Podcast appearances and mentions of Bristol Myers Squibb

The Segment: A Zero Trust Leadership Podcast

Play Episode Listen Later Dec 11, 2025 7:01

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the ever-dynamic landscape of these industries, recent advancements have underscored both the scientific ingenuity and strategic foresight shaping patient care today.Pfizer has unveiled promising clinical trial data for Tukysa, indicating its potential as a first-line maintenance therapy in HER2-positive breast cancer. This development suggests that Tukysa could delay disease progression, offering patients extended survival prospects and an improved quality of life. Additionally, Pfizer's recent licensing agreement with Yaopharma for YP05002—a small molecule GLP-1 agonist currently in Phase 1 trials aimed at obesity treatment—highlights their strategic push into the rapidly evolving obesity treatment market.Meanwhile, Fondazione Telethon, an Italian nonprofit organization, has achieved a significant milestone with FDA approval for Waskyra—the first gene therapy for Wiskott-Aldrich syndrome. This ex vivo gene therapy directly targets the genetic roots of this rare disease, shifting treatment from symptomatic management to addressing underlying causes. This approval is transformative not only for patients suffering from this condition but also for the broader field of gene therapies, heralding a new era in treating rare genetic disorders.On the strategic front, Eli Lilly's decision to establish a $6 billion active pharmaceutical ingredient manufacturing facility in Huntsville, Alabama, marks a pivotal investment in U.S. manufacturing capabilities. This site will be critical in producing APIs for small molecule and peptide medicines, a testament to Lilly's commitment to meeting growing therapeutic demands while bolstering domestic production resilience—a trend gaining momentum across the industry. In oncology, Eli Lilly's Jaypirca demonstrated an impressive reduction in disease progression during Phase 3 trials for chronic lymphocytic leukemia.Biocon's acquisition of Viatris' stake in their biosimilar subsidiary exemplifies the shifting dynamics within the biosimilars market. This move allows Biocon to consolidate its market position as biosimilars gain traction as cost-effective alternatives to branded biologics. Such strategic realignments are indicative of competitive maneuvering aimed at capturing greater market share and driving down healthcare costs.Roche has made strides with compelling results from its Phase 3 trial of giredestrant, an oral selective estrogen receptor degrader showing a 30% reduction in risk for invasive breast cancer recurrence or death. The significance of this development lies in offering an oral alternative to injectable treatments, potentially improving patient adherence and reshaping standard care protocols for hormone receptor-positive breast cancer. Furthermore, Roche has achieved another regulatory milestone with its monoclonal antibody Gazyvaro gaining EU approval for treating lupus nephritis following successful Phase 3 trials.Innovation continues unabated as Formation Bio forms a new subsidiary through a $605 million deal with Lynk Pharmaceuticals. By securing rights to a next-generation immunology asset, Formation Bio positions itself at the forefront of immunological research developments. Concurrently, BioNTech and Bristol Myers Squibb have reported positive results from Phase 2 trials of Pumitamig for triple-negative breast cancer—validating bispecific antibodies' efficacy within oncology.Collaborative efforts are also reshaping industry landscapes. Bora and Corealis have partnered to create an end-to-end contract development and manufacturing organization for oral solid dose drug development. This collaboration aims to streamline processes and provide scalable solutions through a single contracting source, reflecting a shift towards integrated service models that enhance efficiencySupport the show

From the White House to the Boardroom: Tony Scott on Leading Transformative Tech

Play Episode Listen Later Dec 9, 2025 40:15

In this episode of The Segment, host Raghu Nandakumara sits down with one of the most influential technology leaders of our time: Tony Scott, President & CEO of Intrusion and former U.S. Federal CIO under President Obama. With CIO roles at Microsoft, VMware, Disney, General Motors, Bristol Myers Squibb, and Sun Microsystems, Tony brings a rare, decades-wide perspective on how enterprise technology evolves—and where it's heading next.Tony shares his journey through some of the world's most complex organizations, offering a candid look at the forces that drive digital transformation, why organizational silos still shape most architectures, and how AI may finally help dissolve them. He breaks down how cybersecurity models must shift in an era of ubiquitous AI, legacy infrastructure, and escalating regulatory complexity—and explains why continuous monitoring and long-term institutional memory are now essential.We also dive into Tony's leadership philosophy, how he balances transformation with cyber risk, and what he's learned transitioning from CIO to CEO of a cybersecurity company tackling some of today's hardest problems. Key themes discussed:The evolution of the CIO role across decades of transformation Managing cyber risk amid AI proliferation, legacy systems, and modern architectures The importance of “useful life” frameworks for tech modernization Leadership lessons from navigating both public and private sector tech at scale A must-listen for CIOs, CISOs, tech leaders, and anyone preparing their organization for what's next in AI-driven transformation and cybersecurity.

JCO at 2025 ASH: Pirtobrutinib in Untreated CLL

Journal of Clinical Oncology (JCO) Podcast

Play Episode Listen Later Dec 9, 2025 20:17

JCO Editor-in-Chief Dr. Jonathan Friedberg is joined by colleagues Dr. Jennifer Woyach, Dr. Wojciech Jurczak, and Dr. Matthew Davids to discuss simultaneous publications presented at ASH 2025 on pertibrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. TRANSCRIPT The disclosures for guests on this podcast can be found in the show notes. Dr. Jonathan Friedberg: I'm Jonathan Friedberg, editor of Journal of Clinical Oncology, and welcome to JCO After Hours, where we are covering two manuscripts that were presented at the American Society of Hematology meeting 2025 in Orlando, Florida. I am delighted to be joined by colleagues on this call to discuss these pivotal manuscripts which cover the topic of pirtobrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. I will first just introduce our guests, Dr. Woyach. Dr. Jennifer Woyach: Hi, my name is Jennifer Woyach. I am from the Ohio State University. Dr. Wojciech Jurczak: Hello, I am Wojciech Jurczak, working at the National Research Institute of Oncology in Krakow, Poland. Dr. Matthew Davids: Hi, I am Matthew Davids from Dana-Farber Cancer Institute in Boston. Dr. Jonathan Friedberg: We are going to start by just learning a little bit about these two trials that were both large, randomized phase 3 studies that I think answered some definitive questions. We will start with your study, Jennifer. If you could just describe the design of your study and the patient population. Dr. Jennifer Woyach: Absolutely. So this is the BRUIN CLL-314 study, and this is a phase 3 randomized trial of pirtobrutinib versus ibrutinib in patients with CLL or SLL who had not previously been treated with a covalent BTK inhibitor. The patients were both treatment-naive and relapsed/refractory, about one-third of the patients treatment-naive, the rest relapsed/refractory, and they were stratified based upon 17p deletion and the number of prior lines of therapy. The primary objective was looking at non-inferiority of overall response rate over the entire treated population as well as the relapsed/refractory patient population. Key secondary objectives included progression-free survival in the intention-to-treat and the smaller relapsed/refractory and treatment-naive populations. Dr. Jonathan Friedberg: And just comment a little bit on the risk of the patients. Dr. Jennifer Woyach: This study was fairly typical of this cohort of patients. Within the relapsed/refractory patient population, there was a median of one prior line of therapy in each of the groups, up to nine prior lines of therapy in the patients included on the study. For the overall cohort, about two-thirds of the patients were IGHV unmutated, about 15% had 17p deletion, 30% had TP53 mutations, and about 35% to 40% had a complex karyotype, which is three or more abnormalities. Dr. Jonathan Friedberg: And what were your findings? Dr. Jennifer Woyach: Regarding the primary outcome, which is the focus of the publication, we did find that pirtobrutinib was indeed non-inferior and actually superior to ibrutinib for overall response rate throughout the entire patient population and in both the relapsed/refractory and treatment-naive cohorts. PFS is a little bit immature at this time but is trending towards also being significantly better in pirtobrutinib-treated patients compared with ibrutinib-treated patients. Probably most significantly, we found this to be the case in the treatment-naive cohort where there was a striking trend to an advantage of pirtobrutinib versus ibrutinib. Dr. Jonathan Friedberg: And the follow-up that you have on that progression-free survival? Dr. Jennifer Woyach: So we have about 18 months follow-up on progression-free survival. Dr. Jonathan Friedberg: The second study, Wojciech, can you just go through the design and patient population that you treated? Dr. Wojciech Jurczak: Thank you, Dr. Friedberg, for this question. So the BRUIN CLL-313 study was, in fact, the first phase 3 study with pirtobrutinib in exclusively untreated CLL patients. It was a randomized study where we challenged pirtobrutinib versus bendamustine-rituximab. At the time we designed the protocol, bendamustine-rituximab was an option as a standard of care, and Bruton tyrosine kinase monotherapy was used far more commonly than nowadays. The primary target of the study was progression-free survival. We took all untreated patients except for those with 17p deletions. Therefore, it is a good representation for intermediate risk. We had about 60% of the population, 56 to be precise, which was unmutated, evenly distributed into two treatment arms. 17p deleted cases were excluded, but we had about 7% and 8% of TP53 mutated patients as well as about 11% and 7%, respectively, in the pirtobrutinib and bendamustine-rituximab arm of patients with complex karyotype. The progression-free survival was in favor of pirtobrutinib and was assessed by an independent review committee. What is important is that the progression-free survival of the bendamustine-rituximab arm was actually similar to the other studies addressing the same questions, like the comparison with ibrutinib in the ALLIANCE study or zanubrutinib in the SEQUOIA study. What was different was the hazard ratio. In our study, it was 0.20. It was one of the longest effect sizes noted in the frontline BTK study. It represented an 80% reduction in progression-free survival or death. If we compare it to ibrutinib or zanubrutinib, it was 0.39 and 0.42 respectively. Presumably, this great effect contributed towards a trend of overall survival difference. Although survival data are not mature enough, there is a clear trend represented by three patients we lost in the pirtobrutinib arm versus 10 patients lost in the bendamustine-rituximab arm. This trend in overall survival is becoming statistically significant despite the fact that there was a possibility of crossover, and effectively 52.9 patients, which means 18 out of 34 patients relapsing in the bendamustine-rituximab arm, were treated by pirtobrutinib. Dr. Jonathan Friedberg: I am going to turn it over to Matt. The question is: why study pirtobrutinib in this patient population? And then with these two studies, how do you find the patients that were treated, are they representative of people who you see? And do you see this maybe being approved and more widely available? Dr. Matthew Davids: I think in terms of the first question, why study this in a frontline population, we have seen very impressive data with pirtobrutinib in a very difficult-to-treat population of CLL patients. This was from the original BRUIN phase 1/2 study where most of the patients had at least two or three lines of therapy, often both a covalent BTK inhibitor and the BCL2 inhibitor venetoclax, and yet they were still responding to pirtobrutinib. The drug was also very well tolerated in that early phase experience. And actually, we have seen phase 3 data from the BRUIN 321 study comparing pirtobrutinib to bendamustine and rituximab in a relapse population as well. So I think that really motivated these studies to look at pirtobrutinib as a first therapy. You know, often in other cancers of course, we want to use our best therapy first, and I think these studies are an initial step at looking at that. In terms of the second question around the patient population, these are pretty representative patient populations, I would say, for most frontline CLL studies. We see patients who are a bit younger and fitter than sort of the general population of CLL patients who are treated in clinical practice, and I think that is true here as well. Median age in the sort of mid-60s here is a bit younger than the typical patients we are treating in practice. But that is not different from other CLL frontline studies that we have seen recently, so I think it makes it a little bit easier as we kind of think across studies to feel comfortable that these are relatively similar populations. Dr. Jonathan Friedberg: How do you see this either getting regulatory approval or potentially being used compared to current standard of care options? Dr. Matthew Davids: So my understanding is that both of these trials were designed with registrational intent in the frontline setting, and they are both positive studies. That is certainly very encouraging in terms of the potential for an approval here. We have seen in terms of the FDA recently some concerns around the proportion of patients who are coming from North America, and my understanding is that is relatively low on these two studies. But nonetheless, the datasets are very impressive, and so I think it is certainly supportive of regulatory approval for frontline pirtobrutinib. Dr. Jonathan Friedberg: I will ask Jennifer a question. The control arm in your study was ibrutinib, and I think many in the audience may recognize that newer, second-generation BTK inhibitors like acalabrutinib and zanubrutinib are more frequently used now if monotherapy is decided. How do you respond to that, and how would you put your results in your pirtobrutinib arm in context with what has been observed with those agents? Dr. Jennifer Woyach: Yeah, that is a great question. Even though in the United States we are predominantly using acalabrutinib or zanubrutinib when choosing a monotherapy BTK inhibitor, this is actually not the case throughout the entire world where ibrutinib is still used very frequently. The head-to-head studies of both acalabrutinib and zanubrutinib compared to ibrutinib have shown us pretty well what the safety profile and efficacy profile of the second-generation BTK inhibitors is. So even though we do not have a head-to-head study of acalabrutinib or zanubrutinib versus pirtobrutinib, I think, given the entirety of data that we have with all of the covalent BTK inhibitors, I think we can safely look at the pirtobrutinib arm here, how the ibrutinib arm compares or performs in context with those other clinical trials. And though we really can not say anything about pirtobrutinib versus acalabrutinib or zanubrutinib, I think we can still get a good idea of what might be the clinical scenarios in which you might want to choose pirtobrutinib. Dr. Jonathan Friedberg: And Wojciech, do you agree with that? Obviously, I think you have acknowledged that chemoimmunotherapy is rarely used anymore as part of upfront treatment for CLL. So, I guess a similar question. If you were to put the pirtobrutinib result in your study in context with, I guess, more contemporary type controls, would you agree that it is competitive? Dr. Wojciech Jurczak: Well, I think that that was the last study ever where bendamustine-rituximab was used as a comparator arm. So we should notice that smashing difference. Because if we look at the progression-free survival at two years, we have 93.4% in pirtobrutinib arm versus 70.7% in bendamustine-rituximab arm. Bendamustine-rituximab arm did the same as in the other trials, like ALLIANCE or SEQUOIA. Pirtobrutinib did exceptionally well, as pirto is not just the very best BTK inhibitor overcoming the resistance, but perhaps even more important for the first line, it is very well tolerated and is a very selective drug. Now, if we look at treatment-related adverse events, the discontinuation rate, they were hardly ever seen. If we compared the adverse events in exposure-adjusted incidence, literally all adverse events were two or three times higher in bendamustine-rituximab arm except for the bleeding tendency, which however was predominantly in CTCAE grade 1 and 2 with just 0.7% of grade 3 hemorrhage. Therefore, I think that we should actually put the best and the safest drugs upfront if we may, and pirtobrutinib is, or should be, the first choice if we choose monotherapy. Now, I understand that we are not presenting you the data of pirtobrutinib in combination with anti-CD20 or with BCL2 inhibitors, but that is to come. Dr. Jonathan Friedberg: Matt, how would you envision, were regulatory approval granted and this were an option, using this in the upfront patient population? Is there anybody who you would preferentially use this or start on this treatment? Or would this be something that you would tend to reserve for second line? Dr. Matthew Davids: So I would say that in general for most of my patients who would want to start with a continuous BTK inhibitor, I would still use a covalent BTK inhibitor, and I say that for a couple of reasons despite the very promising data from these studies. The first is that the follow-up for both of these phase 3 trials is still quite short, in the range of a median 18 to 24 months. And we know that CLL is a marathon, not a sprint, and these patients are going to probably be living for a very long time. And we do have much longer follow-up from the covalent BTK inhibitors, median of 10-year follow-up with ibrutinib and five to six years with zanubrutinib and acalabrutinib respectively. And you know, I do not think that the pirtobrutinib is going to fall off a cliff after two years, but on the other hand, I think there is a lot of value to long-term data in this disease, and that is why I think for most of my patients I would stick with covalent BTK inhibitors. But the other important factor that we need to consider is patients who are younger and may have many different CLL treatments over the years. We have to be very careful, I think, about how we sequence these drugs. We know right now that we can start with covalent BTK inhibitors and then subsequently patients will respond well to the non-covalent inhibitor pirtobrutinib in later lines of therapy. But right now we do not have prospective data the other way around. So how will the patients on these studies who progress on pirtobrutinib respond to covalent BTK inhibitors? We do not know yet. There have not been a lot of progression events, which is great, but we would like to see some data in that respect to feel more comfortable with that sequence. Now, I do think that particularly for older patients and those who have significant cardiovascular comorbidities, if they wanted to go on a continuous BTK inhibitor, I do think these data really strongly support using pirtobrutinib as the BTK inhibitor of choice in that population. In particular, the cardiovascular risks with pirtobrutinib seem to be quite low. I was very struck in the comparison with BR that the rate of AFib was equivalent between the two arms of the study. And that is really the first time we have seen that with any of these BTK inhibitors, no elevated risk of AFib in a randomized study. I think that is the population where it will get the most traction first, is the upfront, sort of older patient with significant cardiovascular comorbidities. And as the data from these studies mature, I think that we will start to see more widespread use of pirtobrutinib in the frontline setting. Dr. Jonathan Friedberg: Jennifer, I am just curious if you have any personal experience or heard anecdotally about after progression on pirtobrutinib the use of other BTK inhibitors and whether there is a growing experience there. Dr. Jennifer Woyach: I do not think that there is much clinical experience, you know, as Matt alluded to, it certainly has not been tested yet. There has been some data in relapsed CLL suggesting that in people who have resistance mutations to covalent BTK inhibitors after treatment with pirtobrutinib, sometimes those mutations go away. I think most of us are concerned that they are probably not actually gone but maybe in compartments that we just have not sampled, suggesting that sort of approach where you might sequence a covalent inhibitor after a non-covalent in somebody who had already been resistant probably would not work that well. But, you know, in this setting where people had never been exposed to a covalent BTK inhibitor before, we really have no idea what the resistance patterns are going to be like. We assume they will be the same as what we have seen in relapsed CLL, but I think we just need some longer follow-up to know for sure. Dr. Wojciech Jurczak: If I may confront Dr. Davids about the use of covalent BTK inhibitors upfront, well, I think that we should abandon the idea of using the first and the second and the third generation, at least if we don't have medical lines. If we endlessly block the same pathway, it is not going to be effective. So if pirtobrutinib gets approval in first, second line, we do not necessarily have to use it in the first line. I am not here in a position to defend that we should treat patients with pirtobrutinib upfront and not BCL2 time-limited regimen. However, the way I look at CLL patients when choosing therapy is not just how should I treat them now, but what would be the best regimen in 5, 10 years if I have to re-treat them. And in some instances, the idea may be that in this setting we would like to have a BTK inhibitor upfront to have a BCL2 inhibitor later to make it time-limited. Although I understand and I agree with Matthew that if we have an elderly, fragile population, then the charm of having a drug taken once a day in a tablet with literally few cardiovascular adverse events might be an option. Dr. Jonathan Friedberg: And I will give Matt the last word whether he wants to respond to that, and also just as a forward-looking issue, I know both investigators have implied that there will be future studies looking at combinations with pirtobrutinib, and if you have any sense as to what you would be looking for there. Dr. Matthew Davids: The field really is heading toward time-limited therapy for most patients, I would say. There is a bit of a discrepancy right now in the field between sort of what we are doing in academic practice and what is done sort of more widely in community practice. And so right now we are going to see evolving datasets comparing these approaches. We are already seeing data now from the CLL17 study with ibrutinib comparing continuous to time-limited venetoclax-based therapy, and we are seeing similar efficacy benefits from these time-limited therapies without the need for continuous treatment. And so that is where I think some of the future studies with pirtobrutinib combining it with venetoclax and other partners are so important. Fortunately, several of these studies are already ongoing, including a phase 3 trial called CLL18, which is looking at pirtobrutinib with venetoclax, comparing that to venetoclax and obinutuzumab. So I am optimistic that we are going to be developing these very robust datasets where we can actually use pirtobrutinib in the frontline setting as a time-limited therapy as a component of a multi-drug regimen. So far, those early data are very promising. Dr. Wojciech Jurczak: Perhaps last but not least, in a single center we have treated over 300 patients with pirtobrutinib. So eventually some of them relapsed. And I must say that our experience on BCL2 inhibitors, not just venetoclax but including sonrotoclax, are appealingly good. Therefore, by using pirtobrutinib even earlier, we do not block the efficacy of other compounds. Dr. Jonathan Friedberg: All right. Well, I want to thank all of our speakers. I also want to congratulate our two guests who presented these very influential papers at the ASH Annual Meeting, and chose to publish them in JCO, so we thank you for that, and Dr. Davids for your commentary - really appreciated. That is this episode of JCO After Hours. Thank you for your attention. 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. Disclosures Dr. Wojciech Jurczak Consulting or Advisory Role: BeiGene, Lilly, Abbvie/Genentech, Takeda, Roche, AstraZeneca Research Funding: Roche, Takeda, Janssen-Cilag, BeiGene, AstraZeneca, Lilly, Abbvie/Genentech Dr. Jennifer Woyach Consulting or Advisory Role: Pharmacyclics, Janssen, AstraZeneca, Beigene, Loxo, Newave Pharmaceutical, Genentech, Abbvie, Merck Research Funding: Company name: Janssen, Schrodinger, beone, Abbvie, Merck, Loxo/Lilly Dr. Matthew Davids Honoraria: Curio Science, Aptitude Health, Bio Ascend, PlatformQ Health, Plexus Consulting or Advisory Role: Genentech, Janssen, Abbvie, AstraZeneca, Adaptive Biotechnologies, Ascentage Pharma, BeiGene, Lilly, Bristol-Myers Squibb, Genmab, Merck, MEI Pharma, Nuvalent, Inc., Galapagos NV, Schroedinger Research Funding: Ascentage Pharma, Novartis, MEI Pharma, AstraZeneca

Voor €10 met de trein naar Berlijn, hoe dan?

FD Dagkoers

Play Episode Listen Later Dec 9, 2025 15:52

De farmaceutische groothandel Mosadex is gestopt met de levering van de meestgebruikte bloedverdunner in Nederland, Eliquis. Aanleiding daarvoor is een prijsverhoging van het Amerikaanse farmaconcern Bristol Myers Squibb. De Hartstichting maakt zich zorgen dat patiënten hiervan de dupe worden. De bloedverdunner met de stofnaam apixaban wordt in Nederland door meer dan 260.000 patiënten gebruikt. Farma-redacteur Thieu Vaessen praat je bij over dit 'potje armpjedrukken' tussen producent en groothandel. Lees: Groothandel staakt levering belangrijkste bloedverdunner na prijsverhoging Spoorbedrijf GoVolta gaat vanaf maart 2026 een budgettrein rijden tussen Amsterdam en de Duitse steden Hamburg en Berlijn. De verbinding, met kaartjes vanaf €10 voor een enkele reis, moet de opmaat vormen naar meer concurrentie op het internationale spoor. Het bedrijf gaat afgedankte Belgische treinstellen opknappen en hoopt veel pakketreizen te verkopen: vervoer én overnachting. Ook andere vervoerders willen in deze markt springen, maar internationale dagtreinen zijn er nog niet. Redacteur Erik van Rein vertelt waarom. Lees: Nieuwe budgettrein GoVolta brengt reiziger vanaf een tientje naar Berlijn De vijf jaar oude Delftse start-up QuantWare bouwt een fabriek voor een nieuwe generatie kwantumchips die honderd keer krachtiger moet zijn dan de huidige kwantumchips. Daarmee hoopt het bedrijf een sleutelpositie te krijgen op de wereldmarkt voor de volgende generatie supercomputers. De chips die er van de band gaan rollen, hebben een verkoopprijs van €50 mln. FD redacteur Jan Fred van Wijnen vertelt hoe QuantWare de computerwereld denkt te veranderen. Lees: Eerste Nederlandse fabriek voor kwantumchips van €50 mln per stuk Redactie en montage: Floyd Bonder, Sophia Wouda & Nelleke van der Heiden Presentatie: Nelleke van der HeidenSee omnystudio.com/listener for privacy information.

amsterdam hamburg voor nederland naar rein amerikaanse belgische fd duitse daarmee bristol myers squibb berlijn farma aanleiding trein hoe dan redactie eliquis delftse

Keytruda SC Legal Battle and CAR-T Milestones

Play Episode Listen Later Dec 8, 2025 6:32

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of pivotal events shaping the landscape of drug development and patient care. The interplay between scientific advancements, regulatory shifts, and strategic partnerships is setting the stage for significant transformations within the industry.A highlight of recent developments is the legal challenge faced by Merck & Co. regarding its new subcutaneous version of Keytruda. This immunotherapy, already a breakthrough in cancer treatment, has encountered a hurdle in Germany where Halozyme, known for its drug-delivery technologies, has secured a preliminary injunction. This move by a German court halts Merck's activities related to Keytruda SC in Germany and underscores the intricate web of intellectual property rights in drug launches across international markets. The outcome of this case could establish crucial precedents for future commercialization efforts involving advanced drug delivery technologies.Meanwhile, there's promising news from Bristol Myers Squibb as their CAR-T therapy, Breyanzi, receives its fifth FDA approval, this time for marginal zone lymphoma. This approval is particularly noteworthy as it marks Breyanzi as the first CAR-T treatment sanctioned for this specific indication and extends its use across five different types of blood cancers. CAR-T therapies continue to represent a frontier in cancer treatment by leveraging the body's immune system to combat malignancies more effectively. This success story from Bristol Myers Squibb highlights the expanding potential of CAR-T therapies in tackling various hematological cancers, offering renewed hope for patients with limited treatment avenues.On the regulatory front, the FDA's proposal to consider single-trial approvals for certain drugs has sparked considerable debate. While some industry voices express concerns about potential compromises to safety and efficacy standards, others see it as an opportunity to invigorate research and development investments by reducing both time and costs associated with bringing new therapies to market. This shift could indeed accelerate innovation but will necessitate a careful balance to uphold rigorous safety standards.In parallel regulatory news, Daiichi Sankyo has received an "untitled letter" from the FDA over its patient ambassador video for Turalio, indicating ongoing challenges in navigating drug promotion guidelines and patient engagement strategies. Such interactions emphasize the complexities pharmaceutical companies face within regulatory frameworks.Shifting focus to corporate strategies, Mark Cuban's Cost Plus Drugs is exploring a partnership with Humana aimed at addressing prescription drug costs for employers. This collaboration seeks to reduce healthcare expenses through innovative pricing models and distribution channels, reflecting a broader industry trend toward cost containment and value-based care delivery.In another development affecting public health policy, the CDC's Advisory Committee on Immunization Practices has postponed its vote on changes to newborn hepatitis B vaccine policies due to ongoing debates and confusion surrounding the topic. This delay highlights the intricate nature of updating long-standing public health policies, especially those impacting vaccination schedules.From an investment perspective, Freenome's decision to go public through a $330 million SPAC deal stands out. Specializing in developing blood tests for early cancer detection using machine learning technologies, Freenome's move aims to secure capital necessary for advancing its diagnostic tools—potentially transforming cancer screening practices by enabling earlier detection and intervention.In clinical trial news, Praxis Precision Medicines reported positive efficacy results from a Phase 2 trialSupport the show

What Challenges Will Oncologists Face in 2026?

ASCO Daily News

Play Episode Listen Later Dec 4, 2025 22:14

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

Doppel-Warnung der Börsen-Kassandra und Gesundmacher fürs Depot

Play Episode Listen Later Dec 4, 2025 23:18

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Holger Zschäpitz über das Microsoft-Barometer und seine Folgen, das Inditex-Luxusproblem und gute Stimmung bei Salesforce. Außerdem geht es um Eli Lilly, AbbVie, Johnson & Johnson, Novo Nordisk, AstraZeneca, Abbott Laboratories, UnitedHealth Group, Bristol Myers Squibb, Dexcom, Align Technology, ResMed, Hims & Hers, JD Health International, iRhythm Technologies, Pro Medicus, Oscar Health, Xtrackers MSCI World Health Care (WKN: A113FD), Amundi S&P World Health Care Screened (WKN: A3DSTC), Franklin Future of Health and Wellness (WKN A3EFKW), Global X Telemedicine & Digital Health (WKN A2QKQ1), Xtrackers MSCI Genomic Healthcare Innovation (WKN: DBX0R2), Agilent, Roche, Vertex, Microsoft, Meta, Alphabet, Amazon, Nvidia, Salesforce, SAP, Snowflake, Inditex, H&M, Next, LVMH, Hermès, Aumovio, TKMS, Hellofresh, Gerresheimer, Ottobock, Tonies, PSI Software, Verbio, LPKF, Stratec, Thyssenkrupp Nucera, Procredit, Amadeus Fire, Bayer, BASF, Corteva, Syngenta, Formycon und PNE. Die aktuelle "Alles auf Aktien"-Umfrage findet Ihr unter: https://www.umfrageonline.com/c/mh9uebwm Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

Season 3 - Ep.28: Extended interview on dual antiplatelet therapy (DAPT) and shortening its optimal duration

english therapy esc dual optimal novartis declarations shortening bristol myers squibb european society antiplatelet dapt cardiology esc

Play Episode Listen Later Dec 4, 2025 10:04

Host: Emer Joyce Guest: Steffen Massberg Want to watch that extended interview on https://esc365.escardio.org/event/2178?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2178 Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests Emer Joyce and Steffen Massberg have declared to have no potential conflicts of interest to report.

Season 3 - Ep.28: DAPT: how short is too short? - Obesity and atrial fibrillation

Play Episode Listen Later Dec 4, 2025 25:51

This episode covers: Cardiology This Week: A concise summary of recent studies DAPT: how short is too short Obesity and atrial fibrillation Milestones: COURAGE Host: Emer Joyce Guests: Carlos Aguiar, Steffen Massberg, Prash Sanders Want to watch that episode? Go to: https://esc365.escardio.org/event/2178 Want to watch that extended interview on dual antiplatelet therapy (DAPT) and shortening its optimal duration, go to: https://esc365.escardio.org/event/2178?resource=interview Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests Stephan Achenbach, Yasmina Bououdina, Emer Joyce, Nicolle Kraenkel and Steffen Massberg have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Prashanthan Sanders has declared to have potential conflicts of interest to report: advisory board representative University of Adelaide, Medtronic, Boston Scientific, CathRx, Abbott and Pacemate as well as research grants for University of Adelaide: Medtronic, Abbott, Boston Scientific, Becton Dickson. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Season 3 - Ep.28: Extended interview on dual antiplatelet therapy (DAPT) and shortening its optimal duration

english therapy esc dual optimal novartis declarations shortening bristol myers squibb european society antiplatelet dapt cardiology esc

Play Episode Listen Later Dec 4, 2025 10:04

Regulatory Shifts and Breakthrough Therapies Unveiled

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Play Episode Listen Later Dec 4, 2025 7:22

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 pivotal events and breakthroughs shaping the future of this dynamic industry.The pharmaceutical and biotech sectors are experiencing a wave of significant advancements, regulatory shifts, and strategic maneuvers. Recently, Bristol Myers Squibb faced a delay in their Alzheimer's psychosis treatment, Cobenfy, due to site irregularities detected in the ADEPT-2 study. This highlights the critical importance of rigorous clinical trial management. The postponement could influence stakeholders' confidence in timelines for breakthrough treatments in neuropsychiatric disorders.Richard Pazdur, M.D., is preparing to retire from his leadership role at the FDA's Center for Drug Evaluation and Research. This transition period could have profound implications for how new therapies are evaluated, potentially altering approval processes and timelines. His departure marks a significant shift within an agency renowned for its role in drug approvals and regulatory oversight.On the scientific front, Cosmo Pharmaceuticals has reported promising results from two Phase 3 trials of clascoterone, a topical cream designed to treat male-pattern hair loss. The findings suggest that clascoterone could become a transformative treatment by offering a novel mechanism to address androgenetic alopecia through the inhibition of dihydrotestosterone activity at the follicular level. This development underscores an expanding focus on dermatological conditions within biopharma research and offers new hope to millions affected by hair loss.In legal developments, Daiichi Sankyo's successful appeal in its antibody-drug conjugate (ADC) patent dispute with Seagen marks a significant victory with substantial financial implications. The overturning of a $41.8 million verdict illustrates the competitive dynamics in ADC technology, which plays a crucial role in targeted cancer therapies. This case emphasizes the importance of robust intellectual property strategies in maintaining competitive advantages in innovative therapeutic modalities.On the funding front, Excelsior Sciences has secured $95 million to enhance its "smart bloccs" platform for small molecule discovery and production. This investment aims to support advancements in chemical synthesis technologies crucial for accelerating drug development pipelines and fostering collaborations across therapeutics and materials science sectors. Such initiatives underscore the growing emphasis on technological innovation to streamline drug discovery processes.The European Union is making strides toward bolstering supply chain resilience with new regulations aimed at preventing drug shortages. By diversifying local biopharma supply chains and encouraging domestic production, these measures address vulnerabilities exposed by recent global disruptions. This policy shift could lead to more sustainable drug manufacturing practices within Europe, ensuring better preparedness against future crises.Pharvaris has achieved a significant milestone with its Phase 3 trial of deucrictibant meeting primary endpoints. This sets the stage for regulatory filings as a competitor to KalVista Pharmaceuticals' Ekterly in hereditary angioedema treatment. This progress highlights ongoing innovation in addressing rare genetic diseases and fostering competitive therapeutic landscapes.The FDA's approval of Cleveland Diagnostics' IsoPSA test marks a notable advancement in prostate cancer diagnostics. By detecting specific PSA protein variants associated with malignancy risk, IsoPSA represents a step forward in precision medicine. It offers enhanced diagnostic accuracy and potentially improves patient outcomes through early intervention strategies.Overall, these developments reflect the dynamic nature of the pharmacSupport the show

Philip J. Mease, MD, MACR - Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition

PeerView Family Medicine & General Practice CME/CNE/CPE Video Podcast

Play Episode Listen Later Dec 3, 2025 74:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/TEA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 10, 2026.Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

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Philip J. Mease, MD, MACR - Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Dec 3, 2025 74:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/TEA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 10, 2026.Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Philip J. Mease, MD, MACR - Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition

PeerView Internal Medicine CME/CNE/CPE Video Podcast

Play Episode Listen Later Dec 3, 2025 74:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/TEA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 10, 2026.Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Philip J. Mease, MD, MACR - Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition

PeerView Internal Medicine CME/CNE/CPE Audio Podcast

Play Episode Listen Later Dec 3, 2025 74:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/TEA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 10, 2026.Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Philip J. Mease, MD, MACR - Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition

PeerView Family Medicine & General Practice CME/CNE/CPE Audio Podcast

Play Episode Listen Later Dec 3, 2025 74:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/TEA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 10, 2026.Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Philip J. Mease, MD, MACR - Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition

PeerView Clinical Pharmacology CME/CNE/CPE Video

Play Episode Listen Later Dec 3, 2025 74:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/TEA865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 10, 2026.Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Das Novo-Nordisk-Drama und ein lukratives Geldgeschenk vom Staat

Play Episode Listen Later Nov 25, 2025 20:39

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Daniel Eckert über das Rekordhoch bei Alphabet, satte Gewinne bei Broadcom und einen Freudensprung bei Bayer. Außerdem geht es um Amazon, Meta, Tesla, Rheinmetall, Siemens Energy, Commerzbank, Deutsche Bank, Bristol-Myers Squibb, Johnson&Johnson, Zoom, Salesforce, UniGlobal (WKN: 849105) und Vanguard FTSE All-World thesaurierend (WKN: A2PKXG). Exklusiv für Euch als "Alles auf Aktien"-Hörer: Spart jetzt bis zu 83 Euro mit unserem BUSINESS INSIDER Black Friday Angebot. Erhaltet aktuelle News sowie Insights zur Finanzwelt und bleibt immer einen Schritt voraus https://www.businessinsider.de/abo/aaa/?tpcc=offsite_bi_aaa_podcast_bf_25 Die aktuelle "Alles auf Aktien"-Umfrage findet Ihr unter: https://www.umfrageonline.com/c/mh9uebwm Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

What Frontline Treatment Should Be Used in Advanced Ovarian Cancer?

ASCO Daily News

Play Episode Listen Later Nov 20, 2025 25:46

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

Season 3 - Ep.27: 'ChatGPT, MD?': large language models at the bedside - Management decisions in myocarditis

Play Episode Listen Later Nov 20, 2025 23:24

This episode covers: Cardiology This Week: A concise summary of recent studies 'ChatGPT, MD?' - Large Language Models at the Bedside Management decisions in myocarditis Statistics Made Easy: Mendelian randomisation Host: Emer Joyce Guests: Carlos Aguiar, Folkert Asselbergs, Massimo Imazio Want to watch that episode? Go to: https://esc365.escardio.org/event/2179 Want to watch that extended interview on 'ChatGPT, MD?': Large Language Models at the Bedside? Go to: https://esc365.escardio.org/event/2179?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Folkert Asselbergs, Yasmina Bououdina, Massimo Imazio, Emer Joyce, and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Season 3 - Ep.27: Extended interview on 'ChatGPT, MD?': large language models at the bedside

Medical Affairs Unscripted

Play Episode Listen Later Nov 20, 2025 10:00

Host: Emer Joyce Guest: Folkert Asselbergs Want to watch that episode? Go to: https://esc365.escardio.org/event/2179 Want to watch that extended interview on 'ChatGPT, MD?': Large Language Models at the Bedside? Go to: https://esc365.escardio.org/event/2179?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Folkert Asselbergs, Yasmina Bououdina, Emer Joyce, and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. E mma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson. Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

It Doesn't Take Months: How an Expert CMO Builds a TPP That Drives Success - With Jeff Humphrey, MD

Play Episode Listen Later Nov 20, 2025 51:26

Medical Affairs Unscripted welcomes Dr. Jeff Humphrey—an experienced CMO with three decades across Bristol Myers Squibb, Pfizer, Bayer, Kyowa Kirin, and multiple biotechs—to discuss why the Target Product Profile (TPP) is the foundation of effective drug development. He shares a clear framework for "starting with the end in mind," from scientific fit and standards of care to regulatory precedent, investor expectations, and the smart use of AI. Humphrey also underscores the importance of working with patient-first KOLs and reminds listeners that poorly planned development can waste years of people's lives and millions of dollars.

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Sandra Orta, directora general de BMS, explica cómo la inmunoterapia ha cambiado el pronóstico del cáncer de pulmón

Más de uno

Play Episode Listen Later Nov 17, 2025 7:42

La representante de la farmaceutica Bristol-Myers Squibb, pionera en este tipo de tratamiento, ha conversado con Carlos Alsina con motivo del dia mundial de esta enfermedad.

explica pron cambiado orta bristol myers squibb directora general pulm inmunoterapia

Strategic Shifts and Breakthroughs in Pharma Innovation

Artificial Intelligence in Industry with Daniel Faggella

Play Episode Listen Later Nov 17, 2025 4:55

Send us a textGood 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 pivotal changes and advancements that have been shaping our industry.The competitive nature of acquisitions within the biopharma sector has been exemplified by recent strategic buyouts. Lundbeck's decision to outbid Alkermes for Avadel Pharmaceuticals highlights how companies are leveraging acquisitions to expand their capabilities and portfolios. Similarly, Pfizer's finalized acquisition of Metsera after a fierce bidding war with Novo Nordisk underscores the importance of securing valuable assets to strengthen positioning in critical therapeutic areas, such as obesity treatment, where demand continues to rise.Regulatory milestones remain at the heart of industry progress. Organon and Henlius's Poherdy recently received FDA approval as a biosimilar to Roche's Perjeta, offering a new treatment avenue for HER2-positive breast cancer patients. This approval is noteworthy as biosimilars play an essential role in oncology by providing similar efficacy to original biologics but at reduced costs, thereby enhancing healthcare affordability and accessibility. In Europe, the EMA's Committee for Medicinal Products for Human Use has endorsed several innovative drugs, including Otsuka's Dawnzera for hereditary angioedema and Lilly's Inluriyo for certain cancer types. These endorsements reflect the growing pipeline of treatments addressing both rare genetic disorders and widespread diseases.Merck & Co.'s acquisition of Cidara Therapeutics for $9.2 billion underscores a strategic pivot towards bolstering its antiviral portfolio. This deal is particularly significant given Cidara's promising influenza antiviral candidate, initially abandoned by Johnson & Johnson. In an era where infectious diseases pose ever-evolving challenges, Merck's investment in antivirals reflects a commitment to advancing therapeutic solutions in this crucial area.However, drug development's inherent uncertainties were highlighted by Bristol Myers Squibb and Johnson & Johnson's joint anticoagulant venture, which faced termination due to a Phase 3 trial failure. This setback emphasizes the challenges and risks entailed in developing novel therapeutics, particularly within high-stakes areas like cardiovascular health.Leadership changes can significantly impact corporate strategy, as seen with Bavarian Nordic following an unsuccessful private equity takeover attempt. Such shifts can influence investor confidence and reshape strategic directions.Investment trends also paint an optimistic picture for innovation within the sector. European life sciences investor Medicxi's successful raising of €500 million signifies robust financial support for biotech ventures. This influx of capital is vital for propelling early-stage research and development efforts across Europe, fostering breakthroughs in chronic and rare disease treatments.In terms of scientific innovation, advancements in bispecific antibody production through AI/ML-driven molecular design promise higher yields and enhanced quality. These technological innovations could revolutionize complex biologics manufacturing, potentially accelerating timelines and expanding therapeutic possibilities.The regulatory landscape is seeing significant activity as well. Notably, FDA officials introduced a novel pathway aimed at accelerating gene editing therapies' development and approval. By facilitating faster market entry for personalized medicines, this regulatory innovation could pave the way for treatments tailored to individual genetic profiles.Kyowa Kirin's collaboration with Kura Oncology reached a milestone with FDA approval for an oral medication targeting acute myeloidSupport the show

Challenges HR Leaders Face in Adopting Enterprise AI - with Raúl Monroig of Bristol Myers Squibb

Play Episode Listen Later Nov 11, 2025 29:12

Today's guest is Raul Monroig, People Organization Vice President for the Intercon Region at Bristol Myers Squibb. Bristol Myers Squibb manufactures prescription medicines across oncology, hematology, immunology, cardiovascular disease, and neuroscience. With a truly global footprint, the company's research, manufacturing, and commercial presence spans more than 60 countries, and with such scale, of course, comes the complexity of managing a vast workforce. Raul joins Emerj Editorial Director Matthew DeMello to discuss how global HR teams can embrace AI to tackle critical challenges in workforce development. With AI adoption accelerating at breakneck speed, it may be that focusing on a small set of essential skills like curiosity, agility, and customer service orientation — rather than training employees on everything all at once — may be the paradigm shift that helps drive organisational success. Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1.

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Managing Immune-Related Toxicities in Oncology

ASCO Daily News

Play Episode Listen Later Nov 6, 2025 14:59

Dr. Monty Pal and Dr. Pauline Funchain discuss the latest efforts to diagnose, prevent, and treat the series of immune-related adverse events that have emerged in the era of immunotherapy. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I am Monty Pal, a medical oncologist, professor and vice chair of medical oncology at the City of Hope Comprehensive Cancer Center in Los Angeles, California. Now, it is probably no surprise to this audience that immunotherapy has transformed the treatment landscape for multiple cancer types. It remains a pillar of modern oncology. Having said that, I think we have all been baffled by certain toxicities that we run into in the clinic. Today, I am delighted to be joined by Dr Pauline Funchain to discuss some of the checkpoint inhibitor toxicities that people struggle with most. And we will also touch on some side effects of immunotherapy beyond checkpoint inhibitors: CAR-T cells, bispecifics, so on and so forth. Dr Funchain is a dear friend, and she is an associate professor and associate director of cancer research training and education at the Stanford Cancer Institute. She is co-director of the Immunotherapy Toxicity Program and the Skin Cancer Genomics Program at Stanford, where she also serves as associate program director of hematology and oncology fellowship. Dr. Funchain is also the co-founder of ASPIRE, and we are going to talk about that a little bit today, the Alliance for the Support and Prevention of Immune-Related Events. FYI for listeners, if you are interested in our disclosures, they are available at the transcript of this episode. Pauline, thanks so much for joining us today. Dr. Pauline Funchain: Monty, thank you for this invitation. It is always great to talk. Dr. Monty Pal: So, for the audience, Pauline and I know each other from my days as a fellow at City of Hope. She was a resident at Harbor UCLA and a stellar resident at that. It has just been amazing to sort of see your career grow and blossom and to witness all the cool things that you are doing. ASPIRE, in particular, sort of caught my eye. So again, for listeners, this is the Alliance for the Support and Prevention of Immune-Related Events. Can you tell us a little bit briefly about the genesis of that, how that came about? Dr. Pauline Funchain: So, there was a bunch of us who were really struggling, I mean, all of us have struggled with these immune-related adverse events, these irAEs. You know, they are new disease states, and even though they look like autoimmune diseases, they tend to need a whole lot more steroid than autoimmune diseases do and they do not totally present in the same way. And in fact, you know, Triple-M, or Triple-M overlap syndrome, is a completely new irAE, a new immune state that we have never had before the advent of checkpoint inhibitor. And so a Triple-M, for those of you who are not as familiar, that is the constellation of myocarditis, myositis, and myasthenia gravis, something that never occurs as a natural autoimmune disease. So we were starting to realize that there were some major differences with these irAEs and autoimmune diseases. We could not treat them the right way. We really needed to learn more about them. And a bunch of us who had interest in this said, "Look, we really need to be all in one space to talk about what we are doing," because all of our treatments were our own little homegrown brews, and we needed to really get together and understand how to treat these things, how to diagnose them, and then learn more about them. So, Dr. Alexa Meara from Ohio State, Dr. Kerry Reynolds from Mass Gen, we put together this research consortium, brought together all of our irAE friends, got our best subspecialists together in a research consortium, which is now only about a year and a half old. And we made this research consortium, the Alliance for Support of Prevention of Immune-Related Events, and we reached out to ASCO, and ASCO was so kind to grant us a [Alliance for Support and Prevention of Immune-Related adverse Events (ASPIRE)] Community of Practice. So we met for the first time as a Community of Practice at the ASCO Annual Meeting just this past June and really got an ASCO community together to really think about how to again, diagnose, prevent, treat irAEs. Dr Monty Pal: This is interesting to me. The ASCO Community of Practice phenomenon is something that I was not super familiar with. Can you explain to our listenership what is the ASCO Community of Practice model? If you have particular interests, how do you sort of get one started? Dr Pauline Funchain: Yeah, so ASCO has an entire page on their Community of Practice. There are multiple Community of Practice groups or COPs. There are ones for Supportive Oncology and Survivorship. There is Women in Oncology. There is a group for International Medical Graduates. And there is about, I think 10 or 12 now that have a physical presence at ASCO but also a virtual presence on the ASCO Community of Practice site. So, if you were interested in any one of these, and you can see them on the ASCO Communities of Practice sites, you would ask to become a member. Once granted membership, then there is a whole webpage of postings and conversations that people can have. You can get email digests of conversations that happen on the website, and then you can anchor it with in-person participation at the Annual Meeting. Dr Monty Pal: That is awesome, and I can think of so many different foci within oncology that really sort of deserve a Community of Practice. This definitely being one of them. You know, it strikes me as being so interesting. I mean, the checkpoint inhibitors have been around for a while now. I think when you and I were in training, gosh, back then, these were just a little bit of a pipe dream, right? But having said that, I would probably say that more than half of my kidney cancer practice is either on checkpoint inhibitors, and the vast majority have been on one at some point in their past, right? With that in mind, you know, we have all treated a lot of patients with these drugs. Why is it that we still struggle to manage the toxicities? And just to take that one step further, what are some of the toxicities that, perhaps through ASPIRE or through your experience, people struggle with the most? Dr Pauline Funchain: So, I think we are still struggling with these because again, they are new disease states, right? This is what we all experienced with COVID, a brand-new virus and a brand-new syndrome. We now have 20-plus of these as irAEs. And what we have realized about them is the immune activation that happens with these is so much more than what we have seen with autoimmune diseases. So for instance, if you have a Crohn's or ulcerative colitis, you will top out at 40 to 60 milligrams of prednisone if a Crohn's flare or ulcerative colitis flare happens. But for our severe IR colitises, you know, it is at least 1 mg per kg, often goes up to 2 mg per kg. We, in some cases, have done 1 gram pulses if we are worried that somebody is going to perforate. So that was sort of like the first 5 years of treating irAE, and then now in the sort of second 5 years of treating irAE, we have realized that that is a lot of immunosuppression, and we might be able to get away with less with the newer biologics that are on board. So, we are struggling to try to get the data for some of these irAEs that we knew, we have known for a while, but to try to get newer treatments that may immunosuppress less so that you may still be able to retain that tumor response. And in fact, some of the preclinical studies suggest that some of these biologics may actually synergize with the immunotherapy and actually make the immunotherapy more effective from a tumor perspective and calm down the irAE as sort of the bystander effect. So we are still trying to optimize those. Getting up trials in the space has been very difficult. That is one of the reasons for the genesis of ASPIRE because we realized we needed to band together to have a bigger voice in that realm. Then there are other things that are brand new. So we talked about Triple-M. So Triple-M, again, with Triple-M or any myocarditis or myasthenia, I mean, there is about a 50% chance of death from irAE based on the literature. I think we are getting better at recognizing this, and so at Stanford we have some data to say that if you serially follow troponin, that maybe your outcomes are better. You can potentially lower the percentage of cases that are fatal because you can catch them early. I mean, this is all preliminary data, but again, these are all things that are evolving, and we do not all have the right answer. I mean, even the serial troponin thing, I think, is pretty controversial. And in fact, at one of our quarterly Zoom meetings that we are doing in ASPIRE in December is going to sort of flush out that controversy about serial troponin measuring and what is the best thing to use? Would you use something like abatacept or would you use ruxolitinib? Which one is better? I think there is a lot of controversy still about these things. Dr Monty Pal: You have really piqued my curiosity here because you think about the cons of treating irAEs, right? And I worry exactly about what you had mentioned, right, which is, "Gosh, what is going on with this tumor in terms of immunosuppression?" But you think about some of the newer agents, you mentioned ruxolitinib, I have heard of dasatinib, for instance, in this setting. Frankly speaking, a lot of these, as you point out, are really thought of as being also anticancer drugs. So you have really got me thinking about the potential synergy between perhaps suppressing an irAE and augmenting antitumor activity, which I think is very interesting. Am I on the right track with that? Dr Pauline Funchain: I think so, but you will find that a lot of people will not even go there because they are worried about how much immunosuppression you are going to cause. I am at heart a geneticist, but I think an immunologist will happily tell you that the immune system is very complex. There are multiple pathways, and these drugs do not all target the same immune pathways. So if we understand a little bit more about the pathways we are targeting and pick apart the pathways that are really, really tumor relevant and the other pathways that are not tumor relevant, you may be able to piece together a better marriage of tumor response and irAE control. Dr Monty Pal: Kind of on this topic, and again, leaning on your background in genetics, where are we in terms of predicting these irAEs? I mean, you would think the holy grail would be picking out a snip or something of this for it, right, that could potentially identify that patient who is going to get Triple-M or, you know, at the very least a significant high-grade irAE event. Are we anywhere closer to that in 2025? Dr Pauline Funchain: There have been data published. There have been some big GWAS studies. All of the effect sizes are pretty small. So there are some prediction algorithms, but none of them are clinically useful. And I think when you look at the odds ratios, they will increase risk by maybe 20%. I think one of the things that we found in a very small series and supported anecdotally is something as easy as family history of autoimmune disease is probably more predictive at this point than any of those types of markers. I think we will get there, but we are not anywhere near where we would like to be. Things like TMB also, actually, there is some good data about higher TMB, higher risk of irAE too. Dr Monty Pal: Interesting. I see all this data coming through, IL-8 polymorphisms, etc. And I just wondered if any of that was ready for prime time. But I mean, this is a good message for the practicing clinician. Sounds like we are not quite there yet. And I could probably keep you on for another entire podcast to talk about this topic, but let us see if we can at least skim the surface. I never thought I would see the day when BiTEs and CAR-Ts were entering into my kidney cancer practice, but in fact, it is really become central to a lot of our clinical trials in RCC these days. I would be lying if I did not say that I was not struggling with the toxicities and so forth associated with these drugs. Can you give us a quick primer, maybe just good resources that people can go to for managing toxicity with BiTEs and with CAR and with some of these novel therapeutic modalities that we are using in the oncology clinics? Dr Pauline Funchain: I know there is a recently published toxicity manual for BiTEs in hematologic malignancies, I think it was in Blood. CAR-T is covered in many irAE guidelines. So ASCO guidelines actually has a CAR-T [cell therapy guideline], and I would be remiss not to point out that actually ASCO has a, I am a little biased, but a wonderful guideline on irAE that is actually being updated as we speak. We are hoping for publication next year. I find the format of that, there are many guidelines out there, actually. There is ASCO, SITC, ESMO has a guideline for irAE, but I find the formatting of the ASCO guideline to be much easier to flip through during clinic, just because of the visual format of the tables. But that is going to be updated next year. And with CAR-T, there is now multiple publications also in terms of guidelines. But what I will say about bispecifics and CAR-T, so they have very similar toxicities in terms of the cytokine release and also with the ICANS, so the neurotoxicity. But what we have been finding that is really interesting with BiTEs and CAR-T, and actually even with TIL, cytokine release is very similar to some of the IL-2 toxicities but not identical that we see with TIL treatment. But now we are starting to see overlap. So patients who have been treated with immunotherapy and then go on to get a bispecific or then go on to get TIL, so I have seen some colitises that have occurred after the fact. Some of the newer CAR-Ts without checkpoint have been causing some really interesting, probably not in a good way, but interesting biologically, colitises that are really refractory. So we are starting to see some overlap, and again, I think this field is just evolving constantly. Dr Monty Pal: Yeah, no, I almost think I need to go back to that fellowship that you and I did together 20 years ago and, you know, and see if I could repeat some coursework on CAR-T management. You know, Pauline, I could probably keep you on the horn for hours, but this has just been terrific. Thank you so much for sharing all of your insights with us today on the ASCO Daily News Podcast. Dr Pauline Funchain: Thank you for the invitation. It was wonderful to talk about this, and it was wonderful to catch up a little bit, Monty. Dr Monty Pal: Same here, same here. And thanks to our listeners too. If you value the insights you heard today on the ASCO Daily News Podcast, please 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. Find out more about today's speakers:     Dr. Monty Pal   @montypal  Dr. Pauline Funchain @FunchainMD Follow ASCO on social media:      @ASCO on Twitter     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. Pauline Funchain: Consulting or Advisory Role: Merck, Replimune, Sanofi/Regeneron, Immunocore, Tempus Research Funding (Inst.): Pfizer, Bristol-Myers Squibb, IDEAYA Biosciences, Linnaeus Therapeutics Travel, Accommodations, Expenses: Merck

Season 3 - Ep.26: Lp(a): the future starts now - Myocardial infarction in older age and frailty

Play Episode Listen Later Nov 6, 2025 23:16

This episode covers: Cardiology this Week: A concise summary of recent studies Lp(a) - What to expect in the very near future Myocardial infarction in older and frail adults Mythbusters: is beetroot good for your heart? Host: Rick Grobbee Guests: JP Carpenter, Vijay Kunadian, Erik Stroes Want to watch that episode? Go to: https://esc365.escardio.org/event/2177 Want to watch that extended interview on Lp(a), go to: https://esc365.escardio.org/event/2177?resource=interview Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel, Vijay Kunadian and Erik Stroes have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Season 3 - Ep.26: Extended interview on Lp(a) - What to expect in the very near future

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Play Episode Listen Later Nov 6, 2025 8:35

Host: Rick Grobbee Guest: Erik Stroes Want to watch that extended interview on Lp(a), go to: https://esc365.escardio.org/event/2177?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/2177 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Rick Grobbee and Erik Stroes have declared to have no potential conflicts of interest to report.

EP 195 - "Unlocking Truths That Change Your Life And Being Whole" With Nitika Chopra

Finding Grace

Play Episode Listen Later Nov 6, 2025 46:06

In this episode of finding grace I'm joined by Nitika Chopra is the Founder and CEO of Chronicon and The Chronicon Foundation, a pioneering platform and nonprofit uplifting those living with chronic illness through community, advocacy, and education. A seasoned host, speaker, and entrepreneur, she's collaborated with brands like Google, Microsoft, and Bristol-Myers Squibb, hosted a globally distributed talk show, and now leads Truth Talks via substack. Her mission: to create healing spaces where people are empowered to live fully and thrive, on their terms.In this episode you'll discover.Nitika shares what finding grace means to her and journey she's been on.We discussed the continued lack of diversity in the wellness industry, and the importance of using your platforms to create more inclusive, authentic spaces.Nitika shared her powerful story, from being diagnosed with psoriasis at age ten to founding Chronicon, highlighting how resilience, vulnerability, and purpose have shaped her path.We explored the harms of toxic positivity and self-gaslighting, calling for a more compassionate and nuanced approach to healing, especially within chronic illness communities.She touched on the need to bridge the gap between extremes, embracing both struggle and strength, to remove shame and empower others to define their own version of thriving.Nitika spoke about shifting from an illness-based identity toward one rooted in wholeness, seeing healing as an evolving, lifelong practice rather than a fixed destination.Nitika emphasised the healing power of rest and nurturing routines, inviting listeners to reconnect with their inner wisdom and self-love as daily acts of grace.Nitika shares this and so much more.Do reach out to me to continue this conversation.If you want to work with Nitika and find out what she's up to:Instagram @Nitikachopra Substack “The truth today”www.nitikachopra.comYou can find me at : Watch my TEDx talk here Instagram @thehannahwallaceTwitter @hannahwallace_Face book @thehannahwallace Website www.hannah-wallace.com Sign up to my newsletter here Thank you so much for listening please share, subscribe and review it's greatly appreciated and I hope you find grace in your week ahead. Hosted on Acast. See acast.com/privacy for more information.

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Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks

BioSpace

Play Episode Listen Later Nov 5, 2025 26:26

Many of the top stories of 2025 are currently being written. We're on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duke it out over the right to acquire glittery obesity startup Metsera. In the latest development, Pfizer raised its original bid of around $7.27 billion to about $8.1 billion on Monday—only to be usurped again by the indefatigable Novo, which upped its own bid to a cool $10 billion. Meanwhile, the unprecedented drama in the uppermost ranks of the FDA—another top story of 2025—continues as CDER Director George Tidmarsh exits the agency. Tidmarsh reportedly resigned Sunday after being placed on administrative leave amid an investigation into his “personal conduct” at the agency. On Monday, however, Tidmarsh told Endpoints News that he was “second-guessing” his decision. Speaking of the FDA, the regulator appears to have done its own 180—on uniQure's investigational gene therapy for Huntington's disease, three-year data from which sent the biotech's stock into the stratosphere just five weeks ago. Despite previous agreements on protocols and statistical analyses, the agency “no longer agrees” that Phase I/II data for AMT-130 are adequate to provide primary evidence for the application, uniQure said, throwing the timeline for the BLA into question. Another gene therapy player, Sarepta Therapeutics, took a hit this week, as two of its Duchenne muscular dystrophy drugs, Vyondys 53 and Amondys 45, failed a confirmatory trial. Sarepta still plans to file for full approval of the two exon-skipping therapies, however, based on what it called “encouraging trends” in efficacy. Finally, on the genetic medicine front, CBER director Vinay Prasad teased an upcoming paper that will detail the regulator's thinking and a new approach to gene editing approvals. On top of all that, Q3 earnings continue to roll in, with Pfizer, Eli Lilly, Vertex, Bristol Myers Squibb, AbbVie, and more reporting results. One more thing: Have you ever wanted to know more about the inner workings of the Biogen-Eisai Alzheimer's partnership? Check out this profile on BioSpace 40 under 40 honoree Neena Bitritto-Garg, Eisai alum and current CEO of Ensho Therapeutics.

What's News in Earnings: Who Is Winning the Obesity-Drug Arms Race?

WSJ Whatâ€™s News

Play Episode Listen Later Nov 4, 2025 7:47

Bonus Episode for Nov. 4. The weight-loss-drug arms race is only heating up, as Novo Nordisk attempts to snatch drugmaker Metsera away from Pfizer. But can either company compete with Zepbound seller Eli Lilly? WSJ reporter Peter Loftus discusses what earnings from Big Pharma, including AbbVie, Bristol Myers Squibb and Merck, say about the future of the industry and how companies are responding to President Trump's drug-pricing plans, including TrumpRx. WSJ Heard on the Street columnist David Wainer hosts this special bonus episode of What's News in Earnings, where we dig into companies' earnings reports and analyst calls to find out what's going on under the hood of the American economy. Sign up for the WSJ's free Markets A.M. newsletter. Further Reading: Novo Nordisk Sweetens Offer for Metsera - WSJ Pfizer Sues Seeking to Block Novo Nordisk's Effort to Undo Weight-Loss Drug Deal Why Pfizer Can Still Prevail in the Obesity Fight With Novo Nordisk The Day Pharma's Weight-Loss Gold Rush Intensified Pfizer Profit Falls Amid Lower Covid-19 Drug Demand Novo Nordisk Seeks to Outmuscle Pfizer With $9 Billion Bid for Metsera Novo Nordisk to Shake Up Board After Obesity-Market Challenges Mounjaro Powers Eli Lilly to Bumper Quarter of Earnings AbbVie Lifts Profit Outlook as Sales Rise Bristol Myers Squibb Profit Soars, Raises Revenue Guidance Merck Profit Rises on Strong Keytruda Demand GSK Lifts Guidance After Specialty Medicines Boost Sales Novartis Expects to Ride Out Patent Losses With Sales, Profit Growth Ahead Biogen Cuts Full-Year Earnings Guidance, Despite Third-Quarter Profit Rise J&J Lifts Full-Year Sales Outlook, Fueled by Pharma, Med-Device Gains Learn more about your ad choices. Visit megaphone.fm/adchoices

Dr. Sheila Gujrathi - Biotech Entrepreneur & Author, "The Mirror Effect"

Just Get Started Podcast

Play Episode Listen Later Nov 4, 2025 49:20

Episode 472 features Dr. Sheila Gujrathi, a biotech entrepreneur, executive, and champion for under represented leaders. Her new book, "The Mirror Effect: A Transformative Approach To Growth For The Next Generation Of Female Leaders" is out now.Chapters:00:00 Introduction and Book Announcement02:15 The Unmet Need: Writing for My Younger Self05:30 Overcoming Challenges: A Personal Journey09:45 The Power of Mentorship and Sponsorship14:00 Spiritual Growth and Finding Purpose18:20 Building a Personal Board of Directors23:10 The Inner Critic and Self-Compassion28:45 The Importance of Storytelling in Leadership33:00 Navigating Negative Work Environments37:15 Conclusion: Embracing Vulnerability and ConnectionFind Sheila Online:Website: https://sheilagujrathimd.com/ TEDxTalk: https://www.youtube.com/watch?v=2DpDx6T3-X4 LinkedIn: https://www.linkedin.com/in/sheila-gujrathi-md/ Instagram: https://www.instagram.com/sheilagujrathimd/ Book: https://sheilagujrathimd.com/book/ About Sheila:Sheila is a biotech entrepreneur, executive, and champion for under represented leaders. Over the past 25 years, she's had the privilege of developing life-changing medicines for patients with serious diseases while building and running private and public biotech companies—including some exciting exits. Today she's a founder, chairwoman, board director, strategic advisor, and consultant to start-up companies and investment funds. Dr. Gujrathi was the co-founder and former CEO of Gossamer Bio and former Chief Medical Officer of Receptos. Her journey started at Northwestern University, where she earned both her M.D. and biomedical engineering degree, and took her from the halls of Harvard, UCSF, and Stanford to the corporate offices of Fortune 500 companies like McKinsey, Genentech, and Bristol-Myers Squibb.Dr. Gujrathi has earned multiple leadership awards, including AIMBE Fellow, BLOC100 Luminary, Healthcare Technology Report Top 25 Women Leaders in Biotechnology, Corporate Directors Forum Director of the Year, and Fiercest Women in Life Sciences. But what really lights her up is creating the inclusive environments she wished she'd had throughout her career. That's why she co-founded the Biotech CEO Sisterhood, a group of trailblazing female CEOs—because we're all better when we support each other.

Dubiose Angebote für Eure Aktien und Comeback der grünen Energie

PeerView Family Medicine & General Practice CME/CNE/CPE Video Podcast

Play Episode Listen Later Nov 4, 2025 24:26

In der heutigen Folge sprechen die Finanzjournalisten Lea Oetjen und Holger Zschäpitz über das Allzeithoch von Siemens Energy, die Übernahme von Kenvue durch Kimberly-Clark und das große Rätselraten um eine Privatbank. Außerdem geht es um Micron, Alphabet, Biontech, Bristol Myers Squibb, Amazon, OpenAI, Nvidia, Iris Energy, Microsoft, Dell Technologies, Johnson & Johnson, BMW, Continental, Volkswagen, Mercedes-Benz, Aixtron, Deutsche Pfandbriefbank, Lufthansa, Bloom Energy, First Solar, Nextracker, Enphase, Siemens Energy, Linde, Air Liquide, Plug Power, Ballard Power, NEL Asa, Samsung SDI, QuantumScape, GE Vernova, Schneider Electric, Iberdrola, NextEra Energy, Rock Tech Lithium, iShares Global Clean Energy ETF (WKN: A0MW0M), Global X Hydrogen ETF (WKN: A3E40P), Amundi Global Hydrogen ETF (WKN: A1C7AK), WisdomTree Renewable Energy ETF (WKN: A3D7VR), Global X Cleantech ETF (WKN: A2QPB4), Amundi MSCI New Energy ETF (WKN: LYX0CB). Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

April W. Armstrong, MD, MPH - Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care

Play Episode Listen Later Oct 31, 2025 47:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

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April W. Armstrong, MD, MPH - Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Oct 31, 2025 47:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Pharma Shifts: Dual-Action Obesity Drugs & Regulatory Waves

PeerView Internal Medicine CME/CNE/CPE Video Podcast

Play Episode Listen Later Oct 31, 2025 7:12

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's focus is on a series of significant advancements that are poised to reshape the landscape of drug development, regulatory standards, and patient care.Eli Lilly has made remarkable strides with its dual-action obesity medications, Zepbound and Mounjaro. Despite being removed from the CVS formulary, these drugs have achieved exceptional sales figures, reaching $10 billion in a single quarter. This success can be attributed to Lilly's innovative direct-to-consumer sales strategy, which exemplifies how modern marketing approaches can overcome traditional market barriers. Additionally, Eli Lilly's partnership with Walmart to expand access to Zepbound through retail pharmacy pickups exemplifies a strategic approach to enhancing patient access to crucial medications. By leveraging Walmart's extensive retail network, this collaboration facilitates easier access to obesity treatments—a significant public health challenge—enhancing both patient convenience and broadening market reach for Lilly's products. These achievements not only highlight the potential of strategic marketing but also underscore a growing demand for effective obesity treatments within the pharmaceutical industry.In another exciting development, Alnylam Pharmaceuticals has reported impressive sales figures for Amvuttra, a treatment for transthyretin amyloid cardiomyopathy. Surpassing analysts' expectations, this success signals a growing market for treatments targeting rare diseases and emphasizes the importance of strategic market expansion to reach underserved patient populations.Meanwhile, Bristol Myers Squibb's anticipated schizophrenia treatment, Cobenfy, has experienced a lukewarm market entry. While meeting initial expectations in its first year, it has yet to create the breakthrough impact investors anticipated. This situation highlights the challenges even well-hyped pharmaceuticals face upon launch and underscores the need for continuous strategic planning to ensure market penetration and sustained growth.A surprising development in mergers and acquisitions comes from Novo Nordisk's $6.5 billion counteroffer to acquire Metsera, an obesity biotech initially targeted by Pfizer. This aggressive move reflects intense competition in the obesity drug market and illustrates the high stakes involved in acquiring promising biotech assets that could potentially transform treatment paradigms for chronic conditions like obesity.The vaccine industry is navigating its own set of challenges with declining sales across the board. However, Merck's adult pneumococcal vaccine Capvaxive has shown promising initial sales figures. As the first pneumococcal vaccine specifically designed for adults, Capvaxive indicates a potential niche market that Merck could successfully capture.On the regulatory front, significant measures are being taken by the FDA to boost biosimilar availability against drug pricing pressures. New draft guidance aims to eliminate clinical testing requirements for biosimilars and categorize all approved biosimilars as "interchangeable." This initiative could significantly reduce biologic medicine costs post-patent expiration and increase competition in the market, potentially making essential medications more accessible to patients. Additionally, the FDA is proposing streamlined biosimilar approval pathways aimed at reducing overall bio-drug costs—a welcome move reflecting concerted efforts to make essential medications more affordable and accessible globally.Argenx has reported positive trial results for Vyvgart in treating generalized myasthenia gravis (gMG), highlighting its commitment to addressing unmet needs within this patient population. These findings could expand treatment options for gMG patients who have been previously overlooked in thSupport the show

April W. Armstrong, MD, MPH - Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care

Play Episode Listen Later Oct 31, 2025 47:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

April W. Armstrong, MD, MPH - Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care

PeerView Internal Medicine CME/CNE/CPE Audio Podcast

Play Episode Listen Later Oct 31, 2025 47:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

April W. Armstrong, MD, MPH - Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care

PeerView Family Medicine & General Practice CME/CNE/CPE Audio Podcast

Play Episode Listen Later Oct 31, 2025 47:12

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/SMF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until October 7, 2026.Elevating Psoriasis and Comorbidity Management With TYK2 Inhibition: Achieving and Sustaining Outcomes to Transform Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Turning Change into Opportunity: Navigating Ageism and Owning Your Career

The Power of Owning Your Career Podcast

Play Episode Listen Later Oct 27, 2025 35:37

This week on the Power of Owning Your Career Podcast, host Simone Morris welcomes Keith Willis—leadership expert, entrepreneur, and Founder of Core Management Training. Keith's journey is indicative of how careers thrive by intentional design, not by chance. Starting out as a U.S. Army Junior Officer, Keith made the leap to corporate America through the Cameron-Brooks Development & Preparation Program, a pivotal experience that shaped his passion for helping others own their career trajectories. Keith built an impressive resume with award-winning roles in sales and training at industry giants such as Johnson & Johnson, Pfizer, and Bristol Myers Squibb, where he was recognized for his results as both a sales representative and a manager. Inspired by his drive to close the gap between individual performance and transformative leadership, Keith founded Core Management Training, where he equips pharmaceutical and life sciences organizations to turn managers into leaders who drive performance and culture. Today, Keith is also building "Never Look for a Job Again"—an e-zine and course designed to empower professionals to create opportunities rather than wait for them. He believes that anyone can own their career by embracing self-awareness, setting meaningful goals, and building supportive networks. In this candid and practical conversation, Keith shares actionable advice on navigating uncertainty, addressing ageism, and staying true to your authentic self—even when the workplace challenges you to fit in. Listeners will take away Keith's holistic formula for career ownership, practical resources, and the confidence to make bold moves—no matter where they're starting from. Resources Mentioned in the Episode: Never Look for a Job Again (career development guide and upcoming course) PCS to Corporate America by Cameron Brooks Manager Tools & Career Tools podcasts The Long View by Brian Fetherstonhaugh Self-development tools: Audible, LinkedIn Learning, and yes—even ChatGPT! Connect & Learn More: Host Simone E. Morris: LinkedIn | Become a Guest on the Show | 52 Tips for Owning Your Career Keith Willis: Core Management Training | Never Look for a Job Again Follow & Subscribe: Join us on IG at @simonemorrisent for career inspiration Subscribe to our YouTube for inclusive conversations and actionable career strategies Whether you're an aspiring leader, a career changer, or someone looking to unlock your full potential, this episode will inspire you to get behind the wheel of your career and drive your future forward.

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Milind Desai, MD, MBA / Anjali Tiku Owens, MD - Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist

PeerView Heart, Lung & Blood CME/CNE/CPE Video Podcast

Play Episode Listen Later Oct 27, 2025 58:00

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RJP865. CME/MOC/AAPA/IPCE credit will be available until October 27, 2026 .Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

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Milind Desai, MD, MBA / Anjali Tiku Owens, MD - Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist

PeerView Clinical Pharmacology CME/CNE/CPE Audio Podcast

Play Episode Listen Later Oct 27, 2025 57:59

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RJP865. CME/MOC/AAPA/IPCE credit will be available until October 27, 2026 .Fine-Tuning Hypertrophic Cardiomyopathy Care in the CMI Era: Redefining Management for the Modern Heart Failure Specialist In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported through an educational grant from Bristol Myers Squibb.Disclosure information is available at the beginning of the video presentation.

Intel schafft den Turnaround und Hoffen auf Krypto-Bullenmarkt

Play Episode Listen Later Oct 24, 2025 20:49

In der heutigen Folge sprechen die Finanzjournalistinnen Anja Ettel und Lea Oetjen über den Aktientausch zweier einstiger Biotech-Rivalen, die Begnadigung des reichsten US-Häftlings und den Government Shutdown, der zum Risiko für die Amerikaner wird. Außerdem geht es um SAP, Tesla, Chevron, Exxon, Siemens Energy, Deutsche Telekom, T-Mobile, MTU, Beiersdorf, Unilever, Roche, Atoss, Lukoil, Rosneft, Rivian, Biontech, Curevac, Moderna, Bristol Myers Squibb, BlackRock, Solana, Gold, Bitcoin, Ethereum. Wir freuen uns über Feedback an aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

Season 3 - Ep.25: Extended interview on arrhythmias in cardiac amyloidosis

Play Episode Listen Later Oct 23, 2025 9:08

Host: Susanna Price Guest: Stephanie Schwarting Want to watch the episode? Go to: https://esc365.escardio.org/event/2176 Want to watch the extended interview on Arrhythmias in Cardiac Amyloidosis? Go to: https://esc365.escardio.org/event/2176?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis through an independent funding. The programme has not been influenced in any way by its funding partners. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Stephanie Schwarting has declared to have potential conflicts of interest to report: advisory board for Alnylam, Bayer, Pfizer; principal investigator in trials sponsored by Alexion, Novo Nordisk and Intellia. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Season 3 - Ep.25: Arrhythmias in cardiac amyloidosis - Taking the 'O' out of HOCM: managing LVOT obstruction