Podcasts about AbbVie

In this episode of Live Greatly: 2 Minutes of Motivation, Kristel Bauer shares a powerful mindset shift to help you navigate change more effectively at work. Change is inevitable, but it's also something many professionals naturally resist. Our brains are wired for predictability, and when routines are disrupted, it can trigger stress, uncertainty, and overwhelm. The good news? With the right perspective, change doesn't have to feel so overwhelming. In this episode, Kristel shares insights grounded in research on adaptability and performance to help make workplace change more manageable. You'll learn how a simple mental shift can help reduce resistance, build resilience, and support sustainable high performance during times of transition. Hosted by Kristel Bauer, keynote speaker, author, and performance expert. Book Kristel for Your Event or Team Bring these strategies to your organization:

Crain's residential real estate reporter Dennis Rodkin joins host Amy Guth to talk news from the local housing market, including how Chicago home prices flattened out as sales plunged in January. Plus: After weeks of tension, Pritzker strikes more upbeat tone on Bears tax talks; AbbVie investing $380 million on two new plants in North Chicago, adding 300 workers; Rivian doubles down on Illinois for mass-market R2; and Chicago Fed's Goolsbee says tariff ruling could help cool inflation. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. 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

Since podcasting came into existence in the mid-2000s, the space has become increasingly popular, remarkably lucrative and unquestionably saturated. Still, despite the countless millions of podcasts out there, countless millions of people tune in every hour of every day for conversations about every topic – including healthcare.  Joining a world occupied by This Past Weekend, Good Hang and The MM+M Podcast is The Persistence Lab. Launched by AbbVie's corporate affairs team, The Persistence Lab is the pharma giant's 10-episode project to highlight the work undertaken by its researchers, the clinical expertise of HCPs as well as the lived experiences of patients.  The first episode of The Persistence Lab was released late last week and is available wherever you listen to your podcasts.Molly James-Lundak, VP of R&D communications at AbbVie, joined me for a slightly meta conversation about joining the podcast sphere, how the drugmaker brought the idea to life and why it was important to engage with audio content creation.   And for our Trends segment, we're talking about AI in healthcare: Including the tools that actually work, the regulations on the way and the concerns that never go away.  Music: “Deep Reflection” by DP and Triple Scoop Music.   Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Looking to boost creativity, build a purpose-driven brand, or achieve sustainable success without burnout? In this Live Greatly podcast episode, Kristel Bauer sits down with Paige Mycoskie, founder and president of Aviator Nation, for an inside look at how she built one of the most recognizable California lifestyle brands in the world. Paige shares her journey from working in a surf shop to leading a globally loved company — along with her approach to creativity, leadership, company culture, and well-being. You'll also hear how she manages stress, protects her energy, and stays grounded while growing a high-impact brand. This inspiring conversation offers powerful insights for entrepreneurs, leaders, and anyone looking to build success with authenticity and balance. Tune in now! Key Takeaways from This Episode: A look into how Aviator Nation got started How Paige went from working at a surf shop to being the founder of Aviator Nation What Paige does do to boost creativity A look into Paige's leadership style How Paige finds inner balance and manages stress Why Aviator Nation's clothes are made in America Fun things in the works for Aviator Nation About Paige Mycoskie: FOUNDER & PRESIDENT OF AVIATOR NATION Paige Mycoskie is an American artist, fashion designer, and businesswoman, best known as the founder and owner of the 70's-inspired California lifestyle brand, Aviator Nation.  Paige was named GQ Magazines Designer of the Year, one of LA Business Journals Top Bosses Under 30 and was featured in Forbes Magazine as one of the United State's most successful female founders. Born in Texas, and an avid athlete, she was a state Volleyball champion, and on the Arizona State University Water Ski Team all while attending the Walter Cronkite School for Journalism.  Paige began her career at Shape Magazine and shifted focus to freelance photography, video, graphic design, and branding. She developed successful campaigns in branding and commercials, including TOMS Shoes.  Paige then decided to create her own clothing line - sewing, dying, and designing each piece herself.   Her beloved brand, Aviator Nation, was established in 2006 with the focus to create quality Made in America clothing.  Another goal for Paige was to connect fashion with music while raising funds for charities and generating an awareness of our collective consciousness.  Today Aviator Nation is a multi-million dollar business with 16 store locations across the US – including event space Dreamland in Malibu and wellness studio, RIDE, in Santa Monica - and a factory in downtown Los Angeles that employs over 300 people.  The garments are still Made in America after 15 years and Paige continues to inspire other companies to push the limits on manufacturing local.  With a passion for philanthropy, she has worked with a variety of nonprofits including Charity Water; Surf Aid; Heal the Bay; The Flatwater Foundation; and Global Citizen with proceeds aiding in their ongoing campaign to end poverty. The brand also has partnerships with SXSW, Austin City Limits Music Festival; Lollapalooza Music Festival; and with John Mayer's previous concert tours. Website: https://www.aviatornation.com/  Instagram: @aviatornation @paigemycoskie LinkedIn: https://www.linkedin.com/in/paige-mycoskie-17a9b56/  https://www.linkedin.com/company/aviator-nation/  Facebook: https://www.facebook.com/AviatorNation/  Hosted by Kristel Bauer, keynote speaker, author, and performance expert. Book Kristel for Your Event or Team Bring these strategies to your organization:

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

In this Live Greatly 2 Minutes of Motivation episode, Kristel Bauer shares four powerful ways to build happiness and use it as a performance advantage at work and in life. Research shows that when you feel better, you perform better. In this episode, Kristel explores simple, practical strategies to boost well-being, resilience, and success — even in demanding environments. You'll learn how to: • Focus on what's within your control through healthy lifestyle habits • Build stronger, high-quality relationships • Increase happiness through volunteering and service • Strengthen optimism, gratitude, and empowering thinking • Tune into your own needs to sustain energy and motivation Whether you're navigating a busy career, leadership responsibilities, or personal goals, this episode offers tools you can apply immediately. Hosted by Kristel Bauer, keynote speaker, author, and performance expert. Book Kristel for Your Event or Team Bring these strategies to your organization:

Melissa Lavasani & Jay Kopelman join our podcast to discuss how psychedelic policy is actually moving in Washington, DC. Lavasani leads Psychedelic Medicine Coalition, a DC-based advocacy organization focused on educating federal officials and advancing legislation around psychedelic medicine. Kopelman is CEO of Mission Within Foundation, which provides scholarships for veterans and first responders seeking psychedelic-assisted therapy retreats, often outside the United States. The conversation centers on veterans, the VA, and why that system may be the first realistic federal pathway for psychedelic care. Early Themes Lavasani describes PMC's work on Capitol Hill, including hosting events that bring lawmakers, staffers, and advocates into the same room. Her focus is steady engagement. In DC, progress often happens through repeated conversations, not headlines. Kopelman shares his background as a Marine and how his own psychedelic-assisted therapy experience led him to Mission Within. The foundation has funded more than 250 scholarships for veterans and first responders seeking treatment for PTSD, mild traumatic brain injury, depression, and addiction. They connect this work to pending veteran-focused legislation and explain why the VA matters. As a closed health system, the VA can pilot programs, gather data, and refine protocols without the pressures of private healthcare markets. Core Insights A recent Capitol Hill gathering, For Veteran Society, brought together members of Congress and leaders from the psychedelic caucus. Lavasani describes candid feedback from lawmakers. The message was clear: coordinate messaging, avoid fragmentation, and move while bipartisan interest remains. Veteran healthcare is not framed as the final goal. It is a starting point. If psychedelic therapies can demonstrate safety and effectiveness within the VA, broader adoption becomes more plausible. Kopelman raises operational realities that must be addressed: Standardized safety protocols across providers Integration support, not medication alone Clear training pathways for clinicians Real-world data beyond tightly screened clinical trials They also address recent negative headlines involving ibogaine treatment abroad. Kopelman emphasizes the need for shared learning across providers, especially when adverse events occur. Lavasani argues that inconsistency within the ecosystem can slow federal confidence. Later Discussion and Takeaways The discussion widens to federal momentum around addiction and mental health. Lavasani notes that new funding initiatives signal growing openness to innovative treatment models, even if psychedelics are not named explicitly in every announcement. Both guests stress that policy moves slowly by design. Meetings, follow-ups, and relationship building often matter more than public statements. For clinicians, researchers, operators, and advocates, the takeaways are direct: Veterans are likely the first federal pathway Public education remains essential Safety standards must be shared and transparent Integration and workforce development need attention now If psychedelic medicine enters federal systems, infrastructure will determine success. Frequently Asked Questions What do Melissa Lavasani & Jay Kopelman say about VA psychedelic policy? They argue that veteran-focused legislation offers a realistic first federal pathway for psychedelic-assisted care. Is ibogaine currently available through the VA? No. They discuss ibogaine in the context of private retreats and future possibilities, not an existing VA program. Why do Melissa Lavasani & Jay Kopelman emphasize coordination? Lawmakers respond more positively when advocates present aligned messaging and clear priorities. What safety issues are discussed by Melissa Lavasani & Jay Kopelman? They highlight the need for standardized screening, monitoring, integration support, and transparent review of adverse events. Closing Melissa Lavasani & Jay Kopelman provide a grounded look at how psychedelic policy develops inside federal systems. Their message is practical: veterans may be the first lane, but long-term success depends on coordination, safety standards, and sustained engagement. Closing This episode captures a real-time view of how federal policy could shape the next phase of the psychedelic resurgence, especially through veteran-facing legislation and VA infrastructure. Melissa Lavasani & Jay Kopelman argue that coordination, public education, and shared safety standards will shape whether access expands with credibility and care. Transcript Joe Moore: [00:00:00] Hello everybody. Welcome back to Psychedelics Today. Today we have two guests, um, got Melissa Sani from Psychedelic Medicine Coalition. We got Jake Pelman from Mission Within Foundation. We're gonna talk about I bga I became policy on a recent, uh, set of meetings in Washington, DC and, uh, all sorts of other things I'm sure. Joe Moore: But thank you both for joining me. Melissa Lavasani: Thanks for having us. Jay Kopelman: Yeah, it's a pleasure. Thanks. Joe Moore: Yeah. Um, Melissa, I wanna have you, uh, jump in. First. Can you tell us a little bit about, uh, your work and what you do at PMC? Melissa Lavasani: Yeah, so Psychedelic Medicine Coalition is, um, the only DC based Washington DC based advocacy organization dedicated to the advancing the issue of psychedelics, um, and making sure the federal government has the education they need, um, and understands the issue inside out so that they can generate good policy around, around psychedelic medicines. Melissa Lavasani: [00:01:00] Uh, we. Host Hill events. We host other convenings. Our big event every year is the Federal Summit on psychedelic medicine. Um, that's going to be May 14th this year. Um, where we talk about kinda the pressing issues that need to be talked about, uh, with government officials in the room, um, so that we can incrementally move this forward. Melissa Lavasani: Um, our presence here in Washington DC is, is really critical for this issue's success because, um, when we're talking about psychedelic medicines, um, from the federal government pers perspective, you know, they are, they are the ones that are going to initiate the policies that create a healthcare system that can properly facilitate these medicines and make sure, um, patient safety is a priority. Melissa Lavasani: And there's guardrails on this. And, um, you know, there, it's, it's really important that we have. A home base for this issue in Washington DC just [00:02:00] because, uh, this is very complicated as a lot of your viewers probably understand, and, you know, this can get lost in the mix of all the other issues that, um, lawmakers in DC are focused on right now. Melissa Lavasani: And we need to keep that consistent presence here so that this continues to be a priority for members of Congress. Joe Moore: Mm. I love this. And Jay, can you tell us a bit about yourself and mission within Foundation? Jay Kopelman: Yeah, sure. Joe, thanks. Uh, I, I am the CEO of Mission within Foundation. Prior to this, most of my adult life was spent in the military as a Marine. Jay Kopelman: And I came to this. Role after having, uh, a psychedelic assisted therapy experience myself at the mission within down in Mexico, which is where pretty much we all go. Um, we are here to help [00:03:00] provide, uh, access for veterans and first responders to be able to attend psychedelic assisted therapy retreats to treat issues like mild TBI, post-traumatic stress disorder, uh, depression, sometimes addiction at, at a very low level. Jay Kopelman: Um, and, and so we've, we've been doing this for a little more than a year now and have provided 250 plus scholarships to veterans and first responders to be able to access. These retreats and these, these lifesaving medicines. Um, we're also partnered, uh, you may or may not know with Melissa at Psychedelic Medicine Coalition to help advance education and policy, specifically the innovative, uh, therapy Centers of Excellence Act [00:04:00] that Melissa has worked for a number of years on now to bring to both Houses of Congress. Joe Moore: Thank you for that. Um, so let's chat a little bit about what this event was that just, uh, went down, uh, what, what was it two weeks ago at this point? Melissa Lavasani: Yeah. Yeah. It's called For Veteran Society and it's all, um, there's a lot of dialogue on Capitol Hill about veterans healthcare and psychedelics, but where I've been frustrated is that, you know, it was just a lot of. Melissa Lavasani: Talk about what the problems are and not a lot of talk about like how we actually propel things forward. Um, so it, at that event, I thought it was really important and we had three members of Congress there, um, Morgan Latrell, who has been a champion from day one and his time in Congress, um, having gone through the experience himself, um, [00:05:00] at Mission within, um, and then the two chairs of the psychedelic caucus, uh, Lou Correa and Jack Bergman. Melissa Lavasani: And we really got down to the nitty gritty of like w like why this has taken so long and you know, what is actually happening right now? What are the possibilities and what the roadblocks are. And it was, I thought it was a great conversation. Um, we had an interesting kind of dynamic with Latres is like a very passionate about this issue in particular. Melissa Lavasani: Um, I think it was, I think it was really. A great event. And, you know, two days later, Jack Bergman introduced his new bill for the va. Um, so it was kind of like the precursor to that bill getting introduced. And we're just excited for more and more conversations about how the government can gently guide this issue to success. Joe Moore: Hmm. Yeah. [00:06:00] That's fantastic. Um, yeah, I was a little bummed I couldn't make it, but next time, I hope. But I've heard a lot of good things and, um, it's, it sounded like there was some really important messages in, in terms of like feedback from legislators. Yeah. Yeah. Could you speak to that? Melissa Lavasani: Yeah, I mean, I think when, uh, representative Latrell was speaking, he really impressed on us a couple things. Melissa Lavasani: Um, first is that, you know, they really kind of need the advocates to. Coordinate, collaborate and come up with like a, a strategic plan, you know, without public education. Um, talking to members of Congress about this issue is, is really difficult. You know, like PMC is just one organization. We're very little mission within, very little, um, you know, we're all like, kind of new in navigating, um, this not so new issue, but new to Washington DC [00:07:00] issue. Melissa Lavasani: Um, without that public education as a baseline, uh, it's, it's, you have to spend a lot of time educating members of Congress. You know, that's like one of our things is, you know, we have to, we don't wanna tell Congress what direction to go to. We wanna provide them the information so they understand it very intimately and know how to navigate through things. Melissa Lavasani: Um, and secondly. Um, he got pretty frank with us and said, you know, we've got one cha one chance at this issue. And it's like, that's, that's kind of been like my talking point since I started. PMC is like, you have a very limited window, um, when these kind of issues pop up and they're new and they're fresh and you have a lot of the veteran community coming out and talking about it. Melissa Lavasani: And there's a lot of energy there. But now is the time to really move forward, um, with some real legislation that can be impactful. Um, but, you know, we've gotta [00:08:00] be careful. We, we forget, I think sometimes those of us who are in the ecosystem forget that our level of knowledge about these medicines and a lot of us have firsthand experience, um, with these drugs and, and our own healing journeys is, um, we forget that there is a public out there that doesn't have the level of knowledge that we all have. Melissa Lavasani: And, um. We gotta make sure that we're sticking to the right elements of, of, of what needs to happen. We need to be sure that our talking points are on track and we're not getting sideways about anything and going down roads that we don't need to talk about. It's why, um, you know, PMC is very focused on, um, moving forward veteran legislation right now. Melissa Lavasani: Not because we're a veteran organization, but because we're, we see this long-term policy track here. Um, we know where we want to get [00:09:00] to, um. Um, and watching other healthcare issues kind of come up and then go through the VA healthcare system, I think it's a really unique opportunity, um, to utilize the VA as this closed system, the biggest healthcare system in the country to evaluate, uh, how psychedelics operate within systems like that. Melissa Lavasani: And, you know, before they get into, um, other healthcare systems. What do we need to fix? What do we need to pay attention to? What's something that we're paying too much attention to that doesn't necessarily need that much attention? So it's, um, it's a real opportunity to look at psychedelic medicines within a healthcare system and obviously continue to gather the data. Melissa Lavasani: Um, Bergman's Bill emerging, uh, expanding veteran access to emerging treatments. Um, not only mandates the research, it gives the VA authority for this, uh, for running trials and, and creating programs around psychedelic medicines. But also, [00:10:00] one of the great things about it, I think, is it provides an on-ramp for veterans that don't necessarily qualify for clinical trials. Melissa Lavasani: You know, I think that's one of the biggest criticisms of clinical trials is like you're cre you're creating a vacuum for people and people don't live in a vacuum. So we don't necessarily know what psychedelics are gonna look like in real life. Um, but with this expanding veteran access bill that Bergman introduced, it provides the VA an opportunity to provide this access under. Melissa Lavasani: Um, in a, in a safe container with medical supervision while collecting data, um, while ensuring that the veteran that is going through this process has the support systems that it needs. So, um, you know, I think that there's a really unique opportunity here, and like Latrell said, like, we've got one shot at this. Melissa Lavasani: We have people's attention in Congress. Um, now's the time to start acting, and let's be really considerate and thoughtful about what we're doing with it. Joe Moore: Thanks for that, Melissa and Jay, how, [00:11:00] anything to add there on kind of your takeaways from the this, uh, last visit in dc? Jay Kopelman: Yeah, I, I think that Melissa highlighted it really well and there, there were a couple other things that I, I think, you know, you could kind of tie it all together with some other issues that we face in this country, uh, and that. Jay Kopelman: Uh, representative Correa brought up as well, but one of the things I wanted to go back and say is that veterans have kind of led this movement already, right? So, so it's a, it's a good jumping off point, right? That it's something people from both sides of the aisle, from any community in America can get behind. Jay Kopelman: You know, if you think about it, uh, in World War ii, you know, we had a million people serving our population was like, not even 200 million, but now [00:12:00] we have a population of 330 million, and at any given time there might be a million people in uniform, including the Reserve and the National Guard. So it's, it, it's an easy thing to get behind this small part of the population that is willing to sign that contract. Jay Kopelman: Where you are saying, yeah, I'm going to defend my country, possibly at the risk of my l my own life. So that's the first thing. The other thing is that the VA being a closed health system, and they don't have shareholders to answer to, they can take some risks, they can be innovative and be forward thinking in the ways that some other healthcare systems can't. Jay Kopelman: And so they have a perfect opportunity to show that they truly care for their veterans, which don't, I'm not saying they don't, but this would be an [00:13:00] opportunity to show that carrot at a whole different level. Uh, it would allow them to innovate and be a leader in something as, uh, as our friend Jim Hancock will say, you know. Jay Kopelman: When he went to the Naval Academy, they had the world's best shipbuilding program. Why doesn't the VA have the world's best care program for things like TBI and PTSD, which affects, you know, 40 something percent of all veterans, right? So, so there's, there's an opportunity here for the VA to lead from the front. Jay Kopelman: Um, the, these medicines provide, you know, reasonably lasting care where it's kind of a one and done. Whereas with the current systems, the, you know, and, and [00:14:00] again, not to denigrate the VA in any way, they're doing the best job they can with the tools in their toolbox, right? But maybe it's time for a trip to Home Depot. Jay Kopelman: Let's get some new tools. And have some new ways of fixing what's broken, which is really the way of doing things. It's not, veterans aren't broken, we are who we are. Um, but it's a, it's a way to fix what isn't working. So I, I think that, you know, given there's tremendous veteran homelessness still, you know, addiction issues, all these things that do translate to the population at large are things that can be worked on in this one system, the va that can then be shown to have efficacy, have good data, have [00:15:00] good outcomes, and, and take it to the population at large. Joe Moore: Mm-hmm. Brilliant. Thanks for that. And so there was another thing I wanted to pivot to, which is some of the recent press. So we've, um, seen a little bit of press around some, um, in one instance, some bad behavior in Mexico that a FI put out Americans thrive again, put out. And then another case there was a, a recent fatality. Joe Moore: And I think, um, both are tragic. Like we shouldn't be having to deal with this at this point. Um, but there's a lot of things that got us here. Um, it's not necessarily the operator's fault entirely, um, or even at all, honestly, like some medical interventions just carry a lot of risk. Like think, think about like, uh, how risky bypass surgery was in the nineties, right? Joe Moore: Like people were dying a lot from medical interventions and um, you know, this is a major intervention, uh, ibogaine [00:16:00] and also a lot of promise. To help people quite a bit. Um, but as of right now, there's, there's risk. And part of that risk, in my opinion, comes from the inability of organizations to necessarily collaborate. Joe Moore: Like there's no kind of convening body, sitting in the middle, allowing, um, for, and facilitating really good data sharing and learnings. Um, and I don't, I don't necessarily see an organization stepping up and being the, um, the convener for that kind of work. I've heard rumors that something's gonna happen there, and I'm, I'm hopeful I'll always wanna share my opinion on that. Joe Moore: But yeah. I don't know. Jay, from your perspective, is there anything you want to kind of speak to about, uh, these two recent incidents that Americans for Iboga kind of publicized recently? Jay Kopelman: Yeah, so I, I'll echo your sentiment, of course, that these are tragic incidents. Um, and I, [00:17:00] I think that at least in the case of the death at Ambio, AMBIO has done a very good job of talking about it, right? Jay Kopelman: They've been very honest with the information that they have. And like you said, there are risks inherent to these medicines, and it's like anything else in medicine, there are going to be risks. You know, when I went through, uh, when I, when I went through chemo, you know, there were, there are risks. You know, you don't feel well, you get sick. Jay Kopelman: Um, and, and it. There are processes in place to counter that when it happens. And there are processes and, and procedures and safety protocols in place when caring for somebody going through an ibogaine [00:18:00] journey. Uh, when I did it, we had EKG echocardiogram. You're on a heart monitor the entire time they push magnesium via iv. Jay Kopelman: You have to provide a urinalysis sample to make sure that there is nothing in your system that is going to potentially harm you. During the ibogaine, they have, uh, a cardiologist who is monitoring the heart monitors throughout the ibogaine experience. So the, the safety protocols are there. I think it's, I think it's just a matter of. Jay Kopelman: Standardizing them across all, all providers, right? Like, that would be a good thing if people would talk to one another. Um, as, as in any system, right? You've gotta have [00:19:00] some collaboration. You've gotta have standardization, you know, so, you know, they're not called standard operating procedures for nothing. Jay Kopelman: That means that in a, you know, in a given environment, everybody does things the same way. It's true in Navy and Marine Corps, air Force, army Aviation, they have standard operating procedures for every single aircraft. So if you fly, let's say the F 35 now, right? Because it's flown by the Navy, the Marine Corps, and the Air Force. Jay Kopelman: The, the emergency procedures in that airplane are standardized across all three services, so you should have the same, or, you know, with within a couple of different words, the same procedures and processes [00:20:00] across all the providers, right? Like maybe in one document you're gonna change, happy to glad and small dog to puppy, but it's still pretty much the, the same thing. Jay Kopelman: And as a service that provides scholarships to people to go access these medicines and go to these retreats, you know, my criteria is that the, this provider has to be safe. Number one, safety's paramount. It's always gotta be very safe. It should, it has to be effective. And you know, once you have those two things in place, then I have a comfort level saying, okay, yeah, we'll work with this provider. Jay Kopelman: But until those standardized processes are in place, you'll probably see these one-off things. I mean, some providers have been doing this longer than others and have [00:21:00] really figured out, you know, they've, they've cracked the code and, you know, sharing that across the spectrum would be good. Um, but just when these things happen, having a clearing house, right, where everybody can come together and talk about it, you know, like once the facts are known because. Jay Kopelman: To my knowledge, we still don't know all the facts. Like as, you know, as horrible as this is, you still have to talk about like an, has an autopsy been performed? What was found in the patient's system? You know, there, there are things there that we don't know. So we need to, we need to know that before we can start saying, okay, well this is how we can fix that, because we just don't know. Jay Kopelman: And, you know, to their credit, you know, Amio has always been safe to, to the, to the best of my knowledge. You know, I, [00:22:00] I haven't been to Ambio myself, but people that I have worked with have been there. They have observed, they have seen the process. They believe it's safe, and I trust their opinion because they've seen it elsewhere as well. Jay Kopelman: So yeah, having, having that one place where we can all come together when this happens, it, it's almost like it should be mandatory. In the military when there's a training accident, we, you know, we would have to have what's called a safety standout. And you don't do that again for a little while until you figure out, okay, how are we going to mitigate that happening again? Jay Kopelman: Believe me, you can go overboard and we don't want to do that. Like, we don't wanna just stop all care, but maybe stop detox for a week and then come back to it. [00:23:00] Joe Moore: Yeah. A dream would be, let's get like the, I don't know, 10, 20 most popular, uh, or well-known operators together somewhere and just do like a three day debrief. Joe Moore: Hey, everybody, like, here's what we see. Let's work on this together. You know how normal medicine works. And this is, it's hard because this is not necessarily, um, something people feel safe about in America talking about 'cause it's illicit here. Um, I don't understand necessarily how the operations, uh, relate to each other in Mexico, but I think that's something to like the public should dig into. Joe Moore: Like, what, what is this? And I, I'll start digging into that. Um, I, I asked a question recently of somebody like, is there some sort of like back channel signal everybody's using and there's no clear Yes. You know? Um, I think it would be good. That's just a [00:24:00] start, you know, that's like, okay, we can actually kind of say hi and watch out for this to each other. Jay Kopelman: It's not like we don't all know one another, right? Joe Moore: Yes. Jay Kopelman: Like at least three operators we're represented. At the Aspen Ibogaine meeting. So like that could be, and I think there was a panel kind of loosely related to this during Aspen Ibogaine meeting, but Joe Moore: mm-hmm. Jay Kopelman: It, you know, have a breakout where the operators can go sit down and kind of compare notes. Joe Moore: Right. Yeah. Melissa, do you have any, uh, comments on this thread here? And I, I put you on mute if you didn't see that. Um, Melissa Lavasani: all right, I'm off mute. Um, yeah, I think that Jay's hits the nail on the head with the collaboration thing. Um, I think that it's just a [00:25:00] problem across the entire ecosystem, and I think that's just a product of us being relatively new and upcoming field. Melissa Lavasani: Um, uh, it's a product of, you know. Our fundraising community is really small, so organizations feel like they are competing for the same dollars, even though their, their goals are all the same, they have different functions. Um, I think with time, I mean, let's be honest, like if we don't start collaborating and, and the federal government's moving forward, the federal government's gonna coordinate for us. Melissa Lavasani: And not, that might not necessarily be a bad thing, but, you know, we understand this issue to a whole other level that the federal government doesn't, and they're not required to understand it deeply. They just need to know how to really move forward with it the proper way. Um, but I think that it. It's really essential [00:26:00] that we all have this come together moment here so we can avoid things. Melissa Lavasani: Uh, I mean, no one's gonna die from bad advocacy. So like I've, I have a bit of an easier job. Um, but it can a, a absolutely stall efforts, um, to move things forward in Washington DC when, um, one group is saying one thing, another group is saying another thing, like, we're not quite at a point yet where we can have multiple lines of conversation and multiple things moving forward. Melissa Lavasani: Um, you know, for PMC, it's like, just let's get the first thing across the finish line. And we think that is, um, veteran healthcare. And, um, I know there's plenty of other groups out there that, that want the same thing. So, you know, I always, the reason why I put on the Federal Summit last year was I kind of hit my breaking point with a lack of collaboration and I wanted to just bring everyone in the same room and say like, all right, here are the things that we need to talk about. Melissa Lavasani: And I think the goal for this year is, um. To bring people in the same room and say, we talked about [00:27:00] we scratched the surface last year and this is where we need to really put our efforts into. And this is where the opportunities are. Um, I think that is going to, that's going to show the federal government if we can organize ourselves, that they need to take this issue really seriously. Melissa Lavasani: Um, I don't think we've done a great job at that thus far, but I think there's still plenty of time for us to get it together. Um, and I'm hoping with these two, uh, VA bills that are in the house right now and Senate is, is putting together their version of these two bills, um, so that they can move in tandem with each other. Melissa Lavasani: I think that, you know, there's an opportunity here for. Us to show the federal government as an ecosystem, Hey, we, we are so much further ahead and you know, this is what we've organized and here's how we can help you, um, that would make them buy into this issue a bit more and potentially move things forward faster. Melissa Lavasani: Uh, at this point in time, it's, I think that, [00:28:00] you know, psychedelics aren't necessarily the taboo thing that they, they used to be, but there's certainly places that need attention. Um, there's certainly conversations that need to be had, and like I said, like PMC is just one organization that can do this. Um, we can certainly organize and drive forward collaboration, but I, like we alone, cannot cover all this ground and we need the subject matter experts to collaborate with us so we can, you know, once we get in the door, we wanna bring the experts in to talk to these officials about it. Melissa Lavasani: So I. I, I really want listeners to really think about us as a convener of sorts when it comes to federal policy. Um, and you know, I think when, like for example, in the early eighties, a lot of people have made comparisons to the issue of psychedelics to the issue of AIDS research and how you have in a subject matter that's like extremely taboo and a patient population that the government [00:29:00] quite honestly didn't really care about in the early eighties. Melissa Lavasani: But what they did as an ecosystem is really organized themselves, get very clear on what they wanted the federal government to do. And within a matter of a couple years, uh, AIDS research funding was a thing that was happening. And what that, what that did was that ripple effect turned that into basically finding new therapies for something that we thought was a death, death sentence before. Melissa Lavasani: So I think. We just need to look at things in the past that have been really successful, um, and, and try to take the lessons from all of these issues and, and move forward with psychedelics. Joe Moore: Love that. And yes, we always need to be figuring out efficient approaches and where it has been successful in the past is often, um, an opportunity to mimic and, and potentially improve on that. Melissa Lavasani: Yeah. Jay Kopelman: One, one thing I think it's important to add to this part of the conversation is that, [00:30:00] you know, Melissa pointed out there are a number of organizations that are essentially doing the same thing. Jay Kopelman: Um, you know, I like to think we do things a little bit differently at Mission within Foundation in that we don't target any one specific type of service member. We, we work with all veterans. We work with first responders, but. What that leads to is that there are, as far as I've seen, nothing but good intentioned people in this space. Jay Kopelman: You know, people who really care about their patient population, they care about healing, they are trying to do a good job, and more importantly, they're trying to do good. Right? It, it, I think they all see the benefit down the road that this has, [00:31:00] pardon me, not just for veterans, but for society as a whole. Jay Kopelman: And, and ultimately that's where I would like to see this go. You know, I, I would love to see the VA take this. Take up this mantle and, and run with it and provide great data, great outcomes. You know, we are doing some data collection ourselves at Mission within foundation, albeit anecdotal based on surveys given before and after retreats. Jay Kopelman: But we're also working with, uh, Greg Fonzo down at UT Austin on a brain study he's doing that will have 40 patients in it when it's all said and done. And I think we have two more guys to put through that. Uh, and then we'll hit the 40. So there, there's a lot of good here that's being done by some really, really good people who've been doing this for a long time [00:32:00] and want to want nothing more than to, to see this. Jay Kopelman: Come to, come full circle so that we can take care of many, many, many people. Um, you know, like I say, I, I wanna work myself out of a job here. I, I just, I would love to see this happen and then I, you know, I don't have to send guys to Mexico to do this. They can go to their local VA and get the care that they need. Jay Kopelman: Um, but one thing that I don't think we've touched on yet, or regarding that is that the VA isn't designed for that. So it's gonna be a pretty big lift to get the right types of providers into the va with the knowledge, right, with the institutional knowledge of how this should be done, what is safe, what is effective, um, and then it, it's not just providing these medicines to [00:33:00] people and sending them home. Jay Kopelman: You don't just do that, you've gotta have the right therapists on the backend who can provide the integration coaching to the folks who are receiving these medicines. And I'm not just talking, I bga, even with MDMA and psilocybin, you should have a proper period of integration. It helps you to understand how this is going to affect you, what it, what the experience really meant, you know, because it's very difficult sometimes to just interpret it on your own. Jay Kopelman: And so what the experience was and what it meant to you. And, and so it will take some time to spin all that up. But once it's, once it's in place, you know, the sky's the limit. I think. Joe Moore: Kinda curious Jay, about what's, what's going on with Ibogaine at the federal level. Is there anything at VA right now? [00:34:00] Jay Kopelman: At the va? No, not with ibogaine. And, you know, uh, we, we send people specifically for IBOGAINE and five MEO, right? And, and so that, that doesn't preclude my interest in seeing this legislation passed, right? Jay Kopelman: Because it, it will start with something like MDMA or psilocybin, but ultimately it could grow to iboga, right? It the think about the cost savings at, at the va, even with psilocybin, right? Where you could potentially treat somebody with a very inexpensive dose of psilocybin or, or iboga one time, and then you, you don't have to treat them again. Jay Kopelman: Now, if I were, uh, you know, a VA therapist who's not trained in psychedelic trauma therapy. I might be worried [00:35:00] about job security, but it's like with anything, right? Like ultimately it will open pathways for new people to get that training or the existing people to get that training and, and stay on and do that work. Jay Kopelman: Um, which only adds another arrow to their quiver as far as I'm concerned, because this is coming and we're gonna need the people. It's just like ai, right? Like ai, yeah. Some people are gonna lose some jobs initially, and that's unfortunate. But productivity ultimately across all industries will increase and new jobs will be created as a result of that. Jay Kopelman: I mean, I was watching Squawk Box one morning. They were talking about the AI revolution and how there's gonna be a need for 500,000 electricians to. Build these systems that are going to work with the AI [00:36:00] supercomputers and, and so, Joe Moore: mm-hmm. Jay Kopelman: Where, where an opportunity may be lost. I think several more can be gained going forward. Melissa Lavasani: And just to add on what Jay just said there, there's nothing specific going on with Ibogaine at, at the va, but I think this administration is, is taking a real look at addiction in particular. Uh, they just launched, uh, a new initiative, uh, that's really centered on addiction treatments called the Great American Recovery. Melissa Lavasani: And, um, they're dedicating a hundred million dollars towards treating addiction as like a chronic treatable disease and not necessarily a law enforcement issue. So, um, in that initiative there will be federal grant programs for prevention and treatment and recovery. And, um, while this isn't just for psychedelic medicines, uh, I think it's a really great opportunity for the discussion of psychedelics to get elevated to the White House. Melissa Lavasani: Um, [00:37:00] there's also, previous to this announcement last week from the White House, there's been a hundred million dollars that was dedicated at, um, at ARPA h, which is. The advanced research projects, uh, agency for healthcare, um, and that is kind of an agency that's really focused on forward looking, um, treatments and technologies, uh, for, um, a, a whole slew of. Melissa Lavasani: Of issues, but this a hundred million dollars is dedicated to mental health and addiction. So there's a lot of opportunity there as well. So we, while I think, you know, some people are talking about, oh, we need a executive order on Iboga, it's like, well, you know, the, the president is thinking, um, about, you know, what issues can land with his, uh, voting block. Melissa Lavasani: And I think it's, I don't think we necessarily need a specific executive order on Iboga to call this a success. It's like, let's look at what, [00:38:00] um, what's just been announced from the White House. They're, they're all in on. Thinking creatively and finding, uh, new solutions for this. And this is kind of, this aligns with, um, HHS secretaries, uh, Robert F. Melissa Lavasani: Kennedy Junior's goals when he took on this, this role of Health Secretary. Um, addiction has been a discussion that, you know, he has personal, um, a personal tie to from his own experience. And, um, I think when this administration started, there was so much like fervor around the, the dialogue of like, everyone's talking about psychedelics. Melissa Lavasani: It was Secretary Kennedy, it was, uh, secretary Collins at the va. It was FDA Commissioner Marty Macari. And I think that there's like a lot of undue frustration within folks 'cause um, you don't necessarily snap your fingers and change happens in Washington dc This is not the city for that. And it's intentionally designed to move slow so that we can avoid really big mistakes. Melissa Lavasani: Um. [00:39:00] I think we're a year into this administration and these two announcements are, are pretty huge considering, um, you know, the, we, there are known people within domestic policy council that don't, aren't necessarily supportive of psychedelic medicine. So there's a really amazing progress here, and frustrating as it might be to, um, just be waiting for this administration to make some major move. Melissa Lavasani: I think they are making major moves like for Washington, DC These, these are major moves and we just gotta figure out how we can, um, take these initiatives and apply them to the issue of psychedelic medicines. Joe Moore: Thanks, Melissa. Um, yeah, it is, it is interesting like the amount of fervor there was at the beginning. You know, we had, uh. Kind of one of my old lawyers, Matt Zorn, jumped in with the administration. Right. And, um, you know, it was, uh, really cool to [00:40:00] see and hopeful how much energy was going on. It's been a little quiet, kind of feels like a black box a little bit, but I, you know, there was, Melissa Lavasani: that's on me. Melissa Lavasani: Maybe I, we need to be more out in public about like, what's actually happening, because I feel like, like day in and day out, it's just been, you gotta just mm-hmm. Like have that constant beat with the government. Mm-hmm. And, um, it's, it's, it's not the photo ops on the hill, it's the conversations that you have. Melissa Lavasani: It's the dinner parties you go to, it's the fundraisers you attend, you know? Mm-hmm. That's why I, I kind of have to like toot my own horn with PCs. Like, we need to be present here at, at not only on the Hill, not only at the White House, but kind of in the ecosystem of Washington DC itself. There's, it's, there are like power players here. Melissa Lavasani: There are people that are connected that can get things done, like. I mean, the other last week we had a big snow storm. I walked over to my friend's house, um, to have like a little fire sesh with them and our kids, and his next door neighbor came over. He was a member of Congress. I talked about the VA bills, like [00:41:00] we're reaching out to his office now, um, to get them, um, up to speed and hopefully get their co-sponsorship for, uh, the two VA bills. Melissa Lavasani: So, I mean, it, the little conversations you have here are just as important as the big ones with the photo ops. So, um, it, it's, it's really like, you know, building up that momentum and, and finding that time where you can really strike and make something happen. Joe Moore: Mm-hmm. Yeah. Jay, anything to add there? Jay Kopelman: Yeah, I was just gonna say that, you know, I, I, I think the fervor is still there, right? Jay Kopelman: But real life happens. Melissa Lavasani: Yes, Jay Kopelman: yes. And gets in the way, right? So, Melissa Lavasani: yeah, Jay Kopelman: I, I can't imagine how many issues. Secretary Kennedy has every day much less the president. Like there's so many things that they are dealing with on a daily basis, right? It, we, we just have to work to be the squeaky wheel in, in the right way, right. Jay Kopelman: [00:42:00] With the, with the right information at the right time. Like just inundating one of these organizations with noise, it's then it be with Informa, it just becomes noise, right? It it, it doesn't help. So when we have things to say that are meaningful and impactful, we do, and Melissa does an amazing job of that. Jay Kopelman: But, you know, it, it takes time. You know, it's, you know, we're not, this is, this is like turning an aircraft carrier, not a ski boat. Melissa Lavasani: Yeah, Joe Moore: yeah, absolutely. Um, and. It's, it's understandably frustrating, I think for the public and the psychedelic public in particular because we see all this hope, you know, we continue to get frustrated at politics. It's nothing new, right? Um, and we, we wanna see more people get well immediately. [00:43:00] And I, I kind of, Jay from the veteran perspective, I do love the kind of loud voices like, you're making me go to Mexico for this. Joe Moore: I did that and you're making me leave the country for the thing that's gonna fix me. Like, no way. And barely a recognition that this is a valid treatment. You know, like, you know, that is complicated given how medicine is structured here domestically. But it's also, let's face the facts, like the drug war kind of prevented us from being able to do this research in the first place. Joe Moore: You know? Thanks Nixon. And like, how do we actually kind of correct course and say like, we need to spend appropriately on science here so we can heal our own people, including veterans and everybody really. It's a, it's a dire situation out there. Jay Kopelman: Yeah. It, it really is. Um, you know, we were talking briefly about addicts, right? Jay Kopelman: And you know, it's not sexy. People think of addicts as people who are weak-minded, [00:44:00] right? They don't have any self-control. Um, but, but look at, look at the opioid crisis, right? That Brian Hubbard was fighting against in Kentucky for all those years. That that was something that was given to the patient by a doctor that they then became dependent on, and a lot of people died from that. Jay Kopelman: And, and so you, you know, it's, I I don't think it's fair to just put all addicts in a box. Just like it's not fair to put all veterans in a box. Just like it's not fair for doctors, put all their patients in a box. We're individuals. We, we have individual needs. Our, our health is very individual. Like, I, I don't think I should be put in the same box as every other 66-year-old that my doctor sees. Jay Kopelman: It's not fair. [00:45:00] You know, if you, if you took my high school classmates and put us all in a photo, we're all gonna have different needs, right? Like, some look like they're 76, not 66. Some look like they're 56. Not like they're, we, we do things differently. We live our lives differently. And the same is true of addicts. Jay Kopelman: They come to addiction from different places. Not everybody decides they want to just try heroin at a party, and all of a sudden they're addicted. It happens in, in different ways, you know, and the whole fentanyl thing has been so daggum nefarious, right? You know, pushing fentanyl into marijuana. Jay Kopelman: Somebody's smoking a joint and all of a sudden they're addicted to fentanyl or they die. Melissa Lavasani: I think we're having a, Jay Kopelman: it's, it's just not fair to, to say everybody in this pot is the same, or everybody in this one is the same. We have [00:46:00] to look at it differently. Joe Moore: Yeah. I like to zoom one level out and kind of talk about, um, just how hurt we are as a country, as a world really, but as a country specifically, and how many people are out of work for so many. Joe Moore: Difficult reasons and away from their families for so many kind of tragic reasons. And if we can get people back to their families and back to work, a lot of these things start to self-correct, but we have to like have those interventions where we can heal folks and, and get them back. Um, yeah. And you know, everything from trauma, uh, in childhood, you know, adulthood, combat, whatever it is. Joe Moore: Like these things can put people on the sidelines. And Jay, to your point, like you get knee surgery and all of a sudden you're, you know, two years later you're on the hunt for Fentanyl daily. You know, that's tough. It's really tough. Carl Hart does a good job talking about this kind of addiction pipeline and [00:47:00] a few others do as well. Joe Moore: But it's just, you know, kind of putting it in a moral failure bucket. It's not great. I was chatting with somebody about, um, veterans, it's like you come back and you're like, what's gonna make me feel okay right now? And it's not always alcohol. Um, like this is the first thing that made me feel okay, because there's not great treatments and there's, there's a lot of improvements in this kind of like bringing people back from the field that needs to happen. Joe Moore: In my opinion. I, it seems to be shared by a lot of people, but yeah, there's, it's, it's, IGA is gonna be great. It's gonna be really important. I really can't wait for it to be at scale appropriately, but there's a lot of other things we need to fix too, um, so that we can just, you know, not have so many people we need to, you know, spend so much money healing. Joe Moore: Mm-hmm. Jay Kopelman: Yeah. You ahead with that. We don't need the president to sign an executive order to automatically legalize Ibogaine. Right. But it would be nice if he would reschedule it so that [00:48:00] then then researchers could do this research on a larger scale. You know, we could, we could now get some real data that would show the efficacy. Jay Kopelman: And it could be done in a safe environment, you know? And, and so that would be, do Joe Moore: you have any kind of figures, like, like, I've been talking about this for a while, Jay. Like, does it drop the cost a lot of doing research when we deschedule things? Jay Kopelman: I, I would imagine so, because it'll drop the cost of accessing the medicines that are being researched. Jay Kopelman: Right? You, you would have buy-in from more organizations. You know, you might even have a pharma company that comes into this, you know, look at j and j with the ketamine, right? They have, they have a nasal spray version of ketamine that's doing very well. I mean, it's probably their, their biggest revenue [00:49:00] provider for them right now. Jay Kopelman: And, and so. You know, you, it would certainly help and I think, I think it would lower costs of research to have something rescheduled rather than being schedule one. You know it, people are afraid to take chances when you're talking about Schedule one Melissa Lavasani: labs or they just don't have the money to research things that are on Schedule one. Melissa Lavasani: 'cause there's so much in an incredible amount of red tape that you have to go through and, and your facility has to be a certain way and how you contain those, uh, medicines. Oh, researching has to be in a specific container and it's just very cumbersome to research schedule one drugs. So absolutely the cost would go down. Melissa Lavasani: Um, but Joe Moore: yeah, absolutely. Less safes. Melissa Lavasani: Yeah. Joe Moore: Yes. Less uh, Melissa Lavasani: right. Joe Moore: Locked. Yeah. Um, it'll be really interesting when that happens. I'm gonna hold out faith. That we can see some [00:50:00] movement here. Um, because yeah, like why make healing more expensive than it needs to be? I think like that's potentially a protectionist move. Joe Moore: Like, I'm not, I'm not here yet, but, um, look at AbbVie's, uh, acquisition of the Gilgamesh ip. Mm-hmm. Like that's a really interesting move. I think it was $1.2 billion. Mm-hmm. So they're gonna wanna protect that investment. Um, and it's likely going to be an approved medication. Like, I don't, I don't see a world in which it's not an approved medication. Joe Moore: Um, you know, I don't know a timeline, I would say Jay Kopelman: yeah. Joe Moore: Less than six years, just given how much cash they've got. But who knows, like, I haven't followed it too closely. So, and that's an I bga derivative to be clear, everybody, um mm-hmm. If you're not, um, in, in the loop on that, which is hopeful, you know? Joe Moore: Mm-hmm. But I don't know what the efficacy is gonna be with that compared to Ibogaine and then we have to talk about the kind of proprietary molecule stuff. Um, there's like a whole bunch of things that are gonna go on here, and this is one of the reasons why I'm excited about. Federal involvement [00:51:00] because we might actually be able to have some sort of centralized manufacturer, um, or at least the VA could license three or four generic manufacturers per for instance, and that way prices aren't gonna be, you know, eight grand a dose or whatever. Joe Moore: You know, it's, Jay Kopelman: well, I think it's a very exciting time in the space. You know, I, I think that there's the opportunity for innovation. There is the opportunity for collaboration. There's the opportunity for, you know, long-term healing at a very low cost. You know, that we, we have the highest healthcare cost per capita in the world right here in the us. Jay Kopelman: And, and yet we are not the number one health system in the world. So to me, that doesn't add up. So we need to figure out a way to start. Bringing costs down for a lot of people and [00:52:00] at the same time increasing, increasing outcomes. Joe Moore: Absolutely. Yeah. There's a lot of possible outcome improvements here and, and you know, everything from relapse rates, like we hear often about people leaving a clinic and they go and overdose when they get home. Tragically, too common. I think there's everything from, you know, I'm Jay, I'm involved in an organization called the Psychedelics and Pain Association. Joe Moore: We look at chronic pain very seriously, and IGA is something we are really interested in. And if. We could have better, you know, research, there better outcome measures there. Um, you know, perhaps we can have less people on opioids to begin with from chronic pain conditions. Um, Jay Kopelman: yeah, I, I might be due for another Ibogaine journey then, because I deal with chronic pain from Jiujitsu, but, Joe Moore: oh gosh, let's Jay Kopelman: talk Joe Moore: later. Jay Kopelman: That's self inflicted. Some people would say take a month off, but Melissa Lavasani: yeah, Jay Kopelman: I'm [00:53:00] not, I'm not that smart. Joe Moore: Yeah. Um, but you know, this, uh, yeah, this whole thing is gonna be really interesting to see how it plays out. I'm endlessly hopeful pull because I'm still here. Right. I, I've been at this for almost 10 years now, very publicly, and I think we are seeing a lot of movement. Joe Moore: It's not always what we actually wanna see, but it is movement nonetheless. You know, how many people are writing on this now than there were before? Right. You know, we, we have people in New York Times writing somewhat regularly about psychedelics and. Even international media is covering it. What do we have legalization in Australia somewhat recently for psilocybin and MDMA, Czech Republic. Joe Moore: I think Germany made some moves recently. Mm-hmm. Um, really interesting to see how this is gonna just keep shifting. Um Jay Kopelman: mm-hmm. Joe Moore: And I think there's no way that we're not gonna have prescription psychedelics in three years in the United States. It pro probably more like a [00:54:00] year and a half. I don't know. Do you, are you all taking odds? Melissa Lavasani: Yeah. I mean, I think Jay Kopelman: I, I gotta check Cal sheet, see what they're saying. Melissa Lavasani: I think it's safe to say, I mean, this could even come potentially the end of this year, I think, but definitely by the end of 2027, there's gonna be at least one psychedelic that's FDA approved. Joe Moore: Yeah. Yeah. Melissa Lavasani: If you're not counting Ketamine. Joe Moore: Right. Jay Kopelman: I, I mean, I mean it mm-hmm. It, it doesn't make sense that it. Shouldn't be or wouldn't be. Right. The, we've seen the benefits. Mm-hmm. We know what they are. It's at a very low cost, but you have to keep in mind that these things, they need to be done with the right set setting and container. Right. And, and gotta be able to provide that environment. Jay Kopelman: So, but I would, I would love, like I said, I'd love to work myself out of a job here and see this happen, not just for our veterans, [00:55:00] but for everybody. Joe Moore: Mm-hmm. Um, so Melissa, is there a way people can get involved or follow PMC or how can they support your work at PMC? Melissa Lavasani: Yeah, I mean, follow us in social media. Melissa Lavasani: Um, our two biggest platforms are LinkedIn and Instagram. Um, I'm bringing my newsletter back because I'm realizing, um, you know, there is a big gap in, in kind of like the knowledge of Washington DC just in general. What's happening here, and I think, you know, part of PC's value is that we're, we are plugged into conversations that are being had, um, here in the city. Melissa Lavasani: And, you know, we do get a little insight. Um, and I think that that would really quiet a lot of, you know, the, a lot of noise that, um, exists in the, our ecosystem. If, if people just had some clarity on like, what's actually happening or happening here and what are the opportunities and, [00:56:00] um, where do we need more reinforcement? Melissa Lavasani: Um, and, and also, you know, as we're putting together public education campaign, you know. My, like, if I could get everything I wanted like that, that campaign would be this like multi-stakeholder collaborative effort, right? Where we're covering all the ground that we need to cover. We're talking to the patient groups, we're talking to traditional mental health organizations, we're talking to the medical community, we're talking to the general population. Melissa Lavasani: I think that's like another area that we, we just seem to be, um, lacking some effort in. And, you know, ultimately the veteran story's always super compelling. It pulls on your heartstrings. These are our heroes, um, of our country. Like that, that is, that is meaningful. But a lot of the veteran population is small and we need the, like a, the just.[00:57:00] Melissa Lavasani: Basic American living in middle America, um, understanding what psychedelics are so that in, in, in presenting to them the stories that they can relate to, um, because that's how you activate the public and you activate the public and you get them to see what's happening in these clinical trials, what the data's been saying, what the opportunities are with psychedelics, and then they start calling their members of Congress and saying, Hey, there is this. Melissa Lavasani: Bill sitting in Congress and why haven't you signed onto it? And that political pressure, uh, when used the right way can be really powerful. So, um, I think, you know, now we're at this really amazing moment where we have a good amount of congressional offices that are familiar enough with psychedelics that they're willing to move on it. Melissa Lavasani: Um, there's another larger group, uh, that is familiar with psychedelics and will assist and co-sponsor legislation, but there's still so many offices that we haven't been able to get to just 'cause like we don't have all the time in the world and all the manpower in the world to [00:58:00] do it. But, you know, that is one avenue is like the advocates can speak to the, the lawmakers, the experts speak to the lawmakers, and we not, we want the public engaged in this, you know, ultimately, like that's. Melissa Lavasani: Like the best form of harm reduction is having an informed public. So we are not, they're not seeing these media headlines of like, oh, this miracle cure that, um, saved my family. It's like, yes, that can happen psychedelics. I mean, person speaking personally, psychedelics did save my family. But what you miss out of that story is the incredible amount of work I put into myself and put into my mental health to this day to maintain, um, like myself, my, my own agency and like be the parent that I wanna be and be the spouse that I wanna be. Melissa Lavasani: So, um, we, we need to continue to share these stories and we need to continue to collaborate to get this message out because we're all, we're all in the same boat right now. We all want the same things. We want patients to have safe and [00:59:00] affordable access to psychedelic assisted care. Um, and, uh. We're just in the beginning here, so, um, sign up for our newsletter and we can sign up on our website and then follow us on social media. Melissa Lavasani: And, um, I anticipate more and more events, um, happening with PMC and hopefully we can scale up some of these events to be much more public facing, um, as this issue grows. So, um, I'm really excited about the future and I'm, I've been enjoying this partnership with Mission Within. Jay is such a professional and, and it really shows up when he needs to show up and, um, I look forward to more of that in the future. Joe Moore: Fantastic. And Jay, how can people follow along and support mission within Foundation? Jay Kopelman: Yeah, again, social media is gonna be a good way to do that. So we, we are also pretty heavily engaged on LinkedIn and on Instagram. Um, I do [01:00:00] share, uh, a bit of my own stuff as well. On social media. So we have social media pages for Mission within Foundation, and we have a LinkedIn page for mission within foundation. Jay Kopelman: I have my own profiles on both of those as well where people can follow along. Um, one of the other things you know that would probably help get more attention for this is if the general public was more aware of the numbers of professional athletes who are also now pursuing. I began specifically to help treat their traumatic brain injuries and the chronic traumatic encephalopathy that they've, uh, suffered as a result of their time in professional sports or even college sports. Jay Kopelman: And, you know. I people worship these athletes, and I [01:01:00] think that if more of them, like Robert Gall, were more outspoken about these treatments and the healing properties that they've provided them, that it would get even more attention. Um, I think though what Melissa said, you know, I don't wanna parrot anything she just said because she said it perfectly Right. Jay Kopelman: And I'd just be speaking to hear myself talk. Um, but being collaborative the way that we are with PMC and with Melissa is I think, the way to move the needle on this overall. And like she said, if she could get more groups involved in, in these discussions, it would, it would do wonders for us. Joe Moore: Well, thank you both so much for your hard work out there. I always appreciate it when people are showing up and doing this important, [01:02:00] sometimes boring and tedious, but nevertheless sometimes, sometimes exciting work. And um, so yeah, just thank you both and thank you both for showing up here to psychedelics today to join us and I hope we can continue to support you all in the future. Jay Kopelman: Thank you, Joe. Thank you, Joe. It's a pleasure being with you today and with Melissa, of course, always Melissa Lavasani: appreciate the time and space. Joe Moore: Thanks.  

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

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

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

Re-Release:  On this Live Greatly podcast episode, Kristel Bauer sits down with Joe Kudla, the founder and CEO of Vuori, a performance apparel brand inspired by the active California lifestyle.  Kristel and Joe discuss how and why Vuori got started, the importance of embracing a growth mindset in business and in life, a look into the big lessons Joe has learned from his journey with Vuori and more! Tune in now!  Key Takeaways From This Episode A look into how and why Joe started the performance apparel brand, Vuori How Joe navigates the stress of being a Founder Vuori's Happiness Investment  How Joe uses yoga and breathwork as a stress reliever A big life lesson and a big professional lesson Joe has learned from his time at Vuori Joe's leadership style and how he attracts and keeps top talent at Vuori The importance of embracing a growth minsdet How Joe approaches company culture  The team at Vuori sent Kristel out some complimentary clothing.  About Joe Kudla: Joe Kudla is the founder and CEO of Vuori, a performance apparel brand inspired by the active California lifestyle. A yogi, surfer, outdoorsman and former college athlete, he drew upon his experiences to disrupt the market with A New Perspective on Performance Apparel.  Functional, high‑quality clothing that does not sacrifice style—Built to move in. Styled for life.  Founded in 2015, Vuori received a $400 million investment and $4B valuation from SoftBank Vision Fund 2 in 2021, marking one of the largest investments in a private apparel company. Ernst & Young LLP honored Joe with the Entrepreneur Of The Year® 2022 Pacific Southwest Award. He was also named Glossy's Founder of the Year in 2022.  With a background in accounting, Joe founded the IT consulting firm Vaco SanDiego prior to launching Vuori. Today, he lives in Encinitas, CA with his wife and two children. True to the brand ethos, he still makes time every day to get outside and stay active.  Connect with Vuori Website: https://vuoriclothing.com/  LinkedIn: https://www.linkedin.com/company/vuori-inc-/  Instagram: https://www.instagram.com/vuoriclothing/  Facebook: https://www.facebook.com/vuoriclothing  X: https://twitter.com/vuoriclothing  LinkedIn: https://www.linkedin.com/company/vuori-inc-/  About the Host of the Live Greatly podcast, Kristel Bauer: Book Kristel for Your Event or Team Bring these strategies to your organization:

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

In this Live Greatly 2-Minute Motivation podcast episode, Kristel Bauer shares 1 key to being successful and how you can apply it to iachieve you goals. In just two minutes, wou will learn something that can help you create sustainable success in your work and life.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of significant shifts in the industry, marked by leadership changes, scientific advancements, strategic partnerships, and regulatory challenges.Starting with Sanofi, a notable leadership transition has taken place as Paul Hudson steps down from his role as CEO. Belen Garijo from Merck KGaA has stepped into this pivotal role. Her appointment is part of a broader industry trend toward diversifying leadership, especially with more women leading top-tier pharmaceutical companies. The implications of this shift could be profound for Sanofi, potentially stabilizing its operations and revitalizing its research pipeline. Stakeholders are keenly observing how this new leadership might steer Sanofi through complex market dynamics.In regulatory news, Moderna has encountered a significant hurdle with the FDA declining to review its next-generation mRNA flu vaccine. This decision has sparked an ongoing public dialogue between Moderna and U.S. health regulators, underscoring the complexities involved in navigating regulatory pathways for novel mRNA technologies beyond their initial success with COVID-19 vaccines. The Department of Health and Human Services has supported the FDA's decision, emphasizing the critical importance of meticulous scrutiny when it comes to new vaccine platforms. This development highlights the challenges biotech companies face in ensuring compliance with stringent regulatory standards.Financial updates reveal CSL experiencing a sharp decline in net profits, dropping from $2 billion to $384 million year-over-year. This financial downturn has been linked to strategic missteps or operational inefficiencies within the company, prompting a change in leadership. Such shifts reflect broader challenges faced by companies within the biotech sector as they strive to maintain financial stability amid fluctuating market conditions.In contrast, Alnylam Pharmaceuticals has reported its first profitable year despite underwhelming sales figures for its drug Amvuttra in the ATTR-CM market. This milestone is significant for Alnylam as it demonstrates resilience and the potential to pivot successfully amidst market uncertainties. However, the company will need to remain vigilant about revenue streams and market dynamics moving forward.Turning to advertising strategies, Johnson & Johnson's Tremfya continues to buck industry trends by maintaining a strong presence in television advertising through 2026. This strategy is noteworthy given the general decline in traditional media spending across the industry. J&J's commitment highlights its determination to sustain market share against competitors such as AbbVie's Rinvoq and Skyrizi.On the strategic front, Takeda Pharmaceuticals is consolidating its U.S. operations by reducing its Boston presence. By subleasing over 630,000 square feet of office space, Takeda aims to streamline operations and concentrate resources on key development projects at its new Cambridge hub. This move reflects broader industry trends towards operational efficiency and resource optimization.In clinical advancements, BridgeBio has reached a promising milestone with successful Phase 3 trial results for infigratinib in treating dwarfism. This breakthrough offers new therapeutic options for children affected by this condition and exemplifies ongoing innovations in genetic medicine. The success of this trial positions BridgeBio on a path toward regulatory approval, potentially transforming care for patients with limited treatment options.Agilent has achieved FDA approval for its companion diagnostic test alongside Merck's Keytruda for ovarian cancer treatment. This approval highlights the growing importance of precision medicine in oncology, where tailored treatments based on individual paSupport the show

Last Thursday, Hims & Hers launched a compounded versionof Novo's oral Wegovy, approved just before Christmas and launched in early January. Novo was, not surprisingly, none too pleased. FDA Commissioner Marty Makary denounced“illegal copycat drugs” in an X post the same day without naming Hims, which then said it would notsell the oral weight loss drug. Novo sued the consumer healthcare company for patent infringement, seeking potentially hundreds of millions in damages. Thenit emerged that FDA hit Hims with a warning letter last year about infestations of vermin at a facility it owns, including rodents, birds and insects, as well as a live spider in a production area.The timing of all the Hims drama is interesting, because BioSpace was already covering Novo, Lilly and their blockbuster GLP weight loss drugs as both companies—and others—reported 2025 fourth quarter and full year earnings. EliLilly and Novo both reported last Wednesday, and both spoke of Novo's oral Wegovy launch positively. But the calls had two very different tones, as Lilly beat Q4 2025 analyst consensus by more than a billion dollars while Novo projected sales to decline by 5% in 2026.In other recent earnings calls, AbbVie touted strong Skyriziand Rinvoq sales, and the company continues to follow Johnson & Johnson's lead into the psychedelics space. And Biogen discussed the highly anticipated readout of its tau-targetingtherapy for Alzheimer's.Finally, in gene therapy, Sarepta struggles to recover from last year's patient deaths as other DMD contenders near the market; uniQure pauses two arms of a clinical trial for Fabry disease; and Ultragenyx resubmits its in vivo gene therapy UX111 for the treatment of Sanfilippo syndrome type A.

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

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.

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.

APAC stocks were ultimately mixed as the region partially shrugged off the downbeat handover from Wall Street.NVIDIA (NVDA) AI chip sales to China are reportedly stalled by a US security review, and Chinese customers are, meanwhile, not placing H200 chip orders.US House voted (217-214) to pass the USD 1.2tln spending package to fund the government, which was sent to US President Trump, who then signed the bill to end a partial government shutdown, as expected.US President Trump said they are still negotiating with Iran and that there is more than one meeting with Iran; US military shot down an Iranian surveillance drone that approached a US Navy aircraft carrier in the Arabian Sea.European equity futures indicate a softer cash market open with Euro Stoxx 50 futures down 0.1% after the cash market finished with losses of 0.2% on Tuesday.Looking ahead, highlights include Global Final Composite/Services PMIs (Jan), EZ Flash HICP (Jan), Italian CPI Prelim. (Jan), US ADP (Jan), ISM Services (Jan), Riksbank Minutes (Jan), Treasury Refunding Announcement, NBP Policy Announcement, Comments from Fed's Cook, Supply from Germany & US, Earnings from Alphabet, Arm, Qualcomm, ELF, Snap, Uber, Eli Lilly, AbbVie, CME & Bunge.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

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?

Rafael Ojeda, miembro del Comité de Inversiones de Ursus 3 Capital Agencia de Valores, examina el comportamiento de los índices de Wall Street: AMD, Enphase Energy, Eli Lilly, ABBVie, Uber y Alphabet.

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.

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 latest transformative movements within this dynamic arena, focusing on pivotal acquisitions, technological integrations, and regulatory updates shaping the future of healthcare solutions.Starting with strategic corporate maneuvers, Pfizer recently divested its 11.7% stake in GSK's ViiV Healthcare, a prominent player in HIV treatments. This $1.875 billion sale to Shionogi reflects Pfizer's strategy to offset anticipated revenue declines while fortifying Shionogi's position in the HIV treatment landscape. For GSK, the transaction brings a $250 million special dividend, highlighting competitive realignments as companies optimize portfolios in the lucrative HIV market.In another significant investment, Roche plans a $2 billion expansion at Genentech's North Carolina site to produce next-generation drugs targeting metabolic conditions like obesity. This move aligns with Roche's strategy to capture a growing market segment driven by the rising prevalence of obesity-related health issues globally.Exelixis is aggressively pursuing its ambition to become a top contender in the U.S. solid tumor market. With its flagship drug Cabometyx at the forefront, Exelixis anticipates promising Phase 3 results for new blockbuster candidates, underscoring its robust oncology-focused growth strategy. This field continues to attract substantial investment due to an unmet need for effective cancer therapies.Turning to regulatory landscapes, a landmark decision is anticipated from the U.S. Supreme Court regarding the "skinny label" dispute between Hikma Pharmaceuticals and Amarin over generic Vascepa. This case could reshape patent litigation strategies and impact how generics are marketed against branded drugs, influencing future industry practices.Meanwhile, AbbVie and Genmab face reassessment after their Phase 3 trial for Epkinly in diffuse large B-cell lymphoma failed to meet survival endpoints. This outcome may prompt a strategic pivot towards pipeline diversification or new partnerships in oncology.Valneva recently withdrew its chikungunya vaccine Ixchiq from U.S. consideration following an FDA investigation into adverse events, highlighting the complex regulatory environment surrounding vaccine approvals and safety protocols. In contrast, Bristol Myers Squibb's collaboration with Microsoft aims to expedite lung cancer diagnosis using AI technology, reflecting a broader trend of integrating digital health solutions into drug development and patient care.GSK's acquisition of Rapt Therapeutics for $2.2 billion further emphasizes its commitment to innovative immunotherapies addressing unmet needs in food allergy treatments. This move aligns with trends towards personalized medicine as companies explore novel mechanisms for targeted therapeutic interventions.In scientific breakthroughs, Merck and Moderna report sustained efficacy in their cancer vaccine collaboration, showing a 49% reduction in melanoma risk over five years when combined with Keytruda. This sets a strong precedent for developing combination therapies that enhance long-term cancer treatment outcomes.Pfizer's $530 million agreement with Novavax seeks to leverage adjuvant technology across its vaccine programs, underscoring Pfizer's commitment to innovation amid ongoing competition within the vaccine market.Oncology advancements continue as AstraZeneca secures full rights to an armored CAR-T therapy from Abelzeta for $630 million. Targeting glypican-3 proteins associated with certain cancers, this acquisition highlights AstraZeneca's push into advanced cell therapies that promise revolutionary cancer care solutions.Beyond these corporate strategies, ARPA-H envisions transcending traditional vaccine technologies through innovative solutions that could render vSupport 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 some of the most significant events shaping the industry, from innovative drug formulations and regulatory challenges to the dynamic IPO landscape and clinical trial outcomes.Starting with Novo Nordisk, their oral formulation of Wegovy is witnessing substantial uptake, showcasing a strong demand for novel obesity treatments. This rapid adoption underscores a competitive environment where companies like Eli Lilly, with its Zepbound launch, are vying for market share. The introduction of innovative delivery methods in obesity management not only drives immediate commercial success but also highlights a critical area of therapeutic advancement due to the rising global prevalence of obesity.From a regulatory perspective, alignment with bodies like the FDA remains crucial. Companies such as Beam Therapeutics and Cabaletta Bio emphasize this at events like the J.P. Morgan Healthcare Conference, highlighting the importance of clear regulatory pathways in ensuring the successful approval of promising therapies. Conversely, Atara Biotherapeutics' recent setback with an unexpected FDA rejection demonstrates the unpredictability inherent in regulatory processes, which can significantly impact drug development timelines.The IPO market in biotech remains vibrant despite broader market uncertainties. Noteworthy are Agomab Therapeutics and Spyglass Pharma, each preparing for substantial public offerings. Agomab focuses on ALK5 inhibitors for inflammatory diseases, while Spyglass advances drug delivery implants for chronic eye conditions. This wave of IPOs highlights investor confidence in innovative therapies that address unmet medical needs and reflects a broader trend toward precision medicine and novel treatment modalities.In clinical research, AbbVie and Genmab faced a setback when their bispecific antibody failed to meet a crucial endpoint in a Phase III lymphoma study. Such challenges underscore the high stakes involved in oncology drug development, where successes can significantly alter treatment paradigms, yet failures remind us of the inherent risks.Turning to Alzheimer's disease, there is palpable excitement around next-generation treatments under investigation. These candidates promise to reshape the landscape by offering new hope in a field where effective therapies are desperately needed. This is complemented by advancements in manufacturing capabilities recognized as essential to strategic planning beyond 2026, ensuring that production processes can scale efficiently to meet global demands.On the workforce front, Takeda's decision to reduce its U.S. headcount, impacting its neurology teams, reflects industry trends where resource allocation is increasingly focused on core growth areas. Such strategic recalibrations are part and parcel of navigating competitive pressures and evolving market demands.In another realm, ImmunityBio's Phase 1 results for its CD19 CAR-NK cell therapy offer promising insights into innovative oncology approaches. The use of natural killer cells engineered with chimeric antigen receptors could revolutionize cancer treatment by providing targeted therapeutic options for hematological malignancies and potentially solid tumors.Regulatory approvals also continue to shape industry dynamics. SOBI's Aspaveli receiving EU approval for rare kidney diseases marks significant progress in complement inhibition therapies. Meanwhile, Bayer's Eylea approval for retinal vein occlusion-related visual impairment reinforces the vital role of VEGF inhibitors in ophthalmology.Strategic collaborations are also making headlines, as seen with Abelzeta and AstraZeneca's expanded partnership on GPC3 CAR-T therapy through an acquisition focused on China rights. This move illustrates the global interest inSupport 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 dynamic phase shaping the industry, marked by scientific advancements, regulatory changes, and strategic shifts within major companies.Teva Pharmaceuticals is making significant strides under the leadership of CEO Richard Francis. The company is transitioning from its traditional focus on generic drugs to a more innovative biopharmaceutical approach. This strategic pivot aims to position Teva alongside industry giants in the biopharma sector, highlighting the increasing importance of innovation over generics in today's competitive landscape.Similarly, Fujifilm is enhancing its competitive edge by capitalizing on its biologics capacity. Rather than pursuing large mergers and acquisitions, Fujifilm is focusing on internal growth, underscoring a broader industry trend where companies are investing in organic growth and technological enhancements to maintain their market positions. This shift reflects a growing recognition of the value of leveraging unique facility designs and capabilities to boost production and efficiency.In regulatory news, the U.S. Food and Drug Administration (FDA) has mandated that pharmaceutical companies like Sanofi, GSK, AstraZeneca, and CSL include warnings about febrile seizures on flu vaccine labels. While these seizures are typically brief and harmless, transparent communication is crucial to maintain patient trust in vaccination programs. This regulatory update exemplifies the FDA's proactive efforts to enhance drug safety communications and address potential adverse effects associated with vaccines.The FDA has also issued untitled letters to Beone and ImmunityBio for promotional materials that potentially violated advertising guidelines. This action underscores the agency's vigilance in ensuring pharmaceutical marketing practices meet required standards of accuracy and transparency.Meanwhile, former Emergent BioSolutions CEO Robert Kramer faces insider trading allegations related to the sale of company shares before public disclosure of contamination issues at a production facility. This legal action brings to light ongoing scrutiny within the industry regarding corporate governance and ethical practices.In terms of advertising spending, AbbVie's Skyrizi topped annual TV ad spending charts for pharmaceuticals, closely followed by J&J's Tremfya. This highlights the continued emphasis on direct-to-consumer advertising as companies compete for market share in therapeutic areas.Internationally, companies like AbbVie are making strategic moves into emerging therapeutic spaces such as bispecific antibodies. AbbVie's recent deal to enter the PD-1xVEGF bispecific space signifies a growing interest in novel therapeutic modalities that offer potential breakthroughs in cancer treatment.At the policy level, former President Donald Trump announced "The Great Healthcare Plan," targeting insurance industry reforms and drug pricing. Although specifics remain sparse, this initiative reflects ongoing political discourse around healthcare affordability—a critical issue shaping industry strategies and public expectations.Turning our attention to Vedanta Biosciences, the company is reallocating resources toward its lead live bacteria cocktail program by significantly reducing its workforce. This move highlights growing interest in microbiome-based therapies as a novel approach to treating diseases by modulating gut microbiota. Vedanta's focus could have substantial implications for future therapeutic options, particularly in immune-related conditions.At the J.P. Morgan Healthcare Conference (JPM26), Chugai Pharmaceutical emphasized enhancing its recognition in the U.S. biopharma sector through new scientific avenues. This strategy underscores the importance of innovation and collaboration for Support the show

In Episode 34, Dr. Aly-Khan Lalani and Dr. Christopher Wallis sit down with Dr. Fleshner to explore how an academic surgeon transitioned from traditional clinical and research roles into medical entrepreneurship. From tackling Canada's BCG shortage to co-founding a pharmaceutical company that sold for over a billion dollars, Dr. Fleshner walks through how he has built and scaled successful businesses in medicine.This episode delivers a masterclass on growing your impact beyond the clinic without losing your connection to medicine.The View on GU with Lalani & Wallis integrates key clinical data from major conferences and high impact publications, sharing meaningful take home messages for practising clinicians in the field of genitourinary (GU) cancers. Learn more about The View on GU: theviewongu.caThis podcast has been made possible through unrestricted financial support by AbbVie, Astellas, Ipsen, and Merck.

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 latest innovations, strategic shifts, and regulatory updates shaping the industry.Johnson & Johnson's Tecvayli, a promising monotherapy for multiple myeloma, has shown remarkable efficacy in clinical trials. By reducing the risk of disease progression or death by 71% among patients resistant to anti-CD38 therapies, Tecvayli is setting a new standard in oncological treatment. This breakthrough underscores not only its potential as a standalone therapy but also highlights significant advancements in managing multiple myeloma—a cancer notoriously difficult to treat and manage.In regulatory developments, Sanofi has recently completed pricing negotiations with U.S. policymakers, gaining much-needed clarity on drug pricing regulations. However, Sanofi remains cautious as evolving policies could impact future operations. This scenario is emblematic of the broader industry challenge: navigating an uncertain regulatory landscape while maintaining stability and profitability in volatile markets.Astellas Pharma is adapting to its looming patent cliff for the prostate cancer drug Xtandi by focusing on innovation as a strategy for sustainable growth. With patent protection set to expire next year, Astellas emphasizes innovation over acquisitions for revenue protection, reflecting a broader industry trend towards long-term growth strategies rather than short-term gains.Meanwhile, Jazz Pharmaceuticals has sold a priority review voucher for $200 million, highlighting the persistent value of these vouchers which expedite FDA review processes. Such vouchers are becoming essential strategic assets as companies seek competitive advantages through faster market entry.On the technological front, Becton Dickinson's $110 million investment to expand syringe production capabilities demonstrates efforts to meet rising demand for injectable medications like GLP-1s. This initiative not only addresses immediate supply chain needs but also aligns with broader discussions about reshoring pharmaceutical manufacturing in the U.S., enhancing domestic production capabilities.Financially, strategic trends were a focal point at the recent J.P. Morgan Healthcare Conference. Although large-scale mergers and acquisitions were anticipated, none materialized, suggesting an evolving focus towards strategic partnerships and incremental innovations over mega-mergers among industry stakeholders.Looking ahead, AbbVie's projection of strong growth into the 2030s is driven by a robust pipeline and strategic initiatives. As companies navigate a complex landscape defined by innovation demands and regulatory changes, such outlooks underscore the industry's commitment to sustaining growth and innovation while improving patient outcomes through novel treatments and technologies.Italian pharmaceutical company Alfasigma's acquisition of rights to an injectable treatment for HSV encephalitis from a German biotech firm further exemplifies strategic investments aimed at expanding therapeutic portfolios with innovative solutions addressing critical health needs. This move is significant given the limited therapeutic options available for this severe condition.The Novo Nordisk Foundation's $860 million investment in Denmark's BioInnovation Institute underscores efforts to strengthen local biotech ecosystems. By nurturing homegrown biotech and deep tech companies, this initiative positions Denmark as a prominent hub for research and development while facilitating the translation of scientific discoveries into viable therapeutic solutions.Ocugen's promising mid-phase data for its gene therapy targeting eye disease positions it as a potential competitor against market leaders like Apellis and Astellas. The positive phase 2 results highlight gene therapy's growiSupport the show

On this week's episode, Chris Garabedian, Paul Matteis, Mike Yee, and Sam Fazeli recap the 2026 J.P. Morgan Healthcare Conference, noting that the biotech outlook for 2026 is broadly positive. Investor sentiment is noted as healthy but not overheated, and from the specialist community, the outlook is similarly upbeat. On the venture side, the M&A landscape also looks strong, with one of the best pre‑JPM financing weeks in at least a decade. The conversation turns to company updates, with Alnylam's 2030 strategy as well as Moderna's cost-cutting initiatives and upcoming vaccine readouts. On the deal front, the group covers AbbVie's $650M partnership with China-based RemeGen on a next‑gen PD‑1/VEGF bispecific antibody. AI developments were another key theme at JPM, including Pfizer's claim that AI contributed to $5.6B in cost reductions. In regulatory news, FDA flexibility, new CMC guidance for cell and gene therapies, and updates on Dr. Makary's CNPVs are overviewed. Next, the co-hosts cover the latest obesity news, including new oral GLP-1s and potential competition from Pfizer and Amgen in the monthly injectables market, as well as BMS and AbbVie's interest in entering the space. The episode concludes with rapid‑fire round of data updates in DMD, gene therapy, myeloma, cystic fibrosis, and Alzheimer's prevention. *This episode aired on January 16, 2026.

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 landscape marked by rapid transformations and strategic maneuvers that are reshaping the industry.Novo Nordisk is at a pivotal point under the leadership of CEO Maziar Mike Doustdar. The company is navigating a significant transition, focusing on reclaiming its leadership in the glucagon-like peptide-1 (GLP-1) market. This is crucial as GLP-1 receptor agonists are central to diabetes and obesity treatments, areas where Novo Nordisk aims to solidify its presence amidst fierce competition.AstraZeneca is setting ambitious targets, aiming for $80 billion in revenue by 2030. Their confidence is buoyed by strong Phase 3 clinical trial performances, particularly in oncology and rare diseases, underscoring the importance of a robust and successful pipeline. AstraZeneca's acquisition of Modella AI marks an integration of advanced AI models into oncology R&D operations, aligning with industry trends leveraging AI for drug discovery processes. By incorporating AI technologies, AstraZeneca aims to revolutionize precision medicine approaches within oncology treatments.Travere Therapeutics finds itself at a critical juncture with the FDA's delayed decision on Filspari (sparsentan) for focal segmental glomerulosclerosis (FSGS). This potential approval could tap into a significant market opportunity, but the delay highlights regulatory challenges that can impact timelines and revenue forecasts.Gilead Sciences continues to strengthen its position in HIV treatment with lenacapavir's approval for bi-annual dosing. This advancement not only enhances patient compliance but also positions Gilead advantageously for strategic partnerships. Their strategic positioning post-approval of lenacapavir for HIV prevention marks a milestone, emphasizing innovation's role in drug formulations.Leo Pharma's pursuit of partnerships in rare dermatological diseases reflects a broader trend towards specialization and diversification into niche markets. Meanwhile, Ionis Pharmaceuticals is gearing up to launch Tryngolza (olezarsen) for new indications, doubling their sales projections and demonstrating confidence in their RNA-targeted therapy.Caldera's emergence with significant funding points to ongoing investor interest in innovative biotech ventures, particularly those involving cross-border collaborations like their licensed drug from China for inflammatory bowel disease. Cross-border collaborations such as Caldera's venture into inflammatory bowel disease treatments are becoming more prevalent, integrating innovations from different regions to accelerate novel therapy availability for complex diseases.Illumina's efforts to navigate export challenges with China highlight geopolitical factors influencing biotech operations and global supply chains. They are actively working to stabilize their business environment while supporting academic research initiatives. Illumina's collaboration efforts with China amidst geopolitical tensions further demonstrate complexities within international trade relations affecting scientific collaborations.The American Medical Association's investment in "precision education" using data analytics exemplifies how technology is reshaping healthcare education and practice, aiming to enhance outcomes by tailoring learning experiences.AbbVie has committed $100 billion to U.S. research and development over the next decade, focusing on biologics and autoimmune disorders. This substantial investment underscores their commitment to innovation while seeking competitive edge enhancements through tariff exemptions.On clinical fronts, significant advancements are being made in therapies targeting rare diseases such as Sentynl Therapeutics' FDA approval for Zycubo—a novel protein therapy addressing Menkes disease—highlightSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. This morning, we're diving into a series of fascinating updates that underline the vibrant and ever-changing landscape of our industry.The J.P. Morgan Healthcare Conference recently set the stage for some intriguing discussions, particularly from Novo Nordisk. The company is diversifying its metabolic drug development portfolio by exploring innovative avenues, reflecting a broader industry trend where firms seek to balance their core expertise with novel therapeutic areas. This strategic diversification is crucial as companies aim to address complex health issues with an expansive approach to innovation. Novo Nordisk's leadership emphasized this strategic pivot towards diversifying their innovation pipeline beyond traditional metabolic disorders, aiming to keep the company at the forefront of pharmaceutical advancements.Meanwhile, Takeda's R&D head, Andy Plump, brought attention to some challenges currently facing U.S. innovation. Despite a sluggish start at the conference, recent months have been buzzing with significant deal-making activities. This scenario highlights the delicate dance between maintaining steady innovation and navigating regulatory hurdles and economic pressures. However, optimism remains high, with strategic investments and collaborations seen as potential catalysts for rejuvenation in research.Amgen made waves by presenting promising results from an exploratory study of Maritide in weight loss maintenance. The study's outcomes signal a significant milestone in obesity management and set the stage for further clinical trials and potential approval processes. This advancement offers hope in addressing what remains a critical public health issue worldwide.A significant development at the National Institutes of Health (NIH) is the leadership change as Dr. Gary Gibbons steps down as Director of the Heart, Lung, and Blood Institute. This shift adds to a growing list of interim leadership roles across NIH's 27 institutes and centers, which could impact continuity in critical research projects and funding initiatives.On the corporate front, Sonoma Pharmaceuticals announced notable workforce reductions due to financial challenges, while Lyra Therapeutics decided to abandon its rhinosinusitis treatment project alongside laying off its entire team. These decisions highlight the financial volatility that smaller biotech firms face amid competitive pressures and regulatory complexities. In contrast, Pretzel Therapeutics has emerged successfully from turbulent times, demonstrating resilience and adaptability within the biotech sector. Strategic restructuring and leadership realignment have positioned Pretzel Therapeutics for future growth in therapeutic development.A major highlight involves AbbVie entering into an agreement with the White House to reduce Medicaid drug prices while committing a substantial $100 billion investment in U.S. R&D over the next decade. This aligns with broader efforts to make healthcare more affordable while encouraging domestic pharmaceutical investment. AbbVie's substantial commitment towards U.S. R&D speaks volumes about their strategy within TrumpRx program contexts that aim at enhancing market penetration while balancing innovation investment against cost management pressures.Medtronic has expressed readiness to engage in mergers and acquisitions, indicating that medtech companies are poised for expansion through strategic buyouts. This move reflects an industry-wide capacity for growth through consolidation and collaboration. As we look towards mergers and acquisitions within medtech highlighted by Medtronic's intentions, it's clear that strategic M&A activities remain vital for companies seeking to expand capabilities and market presence in this competitive landscape.The FDA has aSupport the show

AbbVie bet nearly $5 billion for the ex-China rights to RemeGen's PD-1/VEGF bispecific and Novartis struck a $1.5 billion Alzheimer's-focused deal with China-based SciNeuro Pharmaceuticals as the 2026 J.P. Morgan Healthcare Conference got underway on Monday. These and other recent tie-ups speak to the therapeutic trends predicted to be hot this year by experts who spoke with BioSpace, who particularly noted that cancer and neuroscience would remain top of the list.  Meanwhile, attendees are still waiting for that “one big M&A deal.” Could it come from Merck? CEO Rob Davis expressed high confidence during the company's JPM presentation on Monday, revealing that Merck is open to deals in the range of “multi tens of billions of dollars.” On the weight loss front, Eli Lilly and Novo Nordisk both updated attendees on the state of play, with Lilly expressingconfidence in its supply chain to support the launch of obesity pill orforglipron and Novo continuing to lament the business it is still losing to compounders.  Just in time for JPM, the IPO window cracked open, with Aktis Oncology debuting on the public markets last week and Veradermics and Eikon Therapeutics announcing their bids to follow suit. A similar thaw occurred last year before the window slammed shut again as myriad policy changes frightened investors. How will this year play out?  2025 had its challenges, especially on the policy front. In his annual letter, Flagship CEO Noubar Afeyan cited “growing contempt” in the U.S. for the scientific method and arapidly emerging Chinese biopharma ecosystem among the greatest challenges facing the industry. And while the funding may now be flowing, it still favors later-stage companies. A .J.P. Morgan report released prior to the conference showed VC funding was down across the board last year, but especially for biotechs recruiting early rounds.  Finally, while JPM is the primary focus, the FDA hasn't taken the week off. Just prior to recording, the regulator requestedthat Lilly and Novo remove the suicide warning from the labels of certain GLP-1 medications after a comprehensive review found no increased risk of suicidal ideation and behavior with these drugs. On the policy front, the FDA continued its quest to accelerate the development of cell and gene therapies with new manufacturing exemptions.  The regulator also took action on two applications this week, approving a rare disease drug developed by Sentynl Therapeutics and Fortress Biotech and denying a cell therapy submitted by Atara Biotherapeutics. To learn about key upcoming FDA action, check out 6 FDA Decisions To Watch in Q1 2026 in ClinicaSpace this week.

Illinois said it was all in on cannabis equity. Crain's reporter John Schroyer talks with host Amy Guth about where it stands on that promise.Plus: Illinois and Chicago seek court order to halt "militarized" immigration enforcement tactics, AbbVie pledges $100 billion U.S. investment to avoid tariffs, longtime Loop Alliance CEO to step down and Chicago's largest farmers market organizer bought a permanent brick-and-mortar home. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Riding the tailwind of a strong 2H25, the days leading up to biotech's annual kickoff meeting in San Francisco delivered billions in capital raised and more than two dozen deals announced. On the latest BioCentury This Week podcast, BioCentury's analysts discuss two of the largest deals announced at the start of the J.P. Morgan Healthcare Conference, a partnership for a bispecific between AbbVie and RemeGen and the launch of “NewCo” AirNexus Therapeutics by Haisco Pharmaceutical and a syndicate led by Frazier Life Sciences.The analysts also discuss Washington Editor Steve Usdin's policy outlook for the year ahead, and Executive Director of Biopharma Intelligence Lauren Martz's analysis of trends in FDA's 2025 approvals.View full story: https://www.biocentury.com/article/658052#JPMHealthcare #BiotechFinancing #BiopharmaPartnerships #FDAApprovals #BiotechPolicy00:00 - Introduction01:55 - JPM Deals11:49 - Policy Outlook19:30 - Trends in Drug ApprovalsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant events and trends reshaping the industry landscape as we approach 2026. The pharmaceutical and biotech sectors are navigating a transformative period marked by scientific advancements, evolving regulatory frameworks, and strategic partnerships.Starting with a shift towards bolstering drug pipelines, mergers and acquisitions (M&A) have gained momentum. In 2025, this trend was largely fueled by impending patent expirations and an optimistic investment climate within biotech. Pharmaceutical companies are strategically pursuing these opportunities to enhance their innovation capabilities, positioning themselves effectively against competitive pressures. AbbVie's recent $5.6 billion agreement with RemeGen is a testament to this strategy. By entering the PD-1xVEGF bispecific antibody market, AbbVie aims to establish a foothold in a promising area of cancer therapeutics. This investment highlights the growing interest in bispecific antibodies due to their dual-targeting potential, offering enhanced treatment efficacy by simultaneously addressing two cancer pathways.Meanwhile, Eli Lilly's collaboration with Nvidia demonstrates the increasing integration of artificial intelligence (AI) in drug discovery. Their $1 billion co-innovation lab investment aims to harness AI technologies to accelerate new therapy development and refine precision medicine approaches. This partnership exemplifies the transformative potential of AI in optimizing research productivity across the industry.On the regulatory front, Atara Biotherapeutics and Pierre Fabre Pharmaceuticals faced challenges with their EBVallo product. The FDA's repeated rejection of this product underscores the intricate regulatory landscape biopharmaceutical companies must navigate. This situation highlights the necessity for clear communication between industry players and regulatory bodies to ensure innovative therapies reach patients needing them most.In clinical development, Bristol Myers Squibb's Camzyos is set for expansion following successful trials in adolescent patients with cardiomyopathy. This advancement signifies a crucial step towards making advanced therapies available to broader patient demographics, potentially transforming cardiology care.Investment in infrastructure remains a priority as AbbVie announces a $175 million development of a new drug-device plant in Arizona. This move aligns with their broader commitment to invest $10 billion into U.S. operations by 2035, underlining the importance of enhancing manufacturing capabilities and securing supply chains in a globalized market.Additionally, Teva's financial maneuvering with Royalty Pharma illustrates how biopharma firms support clinical advancements through strategic funding partnerships. By securing up to $500 million for its vitiligo drug development, Teva highlights the critical role of financial collaborations in advancing therapeutic innovations.All these developments occur amid concerns about potential governmental threats to scientific integrity within the U.S. biotech industry. Flagship Pioneering's CEO warns that policy changes could undermine fundamental scientific principles, potentially hindering innovation and progress within the sector.As we transition into 2026, there's renewed optimism within biopharma driven by increased investor interest and robust R&D initiatives. This resurgence is expected to be a focal point at upcoming conferences like JPM26, where discussions on policy and political influences on drug pricing will be pivotal.In oncology, Merck & Co.'s rumored acquisition of Revolution Medicines could signal an aggressive expansion of its oncology portfolio. This potential transaction would underscore Merck's strategic focus on small moleSupport the show

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

On this week's episode, Sam Fazeli, Paul Matteis, Brian Skorney, and Tess Cameron discuss biotech market sentiment and the sector's strong momentum heading into JPM and 2026, with expectations for increased M&A activity. They note that companies showing strong fundamentals have been rewarded, while policy uncertainty remains a risk. The group also overviews the HHS decision to revise pediatric vaccine recommendations -- removing 17 of the 11 previously recommended shots -- and its potential impact on public health and the sector. The conversation shifts to the first IPO of 2026: Lilly-backed Aktis Oncology, which raised $318M. The co-hosts then discuss rumors of AbbVie or Merck purchasing Revolution Medicines, with Merck potentially paying $32B -- a positive sign for industry deal-making. On the data front, Zenas Biopharma's Phase 3 trial of obexelimab for IgG4-RD met its primary endpoint, while Ultragenyx shared updates on setrusumab for Osteogenesis Imperfecta. The group also highlighted Neumora's Phase 1b Alzheimer's agitation results, noting cautious optimism. The episode closes with discussion on late-stage success for Alumis' envudeucitinib in plaque psoriasis and obesity updates, including Novo Nordisk's oral GLP-1 pill and Arrowhead's significant raise. *This episode aired January 9, 2026. 

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Holger Zschäpitz über den 25.000-Punkte-Triumph beim Dax, Trumps Zorn über die Rüstungsbranche und eine wagemutige Berkshire-Kopie. Außerdem geht es um Nvidia, Intel, AMD, Qualcomm, Siemens, Mercedes, Hyundai, Chubb, Progressive, Union Pacific, NextEra, State Street Industrial Select SPDR ETF (WKN: A14QB3), GE Aerospace, Caterpillar und RTX, Apple, Alphabet, Coca-Cola, Bank of America, American Express, Blackstone, Invitation Homes, Chevron, Nvidia, Taiwan Semiconductor Manufacturing Company, AbbVie, Revolution Medicines, CoreWeave, CrowdStrike, Kratos Defense & Security Solutions, AeroVironment, Rocket Lab, SAP, Yaskawa Electric, Serve Robotics, Hesai, Doosan, FANUC, UiPath, Pony.ai, ABB, Intuitive Surgical, Teradyne, Aptiv, Jungheinrich, ARK Artificial Intelligence & Robotics ETF (WKN: A408AX), iShares Automation & Robotics ETF (WKN: A2ANH0), Global X Robotics & Artificial Intelligence ETF (WKN: A2QPBW), Amundi MSCI Robotics & AI ETF (WKN: A2JSC9), L&G ROBO Global Robotics and Automation ETF (WKN: A12DB1), VanEck Medical Robotics and Bionic Engineering UCITS ETF (WKN: A3DT2R), Amundi NYSE Arca Gold BUGS (WKN: ETF191) 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

In this episode, we'll explore emerging strategies to enhance recovery after stroke. Stroke rehabilitation has long relied on physical, occupational, and speech therapy, but advances in neuroscience are opening new opportunities to directly modulate brain networks, promote plasticity, and hopefully help patients regain function. Dr. Sean Dukelow's work focuses on neurorehabilitation and the mechanisms of recovery after stroke. He's a professor and head of Physical Medicine and Rehabilitation in the Department of Clinical Neurosciences at the University of Calgary. Dr. Dukelow was interviewed by Dr. Cheran Elangovan, vascular neurologist at University of Tennessee Health Science Center. Series 7, Episode 3  Disclosures: Dr. Dukelow serves on the advisory board for Merz and Ipsen, provides consultation for AbbVie, receives speaker fees from Merz

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/JZU865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 18, 2026.Addressing un-MET Needs in NSCLC: Elevating MET-Targeting Options for Patients With a Poor Prognosis In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and MET Crusaders. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from AbbVie.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/JZU865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 18, 2026.Addressing un-MET Needs in NSCLC: Elevating MET-Targeting Options for Patients With a Poor Prognosis In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and MET Crusaders. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from AbbVie.Disclosure information is available at the beginning of the video presentation.

Botox is the most popular procedure in all of cosmetic surgery.  About 10 million people in the US have Botox every year.  While the term "Botox" has become a generic term, there's actually 6 drugs that have Botox like effects - Xeomin, Dysport, Jeuveux, Daxxify, and Letybo are the others.  These drugs all work basically the same way.  But now Abbvie, the company that markets Botox, has applied to the FDA for approval of a new short acting Botox-like drug.  This one, called TrenibotulinumtoxinE (TrenibotE), works within hours (not days), but only lasts 2-3 weeks (instead of 3-4 months).  The only way this one makes sense to me is to mix TrenibotE with Botox to create a hybrid drug that works immediately and lasts 4 months.  But I would expect the costs to be significantly higher than either drug alone.  Watch for this combo in 2026! And listen to this show for the advance notice on the newest advances in cosmetic surgery.

In this episode of "Discovering Grayslake," recorded at The Loop Marketing, the hosts welcome Jennifer Everett, president of Foundation 46 and a Grayslake Middle School reading specialist. Jennifer shares how Foundation 46 supports local teachers and students through flexible grants, fundraising events like Barn Fest, and community activities such as school scavenger hunts. The conversation highlights the importance of community involvement, employer donation matching, and volunteering. Listeners are encouraged to attend events, apply for grants, and help spread the word, all working together to strengthen Grayslake's hometown spirit and support its schools. How Foundation 46 Empowers Grayslake: A Deep Dive into Community-Driven Educational Support Grayslake is more than just a town—it's a community where neighbors look out for each other, and where local organizations like Foundation 46 are making a real difference in the lives of teachers, students, and families. In a recent episode of the "Discovering Grayslake" podcast, recorded at The Loop Marketing at the end of Center Street and Lake, we sat down with Jennifer Everett, a seventh-grade reading specialist at Grayslake Middle School and the current president of Foundation 46. Jennifer, along with our hosts, shared invaluable insights into how Foundation 46 operates, the impact it has, and how every community member can get involved. This blog post unpacks the main themes and actionable tips from the episode, offering a comprehensive guide for anyone interested in supporting education in Grayslake. Whether you're a teacher, parent, business owner, or simply a neighbor who cares, there's a role for you in this hometown effort. What is Foundation 46? Foundation 46 is a local nonprofit dedicated to supporting teachers and students in Grayslake's District 46. Through grants, fundraising events, and community partnerships, the foundation provides resources and opportunities that go beyond what the school budget can cover. Their mission is simple: empower educators, enrich student experiences, and strengthen the community. 1. Flexible, Teacher-Friendly Grants: Fueling Creativity in the Classroom How the Grant Program Works One of the standout features of Foundation 46 is its open, rolling grant application process. Unlike many grant programs that have rigid deadlines, Foundation 46 allows teachers to apply whenever inspiration strikes. Applications are reviewed monthly, making it easier for busy educators to access funding when they need it most. Types of Grants: Project Grants:** $500–$1,000 for classroom projects, materials, or programs. Impact Grants:** Over $1,000 for larger, collaborative, or cross-school initiatives. Application Process: Teachers submit a Google Form detailing their project, its goals, and the number of students impacted. The Foundation uses a rubric to ensure fair, transparent evaluation. If more information is needed, teachers are encouraged to revise and resubmit—Foundation 46 is committed to helping ideas succeed, not just rubber-stamping or rejecting applications. Actionable Tips for Teachers Don't Wait for the "Perfect" Idea:** If you see a need in your classroom, apply! The process is designed to be supportive, not intimidating. Collaborate Across Schools:** Projects that benefit multiple classrooms or schools are especially encouraged. Think Beyond Supplies:** Past grants have funded everything from sensory kits and STEM materials to author visits and family reading nights. Reapply if Needed:** If your application isn't approved the first time, use the feedback to strengthen your proposal and try again. Expert Insight Jennifer Everett emphasizes, "We want to say yes. If you have a creative idea that will benefit students, we're here to help you make it happen." 2. Fundraising with Heart: Barn Fest and Beyond Barn Fest: The Signature Event Barn Fest is Foundation 46's biggest annual fundraiser, held at Jessie Oaks. It's an adult-only evening packed with fun—think mechanical bull rides, live music from Stu the Piano Guy, games, drink specials, and both live and silent auctions. The event is more than just a party; it's a chance for the whole community to rally behind local schools. Key Features: Affordable Tickets:** $25 for teachers, $40 for community members (includes dinner). Community Awards:** The Tom Mescal Award honors outstanding contributors. Unique Auction Items:** From rides in fire trucks to airplane experiences, the auction is always a highlight. Themed Fun:** This year's "Denim and Diamonds" theme blends country charm with a touch of sparkle. Other Fundraising Initiatives Dine-In Shares:** Local restaurants like The Vine and Black Lung host special nights where a portion of proceeds goes to Foundation 46. Scavenger Hunts:** Family-friendly events at local schools encourage exploration and community spirit. Sponsorships:** Local businesses can sponsor events or donate auction items, gaining visibility and goodwill. Actionable Tips for Community Members Attend Events:** Your ticket directly supports grants for teachers. Donate Auction Items:** Unique experiences or services are always in demand. Sponsor a Fundraiser:** Businesses can make a big impact and connect with local families. Host a Dine-In Share:** Restaurant owners, consider partnering with Foundation 46 for a win-win event. Expert Insight Jennifer notes, "We want Barn Fest to be a celebration for everyone, not just teachers. The more the community gets involved, the more we can do for our schools." 3. Maximizing Impact: Employer Matching and Volunteer Power Employer Matching: Double (or Triple) Your Donation Many local companies—including AbbVie, Allstate, Cardinal Health, CDW, First Midwest Bank, Granger, Kraft, Discover, and Motorola—offer matching gift programs. This means your donation to Foundation 46 could be doubled or even tripled, at no extra cost to you. How to Take Advantage: Check with HR:** Ask your employer if they match charitable donations. Submit Your Receipt:** Even event tickets may qualify as a donation. Spread the Word:** Encourage coworkers to participate. Real-World Example: At last year's Barn Fest, a $1,000 donation was matched by Granger, resulting in a $3,000–$4,000 total impact. Volunteering: The Heartbeat of Foundation 46 Like many nonprofits, Foundation 46 relies on a core group of dedicated volunteers—but they're always looking for more hands and fresh ideas. Ways to Volunteer: Join the Board:** Meetings are open to the public, held the first Thursday of each month at Frederick School's Falcon Room. Help at Events:** From setup to auction management, there's a role for everyone. Spread the Word:** Share Foundation 46's mission on social media or within your school community. Jennifer's Wish: "If even a small percentage of our 500 district employees volunteered, we'd have an incredible team. Every bit helps." 4. Expanding the Mission: Scholarships and Community Engagement New Initiatives: Student Scholarships Starting in 2026, Foundation 46 plans to offer student scholarships to help cover costs like sports fees for families in need. This expansion reflects a commitment to supporting not just teachers, but students and their families as well. Community-Building Activities School Scavenger Hunts:** Inspired by Jennifer's own experiences, these events encourage families to explore local schools and connect with each other. Family Reading Nights and Author Visits:** Funded by grants, these programs foster a love of learning and bring the community together. Actionable Tips for Families Participate in Events:** Bring your family to scavenger hunts and reading nights. Apply for Scholarships:** If you need help with extracurricular costs, watch for upcoming opportunities. Stay Informed:** Follow Foundation 46 on social media and sign up for newsletters. 5. How to Get Involved: Your Next Steps For Teachers: Apply for a grant—no idea is too small or too big. Collaborate with colleagues for cross-school projects. For Parents and Community Members: Attend Barn Fest and other events. Volunteer your time or skills. Donate or secure auction items. Check if your employer offers matching gifts. For Local Businesses: Sponsor an event or donate services. Host a dine-in share night. For Everyone: Share Foundation 46's mission on social media. Encourage friends and neighbors to get involved. Attend a board meeting to learn more. Contact Information: Email:** foundation46board@gmail.com Website:** foundation46.org Final Thoughts: Small Actions, Big Impact As Jennifer and the podcast hosts remind us, supporting local schools is a community effort. Whether you're donating, volunteering, or simply spreading the word, every action counts. In the words of our host, "Do one or two random acts of kindness each day—especially during the holiday season. Together, we can make Grayslake an even better place to live, learn, and grow." Subscribe to "Discovering Grayslake" on your favorite platform to stay updated on local stories and opportunities to get involved. Let's keep the hometown spirit alive—support Foundation 46 and help Grayslake's students and teachers thrive!

GUEST BIO:Kate Lopatowski has over 25 years executing successful large-scale meetings and events for Fortune 500 companies including AbbVie, McDonald's, Intel, and Cadillac. With a degree in television production and broadcast news background, she specializes in live events. Her positive attitude, professionalism, and interpersonal communication skills create productive working relationships with clients and crews alike.  HIRE THEM TO SPEAK:Follow Kate Lopatowski: LinkedIn ProfileFollow Scott Bloom: eSpeakers BioFollow eSpeakers: eSpeakers Marketplace  ABOUT NO MORE BAD EVENTS:Brought to you by eSpeakers and hosted by professional emcee, host, and keynote speaker Scott Bloom, No More Bad Events is where you'll hear from some of the top names in the event and speaking industry about what goes on behind the scenes at the world's most perfectly executed conferences, meetings, and more. Get ready to learn the secrets and strategies to help anyone in the event industry reach their goal of putting on nothing less than world-class events.Learn more at nomorebadevents.com.  ABOUT THE HOST:A veteran comedian and television personality who has built a reputation as the go-to choice for business humor, Scott has hosted hundreds of events over two decades for big and small organizations alike. Scott has also hosted his own weekly VH1 series and recently co-hosted a national simulcast of the Grammy Awards from the Palace Theater.As the son of a successful salesman, he was exposed to the principles of building a business at an early age. As a comedian, Scott cut his teeth at renowned improv and comedy clubs. As a self-taught student of psychology, he's explored what makes people tick and has written a book (albeit a farce) on how to get through life. He's uniquely positioned to deliver significant notes on connecting people and making business seriously funny. And who doesn't like to laugh?Learn more about Scott: scottbloomconnects.com PRODUCED BY eSpeakers:When the perfect speaker is in front of the right audience, a kind of magic happens where organizations and individuals improve in substantial, long-term ways. eSpeakers exists to make this happen more often.eSpeakers is where the speaking industry does business on the web. Speakers, speaker managers, associations, and bureaus use our tools to organize, promote, and grow successful businesses. Event organizers think of eSpeakers first when they want to hire speakers for their meetings or events.The eSpeakers Marketplace technology lets us and our partner directories help meeting professionals worldwide connect directly with speakers for great engagements.Thousands of successful speakers, trainers, and coaches use eSpeakers to build their businesses and manage their calendars. Thousands of event organizers use our directories every day to find and hire speakers. Our tools are built for speakers, by speakers, to do things that only purpose-built systems can.Learn more at eSpeakers.com. SHOW CREDITS:Scott Bloom: Host | scottbloomconnects.comJoe Heaps: eSpeakers | jheaps@eSpeakers.com

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

Crain's residential real estate reporter Dennis Rodkin talks with host Amy Guth about the dual markets in the Chicago area, with one soaring as the other stays flat.Plus: CTU to turn over financial audits to congressional committee, Medicare negotiates discounts on two AbbVie drugs, Thoma Bravo's Realpage settles DOJ rental collusion case and Abbott to replace glucose monitors after deaths possibly linked to false readings. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

We love to hear from our listeners. Send us a message. On this week's episode, Cyril Konto, M.D., president, executive director, and CEO at Ichnos Glenmark Innovation (IGI) talks about the promise of multi-specific antibodies, funding the company during the 'biotech winter,' closing a $700 million upfront licensing deal with AbbVie, the impact of China's rising biotech sector, and the keys to successful collaboration. Cyril also discusses IGI's focus on developing innovative therapies for emerging markets, and the shift from animal models to in silico modeling in preclinical research.   Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

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

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