Podcasts about Novartis

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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the dynamic landscape of these industries, exploring significant regulatory shifts, scientific breakthroughs, and strategic corporate maneuvers that are shaping the future of healthcare.The pharmaceutical and biotech sectors are currently navigating a period of profound transition. Recent regulatory developments have captured attention, particularly the U.S. Supreme Court's decision to overturn emergency tariffs imposed by the previous administration. This ruling is pivotal as it alleviates financial pressures on the industry, allowing companies to redirect their resources towards innovation and development. It underscores the interconnectedness of global supply chains and highlights the importance of stable regulatory environments for fostering industry growth.In a notable advancement within oncology, AstraZeneca has achieved FDA approval for its combination therapy of Calquence and Venclexta as an all-oral regimen for first-line chronic lymphocytic leukemia (CLL). This approval not only positions AstraZeneca competitively in the BTK inhibitor market but also signifies a shift towards more patient-friendly treatment regimens. By simplifying therapy, this development promises to enhance patient compliance and improve outcomes, challenging existing standards in CLL care.Meanwhile, internal challenges at the Centers for Disease Control and Prevention have led to a postponement of a critical vaccine advisory panel meeting. This delay occurs amid evolving vaccine policies that have sparked debate within the public health community, potentially impacting immunization strategies and initiatives aimed at bolstering public health.Corporate governance within the industry is also experiencing shifts. Novo Nordisk has nominated two industry veterans to its board as part of an ongoing strategy to align leadership with evolving business objectives. Similarly, Roche is contemplating divesting its once-blockbuster antibiotic Rocephin in response to competitive pressures from generics in Europe. These moves reflect a broader industry trend where companies are re-evaluating their portfolios to better respond to market dynamics and patent expirations.Novartis is making strategic changes as well by selling its stake in Novartis India Limited while maintaining separate commercial and R&D interests in the region. This action highlights a growing trend among pharmaceutical giants towards streamlining operations and focusing on high-growth areas—a strategy aimed at maximizing resource allocation efficiency.Despite narrowly missing a $1 billion revenue target for 2025, Madrigal Pharmaceuticals remains optimistic about the growth prospects of its drug Rezdiifra within the metabolic dysfunction-associated steatohepatitis (MASH) market. The company anticipates further expansion driven by unmet medical needs, underscoring the competitive dynamics within this therapeutic area.In personnel movements that could influence strategic directions, Daiichi Sankyo has appointed former Novartis CMO John Tsai as head of its R&D division. His expertise is expected to bolster Daiichi's focus on oncology and other critical therapeutic areas, potentially accelerating innovation within their drug development pipeline.Meanwhile, Manus Bio has secured a $15 million contract with the U.S. government for domestic supply of shikimic acid, an essential component for producing Tamiflu. This contract highlights efforts to strengthen domestic pharmaceutical supply chains amid global uncertainties—a crucial consideration for ensuring medication availability during crises.In clinical research, a setback was observed with Grail's Galleri cancer blood test trial failing to meet its primary endpoint in collaboration with the NHS. The resulting decline in GrailSupport the show

In this episode of IPS Finance, we examine why Novartis shares surged by 20% and the key factors behind this sharp rally. The discussion also covers how the Pax Silica – US–India agreement has created a positive impact on market sentiment and certain sectors. A crisp analysis to help investors understand the reasons behind the movement and what it could mean for future investment decisions.

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

This episode covers: Cardiology This Week: A concise summary of recent studies Atrial septal defects in adults Conservative and invasive management of chronic coronary syndromes Milestones: 4S trial   Host: Rick Grobbee Guests: JP Carpenter, Annemien van den Bosch, Rasha Al-Lamee, Roxana Mehran Want to watch the episode? Go to: https://esc365.escardio.org/event/2552 Want to watch the extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch 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. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Roxana Mehran has declared to have potential conflicts of interest to report: institutional research payments from Abbott, Alleviant Medical, Chiesi, Concept Medical, Cordis, CPC Clinical Research, Daiichi Sankyo, Duke, Faraday Pharmaceuticals, Idorsia Pharmaceuticals, Janssen, MedAlliance, Medtronic, NewAmsterdam Pharma, Novartis, Novo Nordisk Inc., Population Health Research Institute (PHRI), Protembis GmbH, Radcliffe, RM Global Bioaccess Fund Management, Sanofi US Services, Inc. ; personal fees from: None ; Equity

Host: Rick Grobbee Guest: Annemien van den Bosch Want to watch that extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2552 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch 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: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. 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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a wide array of topics, from groundbreaking therapies and strategic corporate moves to regulatory shifts and industry trends shaping the future of healthcare.We begin with Eli Lilly, which is making significant strides with its combined Zepbound and Taltz therapy, showing promising results in the treatment of psoriasis and obesity. This combination therapy, initially successful in psoriatic arthritis, is set to transform treatment protocols by bridging gaps between psoriasis and obesity. This dual-targeting approach highlights a burgeoning trend in the industry: the use of combination therapies to enhance patient outcomes while streamlining treatment regimens. This strategy not only promises better management of interconnected conditions but also reflects a broader industry goal of maximizing therapeutic reach with existing drugs.Novartis is advancing its portfolio with the oral BTK inhibitor, Rhapsido, following a successful Phase 3 trial for a new chronic hives subtype. This development underscores Novartis's commitment to addressing niche markets and unmet medical needs, emphasizing the pharmaceutical industry's focus on expanding the utility of existing drugs. Additionally, Novartis has entered into a notable partnership with Macrocycle Biotech for cardiovascular drug development. This collaboration represents a broader trend where large pharmaceutical companies seek innovative partnerships to expand their therapeutic portfolios through cutting-edge biotech solutions.Meanwhile, Moderna's influenza vaccine submission has been accepted by the FDA after an initial rejection, illustrating a responsive regulatory environment crucial for timely access to vaccines amid potential flu outbreaks.Johnson & Johnson's $1 billion investment plan in the U.S., focusing on cell therapy, aligns with broader industry trends towards personalized medicine and advanced therapeutic approaches. This investment is part of a strategic pivot towards cell and gene therapies that promise to redefine treatment pathways for complex diseases. Similarly, Bayer's $7.25 billion settlement over Roundup litigation shows an industry keen on resolving legal challenges swiftly to refocus efforts on innovation.Regulatory reforms are also gaining attention, with proposals aimed at streamlining FDA processes to enhance drug access and reduce burdens. These reforms could significantly impact drug development timelines and market entry strategies, reflecting an ongoing discourse on balancing regulation with fostering innovation.On a global scale, Stada's €85 million investment in Saudi Arabia points to a strategic move towards enhancing supply chain resilience in the Middle East and North Africa. This aligns with industry trends focusing on regional manufacturing capabilities to ensure drug availability while reducing logistical complexities.A notable example of strategic resource allocation is Eli Lilly's $100 million upfront payment for CSL's IL-6 antibody development rights. This reflects an adaptive approach where initial clinical setbacks are seen as opportunities for new therapeutic ventures rather than dead ends.Turning our attention to Alzheimer's research, Korsana Biosciences has emerged from stealth mode with substantial funding aimed at developing an anti-amyloid antibody capable of crossing the blood-brain barrier. This effort addresses a critical need within Alzheimer's disease treatment—a field marked by intense competition and scientific challenge. Parallelly, IQVIA Biotech highlights the importance of accelerating early-stage interventions for Alzheimer's through data analytics and optimized clinical trials. Such efforts aim to expedite regulatory approvals and bring new therapies to market faster—a trend indicative of leveragSupport the show

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

a16z general partner Jorge Conde talks with Vasant Narasimhan, CEO of Novartis International, about transforming a 250-year-old conglomerate into a pure play medicines company and unlocking $180 billion of value in the process. They cover Novartis's platform technologies: cell and gene therapies, RNA medicines, and radioligand therapies. They also discuss AI in drug discovery, the rise of China as a biotech competitor, and what Vasant looks for when evaluating startup partnerships, including his advice on the killer experiments and CMC work that can make or break a deal. Resources: Follow Vasant Narasimhan on X: https://twitter.com/VasNarasimhanFollow Jorge Conde on X: https://x.com/JorgeCondeBio  Stay Updated:Find a16z on YouTube: YouTubeFind a16z on XFind a16z on LinkedInListen to the a16z Show on SpotifyListen to the a16z Show on Apple PodcastsFollow our host: https://twitter.com/eriktorenberg Please note that the content here is for informational purposes only; should NOT be taken as legal, business, tax, or investment advice or be used to evaluate any investment or security; and is not directed at any investors or potential investors in any a16z fund. a16z and its affiliates may maintain investments in the companies discussed. For more details please see a16z.com/disclosures. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Will Linssen has been ranked as World's # 1 Leadership Coach by Global Gurus (USA) and recognized as #1 Coach Trainer by Thinkers50 (UK). Furthermore, Will is a Master Certified Coach at the International Coaching Federation (ICF) and co-author of the Marshall Goldsmith Stakeholder Centered Coaching methodology. For over two decades he has been working with executive teams to measurably improve their leadership and team effectiveness. He has held several positions in general management and business management at multinational companies in Europe, North America, and Asia and he has served at the board of several multinationals in Asia. Will travels the globe training executive coaches and coaching business leaders using GCG's highly effective methodology. Clients consistently commend his results-driven personality combined with his confident, energetic, and relatable style. A good listener and problem solver with in-depth business knowledge and cross-cultural understanding, he has been recognized for his creative and analytical skills, and most of his executive clients hold international positions in a wide range of industries at Fortune 500 Cos across USA, LATAM, Europe, Asia, and Australia a.o. AON, Allianz, BAT, Bayer, Coca Cola, GSK, ING, Kimberly Clark, LG, LinkedIn, McDonalds, Novartis, Pepsi, Philips, Philip Morris, Sanofi, Standard Chartered Bank, Saudi Telecom, Saudi Institute of Public Administration, Syngenta, SC Johnson and Uber.More Info: Global Coach GroupSponsors: Become a Guest on Master Leadership Podcast: Book HereAgency Sponsorships: Book GuestsMaster Your Podcast Course: MasterYourSwagFree Coaching Session: Master Leadership 360 CoachingSupport this show http://supporter.acast.com/masterleadership. Hosted on Acast. See acast.com/privacy for more information.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events shaping the landscape of drug development, regulatory scrutiny, and industry advancement. As we navigate this complex terrain, we'll explore how these changes impact both companies and patients.In recent news, Moderna has encountered a substantial hurdle as the FDA declined to review its flu vaccine candidate, mRNA-1010. This decision marks a notable shift from the expedited processes witnessed during the COVID-19 pandemic, reflecting a more cautious regulatory approach under current administrative leadership. Analysts suggest this could indicate broader regulatory changes that might affect future vaccine approvals. Moderna's situation is emblematic of the challenges companies face in maintaining momentum post-pandemic, especially as their research and development spending saw a significant decrease of 31% last year due to completed respiratory trials. This reduction highlights a strategic pivot as the company reassesses its priorities amidst an evolving market landscape.Vertex Pharmaceuticals is making headlines with its ambitious revenue goals outside its established cystic fibrosis franchise. By 2026, Vertex aims to generate $500 million from non-CF medications, with recent launches like Casgevy and Journavx already showing promise by collectively bringing in $175.6 million last year. This diversification strategy is critical for mitigating risks associated with dependence on a single therapeutic area and reflects a broader industry trend towards strategic realignment. Additionally, Vertex remains under close observation within kidney disease portfolios, particularly with Povetacicept—an IgA nephropathy treatment—and the success of Journavx impacting market positions by offering chronic kidney disease patients new therapeutic options.PTC Therapeutics has faced setbacks with its FDA application withdrawal for Translarna, intended for treating nonsense mutation Duchenne muscular dystrophy. The decision came after receiving adverse feedback from the FDA, highlighting the complexities involved in gaining approval for therapies targeting intricate genetic conditions. Such hurdles underscore the high-risk nature of biotech ventures that are heavily reliant on regulatory timelines.Novartis is pushing forward with plans to seek full FDA approval for Vanrafia, its IgA nephropathy drug, despite not meeting primary kidney function goals in Phase 3 trials. This move aligns with a growing trend where companies pursue approval based on secondary endpoints or other supportive data when primary outcomes fall short. Such strategies underscore the competitive and high-stakes environment surrounding drug approval pathways.Novo Nordisk is expanding its production capabilities in Ireland to meet increasing demand for Wegovy, their obesity drug that's seen impressive sales in the U.S. This investment underscores the global potential for obesity treatments and highlights how manufacturing expansions are pivotal to supporting international market entry.In Europe, Amgen has secured approval for Uplizna in treating myasthenia gravis, adding another option to an already crowded treatment landscape but offering patients additional therapeutic choices. Meanwhile, AbbVie has launched a legal challenge against Botox's inclusion in drug pricing negotiations under the Inflation Reduction Act (IRA), arguing it should be excluded due to its plasma-derived nature.Ultragenyx has announced a 10% workforce reduction amid halted gene therapy plans and unsuccessful late-stage trials in brittle bone disease. These adjustments often reflect broader strategic shifts within biopharma companies as they realign focus and resources. Ultragenyx's operational challenges highlight the volatile nature of biotech ventureSupport the show

Die Schweizer Pharmabranche gerät unter Druck: In den USA sollen Medikamentenpreise sinken, und Investitionen von Roche und Novartis fokussieren sich stärker auf den US-Markt. Ist die Schweiz als Pharma-Standort gefährdet? Im Audiopodcast: Analyse.

What if success in business didn't have to come at the expense of your marriage? And what if protecting your relationship didn't mean sacrificing your entrepreneurial dreams?In this Valentine's episode of Mindset Mastery Moments, Dr. Alisa Whyte sits down with husband-and-wife duo Robert and Kay Lee Fukui, founders of Power Couples by Design™, to explore the real challenges entrepreneurial couples face — and how intentional partnership can strengthen both marriage and business.Entrepreneurship often brings stress home, and over 60% of business owners say business pressure negatively impacts their relationships. For married entrepreneurs, the lines between work and home life can blur, creating quiet distance between partners.Robert generated over $150 million in sales working with brands like Coca-Cola, Novartis, and Bristol-Myers Squibb. Kay Lee grew up in a family business and witnessed how entrepreneurship can either strengthen families or slowly erode them.Today, they help couples intentionally design marriages and businesses that thrive side by side.✨ In this Valentine's Special, you'll discover:• The “unspoken separation” that damages marriages and businesses• Why traditional work-life balance often fails entrepreneurial couples• How conflict avoidance hurts both profit and partnership• Practical ways to prevent your business from becoming the “mistress” in your marriage• The six key areas every couplepreneur must audit: teamwork, balance, connection, time, money, and freedomThis conversation is essential listening for couples building businesses together — or anyone supporting a spouse through entrepreneurship.You don't have to choose between love and success.You don't have to sacrifice your marriage to grow your business.But both require intentional design.

On The Kenny & JT Show we welcome in Pro Football Hall of Famer Thurman Thomas. The 2007 inductee played running back for the Buffalo Bills from 1988 – 1989 before finishing his career in Miami. Thurman is in the community this week as part of the Hall's Residency Program presented by Novartis. Our interview is driven by Akron Auto Auction and akronautoauction.com.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Tim Scott, President & CEO of Biocom California, a biopharma executive with more than two decades of experience, including spinning out companies from UC San Diego and leading firms acquired by BioMarin and Novartis, to discuss how California’s life sciences ecosystem became a global innovation engine, why the state’s research and venture networks matter, and how policy headwinds such as the Inflation Reduction Act (IRA) and Most Favored Nation (MFN) reference pricing reshape investment, rare disease development, and competition with Europe and China. Key Topics: Biocom Origins: Municipal policy roots, industry advocacy, ecosystem evolution across California. Innovation Network: University and research density, regional clusters, talent, and collaboration effects. Capital Pathway: NIH and NSF support, SBIR and STTR bridges, venture appetite, and liquidity. MFN and IRA: Pill penalty incentives, orphan exemption stakes, Medicare exposure, and VC pullback. Next-Gen Development: AI-enabled discovery, faster trial enrollment, digital twins, and regulator openness. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

In this episode of the GaryVee Audio Experience, I sit down with legendary marketer Jim Stengel for our 8th annual Super Bowl Advertiser Roundtable. We are joined by CMOs and Presidents from major brands—including Ritz, EOS, Novartis, Cadillac Formula 1, and Tree Hut—to discuss their strategies for maximizing the most expensive 30 seconds in advertising. I share my biggest takeaways from the weekend in Santa Clara and San Francisco, including my thoughts on the "Super Bowl surround sound" my team executed and why I am "petrified" of most celebrity campaigns. We discuss the shifting role of the Super Bowl spot as a "tactic" in a larger, always-on strategy, and I make a bold prediction about what the next era of Super Bowl advertising will look like.You'll learn:Why I view every event, including the Super Bowl, as a "production day" for contentHow to get more value out of experiential marketing by creating thoughtful content with influencersMy philosophy on why most brands should prioritize trial and sampling at the Super BowlWhy the shift to an "interest graph" on social media is forcing marketers to double down on creative relevanceThe immense economic impact of "family moments" and team building for employee retentionMy prediction that a future Super Bowl ad will be an exact replica of a high-performing organic social media post

In der heutigen Folge sprechen die Finanzjournalisten Philipp Vetter und Holger Zschäpitz über sprunghafte Anleger, das krasse Cloudflare-Versprechen und ein furioses Comeback von Luxus. Außerdem geht es um Alphabet, Seagate, Western Digital, Robinhood, Lyft, Mattel, Hasbro, Marriott, Hilton, Ferrari, Kering, Marsh, Arthur Gallgher, Aon und Willis Towers Watson stürzen in den USA ab, dann in Europa: die Aktien von Allianz, Zürich, Axa, Aviva, Raymond James, Charles Schwab, Micron Technology, Cisco, Intel, Verizon, Qualcomm, Toyota, British American Tobacco, Siemens, Novartis, Bayer, Total Energies, GSK, General Motors, AT&T, Bank of America, Applied Materials, Citigroup und Ford, Amundi Global Luxury ETF (WKN: A2H564), iShares Edge MSCI World Value Factor ETF (WKN: A12ATG), iShares Edge MSCI Europe Value Factor ETF (WKN: A12DPP), iShares Edge MSCI USA Value Factor ETF (WKN: A2AP35), iShares Core MSCI World ETF (WKN: A0RPWH). 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. Der Börsen-Podcast 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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In today's episode, we delve into the dynamic landscape of these industries, exploring ambitious strategic plans, regulatory hurdles, scientific breakthroughs, and emerging trends that are shaping the future of healthcare.Let's begin with AstraZeneca, which has set an ambitious target to achieve $80 billion in revenue by 2030. This goal reflects their intention to bring over 25 blockbuster drugs to market, underscoring a commitment to innovation and expansion in their therapeutic portfolio. The focus on cutting-edge research is not just a strategy for growth but also a sign of the broader industry trend where large pharmaceutical companies pursue high-value targets to strengthen their market positions. AstraZeneca is also making strides in the weight-loss market with its new candidate elecoglipron, undergoing an extensive late-stage program to evaluate its efficacy as a monotherapy and in combination treatments for various indications. This development positions AstraZeneca competitively in the burgeoning sector, offering a novel therapeutic option for obesity management.Meanwhile, CSL Limited is undergoing a leadership transition. CEO Paul McKenzie has stepped down under pressure, and Gordon Naylor has been appointed as interim chief. This change highlights the critical role of strategic leadership in navigating industry challenges and maintaining growth trajectories amidst a rapidly shifting market landscape.In a display of financial success, Novartis reported a record-breaking performance for 2025. This achievement led to a 30% increase in CEO Vas Narasimhan's compensation, reaching $32 million. The company's robust financial health is attributed to advancing innovative treatments targeting unmet medical needs, emphasizing how achieving innovation milestones can significantly enhance corporate valuation and leadership rewards.Incyte is preparing for the patent expiration of its blood cancer drug Jakafi in 2028 by focusing on Opzelura, a topical cream that has witnessed a 33% sales increase from the previous year. With sales reaching $678 million, Opzelura's success highlights Incyte's strategic pivot to diversify its product offerings and mitigate risks associated with patent cliffs. This exemplifies how companies must continuously innovate and adapt to maintain competitive advantages.Moderna has entered into a long-term agreement with Mexico to ensure local mRNA vaccine supply through technology transfer to Laboratorios Liomont. This partnership extends Moderna's global footprint and underscores the critical role of mRNA technology in pandemic preparedness and vaccine accessibility, reinforcing its transformative impact on public health strategies.Regulatory landscapes have also seen notable activity. The FDA issued untitled letters concerning potentially misleading drug advertisements from companies like Novo Nordisk, Argenx, and Sobi. Such actions emphasize regulatory vigilance in marketing practices. Additionally, Lilly's Kinsunla failed to secure approval in Scotland, while Regenxbio faced rejection for its gene therapy for Hunter syndrome. These regulatory hurdles highlight the rigorous oversight pharma companies face and the complex pathways drugs must navigate before market approval.Collaborations within the industry are proving crucial for innovation. Merck's collaboration with Calla Lily Clinical Care aims to enhance delivery systems for vaginal therapeutics. Similarly, Bristol Myers Squibb's partnership with Evinova focuses on integrating AI into clinical development processes. These alliances reflect an industry-wide emphasis on leveraging technology to improve drug delivery efficiency and streamline clinical trial operations.Shifting our focus now to scientific advancements and clinical trial results that aSupport the show

Synopsis: At JPM 2026 in San Francisco, Alok Tayi welcomes Michelle Werner, CEO of Alltrna, to Biotech 2050 for a powerful conversation at the intersection of personal mission, platform biology, and rare-disease drug development. Michelle traces her two-decade career across Bristol Myers Squibb, AstraZeneca, and Novartis—and the moment everything changed when her child was diagnosed with a rare disease. That experience led her to Alltrna and its pioneering engineered tRNA platform, designed to correct nonsense mutations across hundreds—potentially thousands—of genetic disorders with a single therapeutic approach. Together, Alok and Michelle explore how tRNAs work, why “stop-codon disease” could redefine rare-disease classification, and how basket trials borrowed from oncology may accelerate development. They dive into delivery strategy, portfolio expansion into CNS and muscle disorders, regulatory innovation, and how AI is reshaping molecular design—offering a rare look at what it takes to build a first-in-class modality from the ground up. Biography: Michelle is a seasoned pharmaceutical executive with more than 20 years in the industry spanning commercial and research & development (R&D) responsibilities. Prior to Alltrna, Michelle served as Worldwide Franchise Head, Solid Tumors at Novartis Oncology, where she was responsible for delivering the disease area strategies across multiple tumors and led business development efforts resulting in a doubling of long-term portfolio value for the franchise. Previous to Novartis, Michelle was a senior leader at AstraZeneca and as Global Franchise Head in Hematology, she was critical in launching multiple indications worldwide for CALQUENCE®. Prior to this, Michelle was Head of US Oncology, where she led the business through dramatic growth in both team and revenue through eight-plus product launches. Previous to AstraZeneca, Michelle was with Bristol-Myers Squibb for 10 years in various positions of increasing responsibility including roles in sales, marketing, and market access in the US and UK, and above market in Europe (based in France) and global almost exclusively in oncology. Michelle started her professional career in R&D, working hands-on with patients at the Oncology Clinical Trials Unit at Harvard Medical School before moving into industry in clinical operations. Outside of her corporate responsibilities, Michelle is a wife and mother to three children and is a member of the rare disease community. She is currently serving a Board appointment for the non-profit organization Rare Disease Renegades, a purpose that fuels her passions both personally and professionally.

Treatment is a significant part of overcoming breast cancer, but what about the mental, physical and emotional challenges this disease presents? Sarah Cipolla and Tawana Davis both relied on their faith to get through breast cancer. Through it all – the ups and downs and good times and setbacks – they had hope for better days and trusted in their faith. Hope and faith are powerful forces during challenging times. Susan G. Komen leads Worship in Pink, a nationwide program that brings breast health education to faith communities. Through this effort, Komen can reach people who don't participate in breast health care and people who rely on their faith to overcome life's challenges. Thanks to Merck and Novartis for supporting the Worship in Pink Program

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 60, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Merck looks to fill Keytruda's shoes; Novartis aims to push through largest expiry period; Novo warns of steep sales decline; Pfizer bullish on obesity; and Lilly expects orforglipron success. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

*Hosted by Radu Palamariu*Steffen Lang runs operations for one of the world's most impactful pharma giants, Novartis, leading over 20,000 associates globally. He started in R&D and now oversees the delivery of life-saving medicines at near-perfect service levels. In this episode, we explored how he built a product-centered, resilient supply network, embraced AI in manufacturing, and tackled the real-time complexity of personalized therapies. We dive deep into leadership, dual supply chain strategies, and how a "never settle" mindset transforms global healthcare.Discover more details here.Follow us on:Instagram: http://bit.ly/2Wba8v7X: https://bit.ly/3J4Wt35LinkedIn: https://bit.ly/4hbidqoFacebook: http://bit.ly/2HtryLd

Dr. Pedro Barata and Dr. Ugwuji Maduekwe discuss the evolving treatment landscape in gastroesophageal junction and gastric cancers, including the emergence of organ preservation as a selective therapeutic goal, as well as strategies to mitigate disparities in care. Dr. Maduekwe is the senior author of the article, "Organ Preservation for Gastroesophageal Junction and Gastric Cancers: Ready for Primetime?" in the 2026 ASCO Educational Book. TRANSCRIPT Dr. Pedro Barata: Hello, and welcome to By the Book, a podcast series from ASCO that features compelling perspectives from authors and editors of the ASCO Educational Book. I'm Dr. Pedro Barata. I'm a medical oncologist at University Hospitals Seidman Cancer Center and an associate professor of medicine at Case Western Reserve University in Cleveland, Ohio. I'm also the deputy editor of the ASCO Educational Book. Gastric and gastroesophageal cancers are the fifth most common cancer worldwide and the fourth leading cause of cancer-related mortality. Over the last decade, the treatment landscape has evolved tremendously, and today, organ preservation is emerging as an attainable but still selective therapeutic goal. Today, I'm delighted to be speaking with Dr. Ugwuji Maduekwe, an associate professor of surgery and the director of regional therapies in the Division of Surgical Oncology at the Medical College of Wisconsin. Dr. Maduekwe is also the last author of a fantastic paper in the 2026 ASCO Educational Book titled "Organ Preservation for Gastroesophageal Junction and Gastric Cancers: Ready for Prime Time?" We explore these questions in our conversations today.  Our full disclosures are available in the transcript of this episode as well. Welcome. Thank you for joining us today. Dr. Ugwuji Maduekwe: Thank you, Dr. Barata. I'm really, really glad to be here. Dr. Pedro Barata: There's been a lot of progress in the treatment of gastric and gastroesophageal cancers. But before we actually dive into some of the key take-home points from your paper, can you just walk us through how systemic therapy has emerged and actually allowed you to start thinking about a curative framework and really informing surgery decision-making? Dr. Ugwuji Maduekwe: Great, thank you. I'm really excited to be here and I love this topic because, I'm terrified to think of how long ago it was, but I remember in medical school, one of my formative experiences and why I got so interested in oncology was when the very first trials about imatinib were coming through, right? Looking at the effect, I remember so vividly having a lecture as a first-year or second-year medical student, and the professor saying, "This data about this particular kind of cancer is no longer accurate. They don't need bone marrow transplants anymore, they can just take a pill." And that just sounded insane. And we don't have that yet for GI malignancies. But part of what is the promise of precision oncology has always been to me that framework. That framework we have for people with CML who don't have a bone marrow transplant, they take a pill. For people with GIST. And so when we talk about gastric cancers and gastroesophageal cancers, I think the short answer is that systemic therapy has forced surgeons to rethink what "necessary" really means, right? We have the old age saying, "a chance to cut is a chance to cure." And when I started out, the conversation was simple. We diagnose the cancer, we take it out. Surgery's the default. But what's changed really over the last decade and really over the last five years is that systemic therapy has gotten good enough to do what is probably real curative work before we ever enter the operating room. So now when you see a patient whose tumor has essentially melted away on restaging, the question has to shift, right? It's no longer just, "Can I take this out?" It's "Has the biology already done the heavy lifting? Have we already given them systemic therapy, and can we prove it safely so that maybe we don't have to do what is a relatively morbid procedure?" And that shift is what has opened the door to organ preservation. Surgery doesn't disappear, but it becomes more discretionary. Necessary for the patients who need it, and within systems that can allow us to make sure that we're giving it to the right patients. Dr. Pedro Barata: Right, no, that makes total sense. And going back to the outcomes that you get with these systemic therapies, I mean, big efforts to find effective regimens or cocktails of therapies that allow us to go to what we call "complete response," right? Pathologic complete response, or clinical complete response, or even molecular complete response. We're having these conversations across different tumors, hematologic malignancies as well as solid tumors, right? I certainly have those conversations in the GU arena as well. So, when we think of pathologic CRs for GI malignancies, right? If I were to summarize the data, and please correct me if I'm wrong, because I'm not an expert in this area, the traditional perioperative chemo gives you pCRs, pathologic complete response, in the single digits. But then when you start getting smarter at identifying biologically distinct tumors such as microsatellite instability, for instance, now you start talking about pCRs over 50%. In other words, half of the patients' cancer goes away, it melts down by offering, in this case, immunotherapy as a backbone of that neoadjuvant. But first of all, this shift, right, from going from these traditional, "not smart" chemotherapy approaches to kind of biologically-driven approaches, and how important is pCR in the context of "Do I really need surgery afterwards?" Dr. Ugwuji Maduekwe: That's really the crux of the entire conversation, right? We can't proceed and we wouldn't be able to have the conversation about whether organ preservation is even plausible if we hadn't been seeing these rates of pathologic complete response. If there's no viable tumor left at resection, did surgery add something? Are we sure? The challenge before this was how frequently that happened. And then the next one is, as you've already raised, "Can we figure that out without operating?" In the traditional perioperative chemo era, pathologic complete response was relatively rare, like maybe one in twenty patients. When we go to more modern regimens like FLOT, it got closer to one in six. When you add immunotherapy in recent trials like MATTERHORN, it's nearly triple that rate. And it's worth noting here, I'm a health services-health disparities researcher, so we'll just pause here and note that those all sound great, but these landmark trials have significant representation gaps that limit and should inform how confidently we generalize these findings. But back to what you just said, right, the real inflection point is MSI-high disease where, with neoadjuvant dual-checkpoint blockade, trials like NEONIPIGAS and INFINITY show pCR rates that are approaching 50% to 60%. That's not incremental progress, that's a whole new different biological reality. What does that mean? If we're saying that 50% to 60% of the people we take to the OR at the time of surgery will end up having no viable tumor, man, did we need to do a really big surgery? But the problem right now is the gold standard, I think we would mostly agree, the gold standard is pathologic complete response, and we only know that after surgery. I currently tell my patients, right, because I don't want them to be like, "Wait, we did this whole thing." I'm like, "We're going to do this surgery, and my hope is that we're going to do the surgery and there will be no cancer left in your stomach after we take out your stomach." And they're like, "But we took out my stomach and you're saying it's a good thing that there's no cancer." And yes, right now that is true because it's a measure of the efficacy of their systemic therapy. It's a measure of the biology of the disease. But should we be acting on this non-operatively? To do that, we have to find a surrogate. And the surrogate that we have to figure out is complete clinical response. And that's where we have issues with the stomach. In esophageal cancer, the preSANO protocol, which we'll talk about a little bit, validated a structured clinical response evaluation. People got really high-quality endoscopies with bite-on biopsies. They got endoscopic ultrasounds. They got fine-needle aspirations and PET-CT, and adding all of those things together, the miss rate for substantial residual disease was about 10% to 15%. That's a number we can work with. In the stomach, it's a lot more difficult anatomically just given the shape of people's stomachs. There's fibrosis, there's ulceration. A fair number of stomach and GEJ cancers have diffuse histology which makes it difficult to localize and they also have submucosal spread. Those all conceal residual disease. I had a recent case where I scoped the patient during the case, and this person had had a 4 cm ulcer prior to surgery, and I scoped and there was nothing visible. And I was elated. And on the final pathology they had a 7 cm tumor still in place. It was just all submucosal. That's the problem. I'm not a gastroenterologist, but I would have said this was a great clinical response, but because it's gastric, there was a fair amount of submucosal disease that was still there. And our imaging loses accuracy after treatment. So the gap between what looks clean clinically and what's actually there pathologically remains very wide. So I think that's why we're trying to figure it out and make it cleaner. And outside of biomarker-selected settings like MSI-high disease, in general, I'm going to skip to the end and our upshot for the paper, which is that organ preservation, I would say for gastric cancer particularly, should remain investigational. I think we're at the point where the biology is increasingly favorable, but our means of measurement is not there yet. Dr. Pedro Barata: Gotcha. So, this is a perfect segue because you did mention the SANO, just to spell it out, "Surgery As Needed for Oesophageal" trial, so SANO, perfect, I love the abbreviation. It's really catchy. It's fantastic, it's actually a well-put-together perspective effort or program applying to patients. And can you tell us how was that put together and how does that work out for patients? Dr. Ugwuji Maduekwe: Yeah, I think for those of us in the GI space, we have SANO and then we also have the OPRA for rectum. SANO for the upper GI is what takes organ preservation from theory to something that's clinically credible. The trial asked a very simple question. If a patient with a GEJ adenocarcinoma or esophageal adenocarcinoma achieved what was felt to be a clinical complete response after chemoradiation, would they actually benefit from immediate surgery? And the question was, "Can you safely observe?" And the answer was 'yes'. You could safely observe, but only if you do it right. And what does that mean? At two years, survival with active surveillance was not inferior to those who received an immediate esophagectomy. And those patients had a better early quality of life. Makes sense, right? Your quality of life with an esophagectomy versus not is going to be different. That matters a lot when you consider what the long-term metabolic and functional consequences of an esophagectomy are. The weight loss, nutritional deficiencies that can persist for years. But SANO worked because it was very, very disciplined and not permissive. You mentioned rigor. They were very elegant in their approach and there was a fair amount of rigor. So there were two main principles. The first was that surveillance was front-loaded and intentional. So they had endoscopies with biopsies and imaging every three to four months in the first year and then they progressively spaced it out with explicit criteria for what constituted failure. And then salvage surgery was pre-planned. So, the return-to-surgery pathway was already rehearsed ahead of time. If disease reappeared, take the patient to the OR within weeks. Not sit, figure out what that means, think about it a little bit and debate next steps. They were very clear about what the plan was going to be. So they've given us this blueprint for, like, watching people safely. I think what's remarkable is that if you don't do that, if you don't have that infrastructure, then organ preservation isn't really careful. It's really hopeful. And that's what I really liked about the SANO trial, aside from, I agree, the name is pretty cool. Dr. Pedro Barata: Yeah, no, that's a fantastic point. And that description is spot on. I am thinking as we go through this, where can this be adopted, right? Because, not surprisingly, patients are telling you they're doing a lot better, right, when you don't get the esophagus out or the stomach out. I mean, that makes total sense. So the question is, you know, how do you see those issues related to the logistics, right? Getting the multi-disciplinary team, getting the different assessments of CR. I guess PETs, a lot of people are getting access to imaging these days. How close do you think this is, this kind of program, to be implemented? And maybe I would assume it might need to be validated in different settings, right, including the community. How close or how far do you think you see that being applied out there versus continuing to be a niche program, watch and wait program, in dedicated academic centers? Dr. Ugwuji Maduekwe: I love this question. So I said at the top of this, I'm a health equity/health disparities researcher, and this is where I worry the most. I love the science of this. I'm really excited about the science. I'm very optimistic. I don't think this is a question of "if," I think it's a question of "when." We are going to get to a point where these conversations will be very, very reasonable and will be options. One of the things I worry about is: who is it going to be an option for? Organ preservation is not just a treatment choice, and I think what you're pointing out very rightly is it's a systems-level intervention. Look at what we just said for SANO. Someone needs to be able to do advanced endoscopy, get the patients back. We have to have the time and space to come back every three to four months. We have to do molecular testing. There needs to be multi-disciplinary review. There needs to be intensive surveillance, and you need to have rapid access to salvage surgery. Where is that infrastructure? In this country, it's mostly in academic centers. I think about the panel we had at ASCO GI, which was fantastic. And as we were having the conversation, you know, we set it up as a debate. So folks were debating either pro-surveillance or pro-surgery. But both groups, both people, were presenting outcomes based on their centers. And it was folks who were fantastic. Dr. Molena, for example, from Memorial Sloan Kettering was talking about their outcomes in esophagectomies [during our session at GI26], but they do hundreds of these cases there per year. What's the reality in this country? 70% to 80% to 90%, depending on which data you look at, of the gastrectomies in the United States occur at low-volume hospitals. Most of the patients at those hospitals are disproportionately uninsured or on government insurance, have lower income and from racial and ethnic minority groups. So if we diffuse organ preservations without the system to support it, we're going to create a two-tiered system of care where whether you have the ability to preserve your organs, to preserve bodily integrity, depends on where you live and where you're treated. The other piece of this is the biomarker testing gap. One of the things that, as you pointed out at the beginning, that's really exciting is for MSI-high tumors. Those are the patients that are most likely to benefit from immunotherapy-based organ preservation. But here's the problem. If the patient isn't tested at time of initial diagnosis before they ever see me as a surgeon, the door to organ preservation is closed before it's ever open. And testing access remains very inconsistent across academic networks. And then there's the financial toxicity piece where, for gastrectomy, pancreatectomy, I do peritoneal malignancies, more than half of those patients experience significant financial toxicity related to their cancer treatment. We're now proposing adding at least two years, that's the preliminary information, right? It's probably going to be longer. At least a couple of years of surveillance visits, repeated endoscopies, immunotherapy costs. How are we going to support patients through that? We're going to have to think about setting up navigation support, geographic solutions, what financial counseling looks like. My patient for clinic yesterday was driving to see me, and they were talking about how they were sliding because it was snowing. And they were sliding for the entire three-hour drive down here. Are we going to tell people like that that they need to drive down to, right, I work at a high-volume center, they're going to need to come here every three months, come rain or snow, to get scoped as opposed to the one-time having a surgery and not needing to have the scopes as frequently? My concern, like I said, I'm an optimist, I think it is going to work. I think we're going to figure out how to make it work. I'm worried about whether when we deploy it, we widen the already existing disparities. Dr. Pedro Barata: Gotcha, and that's a fantastic summary. And as I'm thinking also of what we've been talking in other solid tumors, which one of the following do you think is going to evolve first? So we are starting to use more MRD-based assays, which are based on blood test, whether it's a tumor-informed ctDNA or non-informed. We are also trying to get around or trying to get more information response to systemic therapies out of RNA-seq through gene expression signatures, or development of novel therapeutics which also can help you there. Which one of these areas you think you're going to help this SANO-like approach move forward, or you actually think it's actually all of the above, which makes it even more complicated perhaps? Dr. Ugwuji Maduekwe: I think it's going to be all of the above for a couple of reasons. I would say if I had to pick just one right now, I think ctDNA is probably the most promising and potentially the missing piece that can help us close the gap between clinical and pathologic response. If you achieve clinical complete response and your ctDNA is negative, so you have clinical and molecular evidence of clearance, maybe that's a low-risk patient for surveillance. If you have clinical complete response but your ctDNA remains positive, I would say you have occult molecular disease and we probably need intensified therapy, closer monitoring, not observation. I think the INFINITY trial is already incorporating ctDNA into its algorithm, so we'll know. I don't think we're at the point where it alone can drive surgical decisions. I think it's going to be a good complement to clinical response evaluation, not a replacement. The issue of where I think it's probably going to be multi-dimensional is the evidence base: who are we testing? Like, what is the diversity, what is the ancestral diversity of these databases that we're using for all of these tests? How do we know that ctDNA levels and RNA-seq expression arrays are the same across different ancestral groups, across different disease types? So I think it's probably going to be an amalgam and we're going to have to figure out some sort of algorithm to help us define it based on the patient characteristics. Like, I think it's probably different, some of this stuff is going to be a little bit different depending on where in the stomach the cancer is. And it's going to be a little bit more difficult to figure out if you have a complete clinical response in the antrum and closer to the pylorus, for example. That might be a little bit more difficult. So maybe the threshold for defining what a clinical complete response needs to be is higher because the therapeutic approach there is not quite as onerous as for something at the GE-junction. Dr. Pedro Barata: Wonderful. And I'm sure AI, whether it's digitization of the pathology from the biopsies and putting all this together, probably might play a role as well in the future.  Dr. Maduekwe, it's been fantastic. Thank you so much for sharing your insights with us and also congrats again for the really well-done review published.  For our listeners, thank you for staying with us. Thank you for your time. We will post a link to this fantastic article we discussed today in the transcript of this episode. And of course, please join us again next month on the By the Book Podcast for more insights on key advances and innovations that are shaping modern oncology. Thank you, everyone. Dr. Ugwuji Maduekwe: Thank you. Thank you for having me. Watch the ASCO GI26 session: Organ Preservation for Gastroesophageal and Gastric Cancers: Ready for Primetime? Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:          Dr. Pedro Barata   @PBarataMD    Dr. Ugwuji Maduekwe @umaduekwemd Follow ASCO on social media:          @ASCO on X (formerly Twitter)          ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Pedro Barata:   Stock and Other Ownership Interests: Luminate Medical   Honoraria: UroToday   Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Merck, Ipson, Astellas Medivation, Novartis, Dendreon   Speakers' Bureau: AstraZeneca, Merck, Caris Life Sciences, Bayer, Pfizer/Astellas   Research Funding (Inst.): Exelixis, Blue Earth, AVEO, Pfizer, Merck    Dr. Ugwuji Maduekwe: Leadership: Medica Health Research Funding: Cigna    

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 transformative events reshaping the industry landscape, from regulatory advancements to scientific breakthroughs and strategic business maneuvers.Kicking off with a significant regulatory update, the FDA's Rare Pediatric Disease Voucher Program has been rejuvenated through a newly signed government funding bill. This initiative is designed to expedite the development of treatments for rare pediatric diseases, offering crucial incentives to companies targeting this critical healthcare segment. By reauthorizing this program, there's an expectation of stimulating innovation and potentially bringing more treatments to market for conditions with limited existing therapies. This move underscores a broader commitment to addressing unmet medical needs through incentivized innovation.Turning to corporate developments, Eli Lilly is anticipating substantial growth in revenue despite facing pricing pressures on its key products, Mounjaro and Zepbound. The company projects revenues between $80 billion and $83 billion for 2026, marking a 25% increase from 2025 at the midpoint. This growth is attributed to strong product performance and strategic maneuvers within their pipeline. Eli Lilly has also made strategic decisions by optimizing its pipeline through dropping three clinical-stage drugs, including a gene therapy acquired via Prevail Therapeutics. This move points towards Lilly's focus on concentrating efforts on more promising candidates within their expansive pipeline. Additionally, Eli Lilly is expanding its GLP-1 franchise beyond metabolic diseases into immunology and inflammation with ongoing clinical trials in conditions such as asthma, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This strategic expansion could lead to novel therapeutic options for chronic inflammatory diseases.Similarly, Bristol Myers Squibb is focusing on new growth drivers amid declining sales of legacy drugs. With $48.2 billion in revenue projected for 2025 largely stemming from newer products, BMS is strategically repositioning itself to maintain momentum amidst market changes.Novartis faces its largest patent expiry challenge but remains optimistic about its trajectory. CEO Vas Narasimhan suggests robust strategies are in place to counteract these patent expiries, indicating a strong focus on innovation and strategic planning to navigate these hurdles. Novartis is also refining its oncology strategy by cutting early-stage cancer candidates while adding new ones focused on promising therapeutics—a broader trend of adopting data-driven approaches to streamline drug development pipelines.Meanwhile, AbbVie continues its stronghold in the inflammatory bowel disease market with its blockbuster immunology drugs Skyrizi and Rinvoq. These products significantly contribute to AbbVie's $61.1 billion revenue, highlighting their commitment to maintaining leadership in immunology despite competitive pressures from rivals like Johnson & Johnson.Astellas has exceeded expectations with its cancer drug Vyloy overcoming a trial setback to quadruple sales in the third quarter fiscal year 2025 results. This success underscores the resilience and potential of innovative oncology treatments even when faced with clinical challenges.In financial markets, Veradermics successfully raised $256 million through its IPO, signaling strong investor interest in biotech firms with promising dermatological applications. Concurrently, Eikon Therapeutics marked the largest biotech IPO since 2024 with a $381 million listing on Nasdaq, reflecting renewed investor confidence in biotech ventures. Industry trends indicate a resurgence of interest in public markets exemplified by Eikon Therapeutics' upsized IPO alongside Veradermics' successful Support the show

If you've ever told yourself, "I just need to stay calm," you've been sold a half-truth. Because elite performers don't win by being calm. They win by using emotion as data—and refusing to let it drive the steering wheel. In this masterclass conversation, I sit down with Mindset and Performance Coach Collin Henderson to unpack what actually separates average performers from elite ones: not talent… not even skill… but the ability to reduce internal interference when pressure spikes—on the first tee, on the back nine, or in the biggest moments in business. We break down Collin's "4 levels of confidence," the #1 performance killer (FOPO: fear of other people's opinions), why your brain is always trying to keep you safe (even when it sabotages you), and how to build unshakable confidence through identity, self-talk, and a repeatable process. In this episode, you'll learn: Why emotional regulation isn't "staying calm," but staying in control How to perform confidently without feeling confident Collin's 4 levels of confidence—and why most people get trapped in levels 2–3 The equation that explains choking under pressure: Talent + Skill – Internal Interference How to kill FOPO and stop playing golf (and life) like you're being judged by a panel Why identity is the true ceiling—and how to change it The simple framework to shift your "don'ts" into "do's" and stop carving failure into your nervous system Get your pencils ready and start listening.  P.S. UPDATE: I have decided to start anew on Instagram. Follow me @thepaulsalter for your daily dose of high-performance wisdom, insights, and actions. P.P.S. Curious to learn more about the results my clients are experiencing and what they say about working with me? Read more here. Apply for 1-1 Mindset and Performance Coaching: Click here to apply to work with me. More About Collin Collin Henderson is the founder and CEO of Master Your Mindset, LLC, and one of today's leading voices in mental conditioning. A former two-sport Division I athlete and top-ranked medical sales professional, he left corporate success to coach elite performers full-time. Acclaimed broadcaster Jim Rome calls him "an authority of what matters most — an elite mindset." Collin has authored seven books, hosts the Master Your Mindset podcast, and has trained #1 NBA draft picks, Heisman finalists, and top performers across pro sports and Fortune 500 companies. His trainings have been utilized by organizations like Nike, Microsoft, Salesforce, Amazon, and Novartis. A proud family man and dad of five, Collin also loves Fruity Pebbles, pizza, Ted Lasso, and cute puppy videos on Instagram. Learn more about Collin by visiting his website. Play to Your Potential On (and Off) the Course Schedule a Mindset Coaching Discovery Call Subscribe to the More Pars than Bogeys Newsletter Download my "Play Your Best Round" free hypnosis audio recording. High-Performance Hypnotherapy and Mindset Coaching Paul Salter - known as The Golf Hypnotherapist - is a High-Performance Hypnotherapist and Mindset Coach who leverages hypnosis and powerful subconscious reprogramming techniques to help golfers of all ages and skill levels overcome the mental hazards of their minds so they can shoot lower scores and play to their potential. He has over 16 years of coaching experience working with high performers in various industries, helping them get unstuck, out of their own way, and unlock their full potential. Click here to learn more about how high-performance hypnotherapy and mindset coaching can help you get out of your own way and play to your potential on (and off) the course.  Instagram: @thegolfhypnotherapist  Key Takeaways: Emotions are information, not instructions; use them as data without letting them dictate behavior. You don't have to feel great to perform great; elite performers execute through uncertainty and discomfort. Most people operate with conditional confidence, while unshakable confidence commits without needing results or validation. Talent plus skill minus internal interference determines execution probability, not talent alone. Fear of other people's opinions (FOPO) quietly sabotages performance, even though others are focused on themselves. Negative self-labels reinforce a fixed identity and set a ceiling on performance. Scripted self-talk and repeatable processes prevent the mind from freelancing under pressure. Key Quotes: "Words are the language of the brain. Emotions are the language of the body."  "You don't have to feel great to perform great." "If you can't control your state, you can't control your performance."  "If you want to change your psychology, use your physiology."  "Talent plus skill minus internal interference equals execution probability."  "You never outperform your self-image."  Time Stamps: 00:00: Understanding Emotional Regulation 03:01: The Four Levels of Confidence 05:42: Building Unshakable Confidence 08:22: The Impact of Internal Interference 11:04: The Role of Identity in Confidence 13:42: Self-Talk and Performance 16:32: The Importance of Process in Golf 19:15: Cognitive Diffusion and Overcoming Interference 21:08: Reframing Self-Talk for Success 24:05: The Power of Self-Image and Self-Talk 27:52: Creating a Reset Routine for Performance 29:13: Managing Pressure and Mental Interference 32:44: Detaching Self-Worth from Results 36:40: Building a Balanced Identity 39:34: The Importance of Mindset Training 43:07: The Process of Figuring It Out

This episode covers: Cardiology This Week: A concise summary of recent studies Lp(a) and aortic valve stenosis The truth about climate change and heart disease Snapshots Host: Emer Joyce Guests: JP Carpenter, Borge Nordestgaard, Hugh Montgomery, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2548 Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, 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: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1.  Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Hugh Montgomery has declared to have potential conflicts of interest to report: funded and runs the charity-funded non-profit 'Real Zero'. Unpaid co-chair of the UK Health Alliance on Climate Change, Lancet Countdown on Health and Climate Change. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. 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.

Host: Emer Joyce Guest: Borge Nordestgaard Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2548 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, 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: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. 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.

24, 9 Millionen Franken soll Novartis-Chef Vas Narasimhan für das gute Geschäftsjahr 2025 als Vergütung erhalten. Ein Gehalt, das seit der Annahme der Abzocker-Initiative vor zwölf Jahren nicht mehr ausbezahlt wurde in der Schweiz. Wie ist das einzuordnen?

Episode SummaryPotent in vitro hits often fail in vivo—Martin Marro details how robust assay choice and pathway deconvolution can revive GPCR drug discovery programs.Listeners will learn practical approaches to assay development for GPCR drug discovery, the pitfalls of calcium readouts, and how identifying pathway bias impacts translational success. Dr. Marro shares his experience bridging in vitro–in vivo gaps, refining selection flowcharts, and leveraging pharmacology research to drive clinical candidates. His strategic perspective is rooted in years of leading multimodal discovery teams in pharma and biotech. Key TakeawaysAssay selection critically shapes the trajectory from hit to clinic.Calcium and IP1 assays may not predict in vivo efficacy for all Gq-coupled receptor targetsAlternative pathway analysis may be essential for mechanism elucidation.Persistence in probing beyond standard readouts can rescue high-profile discovery programs. Team structure and collaborative problem-solving are pivotal in resolving translational bottlenecks.Explore Dr. GPCR Resources- Dr. GPCR Ecosystem- Membership & Pricing- Weekly NewsExplore the full depth of GPCR resources, events, and member-exclusive tools with Dr. GPCR Premium.About the GuestDr. Martin Marro leads the Cell Pharmacology group in the DOCTA division at Lilly's Seaport Innovation Center in Boston, MA. Trained as a pharmacologist, Dr. Marro has accumulated over 20 years of experience spanning large pharmaceutical firms—including GSK, Novartis, and Lilly—and innovative biotech such as Tectonic Therapeutic. He holds deep expertise in early drug discovery across small molecules, peptides, and antibody therapeutics for metabolic, cardiovascular, and gastrointestinal diseases.Dr. Marro's research has been central to the discovery and characterization of multiple clinical candidates, with a focus on GPCR target validation, receptor pharmacology, and translational assay strategies. He played a key role in patenting and developing novel fatty acid-conjugated GLP-1 receptor agonists. Driven by the challenge of translating robust in vitro science into clinical proof-of-concept, Dr. Marro's leadership continues to impact the field of GPCR drug discovery.Keywords: gpcr podcast, assay development, pharmacology research.

Doctors Lisa and Sara talk to Consultant Nephrologist Dr Darren Green about patients with Type 2 Diabetes who also have Chronic Kidney Disease and Heart Failure.  We go through a hypothetical case to illustrate some of the finer points of management that can commonly get missed or might not be appreciated. A really detailed talk full of useful practice enhancing tips for this complex group of patients.  Disclaimer: All educational content in this podcast was developed as part of the Circulation Health collaborative working project between Boehringer Ingelheim Limited, Greater Manchester Primary Care Provider Board and Health Innovation Manchester. Content has been created by Circulation Health Clinical Leads for educational purposes, reflecting NHS Clinical Lead and guideline-based recommendations. Boehringer Ingelheim had no input into content development. They have provided financial resources to support Podcast recordings related to this project. Darren would like us to make you all aware that he has working relationships with pharmaceutical industry partners. Specifically, that he has received speak fees and consultancy fees from AstraZeneca, GSK, Novartis, Boehringer Ingelheim, Bayer, and Lilly, and has been part of collaborative working agreements with Novartis, Boehringer Ingelheim, and AstraZeneca. You can use these podcasts as part of your CPD - we don't do certificates but they still count :) Resources: Dr Kevin Fernando counselling diabetic patients starting an SGLT2 Inhibitors like Dapagliflozin or Empagliflozin: https://www.youtube.com/watch?v=pc99SdtlsyU Diabetes UK counselling sheets on SGLT2 inhibitors: https://www.diabetes.org.uk/about-diabetes/looking-after-diabetes/treatments/tablets-and-medication/sglt2-inhibitors Kidney Care UK Patient Booklets: https://kidneycareuk.org/get-support/free-resources/patient-information-booklets/ Pumping Marvellous Heart Failure Charity with patient resources: https://pumpingmarvellous.org/ International Society for Nephrology Toolkit for Initiating or Changing RAASi - Renin Angiotensin Aldosterone System Inhibitors (like ACEis such as Lisinopril or Ramipril, or ARBs like Candesartan on Losartan): https://www.theisn.org/initiatives/toolkits/raasi-toolkit/ Royal College of General Practitioners Acute Renal Failure Toolkit: https://elearning.rcgp.org.uk/course/info.php?id=899 CONFIDENCE trial: Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes | New England Journal of Medicine: https://www.nejm.org/doi/full/10.1056/NEJMoa2410659 ATLAS trial: Efficacy and safety of high-dose lisinopril in chronic heart failure patients at high cardiovascular risk, including those with diabetes mellitus: https://pubmed.ncbi.nlm.nih.gov/11071803/ Metformin lactic acidosis Metformin in Patients With Type 2 Diabetes and Kidney Disease: A Systematic Review: https://jamanetwork.com/journals/jama/article-abstract/2084896 UK AKI Summit report UKKA AKI Summit Report + Recommendations: https://share.google/7uw1GPQ5sV2riJtiV RCGP AKI follow up  post discharge recommendations: https://bjgpopen.org/content/early/2020/06/15/bjgpopen20X101054/tab-figures-data?versioned=true ___ We really want to make these episodes relevant and helpful: if you have any questions or want any particular areas covered then contact us on Twitter @PCKBpodcast, or leave a comment on our quick anonymous survey here: https://pckb.org/feedback Email us at: primarycarepodcasts@gmail.com ___ This podcast has been made with the support of GP Excellence and Greater Manchester Integrated Care Board. Given that it is recorded with Greater Manchester clinicians, the information discussed may not be applicable elsewhere and it is important to consult local guidelines before making any treatment decisions.  The information presented is the personal opinion of the healthcare professional interviewed and might not be representative to all clinicians. It is based on their interpretation of current best practice and guidelines when the episode was recorded. Guidelines can change; To the best of our knowledge the information in this episode is up to date as of it's release but it is the listeners responsibility to review the information and make sure it is still up to date when they listen. Dr Lisa Adams, Dr Sara MacDermott and their interviewees are not liable for any advice, investigations, course of treatment, diagnosis or any other information, services or products listeners might pursue as a result of listening to this podcast - it is the clinicians responsibility to appraise the information given and review local and national guidelines before making treatment decisions. Reliance on information provided in this podcast is solely at the listeners risk. The podcast is designed to be used by trained healthcare professionals for education only. We do not recommend these for patients or the general public and they are not to be used as a method of diagnosis, opinion, treatment or medical advice for the general public. Do not delay seeking medical advice based on the information contained in this podcast. If you have questions regarding your health or feel you may have a medical condition then promptly seek the opinion of a trained healthcare professional.

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Lea Oetjen über den Absturz von PayPal, den neuen Makel des MSCI World und Konkurrenz-Druck für Zalando. Außerdem geht es um Berkshire Hathaway, Amazon, Daimler Truck, AMD, Nvidia, HP Inc., Novo Nordisk, Palantir, Thomson Reuters, Verisk, Shopify, Microsoft, PepsiCo, Merck & Company, Pfizer, Critical Metals Corp, USA Rare Earth MP Materials, United States Antimony, NioCorp Developments, General Motors, Stellantis, Boeing, Corning, GE Vernova, Alphabet, VanEck Vectors Rare Earth/Strategic Metals ETF (WKN: A3CRL9), PLS Group, Albemarle, Lithium Americas, Wisdom Tree Strategic Metals and Rare Earth Miners ETF (WKN: A3EKKT), Sigma Lithium, Lynas Rare Earth, iShares Core MSCI World (WKN: A0RPWH), Xtrackers SLI ETF (WKN: DBX1AA), Novartis, Roche, Xtrackers MSCI Singapore (WKN: DBX0KG), DBS Group, Oversea-Chinese Banking, Sea, Amundi MSCI Nordic ETF (WKN: A2H569), Novo Nordisk und Spotify. 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. Der Börsen-Podcast 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

Rückführung von Verletzten nach Brand in Crans-Montana, Verhandlungen in Abu Dhabi zwischen Russland und der Ukraine, hoher Gewinn bei Novartis, Disney+ feiert 50. Geburtstag der Muppets mit neuer Show

Novartis hat im letzten Jahr einen Gewinn von 17.4 Milliarden US-Dollar verbucht. Das entspricht einer Steigerung von 11 Prozent gegenüber dem Vorjahr. CEO Vas Narasimhan erhält einen Lohn von 24.9 Millionen Franken für 2025. Ausserdem: · Im Grossen Rat sind die Gemüter erhitzt ob der Lohnerhöhung von Vas Narasimhan. · Abstimmungsvorschau zur Tempo-30-Initiative im Baselbiet: Sollen die Gemeinden ein Mitspracherecht bekommen? · Die Bücher-Brocky feiert ihr 30-jähriges Bestehen und wurde unterdessen schon längst zur Institution für Leseratten.

Pfizer reported the first data from its new obesity pipeline, picked up in the nearly $10 billion acquisition of Metsera last fall. While BMO Capital Markets said in a Tuesday note that the data “look competitive,” analysts clamored for more details on Pfizer's earnings call the same morning—and were left wanting more. Meawhile, Merck batted away accusations of “modest growth” from analysts on its own earnings call, as CEO Robert Davis touted “probably the broadest and widest pipelinewe've had in years.” These calls followed Roche last week and Johnson & Johnson before that, but earnings season is just getting started. On the docket today is Eli Lilly, which has been acquisitive of late, plus Novo Nordisk, Novartis, AbbVie and more.  On the regulatory front, the FDA is expected to decideon eight products this month, including REGENXBIO's Hunter syndrome gene therapy RGX-121. The biotech ran into a regulatory snag last week, however, as the FDA placed a clinical hold on two of its programs, including RGX-121. The agency also launched its much-anticipated PreCheck pilot program, which aims to make it easier for companies to build manufacturing plants in the U.S. And President Donald Trump's TrumpRx platform is delayed, potentially amid anti-kickback concerns.  In ClinicaSpace this week, we took a deep dive intothe resurgent psychedelics space, which could see two companies—Compass Pathways and Definium—submit FDAapplications this year. H.C. Wainwright analyst Patrick Trucchio told BioSpace 2026 is set to be “the biggest year from a clinical data standpoint,” since the firm began covering Compass in 2018. And check your inboxes Wednesday for BioPharmExecutive, where we take a look back at the banner IPO year that was 2021: Where are these companies now?

Nachdem Roche letzte Woche seine Jahreszahlen bekannt gegeben hat, informierte nun auch der Basler Pharmakonzern Novartis. Bei der Kommunikation über die Geschäftszahlen und die Herausforderungen gab es grosse Unterschiede.

Outdated training and behaviours impact patient outcomes and can lead to patient risk. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Lisa Sims, executive director of learning strategy & operations at Novartis, for a conversation on modern training for pharma and how AI and data – quality data – can help personalise learning at scale. You can listen to episode 243 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.

Sam Caucci joins the Restaurant Unstoppable Network for a live Q+A on March 9th, 2026 at 11AM EST. To join us and engage with all our guests and events, go to restaurantunstoppable.com/live -OR- to just catch today's guest, head over to restaurantunstoppable.com/cwe and we will get you a link to join that specific event for FREE! Sam Caucci is the founder and CEO of 1Huddle, a workforce technology company that helps organizations find, train, and retain workers using science-backed, quick-burst mobile games. A global keynote speaker, workforce policy advisor, and bestselling author, Sam has helped hundreds of brands—from the U.S. Air Force and UEFA to Loews Hotels, ESPN, Audible, Novartis, and Madison Square Garden—rethink how they onboard and upskill their people. His work on employee engagement and the future of work has been featured in outlets including The Wall Street Journal, CNN, CNBC, Fox Business, Bloomberg, Yahoo Finance, Forbes, and The Huffington Post. On the policy side, Sam has served on workforce innovation and economic policy committees, including for the Biden-Harris Presidential Campaign and the City of Newark's Workforce Development Board, bringing a frontline worker perspective into national and local conversations about jobs and skills. He is the author of the forthcoming book Wasted Talent: How the Promise of the Future of Work Failed Workers and a Plan to Fix It, where he lays out a roadmap to fix broken training systems and ensure every worker has a fair shot. Join RULibrary: www.restaurantunstoppable.com/RULibrary Join RULive: www.restaurantunstoppable.com/live Set Up your RUEvolve 1:1: www.restaurantunstoppable.com/evolve Subscribe on YouTube: https://youtube.com/restaurantunstoppable Subscribe to our email newsletter: https://www.restaurantunstoppable.com/ Today's sponsors: - Restaurant Technologies — the leader in automated cooking oil management. Their Total Oil Management solution is an end-to-end closed loop automated system that delivers, monitors, filters, collects, and recycles your cooking oil eliminating one of the dirtiest jobs in the kitchen.. Automate your oil and elevate your kitchen by visiting rti-inc.com or call 888-779-5314 to get started! - Cerboni - Cerboni is an all-in-one financial solution for restaurants. Reliable tax preparation & Business incorporation. Seamless Payroll and compliance report. Strategic CFO Services That Drive Business Growth. Detailed, custom reporting for complete financial clarity. Dedicated support for restaurants & Multi-location businesses. End-to-end financial management under one roof. - US Foods®. Running a restaurant takes MORE than great food—it takes reliable deliveries, quality products, and smart tools. US Foods® helps you make it. Ready to level up? Visit: usfoods.com/expectmore. - Guest contact info:  Website: 1huddle.co Get the book on Amazon Thanks for listening! Rate the podcast, subscribe, and share! 

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 30, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – AstraZeneca's big China investment pledge; Novartis exec's warning on early trial competitiveness; Chinese biotechs tap IPOs to fund foreign trials; Merck & Co on winning deals; and breaking down the India-EU free trade agreement. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

If you work across time zones, borders, and cultures, this is the show for you. This is your host Leonardo, welcome to The International Business Podcast. AI can now summarise almost anything in seconds. That's powerful, but it makes it easy to stay at the surface. We get headlines, bullet points, "3 key takeaways", and move on. What's lost is context, nuance, and understanding that changes how professionals think and decide in international business. With this new format, host Leonardo Marra pushes in the opposite direction. Instead of a quick AI overview, he built a long‑form deep dive into Japan after 1945: from World War II defeat to economic miracle, bubble, stagnation, and today's super‑aging, innovation‑driven society.Part 1 traces Japan's path from post‑war devastation through U.S. occupation, state‑guided capitalism, keiretsu networks, export‑led growth, oil shocks, the 1980s bubble, and the "lost decades." It links policy, institutions, and social change to Japan's rise and current challenges.Part 2 shifts to practical insights. Guests who live and work in and around Japan share how firms make decisions, how kaizen and relationships function, how demographics reshape strategy, and what foreign executives consistently misunderstand about the Japanese market.--------⁠Join Leonardo on Patreon for Podcast Archive and Bonus episodes (100+ episodes). ⁠--------With guests:Massimiliano Colonna – Director of Communications, Brookings Institution Governance Studies. MPhil in Modern Japanese Studies from Oxford's Nissan Institute, where he researched the internet's role in Japan's political debate.Waka Someno – CEO of YOUNEEDS Co., Ltd. and SOMENO-YA (Tokyo/Osaka). Provides sales, marketing, and legal support for international companies entering Japan. Over 15 years in B2B sales, DX solutions, and market-entry advisory.Jason Durkee – President, Idea Development (Tokyo); co-founder, Practical Training Transfer. 25+ years helping businesspeople innovate, communicate across cultures, and transfer learning to results. CPTD, ATD Japan director, serves 130+ clients annually across Asia.Neal Jansen – Director, Asia Office, Arkansas Economic Development Commission. CEcD with 20+ years in FDI, trade, and workforce development. Fluent in Japanese, builds long-term partnerships between Arkansas and Asian companies.Brett Jason Lee – Learning and performance professional specializing in Asia Pacific; ICF Professional Certified Coach (PCC). Designs learning solutions focused on behavior change, capability building, and cultural context for Japan and the region.Shaun Rein – Founder & Managing Director, China Market Research Group (Shanghai). Author of five bestselling books on China's economy. Works with Fortune 500s, PE firms, and heads of state. Regular contributor to WSJ, FT, NYT, CNBC, CNN, Bloomberg. Harvard MA.Tom Roberts – Founder, Cranberry Leadership International. "The Expat Whisperer." Former Head of Japan - Neurology at UCB (200 people, ~$1B P&L) and MD/President UCB Korea. Forbes Coaches Council member, helps C-Suite leaders navigate cross-border challenges.Jeff O'Dea – Communication Specialist, Inspiringbiz (Tokyo). Since 2010, helps Japanese professionals communicate effectively in English for global meetings. Clients include BMS, Novartis, MSD, Chugai, Merck, UCB, Softbank.Kelvin Ro – Founder, Kagi Career LLC (Tokyo, 15+ years). Coaches non-Japanese professionals on landing jobs in Japan. Author of Three Ways to Land Your First Job in Japan; ranked #2 non-Japanese LinkedIn creator in Japan (Dec 2024).-----If you work across time zones, borders, and cultures, come on the show to share your story. ⁠Connect with the host Leonardo Marra.

Brant Peterson, Vice President & Fellow at Valo Health, joins Data in Biotech to explore how his team leverages real-world data, genetic insights, and machine learning to de-risk drug discovery. From building causal DAGs to identifying patient subtypes in neurodegenerative diseases like Parkinson's, this episode dives deep into a patient-first, data-driven approach to biomedical innovation. What You'll Learn in This Episode: >> How Valo Health uses real-world evidence and EHR data to prioritize drug targets earlier in the development pipeline. >> Why integrating wet lab experiments and causal DAGs accelerates therapeutic validation. >> The importance of genetic pleiotropy and Mendelian randomization in refining disease hypotheses. >> How Valo Health identifies high-impact patient subgroups in neurodegenerative diseases like Parkinson's and Alzheimer's. >> Where machine learning models succeed and fall short, in uncovering mechanisms of disease from sparse longitudinal data. Meet Our Guest Brant Peterson is Vice President & Fellow in Data Science at Valo Health. He brings deep expertise in genetics, computational biology, and biomedical innovation. Formerly a Distinguished Data Scientist at Valo and Computational Biologist at Novartis, Brant focuses on leveraging patient-centric data to drive causal discovery in drug development. About The Host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with Our Guest: Sponsor: CorrDyn, a data consultancyConnect with Brant Peterson on LinkedIn  Connect with Us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

Nach dem Abgang von Trainer Ludovic Magnin übernimmt der Ex-Nationalspieler Stephan Lichtsteiner beim FCB den Trainerposten. Ausserdem: · Nina Jecker wird neue Chefredaktorin der Basler Zeitung · Giovanni Caforio, der neue VR-Präsident von Novartis, mit einem Bekenntnis zum Standort Basel · Roche mit Zwischenerfolg bei Abnehmmedikament

About Leandro Boer:Leandro Boer, MD, PhD, is a seasoned global biopharmaceutical executive and physician specializing in cardiology and cardiovascular pharmacology. Currently serving as Vice President of US Medical, General Medicines at Amgen, he leads medical strategy and execution across cardiovascular, bone, neuroscience, nephrology, and obesity therapeutic areas, overseeing a nationwide organization of over 100 professionals. With more than two decades of experience spanning the United States, Latin America, Canada, Africa, and the Middle East, Dr. Boer has built a distinguished career at leading companies such as Amgen, AstraZeneca, and Novartis.His leadership has shaped global and regional initiatives in medical affairs, clinical development, real-world evidence generation, regulatory strategy, and implementation science. Clinically, his expertise covers resistant hypertension, type 2 diabetes, obesity, heart failure, chronic kidney disease, and hyperlipidemia. Known for combining scientific rigor with strategic vision, Dr. Boer has directed cross-functional teams supporting drug development, commercialization, and lifecycle management across multiple therapeutic areas.A medical doctor trained in cardiology with a Ph.D. in cardiovascular pharmacology from Universidade Estadual de Campinas, Dr. Boer has consistently demonstrated a commitment to advancing evidence-based medicine, patient outcomes, and collaborative leadership within the healthcare ecosystem.Things You'll Learn:The foundation of innovation lies in focusing on what never changes—patients, healthcare providers, and equitable systems of care.Amgen's precision medicine and data-driven strategies prevent “data waste” and ensure every insight contributes to patient outcomes.Machine learning tools like Atomic are accelerating clinical trials by predicting successful sites, leading to faster drug development.The company's bold goal to reduce cardiovascular events by 50% by 2030 relies on partnerships, AI, and implementation science.Representation in clinical research and decentralized trials is crucial to ensuring equitable access and meaningful outcomes for all populations.Resources:Connect with and follow Leandro Boer on LinkedIn.Follow Amgen on LinkedIn and explore their website.

Zur Niederschlagung der Protestbewegung im Iran nahm das Mullah-Regime in den letzten Tagen und Wochen tausende von Toten in Kauf. Die genaue Anzahl der Opfer ist weiterhin unklar. Nun beschäftigte sich der UNO-Menschenrechtsrat in Genf in einer Sondersitzung mit der Gewalt im Iran. Alle Themen: (00:00) Intro & Schlagzeilen (01:05) UNO wirft Führung im Iran «brutale Unterdrückung» vor (05:22) Nachrichtenübersicht (09:52) «Die humanitäre Not wurde am WEF kaum beachtet» (15:44) Medikamentenpreise: Quo vadis Roche und Novartis? (21:24) Milde Urteile im Genfer Motorradbanden-Prozess (26:05) Wie Russland ukrainische Kinder zu seinen Soldaten macht (33:07) Ist Spaniens Schienennetz noch sicher? (37:44) Rückblick auf die Ära Winfried Kretschmann

Join Lindsay Davies, CEO of QVance, and Angela Vollstedt, Global Director of R&D at Novartis, as they discuss why innovation in medicine requires the courage to embrace ambiguity. We explore how women are redefining leadership by moving beyond corporate "precision" to master the art of being an intrapreneur. This podcast is not available for CME/CE/CPD credits. Please visit the Medscape homepage for accredited CME/CE/CPD activities.

The CEOs of Novartis, Authentic Brands and CrowdStrike join the show live from Davos. Responding to the President's criticism of the pharma industry, laying out the impact of tariffs on retail and detailing rising cyber threats across the globe. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

This episode covers: Cardiology This Week: A concise summary of recent studies What´s new in TAVI?  Digital solutions in arrhythmias Mythbusters - Gratitude is heart healthy Host: Emer Joyce Guests: JP Carpenter, Davide Capodanno, Fleur Tjong Want to watch that episode? Go to: https://esc365.escardio.org/event/2528 Want to watch that extended interview on Digital solutions in arrhythmias, go to: https://esc365.escardio.org/event/2528?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, 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: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. 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. Fleur Tjong has declared to have potential conflicts of interest to report: Amsterdam UMC Innovation grant, Heath Holland TKI, Abbott, Dutch Research Council, Boston Scientific.

Host: Emer Joyce Guest: Fleur Tjong Want to watch that extended interview on https://esc365.escardio.org/event/2528?resource=interview Go to: Want to watch that episode? Go to: https://esc365.escardio.org/event/2528 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, 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: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. 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. Fleur Tjong has declared to have potential conflicts of interest to report: Amsterdam UMC Innovation grant, Heath Holland TKI, Abbott, Dutch Research Council, Boston Scientific.

Dr. Hope Rugo and Dr. Vivek Subbiah discuss innovative trial designs to enable robust studies for smaller patient populations, as well as the promise of precision medicine, novel therapeutic approaches, and global partnerships to advance rare cancer research and improve patient outcomes. TRANSCRIPT  Dr. Hope Rugo: Hello and welcome to By the Book, a podcast series from ASCO that features engaging conversations between editors and authors of the ASCO Educational Book. I am your host, Dr. Hope Rugo. I am the director of the Women's Cancers Program and division chief of breast medical oncology at the City of Hope Cancer Center [in Los Angeles]. The field of rare cancer research is rapidly transforming thanks to progress in clinical trials and treatment strategies, as well as improvements in precision medicine and next-generation sequencing that enable biomarker identification. According to the National Cancer Institute, rare cancers occur in fewer than 150 cases per million each year, but collectively, they represent a significant portion of all cancer diagnoses. And we struggle with the appropriate treatment for these rare cancers in clinical practice. Today, I am delighted to be joined by Dr. Vivek Subbiah, a medical oncologist and the chief of early-phase drug development at the Sarah Cannon Research Institute in Nashville, Tennessee. Dr. Subbiah is the lead author of a paper in the ASCO Educational Book titled "Designing Clinical Trials for Patients with Rare Cancers: Connecting the Zebras," a great title for this topic. He will be telling us about innovative trial designs to enable robust studies for small patient populations, the promise of precision medicine, and novel therapeutic approaches to improve outcomes, and how we can leverage AI now to enroll more patients with rare cancers in clinical trials. Our full disclosures are available in the transcript of this episode.  Dr. Subbiah, it is great to have you on the podcast today. Thanks so much for being here. Dr. Vivek Subbiah: Thank you so much, Dr. Rugo, and it is an honor and pleasure being here. And thank you for doing this podcast for rare cancers. Dr. Hope Rugo: Absolutely. We are excited to talk to you. And congratulations on this fantastic paper. It is such a great resource for our community to better understand what is new in the field of rare cancer research. Of course, rare cancers are complex and multifaceted diseases. And this is a huge challenge for clinical oncologists. You know, our clinics, of course, cannot be designed as we are being very uni-cancer focused to just be for one cancer that is very rare. So, oncologists have to be a jack of all trades in this area. Your paper notes that there are approximately 200 distinct types of rare and ultra-rare cancers. And, by definition, all pediatric cancers are rare cancers. Of course, clinical trials are essential for developing new treatment strategies and improving patient outcomes, and in your paper, you highlight some unique challenges in conducting trials in this rare cancer space. Can you tell us about the challenges and how really innovative trial designs, I think a key issue, are being tailored to the specific needs of patients with rare cancer and, importantly, for these trials? Dr. Vivek Subbiah: Rare cancers present a perfect storm of challenges. First, the patient populations are very small, which makes it really hard to recruit enough participants for traditional type trials. Second, these patients are often geographically dispersed across multiple cities, across multiple states, across multiple countries, across multiple zip codes. So, logistics become complicated. Third, there is often limited awareness among clinicians, which delays referrals and diagnosis. Add to that regulatory hurdles, funding constraints, and you can see why rare cancer trials are so tough to execute. To overcome these barriers, we are seeing some really creative novel trial designs. And there are four different types of trial designs that are helping with enrolling patients with rare cancers. The first one is the basket trial. So let us talk about what basket studies are. Basket studies group patients based on shared genetic biomarkers or shared genetic mutations rather than tumor type. So instead of running separate 20 to 30 to 40 trials, you can study one therapy across multiple cancers. The second type of trial is the umbrella trial. The umbrella trials flip that concept of basket studies. They focus on one cancer type but test multiple targeted therapies within it. The third category of innovative trials are the platform studies. Platform trials are another exciting innovation. They allow new treatment arms to be added or removed as the data matures and as the data evolves, making trials more adaptive and efficient. The final category are decentralized tools in traditional trials, which are helping patients participate closer to where they are so that they can sleep in their own bed, which is, I think, a game changer for accessibility.  These designs maximize efficiency and feasibility for rare cancer research and rare cancer clinical trials. Dr. Hope Rugo: I love the idea of the platform trials that are decentralized. And I know that there is a trial being worked on with ARPA-H (Advanced Research Projects Agency for Health) funding in triple-negative breast cancer as well as in lung cancer, I think, and others with this idea of a platform trial. But it is challenged, I think, by precision medicine and next-generation sequencing where some patients do not have targetable markers, or there isn't a drug to target the marker. I think those are almost the same thing. We have really seen that these precision medicine ideas and NGS have moved the needle in helping to identify genetic alterations. This helps us to be more personalized. It actually helps with platform studies to customize trial enrollment. And we hope that this will result in better outcomes. It also allows us, I think, to study drugs even in the early stage setting more effectively. How can these advances be best applied to the future of rare cancers, as well as the challenges of not finding a marker or not having a drug? Dr. Vivek Subbiah: Thank you so much for that question. I think precision medicine and next-gen sequencing, or NGS, are truly the backbone of modern precision oncology. They have transformed how we think about cancer treatment. Instead of treating based on where the tumor originated or where the tumor started, we now look at the genetic blueprint of cancer. The NGS or next-gen sequencing allows us to sequence millions of DNA fragments quickly. Twenty, 30 years ago, they said we cannot sequence a human genome. Then it took almost a decade to sequence the first human genome. Right now, we have academic centers and commercial sequencing companies that are really democratizing NGS across all sites, not just in academic centers, across all the community sites, so that NGS is now accessible. This means that we can identify these actionable alterations like picking needles in haystacks, like NTRK fusions, RET fusions, or BRAF V600E alterations, high tumor mutational burden. This might occur across not one tumor type, across several different tumor types. So for rare cancers, this is critical because some of these mutations often define the best treatment option. Here is why this matters. Personalized therapy, right? Instead of a one-size-fits-all approach, we can tailor treatment to the patient's unique molecular profile. For trial enrollment, this can definitely help because patients can join biomarker-driven trials even if their cancer type is rare or ultra-rare. NGS technology has also helped us in designing rational studies. Many times monotherapy does not work in these cancers. So we are thinking about rational combination strategies. So NGS technology is helping us. Looking ahead, I see NGS becoming routine in clinical practice, not just at major niche academic centers, but everywhere. We will see more tumor-agnostic approvals, more molecular tumor boards guiding treatment decisions in real time. And I think we are seeing an expanded biomarker setup. Previously, we used to have only a few drugs and a handful of mutations. Now with homologous recombination defects, BRCA1/2 mutation, and expanding the HRD and also immunohistochemistry, we are expanding the biomarker portfolio. So again, I personally believe that the future is precision. What I mean by precision is delivering the right drug to the right patient at the right time. And for rare cancers, this isn't just progress. It is survival. And it is maybe the only way that they can have access to these cutting-edge precision medicines. Dr. Hope Rugo: That is so important. You mentioned an important area we will get to in a moment, the tumor-agnostic therapies. But as part of talking about that, do you think that the trials should also include just standard therapies? You know, who do you give an ADC to and when with these rare cancers? Because some of them do not have biomarkers to target and it is so disappointing for patients and providers where you are trying to screen a patient for a trial or a platform trial where you have one arm with this mutation, one arm with that, and they do not qualify because they only have a p53 loss, you know? They just do not have the marker that helps them. But we see this in breast cancer all the time. And it is tough because we don't have good information on the sequencing. So I wonder, you know, just because for some of these rare cancers it is not even clear what to use when with standard treatments. And then that kind of gets into this idea of the tumor-agnostic therapies that you mentioned. There are a lot of new treatments that are being evaluated. We have seen approval of some treatments in the last few years that are tumor-agnostic and based on a biomarker. Is that the best approach as we go forward for rare cancers? And what new treatment options are most exciting to you right now? Dr. Vivek Subbiah: Tumor-agnostic therapies, really close to my heart, are real breakthrough therapies and represent a major paradigm shift in oncology. Traditionally, for the broad listeners here, we are used to thinking about designing clinical trials and therapy like where the cancer originated, breast cancer, kidney cancer, prostate cancer, lung cancer. A tumor-agnostic therapy flips that model. Instead of focusing on the organ, they target the specific genetic alteration or biomarker that drives cancer growth regardless of where the tumor started, regardless of the location of the tumor, regardless of the zip code of the tumor. So why is this so important for rare cancers? Because many rare cancers share molecular features with more common cancers. For instance, NTRK fusion might occur in pediatric sarcoma, a salivary gland tumor, or a thyroid cancer. Historically, each of these would require separate trials, which is nearly impossible, unfeasible to conduct in these ultra-rare cancers like salivary gland cancer or pediatric sarcomas. Tumor-agnostic therapies allow us to treat all those cancers with the same targeted drug if they share that biomarker. Again, we are in 2025. The first tissue-agnostic approval, the historic precedent, was in fact an immunotherapy. Pembrolizumab was approved in 2017, May 2017, as the first immunotherapy to be approved in a tumor-agnostic way for a genomic biomarker, for MSI-High and dMMR cancers. Then came the NTRK inhibitors. So today we have not one, not two, but three different NTRK inhibitors: larotrectinib, entrectinib, and repotrectinib, which show response rates of nearly more than 60 to 75% across a handful of dozens and dozens of cancer types. Then, of course, we have RET inhibitors like selpercatinib, which is approved tissue-agnostic, and pralsetinib, which also shows tissue-agnostic activity across multiple cancers. And more recently, combination therapy with a BRAF and MEK combination, dabrafenib and trametinib, received tumor-agnostic approval for all BRAF V600E tumors with the exception of colorectal cancer. And even recently, you mentioned about antibody drug conjugates. Again, I think we live in an era of antibody drug conjugates. And Enhertu, trastuzumab deruxtecan, which was used first in breast cancer, now it is approved in a histology-agnostic manner for all HER2-positive tumors defined by immunohistochemistry 3+. So again, beyond NGS, now immunohistochemistry for HER2 is also becoming a biomarker. So again, for the broad listeners here, in addition to comprehensive NGS that may allow patients to find treatment options for these rare cancers for NTRK, RET, and BRAF, immunohistochemistry for HER2 positivity is also emerging as a biomarker given that we have a new FDA approval for this. So I would say personally that these therapies are game changers because they open doors for patients who previously had no options. Instead of waiting for years for a trial in their specific cancer type, they can access a treatment based on their molecular profile. I think it is precision medicine at its finest and best. Looking ahead, the third question you asked me is what is exciting going on? I think we will see more of these approvals. My hope is that today, I think we have nine to ten approvals. My hope is that within the next 25 to 50 years, we will have at least 50 to 100 drugs approved in this space based on a biomarker, not based on a location of the tumor type. Drug targeting rare alterations like FGFR2 fusions, FGFR amplifications, ALK fusions, and even complex signatures like high tumor mutational burden. I think we will be seeing hopefully more and more drugs approved. And as sequencing becomes routine, we will identify more patients for these therapies. I think for rare cancers, this is not just innovative approach. This is essential for them to access these novel precision medicines. Dr. Hope Rugo: Yeah, that is such a good point. I do think it is critical. Interestingly in breast cancer, it hasn't been, you know, there is always like two patients in these tumor-agnostic trials, or if that. You know, I think I have seen one NTRK fusion ever. I think that highlights the importance for rare cancers. And you know, I am hoping that that will translate into some new directions for some of our rarer and impossible-to-treat subtypes of breast cancer. It is this kind of research that is really going to make a difference. But what about those people who do not have biomarkers? What if you do not fit into that? Do you think there is a possibility of trying to do treatments for rare cancers in some prospective way that would help with that? You know, it is really a huge challenge. Dr. Vivek Subbiah: Absolutely. I think, you know, you're right, usually many of these rare cancers are driven by specific biomarkers. And again, some of the pediatric salivary gland tumors or pediatric sarcomas like fibrosarcomas, they are pathognomonic with NTRK fusions. And again, given that we have a tumor-agnostic approval, now these patients have access to these therapies. And I do not think that we would have had a trial just for pediatric fibrosarcomas with NTRK fusions. So that is one way. Another way is SWOG, right? The SWOG DART [1609] had this combination dual checkpoint, it was called the DART study dual combination chemotherapy with ipi/nivo. Now here the rare cancer subtype itself becomes a biomarker and they showed activity across multiple rare cancer subtypes. They didn't require a biomarker. As long as it was a rare or ultra-rare cancer, these patients were enrolled into the SWOG DART trial and multiple arms have read out. Angiosarcoma, Kaposi sarcoma, even gestational trophoblastic disease. Again, they have shown responses in these ultra-rare, rare cancers. Sometimes they might be seeing one or two cases a whole year. And I think this SWOG effort, this cooperative group effort, really highlighted the need for such studies without biomarkers as well. Dr. Hope Rugo: That is such a fantastic example of how to try and treat patients in a collaborative way. And in the paper, you also emphasize the need for collaborative research efforts, you know, uniting resource expertise across different ways of doing research. So cooperative groups, advocacy organizations that can really help advance rare cancer research, improve access to new therapies, and I think importantly influence policy changes. I think this already happened with the agnostic approvals. Could you tell us more about that? How can we move forward with this most effectively? Dr. Vivek Subbiah: Personally, I believe that collaboration is absolutely critical and essential for rare cancer research. No single institution, no single individual, or no single state or entity can tackle these challenges alone. The patient populations are small and dispersed. So pooling resources is the only way to run these meaningful trials. Again, it is not like singing, it is like putting a huge, huge, I would say, an opera piece together. It is not a solo, vocal therapy, but rather putting a huge opera piece like Turandot. You know, you mentioned cooperative groups. Cooperative groups, as I mentioned earlier, the SWOG DART program, the ASCO [TAPUR study]. ASCO is doing a phenomenal work of the TAPUR study. Again, this ASCO TAPUR program has enrolled so many patients with rare cancers who otherwise would not have treatment options. NCI-MATCH, the global effort, right? NCI-MATCH and the ComboMATCH are great examples. They bring together hundreds of sites, thousands of clinicians to run large-scale trials that would be impossible for any individual center or institution. These trials have already changed practice. For instance, the DART demonstrated the power of immunotherapy in rare cancers and influenced NCCN guidelines. One of the arms of the NCI-MATCH study from the BRAF V600E arm contributed towards the BRAF V600E tissue-agnostic approval. So, the BRAF V600E tissue-agnostic approval was by a pooled analysis of several studies. The ROAR study, the Rare Oncology Agnostic Research study, the NCI-MATCH dataset of tumor-agnostic cohort, and another pediatric trial, and also evidence from literature and evidence of case reports. And all this pooled analysis contributed to the tissue-agnostic approval of BRAF V600E across multiple rare cancers. There are several patient advocacy organizations which are the real unsung heroes here. Groups like, for instance, we mentioned in the paper, Target Cancer Foundation, don't just raise awareness for rare cancer research, they actively connect patients to trials providing financial, emotional support, and even run their own studies like the TRACK trial. They also influence policy to make access easier. On a global scale, initiatives like DRUP in the Netherlands, the ROME study in Italy, the PCM4EU in Europe are expanding precision medicine across these borders. These collaborations accelerate research, improve trial enrollment, and ensure patients everywhere can have access to these cutting-edge therapies. Again, it is truly a team effort, right? It is a multi-stakeholder approach. Researchers, clinicians, investigators, industry, regulators, academia, patients, patient advocates, and their caregivers all working together. And it takes a village. Dr. Hope Rugo: Absolutely. I mean, what a nice response to that. And I think really exciting and it is great to see your passion about this as well. But it helps all of us, I think, getting discouraged in treating these cancers to understand what is happening moving forward. And I think it is also a fabulous opportunity for our junior colleagues as they rise up in academics to be involved in these international collaborative efforts which are further expanding. One of the things that comes up for clinical trials for patients, and I think it is highlighted with rare cancers because, as you mentioned, people are all over the place, you know, they are so rare. They are all far away. Our patients are always saying to us, "Should I go here for a phase 1 trial?" Can you talk a little bit about how we can overcome these financial and geographic burdens for the patients? You talked about having trials locally, but it is a big financial and just social burden for patients. Dr. Vivek Subbiah: Great point. Financial cost is a major barrier in rare cancer clinical trials. It is a major barrier not just in rare cancer clinical trials, but in clinical trials in general. The economics of rare cancer research are one of the toughest challenges we face. Developing a new drug is already expensive, often billions of dollars. On an average, it takes 2 billion dollars or 2.8 billion dollars according to some data from drug discovery to approval. For rare cancers, the market is tiny, which means the pharmaceutical companies have really little financial incentive to invest. That is why initiatives like the Orphan Drug Act were created to provide tax credits, grants, and market exclusivity to encourage development for rare diseases. Clinical trials themselves are expensive because the small patient populations mean longer recruitment times and higher per-patient costs. Geographic dispersion, as you mentioned, for the patients adds travel, coordination. That is why we need to think out of the box about decentralized trial infrastructure so that we can mitigate some of these expenses. Complex trial designs like basket or platform trials sometimes require sophisticated data systems and regulatory oversight. That is a challenge. And I think some of the pragmatic studies like ASCO TAPUR have overcome those challenges. Advanced technologies like next-gen sequencing and molecular profiling also add significant upfront cost to this. Funding is also limited because rare cancers receive less attention compared to common cancers. Public funding and cooperative group trials help a lot, but I think they cannot cover everything. Patient advocacy organizations sometimes step in to bridge these gaps, but sustainable financing remains a huge challenge. So, the bottom line is without financial incentives and collaborating funding models, many promising therapies for rare cancers would never make it to patients. That is why we need system-wide policy changes, global partnerships, and innovative, effective, seamless trial designs which are so critical so that they can help reduce the cost and make research feasible so that we can deliver the right drug to the right patient at the right time. Dr. Hope Rugo: There is a lot of excitement about the future integration of AI in screening. Just at the San Antonio Breast Cancer meetings, we have a number of different presentations about AI to find markers, even like HER2, and using AI where you would screen and then match patients to clinical trials. Do you have any guidance for the rare cancer community on how to leverage this technology in order to optimize patient enrollment and, I think, identification of the best treatment matches? Dr. Vivek Subbiah: I think artificial intelligence, AI, is a game-changer in the making. Right now, clinical trial is clunky. Matching patients to trial is often manual, time consuming, laborious. You need a lot of personnel to do that. AI can automate this process by analyzing genomic data, medical records, and trial eligibility criteria to find the best matches quickly, accurately, and effectively. For the community, the key is to invest in data standardization and interoperability because AI needs clean, structured data to work effectively. Dr. Hope Rugo: Thank you so much, Dr. Subbiah, for sharing these fantastic insights with us on the podcast today and for your excellent article. Dr. Vivek Subbiah: Thank you so much. Dr. Hope Rugo: We thank you, our listeners, for joining us today. You will find a link to Dr. Subbiah's Educational Book article in the transcript of this episode. And please join us again next month on By the Book for more insightful views on key issues and innovations that are shaping modern oncology.  Thank you. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:        Dr. Hope Rugo   @hoperugo   Dr. Vivek Subbiah @VivekSubbiah Follow ASCO on social media:        ASCO on X  ASCO on Bluesky       ASCO on Facebook        ASCO on LinkedIn        Disclosures:       Dr. Hope Rugo:    Honoraria: Mylan/Viatris, Chugai Pharma   Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer   Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx   Dr. Vivek Subbiah: Consulting/Advisory Role: Loxo/Lilly, Illumina, AADI, Foundation Medicine, Relay Therapeutics, Pfizer, Roche, Bayer, Incyte, Novartis, Pheon Therapeutics, Abbvie Research Funding (Inst.): Novartis, GlaxoSmithKline, NanoCarrier, Northwest Biotherapeutics, Genentech/Roche, Berg Pharma, Bayer, Incyte, Fujifilm, PharmaMar, D3 Oncology Solutions, Pfizer, Amgen, Abbvie, Mutlivir, Blueprint Medicines, Loxo, Vegenics, Takeda, Alfasigma, Agensys, Idera, Boston Biomedical, Inhibrx, Exelixis, Amgen, Turningpoint Therapeutics, Relay Therapeutics Other Relationship: Medscape, Clinical Care Options

Dr. Monty Pal and Dr. Hope Rugo discuss advances in antibody-drug conjugates for various breast cancer types as well as treatment strategies in the new era of oral SERDs for HR-positive breast cancer. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and vice chair of academic affairs here at the City of Hope Comprehensive Cancer Center, Los Angeles. Today, I'm thrilled to be joined by Dr. Hope Rugo, an internationally renowned breast medical oncologist and my colleague here at City of Hope, where she leads the Women's Cancers Program and serves as division chief of breast medical oncology. Dr. Rugo is going to share with us exciting advances in antibody-drug conjugates (ADCs) that are expanding treatment options in various breast cancer types. She'll also address some of the complex questions arising in the new era of oral SERDs (selective estrogen receptor degraders) that are revolutionizing treatment in the hormone receptor-positive breast cancer space. Our full disclosures are available in the transcript of this episode.  Dr. Rugo, welcome, and thanks so much for being on the podcast today. Dr. Hope Rugo: Thank you. Pleasure to be here. Dr. Monty Pal: So, I'm going to switch to first names if you don't mind.  The first topic is actually a really exciting one, Hope, and this is antibody-drug conjugates. I don't know if I've ever shared this with you, but I actually started my training at UCLA, I was a med student and resident there, and it was in Dennis Slamon's lab. I worked very closely with Mark Pegram and a handful of others. This is right around the time I think a lot of HER2-directed therapies were really evolving initially in the clinics. Now we've got antibody-drug conjugates. Our audience is well-familiar with the mechanism there but tell us about how ADCs have really started to reshape therapy for HER2-positive breast cancer. Dr. Hope Rugo: Yeah, I mean, this is a really great place to start. I mean, we have had such major advances in breast cancer just this year, I think really changing the paradigm of treating patients. But HER2-positive disease, we've been used to having sequenced success of new agents. And I think the two biggest areas where we've made advances in HER2-positive disease, which were remarkably advanced this year in 2025, have been in antibody-drug conjugates with trastuzumab deruxtecan and with new oral tyrosine kinase inhibitors (TKIs) that have less of a target on EGFR and more on HER2, so they have an overall more tolerable toxicity profile and therefore a potentially better efficacy in the clinic. At least that's what we're seeing with these new strategies that we couldn't really pursue in the past because of toxicities of the oral TKIs. So, although our topic is ADCs, I'm going to include the TKI because it's so important in our thinking about treating HER2-positive disease. In the metastatic setting, we've seen these remarkable improvements in progression-free and overall survival in the second-line setting with T-DXd, or trastuzumab deruxtecan, compared to T-DM1. And then sequencing ADCs with giving T-DXd after T-DM1 was better than an oral tyrosine kinase or a trastuzumab combination with standard chemotherapy. That was DESTINY-Breast03 and DESTINY-Breast02. So, then we've had other trials since then, and T-DXd has moved into the early-stage setting, which I'll talk about in just a moment. But the next big trial for T-DXd in HER2-positive disease was moving it to the first-line setting to supplant what has become an established treatment for now quite a long time: the so-called CLEOPATRA regimen, which used the combined antibodies trastuzumab, pertuzumab with a taxane as first-line therapy. And then we've proceeded on with maintenance with ongoing HP for patients with responding or stable disease. And we'd seen long-term data showing, you know, at 8 years there was a group of patients whose cancers had never progressed and continued improved overall survival. So, T-DXd was studied in DESTINY-Breast09, either alone or in combination with pertuzumab compared to THP. The patient population had received a little bit more prior treatment, but interestingly, not a lot compared to CLEOPATRA. And they designed the trial to be T-DXd continued until progression with or without pertuzumab versus THP, which would go for six cycles and then stop around six cycles, and then stop and continue HP. Patients who had hormone receptor-positive disease could use hormone therapy, and this is one of the issues with this dataset because, surprisingly in this dataset and one other I'll mention, very few patients took hormone therapy. And even in the maintenance trial, the HER2CLIMB-05, less than 50% took hormone therapy as maintenance. This is kind of shocking to me and highlights an area of really important education, that outcome is improved when you add endocrine therapy for hormone receptor-positive HER2-positive metastatic disease in the maintenance phase, and it's a really important part of treatment. But suffice it to say, you know, you're kind of studying continued chemo versus stopping chemo in maintenance. And T-DXd, as we all expected, in combination with pertuzumab was superior to THP in terms of progression-free survival, really remarkably improved. And you could stop the chemo with toxicity, but most people continued it with T-DXd. Again, not a lot of people got hormone therapy, which is an issue, and you stop the chemo in the control arm. So, this has brought up a lot of interest in trying to use T-DXd as an induction and then go to maintenance, much as we do with the CLEOPATRA regimen with hormone therapy. But it brings up another issue. So first, T-DXd is superior; it's a great treatment. Not everybody needs to have it because we don't know whether it's better to give T-DXd first or second with progression - that we need a little bit longer follow-up. But just earlier this week, interestingly, the third week of December, the U.S. FDA approved T-DXd in the DESTINY-Breast09 approach with pertuzumab. So as I mentioned earlier, there was a T-DXd-alone arm; that arm has not yet reported. So very interesting, we don't know if you need pertuzumab or not. So what about the maintenance? That's the other area where we've made a huge advance here. So, we all want to stop chemo and we want to stop T-DXd. You don't want somebody being nauseated for two years while they're on treatment, and also there's a small number of patients with mostly de novo metastatic HER2-positive disease who are cured of their disease. We'd like to expand that, and I think these new drugs give us the opportunity to improve the number of patients who might be cured from metastatic disease. So the first maintenance study we saw was adding palbociclib, the CDK4/6 inhibitor, to endocrine therapy and HP, essentially. There, we had a remarkable improvement in progression-free survival difference of 15.2 months: 29 to 44 months, really huge. At San Antonio this year, we saw data with this oral tyrosine kinase inhibitor tucatinib, already showed it was great in a triplet, but as maintenance in combination with HP, it showed also a remarkable improvement in progression-free survival. But the numbers were all shifted down. So in PATINA, the control arm was in the 24-month range; here it was the tucatinib-HP arm that was in the 25 months and 16 months for control. So there was a differential benefit in ER-negative and ER-positive disease. So I think we're all thinking that our ideal approach moving forward would be to give T-DXd to most patients, we see how they do, and treat to best response. And then, stop the T-DXd, start HP, trastuzumab, pertuzumab for ER-negative, with tucatinib for ER-positive with palbociclib. We also have early data that suggests that both approaches may reduce the development of brain metastases, an issue in HER2-positive disease, and delay time to progression of brain metastases as seen in HER2CLIMB-05 in very early data - small numbers, but still quite intriguing that you might delay progression of brain metastases with tucatinib that clearly has efficacy in the brain.  So, I think that this is a hugely exciting advance for our patients, and these approaches are quickly moving into the early stage setting. T-DXd compared to standard chemo, essentially followed by THP, so a sequenced approach resulted in more pathologic complete responses than a standard THP-AC-type neoadjuvant therapy. T-DXd alone for eight cycles wasn't better, and that's interesting. We still need the sequenced non-cross-resistant chemo. But I think even more importantly, the data from DESTINY-Breast05 looking at T-DXd versus T-DM1 in patients with residual disease after neoadjuvant HER2-targeted therapy showed a remarkable improvement in invasive disease-free survival with T-DXd versus T-DM1, and quite early. It was a high-risk population, higher risk than the T-DM1 trial with KATHERINE, but earlier readout with a remarkable improvement in outcome. We expect to be FDA approved sometime in the first half of 2026. So then we'll get patients who've already had T-DXd who get metastatic disease. But my hope is that with T-DXd, maybe with tucatinib in the right group of patients or even sequenced in very high-risk disease, that we could cure many more patients with early-stage HER2-positive breast cancer and cure a subset, a greater subset of patients with de novo metastatic disease. Dr. Monty Pal: That's brilliant. And you tackled so many questions that I was going to follow up with there: brain metastases, etc. That was sort of looming in my mind. I mean, general thoughts on an ADC versus a TKI in the context of brain mets? Dr. Hope Rugo: Yeah, it's an interesting question because T-DXd has shown quite good efficacy in this setting. And tucatinib, of course, had a trial where they took patients with new brain mets, so a larger population than we've seen yet for the T-DXd trials, and saw that not only did they delay progression of brain metastases and result in shrinkage of existing untreated brain mets, but that patients who develop a new brain met, they could stay on the same assigned treatment. They got stereotactic radiation, and then the patients who were on tucatinib with trastuzumab and capecitabine had a further delay in progression of brain mets compared to those on the placebo arm, even after treatment of a new one that developed on treatment. So, I think it's hard. I think most of us for a lot of brain mets might start with the tucatinib approach, but T-DXd is also a very important treatment. You know, you're kind of trading off a diarrhea, some liver enzyme elevations with tucatinib versus nausea, which you really have to work on managing because it can be long-delayed nausea, and this risk of ILD, interstitial lung disease, that's about 12%, with most but not all trials showing a mortality rate from interstitial lung disease of just under 1 percent. In the early-stage setting, it was really interesting to see that with T-DXd getting four cycles in the neoadjuvant setting, a lot less ILD noted than the patients who got up to 14 cycles, as I think they got a median of 10 cycles in the post-surgical setting, there was a little bit more ILD. But I think we're going to be better and better at finding this earlier and preventing mortality by just stopping drug and treating earlier with steroids. Dr. Monty Pal: And this ILD issue, it always seems to resurface. There are drugs that I use in my kidney cancer clinic, everolimus, common to perhaps the breast cancer clinic as well, pembrolizumab, where I think the pattern of pneumonitis is quite different, right? What is your strategy for recognizing pneumonitis early in this context? Dr. Hope Rugo: Well, it is, and you know, having done the very early studies in everolimus where we gave it in the neoadjuvant setting and we're like, "Hmm, the patient came in with a cough. What's going on?" You know, we didn't know. And you have mouth sores, you know, we were learning about the drug as we were giving it. What we don't do with everolimus and CDK4/6 inhibitors, for example, is grade 1 changes like radiation pneumonitis, we don't stop, we don't treat it. We only treat for symptoms. But because of the mortality associated with T-DXd, albeit small, we stop drug for grade 1 imaging-only asymptomatic pneumonitis, and some of us treat with a half dose of steroids just to try and hasten recovery. We've actually now published or presented a couple of datasets from trials, a pooled analysis and a real-world analysis, that have looked at patients who were retreated after grade 1 pneumonitis or ILD and tolerated drug very well and none of them died of interstitial lung disease, which was really great to see because you can retreat safely and some of these patients stayed on for almost a year benefiting from treatment. So, there's a differential toxicity profile with these drugs and there are risk factors which clearly have identified those at higher risk: prior ILD, for example. A French group said smoking; other people haven't found that, maybe because they smoked more in France, I don't know. And being of Japanese descent is quite interesting. The studies just captured that you were treated in Japan, but I think it's probably being of Japanese descent with many drugs that increases your risk of ILD. And, you know, older patients, people who have hypoxia, those are the patients. So, how do we do this? With everolimus, we don't have specific monitoring. But for T-DXd we do; we do every nine weeks to start with and then every 12 weeks CT scans because most of the events occur relatively early. Somebody who's older and at higher risk now get the first CT at six weeks. Dr. Monty Pal: This is super helpful. And I have to tell you, a lot of these drugs are permeating the bladder cancer space which, you know, is ultimately going to be a component of my practice, so thank you for all this. We could probably stay on this topic of HER2-positive disease forever. I'm super interested in that space still. But let me shift gears a little bit and talk about triple-negative breast cancer and this evolving space of HR-positive, HER2-low breast cancer. I mean, tell us about ADCs in that very sort of other broad area. Dr. Hope Rugo: So triple-negative disease is the absolute hardest subset of disease that we have to treat because if you don't have a great response in the early stage setting, the median survival is very short, you know, under two years for the majority of TNBCs, with the exception of the small percentage of low proliferative disease subsets. The co-question is what do we do for these patients and how do we improve outcome? And sacituzumab govitecan has been one strategy in the later line setting that was shown to improve progression-free and overall survival, the Trop-2 ADC. We had recently three trials presented with the two ADCs, sacituzumab govitecan and the other Trop-2 ADC that's approved for HR-positive disease, datopotamab deruxtecan. And they were studied in the first-line setting. Two trials with SG, sacituzumab govitecan, those trials, one was PD-L1 positive, ASCENT-04. That showed that SG with a checkpoint inhibitor was superior, so pembrolizumab was superior to the standard KEYNOTE-355 type of treatment with either a taxane or gemcitabine and carboplatin with pembrolizumab for patients who have a combined positive score for PD-L1, 10 or greater. So, these are patients who are eligible for a checkpoint inhibitor, and SG resulted in an improved progression-free survival.  The interesting thing about that dataset is that few patients had received adjuvant or neoadjuvant checkpoint inhibitor, which is fascinating because we give it to everybody now. But access is an issue and timing of the study enrollment was an issue. The other thing which I think we've all really applauded Gilead for is that there was automatic crossover. So, you could get from the company, to try and overcome some of the enormous disparities worldwide in access to these life-saving drugs, you could get SG through the company for free once you had blinded independent central review confirmation of disease progression. Now, a lot of the people who got the SG got it through their insurance, they didn't bill the company, but 80 percent of patients in the control arm received SG in the second-line setting. So that impacts your ability to look at overall survival, but it's an incredibly important component of these trials. So then at ESMO, we saw the data from SG and Dato-DXd in the first-line metastatic setting for patients who either had PD-L1-negative disease or weren't eligible for an immunotherapy. For the Dato study, TROPION-Breast02, that was 10 percent of the patients who had PD-L1-positive disease but didn't get a checkpoint inhibitor, and for the ASCENT-03 trial population it was only 1 percent. Importantly, the trials allowed patients who relapsed within a year of receiving their treatment with curative intent, and the Dato study, TB-02, allowed patients who relapsed while on treatment or within the first six months, and that was 15 percent of the 20 percent of early relapsers. The ASCENT trial, ASCENT-03, had 20 percent who relapsed between 6 and 12 months. The drugs were better than standard of care chemotherapy, the ADCs in both trials, which is very nice. Different toxicity profiles, different dosing intervals, but better than standard of care chemotherapy in the disease that's hardest for us to treat. And importantly, when you looked at the subset of early relapsers, those patients also did better with the ADC versus chemotherapy, which is incredibly important. And we were really interested in that 15 percent of patients who had early relapse. I actually think that six months thing was totally contrived, invented, you know, categorization and doesn't make any sense, and we should drop it. But the early relapsers were 15 percent of TB-02 and Dato was superior to standard of care chemo. We like survival, but the ASCENT trial again allowed the crossover to an approved ADC that improved survival and 80 percent of patients crossed over. In the Dato trial, they did not allow crossover, they didn't provide Dato, which isn't approved for TNBC but is for HR-positive disease, and they didn't allow, of course, pay for SG. So very few patients actually crossed over in their post-treatment data and in that study, they were able to show a survival benefit. So actually, I think in the U.S. where we can use approved drugs already before there's a fixed FDA approval, that people are already switching to use SG or Dato in the first-line setting for metastatic TNBC that's both PD-L1 positive for SG and PD-L1 negative for both drugs. And I think understanding the toxicity profiles of the two drugs is really important as well as the dosing interval to try and figure out which drug to use. Dr. Monty Pal: Brilliant. Brilliant. Well, I'm going to shift gears a little bit. ADCs are a topic, again, just like HER2-positive disease we could stay on forever. Dr. Hope Rugo: Huge. Yes. Dr. Monty Pal: But we're going to shift gears to another massive topic, which is oral SERDs. In broad strokes, right, this utilization of CDK4/6 inhibitors in the context of HR-positive breast cancer is obviously, you know, a paradigm that's been well established at this point. Where do we sequence in oral SERDs? Where do they fit into this paradigm? Dr. Hope Rugo: Ha! This is a rapidly changing area; we keep changing what we're saying every other minute. And I think that there are three areas of great interest. So one is patients who develop ESR1 mutations that allow constitutive signaling through the estrogen receptor, even when there's not estrogen around, and that is a really important mutation that is subclonal; it develops under the pressure of treatment in about 40 percent of patients. And it doesn't happen when you first walk in the door. And what we've seen is that oral SERDs as single agents are better than standard single-agent endocrine therapy in that setting. The problem that we've had with that approach is that we're now really interested in giving targeted agents with our endocrine therapies, not just in the first-line setting where CDK4/6 inhibitors are our standard of care with survival benefit for ribociclib and, you know, survival benefit in subsets with other CDK4/6 inhibitors, and abemaciclib with a numeric improvement. So we give it first line. The question is, what do you do in the second-line setting? Because of the recent data, we now believe that oral SERDs should be really given with a targeted agent. And some datasets which were recently presented, which I think have helped us with that, have been EMBER-3 and then the most recently evERA BC, or evERA Breast Cancer, that looked at the oral SERD giredestrant with everolimus compared to standard of care endocrine therapy with everolimus, where 100 percent of patients received prior CDK4/6 inhibitor and showed a marked improvement in progression-free survival, including in the subsets of patients with a short response, 6-12 months of prior response to CDK4/6 inhibitor and in those who had a PIK3CA pathway mutation. The thing is that the benefit looks like it's much bigger in the ESR1 mutant population, although response was better, PFS wasn't better in the wild type. So, we're still trying to figure that out. We also saw EMBER-3 with imlunestrant and abemaciclib as a second line. Not everybody had had a prior CDK4/6 inhibitor; they compared it to imlunestrant alone, but still the data was quite striking and seemed to cross the need for ESR1 mutations. And then lastly, we saw data from the single arms of the ELEVATE trial looking at elacestrant with everolimus and abemaciclib and showed these really marked progression-free survival data, even though single-arm, that crossed the mutation status. At least for the everolimus combination, abemaciclib analysis is still to come in the mutated subgroups. But really remarkable PFS, much longer.  Single-agent fulvestrant after CDK4/6 inhibitor AI has a PFS in like the three-month range and in some studies, maybe close to five months. These are all at 10-plus months and really looking very good. And so those questions are, is it ESR1 mutation alone? Is it all comers? We'd like all comers, right? We believe in the combination approach and we're learning more about combinations with drugs like capivasertib and other drugs as we move forward. Everybody now wants to combine their targeted agent with an oral SERD because they're clearly here to stay with quite remarkable data. The other issue, so the second issue in the metastatic setting is, does it make a difference if we change to an oral SERD before radiographic imaging evidence of progression? And that was the question asked in the SERENA-6 trial where patients had serial monitoring for the presence of ESR1 mutations in ctDNA. And those who had them without progression on imaging could be randomized to switch to camizestrant with the same CDK4/6 inhibitor or stay on their same AI CDK4/6 inhibitor. And they showed a difference in progression-free survival that markedly favored camizestrant. But interestingly, the people who were on the standard control arm had an ESR1 mutation, we think AIs don't work, they stayed on for nine more months. The patients who were on the camizestrant stayed on for more than 16 months. And they presented some additional subset data which showed the same thing: follow-up PFS data, PFS2, all beneficial in SERENA-6 at the San Antonio [Breast Cancer Symposium]. So, we're still a little bit unclear about that. They did quality of life, and pain was markedly improved. They had a marked delayed time to progression of pain in the camizestrant arm. So this is all a work in progress, trying to understand who should we switch without progression to an oral SERD based on this development of this mutation that correlates with resistance. And, you know, it's interesting because the median time to having a mutation was 18 months and the median time to switch was almost 24 months. And then there were like more than 3,000 patients who hadn't gotten a mutation, hadn't switched, and were still okay. So screening everybody is the big question, and when you would start and who you would change on and how this affects outcome. Patients didn't have access to camizestrant in the control arm, something we can't fix but we have experimental drugs. We're actually planning a trial, I hope in collaboration with the French group Unicancer, and looking at this exact question. You know, if you switch and you change the CDK4/6 inhibitor and then you also allow crossover, what will we see? Dr. Monty Pal: We're coming right to the tail end of our time here, and I could probably go on for another couple of hours with you here. But if you could just give us maybe one or two big highlights from San Antonio, any thoughts to leave our audience with here based on this recent meeting? Dr. Hope Rugo: Yeah, I mean, I talked about a lot of those new data already from San Antonio, and the one that I'd really like to mention which I think was, you know, there were a lot of great presentations including personalized screening presented from the WISDOM trial by my colleague Laura Esserman, fascinating and really a big advance. But lidERA was the big highlight, I think, outside of the HER2CLIMB-05 which I talked about earlier in HER2-positive disease. And this study looked at giredestrant, the oral SERD versus standard of care endocrine therapy as treatment for medium and high-risk early-stage breast cancer. And what they showed, which I think was really remarkable with just about a three-year median follow-up, was an improvement in invasive disease-free survival with a hazard ratio of 0.7. I mean, really quite remarkable and so early. It looked as though this was all driven by the high-risk group, which makes sense, not the medium risk, it's too early. And also that there was a bigger benefit in patients who were on tamoxifen compared to giredestrant versus AI, but for both groups, the confidence intervals didn't cross 1. There's even a trend towards overall survival, even though it's way too early. I think that, you know, really well-tolerated oral drug that could improve outcome in early-stage disease, this is the first advance we've seen in over two decades in the treatment of early-stage hormone receptor-positive disease with just endocrine therapy. I think we think that we don't want to give up CDK4/6 inhibitors because we saw a survival benefit with abemaciclib and a trend with giving ribociclib in the NATALEE trial. So we're thinking that maybe one approach would be to give CDK4/6 inhibitors and then switch to an oral SERD or to have enough data to be able to give oral SERDs with these CDK4/6 inhibitors for early-stage disease. And that's all in the works, you know, lots of studies going on. We're going to see a lot of data with both switching 8,000 patients with an imlunestrant switching trial, an elacestrant trial going on, and safety data with giredestrant with abemaciclib and soon to come ribociclib. So, this is going to change everything for the treatment of early-stage breast cancer, and I hope cure more patients of the most common subset of the most common cancer diagnosed in women worldwide. Dr. Monty Pal: Super exciting. It's just remarkable to hear how this has evolved since 25 years ago, which is really the last time I sort of dabbled in breast cancer.  Thank you so much, Hope, for joining us today. These were fantastic insights. Appreciate you being on the ASCO Daily News Podcast and really want to thank you personally for your remarkable contribution to the field of breast cancer. Dr. Hope Rugo: Thank you very much, and thanks for talking with me today. Dr. Monty Pal: You got it. And thanks a lot to our listeners today as well. You'll find links to all the studies we discussed today in the transcript of this episode. Finally, if you value the insights that you hear 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 opinion of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:   Dr. Monty Pal @montypal Dr. Hope Rugo   @hoperugo 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. Hope Rugo:    Honoraria: Mylan/Viatris, Chugai Pharma   Consulting/Advisory Role: Napo Pharmaceuticals, Sanofi, Bristol Myer   Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Merck, Daiichi Sankyo, AstraZeneca, Gilead Sciences, Hoffman La-Roche AG/Genentech, In., Stemline Therapeutics, Ambryx  

Listen & subscribe on Apple, Spotify, YouTube.Welcome everyone to the weekly San Diego Tech News!I'm Neal Bloom from Rising Tide Partners.My co-host in this episode is Fred Grier, journalist and author of The Business of San Diego substack. He covers the ins-and-outs of the startup world including breaking news, IPOs, fundraising rounds, and M&A through his newsletter.Before we dive in, we wanted to thank and ask our listeners to help us grow the show, leave a review and share with one other person who should be more plugged in with the SD Tech Scene. Thank you for the support and for helping us build the San Diego Startup Community!1/5/2026Draft numbers of total VC Investment into SD Companies in 2025: $3.4BSelect top fundings:* Tech:* ShieldAI $240M, Cybereason $120M, Flock Fleight $60M, Clearspeed $60M, FABRIC8LABS $50M, Equip $46M* Biotech:* Crystalis Therapeutics $205M; Timberlyne Therapeutics $180M; Protego Biopharma $130M; Aspen Neuroscience $115M; Raythera $110M2025 Acquisitions:* Avidity $12B by Novartis* Cidara Therapeutics $9.2B Merck* Capstan Thera $2.1B by AbbVie* Arthrosi Thera $1B* Kate Thera $1.1B* Regulus Therapeutics acquired by Novartis ($1.7B)* Nalu Medical $500MIPOs:* Aardvark Thera* Aptera* Once Upon A Farm* Carlsmed* MapLight Therapeutics2026 Predictions* More IPOs & M&A, market up* Fundings up, in specific areas, more in other markets than SD* More return to office, in specific areasCarta Startup Ranking - San Diego #6Trust & Will Holiday BowlTED announced move to SDCurated Events List – For full list – check The Social CoyoteCES - Jan. 5-10Carlsbad Industry Exchange - Jan. 6JPM - Jan. 12-15State of Venture event - Jan. 29 This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit risingtidepartners.substack.com/subscribe