Podcasts about Sanofi

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

Hey Diabuddy thank you for listening to show, send me some positive vibes with your favorite part of this episode.In Episode 331 of The Healthy Diabetic Podcast, Coach Ken is joined by Graham Hubbard for Episode 003 of the live show, where they dive into how people with diabetes actually make decisions—and why some of the most common metrics may be missing the bigger picture.The conversation covers Time in Range vs A1C, redefining what a personal blood sugar “target” really means, and why stability and variability matter more than chasing perfect numbers. Ken also shares real-world insights on Afrezza, insurance challenges, CGM access, early screening for Type 1 diabetes, and the pros and cons of modern intervention strategies.This episode is raw, honest, and full of practical perspective—exactly what this new live format is designed to deliver.

Every clinical setback carries lessons. That’s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead. The 2025 edition of Fierce Biotech’s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry’s most ambitious late-stage programs now sit inside big pharma portfolios. On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development. To learn more about the topics in this episode: 2025's top 10 clinical trial flops Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma See omnystudio.com/listener for privacy information.

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

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

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

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/FTW865. CME/MOC/AAPA/IPCE credit will be available until January 25, 2027.ECHOing Innovation in COPD: Transforming Patient Care With the Use of Targeted Biologic Therapy In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.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/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/FTW865. CME/MOC/AAPA/IPCE credit will be available until January 25, 2027.ECHOing Innovation in COPD: Transforming Patient Care With the Use of Targeted Biologic Therapy In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.Disclosure information is available at the beginning of the video presentation.

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 insightful updates that highlight the dynamic and rapidly evolving nature of these sectors, driven by scientific advancements, regulatory shifts, and strategic industry maneuvers.Starting with Merck, which is strategically planning for a post-Keytruda era, projecting over $70 billion in annual opportunities over the next decade. With Keytruda's patent expiration looming in 2028, Merck is actively expanding its portfolio through acquisitions and partnerships, focusing on oncology and immunology. These areas have been significantly impacted by Keytruda's success, and Merck's proactive approach aims to sustain growth and innovation beyond its current flagship product. During their 2025 full-year earnings call, CEO Robert Davis emphasized their expansive pipeline, highlighting recent strategic deals as pivotal to Merck's robust pipeline—the broadest it has been in years—signaling long-term growth through diversified therapeutic areas and innovative drug candidates.The U.S. Food and Drug Administration (FDA) is making waves with its regulatory approach to CAR-T cell therapies for autoimmune diseases. This shift reflects an increasing recognition of the potential these therapies hold for transforming treatment paradigms for conditions like lupus and multiple sclerosis. By offering a more flexible regulatory framework, the FDA is encouraging innovation while maintaining a focus on patient safety.In other regulatory news, AstraZeneca faces a setback with the FDA's rejection of its subcutaneous version of Saphnelo for lupus. The decision underscores the challenges associated with developing more patient-friendly administration methods for biologics. However, AstraZeneca remains optimistic about achieving a quick turnaround in the approval process, which could enhance patient adherence by offering a self-administered alternative to intravenous infusions.Sanofi finds itself in the spotlight after CEO Paul Hudson was sanctioned by the UK's Prescription Medicines Code of Practice Authority for making overly ambitious claims about Pfizer's RSV vaccine. This incident illustrates the competitive nature of vaccine procurement and underscores the importance of accurate communication by pharmaceutical leaders.In Massachusetts, Thermo Fisher Scientific is reducing its workforce with the closure of its Franklin site, impacting around 200 employees. This move is part of broader strategic realignments within the industry aimed at optimizing operations and focusing resources on high-growth areas.Acadia Pharmaceuticals faces potential rejection by the European Union for its drug trofinetide intended for Rett syndrome. This highlights ongoing challenges in gaining approval for treatments targeting rare diseases, despite their significant unmet needs.Meanwhile, GSK plans to lay off up to 350 R&D workers across the U.S. and UK as part of efforts to streamline operations and focus on core therapeutic areas. Such layoffs reflect broader industry trends toward consolidation and efficiency amid rising R&D costs.On a more promising note, Pfizer's GLP-1 receptor agonist has demonstrated significant results in a Phase 2b trial for weight loss, validating their substantial investment in this area. The drug's potential to offer competitive weight loss results with monthly dosing positions it as a strong contender in the obesity treatment market. Additionally, Pfizer continues to accelerate its efforts in obesity treatment with promising mid-stage trial results for PF-3944, showing up to a 12.3% weight loss at 28 weeks. This suggests Pfizer is keen on expanding its presence in obesity management through strategic clinical development as competition within this therapeutic area intensifies.The U.S. Department of Health and HumanSupport the show

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/FTW865. CME/MOC/AAPA/IPCE credit will be available until January 25, 2027.ECHOing Innovation in COPD: Transforming Patient Care With the Use of Targeted Biologic Therapy In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.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/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/FTW865. CME/MOC/AAPA/IPCE credit will be available until January 25, 2027.ECHOing Innovation in COPD: Transforming Patient Care With the Use of Targeted Biologic Therapy In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.Disclosure information is available at the beginning of the video presentation.

After 25 years at L'Oréal, Vanessa Clemendot made the leap from beauty to biopharma – and into a workforce being redefined by AI. Now SVP, Global Supply Chain at Sanofi, Vanessa sits down with Caroline Chumakov, Principal, Research at Zero100, to unpack the shift from siloed execution to cross-functional orchestration, the rise of judgment over computation as agents handle the heavy lifting, and why data literacy is now table stakes.Vanessa Clemendot's career across 25 years, 10+ roles, and 3 continents (00:55) The first 90 days at Sanofi (03:58) Working with AI: where computation ends and judgment begins (06:12) Who owns the tech stack? It's not one team (09:34)One dataset + real time decisions = planning in orchestration (11:23) M&A and divestitures across newly split supply chains (13:55) Day one advice: trusting your gut (19:08)

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive into the latest happenings in this dynamic industry.Starting with a look at the projected launch of top drugs anticipated in 2026, it's fascinating to see how these developments are poised to influence the market. These drugs could collectively generate a substantial $45.9 billion in annual sales by 2032, underscoring their economic impact and potential to address unmet medical needs. This reflects a robust pipeline of innovative treatments, marking significant therapeutic advancements on the horizon.Regulatory actions continue to be a pivotal force in shaping market dynamics. The FDA's recent issuance of complete response letters to Aquestive Therapeutics and Pharming resulted in contrasting market reactions, with Aquestive's shares rising while Pharming's declined. This scenario highlights the critical role of regulatory decisions in shaping company fortunes and investor confidence. Additionally, the FDA has introduced a precheck manufacturing program aimed at streamlining domestic drug production processes. This initiative is part of a broader trend to bolster U.S. pharmaceutical manufacturing capabilities amid global supply chain concerns, reflecting an effort to reduce complexities associated with setting up manufacturing plants domestically.In the realm of policy debates, there's notable discord among Trump administration officials over the future of COVID-19 vaccines in the U.S. market. This internal division could have far-reaching implications for public health strategies and vaccine accessibility, emphasizing ongoing challenges in pandemic management and policy alignment.Turning to scientific innovation, Daiichi Sankyo's development of antibody-drug conjugates (ADCs) has faced some setbacks. The company has discontinued an internal next-wave candidate and is experiencing delays in pivotal phase 3 trial readouts for its AstraZeneca-partnered candidate, Datroway. Despite these challenges, ADCs remain a promising area of oncology research due to their targeted therapeutic potential.Positive regulatory feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has provided a boost for companies like Novo Nordisk and Amgen. Novo Nordisk received approval for semaglutide for non-alcoholic steatohepatitis (NASH), highlighting its potential to address this liver disease with limited treatment options. Conversely, Amgen's Tavneos faces a re-review due to data integrity concerns, illustrating the rigorous scrutiny that accompanies pharmaceutical approvals and the importance of maintaining data integrity throughout development.Sanofi's pipeline reflects mixed outcomes as its GCS inhibitor failed a phase 3 trial for Fabry disease but showed promise in Gaucher disease. This underscores the inherent uncertainties and challenges faced in drug development, where promising candidates may not always meet clinical expectations.In broader scientific research, AstraZeneca identified 22 genes potentially linked to chronic diseases following Epstein-Barr virus infection. This finding advances our understanding of viral pathogenesis and its long-term health impacts, potentially guiding future therapeutic interventions.These developments illustrate a dynamic landscape where scientific innovation, regulatory oversight, and market forces converge to shape the future of healthcare. Breakthrough technologies and new therapeutic approaches hold promise for improving patient care and advancing drug development. However, navigating complex regulatory environments and addressing data integrity concerns remain critical challenges that companies must overcome to bring these innovations to market successfully.On another front, Roche's substantial $1.7 billion deal with Sanegene marks its re-engageSupport the show

How Medical Affairs leaders can move their organizations from a supporting role to a strategic driver—through accountability, insight translation, and the smart use of AI. In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick speaks with Greg Carpenter, Global Medical Strategy Leader in General Medicine at Sanofi, for a candid conversation on how Medical Affairs must evolve to remain relevant—and indispensable—in a rapidly changing industry. The discussion focuses on how Medical Affairs leaders can increase their strategic impact across pharma and biopharma organizations. Drawing on experience across commercial, quality, and Medical Affairs functions, Carpenter outlines why broader career paths, business acumen, and accountability are essential to creating Medical Affairs value. The conversation examines how Medical Affairs can move beyond data delivery to translate medical insights into strategy, strengthen cross-functional collaboration, and better support physicians and patients. The episode concludes with a practical discussion on AI in Medical Affairs, including how AI is being used today to improve insights, content development, and efficiency—while reinforcing the importance of human judgment and leadership.

This past December, the FDA issued a Complete Response Letter to drug manufacturer Sanofi in response to Sanofi's application seeking approval for Tolebrutinib, the first in a new category of investigational disease-modifying therapies to undergo FDA review.    A Complete Response Letter is an official letter from the FDA to a drug manufacturer stating that the agency can't approve a new medicine in its current form. It's not an outright "no" that kills a project; it's more like a "not yet." However, this Complete Response Letter raised some issues which, at first glance, don't appear to be easily fixable. Sanofi has pointed out that the issues raised in the Complete Response Letter were markedly different from the guidance they received from the FDA over the course of this approval process. Sanofi has also indicated that it would work with the FDA to find a path forward for Tolebrutinib. Dr. William Conte, an MS Specialist and a principal investigator in the Phase 3 clinical trial for Tolebrutinib, has published an article responding to the FDA's Complete Response Letter. This week, Dr. Conte joins me to discuss the FDA's action and his response to that action.  We have a lot to talk about! Are you ready for RealTalk MS??! This Week: We're at the 2026 ACTRIMS Forum  :22 Check out the official ACTRIMS Forum Insider podcast!  :42 The FDA's Complete Response Letter about Tolebrutinib  1:09 Dr. William Conte responds to the FDA's Complete Response Letter  4:09 Share this episode  38:10 Next week's episode  38:30 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/440 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Support Jon at WALK MS https://realtalkms.com/walkms Find out about ABLEnow Accounts https://ablenow.com JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 440 Guests: Dr. William Conte Privacy Policy

Earnings season is in full swing, and this week on Dividend Talk it's all about what recent earnings and dividend announcements really mean for long-term dividend investing. The conversation covers major earnings from companies likeMicrosoft, SAP, LVMH, Apple, Texas Instruments, Visa, Starbucks, UnitedHealth, and Altria, alongside a wave of European dividend increases from ASML, Deutsche Bank, Sanofi, ABB, KPN, and others. We break down what's driving big price drops, where valuation expectations may have run ahead of reality, and how dividend growth investors should think about volatility during earnings season.

My co-host Ken Suzan and I are welcoming you to episode 171 of our podcast IP Fridays! Today's interview guest is the president of the German Patent and Trademark Office Eva Schewior! But before we jump into this very interesting interview, I have news for you: The US Supreme Court has taken up an important patent law case concerning so-called “skinny labels” for generic drugs. Specifically, the highest US court is reviewing a case in which Amarin accuses generic drug manufacturer Hikma of inciting doctors to use the cholesterol drug Vascepa in violation of patents by providing a limited package insert. In two landmark decisions, the UPC Court of Appeal clarified the criteria for inventive step and essentially confirmed the EPO’s typical “problem-solution” approach (Amgen v Sanofi and Meril v Edwards). However, experts are not entirely sure whether the Court of Appeal’s decisions, particularly those relating to the determination of the closest prior art, deviate from EPO practice. As a result of Brexit, mutual recognition of trademark use between the EU and the UK will cease to apply from January 1, 2026. Use of a trademark only in the UK will then no longer count as use of an EU trademark for the purpose of maintaining rights – and conversely, EU use will no longer count for British trademarks. Bayer is attacking several mRNA vaccine manufacturers in the US (Pfizer, BioNTech, Moderna, and J&J separately). The core allegation: patent infringements relating to old (Monsanto) patents on mRNA stabilization; Bayer is seeking damages, not sales bans. DISCO Pharmaceuticals from Cologne signs an exclusive license agreement with Amgen (potentially up to USD 618 million plus royalties) for novel cancer therapies targeting surface structures. Relevant from an IP perspective: license scope, milestones, data/know-how allocation. And now let's jump into the interview with Eva Schewior! The German IP System in Transition: Key Insights from DPMA President Eva Schewior In an in-depth conversation on the IP Fridays podcast, Eva Schewior, President of the German Patent and Trademark Office (DPMA), outlined how Germany's IP system is responding to rising demand, technological change, and a fundamentally altered European patent landscape. The interview offers valuable insights for innovators, companies, and IP professionals navigating patent, trademark, and design protection in Europe. Sustained Demand and Procedural Efficiency Despite the introduction of the Unitary Patent system, national German IP rights continue to see strong and growing demand. According to Schewior, application numbers at the DPMA have been increasing for years, which she views as a strong vote of confidence in the quality and reliability of German IP rights. At the same time, this success creates pressure on examination capacity. The average duration of patent proceedings at the DPMA is currently around three years and two months from filing to grant, provided applicants request examination early and avoid extensions. Internationally, this timeframe remains competitive. Nevertheless, shortening procedures remains a strategic priority. Search requests alone have risen by almost 50% over the past decade, yet the DPMA still delivers search reports on time in around 90% of cases. To better reflect applicant needs, the DPMA distinguishes between two main user groups: applicants seeking a rapid grant, often as a basis for international filings, and applicants primarily interested in a fast, high-quality initial assessment through search or first examination. Future procedural adjustments are being considered to better serve both groups. The Role of Artificial Intelligence Artificial intelligence already plays a practical role at the DPMA, particularly in patent search, classification, and the translation of Asian patent literature. Schewior emphasized that the office is closely monitoring rapid developments in AI to assess where these tools can further improve efficiency. However, she made clear that AI will remain a supporting technology. In public administration, and especially in IP examination, final decisions must always be taken and reviewed by humans. AI is seen as a way to relieve examiners of routine tasks so they can focus on substantive examination and quality. Maintaining and Monitoring Examination Quality Quality assurance is a central pillar of the DPMA's work. Schewior reported consistently positive feedback from users, but stressed that maintaining quality is a continuous task. The office applies systematic double checks for grants and refusals and uses internal quality management tools to randomly review searches and first office actions during ongoing proceedings. External feedback is equally important. The DPMA's User Advisory Board, which includes patent attorneys, startups, and patent information centers, plays a key role in identifying issues and suggesting improvements. Several of its recommendations have already been implemented. Trademark Filings and Bad-Faith Applications The trademark side of the DPMA has experienced particularly strong growth. In 2025, the office received around 95,000 trademark applications, an increase of approximately 18% compared to the previous year. Much of this growth came from abroad, especially from China. While new trademark types such as sound marks, multimedia marks, and holograms have so far seen only moderate uptake, word marks and figurative marks remain dominant. A growing challenge, however, is the rise in bad-faith trademark filings. The DPMA has responded by intensively training examiners to identify and handle such cases. Procedural reforms following EU trademark law modernization have also shifted competencies. Applicants can now choose whether to bring revocation and invalidity actions before the courts or directly before the DPMA. While courts may act faster, proceedings before the DPMA involve significantly lower financial risk, as each party generally bears its own costs. Accelerated Examination as a Practical Tool Despite rising filing numbers, the DPMA aims to avoid significant delays in trademark proceedings. Organizational restructuring within the trademark department is intended to balance workloads across teams. Schewior highlighted the option of accelerated trademark examination, available for a relatively modest additional fee. In practice, this can lead to registration within a matter of weeks, without affecting priority, since the filing date remains decisive. New Protection for Geographical Indications A major recent development is the extension of EU-wide protection for geographical indications to craft and industrial products. Since late 2025, the DPMA acts as the national authority for German applications in this area. The first application has already been filed, notably for a traditional German product. Under the new system, applications undergo a national examination phase at the DPMA before being forwarded to the EUIPO for final decision. Products eligible for protection must originate from a specific region and derive their quality or reputation from that origin, with at least one production step taking place there. The EU estimates that around 40 German products may qualify. Outreach, SMEs, and Education Schewior underlined the DPMA's statutory duty to inform the public about IP rights, with a particular focus on small and medium-sized enterprises. The office has significantly expanded its presence on platforms such as LinkedIn and YouTube, offering accessible and practical IP content. Studies show that fewer than 10% of European SMEs use IP rights, despite evidence that IP-owning companies generate higher revenues. To address this gap, the DPMA is expanding outreach formats, strengthening cooperation with educational institutions, and publishing new empirical studies, including a forthcoming analysis of patenting behavior among innovative German startups conducted with WIPO. Strategic Challenges Ahead Looking forward, Schewior identified several key challenges: insufficient awareness of IP protection among SMEs and startups, a tendency in some sectors to rely solely on trade secrets, and the growing problem of product and trademark piracy linked to organized crime. From an institutional perspective, the DPMA must remain attractive and competitive in a European system offering multiple routes to protection. This requires legally robust decisions, efficient procedures, qualified staff, and continuous investment in IT and training. Careers at the DPMA Finally, Schewior highlighted recruitment as a strategic priority. The DPMA recently hired around 50 new patent examiners and continues to seek experts in fields such as electrical engineering, e-mobility, IT, and aerospace, as well as IT specialists, lawyers, and staff in many other functions. She emphasized the DPMA's role as Europe's largest national patent office and a globally significant, stable, and family-friendly employer at the forefront of technological development. German and European Patents as Complementary Options In her closing remarks, Schewior addressed the post-UPC patent landscape. Rather than competing, German and European patent systems complement each other. For many SMEs, a German patent alone may be sufficient, particularly where Germany is the core market. At the same time, the possibility of holding both a European patent and a national German patent offers strategic resilience, as national protection can survive even if a European patent is revoked. Her key message was clear: the range of options has never been broader, but making informed strategic choices is more important than ever. If you would like, I can also adapt this article for a specialist legal audience, condense it for a magazine format, or rework it as a thought-leadership piece for LinkedIn or your website. Rolf Claessen: Today's interview guest is Eva Schewior. If you don't know her yet, she is the President of the German Patent and Trademark Office. Thank you very much for being here. Eva Schewior: I'm very happy that you're having me today. Thank you, Mr. Claessen. Rolf Claessen: Shortening the length of procedures has been a stated goal since you took office. What is the current situation, and which measures are in place to achieve this goal? Eva Schewior: First of all, I'm very glad that German IP rights are in high demand. Even though applicants in Europe have multiple options today to obtain protection for their innovations, we have seen increasing application numbers for years at my office, even after the introduction of the Unitary Patent system. I see this as very positive feedback for our work. It is clear, however, that the high number of applications leads to a constantly increasing workload. At the same time, we want to remain attractive for our applicants. This means we must offer not only high-quality IP rights but also reasonable durations of proceedings. Ensuring this remains a central and permanent objective of our strategy. The average duration of proceedings from filing to grant is currently about three years and two months, provided that applicants file an examination request within the first four months after application and do not request extensions of time limits. In other cases, the average duration of proceedings is admittedly longer. With these three years and two months, we do not have to shy away from international comparison. Nonetheless, we strive to get better. In the last few years, we were able to improve the number of concluded proceedings or to keep them at a high level. In some areas, we were even able to shorten durations of proceedings a bit, though not yet to the extent that we would have wished for. Our efforts are often overtaken by the increasing demand for our services. Just to give you an example, in the last ten to fifteen years, search requests increased by nearly fifty percent. Despite this, we managed to deliver search reports in ninety percent of all cases in time, so that customers have enough time left to take a decision on a subsequent application. I have to admit that we are not equally successful with the first official communication containing the first results of our examination. Here, our applicants need a bit more patience due to longer durations of proceedings. But I think I do not have to explain to your expert audience that longer processing times depend on various reasons, which are in no way solely to be found on our side as an examination office. To further reduce the length of proceedings, we need targeted measures. To identify them, we have analyzed the needs of our applicants. It has been shown that there are two main interests in patent procedures. About three quarters of our applicants have a very strong interest in obtaining a patent. They mainly expect us to make fast decisions on their applications. Here we find applicants who want to have their invention protected within Germany but often also wish for subsequent protection outside Germany. The remaining quarter consists of applicants that are solely interested in a fast and high-quality first assessment of the application by means of a search or a first official examination. We observe that these applicants use our services before they subsequently apply outside Germany. This latter group has little interest in continuing the procedure before my office here in Germany. We are currently considering how we can act in the best interest of both groups. What I can certainly say is that we will continue to address this topic. And of course, in general, it can be said that if we want to shorten the duration of proceedings, we need motivated and highly skilled patent examiners. Therefore, we are currently recruiting many young colleagues for our offices in Munich and Jena, and we want to make our procedures more efficient by using new technical options, thus taking workload from patent examiners and enabling them to concentrate on their core tasks and on speedy examination. Rolf Claessen: Thank you very much. I also feel that the German Patent and Trademark Office has become quite popular, especially with the start of the UPC. Some applicants seem to find that it is a very clever option to also file national patents in Germany. Eva Schewior: I think you're perfectly right, and I think we will come to this point later. Rolf Claessen: In 2023, you mentioned artificial intelligence as an important tool for supporting patent examiners. What has happened regarding AI since then? Eva Schewior: Of course, we are already successfully using AI at our office. For instance, in the field of patent search, we use AI-based tools that make our examiners' work easier. We also use AI quite successfully for classification and for the translation of Asian patent literature into English. In the meantime, we have seen a rapid development of AI in the market. I think it is strategically imperative to get an overview and to make realistic assessments of what AI is capable of doing to make our procedures more efficient. Therefore, we are observing the market to find out where AI can perform tasks so that we enable examiners to concentrate on their core business. There are many ideas right now in our office where artificial intelligence can help us tackle challenges, for instance demographic change, which certainly also affects our office, and maintaining our quality standards. We will strategically promote new tools in this field to cope with these challenges. But this much is also clear: humans will always stay in our focus. Especially in public administration, I consider it a fundamental principle that in the end, decisions must be taken and reviewed by humans. AI may help us reach our goals in a more efficient way, but it can never replace patent or trademark examiners. Rolf Claessen: You have made quality improvements in patent examination a priority and have already implemented a number of measures. How would you describe the current situation? Eva Schewior: I often receive positive feedback from different sides that our users are very satisfied with the quality of our examination, and I'm very glad about that. But maintaining this quality standard is a permanent task, and we must not become careless here. For years, for instance, we have established double checks for all grants and rejections. In addition, we have introduced a quality management tool that enables us, even during the examination process, to randomly check the quality of first office communications and searches. This helps us detect critical trends and take appropriate countermeasures at a very early stage. What is also very important when it comes to patent quality is to actively ask our customers for their feedback. We do this in different ways. Just to give you an example, we have a User Advisory Board, which is a panel of external experts implemented a couple of years ago. Discussing questions of quality is regularly on the agenda of this board. We carefully listen to criticism, ideas, and suggestions, and we have already implemented some of them for the benefit of the office and our users. Rolf Claessen: The German Patent and Trademark Office, as the largest patent and trademark office in Europe, records very high numbers of trademark applications. What are you currently especially concerned with in the trademark area? Eva Schewior: In 2025, we saw around ninety-five thousand trademark applications. This is an increase of eighteen percent compared to the previous year, and I have to say that this took us by surprise. Especially applications from outside Germany, and above all from China, have risen significantly. It is of course challenging to cope with such a sudden increase on an organizational level. Another challenge is dealing with trademark applications filed in bad faith, which we are currently seeing more and more of. We have thoroughly trained our trademark examiners on how to identify and handle such applications. As regards the new types of trademarks, the rush has been moderate so far. Sound marks, multimedia marks, or holograms are apparently not yet common solutions for the majority of applicants. The key focus remains on word marks and combined word and figurative marks. Nevertheless, I believe that the new trademark types are a meaningful supplement and may play a greater role as digitization advances. The most significant changes, however, concern procedures. Applicants can now choose whether to file revocation or invalidity actions with the courts or with our office. While courts may proceed somewhat faster, the financial risk is higher. Before the DPMA, each party generally bears its own costs, apart from exceptional cases. Rolf Claessen: How does this dynamic filing development impact the duration of trademark proceedings? Eva Schewior: This is indeed a major organizational challenge. For a long time, our trademark department managed to keep durations of proceedings very short, especially with regard to registration. Despite the recent increases in applications, especially in 2025, we hope to avoid a significant extension of processing times. We have restructured the organization of the trademark department to distribute applications more equally among teams. Applicants should also be aware that it is possible to request accelerated examination for a relatively moderate fee of two hundred euros. This often leads to registration within a very short time. The filing date, of course, always determines priority. Rolf Claessen: Since December 2025, the EU grants protection not only for agricultural products but also for craft and industrial products through geographical indications. Has your office already received applications? Eva Schewior: Yes, we have received our first application, and interestingly it concerns garden gnomes. Protected geographical indications are an important topic because they help maintain traditional know-how in regions and secure local jobs. The DPMA is the competent authority for Germany. Applications go through a national examination phase at our office before being forwarded to the EUIPO, which takes the final decision on EU-wide registration. Eligible products must originate from a specific region and derive their quality, reputation, or characteristics from that origin, with at least one production step taking place there. Rolf Claessen: The DPMA has expanded its outreach activities, including social media. What else is planned? Eva Schewior: Raising awareness of IP rights, especially among small and medium-sized enterprises, is part of our statutory duty. We currently use LinkedIn and YouTube to communicate IP topics in an understandable and engaging way. We also plan dedicated LinkedIn channels, for example for SMEs. Studies show that fewer than ten percent of European SMEs use IP rights, even though those that do earn significantly more on average. In 2026, we will further expand outreach activities, cooperate more closely with universities and educational institutions, and publish new studies, including one on the patenting behavior of innovative German start-ups conducted together with WIPO. Rolf Claessen: Where do you see the biggest future challenges in IP? Eva Schewior: Germany depends on innovation, but awareness of IP protection is still insufficient, particularly among SMEs and start-ups. Some companies deliberately avoid IP rights and rely on trade secrets, which I consider risky. Another growing concern is the increase in product and trademark piracy, often linked to organized crime. For our office, remaining attractive and competitive is crucial. Applicants have many options in Europe, so we need fast procedures, legally robust decisions, qualified staff, and modern IT systems. Rolf Claessen: The DPMA is currently recruiting. Which areas are you focusing on? Eva Schewior: Our focus is on patent examination and IT. We recently hired fifty new patent examiners and are particularly looking for experts in fields such as electrical engineering, e-mobility, IT, and aerospace. We are Europe's largest national patent office and offer meaningful, secure jobs with fair compensation and strong development opportunities. Rolf Claessen: Is there a final message you would like to share with our listeners? Eva Schewior: The Unitary Patent system has created many new options. German and European patent systems do not compete; they complement each other. For many SMEs, a German patent may already be sufficient, especially where Germany is the core market. Holding both European and national patents can also be a strategic advantage. My key message is: be aware of the options, stay informed, and choose your IP strategy deliberately. Rolf Claessen: Thank you very much for being on IP Fridays. Eva Schewior: Thank you for having me. It was a pleasure.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant advancements and trends shaping the industry landscape, offering insights into how companies are navigating scientific, regulatory, and market challenges.The pharmaceutical and biotech sectors are in a dynamic period marked by substantial scientific advancements and strategic developments. Among the key players, Sanofi is demonstrating resilience despite geopolitical challenges affecting vaccine policies in the United States. The company's CEO, Paul Hudson, remains optimistic about their vaccine portfolio even amidst a slight downturn in vaccine sales, which decreased by 2.5% in the fourth quarter of 2025 and 1.2% for the entire year. This scenario highlights the broader industry challenge of maintaining focus on long-term goals while adapting to fluctuating market dynamics. In parallel developments, Sanofi has decided to discontinue its efforts to develop a next-generation mRNA seasonal flu vaccine after two and a half years of attempting to revolutionize flu prevention with mRNA technology. This halt underscores the challenges associated with mRNA vaccines in addressing seasonal flu strains despite their success during the COVID-19 pandemic.Roche is gearing up for an eventful 2026 with ten new molecules entering late-stage testing. Potential launches, including the breast cancer candidate giredestrant, are on the horizon. However, they face challenges as their eye drug Vabysmo underperformed against projections, and their Tecentriq failed in an early lung cancer study. These outcomes underscore the inherent risks of pharmaceutical research and development, illustrating how clinical trial results can substantially impact company trajectories. Additionally, Roche has decided to remove Kiniksa's fibrosis drug from its Phase 2 pipeline as part of a broader quarterly review. This decision reflects ongoing reassessment activities by pharmaceutical companies aiming to optimize resource allocation and focus on promising candidates. Roche also unveils its ambition to become a major player within obesity treatment markets—directly challenging industry leaders like Novo Nordisk—by securing top-three positioning during company earnings presentations last year—a strategic pivot towards obesity reflecting broader industry trends focusing increasingly upon metabolic disorders amid rising global prevalences thereof worldwide today.In a notable achievement, Tenpoint Therapeutics has secured FDA approval for Yuvezzi, an innovative vision-correction eye drop addressing presbyopia—a common age-related condition. The approval stems from combining two existing eye drop formulations, showcasing how repurposing compounds can lead to new therapeutic options. With $235 million raised to support its Q2 launch, Tenpoint's confidence in Yuvezzi's market potential is clear.The biopharma merger and acquisition landscape is evolving as companies shift focus from acquiring blockbuster drugs to enhancing capabilities across the drug development continuum. This strategic pivot reflects a more integrated approach to growth, aimed at building comprehensive portfolios that address various stages of drug commercialization and development.AstraZeneca has announced a substantial $15 billion investment in China by 2030 to expand its cell therapy and radioconjugate capabilities. This move underscores China's strategic importance as a biopharma market and highlights AstraZeneca's commitment to leveraging innovative technologies to enhance therapeutic offerings. AstraZeneca is making significant strides with this investment aimed at advancing its capabilities in China through 2030. This strategic move highlights the growing importance of personalized medicine and targeted therapies in emerging markets like China.ReguSupport the show

No te pierdas todos los martes y jueves en punto de las 16:00hrs en tu programa ¡Pulso Saludable! junto a Liliana Noble Alemán. Como cada semana nos comparte temas de salud que nos ayudarán a nuestra vida diaria junto a su grupo de expertos. Hoy hablamos de: IMSS, ISSSTE,COFEPRIS, SANOFi, Astra Zebeca, secretsria de Salud e IMSS- Bienestar No te pierdas todos los martes y jueves en punto de las 16:00hrs en tu programa ¡Pulso Saludable! junto a Liliana Noble Alemán. Como cada semana nos comparte temas de salud que nos ayudarán a nuestra vida diaria junto a su grupo de expertos.

We love to hear from our listeners. Send us a message.In episode 121 of Cell & Gene: The Podcast, Host Erin Harris talks to Scribe Therapeutics' CEO and Co-Founder Benjamin Oakes about building next‑generation CRISPR and epigenetic editing tools to move genetic medicine beyond rare disease into common cardiometabolic indications. Oakes shares Scribe's engineered CasX platform and epigenetic silencers, preclinical data from its various programs, and why exquisite specificity and low-dose LNP delivery are essential to treating patients safely. They also explore Scribe's partnerships with Sanofi and Lilly, the company's cardiometabolic-first strategy co-developed with Dr. Jennifer Doudna, and Oakes' conviction that genetic medicines can fundamentally reshape healthspan and the future of preventive cardiovascular care.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

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 whirlwind of activity in the industry, where scientific breakthroughs, regulatory shifts, and strategic collaborations are all reshaping the future of healthcare.Let's start with a look at the ongoing efforts by the Trump administration to negotiate Medicare drug prices under the Inflation Reduction Act. This initiative is set to impact 15 high-profile drugs, marking a significant push towards more stringent pricing regulations. The aim is to make medications more affordable for patients, but this move could also compel pharmaceutical companies to rethink their pricing strategies and revenue models. Such regulatory changes underscore a broader trend toward cost containment in healthcare, a critical issue as drug prices continue to be a major concern for policymakers and consumers alike. Additionally, proposed changes to Medicare Advantage rates by the Trump administration could lead to benefit cuts or market exits by insurers, highlighting ongoing uncertainties in healthcare financing that could significantly impact patient access to care.In the realm of oncology, Johnson & Johnson has achieved another milestone with its Darzalex Faspro. This drug has received FDA approval for an expanded indication in treating newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplants. This approval is not just a regulatory win; it reflects the growing importance of combination therapies in enhancing treatment outcomes for complex diseases like multiple myeloma. The shift towards combination regimens is a notable trend in oncology, aiming to maximize therapeutic efficacy and improve patient survival rates.Meanwhile, Teva Pharmaceuticals is bracing for a potential slowdown come 2026 after a period of growth. This projection highlights the inherent volatility in the pharmaceutical market, where external factors such as regulatory changes and competitive pressures can swiftly alter financial trajectories. Companies like Teva must remain agile and adaptable to navigate these unpredictable waters.On the innovation front, Cellares has secured $257 million in a Series D funding round aimed at expanding its cell therapy contract manufacturing operations globally. This significant investment underscores an increasing demand for advanced therapeutic manufacturing capabilities, reflecting the industry's pivot towards personalized medicine and cell-based therapies. As the landscape of medicine shifts towards more individualized approaches, companies like Cellares are positioning themselves at the forefront of this transformative trend.Novo Nordisk is actively exploring new growth avenues, with its business development head engaging in numerous strategic meetings at the J.P. Morgan Healthcare Conference. This proactive approach illustrates how critical partnerships and acquisitions are becoming for pharmaceutical companies looking to maintain a competitive edge and drive innovation forward. Novo Nordisk's pursuit of Metsera aligns with broader industry trends where strategic acquisitions are leveraged to bolster pipelines with innovative therapies.Pfizer continues to dominate the vaccine production arena despite challenging market conditions that have seen competitors like Sanofi face setbacks. This leadership can be attributed to Pfizer's robust product pipeline and strong relationships with healthcare providers, highlighting how trust and reliability remain crucial components of success in this field.In gene therapy news, Eli Lilly has forged a $1.1 billion agreement with Seamless Therapeutics aimed at developing gene-editing medications for hearing loss. This collaboration is indicative of gene therapy's expanding scope, offering hope for addressing previously untreatable conditions Support the show

From Trinidad to a $200K Career in Texas: How Kanika Bhagan Mastered the U.S. Medical Sales Market.Can you move to a brand-new country and double your income in less than a year? In this episode of Medical Sales U, Kanika Bhagan reveals the exact strategy she used to transition 17 years of experience from the Caribbean to landing a $200,000 role in the competitive Dallas, Texas market.Kanika's journey is a masterclass in career reinvention. Despite having nearly two decades of experience with giants like Sanofi and AstraZeneca, she faced the "overwhelming" challenge of a new culture and a new market. She shares how she stayed consistent—applying for jobs at 4:00 AM—and why maintaining a "solid reputation" is the most valuable currency in Medical Sales.Watch to learn:The "Business Plan" secret that seasoned veterans often miss.How to network on LinkedIn without getting ghosted.Why a "No" from a hiring manager might actually be your next big lead.Timestamps0:00 - Introduction: Meet Kanika Bhagan0:27 - From $95k to $200k: The Power of Investing in Yourself1:45 - Moving from Trinidad to Dallas: Overcoming the Fear of the Unknown3:12 - The Reality of Networking in the Texas Med-Sales Market5:42 - Why Your Resume Isn't Enough: The Business Plan Strategy7:45 - Using AI to Research Products & Competition9:30 - LinkedIn Secrets: How to Reach Out Without Being "Salesy"12:15 - Breaking In via Contract Work (IQVIA & Abbott)14:05 - How to Turn a Job Rejection into a Future Referral18:40 - Resilience & Professionalism: Advice for Seasoned Pros24:30 - Tips for Moving to a Brand New Market28:00 - Why Dallas is the Ultimate City for FamiliesConnect with Kanika Bhagan on LinkedIn: https://www.linkedin.com/in/kanika-ramkissoon/READY TO BREAK INTO MEDICAL SALES? We help professionals transition into top-tier medical sales roles: medicalsalesu.com/#MedicalSales #MedicalDeviceSales #CareerTransition #PharmaceuticalSales #DallasJobs #NetworkingTips #MedicalSalesYou #JobInterviewStrategy

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 significant scientific advancements, regulatory challenges, and strategic investments that are shaping the future of healthcare.Let's begin with Moderna's recent decision to halt its late-stage vaccine trials, a move reflective of a broader trend of vaccine hesitancy in the United States. Moderna's CEO Stéphane Bancel pointed to shifts in government policy and an increasing public skepticism towards vaccines as pivotal reasons for this decision. This development signals a potential slowdown in vaccine research and development investments across the industry. The implications are profound, as vaccine hesitancy could impact public health initiatives and the readiness to tackle future pandemics.In parallel developments, Sanofi is navigating its own set of challenges with its eczema treatment. Despite plans to file for FDA approval for its OX40 blocker following the Phase III COAST 2 trial, results were mixed, echoing earlier data that analysts found underwhelming. This situation highlights the inherent uncertainties in drug development and raises questions about the treatment's potential market success. As Sanofi persists, the broader industry is reminded of the complexities involved in bringing new therapies to market, particularly in dermatology where unmet needs remain significant.Meanwhile, Chinese biotech firm Corxel has secured an impressive $287 million in Series D1 funding to push forward its oral GLP-1 therapy, CX11. This funding will support its mid-stage development in the US and preparations for Phase III studies. The investment underscores a robust interest in GLP-1 therapies known for their efficacy in treating type 2 diabetes and obesity. The competitive landscape for these therapies is heating up, with major players vying for market dominance through novel delivery mechanisms and enhanced patient outcomes. Notably, Novo Nordisk's oral Wegovy is advancing while Eli Lilly's Orforglipron faces delays, highlighting the strategic importance of timely development and market entry in capturing lucrative opportunities within this therapeutic area.On the regulatory front, a notable legislative challenge has emerged with the failure to reauthorize the FDA's rare pediatric disease priority review voucher program for 2024. Advocates are calling for its reinstatement given its critical role in incentivizing the development of rare disease treatments through expedited review processes. Such regulatory changes underscore the delicate balance between encouraging innovation and ensuring rigorous standards, a dynamic that continuously shapes R&D strategies within the industry.In oncology, Bristol Myers Squibb is making headlines with an $850 million investment in Janux Therapeutics' tumor-activated drugs. This significant investment reaffirms BMS's commitment to pioneering cancer therapies that promise better patient outcomes through innovative mechanisms of action. The focus on oncology reflects a broader industry trend towards precision medicine and targeted treatments aimed at improving efficacy while minimizing side effects.As we pivot to manufacturing developments, Lotte Biologics is expanding its capabilities with plans to launch its Syracuse ADC hub by 2026. This expansion aligns with global efforts to enhance manufacturing quality and capacity, crucial factors as biopharmaceuticals become more complex and demand increases.Turning our attention to financial achievements within the industry, Samsung Biologics has reached a historic milestone by becoming the first Korean biopharmaceutical company to surpass a profit threshold of 2 trillion won ($1.36 billion). This accomplishment spotlights the growing influence of contract manufacturing organizations (CMOs) like Samsung BiologicsSupport the show

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.

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

How do we rebuild trust in vaccines when fear and misinformation stand in the way, especially for autistic individuals and their families?In this episode of Patient Advocacy Voices, host Eric Racine is joined by co-host Heather Entenmann, U.S. Public Health Engagement Lead at Sanofi, for a thoughtful conversation on vaccine confidence, trust, and inclusion. Together, they welcome two leading voices in public health and advocacy: Danielle Hall, former Vaccine Education Lead at the Autism Society of America, and Dr. Kelly Moore, President and CEO of Immunize.org.Drawing on lived experience, decades of public health leadership, and frontline advocacy work, the conversation explores why the long-debunked myth linking vaccines and autism continues to persist, and why rebuilding trust requires more than facts alone. The discussion highlights how healthcare experiences, sensory needs, anxiety, and empathy all play critical roles in shaping vaccine decisions, and what advocacy leaders and providers can do differently to better support autistic individuals and their families.In this episode, you'll gain insights on:Why misinformation about vaccines and autism endures, and how to address it with empathy, not judgmentHow healthcare experiences and sensory needs influence vaccine confidence in the autism communityPractical ways providers and vaccination sites can reduce anxiety and create more inclusive, respectful experiences for immunizations in any disease areaHow advocacy organizations, healthcare professionals, and trusted messengers can counter misinformation by leading with empathy and authenticityThis conversation is a powerful reminder that rebuilding trust in public health starts with listening, understanding lived experiences, and meeting people where they are, because confidence is built not just through evidence, but also through empathy.

When Anne Adam and Maria Viola joined Sanofi, they were tasked with activating a long-dormant EVP that was disconnected from corporate brand. We hear how employee advocacy and the signature Sanofi scent made people excited to return to the office. Anne Adam is the Global Employer Brand Marketing Manager, and Maria Viola is the Global Employer Brand Content and Creative Lead at Sanofi. Anne Adam on LinkedIn: https://www.linkedin.com/in/anneadam/ Maria Viola on LinkedIn: https://www.linkedin.com/in/eugeniaviola/ Working at Sanofi: https://jobs.sanofi.com/en The Sanofi Feeling: https://jobs.sanofi.com/en/sanofi-feeling

Synopsis: At a moment when biotech is rethinking growth, innovation, and patient impact, Alok Tayi sits down with Christophe Bourdon, Chief Executive Officer of LEO Pharma, to explore what it truly means to build a purpose-driven, commercial-stage biotech. Drawing on three decades across Sanofi, Alexion, Amgen, and now LEO Pharma, Christophe shares a clear conviction: innovation only matters when it meaningfully changes patients' lives. At LEO Pharma, that belief is shaping a focused strategy in medical dermatology, where over one-third of the global population is affected and thousands of skin diseases still lack approved treatments. The conversation spans LEO Pharma's evolution into a nearly $2B growth company, the rise of first-in-class therapies in atopic dermatitis and chronic hand eczema, and why formulation science, rare disease execution, and “white-glove” patient support are essential to changing standards of care. Christophe also offers sharp perspectives on AI-enabled scouting, the accelerating innovation coming out of China, and why biotech must resist “me-too” products in favor of true clinical breakthroughs. From JPMorgan Healthcare Conference insights to deeply human stories of rare disease care at 4 a.m., this episode is a masterclass in disciplined growth, differentiated innovation, and patient-first leadership. Biography: Christophe joined LEO Pharma as CEO in April 2022 and has since led the company through a strategic transformation, sharpening its focus on innovation and external partnerships. Under his leadership, LEO Pharma has accelerated growth in key markets, advanced its pipeline, and strengthened its culture, reinforcing its position as a global leader in medical dermatology. Before joining LEO Pharma, he served as CEO of Orphazyme A/S. Earlier in his career, he held senior leadership roles at Amgen, including Senior Vice President and General Manager for the U.S. Oncology Business, and at Alexion as Senior Vice President, EMEAC, overseeing the commercial development of ultra-orphan therapies across 40 countries. Christophe holds an MBA from the International Institute for Management Development (IMD) in Lausanne, Switzerland, and a B.A. from the Institut Supérieur de Gestion (ISG) in Paris, France.

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

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

If you work in media, marketing, or advertising, you know this tension: Screens dominate. Measurement has lagged. And it's harder to answer questions like “Where does attention really happen?” and “What actually moves people…and how do I prove it?” This episode offers some answers, from three executives I spoke with at CES 2026. Though we talk about the newest cool tools (it IS the largest consumer tech show), these conversations explore how media works when it follows consumers from the couch to the car, in stores, in culture, and across audio—and how measurement is finally catching up to meaning. Learn what's working now and what's coming next, according to: Jim Riley, President of Stingray U.S., explains how audio, ambient TV, karaoke, and in-car experiences are converging—and how their effort to connect these environments creates value for brands, platforms, and consumers alike.  From FAST channels to automotive dashboards, Jim shares how following people across screens (and beyond them) is reshaping media strategy. (And don't miss an archival image of Jim making music “back in the day” himself!) Kimberly Hairston-Hicks, CMO of Sanofi's Gold Bond, brings a powerful brand perspective rooted in authenticity and cultural relevance. She talks candidly (and I sing) about letting go of control, redefining success beyond impressions, and building partnerships based on shared values—showing how human connection and business results don't have to be at odds. Hint: They paired perfectly with celebrity Chelsea Handler over shared values and love of the product! Chelsea Handler Skiing with Gold Bond! (And learn why Kimberly wears a “cape,” and owes a debt of gratitude to women who help women!) Jennifer Louie Oon, SVP of Sales at DAX US, closes the loop with a look at audio advertising today—and why its moment is now…especially when brands can reach markets or audiences other platforms  or apps often miss. She explains how DAX is solving for that, along with measurement tools that can finally demonstrate audio's impact in real time and the power of advertisers still having presence in screen-free moments. (And find out why old school Legos really grabbed her during the world's largest tech show!)  Get some practical thought starters on audio advertising, brand authenticity, media measurement, and human-centered marketing—without the jargon or hype…and with a little bit of singing and laughs! Key Moments & Time Codes 00:00–01:22 — Why this episode connects audio, TV, brand marketing, and ad tech 03:29–04:43 — Why karaoke is becoming a serious media business Jim Riley explains how Stingray turned a universal behavior—singing in the car—into a gamified, social, and monetizable experience across TVs and automotive dashboards. 05:40–06:20 — From couch to car to checkout Jim outlines Stingray's vision for linking TV, in-car audio, and retail media—following consumers across environments and tying media exposure to real-world action. 08:02–08:37 — When advertising doesn't belong everywhere A candid discussion on why karaoke stays ad-free, how premium experiences are monetized differently, and what “everybody wins” actually looks like in practice. 12:44–13:20 — “Let it go” as a marketing strategy Kimberly Hairston-Hicks shares why perfection is the enemy of progress—and how letting go of control creates stronger brands and better outcomes. 18:19–20:29 — Authenticity beats star power Kimberly breaks down the Gold Bond–Chelsea Handler partnership, revealing why shared values—not celebrity size—drive cultural relevance and real KPIs. 21:01–22:11 — When impressions aren't the point anymore A reframing of success: why cultural moments, memory, and longevity matter just as much as raw reach—and how brands should measure that. 26:07–27:25 — Beauty, confidence, and showing up fully A powerful, personal exchange on how products—and leadership—can change how people feel about themselves, from the boardroom to daily life. 35:07–36:05 — Audio measurement finally catches up Jennifer Louie Oon explains how DAX is using brand-lift measurement to prove what audio has always delivered—and why this changes how brands plan media. 37:18–38:06 — Why audio's moment is now Screen-free moments, smarter targeting, and better measurement come together—making the case for audio as a core, not supplemental, channel in 2026 planning. Connect with: Jim Riley Kimberly Hairston-Hicks Jen Oon Connect with E.B. Moss and Insider Interviews: With Media & Marketing Experts            LinkedIn: https://www.linkedin.com/in/mossappeal Instagram: https://www.instagram.com/insiderinterviews Facebook: https://www.facebook.com/InsiderInterviewsPodcast/ Threads: https://www.threads.net/@insiderinterviews Substack: Moss Hysteria Please follow Insider Interviews, share with another smart business leader, and leave a comment on @Apple or @Spotify… or a tip in my jar!: https://buymeacoffee.com/mossappeal!  THANK YOU for listening!

El director de Renta Variable de Singular Bank, Nicolás López, ofrece su perspectiva sobre el mercado español y las tecnológicas americanas. También se abordan movimientos en el sector bancario y farmacéutico, con atención a Unicredit y Sanofi.

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

Kate Haviland, former CEO of Blueprint Medicines, on how the company transitioned to a precision immunology company and was acquired by Sanofi for $9.5 billion.

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

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 landscape rich with scientific advancements, strategic industry shifts, and regulatory developments that are shaping the future of healthcare.Let's start with AstraZeneca's recent success in the lupus treatment field. Their Phase 3 clinical trial for a self-administered subcutaneous form of Saphnelo marks a significant milestone. This new administration route could enhance patient convenience and accessibility, positioning AstraZeneca favorably against competitors like GlaxoSmithKline's Benlysta. The move underscores a growing trend in the industry towards more patient-friendly drug delivery systems, which could revolutionize treatment adherence and outcomes for autoimmune diseases.Turning our attention to Argenx, the company is navigating a pivotal leadership transition following the launch of Vyvgart, their autoimmune drug. This shift highlights the company's strong footing in the market after successfully obtaining regulatory approval and introducing Vyvgart. The potential expansion of its reach could further solidify Argenx's standing in the competitive autoimmune sector.Alumis is also making waves with its TYK2 inhibitor for psoriasis treatment, having reported promising Phase 3 data. This development places it as a formidable contender to Bristol Myers Squibb's Sotyktu. The positive trial results have not only boosted Alumis' stock value but also reflect a broader interest in immunomodulatory treatments which offer patients alternative therapeutic options with potentially fewer side effects.In an innovative leap within obesity management, Arrowhead Pharmaceuticals is advancing its dual gene-silencing assets aimed at reducing fat. Early-phase data indicates promising results, highlighting gene therapy's potential as a viable strategy for tackling complex conditions like obesity. This approach could pave the way for more personalized and effective treatments, aligning with the industry's gradual shift towards precision medicine.On the regulatory front, there's been notable movement with significant updates affecting drug approvals and recommendations. The Centers for Disease Control and Prevention's decision to remove six vaccines from the recommended childhood immunization schedule has stirred controversy due to its opaque review process. Such decisions carry profound implications for public health policies and vaccine uptake, sparking debates about safety and transparency.Meanwhile, GlaxoSmithKline's Exdensur has gained approval in Japan for two new indications, showcasing efforts to expand existing drugs' therapeutic applications across different markets. However, Sanofi has faced hurdles with the FDA rejecting its multiple sclerosis drug due to serious safety concerns, including liver injury risks. This rejection underscores the delicate balance regulatory bodies must maintain between efficacy and safety when evaluating new therapeutics.Amgen's strategic acquisition of a UK biotech firm for up to $840 million exemplifies ongoing industry consolidation trends. By integrating preclinical blood cancer programs into its portfolio, Amgen aims to strengthen its oncology pipeline—a critical area in today's competitive cancer treatment landscape. Similarly, Roche has strategically invested $100 million in a licensing deal with Structure Therapeutics to secure its position within the GLP-1 therapeutics sphere for metabolic disorders.These strategic acquisitions and partnerships highlight an industry focused on bolstering pipelines through external collaborations—essential for maintaining competitive edges in high-stakes therapeutic areas like oncology and metabolic disorders. As companies endeavor to innovate while ensuring safety, their efforts promise to enhance patient care by addressing unmet mSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. As we delve into the year 2025, it's clear that the pharmaceutical and biotech industries have been navigating a complex landscape filled with both challenges and remarkable advancements. Despite regulatory uncertainties and broader economic fluctuations, the FDA approved 55 new treatments and vaccines this year. Although this figure represents a slight decline from previous years, it underscores the sector's resilience and steadfast commitment to innovation even amid external pressures.One significant development in oncology comes from Incyte, which is advancing its application for FDA approval of a seven-drug Monjuvi regimen as a first-line treatment for diffuse large B-cell lymphoma. This move is backed by positive Phase 3 trial results, highlighting Monjuvi's potential to enhance treatment options for this aggressive cancer type. However, Incyte may face hurdles in gaining regulatory approval and achieving commercial success, reflecting the competitive nature of oncology therapeutics.In obesity management, Novo Nordisk introduced its once-daily Wegovy pill in the U.S., marking a milestone in the field. Priced at $149 per month for cash-paying patients with potential discounts for those insured, Wegovy's launch could shift market dynamics significantly by offering a more accessible treatment option. This aligns with the growing global focus on obesity as a critical public health issue.The industry also saw substantial investments to bolster manufacturing capabilities. Daiichi Sankyo announced plans to invest $1.9 billion to expand Enhertu production facilities across countries such as the United States, China, Japan, and Germany. This strategic move aims to strengthen supply chain robustness and meet anticipated demand for Enhertu, a pivotal player in cancer therapeutics. Meanwhile, economic pressures are palpable as drugmakers raised prices on over 350 products at the start of the year, surpassing previous years' increases. This reflects ongoing tensions around drug pricing policies and affordability, posing challenges for industry stakeholders and patients alike.The labor landscape within biopharma has been affected as well, with layoffs increasing by 16% year-over-year in 2025. These reductions highlight ongoing cost-cutting measures amid financial uncertainties and strategic realignments within companies. Yet, strategic partnerships continue to shape research and development efforts, particularly in autoimmune diseases. Sanofi's collaboration with AI biotech Earendil Labs could potentially reach $2.5 billion, emphasizing the increasing role of artificial intelligence in drug discovery and development processes. These collaborations are poised to accelerate advancements in personalized medicine and innovative therapeutic approaches.Regulatory activities have also seen notable developments this year. GSK's Nucala received approval for treating COPD in China, expanding its therapeutic scope beyond asthma. This regulatory progress signifies opportunities for existing drugs to access new markets and indications. However, the National Institutes of Health faced leadership challenges with the departure of its National Institute of Neurological Disorders and Stroke director. This adds to a series of leadership changes across NIH institutes, raising concerns about stability within this pivotal organization responsible for advancing medical research.Turning now to significant scientific advancements and clinical trials, promising results emerged from studies focused on cellular energy boosters aimed at treating Alzheimer's disease. A molecule that restores cellular energy was shown to reverse cognitive decline in mice with advanced Alzheimer's, suggesting a potential new class of therapeutics for this debilitating condition. Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events that are shaping the landscape of this dynamic industry. The ever-evolving arena of drug approvals, regulatory challenges, and strategic shifts continues to captivate stakeholders across the globe.Sanofi's recent acquisition of Dynavax for $2.2 billion illustrates a prevailing trend within the sector—mergers and acquisitions aimed at expanding vaccine portfolios in response to global health priorities. This strategic move provides Sanofi with access to Heplisav-B, a hepatitis B vaccine, thereby reinforcing the importance of broadening vaccine offerings amid ongoing global health concerns.The U.S. Food and Drug Administration (FDA) has been active in granting approvals for new therapies, reflecting ongoing efforts to address a wide range of medical needs. Agios Pharmaceuticals has received approval for Aqvesme, a treatment designed specifically for anemia in patients with either alpha- or beta-thalassemia. Meanwhile, Vanda Pharmaceuticals has secured approval for Nereus, a novel motion sickness treatment. These approvals highlight the FDA's dedication to advancing treatments for both common and rare medical conditions.A noteworthy milestone was achieved by Omeros Corporation as it secured FDA approval for Yartemlea—its first U.S. approval in 31 years. This drug is a novel treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, underscoring the industry's focus on developing therapies for niche yet critical medical conditions.Verastem Oncology has opted to halt its phase 1/2 trial of a KRAS G12C inhibitor targeting non-small cell lung cancer due to increasing competition from next-generation inhibitors. This decision reflects the competitive and rapidly evolving landscape of oncology therapeutics where companies must adapt their strategies based on interim data and market dynamics.Foresee Pharmaceuticals has reported promising phase 3 results for Camcevi in treating central precocious puberty (CPP), a rare hormonal disorder. This demonstrates the potential for repurposing established drugs to address unmet needs in pediatric endocrinology.Inflarx is actively exploring partnerships to revitalize its C5a antibody vilobelimab which was initially developed for pyoderma gangrenosum but faced setbacks after a terminated phase 3 trial. The company's persistence in seeking new pathways forward exemplifies the challenges and resilience required in drug development, especially for rare diseases.Regulatory hurdles remain a significant challenge as illustrated by Outlook Therapeutics' ophthalmic bevacizumab facing another FDA rejection. Such outcomes emphasize the stringent regulatory environment that companies must navigate to bring innovative therapies to market.A federal judge's temporary pause on the 340B rebate pilot underscores ongoing legal and regulatory debates impacting healthcare policy and industry operations. The contentious rollout of this pilot reflects broader tensions between administrative actions and healthcare stakeholders.As we look forward, industry analysts anticipate that the surge in mergers and acquisitions observed in late 2025 will persist into 2026. Companies are driven by growth aspirations through strategic acquisitions aimed at expanding their pipelines and market reach.Despite positive advancements, some companies face setbacks. Johnson & Johnson's discontinuation of its $1.2 billion eczema therapy due to unsatisfactory clinical results highlights the inherent risks and unpredictability of drug development. Similarly, Genmab's withdrawal of a cancer drug from development underscores these challenges within oncology research.In contrast, Neuralink's plans to ramp up production of its brain-computer interface devices highliSupport the show

Behzad Najafian, MD, Professor, Department of Laboratory Medicine & Pathology, Department of Medicine at the University of Washington, Washington, USA discusses the use of artificial intelligence in identifying and managing lysosomal disorders.This continuing education activity is provided through collaboration between the Lysosomal and Rare Disorders Research and Treatment Center (LDRTC), CheckRare CE, and AffinityCE. This activity provides continuing education credit for physicians, physician assistants, nurses, nurse practitioners, and genetic counselors. A statement of participation is available to other attendees.To obtain CME/CE credit, visit https://checkrare.com/learning/p-grids2025-session1-ai-in-medicine-transforming-the-landscape-of-tissue-based-diagnostics/Learning ObjectivesDescribe recent advances in the applications of AI in lysosomal disorder diagnosis and its clinical relevanceFacultyBehzad Najafian, MD Professor, Department of Laboratory Medicine & Pathology, Department of Medicine, University of WashingtonDisclosuresAffinityCE staff, LDRTC staff, planners, and reviewers, have no relevant financial relationships with ineligible companies to disclose. Faculty disclosures, listed below, will also be disclosed at the beginning of the Program.Behzad Najafian, MDDr. Najafian is on the Advisory Board/Consultant for Sanofi, Amicus, Avrobio, 4DMT,Sangamo, Freeline, AceLink, Relay, CRISPR, ELOXX, SPARK, UNIQURE. He receives grants/research support from Amicus. Mitigation of Relevant Financial RelationshipsAffinityCE adheres to the ACCME's Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CME activity, including faculty, planners, reviewers, or others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. Conflicts of interest for presenting faculty with relevant financial interests were resolved through peer review of content by a non-conflicted reviewer.Accreditation and Credit DesignationPhysiciansThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.Physician AssistantsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physician Assistants should claim only the credit commensurate with the extent of their participation in the activity.NursesAffinityCE is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation (ANCC). This activity provides a maximum of 1 hours of continuing nursing education credit.Nurse PractitionersAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Nurse practitioners should claim only the credit commensurate with the extent of their participation in the activity.Genetic CounselorsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Genetic Counselors should claim only the credit commensurate with the extent of their participation in the activity.Other ProfessionalsAll other health care professionals completing this continuing education activity will be issued a statement of participation indicating the number of hours of continuing education credit. This may be used for professional education CE credit. Please consult your accrediting organization or licensing board for their acceptance of this CE activity. Participation CostsThere is no cost to participate in this activity.CME InquiriesFor all CME policy-related inquiries, please contact us at ce@affinityced.comSend customer support requests to cds_support+ldrtc@affinityced.com

Shunji Tomatsu, MD, PhD, Professor and Head, Nemours Children's Health, Delaware, USA; Alessandra d'Azzo, PhD, Emerita Faculty, Genetics, St. Jude Children's Research Hospital, Tennessee, USA; Merve Emecen Sanli, MD, Associate Professor, Department of Pediatrics, University of Texas Southwestern Medical Center, Texas, USA; and Ryan Colburn, patient with Pompe disease and president of Odimm Inc, discuss new and emerging gene therapies for lysosomal disorders.This continuing education activity is provided through collaboration between the Lysosomal and Rare Disorders Research and Treatment Center (LDRTC), CheckRare CE, and AffinityCE. This activity provides continuing education credit for physicians, physician assistants, nurses, nurse practitioners, and genetic counselors. A statement of participation is available to other attendees.To obtain CME/CE credit, please visit https://checkrare.com/learning/p-grids2025-session6-current-issues-in-gene-therapies-for-lysosomal-disorders/  Learning ObjectivesDescribe current and emerging gene therapy data in lysosomal disorders and its clinical relevanceDescribe role of patients in gene therapy developmentFacultyShunji Tomatsu, MD, PhD, Professor and Head, Nemours Children's HealthAlessandra d'Azzo, PhD, Emerita Faculty, Genetics, St. Jude Children's Research HospitalMerve Emecen Sanli, MD, Associate Professor, Department of Pediatrics, University of Texas Southwestern Medical CenterRyan Colburn. Odimm, Inc.DisclosuresAffinityCE staff, LDRTC staff, planners, and reviewers, have no relevant financial relationships with ineligible companies to disclose. Faculty disclosures, listed below, will also be disclosed at the beginning of the Program.Shunji Tomatsu, MD, PhD Dr. Tomatsu has received the following grants: Morquio Foundations and families: Scarlett Grifith, Bennett, A Cure for Roberts, and Morquio Conference; MPS Societies: Japanese, National, and Austrian; NIH grants: 1-R01-HD102545, NIH, NICHD, Tomatsu (PI), 1R01HD104814-01A1, NIH, NICHD, Langan, T.J. (PI), Role: Site-PI, R43HD114328-01, NIH, ACOSTA, WALTER (PI), Role: site PI, 1R43AR084638-01, NIH, MOUNZIH, KHALID (PI); Foundation of NIH: FNIH RFP NUMBER: 2022-BGTC-005 Tomatsu (PI). Alessandra d'Azzo, PhDDr. D'Azzo has no relevant financial relationships to disclose.Merve Emecen Sanli, MDDr. Sanli has no relevant financial relationships to disclose.Ryan ColburnMr. Colburn has an advisory, consulting and/or project based relationship or stock holding with: Abeona Therapeutics, Amicus Therapeutics, Astellas Gene Therapies, Avidity Biosciences, Bayer, Catalyst Pharmaceuticals, Denali Therapeutics, M6P Therapeutics, Sangamo Therapeutics, Sanofi, Solid Biosciences.Mitigation of Relevant Financial RelationshipsAffinityCE adheres to the ACCME's Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CME activity, including faculty, planners, reviewers, or others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. Conflicts of interest for presenting faculty with relevant financial interests were resolved through peer review of content by a non-conflicted reviewer.Accreditation and Credit DesignationPhysiciansThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.Physician AssistantsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physician Assistants should claim only the credit commensurate with the extent of their participation in the activity.NursesAffinityCE is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation (ANCC). This activity provides a maximum of 1 hours of continuing nursing education credit.Nurse PractitionersAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Nurse practitioners should claim only the credit commensurate with the extent of their participation in the activity.Genetic CounselorsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Genetic Counselors should claim only the credit commensurate with the extent of their participation in the activity.Other ProfessionalsAll other health care professionals completing this continuing education activity will be issued a statement of participation indicating the number of hours of continuing education credit. This may be used for professional education CE credit. Please consult your accrediting organization or licensing board for their acceptance of this CE activity. Participation CostsThere is no cost to participate in this activity.CME InquiriesFor all CME policy-related inquiries, please contact us at ce@affinityced.comSend customer support requests to cds_support+ldrtc@affinityced.com

Oral Alpan, MD, Immunologist, Amerimmune, Virginia, USA; Svenja Keller, PhD student, University of Zurich, Switzerland; Shoshana Revel-Vilk, MD, PhD, Director, Gaucher Unit & Pediatric Hematology/Oncology Unit, Shaare Zedek Medical Center, Jerusalem, Israel; Patrick Deegan, MD, Consultant Metabolic Physician, University of Cambridge, UK; and Ravi Kamath, MD, PhD, Head of Musculoskeletal Radiology, Inova Health System, Virginia, USA, discuss the applications of AI in the diagnosis and treatment of lysosomal disorders.This continuing education activity is provided through collaboration between the Lysosomal and Rare Disorders Research and Treatment Center (LDRTC), CheckRare CE, and AffinityCE. This activity provides continuing education credit for physicians, physician assistants, nurses, nurse practitioners, and genetic counselors. A statement of participation is available to other attendees.To obtain CME/CE credit, visit https://checkrare.com/learning/p-grids2025-session4-expanded-applications-of-ai-in-lysosomal-disorders/Learning ObjectivesDescribe how emerging AI and machine learning technologies are advancing disease modeling and biomarker development.Describe how emerging AI and machine learning technologies are advancing therapeutic target identification across lysosomal disorders.FacultyOral Alpan, MD, Immunologist, AmerimmuneSvenja Keller, PhD student, University of ZurichShoshana Revel-Vilk, MD, PhD, Director, Gaucher Unit & Pediatric Hematology/Oncology Unit, Shaare Zedek Medical CenterPatrick Deegan, MD, Consultant Metabolic Physician, University of CambridgeRavi Kamath, MD, PhD, Head of Musculoskeletal Radiology, Inova Health SystemDisclosuresAffinityCE staff, LDRTC staff, planners, and reviewers, have no relevant financial relationships with ineligible companies to disclose. Faculty disclosures, listed below, will also be disclosed at the beginning of the Program.Oral Alpan, MD Dr. Alpan has no relevant financial relationships to disclose.Svenja KellerMs. Keller has no relevant financial relationships to disclose.Shoshana Revel-Vilk, MD, PhDDr. Revel-Vilk receives grant/research support from Sanofi and Takeda. She is a member of the Speakers Bureau for Sanofi and Takeda, and a member of the Advisory Board for Takeda.Patrick Deegan, MDDr. Deegan is a consultant and advisory board member with Sanofi, Takeda, and Amicus.He also receives research support from Sanofi and Amicus.Ravi Kamath, MD, PhDDr. Kamath is on an advisory board for Intrinsic Therapeutics. He is also a consultant forSanofi, Takeda, and Spur Therapeutics.Mitigation of Relevant Financial RelationshipsAffinityCE adheres to the ACCME's Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CME activity, including faculty, planners, reviewers, or others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. Conflicts of interest for presenting faculty with relevant financial interests were resolved through peer review of content by a non-conflicted reviewer.Accreditation and Credit DesignationPhysiciansThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.Physician AssistantsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physician Assistants should claim only the credit commensurate with the extent of their participation in the activity.NursesAffinityCE is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation (ANCC). This activity provides a maximum of 1 hours of continuing nursing education credit.Nurse PractitionersAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Nurse practitioners should claim only the credit commensurate with the extent of their participation in the activity.Genetic CounselorsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Genetic Counselors should claim only the credit commensurate with the extent of their participation in the activity.Other ProfessionalsAll other health care professionals completing this continuing education activity will be issued a statement of participation indicating the number of hours of continuing education credit. This may be used for professional education CE credit. Please consult your accrediting organization or licensing board for their acceptance of this CE activity. Participation CostsThere is no cost to participate in this activity.CME InquiriesFor all CME policy-related inquiries, please contact us at ce@affinityced.comSend customer support requests to cds_support+ldrtc@affinityced.com

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/AAPA information, and to apply for credit, please visit us at PeerView.com/SCE865. CME/AAPA credit will be available until December 18, 2026.First Move Matters: Playing to Win in EoE – From Emergency Department Recognition to Continued Care Strategies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.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/AAPA information, and to apply for credit, please visit us at PeerView.com/SCE865. CME/AAPA credit will be available until December 18, 2026.First Move Matters: Playing to Win in EoE – From Emergency Department Recognition to Continued Care Strategies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.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/AAPA information, and to apply for credit, please visit us at PeerView.com/SCE865. CME/AAPA credit will be available until December 18, 2026.First Move Matters: Playing to Win in EoE – From Emergency Department Recognition to Continued Care Strategies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.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/AAPA information, and to apply for credit, please visit us at PeerView.com/SCE865. CME/AAPA credit will be available until December 18, 2026.First Move Matters: Playing to Win in EoE – From Emergency Department Recognition to Continued Care Strategies In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.Disclosure information is available at the beginning of the video presentation.

Chinese data shows the nation's economic slowdown deepened in November, Hong Kong pro-democracy activist and media mogul Jimmy Lai was convicted on all charges in a landmark national security trial, Sanofi shares are down after two setbacks for the company's multiple sclerosis treatment, ServiceNow is reportedly in talks to buy cybersecurity startup Armis, and Zootopia 2 has hit $1 billion at the box office.  Squawk Box is hosted by Joe Kernen, Becky Quick and Andrew Ross Sorkin.  Follow Squawk Pod for the best moments, interviews and analysis from our TV show in an audio-first format. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Dr Lucia Moreira Teixeira - CLIENT STORY  Lucia is the Immunology Lead at Sanofi.  In this episode we talk about:  The benefits and challenges of living and working in different countries.  How leveraging the Career Pivots® Compass methodology has resulted in rapid progress from Principal Scientist > Principal Scientist II > Team Lead in under 5 years.   The personal development benefits all aspects of life.  Connect with Lucia  https://www.linkedin.com/in/moreirateixeiralucia/    Kickstart your Intentional Careers Journey  Take the Career Accelerator Scorecard: https://scorecard.intentional-careers.com/strategy  Register for a free Intentional Careers workshop: https://intentional-careers.com/workshop/  Read The Book 'Intentional Careers for STEM Women': https://amzn.eu/d/bL9r8h0    Connect with Hannah  https://hannahnikeroberts.com/  www.linkedin.com/in/hannahrobertscoaching  www.facebook.com/drhannahroberts  X (Twitter) @HannahNikeR  Instagram @drhannahroberts  TikTok @drhannahroberts  YouTube @drhannahroberts   

Welcome to a RealTalk MS special series on MS clinical trials. This special series is made possible through a generous grant from Sanofi. In this final episode of this series, you'll meet Jan Janisch-Hanzlik. Jan lives with MS and is a participant in one of the clinical trials evaluating the safety and efficacy of CAR-T cell therapy for MS.  In CAR-T cell therapy, blood is taken from the patient or a healthy donor, much as you would donate blood. This blood is sent to a lab, where the white blood cells, or T-cells, are separated out and reprogrammed to carry a receptor designed to fight a particular condition. This receptor is known as a chimeric antigen receptor, or CAR. Over several weeks in the lab, these fortified T-cells multiply until there are millions of them, then they're reintroduced to the patient by intravenous infusion. CAR-T cell therapy is already used to treat some blood cancers, and Jan is the first person in the world to receive this one-and-done treatment to treat MS. She's joining us to share her experience participating in the clinical trial and to give us an update on how she's doing following her treatment.  This special episode of RealTalk MS is made possible by a generous grant from Sanofi. Sanofi has two ongoing Phase 3 clinical trials in MS studying Frexalimab, an investigational second-generation anti-CD40 ligand monoclonal antibody. If you are interested in learning more about these clinical trials, please visit SanofiStudies.com SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/ct4 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! Privacy Policy

Stig Brodersen is joined by Tobias Carlisle & Hari Ramachandra for another round of stock pitches. They discuss Sanofi, Remitly, and Crocs. IN THIS EPISODE YOU'LL LEARN: 00:00:00 - Intro 00:01:54 - Why Hari is bullish on Sanofi's strong vaccine and immunology pipeline (Ticker: NYSE: SNY) 00:05:30 - The bear case for Sanofi, including patent cliffs 00:19:26 - Why Stig is bullish on Remitly, highlighting operational leverage and a secular shift in digital payments and remittances (Ticker: NASDAQ: RELY) 00:43:10 - The bear case for Remitly, including pursuing the wrong strategy and excessive stock-based compensation 00:50:50 - Why Toby is bullish on Crocs, focusing on valuation and global growth (Ticker: NASDAQ: CROX) 01:02:36 - The bear case for Crocs, including tariffs and changing fashion trends 01:18:08 - Which live events we have planned for our Mastermind Community in 2026 — and how you can join Disclaimer: Slight discrepancies in the timestamps may occur due to podcast platform differences. BOOKS AND RESOURCES Join the exclusive ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TIP Mastermind Community⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ to engage in meaningful stock investing discussions with Stig, Clay, Kyle, and the other community members Check out our event in Montana Join us in Omaha for Berkshire Hathaway's annual shareholders' meeting Tobias Carlisle's book, Soldier of Fortune Stig Brodersen's Portfolio and Track record Listen to Mastermind Discussion Q3 2025 | YouTube video Listen to Mastermind Discussion Q2 2025 | YouTube video Listen to Mastermind Discussion Q1 2025 | YouTube video Listen to Mastermind Discussion Q4 2024 | YouTube video Listen to Mastermind Discussion Q3 2024 | YouTube video Listen to Mastermind Discussion Q2 2024 | YouTube video Listen to Mastermind Discussion Q1 2024 | YouTube video Tobias Carlisle's podcast, The Acquirers Podcast Tobias Carlisle's ETF, ZIG Tobias Carlisle's ETF, Deep Tweet directly to Tobias Carlisle Hari's Blog: BitsBusiness.com Tweet directly to Hari Related ⁠⁠⁠⁠⁠⁠⁠⁠books⁠⁠⁠⁠⁠⁠⁠⁠ mentioned in the podcast Ad-free episodes on our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠Premium Feed⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ NEW TO THE SHOW? Get smarter about valuing businesses in just a few minutes each week through our newsletter, ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠The Intrinsic Value Newsletter⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Check out our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠We Study Billionaires Starter Packs⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Follow our official social media accounts: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠X (Twitter)⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ | ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ | ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Instagram⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ | ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Facebook⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ | ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TikTok⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Browse through all our episodes (complete with transcripts) ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠here⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Try our tool for picking stock winners and managing our portfolios: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠TIP Finance Tool⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Enjoy exclusive perks from our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠favorite Apps and Services⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Learn how to better start, manage, and grow your business with the ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠best business podcasts⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ SPONSORS Support our free podcast by supporting our sponsors: Simple Mining Human Rights Foundation Unchained HardBlock Linkedin Talent Solutions Kubera Vanta reMarkable Onramp Public.com Netsuite Shopify Abundant Mines Horizon Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://theinvestorspodcastnetwork.supportingcast.fm