treatment underscores the industry's commitment to addressing one of today's most pressing public health challenges. As Eli Lilly navigates competitive obesity treatment landscapes amidst significant revenue growth tempered by falling drug prices, it highlights industry-wide trends focusing on metabolic disorders as lucrative therapeutic opportunities while balancing financial performances against strategic pivots and regulatory changes. Turning to respiratory diseases, Merck's portfolio tells two different stories. Winrevair for Pulmonary Arterial Hypertension is on a growth trajectory, while Ohtuvayre for Chronic Obstructive Pulmonary Disease has seen a decline in sales. This contrast illustrates the dynamic nature of therapeutic adoption and market demand within respiratory care, reminding us of the constant evolution within disease treatment markets. AstraZeneca is navigating complex regulatory landscapes with its approach to the U.S. "Most Favored Nation" drug pricing policy by excluding certain reference markets in its forecasts. This strategy highlights the challenges pharmaceutical companies face in adapting to policies aimed at controlling drug prices while maintaining market viability. In immunology, AbbVie is defending its leading drug Skyrizi against new competitors like Johnson & Johnson's Icotyde for plaque psoriasis. Skyrizi's impressive 30.9% sales growth in early 2026 showcases AbbVie's robust market position and strategic focus on immunology—a field that continues to see intense innovation and competition. Regeneron has faced setbacks with Eylea due to regulatory delays, causing quarterly sales to dip below $1 billion for the first time since 2018. This situation underscores the critical impact regulatory environments can have on revenue generation and highlights the need for strategic agility within pharma companies. Teva Pharmaceuticals is experiencing a successful transformation under CEO Richard Francis, driven by its innovative portfolio including Austedo, Uzedy, and Ajovy. This shift from generics to branded pharmaceuticals marks Teva's commitment to innovation and sustainable growth. In oncology collaboration news, Bristol Myers Squibb has ended its partnership with Zymeworks on a Phase 1 cancer bispecific antibody project from Celgene. This decision emphasizes the complexities of biotech collaborations and the necessity for strategic alignment in advancing cancer treatment pipelines. Unfortunately, not all news is positive. GSK and Alector have halted a Phase 2 trial of their Alzheimer's candidate after interim analysis showed it was unlikely to meet primaSupport the show

First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi welcoming Belén Garijo as CEO. Still to come this week are Eli Lilly, AstraZeneca, Regeneron and many more.Lilly will undoubtedly discuss its recent streak of dealmaking, including a $2.25 billion pact with AI biotech Profluent, plus buyouts of Ajax Therapeutics for up to $2.3 billion and Kelonia Therapeutics for up to $7 billion.Meanwhile, Regeneron earned FDA approval for the highly anticipated gene therapy that will now be known as Otarmeni. The same day the approval came down, Regeneron also struck a deal with the White House.Over at the FDA, the agency has requested—again—that Amgen remove the autoimmune therapy Tavneos from the market. Separately, the FDA has issued three Commissioner's National Priority Vouchers to unnamed psychedelic drug developers. Finally, who will replace Vinay Prasad, the head of the agency's Center for Biologics Evaluation and Research (CBER), who departs at the end of April after one year as the biologics chief?

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements and regulatory updates that are shaping the future of the industry. At the latest meeting of the American Association for Cancer Research, innovative cancer therapies were in the spotlight. Merck showcased its PD-1xVEGF bispecific antibody for non-small cell lung cancer, combining immune checkpoint inhibition with anti-angiogenic strategies. This novel approach could enhance efficacy and safety compared to existing treatments. Despite these promising developments, Merck remains cautious about disclosing its Phase 3 trial plans, likely due to competitive pressures. The conference also featured industry veterans like Dr. Daniel Chen, who is pioneering "smart" cancer drugs through his startup. These antibody-drug conjugates aim to deliver targeted therapies with precision, minimizing off-target effects—a clear nod towards personalized medicine tailored to the genetic profiles of tumors. Revolution Medicines is making strides in targeting RAS mutations, particularly in pancreatic cancer, with its lead candidate daraxonrasib showing promise in Phase 3 trials. This positions the drug as a potential breakthrough for this challenging cancer type. Their broader pipeline suggests a strategic focus on exploiting RAS pathways, heralding a new wave of targeted cancer therapies. Meanwhile, National Cancer Institute Director Letai reassured attendees about stable research funding amidst political uncertainties, aiming to sustain momentum in cancer research advancements. Regulatory concerns were also a focal point at AACR. Dr. Richard Pazdur expressed anxiety over political influences impacting the U.S. FDA, reflecting broader challenges within regulatory frameworks that could affect drug approval processes and innovation timelines. On an international note, Zai Lab's global expansion ambitions were examined. Transitioning from licensing deals to independent biopharmaceutical development illustrates China's growing influence in biotech, though scaling operations across diverse regulatory environments presents significant challenges. In another significant development, Regeneron secured FDA approval for a pioneering gene therapy, underscoring rapid advances toward personalized therapies for genetic disorders. This marks a new era in genetic medicine and highlights the transformative potential of gene therapy. Meanwhile, Pfizer's strategic post-COVID-19 restructuring has resulted in further layoffs in Ireland, reflecting broader industry trends towards financial recalibration. Such moves underscore the ongoing adjustments companies face as they adapt to post-pandemic market dynamics. Pfizer's strategic portfolio management reflects a trend towards focusing resources on promising late-stage assets while deprioritizing earlier-stage projects that don't align with evolving goals. Roche's oral selective estrogen receptor degrader giredestrant remains a focal point despite clinical data concerns. Positioned as a potential major product in oncology, it illustrates the complexities involved in commercializing promising therapies amid data uncertainties. Sanofi continues to drive growth with Dupixent while preparing legal defenses to extend U.S. exclusivity beyond 2031—a strategic effort to protect revenue streams against generic competition. Conversely, AbbVie's attempt to introduce a Botox successor faced setbacks due to manufacturing-related issues flagged by the FDA, highlighting the complexities of meeting stringent regulatory standards. Avalyn Pharma's $182 million IPO signifies strong investor confidence in late-stage respiratory drug candidates, emphasizing efforts to innovate in chronic disease management. Regulatory dynamics are evolving too, with initiatives aimed at exSupport the show

The FDA has approved Regeneron's gene therapy for a rare form of inherited deafness, and it's free for Americans. Regeneron CEO Leonard Schleifer discusses the breakthrough treatment, drug pricing, AI's role in medical innovation, and what breakthroughs might come next. Co-chair of the President's Council of Advisors on Science and Technology David Sacks was one of the original executives at PayPal, alongside Elon Musk and Peter Thiel. As an AI and crypto advisor to President Trump, the All In Podcast co-host is helping shape AI regulation and policy in the United States. He comments on the government's complicated relationship with Anthropic and the ongoing feud between Elon Musk and Sam Altman. Plus, a U.S. soldier was arrested for his winning Polymarket bet on the capture of Venezuelan leader Nicolás Maduro, and Intel reported a blowout quarter.   David Sacks - 17:43 Leonard Schleifer - 29:21   In this episode: Becky Quick, @BeckyQuick Joe Kernen, @JoeSquawk Andrew Ross Sorkin, @andrewrsorkin Katie Kramer, @Kramer_Katie Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Regeneron has recently achieved a pivotal milestone with the FDA's approval of its hearing loss gene therapy, Otarmeni. This approval, facilitated through the FDA's Commissioner's National Priority Voucher Program, emphasizes the expanding recognition of gene therapies as essential therapeutic modalities. Otarmeni stands out as it directly targets an underlying genetic cause of hearing loss, marking a significant advancement in audiological medicine. Traditionally, hearing loss has been managed with hearing aids or cochlear implants, which do not address the root cause. Otarmeni represents a transformative approach by correcting genetic deficiencies, offering patients a chance for improved auditory function. This achievement not only highlights Regeneron's innovative capabilities but also sets a precedent encouraging other companies to explore genetic disorder treatments. Eli Lilly's development of AK-OTOF, targeting otoferlin deficiencies crucial for auditory processes, further signifies robust competition in this space. Currently under Phase 1/2 clinical trials, AK-OTOF is anticipated to continue research efforts until 2028. These advancements illustrate a promising pipeline of treatments that could potentially revolutionize patient care. The regulatory landscape is adapting to accommodate such novel therapies, with programs like the FDA's National Priority Voucher Program playing a crucial role in expediting access to groundbreaking treatments. From a scientific perspective, therapies like Otarmeni underscore the importance of understanding genetic mechanisms in disease pathogenesis. By modifying faulty genes within cells, these therapies offer hope not only for hearing loss but for a range of genetic disorders as well. Turning our attention to Novo Nordisk's progress with oral semaglutide for adolescent Type 2 diabetes; the company has announced positive clinical trial results extending its use beyond obesity treatment. This development is significant given the increasing prevalence of Type 2 diabetes among younger populations. Oral GLP-1 receptor agonists could revolutionize diabetes management by providing an alternative to injections, potentially improving compliance and quality of life for patients. In regulatory practices, there is a growing call for transparency. A citizen petition urges the FDA to refine disclosure protocols concerning Complete Response Letters (CRLs), aligning with industry demands for clarity in drug approval processes. Enhanced transparency could lead to more efficient regulatory pathways and strengthen trust between pharmaceutical companies and regulators. Roche's recent earnings report reveals challenges beyond currency fluctuations, as several key drugs underperformed against expectations. This raises questions about Roche's strategic positioning amid intense competition and market dynamics. Conversely, AbbVie's $1.4 billion investment in North Carolina to establish a new production base highlights strategic expansions aimed at meeting rising pharmaceutical demand. Technological innovation continues shaping industry strategies with Merck & Co.'s collaboration with Google Cloud aimed at enhancing AI capabilities—a $1 billion initiative focusing on transforming healthcare professional engagement through data analytics and AI insights. Such collaborations are likely to optimize marketing strategies and improve patient outcomes by facilitating personalized healthcare interactions. Meanwhile, Sanofi's defense of Dupixent amid R&D setbacks exemplifies how breakthrough biologics can drive revenue growth despite challenges. These developments highlight an industry undergoing transformation towards transparency, innovative treatments, strategic expansion, and technological adoption—promisingSupport the show

President Donald Trump when asked by a reporter how long he is willing to wait until he gets a response from Iran to U.S. peace proposals, replies, 'Don't rush me'; Senate Republicans take the first step in budget reconciliation, passing a budget resolution after a long session that ended in the middle of night, that will allow them to pass three years of funding for federal immigration enforcement without Democratic votes and the reforms the Democrats have demanded; House passes legislation waiving federal drilling permit requirements for geothermal operations; President Trump announces a drug pricing agreement with the pharmaceutical company Regeneron, last of 17 drug companies targeted by the administration; Justice Department reclassifies medical marijuana as a lower-risk drug. We will talk about it with Washington Post White House reporter Dan Diamond (32); Rep. Thomas Massie (R-KY) introduces a bill aimed at preventing what he sees as unconstitutional surveillance by the federal government. This comes as a key foreign spying tool – known as Foreign Intelligence Surveillance Act (FISA) Section 702 – expires in a week and debate heats up over how to protect Americans who have their conversations recorded inadvertently; U.S. Attorney for DC Jeanine Pirro announces charges against two Chinese nationals accused of running a 'scam compound' in Burma that targeted Americans to steal their life savings, perhaps $700 million in all; First Lady Melania Trump speaks at the annual First Lady's Luncheon for spouses of elected officials; Children of reporters ask House Minority Leader Hakeem Jeffries (D-NY) questions on National Take Our Daughters and Sons to Work Day. Learn more about your ad choices. Visit megaphone.fm/adchoices

President Trump gathers in the Oval Office to announce a landmark Most Favored Nation drug pricing deal with Regeneron, the 17th and final pharmaceutical company to sign on, representing 86% of the branded drug market. The announcement includes a gene therapy that restored hearing to two year old Travis Smith, offered free to all eligible American children. Trump also confirms medical marijuana is being rescheduled to Schedule III. The press conference pivots quickly to updates on the Iran military operation, where Trump insists Iran's navy is at the bottom of the sea and the Strait of Hormuz stays closed until a deal is signed. He closes with a detailed and somehow charming tangent about the Lincoln Memorial Reflecting Pool getting a $1.5 million renovation instead of the previously planned $301 million overhaul.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most intriguing advancements and strategic moves shaping the future of drug development and patient care. Regeneron has recently ventured into the radiopharmaceuticals market through a substantial $2.1 billion agreement with Australia's Telix Pharmaceuticals. This move marks a significant diversification from Regeneron's traditional focus, such as obesity treatments, to an area that combines radioactive isotopes with targeting molecules for diagnosing and treating diseases like cancer more effectively. The strategic alliance positions Regeneron as a formidable player in this emerging field, promising to expand its therapeutic portfolio and revenue streams. In oncology innovation, GSK is pushing forward with a bold initiative, conducting Phase 3 trials for antibody-drug conjugates (ADCs) in collaboration with Hansoh Pharmaceutical. This effort underscores GSK's commitment to expanding its oncology pipeline, particularly in targeting unmet medical needs through innovative therapies. Antibody-drug conjugates are designed to deliver cytotoxic agents directly to cancer cells, minimizing damage to healthy tissues and offering a precision approach to cancer treatment. Allogeneic CAR-T therapies are also making waves, with Allogene Therapeutics reporting promising early data from their off-the-shelf CAR-T therapy, cema-cel. This therapy effectively eradicated minimal residual disease in lymphoma patients, highlighting the potential of allogeneic approaches to provide accessible cancer treatments without the logistical complexities of autologous methods. In another significant milestone, Ideaya Biosciences, in collaboration with Servier, achieved success with their eye cancer drug candidate meeting its primary endpoint in a crucial Phase 2/3 trial. This success sets the stage for an accelerated FDA approval filing, offering new hope for patients dealing with this challenging condition. Revolution Medicines has made notable progress in oncology as well, with its highly anticipated RAS inhibitor demonstrating improved survival outcomes in a Phase 3 trial for pancreatic cancer. Extending survival by an average of six months compared to chemotherapy could redefine treatment paradigms for one of the most aggressive cancer types. Not every development has been favorable, however. Replimune faced its second FDA rejection for its melanoma candidate RP1, leading to workforce reductions—a testament to the rigorous nature of regulatory approvals and the challenges companies face when bringing novel therapies to market. Meanwhile, BioNTech and Synox Therapeutics are advancing towards FDA approval for their tumor-targeting therapies. These efforts could intensify competition within the oncology space, challenging established giants like AstraZeneca and Daiichi Sankyo. In pain management, AbbVie has expanded its portfolio through a $745 million deal with Haisco Pharmaceutical Group for two non-opioid pain treatment candidates. This move aligns with growing demand for non-opioid alternatives amid the opioid crisis, reflecting a strategic shift towards safer pain management solutions. Spyre Therapeutics has also reported positive Phase 2 results for its ulcerative colitis drug, setting it up as a potential competitor against Takeda's Entyvio. Success here could enhance therapeutic options for patients struggling with this chronic condition, highlighting continued innovation in gastrointestinal disorders. Eli Lilly's recent success with its BTK inhibitor Jaypirca marks a pivotal moment in chronic lymphocytic leukemia (CLL) treatment strategies. Having demonstrated substantial efficacy in a Phase 3 clinical trial—the fourth positive readout—Jaypirca establishes itself as an industry first. Its fixed-duratioSupport the show

Dr. Monty Pal speaks with internationally acclaimed hematologists Dr. Vincent Rajkumar and Dr. Saad Usmani about the AQUILA trial in high-risk smoldering multiple myeloma, as well as advances in CAR-T and other evolving treatment strategies in the myeloma space. TRANSCRIPT Dr. Monty Pal: Hello everyone and welcome to the ASCO Daily News Podcast. I'm your host, Monty Pal. I'm a medical oncologist, underline medical oncologist, a professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. You're going to understand why I underlined "medical oncologist" there. I'm actually on the line today with two amazing hematologists. Today, we're going to actually explore treatments for high-risk smoldering multiple myeloma following the FDA's approval last year of daratumumab for the first-ever treatment of this indication. Now, this is based on the AQUILA trial, and this represents a huge shift in our traditional watch-and-wait approach to active disease interception. We're going to consider whether this landmark trial published in The New England Journal translates to day-to-day practice. I think it does, and we'll certainly make an argument for that. And I'm so fortunate today to have two internationally acclaimed experts here in the conversation: Dr. Vincent Rajkumar, senior author on the manuscript, and Dr. Saad Usmani, also an expert in his own right in myeloma. Dr. Rajkumar is the lead investigator of the AQUILA study. He's a professor of medicine and consultant in the divisions of hematology and hematopathology at the Mayo Clinic in Rochester, Minnesota. He actually chairs the Myeloma, Amyloidosis, Dysproteinemia Program. He is also editor-in-chief of the Blood Cancer Journal. Dr. Usmani, he and I actually go way, way back. We actually did the AACR Molecular Biology in Clinical Oncology course, I want to say in 2006, so this is our 20-year anniversary, Saad. He's the chief of the myeloma service at the MSK Cancer Center and a professor of medicine at the Weill Cornell Medical College in New York.  Saad, Vincent, welcome. Dr. Saad Usmani: Thank you so much for having me, Monty. Dr. Vincent Rajkumar: Yeah, thanks, Monty. A pleasure to be here. Dr. Monty Pal: Thanks. And just a quick note for our listeners, all of our disclosures are available in the transcript of this episode. First off, Saad, did I get that right? Was it 2006 when we did that course together? Dr. Saad Usmani: Yeah, 20 years. We are coming up to our 20-year anniversary. It's remarkable to have seen our careers move the way they have, Monty. Dr. Monty Pal: Oh my gosh. And for all the fellows who are on the line, that AACR Molecular Biology and Clinical Oncology course, it's sometimes overlooked. Wonderful primer on translational science. Okay, now we're going to get to the heart of the matter here, the AQUILA trial. So this was a study, Vincent, that you led. I wonder if you'd walk us through the primary endpoints in the study. What are we looking at in the AQUILA trial specifically? Dr. Vincent Rajkumar: Thanks so much. Again, as you mentioned, smoldering multiple myeloma has just been a condition that we watch and wait. And the first thing that I want to clarify here is that the AQUILA trial is looking at only a subset of smoldering multiple myeloma. That is the high-risk smoldering multiple myeloma. It was defined the way high-risk smoldering myeloma was defined at the time the trial was designed. It randomized 390 patients. One arm got daratumumab single agent in an attempt to delay progression to active myeloma and possibly prolong survival. And the other arm was the traditional observation. The primary endpoint, therefore, was time to active multiple myeloma. Other endpoints included time to when patients needed to start therapy for active multiple myeloma, which can vary based on physician judgment, and overall survival. Of course, response rate, complete response rate, and others were also endpoints. Dr. Monty Pal: That's interesting. And you know, I wanted you to riff a little bit on this definition of high-risk smoldering myeloma. Can you tell our audience how that's sort of evolved over the years? Dr. Vincent Rajkumar: Yes. I mean, if you step back, monoclonal gammopathy of undetermined significance has only a 1% per year risk of progression. Smoldering multiple myeloma, all comers have a 10% per year risk of progression. And over the years, trials have been done in the whole population, and then more recently, we felt we should really focus on the people with high-risk smoldering, defined as a 50-50 risk of progression in 2 years. That's like a 25% per year risk of progression in the first 2 years, which is a very high risk for the patient and something that would justify prophylactic intervention. And that definition initially was based on just high levels of monoclonal protein like more than 3 grams, the IgA subtype of myeloma, the suppression of uninvolved immunoglobulins. Others have used bone marrow flow cytometry markers, cytogenetics. Those combinations of factors were available at the time the AQUILA trial was designed, and a select combination was used. Later on, we found that we could match almost all of that in a very simple risk stratification using just the percentage of bone marrow plasma cells, the level of the M-spike, and the free light chain ratio, all three of which are available to all patients with smoldering at the time of diagnosis. So you don't need any special testing. So more than 20% plasma cells, more than 20 for the light chain ratio, and more than 2 grams for the M-spike. If someone has any two of the three, that is high-risk smoldering multiple myeloma according to the IMWG, but that definition, of course, came in 2020 after the AQUILA trial completed accrual. Dr. Monty Pal: That's interesting because this sort of flips the traditional paradigm where biomarkers get more and more complex as time goes on. Am I right in saying this sort of simplifies things a little bit? It uses standard laboratory or clinical parameters to gauge this category? Dr. Vincent Rajkumar: Absolutely. People were using suppression of uninvolved immunoglobulins, and those levels are not standardized, often vary by race. Also, the other aspect was the abnormal plasma cells on flow cytometry. Again, labs define it differently. So this makes it much more simple. But the IMWG also did a separate exploratory cohort within that paper where we added cytogenetics and we added scoring systems to improve on this further. So it simplified it for regular clinical practice and for like trials. But if you have a patient in front of you, the IMWG paper also has more complex scoring systems where you can take more than 20; 21 is more than 20, so is 51. And so, you can use the actual numbers that a patient has, additional variables like cytogenetics, and get a more refined estimate of what is the true risk of progression. Dr. Monty Pal: That's really helpful. Now, you told us about the primary endpoints, you've helped us define high-risk smoldering myeloma. Can you give us a sense of the top-line results from AQUILA? Dr. Vincent Rajkumar: Yes, I think the most important one was the primary endpoint, time to multiple myeloma, was at 5 years, the progression-free survival was 63% in the daratumumab arm compared to 41% in the observation arm. So, you know, approximately 60% of patients in the observation arm had already progressed by 5 years. And that number was about 40% for the daratumumab arm. We also looked at time to starting myeloma therapy, which is clinically actually quite meaningful because, you know, myeloma therapy means patients get a quadruplet for induction, they get stem cell transplant, they get endless maintenance, they get ongoing therapy virtually for the entire duration. So, preventing the need for myeloma therapy is in and of itself, I think, a major endpoint. And that at 3 years, 40% of people in the observation arm required full myeloma therapy compared to only 20% in the daratumumab arm. So there's a significant reduction in the risk of developing active myeloma as well as the need for myeloma therapy by using a time-limited 3 years of daratumumab single agent. Dr. Monty Pal: Perfect summary of the results. And maybe, Saad, I'm going to bring you into the conversation now. How does this sort of influence your day-to-day practice for smoldering myeloma? Is this something that you've incorporated for that high-risk subset? Dr. Saad Usmani: Thank you, Monty, and I agree. I think that's a really nice summary from Vincent. This study is very important for several reasons. It's actually the third clinical trial that has demonstrated that patients who are in the high-risk smoldering myeloma category benefit from an early intervention that delays the progression to active myeloma or to end-organ damage. And so having a nuanced discussion with our patients in the clinic becomes very important. Having this discussion around as an option becomes very important. And like Vincent said, when we look at that high-risk smoldering myeloma patient population, someone who has 22, 23% plasma cells versus, you know, 45, 50, you know, it's going to be a different discussion each time. But I think it's a very important first step. And I think this sets up the stage for us to design clinical trials where we can ask other questions on what would be better than daratumumab alone in terms of delaying progression in these patients. The other thing that I do want to highlight, and Vincent touched upon this a little bit, that the treatment in this clinical trial was for a fixed duration of treatment. So it was not forever treatment. This is maybe something that Vincent, you can even comment on a little bit more because the question we get after having this discussion is, "Okay, what do we do with patients who are going to be progressing to active myeloma?" Whether we can utilize anti-CD38 therapies for those. So Vincent, I would love your take on this too. Dr. Vincent Rajkumar: Yeah, I think, you know, the main philosophical change for me was previously, the thing was 'don't treat', and now for high-risk smoldering multiple myeloma, the question is, is daratumumab the best treatment or can we do something better? And those trials are thankfully ongoing. One of them has already completed accrual, isatuximab-len-dex versus len-dex. And another one is ongoing in ECOG, almost close to finishing accrual. And in the future, we'll be trying to see if we can use early intervention to even cure and prevent progression altogether.  So we are in this phase where we have one approved regimen, one approved drug, and we are not sure whether we can improve on that. The question is, "is a myeloma-like therapy better than monotherapy" would be the next question, and then what would we do further beyond that? In this context, whenever we have patients like this, one of the questions that comes up, as Saad mentioned, is how does this affect newly diagnosed myeloma therapy if somebody has been treated for smoldering and things like that? How will they be considered for clinical trials? Would they be considered as relapse myeloma or still newly diagnosed myeloma? And those are important discussions for clinical trialists to keep in mind, but I think for clinical practice, your duty is to the patient in front of you. If they have high-risk smoldering myeloma and there's data that there's treatments that can delay progression significantly, delay the need for myeloma therapy significantly, that's the highest priority. We'll cross that bridge.   There are so few patients going on clinical trials right now that if such a patient were to later on progress and wants to enter in a newly diagnosed myeloma trial later, years later, we can figure that out later. I feel like the most important discussion is what to do for that patient today. I still prefer a clinical trial if one was available. If one was not available, I'd prefer early intervention, but have an informed discussion with the patient because some of them may wish to delay therapy still. Some of them may have very borderline numbers that you want to watch them closely. Some of them may be having other comorbidities that prevent need for therapy. Some of them maybe have had the smoldering for a long time and you already know it's stable. So a lot of factors go in, and I think it's not a one-size-fits-all. Dr. Monty Pal: This is a terrific discussion, and you know, it sort of segues into maybe a question around biology. And this is something I was going to get to a little bit later, but Saad, I'm glad you brought it up. I'll liken it to the only thing I know, which is kidney cancer. So, you know, in kidney cancer, we use checkpoint inhibitors as adjuvant therapy. And there's this question of whether or not it breeds some resistance in the localized setting to ultimately what the patient might potentially be exposed to in the metastatic setting. Tell me your thoughts on this, Vincent, then maybe Saad separately. If you treat a patient with daratumumab in this high-risk smoldering setting, could it theoretically sort of limit options in the refractory setting now that we have regimens like DRBD that are kind of being utilized, or daratumumab with teclistamab? Vincent, I'll throw that to you first. Dr. Vincent Rajkumar: This is a great question, and it's usually asked when we've done the lenalidomide trials actually. We try to put the question back. If that was your concern, how would you actually solve it? Is it really biology that's going to answer that? Or is it a randomized trial? So the experiment has been done three times now where early intervention has been given. And if there was some detriment because of that, that would be reflected in the overall survival. In all three trials, there's no such detriment seen. In the first lenalidomide-dex trial, there was an improvement in overall survival. In the AQUILA trial again, the confidence interval doesn't cross one, and patients had better long-term survival on AQUILA, but certainly not less. We've also examined PFS2 data, and that doesn't seem to be affected. So yes, there is a theoretical concern, and that concern cannot be allayed for new treatments which we have not even tried, like tec-dara, and whether that effect would be there or not. But so far, I don't see it. And I think the onus is on proof of that in order to prevent people from getting early therapy. Dr. Monty Pal: Yeah. Saad, your thoughts on that? And before you jump in, I'll mention, we're kind of taking the same approach in kidney cancer, we're trying to really do studies to see whether or not, you know, immunotherapy rechallenge in these contexts, you know, really lends any substantial benefit. So far, the results have been interesting. I don't think we have enough numbers as yet to capture the impact of adjuvant therapy as it translates to metastatic, but I see so many similarities between the scenarios that you're facing in myeloma and what we're facing in RCC. Saad, your thoughts? Dr. Saad Usmani: Thanks, Monty. I'll go back to something that Vincent alluded to a few minutes ago about the way that we risk-stratify patients within smoldering myeloma. Right now, we are relying more on a disease burden-based stratification looking at the percentage of plasma cells in the bone marrow, the monoclonal protein, as well as the involved light chain versus the uninvolved light chain ratio. However, there are efforts underway to actually incorporate genomics into that schema and try to refine that definition of high-risk smoldering. And there have been two papers that came out in the latter half of last year. In fact. Dr. Rajkumar and I are co-senior authors on one effort where we can identify genomic myeloma in patients in precursor conditions. One of the key things that came out of that effort was that within the high-risk smoldering myeloma category, about 90% of the patients are genomically myeloma. So this whole debate of whether we need to intervene for those patients, I think, you know, we have sufficient biologic evidence that yes, we need to intervene for those patients.  I think that the next real step, like Vincent stated, is how do we intervene in those patients? And those clinical trials kind of are ongoing. We will probably need to have more validation of those genomic models being incorporated, but that's what I see in the future. I wouldn't be concerned for the patients being seen today with that query about the disease biology evolving because if I'm seeing a patient today in March of the first quarter of 2026 and offering them monotherapy daratumumab in their high-risk smoldering situation for the next 3 years and then they progress to myeloma after another couple of years, we are talking about what would be the treatment options for them in 2031, 2032. So I think the field is moving so fast, we have a lot of novel therapies coming into that frontline setting rapidly, so our options at that time would be very different. So, you know, I just wanted to kind of set up the stage for saying, you know, our tools are getting better in delineating which patients will need that intervention. And then eventually, I think, you know, we'll have much better options for newly diagnosed myeloma patients at the time when they need it in the future. Dr. Monty Pal: Just absolutely brilliant, absolutely brilliant. I love that summary. I think that you're absolutely right in saying that, you know, you've got to think about what you're going to do for that patient sort of in the moment, what's going to optimize their outcome and agree that the landscape is evolving very rapidly.  I'd be remiss, Saad, if I didn't ask you about something that I've been following in terms of your career trajectory. You've developed quite a reputation for your leadership in trials looking at CAR T-cell therapies for myeloma. Can you give us a sense of where that stands in broad terms? Dr. Saad Usmani: Certainly, Monty. I think the CAR Ts have slowly made their way from late relapse to early relapse. And now we have clinical trials that have completed accrual in the frontline setting comparing them to standard-of-care treatment for both older myeloma patients or transplant-ineligible patients, as well as younger transplant-eligible patients where we're actually trying to replace transplants with BCMA-directed CAR T-cell therapies. The nuance there would be we want to equal or better the survival outcomes that we've accomplished without compromising on the safety side of things for patients. Those therapies are moving into earlier lines. And more excitingly, you know, that's just the first wave of CARs. The next wave of CAR technology is coming, and it's going to be in vivo CARs where we may not need lymphodepleting chemotherapy, we may not even need as stringent regulatory nuances that we do for cellular therapies today. So, you know, I think the field is moving rapidly, and it's going to be a very interesting landscape to see over the next 5 to 6 years. Dr. Monty Pal: Yeah, you know, it's so interesting. I know in the solid tumor space, we're trying to replicate the success that you've had with CAR T and bispecifics, and I do see some light at the end of the tunnel. I'm seeing some really promising agents being developed, but clearly, we have so much to learn from our colleagues in hematology. Well, I have to tell you, this has just been a phenomenal conversation. Vincent, congratulations on your leadership of the AQUILA trial. Clearly, a big paradigm shift in the field. Saad, thank you for offering your expert insights and really giving us also a glimpse at the future of myeloma. Really appreciate having you both on the podcast today. Dr. Vincent Rajkumar: Thank you, Monty. Dr. Saad Usmani: Thank you so much. Dr. Monty Pal: And thank you so much to our listeners for your time today. Finally, if you value the insights that you hear from 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. Monty Pal    @montypal   Dr. Vincent Rajkumar @VincentRK Dr. Saad Z. Usmani @szusmani   Follow ASCO on social media:           ASCO on X     ASCO on Bluesky          ASCO on Facebook           ASCO on LinkedIn           Disclosures:        Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview      Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical    Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis    Dr. Vincent Rajkumar: Honoraria: Research to Practice, Medscape Patents, Royalties, Other Intellectual Property: Authorship Royalties from Up To Date Dr. Saad Usmani: Consulting or Advisory Role: Janssen Oncology, GlaxoSmithKline, Abbvie, Bristol-Myers Squibb/Celgene, Regeneron, AstraZeneca, Sanofi Research Funding: Janssen Oncology, Bristol-Myers Squibb, K36 Therapeutics, Abbvie, Regeneron  

@crashkolnikov on X, and author of Notes From The Beauty Contest Substack, joins the show. Notes From The Beauty Contest is a long form Substack that focuses on stocks that are somewhat under covered elsewhere. It got its start with a deep dive into Regeneron, which is a primary focal point of this discussion. We hope you enjoy. Sponsorship InformationThank you to ⁠⁠⁠⁠⁠⁠⁠Trata⁠⁠⁠⁠⁠⁠⁠ for sponsoring the show.If you're listening to this podcast, you'll like Trata. Trata is buyside to buyside conversations on individual stocks. Trata makes finding a bull or bear on any stock as easy as clicking two buttons. Over 125 funds globally contribute that collectively cover 2000+ tickers. Trata raised over $3mm coming out of Y Combinator. Before you would track 13Fs, now you can understand what funds are actually thinking. You can join as a lurker or you can join as a contributor and Trata will pay you hundreds of dollars per call. For a free trial, go to ⁠⁠⁠⁠⁠⁠⁠trytrata.com/brew⁠⁠⁠⁠⁠⁠⁠ OG Sponsor Shoutout:Thank you to ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Fiscal.ai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ for sponsoring the show. DISCOUNT INFO: If you use the affiliate link ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠fiscal.ai/brew⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, you will automatically get 2 weeks of Fiscal Pro for Free and if you find that you want to upgrade, my link will get you 15% off any paid plans. About ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Fiscal.ai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Fiscal.ai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ is the complete modern data terminal for global equities.The ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Fiscal.ai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ platform combines a powerful user experience with all the financial data capabilities that professional investors need. Users get up to 20 years of historical financials for all stocks globally that they can easily chart, compare, or export into their own models. And unlike legacy data terminals where it can take hours or even days, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Fiscal.ai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠'s data is updated within minutes of earnings reports. ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Fiscal.ai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ also tracks all the company-specific Segment & KPI data so you don't have to. Like to track Amazon's Cloud Revenue? They've got it.How about Spotify's premium subscribers? Or Google's quarterly paid clicks?They've got all of it.

Dr. Monty Pal and Dr. Vamsi Velcheti discuss the evolving treatment landscape in EGFR-mutated non-small cell lung cancer, including landmark trials like FLAURA2, novel drug therapies, and the growing importance of ctDNA and MRD testing. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, I'm truly delighted to introduce Dr. Vamsi Velcheti, who's a professor of medicine and the chief of hematology-oncology at the Mayo Clinic in Jacksonville, Florida. We'll be discussing the expanding treatment landscape in EGFR-positive lung cancer and how to navigate the challenges of balancing treatment efficacy, toxicity, and patient quality of life in the EGFR-positive space.  Just FYI, our full disclosures are available in the transcript of this episode.  Vamsi, it's so great to have you on the podcast. Thank you so much for being here. Dr. Vamsi Velcheti: Thank you, Monty. It's a pleasure to be here with you. It's a really exciting topic and there are a lot of updates in the EGFR space. Dr. Monty Pal: So, I'm going to need your help with this because I'll be honest with you, I see very little lung cancer, if any, in my practice. I'm pretty much exclusively kidney cancer these days. I'm coming on 20 years at City of Hope now, and I still remember when trials like ECOG 1599 were presented with, you know, platinum doublets. And, of course, the field has changed a lot since then. But tell us a little bit about the first-line landscape, and I think just for the sake of time, we're going to stick with EGFR-positive disease here. What does it look like these days? Dr. Vamsi Velcheti: Monty, the foundation of care remains the third-generation EGFR inhibitors. These are selective EGFR inhibitors, like osimertinib. We've had an evolution of the development of these TKIs. Like, you know, we had the first-generation, second-generation, not-so-selective EGFR inhibitors. Now we have mutant-selective EGFR inhibitors in the clinic, and they're doing a really good job. And these are quite effective in patients who have classical activating mutations. But the reality is that these have not been transformative. These agents have fundamentally changed the response patterns, excellent CNS penetration, and very good tolerability profile. However, we don't see a lot of durability in terms of the response. So, what's different today is now there have been several trials in combination with these third-generation EGFR inhibitors that have really laid the foundation of how we kind of think about EGFR-positive disease. At the high level, there are a lot of challenges to selecting the patients for these combination-based modalities. I'm assuming we'll be talking more about these different trials and different approaches. Some of these combination-based strategies have really moved the needle in terms of improving overall survival and really improving long-term outcomes and durability in our patients. Dr. Monty Pal: And we are going to get into the weeds on this in just a moment. But I did kick off this podcast talking about chemotherapy, ECOG 1599. It does seem as though chemotherapy is still a component of management in advanced non-small cell lung cancer. So, can you tell us about, perhaps first, you mentioned osimertinib, you know, some of these next-generation EGFR inhibitors. Tell us about the role of chemo plus osimertinib. Dr. Vamsi Velcheti: That's exactly where I was going with the combination-based strategies. You know, we first started off with our earlier trials in the EGFR space evaluating the question of, are targeted therapies, are these highly effective, third-generation, EGFR-selective inhibitors, superior to platinum-doublet chemotherapy? And we've had multiple trials demonstrating that, like the FLAURA trial and in the past with second-generation EGFR inhibitors like erlotinib and gefitinib and afatinib. So, we know that these TKIs actually perform better than platinum-doublet chemotherapy. Now, we have a large, global, phase 3 trial data from the FLAURA2 trial, which looks at the question, "Hey, you know, osimertinib is better than chemotherapy, platinum-doublet chemotherapy. Can we do even better by combining osimertinib with platinum-doublet chemotherapy?" So, FLAURA2 answered that question. This is a large, phase 3 trial, and it's a positive trial with improved durability of disease control and improving overall survival with combination with chemotherapy. So, it's a very important and landmark trial, and essentially combining osimertinib with a platinum-based chemotherapy improved responses, deepened responses, and improved overall survival and really changing the disease trajectory. And this strategy is definitely compelling, especially in patients who have certain clinical high-risk features like, you know, patients who have high disease burden or patients who are sometimes having rapid disease progression early on osimertinib, especially with patients who have a lot of visceral disease burden. So, intensifying treatments up front could alter the natural trajectory of the disease. Dr. Monty Pal: So, you sort of alluded to this in that last part there, but is that kind of how you in clinical practice select? Is it based on, you know, visceral involvement? Is it based on rapidity of disease where you think about adding chemotherapy to osimertinib? Maybe you can give us the corollary. Which patients do you just use osimertinib alone in, for instance? Dr. Vamsi Velcheti: Definitely, there are some patients who have low disease burden and they have the classical mutations, like an exon 19 deletion. And these patients, especially if they don't have a lot of disease burden, they don't have CNS involvement, there may be a subset of patients who could just do fine on osimertinib of course, with close monitoring of the disease. I guess we'll get into that later, how do we do that with either ctDNA or like closer imaging or both. So, there may be some opportunity to kind of escalate patients' treatments based on certain clinical characteristics or radiographic characteristics or certain biological characteristics informed by ctDNA or other approaches. Dr. Monty Pal: No, that's interesting. And you're right, we will chat about ctDNA in just a bit. But before we get there, I think one of the big agents that has really sort of come to the fore in advanced non-small cell lung cancer is amivantamab. I've heard a lot about this in the context of even kidney cancer because in certain subsets, I'm interested in MET-directed therapies and so forth, right? So maybe tell us a little bit about the mechanism of amivantamab first, and then maybe tell us about this pivotal MARIPOSA trial where it's combined with lazertinib. Dr. Vamsi Velcheti: So, the MARIPOSA trial compared lazertinib alone with amivantamab plus lazertinib. And this trial demonstrated overall survival advantage, and there were key differences in terms of tolerability and the safety of amivantamab, which is an EGFR and MET bispecific, and there were certain kind of unique toxicity profiles that make it a little different than the intensification approach with chemotherapy through the FLAURA2 trial. So, there's a trade-off in terms of the toxicity profile. It's a different agent and a different management protocol in terms of dermatological toxicity management that clinicians need to be comfortable with. And also, there are certain unique issues in terms of amivantamab; there's a higher rate of infusion-related reactions, there's an increased risk for edema and VTEs because of amivantamab. Certainly a different toxicity profile, different management paradigm there in terms of longitudinal care of these patients requiring dermatological care and like, you know, close monitoring and prophylaxis VTEs. But having said that, definitely it's a different strategy, and it kind of changes the biology and the natural history of the cancers, and we do see some durability of responses that we see with the MARIPOSA. So, it's certainly a great alternative, at least for some patients. Dr. Monty Pal: That was a great overview of MARIPOSA. Now comes the really difficult question, which is, how do you choose between the two? You have these two great options, right, for EGFR-positive patients. You've already highlighted some of the distinctions in terms of toxicity. I think the audience is well aware of the side effects of chemo-doublet, perhaps even the EGFR-based therapies. Amivantamab is quite new. Give us a sense of how you in clinical practice decide between the two potential options here. Dr. Vamsi Velcheti: Yeah, I think that's the big challenge. I think these are two independent strategies that have evolved through the phase 3, and both of them have demonstrated overall survival benefit. So, the way I think about this is in three dimensions, right? Like, the disease biology, the patient priorities, and feasibility of care delivery. So, when I talk about the disease biology, you know, the mechanism is very different, and MET is a very dominant driver of disease in EGFR-altered patients and it's a significant mechanism of resistance, acquired resistance to TKIs. So, certainly I think there's a patient population that could benefit from a MET-directed therapy up front. However, we don't have great data to kind of really demonstrate how using amivantamab in the front line is going to change that. And are there like perhaps like some patients who we could identify who would benefit from such a strategy? Very recently, there have been some approvals in the second-line setting in lung cancer, not in the EGFR space, but like in generally in lung cancer, with the MET ADCs, and those drugs are approved with a companion diagnostic, which requires MET IHC testing. So, what has happened, at least in large academic practices and also I think in the community now, they have been checking for MET IHC expression more routinely in lung cancer. What we have been doing in our institution is we have been doing MET IHC as a reflex for all patients with EGFR, not just EGFR, but all non-small cell lung cancer patients. What that has done is now, like, we have been increasingly testing patients with EGFR for MET. And there's clearly a subset of patients who have de novo MET expression and a high MET expression. And those patients, I've been kind of like preferentially treating them with the MARIPOSA regimen. But again, I have to caution the audience that we still don't have data that MET IHC is going to help us make those decisions, whether it's better than like a FLAURA2 regimen. But however, in the second-line setting in the CHRYSALIS trial, we know that MET is a very powerful predictor of response to amivantamab. We really need more data there, but that's what I have been doing in my practice. But also, there's a lot of patient preference here. Like, there are some patients who don't want chemotherapy, and they want a non-chemotherapy approach. So, certainly there are some patients who prefer to have amivantamab. And now with the amivantamab, the subcutaneous version, the infusion reactions and the logistics of actual administration of amivantamab are more favorable with the subcutaneous approval. So, those are some of the elements that we need to take into account. Dr. Monty Pal: Well, I want to hone in on that because this subcutaneous administration route has been a big debate that I've seen on social media. Tell us, how much easier does it actually make the amivantamab experience? Does it cut down on the rash? Is it just infusion reactions? What's been your clinical experience? Vamsi Velcheti, MD: So, the subcutaneous administration of amivantamab has definitely improved the infusion reaction issue. Very rarely patients have infusion reaction now with the subcutaneous injections. And also, the infusion time is much, much shorter. Like we don't need a lot of infusion time, which is sometimes a challenge in busy infusion clinics. We need to take that into account. As far as the impact of the subcutaneous formulation on dermatological toxicity, we haven't really seen significant difference in terms of the intensity or rates of dermatological toxicity with subcutaneous. The benefits are really with the infusion reaction, the ease of administration. And interestingly, in the PALOMA trial, it also seems to be, even though this was not the primary endpoint of the study, there seems to be some suggestion that the subcutaneous amivantamab seems to have improved OS compared to the IV amivantamab. We don't really understand why, but that's a finding from the trial that's very intriguing. Dr. Monty Pal: That is really fascinating. I'm kind of curious to see how that's going to pan out. I'm going to shift gears a little bit here. And, you know, as we sort of close, I wanted to talk a little bit about biomarkers. I mean, this is obviously not a lung cancer-specific issue. It's something we think about across the board. But what I will say is that there are certain commonalities, and in bladder cancer, we think a lot now about ctDNA. But you've been way ahead of the game in lung cancer. Tell us how you guys use ctDNA, maybe both from the standpoint of monitoring for mutational status, but if you can, maybe offer some insights into some of these new MRD tests that are available too. Dr. Vamsi Velcheti: Yeah, it's rapidly evolving. Certainly, I think in the lung cancer space, you know, this has really kicked off in the lung cancer space with incorporating ctDNA into the workflow. Of course, you know, like baseline evaluation, we still kind of heavily rely on tissue genomic sequencing. But as you know, with targeted therapy, a lot of these patients have disease that evolves over time, and changes in terms of mutational pattern driving acquired resistance is a major issue across different molecular subtypes. And especially so in EGFR, when there are certain actionable opportunities associated with that transformation. So, we need to kind of have like a longitudinal snapshot of how we monitor these patients. So, the ctDNA has come to be like a tool that has now come to the forefront of clinical workflow, and almost all my patients who are having disease progression have ctDNA for kind of evaluating for resistance and informing treatment decisions, especially in EGFR. But having said that, there are a lot of challenges in terms of using ctDNA as a tool for monitoring. There are a lot of different types of assays and different platforms, and being able to use this as a quantitative tool that would be used along with the CT scans that we routinely use in clinical practice has been a challenge. And I think I would love to hear your perspectives as well, Monty, about how you're thinking about that in bladder and other disease contexts. But having said that, I think there's a lot of opportunity to incorporate ctDNA and MRD assays into clinical decision-making. Right now, in terms of clinical trials and clinical development, there have been some very interesting trials that are currently ongoing, especially in the EGFR space. We know that patients who clear ctDNA, based on some retrospective data and also like some retrospective-prospective data from trials that have already read out, that patients who clear ctDNA early with target therapy tend to do much better. They have a longer durability of response. There may be a subset of patients who have, even though they're having radiographic response, they have persistent ctDNA after a certain time point of initiation of targeted therapy. Those patients may require escalation of therapy. We don't yet know. I can't recommend that as a standard right now because we don't have clinical evidence to support that. But however, some of the clinical trials, like the ELIOS trial that's being done right now, that's actually completed enrollment, we'll hopefully see the results very soon. So, there is an emerging thought that instead of intensifying treatment for all patients with EGFR, there may be a population that may be just fine with frontline osimertinib monotherapy and introducing the intensification strategy at the time of emergence of MRD or progression on ctDNA before radiographic progression. So, there are a lot of adaptive molecular response criteria that we are kind of exploring in clinical trials that could inform how the future is going to look like for EGFR and other perhaps targeted therapies as well. So, it's fascinating, and I think there's a lot of opportunity there. Dr. Monty Pal: You know, you asked for my perspective. I actually think that what you highlighted there is the most interesting opportunity for ctDNA: the ability to de-escalate therapy. In terms of drug development, we've done so much to bring new therapies to patients, and now it's a bit of an embarrassment of riches, but the downside is that I feel like we tend to overtreat a lot of patients in the clinic. So, I definitely view MRD, you know, some of these other ctDNA techniques with methylation and so forth that may not be sort of tumor-dependent or bespoke could be incredibly, incredibly helpful. You touched on sort of the future, right, in this last section here with biomarkers. But give us a sense now in terms of novel drug therapies in the EGFR space. What are you most excited about moving forward in 2026 and beyond? Dr. Vamsi Velcheti: Yeah, I think there's a lot going on in this space, and not just this space, but across lung cancer and others as well. Like looking at the next generation of targets for ADCs. And I think a lot of these have to do with…so far in the drug development space, as you know, the improvements in clinical outcomes has been very incremental. So, we really need to make that big leap. And I think the big leap is not going to come from, in my opinion, from the next ADC, but it's going to come from how we tailor treatments and how we monitor disease better and how do we kind of incorporate the next treatment earlier and not wait for the radiographic progression. So, there's a lot of opportunity there to integrate biomarkers and dynamic biomarkers into clinical trial design and incorporating the recent advances in terms of drug design. You know, we have a lot of assets in the EGFR space, the next-generation EGFR inhibitors that are kind of designed with resistance in mind and rational combination, knowing when to introduce those combinations is also equally important. So, there's a lot going on, really exciting times to be in drug development. The one thing that I really hope will come to the forefront in drug development, not just for lung cancer, but all disease groups, is to kind of really be thoughtful about how we incorporate these really cool molecular monitoring tools and creating a composite score with imaging to be able to like really design the next generation of clinical trials. Dr. Monty Pal: You're so spot-on with that. I definitely think that we're getting to this point where, you know, we could think about the next BiTE, the next CAR-T, the next ADC. But, you know, maybe it's time for us to start really honing in on appropriate applications of these drugs, honing in on the right dose and what have you, because I definitely see some issues there.  Vamsi, this has just been terrific. I really want to thank you so much for sharing your fantastic insights with us today on the ASCO Daily News Podcast, and I really appreciate all your efforts to move the field of lung cancer forward. Dr. Vamsi Velcheti: Thanks, Monty. I really enjoyed the conversation. Dr. Monty Pal: Yeah, this was terrific.  And thanks to our listeners as well. If you value the insights that you hear from 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. Monty Pal   @montypal  Dr. Vamsi Velcheti @VamsiVelcheti Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Vamsi Velcheti:   Honoraria: Galvanize Therapeutics  Consulting or Advisory Role: Bristol-Myers Squibb, Merck, AstraZeneca/MedImmune, GSK, Amgen, Taiho Oncology, Novocure, Regeneron, Takeda, Janssen Oncology, Picture Health Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline

Over 1.5million adults in the UK tried weight loss drugs in 2024-25. Many swear by them, but they have been associated with side effects including nausea and, in some cases, extremely painful gallstones. But what does the evidence actually tell us, and what is the wider impact on the way we view our bodies in society?James Gallagher is joined by Professor of Cardiometabolic Medicine at the University of Glasgow Naveed Sattar, Dr Beverley O'Hara, Lecturer in Public Health Nutrition at Leeds Beckett University, and Dr Margaret McCartney, resident Inside Health GP. They discuss what the evidence tells us about the potential known side effects of these weight loss drugs, and the potential impact their use has on our view of obesity as a society. We also hear from Sarah Le Brocq, who has struggled with obesity all her adult life and has been on these drugs for the past 2-3 years about her experiences. Margaret McCartney has no conflicts of interest to declare.Beverley O'Hara has no conflicts of interest to declare. She has 2 roles with the Association for the Study of Obesity (voluntary academic positions).Naveed Sattar has consulted for and/or received speaker honoraria from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Carmot Therapeutics, Eli Lilly, Gan & Lee, GlaxoSmithKline, Hanmi Pharmaceuticals, Kailera, Mass Medicines, Menarini-Ricerche, Metsera, Novo Nordisk, Pfizer, Regeneron, Roche, UCB Pharma, and Verdiva Bio; and received grant support paid to his University from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche.Presenter: James Gallagher Producer: Hannah Fisher Researcher: Tom Hunt Production coordinator: Stuart Laws Content Editor: Ilan Goodman