Podcasts about regeneron

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.  

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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

Tras la pérdida de los primeros soportes en Europa, el análisis pasa por ver hasta dónde llegará el giro bajista de estos últimos días. En el caso del Ibex, a partir de los 17.000 puntos la ecuación rentabilidad/riesgo ya se supone atractiva en busca de un repunte hacia máximos del año. En Estados Unidos la fotografía es más nítida e invita a esperar al menos a los 6.600 puntos del S&P 500 o los 24.000 puntos del Nasdaq 100, donde se abrieron los grandes huecos alcistas tras las primeras noticias de distensión geopolítica. Para aprovechar esas zonas de compra que pueden abrirse en cualquier momento, Joan Cabrero señala tres valores internacionales interesantes como son AMD, Marvell y Regeneron Pharma. Porque ahora mismo no se trata de estar dentro por estar, sino de estar preparado para cuando de verdad merezca la pena. Y esa oportunidad, aunque hoy no esté, volverá. Siempre vuelve.

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

In Belf's News Gallery, Greg goes over everything trending in the news including the reclassification of Marijuana, the Israel and Lebanon ceasefire, the prediction market insider trading scandal, the NFL draft, Trump's deal with pharmaceutical company Regeneron, the Strait of Hormuz and Iran, the mass shooting in Baton Rouge, and more...See omnystudio.com/listener for privacy information.

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  

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 Sciences Advisory Council, interview Angelica Lackey Mirzoca, MPH, about her research on social vulnerability and EoE. 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] 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 — research on social vulnerability and eosinophilic esophagitis (EoE) — and today's guest, Angelica Lackey Mirzoca, a fourth-year medical student at the University of North Carolina School of Medicine in Chapel Hill.   [1:38] Angelica will start an internal medicine residency this summer and is planning to do a fellowship in GI and liver disease. Before medical school, she studied public health nutrition at UNC and worked in clinical research in eosinophilic diseases.   [1:58] Angelica has been able to use her analytic and public health skills as a member of UNC's EoE Research Group, which is part of the larger Center for Esophageal Diseases and Swallowing, led by Dr. Evan Dellon.   [2:15] Ryan sees Dr. Dellon as his GI. Dr. Dellon has been a guest on the Real Talk: Eosinophilic Diseases podcast. Ryan says Dr. Dellon is wonderful, and many in the community look up to him. It's exciting that Angelica is doing research alongside him.   [2:38] Dr. Craig Reed, part of the EoE Group, who works closely with Dr. Dellon, invited Angelica to a research meeting. She's always had an interest in digestive tract function and diseases.   [2:55] When Angelica was growing up, her father had Barrett's Esophagus. She saw him choking a lot when he was swallowing. It was really scary.   [3:04] Angelica says that being in the EoE space and appreciating the impact that problems swallowing have, not only on the patient's everyday life but on the people around the patient, it was important to her to dedicate her skills and time to EoE.   [3:37] Angelica researched EoE and social vulnerability. Her abstract at the 2025 Digestive Diseases Week was titled "Increasing Social Vulnerability Impacts Presentation and Decreases Treatment Response in Eosinophilic Esophagitis."   [3:58] Angelica explains that social vulnerability is a term to describe the context of people's day-to-day lives and the barriers and obstacles they navigate.   [4:07] In this context, their lived experience has a dramatic impact on people's ability to anticipate and recover from different stressors.   [4:16] Some groups are notably more vulnerable, including kids, older adults, single-parent households, and people who live with physical and mental disabilities.   [4:28] Social vulnerability can be measured qualitatively in terms of socio-economic status and household composition. Other composite scores or variables can serve as quantitative assessments of social vulnerability.   [4:50] Ryan says he does research for graduate school associated with climate vulnerability and infrastructure. He has done some work with the CDC's Social Vulnerability Index and the Climate and Environmental Justice Screening Tool.   [5:20] Angelica says they used the CDC's Social Vulnerability Index in the study. It's a 16-variable composite score with four overarching themes. It's down to the Census Track level. You can associate it with patient zip codes.   [5:37] The SVI can populate into patient charts or a QI database. It was very easy to incorporate into the database.   [5:50] The QI database was developed to help people understand what neighborhoods and communities might need additional support in natural disasters. It includes variables that impact people's health day-to-day.    [6:18] Angelica says health equity is core to everything she does. Participating in the EoE research, it was important to her to consider the social vulnerability, or people's lived reality, and how it impacts their ability to feel empowered to access care.   [6:42] Angelica talks about people not knowing what's wrong with them, choking. Angelica worked in restaurants for 12 years before going to medical school. She listened to a lot of people share their struggles to communicate with the doctors.   [7:09] Holly says when she worked at a major children's hospital in an EoE clinic, they had local patient families and patients that flew in from farther away. The local patients got to see her weekly for feeding therapy. That's when she started doing telehealth.   [8:04] Angelica says the biggest strength of the database is its size. Having 1,400 people and adding every new diagnosis they get at UNC, and every new diagnosis over the past 23 years.   [8:25] There are adult (60%) and child (40%) patients in the database. There is also a good range of social vulnerability among the patients.   [8:42] Ryan notes that one of the findings of this research was that people with higher social vulnerability often experience delays in diagnosis.    [8:52] Angelica says most of the work was postulating on what could be the things that kept people from being diagnosed early, which is important. Angelica hopes that all institutions work to ensure that early endoscopies and biopsies are done.   [9:!2] The new guidelines help. Having that high index of suspicion for everyone, not basing it on demographics or judging by appearance, for whether someone needs biopsies or not.   [9:28] Social vulnerability includes access to care, getting endoscopies and biopsies, having health insurance, and ER care, which is expensive even with insurance. Specialty copays are expensive. Transportation is expensive.   [9:53] Taking time off work can be hard. People take time off to get care for their children, but often not for themselves.   [10:18] Ryan was diagnosed in 2002. Knowledge of EoE was not widespread, but his parents took off work and took him to doctors out of state. They had insurance that covered it. He saw five or six physicians in multiple states before he got a diagnosis.   [10:42] Ryan's situation is not feasible for most people. He says he is fortunate to have gotten to a doctor who had the expertise to diagnose EoE.   [10:51] Ryan says Dr. Emily McGowan was a guest on the Real Talk: Eosinophilic Diseases podcast (Episode 15), speaking on access to specialty care for EoE. She had researched urban and rural populations getting diagnosed with EoE.   [11:05] Her research showed that if you're near a center that can diagnose you, you get diagnosed more frequently, which brings it back to access to care.   [11:19] Angelica's research did not look at the urban/rural divide. That's something that may be a future direction of research. Eighty percent of North Carolina, where the study was located, is rural.   [11:41] The Social Vulnerability Index shows there is the highest vulnerability in more rural areas, especially Eastern North Carolina. Angelica imagines that the urban/rural divide plays a big role.   [11:59] Holly grew up in rural New York. She wasn't diagnosed until her twenties. She had issues, but her parents couldn't take her to be diagnosed. It's reassuring to have someone look into this, because when people do research, things change.   [12:30] Ryan says all of these points make a lot of sense on the diagnostic side. If you are in a more socially vulnerable place, you don't have the resources. You can't go and get that diagnosis.   [12:41] Ryan mentions the study found a difference in symptoms, such as vomiting, nausea, and abdominal pain. Ryan asks what that tells us about how EoE may affect patients differently in these different circumstances.   [12:53] Angelica says the study group was 40% children, and children can present with different symptoms, like belly pain and regurgitation. They're eating different foods and may not be noticing solid foods getting stuck as often.   [13:20] Anglica says there can be a lot of overlap with GERD and EoE. There may be some gut-brain interaction. There's a lot of psycho-social stress among people who have higher social vulnerability. That often manifests with the motility of the GI tract.   [13:56] Angelica says their database doesn't include people who have eosinophilic GI diseases outside of EoE.   [14:13] Holly says the study also showed that patients with higher social vulnerability were less likely to respond to swallowed steroid treatments, even after accounting for factors like age and insurance. Holly asks Angelica to explain this finding.   [14:34] Angelica says this is really important. The way you manage EoE is very patient-specific. The new guidelines give jurisdiction to you, as a patient, and your provider in deciding other things.   [14:51] You can choose dietary therapy first, or topical steroids first. People can take PPIs. They used to be required first, but now they are not. Topical steroids, the ones that you swallow, are common. Cutting out foods from your diet can be challenging.   [15:17] Some people don't love the idea of taking medicine daily in their twenties or thirties.   [15:32] The fact that you would start a patient on something and not see a histologic response opens up the door to follow-up questions of why it is not working.   [15:50] Holly says the pattern wasn't shown in people using diet-based treatments and asks what might explain that difference. She mentions that dietary elimination groceries are expensive, compared to having good insurance covering the medicine.   [16:14] Angelica says Dr. Dellon and part of the group did a study a couple of years ago looking at the cost of dietary elimination for patients. There was a lot of heterogeneity in diet elimination. It wasn't all six food elimination. It was different for everybody.   [16:36] They found that it was cheaper for patients to do elimination diets than to pay for the compounded medicines.   [16:44] Angelica was doing interviews recently for her residency, and a patient told her that when they were first diagnosed, it was hundreds of dollars for their compounded medicine, and they couldn't afford it.   [17:00] Angelica says diet therapy can be different for children versus adults. Adults are sometimes very motivated to try diet therapy. The team wondered if that motivation could influence their outcomes or their ability to adhere to eliminating things.   [17:23] Holly remembers sitting with the social worker at the Children's Hospital of Colorado GDP Clinic, talking about explaining when you're dairy-free, looking at ingredients like whey. There's so much that comes with it. It's confusing.   [17:41] Ryan says he has used swallowed steroids; he's now on a biologic. He's done diet elimination. Groceries are expensive, but there are ways to work around that. Insurance can be frustrating with step therapies, so sometimes diet is the best option.   [18:18] Ryan asks if a delayed diagnosis can impact symptom severity and disease progression, and therefore, the response to treatment options. Is the later diagnosis you see with more socially vulnerable populations playing into the treatment response?   [18:34] Angelica says the delayed diagnosis can lead to a more acute change in the lining of the esophagus, to become more fibrotic and tougher, and the esophagus loses some of its natural flexibility. She says we do wonder if that can be a component of it.   [18:59] Angelica says that's one of the limitations of the study. We need follow-up information to look longitudinally at some of the more recent endoscopies and the outcomes for these patients. She says that's something that we hope to do.   [19:16] Ryan asks about information about disease severity within the data set. Angelica says they have information on the severity scores of patients.   [19:54] The data showed that patients with higher social vulnerability had more of a mixed inflammatory phenotype compared to people with lower social vulnerability.   [20:09] Ryan notes that there are so many different angles to look at. He says in doing research, especially when working with medical charts, you can't get everything for such a large population. What you're able to figure out from all this is so cool.   [20:24] Holly says she was the person who ended up in the ED with a food impaction, and that could have been avoided. She loves that Angelica is researching it.   [20:44] Holly asks what the key takeaways are for clinicians from this research.   [20:54] Angelica says a key takeaway for all clinicians caring for people with EoE is that you have to take into consideration the vulnerabilities that patients are navigating. We operate within a complicated health system that needs to be more efficient.   [21:14] Angelica says you get more messages daily and have a lot of competing needs. It can be easy to assume that this patient in front of me is doing well enough and has access to what they need to be supported.   [21:31] Patients having space to ask a question about something important to them can be validating and affirming. Whether patients want to share at that encounter, or at the next. It normalizes that we humans need help navigating life, because it's hard.   [22:20] Holly talks about providers sitting down with you and asking if you have access to drive to this specialty pharmacy, or if you live in a home where this medicine can be delivered to you safely. It's nice to have someone ask what's going to work best for you.   [22:49] Angelica agrees. She says the Social Vulnerability Index can be incorporated into Epic. You can look at a high score and make sure the patient has a social worker and care management. Make it standard procedure to discuss it with patients.   [23:10] Ryan explains to listeners that Epic is where all patient information and records are stored. Holly mentions that her office doesn't have Epic, and she misses having electronic medical records.   [23:34] Ryan says as a patient, it's impactful that his healthcare team considers his life outside the doctor's office and that he is sticking with his care and can find care that works well for him.   [24:11] Angelica says it's important that patients understand that the spaces they are in outside the clinic do impact their health. Up to 80% of our health is influenced by things outside of the hospital and clinic, like health behaviors, exercise, smoking, and alcohol.   [24:36] Angelica says your physical environment is so important: the quality of your housing, your carpet, the pollution in your air, working in a factory, working with animals, that's important to consider.   [25:00] Angelica says your general stress level is important. That can be worse when you live in an environment that's very noisy or where you don't feel physically safe. Those are very important things to share with your doctors.   [25:25] Ryan speaks of research he does on California wildfires, where the power might be turned off for days at a time to avoid starting fires, which can spoil refrigerated foods or medicines that are difficult to replace. Where you live has major impacts.   [26:31] Angelica says something we want to do is to look at a pooled subset of around 80 patients to see what is going on with their swallowed steroid treatment. You can discern quite a lot from a chart review by the questions patients send to their team.   [26:56] Questions might be things like confusion about how to take the medication, any trouble with insurance claims, or if the medicines are touching the throat the way they're supposed to be. Is the throat not getting adequate exposure to the medicine?   [27:20] A thought the team had was that if there's increased chronic stress, that increases the allostatic load, and that can impact total inflammation. Will that make the mucosa in some people inherently resistant, and do they need bigger doses to treat the disease?   [27:42] Angelica says we're also going to incorporate the jobs they are working and the potential exposures they have there. How far they live from UNC Main, and if they are living in a rural county or not. They are trying to identify specific areas to help patients.   [28:08] Ryan speaks of the benefits and drawbacks of integrating AI into patient records. In chronic cases, the AI summaries are skimming over important details.   [28:45] Angelica says they are using AI at UNC, a lot of times when people are being admitted to the ED. It's also being used in the clinic. Angelica sees that AI edits out important details of a patient's social history.   [29:27] Holly says her office is trialing an AI, and she has learned she can teach it what is necessary to include in the notes. It can be good if you use it appropriately and train it.   [30:03] Ryan says his father recently had a prescription denied because the AI said he didn't have the disorder. He was diagnosed 20 years ago. It took several phone calls to override the AI and see in his chart that he needed this medication.   [30:54] Angelica says she hopes that this study can be the beginning of a conversation.   [31:00] Health equity is important in all of medical care. Angelica hears more about it in a primary care setting. She looks forward to health equity becoming the core of GI and liver diseases and to how we approach that care.   [31:20] Having the conversation can be the beginning of advocacy. It will be the beginning of having medications be more affordable, so you do not have to try and fail so many medications before you get the one that works for you.   [31:40] Angelica says every hour of not having the medication that works for them is hard for people. This research was a relatively simple project that answered some very important questions and left us with many more important questions to answer.   [32:00] Angelica hopes it shows the feasibility of using these tools that we already have in the community, to start making everyone's health better, and not just people who have access.   [32:15] Ryan says we're excited that you're here talking about this with us. We'd also like to congratulate you on receiving an award last year at Digestive Disease Week.   [32:23] It was an honor to recognize you with the American Gastroenterological Association APFED Abstract Award for your outstanding research that we've been discussing today.   [32:31] The abstract, "Increasing Social Vulnerability Impacts Presentation and Decreases Treatment Response in Eosinophilic Esophagitis," was selected in recognition of its significant contributions to the field.   [32:47] Angelica says it was such an honor. It means a lot to her because she conceptualized and executed this project, with so much support from Dr. Dellon and the larger EoE Group. She says she couldn't have done it without them.   [33:05] Angelica says, most importantly, the project was a small win for health equity. She hopes that it starts a lot of important conversations and that we continue to be more attuned to the social drivers that impact our really vulnerable patient population.   [33:30] Angelica's final words: For patients, caregivers, and loved ones, I encourage you to ask questions. There are no stupid or silly questions. If you feel silly asking, how you feel is valid, but it's really important that you get your questions answered.   [33:55] It's OK to say you don't know what questions to ask. You are the expert on what you need and what is important to you. Ask questions, and say when you don't know what to ask.   [34:40] Holly thinks that's great for people with a new diagnosis, or children. Ask, what would you ask, if you were in my shoes?   [34:54] Ryan thinks this is a great start for listeners who are newly diagnosed. If you'd like to learn more about eosinophilic disorders, we encourage you to visit apfed.org and check out the links in the show notes.   [35:09] If you're looking for a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [35:18] 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.   [35:28] If you've been personally impacted by eosinophilic disorders and are interested in sharing your experience, please check out APFED.org/shareyourstory.   [35:37] Ryan thanks Angelica for joining us today. This was a super insightful conversation. Angelica thanks Ryan and Holly for having her on. It was a pleasure getting to talk today.   [35:54] Holly thanks Angelica and also 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 Angelica Lackey Mirzoca, MPHpubmed.ncbi.nlm.nih.gov/41551662 apfed.org/blog/may-2025-research-roundup-ddw-edition gastro.org/news/introducing-the-2025-aga-research-foundation-awardees   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "When I was growing up, my Dad had Barrett's Esophagus. I saw him choking a lot when he was swallowing. It was really scary. And so, being in the EoE space…was really important and attractive to me." — Angelica Lackey Mirzoca, MPH   "We used the CDC's Social Vulnerability Index in the study. It's a 16-variable composite score with four overarching themes. It's down to the Census Track level. You can associate it with patient zip codes." — Angelica Lackey Mirzoca, MPH   "Health equity is core to everything I do. Having the opportunity to participate in the EoE research, I felt it was important that we considered the social vulnerability, or people's lived reality, and how that impacts their ability to access care." — Angelica Lackey Mirzoca, MPH   "Most of the work was postulating on what could be the things that kept people from being diagnosed early, something that's really important." — Angelica Lackey Mirzoca, MPH   "I encourage you to ask questions…It's OK to say you don't know what questions to ask. You are the expert on what you need and what is important to you. Ask questions, and say when you don't know what to ask." — Angelica Lackey Mirzoca, MPH   Guest Bio: Angelica Lackey Mirzoca, MPH

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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

After Friday's news that Center for Biologics Evaluation & Research Chief Vinay Prasad will leave the FDA—again—at the end of April, stocks for several rare disease drug developers popped. UniQure, in particular, was up 51% in premarket trading on Monday. Prasad in a meeting last Thursday with select journalists called the biotech's Huntington's treatment AMT-130 a “failed” therapy, according to STAT News. Shares of Replimune and REGENXBIO—which have suffered rejections during the past year—also rose.One person who is not impressed with the plethora of rare disease drug rejections of late—H.C. Wainwright said in a note Tuesday that there have been at least five cell and gene therapies they believe could have been approved under prior FDA officials—is Wisconsin Senator Ron Johnson. Tuesday, Bloomberg News reported that Johnson has launched an investigation into these recent denials.Johnson called the FDA's request that uniQure conduct a sham surgery-controlled trial of AMT-130 “bureaucratic idiocy,” according to the publication. Meanwhile, uniQure and the FDA appear to be on different pages regarding the design of this prospective trial, with uniQure Chief Medical Officer Walid Abi-Saab referring to a 10-12 hour surgery during which [burr] holes would be drilled in patients' skulls and Prasad claiming on a media call last week that it would require only “one to three nicks in the scalp.”In other news, no episode of The Weekly would be complete without our weekly weight loss segment. Roche and Zealand Pharma's amylin analog fell short of Eli Lilly's rival candidate eloralintide; AbbVie reported what analysts called “competitive” results, with its amylin analog eliciting nearly 10% weight loss at 13 weeks in a Phase 1 trial; and Regeneron touted a much-needed Phase 3 win for Hansoh-partnered dual GLP-1/GIPR agonist olatorepatide in China. Beyond data, Novo Nordisk and Hims & Hers are together again, with Novo striking a deal to sell its injectable and oral GLP-1 medicines through the telehealth provider.Elsewhere on the business side of biopharma, experts are reporting a cut-throat atmosphere behind doors on the M&A front as the supply of companies available to buy dwindles.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world.We start with a significant personnel change at the FDA, where Vinay Prasad, M.D., is set to depart by the end of April. Known for his contentious interactions with the biopharma industry, particularly concerning vaccines and cell and gene therapies, his departure may signal shifts in regulatory priorities and approaches. Industry stakeholders are closely watching how his exit will affect upcoming decisions and relations between regulatory bodies and biopharma companies.In a strategic collaboration, Novo Nordisk and Hims & Hers have settled their public disputes by agreeing to distribute Novo's Ozempic and Wegovy through Hims' telehealth platform. This partnership highlights the increasing importance of digital health platforms in expanding medication access, particularly for chronic conditions like obesity and diabetes. This trend reflects a broader movement where legacy pharmaceutical companies are turning to digital avenues to enhance patient reach.On the clinical trial front, Ipsen has decided to halt the development of its lymphoma drug Tazverik after safety concerns were raised by an independent data monitoring committee. This decision underscores the rigorous safety standards in place for clinical trials and the ongoing challenge of balancing potential therapeutic benefits against safety risks. Similarly, Roche's oral SERD giredestrant failed to meet its primary endpoint in a phase 3 trial for first-line breast cancer treatment, raising questions about the limits of selective estrogen receptor degraders despite previous successes in adjuvant and second-line settings. The complexity of translating promising mechanisms into consistent clinical outcomes across different stages of treatment is highlighted here.Regulatory challenges remain a significant theme, with Novo Nordisk's Indiana plant facing scrutiny that led to the FDA rejecting Incyte's application for Zynyz as a first-line treatment for non-small cell lung cancer. This incident underscores how manufacturing issues can heavily impact drug approval processes and highlights the critical nature of compliance with regulatory standards.In terms of new drug approvals, Bristol Myers Squibb has received FDA approval for Sotyktu, a first-in-class oral TYK2 inhibitor for treating psoriatic arthritis. This approval not only broadens treatment options for patients but also reinforces the ongoing trend towards developing targeted therapies with novel mechanisms of action. Additionally, Bristol Myers Squibb is gaining momentum with its cereblon E3 ligase modulator (celmod), mezigdomide, achieving statistically significant improvement in progression-free survival among multiple myeloma patients in a Phase 3 trial. This success solidifies BMS's position in hematologic oncology and demonstrates the potential of targeted protein degradation as a therapeutic strategy.The industry is also witnessing significant financial transactions and restructuring efforts. Lonza's decision to sell a majority stake in its capsule business to Lone Star Funds for $3 billion reflects strategic realignments as companies focus on core competencies while leveraging partnerships to optimize business operations.Meanwhile, regulatory scrutiny persists as Democratic lawmakers are investigating 11 pharmaceutical companies regarding their pricing agreements under the previous administration's "most favored nation" clause. This inquiry aims to understand whether these deals have indeed resulted in cost savings for Medicaid, highlighting ongoing concerns about drug pricing transparency and affordability.In another strategic move aimed at bolstering innovation, Regeneron reported promising results from a phase 3 trial conducted by its Chinese partner on a drug mirroring Zepbound's efficacy in obesity treatmenSupport the show

How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations.Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional interoperability, and AI reliability — and walks through the foundational steps companies should take, the organizational challenges they'll hit, and what measurable results look like when governance is done right.A few of Cary's key takeaways:Regulatory submissions are no longer just documents — they're structured data that demands consistent master data, controlled vocabularies, and traceable lineageStart with scope and pain points, not a boil-the-ocean exercise — pilot governance in one or two high-value use cases, then scaleData ownership belongs in the business, not IT — IT facilitates, but stewards and business owners should be accountable for their dataTools support governance but don't replace it — get the people and process foundation right before selecting platformsAI reliability depends on governed data — without standardized inputs and clear provenance, models produce unreliable or unexplainable outputsTie governance to business outcomes people are already measured on — submission cycle time, audit readiness, right-first-time metrics — or compliance won't stickAbout Cary SmithsonCary Smithson is Managing Partner and Owner of LeapAhead Solutions, Inc., where she leads a consulting practice focused on IT strategy, data governance, and business process consulting for life sciences. She leads the DIA RIM Working Group and the DIA RIM Intelligent Automation Team and co-authored the DIA RIM eBook. With experience spanning large consulting firms (Grant Thornton, PharmaLex), enterprise technology organizations (OpenText), and her own practice, Cary has served clients including Regeneron, Bristol-Myers Squibb, Johnson & Johnson, Daiichi Sankyo, Bayer, and BeiGene. She is a recognized thought leader who regularly presents at industry conferences on regulatory information management, intelligent automation, and AI adoption in life sciences.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

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 Sciences Advisory Council, interview Jessica Grady, a patient advocate living with EoE. 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.   [1:13] Holly introduces today's topic — eosinophilic esophagitis and life transitions — and today's guest, Jessica Grady, a patient advocate living with EoE.   [1:35] Jessica is a mom who was diagnosed with EoE in her 20s, after years of unexplained symptoms: acid reflux, GERD, food impaction, and anxiety around food. For about six years, Jessica searched for answers while dealing with these issues.   [2:00] Since then, Jessica has tried PPIs, steroids, and two clinical trials. She was always interested in the research, so being part of it has been valuable to her. There's a lot of work involved in clinical trials, and it's not easy.   [2:29] Jessica is managing her condition and has hit her second endoscopy with remission, with dupilumab. That's exciting, after her long journey. It has taught her the importance of advocating for yourself and staying hopeful with a chronic condition.   [3:01] After college, Jessica was going out with friends, and had pain almost like ulcers in her stomach. She thought maybe she was going out too much.   [3:20] One day at lunch, water got stuck. Jessica says it was like gargling; it wouldn't go down. Finally, it went down, and she took a bite of food, and that got stuck. That was her first episode. After that, Jessica has had food impactions as her main symptom.   [3:54] Jessica says it's quite a reality check when you're choking on water. How is that even possible? Once that happened, Jessica kicked herself into gear and had an endoscopy.   [4:12] Food impaction is Jessica's number one symptom. She has been to dinners where it happened, and she calmly excused herself from the table until she could finally get the food to go down.   [4:34] As Jessica aged, her food impactions started getting longer. That was terrifying, especially as a Mom needing to take care of her baby.   [4:52] Holly shares how she had symptoms from infancy and all the way through her childhood, and it was diagnosed as anxiety, until she started working in an EoE clinic and recognized her symptoms. Getting an EoE diagnosis is often very challenging.   [5:40] Jessica went to three different hospitals in her area. She didn't know what kind of doctor to look for. She went to a GI, got an endoscopy, and woke up with a fat lip. The doctor told her not to have caffeine and start on PPIs.   [6:11] There was no mention of a biopsy or EoE. She was told she had bad acid reflux and ulcers.   [6:35] The PPIs didn't help. She still had acid reflux and impactions. She was still uncomfortable.   [6:47] Jessica switched to another healthcare system and got closer to the answer, with more endoscopies and testing, but there was no research with it.   [7:02] Finally, Jessica switched to where she is today. There is a doctor and research. They run clinical trials. She gets the latest and greatest updates. She feels like it has helped her get to where she is today.   [7:21] Jessica said the doctor knew what to look for. The moment she described her symptoms, the doctor said it would need to be confirmed with a biopsy, but she has EoE. Jessica asked what now?    [7:34] Ryan says, we hear a lot of difficulty with diagnosis because not all doctors know what to look for. If they see ulcers or other common symptoms that people with EoE have, they can very easily misdiagnose. It's a tricky diagnosis to make.   [8:03] Jessica says that before her EoE diagnosis, doctors told her she had GERD, acid reflux, ulcers, and anxiety around food. They asked what her food choices were and if she was taking too big bites.   [8:12] Jessica asked the doctors why she always needs to have a bottle of water with her, and why she feels panic if there's something like a soft pretzel. They told her she was hyperactive and had anxiety. Jessica felt that that was not making sense.   [8:40] That is why Jessica feels it is so important to advocate. There's a lot of time involved when you're misdiagnosed. You get your hopes up and have lots of highs and lows. It's exhausting.   [8:53] Ryan says that when you do get diagnosed, you can start to treat the underlying condition properly, make progress, feel better, and feel like you're being listened to.   [9:30] Jessica's current course of treatment is PPIs and dupilumab. She's learned her food triggers. Being on the biologic means she doesn't have to worry as much about her triggers, but they can still cause symptoms. She doesn't eat nuts or pineapple.   [10:16] Jessica used to eat cottage cheese if she had acid reflux, but now she knows dairy is one of the worst things to have. She does her best to be mindful. She's really thankful that she's in remission now and can be like everyone else at the dinner table.   [11:04] Holly mentions that there are many trigger foods. It's patient-dependent. Dairy is the number one trigger, but we all have different little triggers, like pineapple. Holly's EoE is triggered by any melon. Ryan's EoE is triggered by apples and rice.   [11:48] Holly avoids all trigger foods for fear of an impaction or throwing up.   [12:27] Jessica says, if she wants to have an ice cream cone and live her life like everyone else, she will, but then she has guilt and wonders if it will do something to her later. She limits the high-allergy foods. If she has ice cream, she won't have cheese.   [13:06] Jessica monitors her food as much as possible. Her GI tells her that, since she's in remission, she doesn't need to be that careful. But she has anxiety because you never know if she will have a problem.   [13:21] Since Jessica has been in remission, she has recently gone from weekly to bi-weekly injections. But she is now hyper-vigilant for symptoms and starts each day with a sip of water to see how it goes down and if there are any bumps in the road.   [14:21] Jessica's GI had told her that she was only allergic to a few nuts and she could try other kinds of nuts. She tried cashews once and had a reaction. She reported it to her GI, and then he told her to avoid all nuts.   [14:47] Jessica recently went to her allergist to be retested for common allergies. The tests came back negative for every allergy. She doesn't know if that was because of being on the biologic treatment.   [16:01] Jessica's profession is clinical trial technology. That helped her to understand what a clinical trial is, how to enroll, and patient recruitment. When she went to a hospital with GI research, she asked about it. They had openings, and she enrolled.   [16:33] Jessica was interested in clinical trials because she was desperate for options and answers. Also, the cost of endoscopies adds up. Clinical trials are free. Sometimes you get paid. That was a big win for Jessica.   [17:09] When there was an option for a new treatment, she jumped at it both times. She participated in two trials. She didn't make it through them.   [17:21] In the first trial, Jessica's biopsies had two out of three criteria the trial was looking for, although she had active EoE.   [17:33] In the second trial, Jessica had a provision device she used to write a daily diary entry in. She was pretty far in, but then she had tech issues and emailed for help. That's not part of the protocol. If your diary is not logged correctly, you are out of the trial.   [17:57] That trial was an oral medication. She doesn't know if she was on the placebo or not. Jessica is always open to trials. She thinks they are very beneficial.   [18:46] After leaving the first trial, when Jessica's biopsies didn't meet the criteria, Jessica asked the clinical research nurse to keep her in mind for future trials, so she learned of the second trial.    [19:07] Jessica says she put a lot of time and effort into the second trial, with check-ins and multiple endoscopies, until she was dropped from it. It was challenging and very disappointing when she was dropped from the second trial. She was hopeful.   [19:40] At that point, Jessica changed course and started corticosteroid treatment. The inhaler didn't work. Then she did the slurry mix, and that didn't work, and then she did the injections.   [20:09] Ryan notes that Real Talk has talked to many researchers who have run clinical trials. Every time, they say they are so grateful for the community volunteering their time.   [20:21] They're very aware that some difficulties and challenges come up. Not all patients can make it to the end of the trial, whether that's on the research side or on the patient side.   [20:34] Ryan says the eosinophilic-associated disorder community, in general, is so willing to volunteer their time and participate in these things, and further research for the overall community. Ryan says it's good to hear that Jesica tried to participate.   [21:01] Jessica says she thinks it's valuable. She recommends that anyone who is interested should look into it, especially if you know you have something that's for the rest of your life. What do you have to lose?   [21:12] Jessica says she has something that can't be cured, so what is she going to do? She wants to be the tester. She wants to find something to help her. She doesn't want to choke anymore.   [21:29] Jessica wasn't a mom when she started in these clinical trials. Now she is a mother of two; she explains what conditions she would require to participate in another trial. She wants the opportunity for telemedicine visits except for when she needs a test.   [23:43] There are a lot of challenges. Jessica says that's why she is so passionate about patients and getting therapies to them. It's hard to try to do it all.   [24:24] Jessica was able to get off dupilumab when she was pregnant. She had acid reflux but no other symptoms, choking episodes, or food impactions during her pregnancy.   [25:05] Three months post-partum, it came back with a vengeance. Jessica had her first food impaction that was over 40 minutes. Earlier food impactions had been for seconds or a few minutes. It was terrifying.   [25:27] At three months post-partum, Jessica had to go back on dupilumab. No one could tell her it was safe for her child while breastfeeding. The doctor said it should be digested. It should be OK. "Should" is hard for a post-partum new mother to hear.   [26:08] In Jessica's second pregnancy, she confidently got off dupilumab again, and everything was great. Exactly three months after the birth of the second baby, she had a 45-minute food impaction.   [26:24] She thought she had to go to the ER. She was at the sink trying to get the food up, while her husband took care of the children. Finally, she recovered from the food impaction.   [27:12] Jessica had some spare dupilumab in the refrigerator from before her pregnancy. She called her GI, said she needed to go back on the dupilumab, and started it that day. On dupilumab, she hasn't had a food impaction since.   [27:52] Jessica looks at dupilumab as her lifeline. She gets to be like everybody else when she's on it. She is blessed and thankful for it. It wasn't approved for EoE until 2022. It has been a long ride to figure out how not to choke.   [28:12] Now that Jessica knows she has something that's saving her, changing from weekly to bi-weekly dupilumab injections is scary. If I don't do it this week, are we sure I'm not going to start choking again? Jessica thinks the next impaction will last an hour.   [29:06] Jessica advises people starting a family to make sure they have a care plan in place. Your doctors, family, and others need to be aware of and understand what's going on with you.    [29:19] Make sure that you're communicating. This is especially important for a woman with a GI and an OB. Make sure everyone's speaking the same language. When it comes to GI and allergy, Jessica wants to ask if they can get together on a call.   [29:41] Prepare safe and easy foods for post-partum. People may be dropping off food. Be mindful of what is safe for you to eat. Ask for a lot of help and try to have your care plan together.   [29:57] Jessica was having calls with her GI doctor when she was planning, once she was pregnant, during pregnancy, and post-partum. There was never a time when she wasn't doing check-ins to primary care, allergy, and GI.   [30:14] Have a care plan and know your trends. Jessica didn't realize the post-partum choking episode would repeat after the second birth. She thought it was a one-off. [30:38] If you have an episode, your body is telling you something. Follow the protocol you made for yourself.   [30:47] Once that food impaction happened the second time, Jessica knew exactly what to do because it had happened before. The problem was that she hadn't been proactive in starting on dupilumab before the food impaction happened.   [31:03] Jessica says her first dilation could only get to 12, so she had to have a second dilation to get to a normal 15.    [31:29] Jessica says she thought she was immortal. It only happened once; she supposed it wouldn't happen again.   [32:16] Holly says she loves to travel. When she travels, she brings along a medical emergency kit. The quality of life matters.   [32:36] Jessica watches for signs of EoE in her children. They're not showing signs of it. Anything could happen, and she takes it day by day. If the time comes and it happens, Jessica will know what to do, rather than going in clueless.   [34:44] Ryan says his parents didn't believe he had EoE before he was diagnosed.   [35:08] Jessica's last words: I would say the most challenging part of living with EoE is the unpredictability and not knowing, and the lifelong illness with that. You've got to be comfortable in the unknown.   [35:23] There's a lot of innovation and research right now, so I think more answers are coming. Be aware. See what's going on. Be more in tune with yourself. If you feel like things are happening, be mindful of that. Be comfortable knowing that it's unpredictable.   [35:50] That's the most challenging part of having EoE. Always trust your gut. Advocate for yourself. It took me years to get answers, but persistence is what got me there.   [36:05] Ryan says, that's a great outlook. Keep looking for new answers. Take it one step at a time. Be mindful and on the lookout.   [36:14] Ryan thanks Jessica for joining us today and sharing about your experience and your journey with EoE. I think this will be a super helpful conversation for our listeners.   [36:22] 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.   [36:29] If you're looking to find a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [36:37] 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.    [36:48] Ryan thanks Jessica for joining us today. This was a great conversation. Jessica thanks Ryan and Holly for having her on.   [36:59] Holly thanks Jessica and also 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   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "I'm managing my condition and have hit my second endoscopy with remission, with dupilumab." — Jessica Grady   "It's quite a reality check when you're choking on water. How is that even possible? Once that happened, I kicked myself into gear and had an endoscopy." — Jessica Grady   "If I want to have an ice cream cone and live my life like everyone else, I will, but then I have guilt and wonder if it will do something to me later." — Jessica Grady   "I advise people starting a family to make sure they have a care plan in place. Your doctors, family, and others need to be aware of and understand what's going on with you." — Jessica Grady   "I would say the most challenging part of living with EoE is the unpredictability and not knowing, and the lifelong illness with that. You've got to be comfortable in the unknown." — Jessica Grady   "There's a lot of innovation and research right now, so I think more answers are coming. Be aware. See what's going on. Be more in tune with yourself. If you feel like things are happening, be mindful of that. Be comfortable knowing that it's unpredictable." — Jessica Grady   Guest Bio: Jessica Grady, Patient Advocate

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

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

Dr. Monty Pal and Dr. Ari Rosenberg discuss the evolution of treatment strategies in head and neck cancers, including the challenges of treating both HPV-positive and HPV-negative disease and the emergence of blood-based biomarkers to advance personalized therapy across different subtypes. 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, professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, we're going to explore the evolving landscape of treatment strategies in head and neck cancer management, including locoregionally advanced head and neck squamous cell carcinoma, which happens to be on the rise in United States, in part due to spike in HPV-mediated oropharyngeal cancers. We're also going to discuss the emerging strategies of using blood-based biomarkers to really advance personalized therapy. Joining me for this discussion is Dr. Ari Rosenberg. He's a medical oncologist focused on head and neck cancer, and he's an associate professor – congratulations on the recent promotion – at the University of Chicago. The University of Chicago has really produced luminaries in this field, Dr. Rosenberg included. I've had the pleasure of getting to know Dr. Ezra Cohen over the years, who really had his grounding there, and of course Everett Vokes, former ASCO President. I'm really looking forward to this conversation, Ari. Thanks so much for joining us. Dr. Ari Rosenberg: Thanks, Monty. Thanks for the invitation. Dr. Monty Pal: You got it. And just a quick note for our listeners, our full disclosures are going to be in the transcript at the end of this episode. So let's start with the basics, if you don't mind. So, head and neck cancers are very diverse and they're challenging, right? In the sense that they're near vital organs, the treatments, you know, as we all saw during fellowship, if not now in clinical practice. They can really have such a major impact on vital organ function, speech, swallowing, et cetera. Can you just comment on head and neck cancers that are on the rise in the U.S.? I alluded to this briefly. Particularly, we've heard this in the context of colorectal cancer and so forth. Are you actually seeing younger adults being affected by this? Dr. Ari Rosenberg: Yeah, thanks for that. The vast majority of head and neck cancers are head and neck squamous cell carcinomas, as I'm sure many of the listeners recall as well from fellowship or their current training. And as you alluded to, the organ function, long-term and functional quality of life outcomes are quite important, particularly in the context that these develop in high value real estate, parts of our head and neck area that we use for speaking, swallowing, all sorts of other essential functions as well. As you also alluded to, we think of this in two different particular subtypes of head and neck cancer. The historical head and neck cancer from 50, 60 years ago was almost exclusively related to carcinogen exposure, tobacco, alcohol use, and that subtype of carcinogen-induced head and neck cancer has been slowly declining. However, over the last now several decades, we've been seeing an increase in primary oropharyngeal squamous cell carcinoma, mostly tonsil, base of tongue. These are attributable to HPV, human papillomavirus exposure. And that's now the majority of the head and neck cancers that we tend to see in our clinic. As you also alluded to, these have very different prognoses as well. HPV-related head and neck cancer has a much more favorable prognosis where much of the interest has been in can we de-intensify to optimize long-term function? But then the non-HPV-related head and neck cancer, or what we call HPV-negative head and neck cancer, continue to be very, very challenging. We only managed to cure about half of these folks, with many of these patients developing the current disease. These patients, in addition to being difficult to treat, also have major impacts both in terms of the treatments they undergo as well as their disease that can impact their function and quality of life. And you hinted at this a little bit, but we have been seeing an increase in younger patients with HPV-negative head and neck cancer as well, which is quite concerning. Younger patients, oftentimes never smokers, never drinkers, who are developing non-HPV-negative head and neck cancer. And that's been a little bit of a more recent trend that we've been seeing as well. So, definitely a lot of work to be done to optimize and improve outcomes across all of these different head and neck cancer subtypes. Dr. Monty Pal: I mean, I'm just curious, you know, in the context of colorectal cancer, one of the things that we talk about is the potential role of the microbiome driving some of these young-onset cancers with, you know, perhaps there being an impact on, for instance, inflammation and the gut and what have you. Tell me about head and neck cancer. Is this anything known as to why younger patients might be getting diagnosed with non-HPV type cancers? It's odd to me. Dr. Ari Rosenberg: Yeah, it's a great question. A lot of people are working on it. I think we folks have hypotheses, but it hasn't totally panned out exactly what's going on there. It does have a little bit more of a tendency towards women, whereas historically head and neck cancer is much more common in men than it is in women. But lots of people working on that, whether it's related to chronic inflammation, whether it's related to the microbiome. Whether it's related to dental exposure, dental work. So, a lot of folks trying to parse that out because I agree with you, it needs to be identified alongside improving treatment paradigms for these patients, the young ones and the older patients as well. Dr. Monty Pal: Interesting, interesting. You know, one of the phenomena that was sort of coming around when I was in training 25 years ago was this role of sort of induction therapy for head and neck cancers. And of course, it's really come full circle now to include checkpoint inhibitors and so forth. Tell me a little bit about this and how you apply it, maybe in an HPV-mediated context, maybe in a non-HPV context. Dr. Ari Rosenberg: Yeah, absolutely. Induction chemotherapy, as you alluded to, or neoadjuvant chemotherapy, depending on what the locoregional treatment approach is. Similar to other cancer types where systemic control early on has many potential advantages in this setting. Now, in head and neck cancer, even though induction chemotherapy is quite active in head and neck cancer, both HPV-positive and HPV-negative with pretty good response rates. A survival advantage for all comers with local regionally advanced disease remains unproven. There's been two randomized trials, both underpowered, but essentially did not show a survival advantage, showing that induction chemotherapy for all patients with locoregionally advanced and neck cancer can't be justified for a survival advantage. That being said though, there remains a number of potential advantages of giving induction or neoadjuvant chemotherapy, of course, improving systemic control and debulking the disease early on has potential advantages, and predicting the responsiveness to subsequent radiation treatment. We know for some time in head and neck cancer that the percentage of shrinkage or the response to induction chemotherapy actually predicts outcome related to radiation as a dynamic biomarker where response can be used to select patients, for example, for de-escalated radiation has been an area of active investigation, active research. And it also remains a key opportunity to evaluate predictive biomarkers and understanding pre and post treatment to better understand the biology. I'll just add to your question that recently over this past year, we also saw phase 3 data for neoadjuvant immunotherapy for a subset of head and neck cancer that is surgically resectable. And so that's reintroducing the potential benefit in the immunotherapy era of incorporating immunotherapy in the neoadjuvant or the induction setting as part of the evolving treatment paradigm for these diseases. Dr. Monty Pal: That's really interesting. And you kind of alluded to already several topics that I plan to hit on, you know, for instance, the role of immune checkpoint inhibitors, induction, chemotherapy, and so forth. And you started to touch on biomarkers. And of course, I think that's something near and dear to many of us in academic oncology. One thing that we've started talking a lot about in the context of colorectal cancer is circulating tumor DNA. How do you think this might fit in the context of head and neck cancer? Can you give us a flavor for that? Dr. Ari Rosenberg: Yeah, absolutely. In head and neck cancer, the current landscape is most developed for circulating tumor DNA for HPV-related head and neck cancer. The advantage of HPV-related head neck cancer is that you have a distinctive HPV DNA that does tend to spill out into the peripheral blood and can be detected using various different blood-based assays. And because of that advantage as a tissue agnostic approach, it turns out that a number of HPV DNA plasma assays are actually quite sensitive and quite specific. And a number of them have indeed been commercialized. Of course, not only for detecting a baseline, but also grading responsiveness during treatment and probably most importantly in the post-treatment surveillance setting, the detection of HPV DNA in the plasma remains a very important and substantial predictor of developing recurrent disease. There's been a number of trials that have been emerging looking at ctDNA and HPV-related head and neck cancer, using it, for example, as a strategy to deescalate patients. That was something we saw this past ASCO from the Dana-Farber group, and also using it to early detect recurrence and potentially intervene earlier for patients with minimal residual disease positivity. So, that remains evolving and as many folks are, I think, already using it in the clinic. But ctDNA also has a lot of potential for HPV-negative head and neck cancer. This is actually a bit more challenging to develop because you don't have that HPV DNA that you can track predictably because the tumor is an HPV- negative disease are much more heterogeneous, but there are a number of data that are coming out both for personalized assays such as Signatera or some of the other assays that require tumor. Unlike colon cancer, which you referenced, where most patients get surgery upfront, in head and neck cancer, many of the patients receive non-surgical pre-chemoradiation. So sometimes the amount of tumor available to generate a personalized assay is more limited and can be one of the challenges that we see in head neck cancer. But certainly that also seems to be emerging. And there's also further assays that are being developed for HPV-negative head neck cancers, such as methylomic signatures and others that may be tissue informed or tissue agnostic. And these are also emerging, particularly in the post-treatment surveillance setting as strong predictors of recurrent disease. So while we're certainly behind some of these other more common tumor types, colon cancer, lung cancer, we're right there with them and more and more trials are going report out, including a number of trials in our upcoming [University of Chicago] Head and Neck Cancer Symposium where I'll be presenting some data and others in the field will be presenting some data looking at ctDNA both for HPV-positive and for HPV- negative to try to improve outcomes for these patients. Dr. Monty Pal: That's so interesting. I've got to tell you that in kidney cancer, what I deal with day to day is a very low shedding disease, right? So techniques as opposed to ctDNA looking for tumor-informed information, that might be less preferred to something like methylomics where you might not necessarily be so contingent on what's happening in the primary tumor. I'm really interested in you mentioning that. Just a point of clarification, this is something I'm trying to wrap my head around. You'd mentioned circulating tumor HPV DNA, right? I assume this is markedly different from just looking for HPV titers in the patient, right? So is this actually incorporated elements of HPV within, you know, essentially host genome, if you will? Dr. Ari Rosenberg: Yeah, correct. This is circulating tumor HPV DNA. And we think of it biologically as a plasma-based tumor DNA biomarker that's specific for HPV-related head and neck cancers. Dr. Monty Pal: Got it, got it. It makes me wonder whether or not this might be applicable to diseases like cervical cancer and so forth where there's also extensively, you know, biology driven by HPV. Is that fair? Dr. Ari Rosenberg: Yes, definitely. And in the head and neck cancer field, much of this ctDNA actually was derived from a different viral mediated head neck cancer, is less common in the U.S., but nasopharyngeal cancer, which is oftentimes associated with EBV. That has been a biomarker for quite some time in nasopharyngeal cancer. Of course, in places where EBV-associated nasopharyngeal cancer, is endemic, such as East Asia, this has been around for quite some time, but we've been using that in the U.S., and there's been trials that have used EBV DNA plasma to predict recurrence and stratify for adjuvant treatment, for example. And so now with HPV, it's much more applicable to our US population because the vast majority of our head and neck cancer patients that we see in the US that are viral mediated in the US tend to be HPV-related. So having assays that we can use to improve outcomes for that biological subset remains of particular interest for us. Dr. Monty Pal: Yeah, that's fascinating. By the way, for the fellows listening, there's tons of boards pearls here that Dr. Rosenberg shared, EBV-associated cancers, the role of HPV and treatment association. So if you're recertifying anytime soon, I definitely think there's notes to take from this conversation indeed. I wanted to shift gears a little bit. And obviously, you're a prolific researcher. I don't think anyone goes through their fellowship in medical oncology without recounting these experiences of our head and neck patients really suffering from treatment-related toxicities. It's a real challenge. And I'm just wondering, I know a big body of work that you're focused on is really using multimodality treatment paradigms to perhaps reduce the cumulative treatment burden of patients with head and neck cancers. Can you talk about that a little bit? Dr. Ari Rosenberg: Yeah, definitely. Thanks for the question. And before I start going into some of the strategies, I'll just say that head and neck cancer, this is particularly for the fellows that are listening as well, just in reference to your prior comment, that this is really a multidisciplinary disease. At our center, all head and neck cancer patients are seen upfront at that first visit by all three specialties, med onc, rad onc, and surgery, because the choice and sequencing of modalities to optimize not only survival, but also functional quality of life outcome is so critical. And I think that's probably the biggest takeaway for anyone who treats a lot of head and neck cancer or will be treating a lot of head and neck cancer in the clinic. But in terms of more specific attempts at trying to optimize some of those parameters that you described, we really think about these separately in terms of HPV-positive and HPV-negative head and neck cancer. For HPV-positive head and neck cancer, the cure rates are quite high with chemo radiation, although not for everyone. There's still about 15, 10 to 15 % of folks that will develop a recurrence. But for the vast majority of patients, standard chemoradiation is quite a cure to therapy, but the toxicity associated with that can be quite substantial. And so there's been a number of attempts to try to deescalate treatment. It turns out that deescalating everyone with locoregionally advanced HPV-positive head and neck cancer is not a good strategy because it's not able to select out the patients that really do need full dose treatment. And we have seen some negative trials that show inferior outcomes when everyone is deescalated. But what does remain promising is again, trying to select out who the best candidates are for deescalated treatment. The folks at MSK have hypoxia imaging that they're using in trials that looks quite promising to select for the more favorable deescalatable biology. At our center, we've been interested in using induction chemotherapy to stratify response and select patients for deescalated treatment with excellent survival outcomes and reduce toxicity with deescalated treatment. And more recently, ctDNA that us and other groups, such as the Dana-Farber group, is using. And that also looks quite promising. Again, how do you select the patient who will do well with less radiation versus the ones that really need the full doses and volumes of radiation? And then for HPV-negative head and neck cancer, this is a much trickier disease because already the survival outcomes are not like we want it to be. Trying to figure out how to improve survival outcomes remains an important thing. Using immunotherapy seems to be one of the key cornerstones to that. But these are patients that also suffer from a lot of toxicity related to their treatment. We completed a trial not too long ago that we published this past year where we, in HPV-negative head and neck cancer patients, de-intensified the radiation for responders to neoadjuvant chemoimmunotherapy. And those patients did similar, if not even a little bit better, than the non-responders who got full dose treatment. So something that does warrant further investigation as well. How do we not only improve survival for those patients, but also reduce some of the long-term toxicities? Dr. Monty Pal: This is brilliant. I'm taking so many notes as you were mentioning these items. There are so many areas where I think the research crosses over. I already mentioned, know, ctDNA, for instance, and metabolomics and the places where that might apply to kidney cancer. The hypoxia imaging really caught my ear too. Obviously, kidney cancer is disease highly predicated on hypoxia. So thank you for all of this. We've got about a minute or so. So, I'm going to ask you for a really tall task here. Can you tell us what you foresee being some of the biggest challenges that sort of lie ahead and head and neck cancer. You've already kind of alluded to it with ongoing research, but if you had to pick maybe 2, 3 problems, the very most that we really need to get to and head and neck cancer, what would that be? Dr. Ari Rosenberg: Yeah, that's a great question. Obviously, lots of things to be done, but if I'm going to limit it to just a couple, I would say number one is really trying to improve the survival for HPV negative local regionally advanced head and neck cancer. We talked early on about how we are seeing, you know, of course we see many of these people that were smokers and drinkers, but also seeing these in younger patients, in patients without a history of tobacco use. Some of these are very biologically aggressive and we need better treatments beyond surgery, beyond chemo radiation, beyond immunotherapy to improve outcomes for these patients and cure more of them. So, I would say that's one big area. And the other is, which we didn't speak about so much in this talk, but remains one of the biggest challenges that we see in the clinic is the recurrent metastatic head and neck cancer patients. This is an incredibly challenging disease to treat, not only with poor survival, but also with substantial impacts on quality of life and function. mean, these are bad recurrences that cause a lot of pain, functional deficits, really impacts quality of life as well. So developing novel therapies, many of which are currently in clinical trials and many of which are currently continuing to be developed, remains so critical. How do we develop better systemic therapies, better targeted therapies, better biomarkers for recurrent metastatic head neck cancer to improve their survival and quality of life and functional outcomes. Those are the two big areas that require the most work at this time within the head and neck cancer field. Dr. Monty Pal: That's brilliant. I mean, I have to tell you I could probably talk to you all day about this, such a fascinating topic. It's a very exciting time in the field. Thank you, Dr. Rosenberg, for all your incredible contributions and thanks for sharing with us your insights on the ASCO Daily News Podcast. Dr. Ari Rosenberg: Yeah, and thanks for the introduction. Hope to do it again soon. Dr. Monty Pal: And many thanks to our listeners for your time today. 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. More on today's speakers:      Dr. Monty Pal   @montypal  Dr. Ari Rosenberg @AriRosenbergMD 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. Ari Rosenberg:     Stock and Other Ownership Interests: Privo Technologies Consulting or Advisory Role: Nanobiotix, EMD Serono, Vaccitech, Novartis, Eisai, Astellas Pharma, Regeneron, RAPT Therapeutics, Geovax Labs, Janssen, Summit Therapeutics Speakers' Bureau: Coherus Biosciences Research Funding (Inst.): Hookipa Biotech, EMD Serono, Purple Biotech, Bristol-Myers Squibb/Celgene, BeiGene, Abbvie, Astellas Pharma, Pfizer, Janux Therapeutics

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 breakthroughs and strategic maneuvers that are reshaping the landscape of this dynamic industry.Roche is making waves with its antibody Gazyva, initially recognized for cancer treatment. The company has successfully ventured into autoimmune diseases, targeting kidney conditions. Recent phase 3 trials have reinforced Gazyva's efficacy in treating immune-mediated kidney diseases, building on its prior approval for lupus nephritis. This marks a potential paradigm shift from oncology to autoimmune therapy applications, offering a promising new avenue for treating complex kidney disorders. Such advancements underscore the power of immune modulation in addressing severe health conditions.Turning to oncology, Eli Lilly is expanding the use of its cancer drug, Retevmo. Originally approved for specific lung and thyroid cancers with rare biomarkers, Lilly is now exploring its use in the adjuvant setting for non-small cell lung cancer. This effort reflects a broader trend in oncology: companies are increasingly looking to extend the application of targeted therapies beyond their initial indications. This expansion could significantly enhance treatment options and improve patient outcomes.In ophthalmology, Ocular Therapeutix is preparing for an FDA filing following positive phase 3 results for its wet age-related macular degeneration treatment. Their candidate, AXPAXLI, showed superior efficacy compared to Regeneron's Eylea in head-to-head trials. Despite investor skepticism, Ocular remains confident in its product's potential to impact retinal disease management positively. The competitive landscape in ophthalmology is fierce, and innovative treatments with substantial clinical benefits over existing therapies can redefine standards of care.Eli Lilly is also strategically stockpiling Orforglipron, its oral GLP-1 candidate, in anticipation of FDA approval for obesity treatment. This proactive measure aims to prevent supply chain issues seen during previous GLP-1 launches. It reflects an industry-wide focus on ensuring product availability at launch to meet growing market demand effectively.On the regulatory front, there are significant shifts as well. The Trump administration's renewed pilot of 340B rebates aims to optimize drug pricing frameworks. Novartis has secured a long-term supply agreement with Niowave for Actinium-225 (Ac-225), crucial for developing targeted cancer therapies. This highlights the sustained demand for radiopharmaceutical isotopes as part of precision medicine initiatives.Biopharma funding is expected to recover steadily by 2026, albeit with a cautious approach favoring de-risked assets over broader platform technologies. Venture capitalists prefer predictable returns amidst an evolving market landscape.Now, let's turn to Japan, where Innovacell is planning a $92 million IPO on the Tokyo Stock Exchange. This move signals a renewed interest in biotech within the region after a long drought in IPOs. Financial strategies like these are vital for advancing cell therapies that hold promise for treating conditions once deemed challenging.Gilead Sciences has acquired synthetic lethal therapy from Genhouse Bio through a $1.5 billion deal, further underscoring the growing interest in synthetic lethality as a novel cancer treatment approach. This strategy focuses on targeting tumors while sparing normal cells, offering more effective therapies with fewer side effects.In mental health innovations, Compass Pathways has reported positive results from its pivotal trial using psilocybin for treatment-resistant depression. The success of this phase 3 trial highlights the potential role of psychedelics in psychiatric care and could revolutionize mental health treatments by providing new options Support the show

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

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 announcements and strategic initiatives that are shaping the landscape of drug development and patient care.Starting with a notable investment move, Eli Lilly has announced a $3.5 billion manufacturing facility in Pennsylvania, marking a significant milestone in their "Lilly in America" initiative. This facility is set to focus on injectables and devices, reinforcing Lilly's dedication to expanding its manufacturing capabilities within the United States. These types of investments are increasingly crucial as they aim to enhance supply chain resilience and support the production of complex biologics and innovative therapies—a step that could prove pivotal in maintaining a competitive edge in the global pharmaceutical market.Meanwhile, Regeneron's Eylea franchise is encountering challenges with declining sales, even with the introduction of Eylea HD. This situation highlights the difficulties companies face in maintaining market share amidst fierce competition and evolving treatment paradigms in ophthalmology. It underscores the importance of continuous innovation and effective lifecycle management strategies to sustain product competitiveness in a rapidly changing industry environment.Takeda is also navigating turbulent waters with its ADHD medication Vyvanse facing generic competition. Despite this, Takeda maintains an optimistic outlook for future growth by narrowing the revenue gap between declining Vyvanse sales and contributions from new products. This transition is reflective of a broader industry trend where companies pivot towards novel therapeutics to offset revenue losses from patent expirations, exemplifying strategic adaptation in response to market dynamics.AstraZeneca's ambitious $18.5 billion obesity deal with China's CSPC exemplifies the growing focus on metabolic disorders driven by rising global obesity rates. This partnership not only reinforces AstraZeneca's expansion strategy into China but also highlights the increasing importance of addressing obesity—a major public health challenge with significant healthcare cost implications. The deal marks a strategic push to leverage advanced therapeutic approaches, particularly targeting GLP-1 and GIP receptors with long-acting dual agonists. Additionally, AstraZeneca's further $15 billion pledge for investments in Chinese cell therapies and radiopharmaceuticals is expected to enhance its capabilities in personalized medicine and expand its global presence across key therapeutic areas—a reflection of a broader industry trend towards asset-centric deals prioritizing targeted acquisitions over traditional mergers.Novo Nordisk's ongoing legal challenge against drug pricing provisions in the Inflation Reduction Act (IRA) is gaining momentum, with support from the U.S. Chamber of Commerce urging the Supreme Court to review the case. This legal battle underscores ongoing tensions between pharmaceutical companies and regulatory frameworks aimed at controlling drug prices, reflecting broader debates on healthcare affordability and access—a critical issue that continues to shape policy discussions across the industry.Across the Atlantic, CDMO Vetter's €480 million investment in a new plant in Germany signals robust growth in contract development and manufacturing services. This expansion aligns with increasing demand for outsourcing solutions in biopharmaceutical production, driven by complex manufacturing processes and capacity constraints faced by many biotech firms. Such investments are pivotal as they aim to enhance production capabilities and meet growing demands for innovative biologics.Quince Therapeutics recently experienced a setback with its steroid delivery technology for ataxia-telangiectasia, illustrating the Support the show

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 Sciences Advisory Council, interview Beth Morgan, a medical billing advocate and consultant, on navigating your medical bills. 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] 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, Medical Billing, and today's guest, Beth Morgan, a medical billing advocate and consultant.   [1:31] Beth says a medical billing consultant is an individual who assists someone with medical bills to make sure that they are accurate and correct, and that they match the medical records, which are notes that the provider makes.   [1:48] The medical billing consultant or advocate can make sure the bills are paid correctly and that the charges are within the reasonable prices for the treatment area.   [2:19] Beth explains how medical insurance covers healthcare costs. It protects the patients and providers from very high expenses. It can also possibly help with the stress of navigating healthcare systems.   [2:36] The goals of medical insurance are to help cover patient costs for treatments, preventive care, and prescriptions. It can also provide resources for telehealth visits or support visits, if needed.   [2:48] With a telehealth visit, you, the patient, have to make sure that your insurance plan covers and allows it. Sometimes, the cost of a telehealth visit can be more than if you were to go to the office.   [3:27] Beth says most people look at what insurance will cost them per month. They fail to look at their yearly deductible, per person or per family, their prescription costs, or what it will cost to see a specialist. They don't consider what therapies will cost them.   [4:08] Beth had a client whose insurance company would only cover in-state providers. If she went out of state, she wouldn't be covered; even an emergency might not be covered. You have to look at the "nitty-gritty" of the policy.   [4:32] Beth says the biggest things are the deductible and copay, or co-insurance. Don't just look at the cost. Most people will take out the $10,000 or $5,000 deductible plans, saying it only costs $75 for the entire family. What does it actually cover?   [5:00] You don't want sudden surprises when you get to the emergency room. You want to know what your copay will be when you go into an emergency room.   [5:11] Holly agrees with Beth and notes that Real Talk listeners have chronic illness. Some have multiple illnesses. When you're selecting insurance plans, those are the things you have to look into.   [5:27] Patients with EoE often need endoscopies and other specialized procedures. Holly asks for tips on how someone can know what an endoscopy or other procedure will potentially cost.   [5:41] Beth says to ask the doctor what the CPT code is. That's the code that describes the treatment. Then look up that CPT code on the insurance company website. They will show an estimated cost for that treatment, for a rough idea of the cost.   [6:10] Keep in mind that it will not tell you what the providers will charge or what the hospital fee will be.   [6:21] Holly says she has EoE and MS. She asks a social worker for the CPT code for every procedure so she has a record to double-check when the bill comes. The CPT code is the key.   [6:50] Holly is a speech pathologist who does feeding therapy. She says to look at your plan to see if therapy is a copay or if it goes toward your deductible. If it goes toward your deductible, it will be very expensive until you meet that deductible.   [7:10] People living with an eosinophilic disorder may find themselves in the ER for a variety of reasons. Holly was there this week with a food impaction. For others, it could be a pain flare or an asthma attack.   [7:26] Holly asks how families can be prepared for medical bills related to emergency care.   [7:40] Beth replies, You also have on that bill the ER doctor and the ambulance fee, including mileage, which must be accurate or rounded up to the next mile. Track the mileage in your car.   [8:43] Who will be transporting you: volunteers from the fire department, a hospital ambulance, or an outside ambulance? Are you going under Basic Life Support or Advanced Life Support?   [9:05] Once you get to the ER, have someone else with you who can advocate for you. Sometimes, staff will bring you forms to sign before they treat you. If you're in a lot of pain, you're not in your right mind to sign those forms; you're only thinking of your pain.   [9:53] Ryan says a friend of his went to his doctor's office for a prescription refill. Typically, he pays a $25.00 copay per visit. This prescription refill visit was not covered in the same way as other visits, and he received a bill for over $200. The insurance company only covers maintenance appointments.   [10:48] Beth says an Explanation of Benefits (EOB) comes from your insurance company. It shows what the doctor charged, what the insurance company paid, and what you owe.   [11:07] A medical bill is what your provider sends you. Beth always asks the provider to send the bill after the insurance company has paid. That way, you know the insurance company has paid on the bill, and there are no surprises.   [11:25] When the provider bills you, the insurance company may have paid something on it, or it may have applied the bill toward your deductible or copay.   [11:44] When a patient receives a provider bill, Beth says they can go to a company called FAIR Health to see today's rates of what should be charged. Insurance companies negotiate rates with providers.   [12:04] Beth says that an out-of-network provider of physical therapy can charge, for example, $160 a visit, and you have to pay out-of-pocket. They can send it to your insurance company, and the insurance company may only pay 30% of the charge.   [12:20] Call the insurance company to ask questions about your insurance. Utilize the estimated costs feature on your insurance company's website.   [12:32] Beth says she always keeps the page of her health insurance booklet that shows what a PCP office visit, or outpatient specialist visit, will cost. Most people get the book and toss it out, but that page is very helpful.   [12:53] If you go into the emergency room, you might have a $300 copay just to be seen, but if you ask them to bill you after they bill your insurance company, most places should respect that.   [13:11] Beth says that most of the time, the red flags that she looks for on medical bills are supply items. Most supply items are included in the cost of the hospital visit. She says a surgical hospital visit is like an oil change.   [13:42] Beth compares a surgery to an oil and filter change. When you go in for surgery, the drape they put over you is included. You only pay for the supply items you walk out with.   [15:15] Beth says, If there's something wrong on your medical bill, your insurance rep may not know the answer. Most insurance companies have outsourced their billing questions. Start with the billing department of the hospital.   [15:35] Ask, "Why did you bill me for an X, Y, Z, when I didn't have an X, Y, Z? I had an A, B, C. Can we re-examine this, please?" Another thing is to go back to your provider.    [15:52] The provider can request medical notes, which are part of your patient record, and you can look at them yourself. Beth says, for hospital stays, she always tells people to ask for a completely itemized bill.   [16:12] Holly agrees.   [16:20] Beth says you have to look at the itemized bill. Does something make sense to you? Does it look a little unreasonable? That's easy to see.   [16:26] Ryan says when you call your insurance company, it can be time-consuming to reach the person who can answer your question, but it's important to do so, especially for expensive things like hospital stays. Doctor's office visits can also be expensive.   [16:58] Something else that can be tricky is medications. Especially for those of us with chronic illnesses and the rare diseases that we work with here at APFED, costs can be quite high for some of the medications patients take.   [17:20] Beth says, When you call the insurance company, ask for the name of the person you are talking to. Write down the name, date, and time that you spoke to the person. Ask them for a call reference number, where they are located, and what was discussed so you have record of that information.   [18:04] For medications, you can look up prices through GoodRx or other prescription websites that might give you an estimate of what the possible cost could be.   [18:20] If your provider states on the prescription, Do not substitute or give generics, you might be paying full price. Otherwise, most pharmacies will offer you the generics.   [18:35] Holly asks, If someone feels overwhelmed by billing or insurance issues, where can they go for help? Are there resources that you recommend?   [18:45] Beth says, There is a patient advocate group, with individuals across all 50 states, that will help you with medical bills and advise you on everything else. Your provider's office or the facility also might have someone who could help you.   [19:11] Beth says she would look for patient advocates like social workers. Make sure whoever you work with has medical knowledge.    [19:26] Ryan says, talking with the billing department can feel a little antagonistic, but they are there to help you. If you talk to the right people and ask the right questions, you can figure out what's going on and get some answers.   [19:40] Beth agrees and says, Always write down your questions. Ryan adds, Always write down the answers and ask the name of the person you are talking to. Beth reminds you to ask for the call reference number. They keep a record of every call.   [20:09] Beth's last words about medical billing: "The most important thing is keeping track of what's going on. I recommend using a calendar, like a planner, that you can write 'I saw Dr. J. Smith, EoE Specialist. Discussed flare-ups,' and the time and date."   [20:30] "Keep a record. That way, in this planner, you can go back to it and match it up. If possible, have someone with you or on the phone with you when you talk with them. The other person can take notes, which is very important."   [20:39] "You need to have the backup and the understanding. If you don't understand something, ask questions." Ryan says, Those are good tips for everyone.   [21:14] For our listeners who would like to learn more about eosinophilic disorders, please visit apfed.org.   [21:20] To learn more about navigating healthcare in the United States with eosinophilic disorders, please check out NavigateEOSCare.org. We'll include links to both of those in the show notes below.   [21:29] Ryan thanks Beth Morgan for joining us today. This was an insightful conversation for everyone. Beth thanks Ryan and Holly for having her on.   [21:35] Holly also thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Beth Morgan, President & CEO of Medical Bill Detectives NavigateEOSCare.org Patient Advocate Foundation   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   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "Medical insurance covers healthcare costs. It protects the patients and caregivers from very high expenses. It can also possibly help with the stress of navigating the healthcare systems." — Beth Morgan   "Most people look at what insurance will cost them per month. They fail to look at what their yearly deductible might be, per person or per family." — Beth Morgan   "Ask the doctor what the CPT code is. That's the code that describes the treatment. Then go to the insurance company's website. Most insurance plans have it. They will give you an estimated cost for that." — Beth Morgan   "Keep a record. That way, in this planner, you can go back to it and match it up. If possible, have someone with you or on the phone with you when you talk with them. The other person can take notes, which is very important." — Beth Morgan   "For hospital stays, I always tell people to ask for a completely itemized bill." — Beth Morgan   "I would look for patient advocates like social workers. Make sure whoever you work with has medical knowledge." — Beth Morgan    Guest Bio: Beth Morgan, President & CEO of Medical Bill Detectives, has been a Certified Professional Coder (CPC) and Compliance Specialist (MCS-P) since 2004. Over the past 20 years, she has worked in several areas of the medical profession, doing billing and coding for all sorts of providers. Her knowledge and expertise have enabled her to not only reduce providers' accounts receivable but also medical bills by 51%. She has access to a broad base of insurance company policy information and is an information contributor to radio and TV shows, as well as magazine articles. Medical Bill Detectives reviews medical bills for errors and overcharges, reducing them to Usual Reasonable and Customary charges, for negotiating discounts on medical bills. We are able to review bills for all 50 states.   Aphadvocates.org/speakers/beth-morgan/ Seakexperts.com/members/7326-beth-morgan 

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

This is the 71st episode in my drug pronunciation series. In this episode, I divide Dupixent and dupilumab into syllables, tell you which syllables to emphasize, and share my sources. The written pronunciations are below and in the show notes on https://www.thepharmacistsvoice.com.   EoE is mentioned in this episode. To learn more about eosinophilic esophagitis, watch the following YouTube video: https://bit.ly/4pplm8w    Note: we don't cover pharmacology in this series. Just pronunciations.   We're changing to a new format in February 2026! Click to sign up for The Pharmacist's Voice® monthly email newsletter to get notified about each new (MONTHLY) episode. https://bit.ly/3AHJIaF    Dupixent = DU-pix-ent DU, like dual pix, like pixel ent, like [part of] the last syllable of the word, president  Emphasize DU Written Pronunciation Source: Dupixent's Patient information on the Regeneron's Website https://www.regeneron.com/downloads/dupixent_ppi.pdf (accessed 1-5-26) Spoken Pronunciation Example: Dupixent injection demonstration video - first 20 sec on dupixent.com (accessed 1-5-26) and Dupixent's YouTube channel https://www.youtube.com/@DUPIXENT (accessed 1-5-26)   dupilumab = doo-PIL-ue-mab Du, like dual PIL, like pillow ue, like the letter in the alphabet, "U' mab, which is the stem for monoclonal antibodies  Emphasize PIL Written pronunciation source: USP Dictionary Online and MedlinePlus.gov   Spoken Pronunciation Examples: Podcast episodes on Dupixent's YouTube channel (in the first 20 sec) and Dupixent injection demonstration video - in the first 20 sec on dupixent.com.   If you know someone who would like to learn how to say Dupixent and dupilumab, please share this episode with them. Subscribe for all future episodes. This podcast is on all major podcast players and YouTube. Popular links are below. ⬇️   Apple Podcasts   https://apple.co/42yqXOG  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt   Host Background: Kim Newlove has been an Ohio pharmacist since 2001 (BS Pharm, Chem Minor). Her experience includes hospital, retail, compounding, and behavioral health. She is also an author, voice actor (medical narrator and audiobook narrator), podcast host, and consultant (audio production and podcasting).    Other episodes in this series The Pharmacist's Voice Podcast Episode 362, Pronunciation Series Episode 70 (Corlanor) The Pharmacist's Voice Podcast Episode 360, Pronunciation Series Episode 69 (Kisunla) The Pharmacist's Voice Podcast Episode 358, Pronunciation Series Episode 68 (Journavx) The Pharmacist's Voice Podcast Episode 356, Pronunciation Series Episode 67 (Zanaflex) The Pharmacist's Voice Podcast Episode 352, Pronunciation Series Episode 66 (Yescarta) The Pharmacist's Voice Podcast Episode 350, Pronunciation Series Episode 65 (Xarelto) The Pharmacist's Voice Podcast Episode 349, Pronunciation Series Episode 64 (acetaminophen) The Pharmacist's Voice Podcast Episode 348, Pronunciation Series Episode 63 (Welchol/colesevelam) The Pharmacist's Voice Podcast Episode 346, Pronunciation Series Episode 62 (valacyclovir) The Pharmacist's Voice Podcast Episode 343, Pronunciation Series Episode 61 (ubrogepant) The Pharmacist's Voice Podcast Episode 341, Pronunciation Series Episode 60 (topiramate) The Pharmacist's Voice Podcast Episode 339, Pronunciation Series Episode 59 (Suboxone) The Pharmacist's Voice Podcast Episode 337, Pronunciation Series Episode 58 (rosuvastatin)  The Pharmacist's Voice Podcast Episode 335, Pronunciation Series Episode 57 (QVAR) The Pharmacist's Voice Podcast Episode 333, Pronunciation Series Episode 56 (pantoprazole)  The Pharmacist's Voice Podcast Episode 330, Pronunciation Series Episode 55 (oxcarbazepine) The Pharmacist's Voice Podcast Episode 328, Pronunciation Series Episode 54 (nalmefene) The Pharmacist's Voice Podcast Episode 326, Pronunciation Series Episode 53 (Myrbetriq) The Pharmacist's Voice Podcast Episode 324, Pronunciation Series Episode 52 (liraglutide)  The Pharmacist's Voice Podcast Episode 322, Pronunciation Series Episode 51 (ketamine) The Pharmacist's Voice Podcast Episode 320, Pronunciation Series Episode 50 (Jantoven) The Pharmacist's Voice Podcast Episode 318, Pronunciation Series Episode 49 (ipratropium) The Pharmacist's Voice Podcast Episode 316, Pronunciation Series Episode 48 (hyoscyamine) The Pharmacist's Voice Podcast Episode 313, Pronunciation Series Episode 47 (guaifenesin) The Pharmacist's Voice Podcast Episode 311, Pronunciation Series Episode 46 (fluticasone) The Pharmacist's Voice Podcast Episode 309, Pronunciation Series Episode 45 (empagliflozin) The Pharmacist's Voice Podcast Episode 307, Pronunciation Series Episode 44 (dapagliflozin) The Pharmacist's Voice Podcast Episode 304, Pronunciation Series Episode 43 (cetirizine)  The Pharmacist's Voice Podcast Episode 302, Pronunciation Series Episode 42 (buspirone)  The Pharmacist's Voice Podcast Episode 301, Pronunciation Series Episode 41 (azithromycin) The Pharmacist's Voice Podcast Episode 298, Pronunciation Series Episode 40 (umeclidinium) The Pharmacist's Voice Podcast Episode 296, Pronunciation Series Episode 39 (Januvia)  The Pharmacist's Voice Podcast Episode 294, Pronunciation Series Episode 38 (Yasmin) The Pharmacist's Voice Podcast Episode 292, Pronunciation Series Episode 37 (Xanax, alprazolam) The Pharmacist's Voice Podcast Episode 290, Pronunciation Series Episode 36 (quetiapine)  The Pharmacist's Voice Podcast Episode 287, pronunciation series ep 35 (bupropion) The Pharmacist's Voice Podcast Episode 285, pronunciation series ep 34 (fentanyl) The Pharmacist's Voice Podcast Ep 281, Pronunciation Series Ep 33 levothyroxine (Synthroid) The Pharmacist's Voice ® Podcast Ep 278, Pronunciation Series Ep 32 ondansetron (Zofran) The Pharmacist's Voice ® Podcast Episode 276, pronunciation series episode 31 (tocilizumab-aazg) The Pharmacist's Voice ® Podcast Episode 274, pronunciation series episode 30 (citalopram and escitalopram) The Pharmacist's Voice ® Podcast Episode 272, pronunciation series episode 29 (losartan) The Pharmacist's Voice Podcast Episode 269, pronunciation series episode 28 (tirzepatide) The Pharmacist's Voice Podcast Episode 267, pronunciation series episode 27 (atorvastatin)  The Pharmacist's Voice Podcast Episode 265, pronunciation series episode 26 (omeprazole) The Pharmacist's Voice Podcast Episode 263, pronunciation series episode 25 (PDE-5 inhibitors) The Pharmacist's Voice Podcast Episode 259, pronunciation series episode 24 (ketorolac) The Pharmacist's Voice ® Podcast episode 254, pronunciation series episode 23 (Paxlovid) The Pharmacist's Voice ® Podcast episode 250, pronunciation series episode 22 (metformin/Glucophage) The Pharmacist's Voice Podcast ® episode 245, pronunciation series episode 21 (naltrexone/Vivitrol) The Pharmacist's Voice ® Podcast episode 240, pronunciation series episode 20 (levalbuterol) The Pharmacist's Voice ® Podcast episode 236, pronunciation series episode 19 (phentermine)  The Pharmacist's Voice ® Podcast episode 228, pronunciation series episode 18 (ezetimibe) The Pharmacist's Voice ® Podcast episode 219, pronunciation series episode 17 (semaglutide) The Pharmacist's Voice ® Podcast episode 215, pronunciation series episode 16 (mifepristone and misoprostol) The Pharmacist's Voice ® Podcast episode 211, pronunciation series episode 15 (Humira®) The Pharmacist's Voice ® Podcast episode 202, pronunciation series episode 14 (SMZ-TMP) The Pharmacist's Voice ® Podcast episode 198, pronunciation series episode 13 (carisoprodol) The Pharmacist's Voice ® Podcast episode 194, pronunciation series episode 12 (tianeptine) The Pharmacist's Voice ® Podcast episode 188, pronunciation series episode 11 (insulin icodec)  The Pharmacist's Voice ® Podcast episode 184, pronunciation series episode 10 (phenytoin and isotretinoin) The Pharmacist's Voice ® Podcast episode 180, pronunciation series episode 9 Apretude® (cabotegravir) The Pharmacist's Voice ® Podcast episode 177, pronunciation series episode 8 (metoprolol)  The Pharmacist's Voice ® Podcast episode 164, pronunciation series episode 7 (levetiracetam) The Pharmacist's Voice ® Podcast episode 159, pronunciation series episode 6 (talimogene laherparepvec or T-VEC)  The Pharmacist's Voice ® Podcast episode 155, pronunciation series episode 5 Trulicity® (dulaglutide)  The Pharmacist's Voice ® Podcast episode 148, pronunciation series episode 4 Besponsa® (inotuzumab ozogamicin) The Pharmacist's Voice ® Podcast episode 142, pronunciation series episode 3 Zolmitriptan and Zokinvy The Pharmacist's Voice ® Podcast episode 138, pronunciation series episode 2 Molnupiravir and Taltz The Pharmacist's Voice ® Podcast episode 134, pronunciation series episode 1 Eszopiclone and Qulipta   Kim's websites and social media links: ✅ Guest Application Form (The Pharmacist's Voice Podcast) https://bit.ly/41iGogX ✅ Monthly email newsletter sign-up link https://bit.ly/3AHJIaF  ✅ LinkedIn Newsletter link https://bit.ly/40VmV5B ✅ Business website https://www.thepharmacistsvoice.com ✅ Get my FREE eBook and audiobook about podcasting ✅ 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About Bari Kowal:Bari Kowal is a senior biopharmaceutical executive with over 30 years of experience leading global operations, clinical development, and strategic portfolio management. As Senior Vice President at Regeneron, she oversees development operations, enterprise-wide portfolio strategy, risk management, and major technology initiatives, helping guide the company's continued growth and innovation. Her career spans leadership roles at Pfizer, ICON Clinical Research, Valera Pharmaceuticals, PDL BioPharma, GenVec, and Covance, where she built high-performing teams and drove operational excellence across clinical operations and strategic programs. Bari also serves on the Board of Directors of TransCelerate BioPharma Inc., contributing to industry-wide efforts to streamline and strengthen clinical trial execution. She is known for her governance expertise, collaborative leadership style, and ability to deliver organizational transformation at scale. Bari holds a master's degree in neuroscience from New York University, with additional academic training from the University of Pennsylvania and Binghamton University.Things You'll Learn:Expanding access to clinical trials requires educating both patients and physicians, many of whom are unfamiliar with how to engage in research. Better awareness can dramatically increase participation and diversify trial populations.Technology alone will not speed up drug development unless systems are connected end-to-end. Interoperability is the real catalyst for reducing inefficiencies across discovery, development, and regulatory submission.Clean, structured data is the foundation of meaningful AI adoption in healthcare. Without it, predictive models and trial optimization tools cannot reach their potential.Trial complexity is one of the most significant barriers to faster development timelines. Streamlining procedures, reducing unnecessary tests, and learning from regulatory feedback can significantly accelerate progress.Sustainable clinical research requires equipping trial sites with greater capacity and support. Even when the right patients are identified, sites must be capable of enrolling and managing them effectively.Resources:Connect with and follow Bari Kowal on LinkedIn.Follow Regeneron on LinkedIn and visit their website.

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 19, 2025. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Regeneron caught between success and expiry; Q3's top 10 drugs; Lilly's Retatrutide Raises Weight-Loss Bar; Pfizer stands by vaccines investment; and Sanofi Upbeat Despite Tolebrutinib Tribulations. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XA4W4OYCVRCSNHW5ZL7TUFJF2U/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the ever-evolving landscape of pharmaceuticals and biotechnology, a series of strategic transactions and scientific advancements are reshaping the industry.BioMarin's acquisition of Amicus Therapeutics for $4.8 billion is a significant highlight, marking the company's largest transaction to date. This move signifies a strategic pivot towards enhancing its capabilities in the rare disease sector, leveraging Amicus's expertise and robust pipeline to potentially improve patient outcomes in this highly specialized area. This acquisition is expected to enrich BioMarin's portfolio significantly with promising assets from Amicus, reflecting a strategic shift under new leadership towards rare disease treatments.Regulatory affairs have seen considerable activity as well, with the FDA raising concerns over manufacturing practices at Catalent's gene therapy facility. These issues, documented in a Form 483 following inspections, particularly pertain to the production of Elevidys. Such regulatory scrutiny emphasizes the critical importance of maintaining compliance with manufacturing standards in gene therapy—a burgeoning field within biotech that holds immense promise for treating genetically-driven conditions.The FDA's oversight extends beyond manufacturing practices to advertising, as evidenced by an untitled letter issued to Bristol Myers Squibb regarding their Cobenfy TV ad. This action is part of the FDA's broader initiative to ensure that direct-to-consumer marketing materials accurately portray drug benefits and risks, thereby protecting public health.In another strategic move, Alvotech and Teva are gearing up for the 2026 U.S. launch of an Eylea biosimilar following a settlement with Regeneron. This development highlights the competitive dynamics within the biosimilar market—a segment poised for growth as patents on major biologics expire, offering more cost-effective alternatives and expanding treatment access.Meanwhile, Clovis Oncology has achieved a milestone with Rubraca, which transitioned from accelerated approval to full FDA endorsement for prostate cancer treatment after five years. This progression underscores Rubraca's demonstrated efficacy and safety profile in addressing advanced prostate cancer—a notable achievement amid an increasingly competitive oncology market.Policy changes proposed by Health and Human Services Secretary Robert F. Kennedy Jr. could have profound implications by disrupting funding streams for hospitals providing gender-affirming care to minors. The potential impact on healthcare providers and patients who rely on these services is significant.Turning to clinical trials, Daiichi Sankyo has seen success with Enhertu receiving FDA approval for first-line HER2-positive breast cancer treatment. Nonetheless, challenges persist as a separate phase 3 trial for another antibody-drug conjugate was paused due to unexpected patient deaths. Meanwhile, Takeda plans to seek FDA approval for its TYK2 inhibitor following successful phase 3 trials in psoriasis—indicating promising potential in autoimmune disease therapies.Strategic shifts are evident across organizations as well, highlighted by Kathy Fernando's departure from Pfizer to join Replicate Bioscience as Chief Business Officer. Her new role focuses on advancing Replicate's self-replicating RNA technology platform—an area gaining traction due to its implications for vaccine development and therapeutic applications.On the clinical trials front, Altimmune reported encouraging results from a 48-week study on metabolic dysfunction-associated steatohepatitis (MASH). Their GLP-1/glucagon dual receptor agonist demonstrated sustained weight loss and improvements in non-invasive liver fibrosis measures—offering new hope for MASH patients who face limited treSupport the show

Q3 reporting left investors with a familiar challenge: hundreds of stocks traded lower after earnings, and only a few are worth deeper attention. Ben Silverman explains how he narrows that universe by looking at post-earnings insider behavior, focusing on where management actions diverge from prior patterns. He walks through cases such as Norwegian Cruise Line's first executive purchase since 2016, the Sonos CEO buying again after a 45 percent rally, and Chubb's 1.2 billion dollar buyback executed as management called shares "well below intrinsic value."Then Christine Short, Director of Research, TMX Datalinx, examines what companies signaled before they reported through changes in their confirmed earnings dates, a form of corporate "body language." She highlights real Q3 moves including Verizon delaying its date by eight days (shares down about 3 percent after earnings) and Regeneron moving up by two days (shares up about 12 percent after results), illustrating how timing decisions can hint at the tone of upcoming announcements.A concise look at how pre- and post-earnings behavior can shape positioning into year-end.Verity was acquired by TMX Group in October 2025.

How should retina specialists integrate next-generation anti-VEGFs into everyday wet AMD care? In this episode of “Anti-VEGFs: The Next Generation,” David Miller, MD, speaks with Esther Kim, MD, and Ehsan Rahimy, MD, about real-world issues facing wet AMD care, such as navigating crowded drug fridges, attempting interval extensions, and switching from legacy agents to next-generations treatments.  This editorially independent series is supported with advertising by Regeneron.

How should retina specialists integrate next-generation anti-VEGF agents into real-world DME care? In this episode of “Anti-VEGFs: The Next Generation,” David Miller, MD, speaks with Esther Kim, MD, and Ehsan Rahimy, MD, about first-line agent selection, when to transition to newer options, how to incorporate steroids thoughtfully, and crafting dosing strategies that balance durability, efficacy, and adherence for working-age patients—without overpromising outcomes.This editorially independent series is supported with advertising by Regeneron.

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 compelling advancements and challenges that are shaping this dynamic industry.Pfizer has recently unveiled phase 3 results for its hemophilia drug Hympavzi, positioning it as a formidable competitor against Sanofi's Qfitlia and Novo Nordisk's Alhemo. The data suggests Hympavzi offers robust efficacy, potentially revolutionizing hemophilia treatment and enhancing patient outcomes significantly. This development is not just about competition; it represents a critical stride forward in patient care for those affected by this debilitating condition.UCB plans to seek regulatory approval for Fintepla to treat an additional epileptic disorder following positive phase 3 trial results in patients with CDKL5 deficiency disorder. This decision reflects promising results and could offer new hope to patients with limited treatment options, further cementing Fintepla's position in epilepsy management.Gene therapy continues to shine with CSL's Hemgenix demonstrating sustained long-term benefits. After five years of follow-up, a single dose has reduced annualized bleeding rates by an impressive 90% in hemophilia B patients within the Hope-B study. Such long-term efficacy highlights gene therapy's transformative potential, offering lasting improvements in quality of life for patients with genetic disorders.Regulatory frameworks are also evolving, as evidenced by the CDC's Advisory Committee on Immunization Practices (ACIP) voting to modify hepatitis B vaccine guidance for newborns. This decision advocates an individualized approach, sparking debate over vaccination strategies, which reflects the complexities and delicate balance required in public health policies today.Regeneron is making strides to simplify treatment regimens for T-cell engagers Lynozyfic and Ordspono. By reducing regimen complexity, they aim to improve patient compliance and expand access, thus enhancing the potential impact on cancer care—a crucial step toward broader therapeutic accessibility.In an effort to address cost barriers and stimulate domestic production of generics, Mark Cuban has proposed lowering FDA fees. This proposal highlights ongoing discussions around regulatory reforms needed to boost generics manufacturing in the United States. Such initiatives align with broader industry goals of increasing access to affordable medications.Despite these advancements, industry insiders have expressed concerns about "unprecedented turmoil" within the FDA. These challenges underscore the critical role of stable leadership in maintaining public trust and ensuring effective regulation amidst rapid scientific progress.Obesity treatments are gaining significant attention as companies like Wave Life Sciences and Structure Therapeutics report promising data, capturing increased investor interest. This trend underscores a growing focus on innovative pharmacological approaches to address obesity—a complex, multifactorial condition that affects millions globally.The strategic landscape of cancer diagnostics is also evolving, as evidenced by Natera's acquisition of Foresight Diagnostics. This deal underscores ongoing industry consolidation efforts aimed at enhancing technological capabilities and expanding market presence—a testament to the critical role diagnostics play in comprehensive cancer care strategies.As we observe these developments, it's clear that scientific innovation coupled with strategic regulatory maneuvers is shaping the future of healthcare. These advancements offer profound implications for patient care, providing new hope through advanced therapies while highlighting the importance of effective regulation and strategic partnerships.Precision medicine continues to extend beyond oncology into fields like cardiometabolic and neSupport the show

Dr. Monty Pal and Dr. Jason Westin discuss the federal funding climate for cancer research and the persistent problem of drug shortages, two of the major concerns facing the oncology community in 2026. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I am your host, Dr. Monty Pal. I am a medical oncologist and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. There are always multiple challenges facing oncologists, and today, we discuss two of them that really stand out for 2026: threats to federal funding for cancer research and the persistent problem of drug shortages. I am thrilled to welcome Dr. Jason Westin, who believes that one way to meet these challenges is to get oncologists more involved in advocacy, and he will share some strategies to help us meet this moment in oncology. Dr. Westin is a professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, but he actually wears a lot of hats within ASCO. He is a member of the Board of Directors and has also previously served as chair of ASCO's Government Relations Committee. And he is also one of the inaugural members of ASCO's Political Action Committee, or PAC. He has testified before Congress about drug shortages and many other issues. Dr. Westin, I am really excited to have you on the podcast today and dive into some of these elements that will really impact our community in 2026. Thanks so much for joining us today. Dr. Jason Westin: Thank you for having me. Dr. Monty Pal: You've had such a range of experience. I already alluded to you testifying before Congress. You've actually run for office before. You wear so many different hats. I'm used to checking my PubMed every other day and seeing a new paper out from you and your group, and you publish in the New England Journal [of Medicine] on practice-setting standards and the diseases that you treat. But you've also done all this work in the domain of advocacy. I can't imagine that balancing that is easy. What has sort of motivated you on the advocacy front? Dr. Jason Westin: Advocacy to me is another way to apply our skills and help more people than just those that you're sitting across from at the time. Clinical research, of course, is a tool to try and take what we know and apply it more broadly to people that you'll never meet. And advocacy, I think, can do the same thing, where you can have a conversation with a lawmaker, you can advocate for a position, and that hopefully will help thousands or maybe even more people down the road who you'd never get to directly interact with. And so, I think it's a force multiplier in the same way that research can be. And so, I think advocacy is a wonderful part of how doctors care for our patients. And it's something that is often difficult to know where to start, but once people get into advocacy, they can see that the power, the rewarding nature of it is attractive, and most people, once they get going, continue with that through the rest of their career. Dr. Monty Pal: So, I'll ask you to expand on that a little bit. We have a lot of our younger ASCO members listening to this podcast, folks that are just starting out their careers in clinical practice or academia. Where does that journey begin? How do you get to the point that you're testifying in front of Congress and taking on these bigger sort of stances for the oncology community? Dr. Jason Westin: Yeah, with anything in medicine and in our careers, you have to start somewhere. And often you start with baby steps before you get in front of a panel of senators or other high-profile engagement opportunities. But often the first setting for junior colleagues to be engaged is doing things – we call them "Hill Days" – but basically being involved in kind of low-stakes meetings where you're with a group of peers, some of whom have done this multiple times before, and can get engaged talking to members of representatives' offices, and doing so in a way where it's a natural conversation that you're telling a story about a patient in your clinic, or that you're telling a personal experience from a policy that impacted your ability to deliver optimal care. It sounds stressful, but once you're doing it, it's not stressful. It's actually kind of fun. And it's a way that you can get comfort and skill with a group of peers who are there and able to help you. And ASCO has a number of ways to do that, both at the federal level, there's the Hill Day where we each April have several hundred ASCO members travel to Capitol Hill. There's also state engagement that can be done, so-called visiting at home, when representatives from the U.S. Congress or from state legislators are back in district. You can meet with your own representatives on behalf of yourself, on behalf of your organization, and advocate for policies in a way that can be beneficial to your patients. But those initial meetings that are in the office often they're low stakes because you could be meeting not with the representative but with their staff. And that staff sometimes is as young or even younger than our junior colleagues. These sometimes can be people in their 20s, but they're often extremely knowledgeable, extremely approachable, and are used to dealing with people who are new to advocacy. But they actually help make decisions within the office. So it's not a waste of time. It's actually a super useful way to engage. So, it's that first step of anything in life. The activation energy is always high to do something new. But I'd encourage people who are listening to this podcast already having some level of interest about it to explore ways that they could engage more. Dr. Monty Pal: You know, I have to tell you, I'm going to riff on what you just said for a second. ASCO couldn't make it any easier, I think, for folks to participate and get involved. So, if you're listening to this and scratching your head and thinking, "Well, where do I begin? How do I actually sign on for that meeting with a local representative?" Go to the ASCO ACT Network website. And I'll actually talk to our producer, Geraldine, to make sure we've got a link to that somewhere associated with this podcast after it's published, Jason, but I actually keep that on my browser and it's super easy. I check in there every now and then and see if there's any new policy or legislation that ASCO, you know, is sort of taking a stance on, and it gives me some fodder for conversation with my local representatives too. I mean, it's just an awesome, awesome vehicle. I'm going to segue right from there right to the issues. So, you and I are both at academic centers. You know, I think this is something that really pervades academia and enters into implications for general clinical practice. There's been this, you know, massive sort of proposal for decreased funding to the NCI and to the NIH and so forth. Tell us what ASCO is doing in that regard, and tell us perhaps how our community can help. Dr. Jason Westin: We live in interesting times, and I think that may be an understatement x 100. But obviously investments in research are things that when you're at an academic center, you see and feel that as part of your daily life. Members of Congress need to be reminded of that because there's a lot of other competing interests out there besides investing in the future through research. And being an elected representative is a hard job. That is something where you have to make difficult choices to support this, and that may mean not supporting that. And there's lots of good things where our tax dollars could be spent. And so, I'm sympathetic to the idea that there's not unlimited resources. However, ASCO has done an excellent job, and ASCO members have led the charge on this, of stating what research does, what is the benefit of research, and therefore why should this matter to elected representatives, to their staff, and to those people that they're elected to serve. And ASCO has led with a targeted campaign to basically have that message be conveyed at every opportunity to elected representatives. And each year on Hill Day, one of the asks that we have is to continue to support research: the NCI, NIH, ARPA-H, these are things that are always in the asks to make sure that there's appropriate funding. But effectively playing offense by saying, "It's not just a number on a sheet of paper, this is what it means to patients. This is what it means to potentially your loved ones in the future if you are in the opposite situation where you're not on the legislative side, but you're in the office receiving a diagnosis or receiving a difficult piece of news." We only have the tools we have now because of research, and each breakthrough has been years in the making and countless hours spent funded through the engine of innovation: clinical research and translational research. And so ASCO continues to beat that drum. You mentioned earlier the ACT Network. Just to bring that back again is a very useful, very easy tool to communicate to your elected representatives. When you sign up on the ASCO ACT website, you get emails periodically, not too much, but periodically get emails of, "This is a way you can engage with your lawmakers to speak up for this." And as you said, Monty, they make it as easy as possible. You click the button, you type in your address so that it figures out who your elected representatives are, and then it will send a letter on your behalf after like five clicks to say, "I want you to support research. I want you to vote for this particular thing which is of interest to ASCO and by definition to members of ASCO." And so the ACT Network is a way that people listening can engage without having to spend hours and significant time, but just a few clicks can send that letter to a representative in Congress. And the question could be: does that matter? Does contacting your senator or your elected representative do anything? If all they're hearing is somebody else making a different argument and they're hearing over and over again from people that want investments in AI or investments in something else besides cancer research, whatever it is, they may think that there's a ground shift that people want dollars to be spent over here as opposed to at the NIH or NCI or in federally funded research. It is important to continue to express the need for federal funding for our research. And so, it really is important for folks to engage. Dr. Monty Pal: 100%. One of the things that I think is not often obvious to a lot of our listeners is where the support for clinical trials comes from. You know, you've obviously run the whole gamut of studies as have I. You know, we have our pharmaceutical company-sponsored studies, which are in a particular bucket. But I would say that there's a very important and critical subset of studies that are actually government funded, right? NCI-funded clinical trials. If you don't mind, just explain to our audience the critical nature of the work that's being done in those types of studies and if you can, maybe compare and contrast the studies that are done in that bucket versus perhaps the pharmaceutical bucket. Dr. Jason Westin: Both are critical, and we're privileged that we have pharma studies that are sponsored and federally funded clinical research. And I think that part of a healthy ecosystem for us to develop new breakthroughs has a need for both. The pharma sponsored studies are done through the lens of trying to get an approval for an agent that's of interest so that the pharma company can then turn around and use that outside of a clinical trial after an FDA approval. And so those studies are often done through the lens of getting over the finish line by showing some superiority over an existing treatment or in a new patient population. But they're done through that lens of kind of the broadest population and sometimes relatively narrow endpoints, but to get the approval so that then the drug can be widely utilized. Clinical trials done through cooperative groups are sometimes done to try and optimize that or to try and look at comparative things that may not be as attractive to pharma studies, not necessarily going for that initial approval, but the fine tuning or the looking at health outcomes or looking at ensuring that we do studies in representative populations that may not be as well identified on the pharma sponsored trials, but basically filling out the gaps in the knowledge that we didn't gain from the initial phase 3 trial that led to the approval. And so both are critical. But if we only do pharma sponsored trials, if we don't fund federally supported research and that dries up, the fear I have, and many others have, is that we're going to be lacking a lot of knowledge about the best ways to use these great new therapies, these new immune therapies, or in my team, we do a lot of clinical trials on CAR T-cell therapies. If we don't have federally funded research to do the important clinical studies, we'll be in the dark about the best ways to use these drugs, and that's going to be a terrible shame. And so we really do need to continue to support federal research. Dr. Monty Pal: Yeah, there are no softball questions on this podcast, but I think everybody would be hard pressed to think that you and I would come on here and say, "Well, no, we don't need as much money for clinical trials and NCI funding" and so forth. But I think a really challenging issue to tackle, and this is something we thought to ask you ahead of the podcast, is what to do about the general climate of, you know, whether it's academic research or clinical practice here that seems to be getting some of our colleagues thinking about moving elsewhere. I've actually talked to a couple of folks who are picking up and moving to Europe for a variety of considerations, other continents, frankly. The U.S. has always been a leader when it comes to oncology research and, one might argue, research in general. Some have the mindset these days that we're losing that footing a little bit. What's your perspective? Are you concerned about some of the trends that you're seeing? What does your crystal ball tell you? Dr. Jason Westin: I am highly concerned about this. I think as you said, the U.S. has been a leader for a long time, but it wasn't always. This is not something that's preordained that the world-leading clinical research and translational research will always be done in the United States. That is something that has been developed as an ecosystem, as an engine for innovation and for job development, new technology development, since World War II. That's something that through intentional investments in research was developed that the best and brightest around the world, if they could choose to go anywhere, you wanted them to come to work at universities and academic places within the United States. And I think, as you said, that's at risk if you begin to dry up the investment in research or if you begin to have less focus on being engaged in research in a way that is forward thinking, not just kind of maintaining what we do now or only looking at having private, for profit sponsored research. But if you don't have the investment in the basic science research and the translational research and the forward-thinking part of it, the fear is that we lose the advantage and that other countries will say, "Thank you very much," and be happy to invest in ways to their advantage. And I think as you mentioned, there are people that are beginning to look elsewhere. I don't think that it's likely that a significant population of researchers in the U.S. who are established and have careers and families – I don't think that we're going to see a mass exodus of folks. I think the real risk to me is that the younger, up-and-coming people in undergraduate or in graduate school or in medical school and are the future superstars, that they could either choose to go into a different field, so they decide not to go into what could be the latest breakthroughs for cancer patients but could be doing something in AI or something in a different field that could be attractive to them because of less uncertainty about funding streams, or they could take that job offer if it's in a different country. And I think that's the concern is it may not be a 2026 problem, but it could be a 2036 or a 2046 problem that we reap what we sow if we don't invest in the future. Dr. Monty Pal: Indeed, indeed. You know, I've had the pleasure of reviewing abstracts for some of our big international meetings, as I'm sure you've done in the past too. I see this trend where, as before, we would see the preponderance of large phase 3 clinical trials and practice setting studies being done here in the U.S., I'm seeing this emergence of China, of other countries outside of the U.S. really taking lead on these things. And it certainly concerns me. If I had to sort of gauge this particular issue, it's at the top of my list in terms of what I'm concerned about. But I also wanted to ask you, Jason, in terms of the issues that are looming over oncology from an advocacy perspective, what else really sort of keeps you up at night? Dr. Jason Westin: I'm quite concerned about the drug shortages. I think that's something that is a surprisingly evergreen problem. This is something that is on its face illogical that we're talking about the greatest engine for research in the world being the United States and the investment that we've made in drug development and the breakthroughs that have happened for patients all around the world, many of them happen in the United States, and yet we don't necessarily have access to drugs from the 1970s or 1980s that are cheap, generic, sterile, injectable drugs. This is the cisplatins and the vincristines and the fludarabine type medications which are not the sexy ones that you see the ads in the magazine or on TV at night. These are the backbone drugs for many of our curative intent regimens for pediatrics and for heme malignancies and many solid tumors. And the fact that that's continuing to be an issue is, in my opinion, a failure to address the root causes, and those are going to require legislative solutions. The root causes here are basically a race to the bottom where the economics to invest in quality manufacturing really haven't been prioritized. And so it's a race to the cheapest price, which often means you undercut your competitor, and when you don't have the money to invest in good manufacturing processes, the factory breaks down, there's no alternative, you go into shortage. And this has been going on for a couple of decades, and I don't think there's an end in sight until we get a serious solution proposed by our elected officials. That is something that bothers me in the ways where we know what we should be doing for our patients, but if we don't have the drugs, we're left to be creative in ways we shouldn't have to do to figure out a plan B when we've got curative intent therapies. And I think that's a real shame.  There's obviously a lot of other things that are concerning related to oncology, but something that I have personally had experience with when I wanted to give a patient a CAR T-cell, and we don't have a supply of fludarabine, which is a trivial drug from decades ago in terms of the technology investments in genetically modified T-cells, to not then have access to a drug that should be pennies on the dollar and available at any time you want it is almost like the Air Force investing in building the latest stealth bomber, but then forgetting to get the jet fuel in a way that they can't use it because they don't have the tools that they need. And so I think that's something that we do need to have comprehensive solutions from our elected officials. Dr. Monty Pal: Brilliantly stated. I like that analogy a lot. Let's get into the weeds for a second. What would that proposal to Congress look like? What are we trying to put in front of them to help alleviate the drug shortages? Dr. Jason Westin: We could spend a couple hours, and I know podcasts usually are not set up to do that. And so I won't go through every part. I will direct you that there have been a couple of recent publications from ASCO specifically detailing solutions, and there was a recent white paper from the Senate Finance Committee that went through some legislative solutions being explored. So Dr. Gralow, ASCO CMO, and I recently had a publication in JCO OP detailing some solutions, more in that white paper from the Senate Finance. And then there's a working group actually going through ASCO's Health Policy Committee putting together a more detailed proposal that will be published probably around the end of 2026. Very briefly, what needs to happen is for government contracts for purchasing these drugs, there needs to be an outlay for quality, meaning that if you have a manufacturing facility that is able to deliver product on time, reliably, you get a bonus in terms of your contract. And that changes the model to prioritize the quality component of manufacturing. Without that, there's no reason to invest in maintaining your machine or upgrading the technology you have in your manufacturing plant. And so you have bottlenecks emerge because these drugs are cheap, and there's not a profit margin. So you get one factory that makes this key drug, and if that factory hasn't had an upgrade in their machines in 20 years, and that machine conks out and it takes 6 months to repair or replacement, that is an opportunity for that drug to go into shortage and causes a mad dash for big hospitals to purchase the drug that's available, leaving disparities to get amplified. It's a nightmare when those things happen, and they happen all the time. There are usually dozens, if not hundreds, of drugs in shortage at any given time. And this has been going on for decades. This is something that we do need large, system-wide fixes and that investment in quality, I think, will be a key part. Dr. Monty Pal: Yeah, brilliantly said. And I'll make sure that we actually include those articles on the tagline for this podcast as well. I'll talk to our producer about that as well.  I'm really glad you mentioned the time in your last comment there because I felt like we just started, but in fact, I think we're right at our close here, Jason, unfortunately. So, I could have gone on for a couple more hours with you. I really want to thank you for these absolutely terrific insights and thank you for all your advocacy on behalf of ASCO and oncologists at large. Dr. Jason Westin: Thank you so much for having me. I have enjoyed it. Dr. Monty Pal: Thanks a lot. And many thanks to our listeners too. You can find more information about ASCO's advocacy agenda and activities at asco.org. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks so much. ASCO Advocacy Resources: Get involved in ASCO's Advocacy efforts: ASCO Advocacy Toolkit Crisis of Cancer Drug Shortages: Understanding the Causes and Proposing Sustainable Solutions, JCO Oncology Practice 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. Find out more about today's speakers:     Dr. Monty Pal   @montypal   Dr. Jason Westin @DrJasonWestin   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. Jason Westin: Consulting or Advisory Role: Novartis, Kite/Gilead, Janssen Scientific Affairs, ADC Therapeutics, Bristol-Myers Squibb/Celgene/Juno, AstraZeneca, Genentech/Roche, Abbvie, MorphoSys/Incyte, Seattle Genetics, Abbvie, Chugai Pharma, Regeneron, Nurix, Genmab, Allogene Therapeutics, Lyell Immunopharma Research Funding: Janssen, Novartis, Bristol-Myers Squibb, AstraZeneca, MorphoSys/Incyte, Genentech/Roche, Allogene Therapeutics

Consultorio bursátil de noviembre de 2025 en el que Adrián Godás y Paco Lodeiro respondemos a las preguntas de los oyentes. Las preguntas generales de este mes son sobre montar un vehículo de inversión, el AutoFX en Interactive Brokers, las baterías de sodio, endeudarse en yenes para invertir en empresas japonesas, analizar la sostenibilidad de los dividendos, analistas de Seeking Alpha y sobre implementar un second brain. Y las dudas sobre empresas y sectores son sobre Judges Scientific, Regeneron y Vertex, Hermes e invertir en lujo, Duolingo, Constellation Software y el cobre, Fenix Resources, Tinybuild y Take-Two y sobre District Metals. Podéis enviar las consultas a academiadeinversion.com/contacto o a paco@academiadeinversion.com Patrocinador del programa Paleobull, con código de descuento para los oyentes.

Dr. Linda Duska and Dr. Kathleen Moore discuss key studies in the evolving controversy over radical upfront surgery versus neoadjuvant chemotherapy in advanced ovarian cancer. TRANSCRIPT Dr. Linda Duska: Hello, and welcome to the ASCO Daily News Podcast. I am your guest host, Dr. Linda Duska. I am a professor of obstetrics and gynecology at the University of Virginia School of Medicine.  On today's episode, we will explore the management of advanced ovarian cancer, specifically with respect to a question that has really stirred some controversy over time, going all the way back more than 20 years: Should we be doing radical upfront surgery in advanced ovarian cancer, or should we be doing neoadjuvant chemotherapy? So, there was a lot of hype about the TRUST study, also called ENGOT ov33/AGO-OVAR OP7, a Phase 3 randomized study that compares upfront surgery with neoadjuvant chemotherapy followed by interval surgery. So, I want to talk about that study today. And joining me for the discussion is Dr. Kathleen Moore, a professor also of obstetrics and gynecology at the University of Oklahoma and the deputy director of the Stephenson Cancer Center, also at the University of Oklahoma Health Sciences.  Dr. Moore, it is so great to be speaking with you today. Thanks for doing this. Dr. Kathleen Moore: Yeah, it's fun to be here. This is going to be fun. Dr. Linda Duska: FYI for our listeners, both of our full disclosures are available in the transcript of this episode.  So let's just jump right in. We already alluded to the fact that the TRUST study addresses a question we have been grappling with in our field. Here's the thing, we have four prior randomized trials on this exact same topic. So, share with me why we needed another one and what maybe was different about this one? Dr. Kathleen Moore: That is, I think, the key question. So we have to level-set kind of our history. Let's start with, why is this even a question? Like, why are we even talking about this today? When we are taking care of a patient with newly diagnosed ovarian cancer, the aim of surgery in advanced ovarian cancer ideally is to prolong a patient's likelihood of disease-free survival, or if you want to use the term "remission," you can use the term "remission." And I think we can all agree that our objective is to improve overall survival in a way that also does not compromise her quality of life through surgical complications, which can have a big effect. The standard for many decades, certainly my entire career, which is now over 20 years, has been to pursue what we call primary cytoreductive surgery, meaning you get a diagnosis and we go right to the operating room with a goal of achieving what we call "no gross residual." That is very different – in the olden days, you would say "optimal" and get down to some predefined small amount of tumor. Now, the goal is you remove everything you can see.  The alternative strategy to that is neoadjuvant chemotherapy followed by interval cytoreductive surgery, and that has been the, quote-unquote, "safer" route because you chemically cytoreduce the cancer, and so, the resulting surgery, I will tell you, is not necessarily easy at all. It can still be very radical surgeries, but they tend to be less radical, less need for bowel resections, splenectomy, radical procedures, and in a short-term look, would be considered safer from a postoperative consideration. Dr. Linda Duska: Well, and also maybe more likely to be successful, right? Because there's less disease, maybe, theoretically. Dr. Kathleen Moore: More likely to be successful in getting to no gross residual. Dr. Linda Duska: Right. Yeah, exactly. Dr. Kathleen Moore: I agree with that. And so, so if the end game, regardless of timing, is you get to no gross residual and you help a patient and there's no difference in overall survival, then it's a no-brainer. We would not be having this conversation. But there remains a question around, while it may be more likely to get to no gross residual, it may be, and I think we can all agree, a less radical, safer surgery, do you lose survival in the long term by this approach? This has become an increasing concern because of the increase in rates of use of neoadjuvant, not only in this country, but abroad. And so, you mentioned the four prior studies. We will not be able to go through them completely. Dr. Linda Duska: Let's talk about the two modern ones, the two from 2020 because neither one of them showed a difference in overall survival, which I think we can agree is, at the end of the day, yes, PFS would be great, but OS is what we're looking for. Dr. Kathleen Moore: OS is definitely what we're looking for. I do think a marked improvement in PFS, like a real prolongation in disease-free survival, for me would be also enough. A modest improvement does not really cut it, but if you are really, really prolonging PFS, you should see that-  Dr. Linda Duska: -manifest in OS. Dr. Kathleen Moore: Yeah, yeah. Okay. So let's talk about the two modern ones. The older ones are EORTC and CHORUS, which I think we've talked about. The two more modern ones are SCORPION and JCOG0602. So, SCORPION was interesting. SCORPION was a very small study, though. So one could say it's underpowered. 170 patients. And they looked at only patients that were incredibly high risk. So, they had to have a Fagotti score, I believe, of over 9, but they were not looking at just low volume disease. Like, those patients were not enrolled in SCORPION. It was patients where you really were questioning, "Should I go to the OR or should I do neoadjuvant? Like, what's the better thing?" It is easy when it's low volume. You're like, "We're going." These were the patients who were like, "Hm, you know, what should I do?" High volume. Patients were young, about 55. The criticism of the older studies, there are many criticisms, but one of them is that, the criticism that is lobbied is that they did not really try. Whatever surgery you got, they did not really try with median operative times of 180 minutes for primary cytoreduction, 120 for neoadjuvant. Like, you and I both know, if you're in a big primary debulking, you're there all day. It's 6 hours. Dr. Linda Duska: Right, and there was no quality control for those studies, either. Dr. Kathleen Moore: No quality control. So, SCORPION, they went 451-minute median for surgery. Like, they really went for it versus four hours and then 253 for the interval, 4 hours. They really went for it on both arms. Complete gross resection was achieved in 50% of the primary cytoreduced. So even though they went for it with these very long surgeries, they only got to the goal half the time. It was almost 80% in the interval group. So they were more successful there. And there was absolutely no difference in PFS or OS. They were right about 15 months PFS, right about 40 months OS.  JCOG0602, of course, done in Japan, a big study, 300 patients, a little bit older population. Surprisingly more stage IV disease in this study than were in SCORPION. SCORPION did not have a lot of stage IV, despite being very bulky tumors. So a third of patients were stage IV. They also had relatively shorter operative times, I would say, 240 minutes for primary, 302 for interval. So still kind of short. Complete gross resection was not achieved very often. 30% of primary cytoreduction. That is not acceptable. Dr. Linda Duska: Well, so let's talk about TRUST. What was different about TRUST? Why was this an important study for us to see? Dr. Kathleen Moore: So the criticism of all of these, and I am not trying to throw shade at anyone, but the criticism of all of these is if you are putting surgery to the test, you are putting the surgeon to the test. And you are assuming that all surgeons are trained equally and are willing to do what it takes to get someone to no gross residual. Dr. Linda Duska: And are in a center that can support the post-op care for those patients. Dr. Kathleen Moore: Which can be ICU care, prolonged time. Absolutely. So when you just open these broadly, you're assuming everyone has the surgical skills and is comfortable doing that and has backup. Everybody has an ICU. Everyone has a blood bank, and you are willing to do that. And that assumption could be wrong. And so what TRUST said is, "Okay, we are only going to open this at centers that have shown they can achieve a certain level of primary cytoreduction to no gross residual disease." And so there was quality criteria. It was based on – it was mostly a European study – so ESGO criteria were used to only allow certified centers to participate. They had to have a surgical volume of over 36 cytoreductive surgeries per year. So you could not be a low volume surgeon. Your complete resection rates that were reported had to be greater than 50% in the upfront setting. I told you on the JCOG, it was 30%. Dr. Linda Duska: Right. So these were the best of the best. This was the best possible surgical situation you could put these patients in, right? Dr. Kathleen Moore: Absolutely. And you support all the things so you could mitigate postoperative complications as well. Dr. Linda Duska: So we are asking the question now again in the ideal situation, right? Dr. Kathleen Moore: Right. Dr. Linda Duska: Which, we can talk about, may or may not be generalizable to real life, but that's a separate issue because we certainly don't have those conditions everywhere where people get cared for with ovarian cancer. But how would you interpret the results of this study? Did it show us anything different? Dr. Kathleen Moore: I am going to say how we should interpret it and then what I am thinking about. It is a negative study. It was designed to show improvement in overall survival in these ideal settings in patients with FIGO stage IIIB and C, they excluded A, these low volume tumors that should absolutely be getting surgery. So FIGO stage IIIB and C and IVA and B that were fit enough to undergo radical surgery randomized to primary cytoreduction or neoadjuvant with interval, and were all given the correct chemo. Dr. Linda Duska: And they were allowed bevacizumab and PARP, also. They could have bevacizumab and PARP. Dr. Kathleen Moore: They were allowed bevacizumab and PARP. Not many of them got PARP, but it was distributed equally, so that would not be a confounder. And so that was important. Overall survival is the endpoint. It was a big study. You know, it was almost 600 patients. So appropriately powered. So let's look at what they reported. When they looked at the patients who were enrolled, this is a large study, almost 600 patients, 345 in the primary cytoreductive arm and 343 in the neoadjuvant arm. Complete resection in these patients was 70% in the primary cytoreductive arm and 85% in the neoadjuvant arm. So in both arms, it was very high. So your selection of site and surgeon worked. You got people to their optimal outcome. So that is very different than any other study that has been reported to date. But what we saw when we looked at overall survival was no statistical difference. The median was, and I know we do not like to talk about medians, but the median in the primary cytoreductive arm was 54 months versus 48 months in the neoadjuvant arm with a hazard ratio of 0.89 and, of course, the confidence interval crossed one. So this is not statistically significant. And that was the primary endpoint. Dr. Linda Duska: I know you are getting to this. They did look at PFS, and that was statistically significant, but to your point about what are we looking for for a reasonable PFS difference? It was about two months difference. When I think about this study, and I know you are coming to this, what I thought was most interesting about this trial, besides the fact that the OS, the primary endpoint was negative, was the subgroup analyses that they did. And, of course, these are hypothesis-generating only. But if you look at, for example, specifically only the stage III group, that group did seem to potentially, again, hypothesis generating, but they did seem to benefit from upfront surgery.  And then one other thing that I want to touch on before we run out of time is, do we think it matters if the patient is BRCA germline positive? Do we think it matters if there is something in particular about that patient from a biomarker standpoint that is different? I am hopeful that more data will be coming out of this study that will help inform this. Of course, unpowered, hypothesis-generating only, but it's just really interesting. What do you think of their subset analysis? Dr. Kathleen Moore: Yeah, I think the subsets are what we are going to be talking about, but we have to emphasize that this was a negative trial as designed. Dr. Linda Duska: Absolutely. Yes. Dr. Kathleen Moore: So we cannot be apologists and be like, "But this or that." It was a negative trial as designed. Now, I am a human and a clinician, and I want what is best for my patients. So I am going to, like, go down the path of subset analyses. So if you look at the stage III tumors that got complete cytoreduction, which was 70% of the cases, your PFS was almost 28 months versus 21.8 months. Dr. Linda Duska: Yes, it becomes more significant. Dr. Kathleen Moore: Yeah, that hazard ratio is 0.69. Again, it is a subset. So even though the P value here is statistically significant, it actually should not have a P value because it is an exploratory analysis. So we have to be very careful. But the hazard ratio is 0.69. So the hypothesis is in this setting, if you're stage III and you go for it and you get someone to no gross residual versus an interval cytoreduction, you could potentially have a 31% reduction in the rate of progression for that patient who got primary cytoreduction. And you see a similar trend in the stage III patients, if you look at overall survival, although the post-progression survival is so long, it's a little bit narrow of a margin.  But I do think there are some nuggets here that, one of our colleagues who is really one of the experts in surgical studies, Dr. Mario Leitao, posted this on X, and I think it really resonated after this because we were all saying, "But what about the subsets?" He is like, "It's a negative study." But at the end of the day, you are going to sit with your patient. The patient should be seen by a GYN oncologist or surgical oncologist with specialty in cytoreduction and a medical oncologist, you know, if that person does not give chemo, and the decision should be made about what to do for that individual patient in that setting. Dr. Linda Duska: Agreed. And along those lines, if you look carefully at their data, the patients who had an upfront cytoreduction had almost twice the risk of having a stoma than the patients who had an interval cytoreduction. And they also had a higher risk of needing to have a bowel resection. The numbers were small, but still, when you look at the surgical complications, as you've already said, they're higher in the upfront group than they are in the interval group. That needs to be taken into account as well when counseling a patient, right? When you have a patient in front of you who says to you, "Dr. Moore, you can take out whatever you want, but whatever you do, don't make me a bag." As long as the patient understands what that means and what they're asking us to do, I think that we need to think about that. Dr. Kathleen Moore: I think that is a great point. And I have definitely seen in our practice, patients who say, "I absolutely would not want an ostomy. It's a nonstarter for me." And we do make different decisions. And you have to just say, "That's the decision we've made," and you kind of move on, and you can't look back and say, "Well, I wish I would have, could have, should have done something else." That is what the patient wants. Ultimately, that patient, her family, autonomous beings, they need to be fully counseled, and you need to counsel that patient as to the site that you are in, her volume of disease, and what you think you can achieve. In my opinion, a patient with stage III cancer who you have the site and the capabilities to get to no gross residual should go to the OR first. That is what I believe. I do not anymore think that for stage IV. I think that this is pretty convincing to me that that is probably a harmful thing. However, I want you to react to this. I think I am going to be a little unpopular in saying this, but for me, one of the biggest take-homes from TRUST was that whether or not, and we can talk about the subsets and the stage III looked better, and I think it did, but both groups did really well. Like, really well. And these were patients with large volume disease. This was not cherry-picked small volume stage IIIs that you could have done an optimal just by doing a hysterectomy. You know, these were patients that needed radical surgery. And both did well. And so what it speaks to me is that anytime you are going to operate on someone with ovary, whether it be frontline, whether it be a primary or interval, you need a high-volume surgeon. That is what I think this means to me. Like, I would want high volume surgeon at a center that could do these surgeries, getting that patient, my family member, me, to no gross residual. That is important. And you and I are both in training centers. I think we ought to take a really strong look at, are we preparing people to do the surgeries that are necessary to get someone to no gross residual 70% and 85% of the time? Dr. Linda Duska: We are going to run out of time, but I want to address that and ask you a provocative question. So, I completely agree with what you said, that surgery is important. But I also think one of the reasons these patients in this study did so well is because all of the incredible new therapies that we have for patients. Because OS is not just about surgery. It is about surgery, but it is also about all of the amazing new therapies we have that you and others have helped us to get through clinical research. And so, how much of that do you think, like, for example, if you look at the PFS and OS rates from CHORUS and EORTC, I get it that they're, that they're not the same. It's different patients, different populations, can't do cross-trial comparisons. But the OS, as you said, in this study was 54 months and 48 months, which is, compared to 2010, we're doing much, much better. It is not just the surgery, it is also all the amazing treatment options we have for these patients, including PARP, including MIRV, including lots of other new therapies. How do you fit that into thinking about all of this? Dr. Kathleen Moore: I do think we are seeing, and we know this just from epidemiologic data that the prevalence of ovarian cancer in many of the countries where the study was done is increasing, despite a decrease in incidence. And why is that? Because people are living longer. Dr. Linda Duska: People are living longer, yeah. Dr. Kathleen Moore: Which is phenomenal. That is what we want. And we do have, I think, better supportive care now. PARP inhibitors in the frontline, which not many of these patients had. Now some of them, this is mainly in Europe, will have gotten them in the first maintenance setting, and I do think that impacts outcome. We do not have that data yet, you know, to kind of see what, I would be really interested to see. We do not do this well because in ovarian cancer, post-progression survival can be so long, we do not do well of tracking what people get when they come off a clinical trial to see how that could impact – you know, how many of them got another surgery? How many of them got a PARP? I think this group probably missed the ADC wave for the most part, because this, mirvetuximab is just very recently available in Europe. Dr. Linda Duska: Unless they were on trial. Dr. Kathleen Moore: Unless they were on trial. But I mean, I think we will have to see. 600 patients, I would bet a lot of them missed the ADC wave. So, I do not know that we can say we know what drove these phenomenal – these are some of the best curves we've seen outside of BRCA. And then coming back to your point about the BRCA population here, that is a really critical question that I do not know that we're ever going to answer. There have been hypotheses around a tumor that is driven by BRCA, if you surgically cytoreduced it, and then chemically cytoreduced it with chemo, and so you're starting PARP with nothing visible and likely still homogeneous clones. Is that the group we cured? And then if you give chemo first before surgery, it allows more rapid development of heterogeneity and more clonal evolution that those are patients who are less likely to be cured, even if they do get cytoreduced to nothing at interval with use of PARP inhibitor in the front line. That is a question that many have brought up as something we would like to understand better. Like, if you are BRCA, should you always just go for it or not? I do not know that we're ever going to really get to that. We are trying to look at some of the other studies and just see if you got neoadjuvant and you had BRCA, was anyone cured? I think that is a question on SOLO1 I would like to know the answer to, and I don't yet, that may help us get to that. But that's sort of something we do think about. You should have a fair number of them in TRUST. It wasn't a stratification factor, as I remember. Dr. Linda Duska: No, it wasn't. They stratified by center, age, and ECOG status Dr. Kathleen Moore: So you would hope with randomization that you would have an equal number in each arm. And they may be able to pull that out and do a very exploratory look. But I would be interested to see just completely hypothesis-generating what this looks like for the patients with BRCA, and I hope that they will present that. I know they're busy at work. They have translational work. They have a lot pending with TRUST. It's an incredibly rich resource that I think is going to teach us a lot, and I am excited to see what they do next. Dr. Linda Duska: So, outside of TRUST, we are out of time. I just want to give you a moment if there were any other messages that you want to share with our listeners before we wrap up. Dr. Kathleen Moore: It's an exciting time to be in GYN oncology. For so long, it was just chemo, and then the PARP inhibitors nudged us along quite a bit. We did move more patients, I believe, to the cure fraction. When we ultimately see OS, I think we'll be able to say that definitively, and that is exciting. But, you know, that is the minority of our patients. And while HRD positive benefits tremendously from PARP, I am not as sure we've moved as many to the cure fraction. Time will tell. But 50% of our patients have these tumors that are less HRD. They have a worse prognosis. I think we can say that and recur more quickly. And so the advent of these antibody-drug conjugates, and we could name 20 of them in development in GYN right now, targeting tumor-associated antigens because we're not really driven by mutations other than BRCA. We do not have a lot of things to come after. We're not lung cancer. We are not breast cancer. But we do have a lot of proteins on the surface of our cancers, and we are finally able to leverage that with some very active regimens. And we're in the early phases, I would say, of really understanding how best to use those, how best to position them, and which one to select for whom in a setting where there is going to be obvious overlap of the targets. So we're going to be really working this problem. It is a good problem. A lot of drugs that work pretty well. How do you individualize for a patient, the patient in front of you with three different markers? How do you optimize it? Where do you put them to really prolong survival? And then we finally have cell surface. We saw at ASCO, CDK2 come into play here for the first time, we've got a cell cycle inhibitor. We've been working on WEE1 and ATR for a long time. CDK2s may hit. Response rates were respectable in a resistant population that was cyclin E overexpressing. We've been working on that biomarker for a long time with a toxicity profile that was surprisingly clean, which I like to see for our patients. So that is a different platform. I think we have got bispecifics on the rise. So there is a pipeline of things behind the ADCs, which is important because we need more than one thing, that makes me feel like in the future, I am probably not going to be using doxil ever for platinum-resistant disease. So, I am going to be excited to retire some of those things. We will say, "Remember when we used to use doxil for platinum-resistant disease?" Dr. Linda Duska: I will be retired by then, but thanks for that thought. Dr. Kathleen Moore: I will remind you. Dr. Linda Duska: You are right. It is such an incredibly exciting time to be taking care of ovarian cancer patients with all the opportunities.  And I want to thank you for sharing your valuable insights with us on this podcast today and for your great work to advance care for patients with GYN cancers. Dr. Kathleen Moore: Likewise. Thanks for having me. Dr. Linda Duska: And thank you to our listeners for your time today. You will find links to the TRUST study and other studies discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:   Dr. Linda Duska  @Lduska Dr. Kathleen Moore Follow ASCO on social media:     @ASCO on X (formerly Twitter) ASCO on Bluesky   ASCO on Facebook     ASCO on LinkedIn     Disclosures of Potential Conflicts of Interest:    Dr. Linda Duska:   Consulting or Advisory Role: Regeneron, Inovio Pharmaceuticals, Merck, Ellipses Pharma  Research Funding (Inst.): GlaxoSmithKline, Millenium, Bristol-Myers Squibb, Aeterna Zentaris, Novartis, Abbvie, Tesaro, Cerulean Pharma, Aduro Biotech, Advaxis, Ludwig Institute for Cancer Research, Leap Therapeutics  Patents, Royalties, Other Intellectual Property: UptToDate, Editor, British Journal of Ob/Gyn  Dr. Kathleen Moore: Leadership: GOG Partners, NRG Ovarian Committee Chair Honoraria: Astellas Medivation, Clearity Foundation, IDEOlogy Health, Medscape, Great Debates and Updates, OncLive/MJH Life Sciences, MD Outlook, Curio Science, Plexus, University of Florida, University of Arkansas for Medical Sciences, Congress Chanel, BIOPHARM, CEA/CCO, Physician Education Resource (PER), Research to Practice, Med Learning Group, Peerview, Peerview, PeerVoice, CME Outfitters, Virtual Incision Consulting/Advisory Role: Genentech/Roche, Immunogen, AstraZeneca, Merck, Eisai, Verastem/Pharmacyclics, AADi, Caris Life Sciences, Iovance Biotherapeutics, Janssen Oncology, Regeneron, zentalis, Daiichi Sankyo Europe GmbH, BioNTech SE, Immunocore, Seagen, Takeda Science Foundation, Zymeworks, Profound Bio, ADC Therapeutics, Third Arc, Loxo/Lilly, Bristol Myers Squibb Foundation, Tango Therapeutics, Abbvie, T Knife, F Hoffman La Roche, Tubulis GmbH, Clovis Oncology, Kivu, Genmab/Seagen, Kivu, Genmab/Seagen, Whitehawk, OnCusp Therapeutics, Natera, BeiGene, Karyopharm Therapeutics, Day One Biopharmaceuticals, Debiopharm Group, Foundation Medicine, Novocure Research Funding (Inst.): Mersana, GSK/Tesaro, Duality Biologics, Mersana, GSK/Tesaro, Duality Biologics, Merck, Regeneron, Verasatem, AstraZeneca, Immunogen, Daiichi Sankyo/Lilly, Immunocore, Torl Biotherapeutics, Allarity Therapeutics, IDEAYA Biosciences, Zymeworks, Schrodinger Other Relationship (Inst.): GOG Partners

In this episode, Dr. Anthony Youn sits down with beauty influencer Amy Chang to talk about her personal journey from struggling with acne to becoming one of today's most trusted voices in skincare and anti-aging. Amy opens up about the cutting-edge treatments she experienced in Korea—like Regeneron and Ultra Cool—and how they transformed her approach to skin health. She also shares the surprising impact that cutting back on alcohol had on her complexion, along with the details of her daily skincare routine. Together, Dr. Youn and Amy dive into the pros and cons of popular cosmetic procedures, the lifestyle shifts that make the biggest difference for healthy skin, and Amy's candid advice on how to know if (and when) it might be time to consider a facelift. It's an honest, practical, and inspiring conversation packed with takeaways for anyone who wants to look and feel their best.