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Max Martina on Mastering Adaptive Leadership for Complex Challenges in Modern Business Cambridge-leadership.com About the Guest(s): Max Martina is an accomplished leader in the field of change leadership, currently serving as the President of Cambridge Leadership Associates, a prominent consultancy founded at Harvard’s Kennedy School of Government. With a robust background spanning over two decades in corporate management and startups, Max is also a partner at the executive advisory firm Nofsinger Group. His extensive consultancy expertise encompasses working with C-suite and board-level executives across both public and private sectors, with clients including major companies such as PepsiCo, IHG, Microsoft, Pfizer, Amgen, and Intel, along with organizations like the United Nations. Max has been featured in media outlets including CNN, NPR, and MSNBC and brings a wealth of knowledge to the realm of leadership consulting. Episode Summary: In this engaging episode of the Chris Voss Show, host Chris Voss welcomes Max Martina, a distinguished leader in change leadership, to explore the current dynamics and the pressing need for adaptive leadership in today’s fast-evolving world. The conversation delves into the intricacies of adaptive leadership, contrasting traditional models and emphasizing the necessity for a flexible, behavior-focused approach to tackle complex issues within organizations. Listeners get an in-depth look at how leadership is evolving with the rapid rise of AI, economical upheavals, and global challenges. Throughout the discussion, Voss and Martina highlight the notion that leadership is not synonymous with authority and that true leaders are those who practice and exhibit flexible behaviors suited to ever-changing environments. They explore the limitations of traditional leadership dogmas, such as trait theory, and the advantages of adaptive leadership, grounded in behavior and self-awareness. Martina shares insights into how executives can foster an environment that thrives amidst uncertainty, focusing on critical areas such as diagnostics, experimentation, and the shift from individual contributors to team-based leadership. This episode is a valuable resource for anyone interested in understanding modern leadership dynamics and how to apply these principles effectively. Key Takeaways: Adaptive leadership diverges from traditional theories, focusing on flexibility and behaviors over positions of authority. The need for self-awareness and behavior change is critical for effective leadership, particularly amid today’s rapid technological advancements. Adaptive leadership emphasizes diagnostics and experimentation in solving complex, adaptive problems that cannot be addressed by technical solutions alone. Building organizational capacity involves shifting from a focus on individual execution to fostering a conducive environment that supports collective learning and problem-solving. With AI driving unprecedented changes, the necessity for adaptive leadership has become more pronounced to keep up with the escalating rate of transformation. Notable Quotes: “Leadership isn’t about having authority; it’s about practicing certain behaviors regardless of your role or title.” “We’re outpacing humanity’s ability to respond systemically to the complexity that exists, and the antidote is leadership.” “Change isn’t hard, but adapting to the losses that change brings is what challenges us the most.” “Successful leadership requires diagnostics – understanding the source of the problem and the stakeholders involved.” “Organizations today need leaders who can not only solve problems but are curious enough to experiment and find new solutions.”
This episode covers: Cardiology This Week: A concise summary of recent studies Atrial septal defects in adults Conservative and invasive management of chronic coronary syndromes Milestones: 4S trial Host: Rick Grobbee Guests: JP Carpenter, Annemien van den Bosch, Rasha Al-Lamee, Roxana Mehran Want to watch the episode? Go to: https://esc365.escardio.org/event/2552 Want to watch the extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Roxana Mehran has declared to have potential conflicts of interest to report: institutional research payments from Abbott, Alleviant Medical, Chiesi, Concept Medical, Cordis, CPC Clinical Research, Daiichi Sankyo, Duke, Faraday Pharmaceuticals, Idorsia Pharmaceuticals, Janssen, MedAlliance, Medtronic, NewAmsterdam Pharma, Novartis, Novo Nordisk Inc., Population Health Research Institute (PHRI), Protembis GmbH, Radcliffe, RM Global Bioaccess Fund Management, Sanofi US Services, Inc. ; personal fees from: None ; Equity
Host: Rick Grobbee Guest: Annemien van den Bosch Want to watch that extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2552 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson
Thrive Corporate: Success Guide Wise Mind In this episode of Tim Stating the Obvious, host Tim Staton sits down with Edward Bjurstrom, author of The Success Guide: How to Thrive in the Corporate Environment. Drawing from over 40 years leading in biopharma at companies like Amgen and Gilead Sciences, Edward shares a practical roadmap for how to survive in corporate America and how to thrive in the corporate world—whether you're navigating high-stakes regulated environments or aiming to get promoted faster in a large company. Edward explains how to think and work holistically, balancing the rational mind (logic and facts) with the emotional mind (feelings and intuition) to reach the wise mind—that integrated state where decisions feel clear and effective. He dives into the rational mind vs emotional mind dynamic, why the wise mind rational mind emotional mind balance matters so much in leadership, and how understanding the psychological definition of a flow state can unlock peak individual and team performance. You get actionable insights on avoiding common pitfalls, fostering trust and accountability, and applying concepts like design thinking understanding how designers think and work to solve complex corporate challenges. Whether you're dealing with burnout, mistrust, or just wanting sustained success, Edward's lessons from his book offer a no-nonsense guide to building excellence without sacrificing well-being. Connect with Tim: Website: timstatingtheobvious.com Facebook: https://www.facebook.com/timstatingtheobvious YouTube: https://www.youtube.com/channel/UCHfDcITKUdniO8R3RP0lvdw Instagram: @TimStating TikTok: @timstatingtheobvious LinkedIn: https://www.linkedin.com/in/tim-staton-04b41a271/ SKOOL Community: https://www.skool.com/timstatingtheobvious-9537/about?ref=de9c7e65d8ba4eeabc1a8eea413c125b Enroll in the Leadership Course: https://themanyhatsofleadership.learnworlds.com/course/the-edge-mindset Connect with Edward Bjurstrom Book: https://www.amazon.com/dp/B0G4RBL543 Website : www.mountaintopconsul.com LinkedIn: linkedin.com/in/edwardbjurstrom Facebook: https://www.facebook.com/edward.bjurstrom
Ed Bjurstrom has decades of experience in management working in the pharmaceutical industry, including companies such as Amgen and Gilead Sciences. He owned Mountain Top Consulting and recently wrote a new book titled, "The Success Guide: How to Thrive in the Corporate Environment: A Focused Roadmap for Achieving Peak Performance, Leadership Excellence, and Building a Trust-Based Culture." Order your personal copy of his book at the link below! TIMESTAMPS 0:00 Introduction to Bjurstrom's Leadership Experience 2:55 How did your engineering brain aid you and challenge you in your leadership experience? 5:50 How difficult is it to change your thinking to encourage success? 8:40 How do you keep your emotions from hijacking your leadership when under stress? 12:50 What do you mean by being in a "zone of creative tension?" 17:13 How do you manage to get the rest and sleep you need while working in a demanding position? 20:50 What advice would you give a manager in trying to align people with their passions at work? 24:16 What is the "flow state?" 28:42 If you were building a team today, what characteristics would you look for in potential team members? 32:00 Closing Remarks "The Success Guide" Link: https://www.amazon.com/Success-Guide-Environment-Performance-Trust-Based-ebook/dp/B0G3YHKCDN/ref=sr_1_1?crid=27LN92PHV2VNS&dib=eyJ2IjoiMSJ9.tsXSY6Kn6S7ULsiMykokv5BwJrLUI2CpszYHxzUOgG97mMvLN9zJla7EA9y5JOPRgzB-mFPbL-40Ly0rXTv7qMzaJutCnWtrP8HA8WM0amSbTgNmk46QI6pl9zJJfHdVUwN4ezGpBVSIlD3Py-saEA.e8HgV-305B9a5o9UYfyq9zr6XyT_TSmnw2dgPvyQEpM&dib_tag=se&keywords=the+success+guide+how+to+thrive+in+the+corporate+environment&nsdOptOutParam=true&qid=1770905320&sprefix=how+to+thrive+in+a+corporate+e%2Caps%2C199&sr=8-1 Mountain Top Consulting: https://www.linkedin.com/company/mountain-top-consulting-llc/about/ Questions or comments? Email us at podcast@blackaby.org DONATE: If you have enjoyed this podcast and want to support our ministry into the next 20 years, click here: https://bit.ly/382Exi3 RESOURCES: Mark your calendars for May 18-20, 2026 when Richard will be presenting Experiencing God – Part 2 at the Cove in Asheville, NC. More info to come. Join Blackaby Ministries' next Spiritual Leadership Coaching Workshop here: https://www.blackabycoaching.org/workshop CONNECT: X: @richardblackaby Facebook: https://bit.ly/2WvZPzw Read Richard's latest blog posts at www.richardblackaby.com
Kevin Horner's Technical Tuesday covers the S&P 500 (SPX), Amazon (AMZN), and Amgen (AMGN). On the SPX, he looks at support and resistance levels, and warns that if it breaks down, it could move fast. Amazon is “by no means in a bullish pattern,” but he marks the location of its pullback, calling the $198 level “very interesting.” Amgen is looking to break out of a bull flag, with consolidation over the past week or so. ======== Schwab Network ========Empowering every investor and trader, every market day.Options involve risks and are not suitable for all investors. Before trading, read the Options Disclosure Document. http://bit.ly/2v9tH6DSubscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/About Schwab Network - https://schwabnetwork.com/about
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events shaping the landscape of drug development, regulatory scrutiny, and industry advancement. As we navigate this complex terrain, we'll explore how these changes impact both companies and patients.In recent news, Moderna has encountered a substantial hurdle as the FDA declined to review its flu vaccine candidate, mRNA-1010. This decision marks a notable shift from the expedited processes witnessed during the COVID-19 pandemic, reflecting a more cautious regulatory approach under current administrative leadership. Analysts suggest this could indicate broader regulatory changes that might affect future vaccine approvals. Moderna's situation is emblematic of the challenges companies face in maintaining momentum post-pandemic, especially as their research and development spending saw a significant decrease of 31% last year due to completed respiratory trials. This reduction highlights a strategic pivot as the company reassesses its priorities amidst an evolving market landscape.Vertex Pharmaceuticals is making headlines with its ambitious revenue goals outside its established cystic fibrosis franchise. By 2026, Vertex aims to generate $500 million from non-CF medications, with recent launches like Casgevy and Journavx already showing promise by collectively bringing in $175.6 million last year. This diversification strategy is critical for mitigating risks associated with dependence on a single therapeutic area and reflects a broader industry trend towards strategic realignment. Additionally, Vertex remains under close observation within kidney disease portfolios, particularly with Povetacicept—an IgA nephropathy treatment—and the success of Journavx impacting market positions by offering chronic kidney disease patients new therapeutic options.PTC Therapeutics has faced setbacks with its FDA application withdrawal for Translarna, intended for treating nonsense mutation Duchenne muscular dystrophy. The decision came after receiving adverse feedback from the FDA, highlighting the complexities involved in gaining approval for therapies targeting intricate genetic conditions. Such hurdles underscore the high-risk nature of biotech ventures that are heavily reliant on regulatory timelines.Novartis is pushing forward with plans to seek full FDA approval for Vanrafia, its IgA nephropathy drug, despite not meeting primary kidney function goals in Phase 3 trials. This move aligns with a growing trend where companies pursue approval based on secondary endpoints or other supportive data when primary outcomes fall short. Such strategies underscore the competitive and high-stakes environment surrounding drug approval pathways.Novo Nordisk is expanding its production capabilities in Ireland to meet increasing demand for Wegovy, their obesity drug that's seen impressive sales in the U.S. This investment underscores the global potential for obesity treatments and highlights how manufacturing expansions are pivotal to supporting international market entry.In Europe, Amgen has secured approval for Uplizna in treating myasthenia gravis, adding another option to an already crowded treatment landscape but offering patients additional therapeutic choices. Meanwhile, AbbVie has launched a legal challenge against Botox's inclusion in drug pricing negotiations under the Inflation Reduction Act (IRA), arguing it should be excluded due to its plasma-derived nature.Ultragenyx has announced a 10% workforce reduction amid halted gene therapy plans and unsuccessful late-stage trials in brittle bone disease. These adjustments often reflect broader strategic shifts within biopharma companies as they realign focus and resources. Ultragenyx's operational challenges highlight the volatile nature of biotech ventureSupport the show
Dr. Prem Subramanian, of the University of Colorado Sue Anschutz-Rodgers Eye Center and School of Medicine, talks with host Ben Shaberman about thyroid eye disease (TED), a condition that is often misdiagnosed and can cause a range of symptoms including discomfort and vision loss. Dr. Subramanian discusses potential causes, symptoms, and therapeutic approaches. This episode is sponsored by Amgen.
Combo treatment aims to be latest to enter the weight loss space; Amgen refuses to remove drug from market despite FDA request; Novo Nordisk threatens legal action against Hims & Hers; an oral film formulation of sildenafil is approved; and the FDA accepts the NDA for zanzalintinib plus atezolizumab for metastatic colorectal cancer.
On this week's episode, Graig Suvannavejh, Chris Garabedian, Eric Schmidt, and Yaron Werber kick off with a look at a big week for biotech IPOs, led by Veradermics and Eikon Therapeutics. The co-hosts note that this could mark the start of a healthy year for high‑quality IPOs, with many companies entering the market with mature assets Generate Biomedicines' S‑1 filing was highlighted as another positive signal for the industry. The conversation moves to policy, including Amgen's decision not to withdraw Tavneos after the FDA flagged data from a 2021 trial conducted by ChemoCentryx before it was acquired by Amgen. The group also discusses the narrowly passed spending bill that reauthorizes the FDA's rare pediatric disease priority review voucher program and the White House's rejection of fast‑track review for Compass Pathways' psychedelic. In obesity news, the group discusses Dr. Makary's signaling FDA will take action against compound pharmacies following HIMS' announcement that they will provide compounded semaglutide pills. The co-hosts also highlight promising clinical data from Pfizer and Metsera's GLP‑1 program and Amgen's investigational MariTide, which seem to reaffirm each other's data and the competition between Novo and Lilly. There's also discussion on the broader obesity landscape. In company updates, the group covers GSK returning rights to Wave for its lead rare disease asset. The episode concludes with discussion of GSK's decision to hold on a Phase 3 trials for its long‑acting TSLP program and upcoming Ocular Therapeutix wet AMD data. *This episode aired on February 6, 2026.
Host: Emer Joyce Guest: Borge Nordestgaard Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2548 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.
This episode covers: Cardiology This Week: A concise summary of recent studies Lp(a) and aortic valve stenosis The truth about climate change and heart disease Snapshots Host: Emer Joyce Guests: JP Carpenter, Borge Nordestgaard, Hugh Montgomery, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2548 Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Hugh Montgomery has declared to have potential conflicts of interest to report: funded and runs the charity-funded non-profit 'Real Zero'. Unpaid co-chair of the UK Health Alliance on Climate Change, Lancet Countdown on Health and Climate Change. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.
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 transformative landscape of the industry, where scientific advancements, strategic corporate maneuvers, and regulatory shifts are paving new paths for drug development and patient care.Starting with Amgen's recent progress, the company has achieved a significant milestone with its phase 2 trial of daxdilimab for discoid lupus erythematosus. This breakthrough could mark a turning point in lupus treatment, a notoriously challenging area due to the disease's complexity and variability. The success of daxdilimab may lead to more targeted biologic therapies that improve outcomes for patients with limited options. Additionally, Amgen's decision to resist the FDA's request to withdraw Tavneos underscores the intricate dynamics of regulatory negotiations, especially for treatments addressing niche conditions with critical patient needs. This scenario exemplifies the challenges in balancing regulatory scrutiny with clinical efficacy and patient needs.Novo Nordisk continues to assert its position in the competitive landscape of metabolic disorder treatments. Despite Pfizer's acquisition of Metsera, Novo is steadfast in advancing GLP-1 therapies, particularly focusing on innovative formulations that enhance patient compliance and efficacy. Novo Nordisk is also focusing on its oral version of Wegovy amid market pressures. Despite analyst concerns about this strategy's sufficiency, Novo remains confident in stabilizing its market position. The oral formulation represents an important innovation in drug delivery systems, potentially enhancing patient compliance and expanding therapeutic reach. This determination reflects Novo's long-term strategy to lead in obesity treatments, an area where GLP-1 receptor agonists have shown substantial promise.In another significant development, Eli Lilly has reported remarkable financial performance driven by its GLP-1 receptor agonists Mounjaro and Zepbound. These drugs have propelled revenues to $11.7 billion in the fourth quarter, surpassing analyst expectations and highlighting the growing demand for GLP-1 therapies crucial in managing diabetes and obesity.In a push for innovation, the U.S. Department of Health and Human Services has launched a $100 million prize for developing broad-spectrum antiviral therapies. This initiative comes at a crucial time when global health challenges demand versatile therapeutic solutions capable of addressing various viral threats. The competition encourages novel approaches in antiviral drug development, potentially leading to breakthroughs that could revolutionize infectious disease management.GSK's new CEO, Luke Miels, is setting a strategic course by identifying mergers and acquisitions valued between $2 billion and $4 billion as "hidden in plain sight" opportunities. This strategy mirrors a broader industry trend where companies bolster their pipelines through acquisitions that complement existing portfolios and expedite market entry for innovative therapies.The National Institutes of Health faces its own set of challenges amidst public scrutiny. Director Jayanta Bhattacharya's public dismissal of any link between vaccines and autism represents a crucial step toward reaffirming public trust in vaccination programs. This statement is vital in dismantling pervasive myths contributing to vaccine hesitancy and reinforcing the scientific consensus on vaccine safety.PrimeGen's pursuit of a SPAC route to Nasdaq highlights evolving capital-raising strategies within biotech, especially as stem cell therapies emerge as promising treatments for various conditions. Securing adequate funding through innovative financial instruments is critical for advancing research from preclinical stages to clinical applications.BioNTech's multi-modality platformSupport the show
Die Krebsfrüherkennung ist ein Thema, das oft verunsichert und gleichzeitig viel bewirken kann. Wir ordnen ein, für wen Früherkennung sinnvoll ist, was sie leisten kann und wo ihre Grenzen liegen. Ausserdem in dieser Folge: Welche Krebsarten in der Schweiz Früherkennungsprogramme oder Empfehlungen haben und warum diese Angebote so wichtig sind. Diese Folge richtet sich an dich, wenn du dich fragst, was Früherkennung für dich persönlich oder deine Angehörigen bedeutet. Erfahre, welche Möglichkeiten es gibt und was du jetzt für deine eigene Früherkennung tun kannstDiese Folge wird ermöglicht dank der Unterstützung von Amgen, Astellas, AstraZeneca und MSD. Wir freuen uns sehr über Rückmeldungen, Ideen und Themenvorschläge für unseren Podcast. Schreib uns gerne auf Instagram (@lebenmitkrebs_ch), Facebook (@LebenmitKrebsSchweiz) oder via E-Mail auf info@lebenmitkrebs.ch. Alles Liebe Nadine & Sandra Disclaimer:Gekennzeichnete Folgen wurden mit finanzieller Unterstützung der jeweiligen Unternehmen erstellt. Die Unternehmen haben keinen Einfluss auf den finalen Inhalt der Folgen. Die Unternehmen sowie die Produzentin übernehmen keine Verantwortung für wiedergegebenen Meinungen und Aussagen von Interviewpartnern in den jeweiligen Folgen. Die unterstützenden Unternehmen und die Redaktion geben ebenso wenig individuelle Empfehlungen in Bezug auf die Diagnose oder den Behandlungsplan von Patienten und Patientinnen. Diese Fragen sind mit den behandelnden Ärzt*innen zu besprechen.
In this week's episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Ahmed Enayetallah, PhD, MBBCh, Chief Development Officer at Dompé Farmaceutici, a company founded as the first compounding pharmacy in Milan, Italy, which has grown into a global biopharmaceutical company over 130 years. Currently, the company has a therapeutic pipeline focused on nerve growth factor (NGF)-based therapeutics in ocular diseases, including non-arteritic anterior ischemic optic neuropathy (NAION). Dompé has been a pioneer in translating NGF biology into medicine, building on decades of research by Nobel laureate Dr. Rita Levi-Montalcini. Dr. Enayetallah has a robust background in clinical research and deep expertise in drug development. His career has spanned several high-profile leading roles at pharmaceutical and biotechnology companies such as Amgen, Biogen, Pfizer and Alexion. He has led efforts in personalized medicine and oversaw multiple successful clinical programs that brought novel therapies to patients with high unmet needs. Prior to joining Dompé, he led the development organization at BlueRock Therapeutics. Dr. Enayetallah earned his medical degree from the University of Cairo and completed his PhD in Pharmacology and Toxicology at the University of Connecticut. Tune in to learn more about NGF biology and how it is being leveraged therapeutically in ocular diseases with high unmet need. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/xtalks/ Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured
Markets digest a flood of major earnings while tech volatility takes center stage. Jim Cramer interviewed NVIDIA CEO Jensen Huang and talks the AI trade scrutiny. Huang weighs in on OpenAI's massive fundraising round. Ke reports from AMD, Amgen, Chipotle, Mondelez and Super Micro. Christopher Rolland, Senior Analyst at Susquehanna, analyzes what the AMD results mean for the broader semiconductor trade.Jackson Ader, Senior Research Analyst at KeyBanc, joins to discuss the ongoing software selloff, while Venu Krishna, Head of U.S. Equity Strategy at Barclays, offers insight on market positioning and earnings momentum. A look ahead to Alphabet's earnings with Gil Luria, Managing Director and Senior Software Analyst at D.A. Davidson. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
We track some big moves in software stocks – and have an all-star line-up of reporters to tell us which companies are down the most and why this is all happening. Plus, it's a new era for Disney. We hear from Jim Stewart – who wrote the book on that company – about what could be next for the media giant with a new CEO in charge. And, we break down what to watch from Amgen, Chipotle and AMD earnings. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
European bourses opened stronger, but sentiment has dipped off best levels; US equity futures are modestly firmer, with mild outperformance is seen in the NQ.DXY is flat, Antipodeans benefit from a rebound in metals prices with outperformance in the Aussie after the RBA hiked rates by 25bps (as expected), whilst the SoMP noted that underlying inflation is higher than expected.Fixed income on the backfoot with supply in focus in a shutdown-thinned US docket.Crude prices initially lower but now flat; India to stop importing Russian oil as part of the trade deal with the US. Metals rebound with spot gold returning above USD 4900/oz.Looking ahead, highlights include US RCM/TIPP (Feb), New Zealand Unemployment (Q4), Australian S&P PMIs Final (Jan), Speakers including Fed's Bowman, Barkin & ECB's Lagarde.December JOLTS has been postponed, on account of the US government shutdown. Earnings from AMD, Supermicro, Amgen, Amcor, PayPal, PepsiCo, Pfizer, Merck.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk
APAC stocks were mostly higher with several bourses firmly recovering from the prior day's sell-off, as the region took impetus from the positive handover from Wall Street.US President Trump announced that India will stop buying Russian oil, while the US will be lowering tariffs on India to 18% from 25%.RBA hiked the Cash Rate by 25bps as expected in a unanimous decision, marking the first hike in over two years; RBA's SoMP noted that underlying inflation is higher than expected and GDP growth has continued to pick up.US BLS will not release the January jobs report on Friday due to the partial US Government shutdown, while December JOLTS (due 3rd Feb) has also been postponed.European equity futures indicate a positive cash market open with Euro Stoxx 50 futures up 0.4% after the cash market closed with gains of 1.0% on Monday.Looking ahead, highlights include Turkish Inflation (Jan), French Prelim. CPI (Jan), RCM/TIPP (Feb), New Zealand Unemployment (Q4), Australian S&P PMIs Final (Jan), Speakers including Fed's Bowman, Barkin & ECB's Lagarde, Supply from UK & Germany, Earnings from AMD, Supermicro, Amgen, Amcor, PayPal, PepsiCo, Pfizer, Merck & Publicis.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk
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
The most effective way to drive change in healthcare is to focus on what remains constant: serving patients. In this episode, sponsored by Amgen. Leandro Boer, Vice President of US Medical and General Medicines at Amgen, discusses how the company is reimagining care delivery to enhance access and outcomes, particularly for underserved populations. He explains how precision medicine, multi-omics, and advanced data use are driving innovation and preventing “data waste,” while Amgen invests heavily in R&D, including a $600 million Innovation and Discovery Science Center. Leandro highlights the role of technology in accelerating clinical trials through machine learning and anticipates three major shifts within the next five years: faster drug development, reduced administrative burden through the use of AI, and improved patient identification via care pathway automation. He also highlights Amgen's goal to reduce cardiovascular events by 50% by 2030, the importance of diverse clinical representation through the RISE initiative, and the company's commitment to employee well-being as the foundation for improved patient care. Tune in and learn how innovation, equity, and purpose-driven leadership are transforming the future of healthcare! Resources: Connect with and follow Leandro Boer on LinkedIn. Follow Amgen on LinkedIn and explore their website.
It's YOUR time to #EdUp with Dr. Edward Bush, President, Cosumnes River CollegeIn this episode, President Series #442, powered by Ellucian, & sponsored by the 2026 InsightsEDU Conference in Fort Lauderdale, Florida, February 17-19,YOUR cohost is Dr. Bernard A. Polnariev, Vice President for Administrative Services, UCNJYOUR host is Dr. Joe SallustioHow does a 15,000 student California community college become an Aspen Prize finalist twice while transfer students perform 20 points ahead of peers at selective universities?Why do Takeda, Amgen & the Navy base now pay for students to attend & request custom bachelor's degrees in bio manufacturing & applied cybersecurity to fill over 750 unfilled nationwide jobs?What does authentic relationship building mean for higher education's future when technology matters but connections with local economies & communities ultimately sustain institutional relevance?Listen in to #EdUpThank YOU so much for tuning in. Join us on the next episode for YOUR time to EdUp!Connect with YOUR EdUp Team - Elvin Freytes & Dr. Joe Sallustio● Join YOUR EdUp community at The EdUp ExperienceWe make education YOUR business!P.S. Want to get early, ad-free access & exclusive leadership content to help support the show? Become an #EdUp Premium Member today!
Big Pharma goes global, precious metals go vertical - then crash, and Wall Street braces for a new Fed era. Market View tracks AstraZeneca’s New York debut and what it signals about the race between the US and China for drug innovation. Gold and silver suffer their worst rout in decades after news of Kevin Warsh as Donald Trump’s pick for Fed chair. US stocks wobble as investors reassess rate-cut risks and a packed earnings week led by Disney, Amazon and Alphabet. Back home, Singapore’s STI holds the 4,900 line with United Overseas Land, ST Engineering and Wilmar in focus. All that and more, hosted by Michelle Martin with Ryan Huang. Hear about : AstraZeneca, Nio, Sony, UOB, Amgen, Merck, Pfizer, Palantir, Disney, Alphabet, Uber, Amazon, ST Engineering, Wilmar InternationalSee omnystudio.com/listener for privacy information.
«Tyrosinkinase Inhibitoren» - diese Therapie klingt kompliziert, ist jedoch gar nicht so schwer zu verstehen. Wir schauen uns an wie Krebszellen durch falsche Wachstumssignale angetrieben werden und wie TKI genau dort ansetzen und bremsen. Diese Folge wird ermöglicht dank der Unterstützung von Amgen, AstraZeneca und GSK. Mit ihrer kontinuierlichen Forschung setzen sie sich für neue, wirksamere Krebstherapien ein und arbeiten daran, die Lebensqualität von Patientinnen und Patienten zu verbessern.Wir freuen uns sehr über Rückmeldungen, Ideen und Themenvorschläge für unseren Podcast. Schreib uns gerne auf Instagram (@lebenmitkrebs_ch), Facebook (@LebenmitKrebsSchweiz) oder via E-Mail auf info@lebenmitkrebs.ch. Alles Liebe Nadine & Sandra Disclaimer:Gekennzeichnete Folgen wurden mit finanzieller Unterstützung der jeweiligen Unternehmen erstellt. Die Unternehmen haben keinen Einfluss auf den finalen Inhalt der Folgen. Die Unternehmen sowie die Produzentin übernehmen keine Verantwortung für wiedergegebenen Meinungen und Aussagen von Interviewpartnern in den jeweiligen Folgen. Die unterstützenden Unternehmen und die Redaktion geben ebenso wenig individuelle Empfehlungen in Bezug auf die Diagnose oder den Behandlungsplan von Patienten und Patientinnen. Diese Fragen sind mit den behandelnden Ärzt*innen zu besprechen.
IP Fridays - your intellectual property podcast about trademarks, patents, designs and much more
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.
On this week's episode, Josh Schimmer, Sam Fazeli, Brian Skorney, and Yaron Werber kick off with a discussion on policy with special guest BIO's CEO John Crowley, overviewing what it means for the U.S. to “win” the biotech race against China, emphasizing the need for innovation and ensuring access to medicines. The conversation shifts to the latest at the FDA, where John acknowledges concerns around consistency at the agency and expresses optimism following conversations with FDA leadership at the JP Morgan Healthcare conference earlier this month. Next, the co-hosts discuss major investments in China, including AstraZeneca's $15B commitment to China through 2030, focusing on R&D, manufacturing, and partnerships. Shifting back to U.S. policy, the group addresses the growing measles outbreak, highlighting the belief that science, data, and policy pressure will win out over anti-science rhetoric. Next, John notes that codifying MFN would be devastating for the industry. The conversation turns to deals, with Merck's decision not to acquire Revolution Medicines, noting that the company's current strong cash position and recent deals will likely make them attractive to Big Pharma in the future. Next, Eikon Therapeutics' planned $273.5M IPO is also highlighted. The episode concludes with an overview of the FDA's clinical hold on a Regenxbio gene therapy and discussion on Amgen stepping away from its OX40 partnership. *This episode aired on January 30, 2026.
Listen or watch along as we talk about Psychological support service at the Royal National Hospital for Rheumatic Diseases (RNHRD), Bath UK.In this episode, podcast host Mel Brooke, BIRDs Patient and Public Engagement Programme talks with Dr Natalie Slay, Specialist Clinical Psychologist at the RNHRD, RUH Bath about the emotional and psychological side of living with rheumatic disease. We explore how diagnosis affects identity, why stress and overwhelm are so common, and how simple tools like self-compassion and the “stress bucket” can help people understand their mental load and find steadier ways to cope.Useful Links:Wren ProjectNHS Every Mind mattersTalking Therapies (NHS)5 Steps to Mental Wellbeing (NHS)Other resources mentioned:Stress bucketResource packExplaining threat-drive-soothe I Haven't Been Entirely Honest with You” a book by Miranda Hart - (available in book stores)Paul Gilbert and the Compassion-Focused Therapy (CFT) - (you can search for this on the internet)Connect further with us:Have questions or thoughts about our information Podcast library? Interested in joining BIRDs patient research panel? Email Mel at ppe@birdbath.org.ukBe sure to subscribe, rate, and review the podcast to help us continue sharing information that matters!The Patient and Public Engagement Programme has been supported by hands-off sponsorships from Eli Lilly and Company Limited, UCB and Amgen -all of whom have provided grant funding but who have were not involved in the development, content or editorial control of this podcast, nor the subsequent review and approval of these materials or general running of the patient and public engagement programme.We would also like to thank The Arnold Clark Community Fund, The Cumber Family Charitable Trust, Medlock Charitable Trust, The Ray Harris Charitable Trust and The Hospital Saturday Fund.Thank you to all our sponsors for helping us to bring you information that supports you and helps to increase your knowledge of rheumatic diseases.Please visit the BIRD website to sign up for news at www.birdbath.org.uk
About Leandro Boer:Leandro Boer, MD, PhD, is a seasoned global biopharmaceutical executive and physician specializing in cardiology and cardiovascular pharmacology. Currently serving as Vice President of US Medical, General Medicines at Amgen, he leads medical strategy and execution across cardiovascular, bone, neuroscience, nephrology, and obesity therapeutic areas, overseeing a nationwide organization of over 100 professionals. With more than two decades of experience spanning the United States, Latin America, Canada, Africa, and the Middle East, Dr. Boer has built a distinguished career at leading companies such as Amgen, AstraZeneca, and Novartis.His leadership has shaped global and regional initiatives in medical affairs, clinical development, real-world evidence generation, regulatory strategy, and implementation science. Clinically, his expertise covers resistant hypertension, type 2 diabetes, obesity, heart failure, chronic kidney disease, and hyperlipidemia. Known for combining scientific rigor with strategic vision, Dr. Boer has directed cross-functional teams supporting drug development, commercialization, and lifecycle management across multiple therapeutic areas.A medical doctor trained in cardiology with a Ph.D. in cardiovascular pharmacology from Universidade Estadual de Campinas, Dr. Boer has consistently demonstrated a commitment to advancing evidence-based medicine, patient outcomes, and collaborative leadership within the healthcare ecosystem.Things You'll Learn:The foundation of innovation lies in focusing on what never changes—patients, healthcare providers, and equitable systems of care.Amgen's precision medicine and data-driven strategies prevent “data waste” and ensure every insight contributes to patient outcomes.Machine learning tools like Atomic are accelerating clinical trials by predicting successful sites, leading to faster drug development.The company's bold goal to reduce cardiovascular events by 50% by 2030 relies on partnerships, AI, and implementation science.Representation in clinical research and decentralized trials is crucial to ensuring equitable access and meaningful outcomes for all populations.Resources:Connect with and follow Leandro Boer on LinkedIn.Follow Amgen on LinkedIn and explore their website.
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.
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.
Today's guest is Emma Vitalini, Head of Global Digital Health Technology Innovation at Amgen, where she leads initiatives at the intersection of digital health, data strategy, and clinical innovation. Emma joins Emerj Editorial Senior Editor Marilie Fouche to explore how data and AI are reshaping patient recruitment, consent, and execution in clinical trials, with a focus on decentralized models, scalable compliance, and explainable AI in regulated environments. Emma also shares practical guidance for enterprise leaders on where AI is delivering near-term ROI today, including accelerating patient screening by surfacing unstructured data, reducing enrollment delays through digital and remote monitoring tools, and designing modular, plug-and-play AI platforms that balance speed, flexibility, and regulatory trust. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the 'AI in Business' podcast! If you've enjoyed or benefited from some of the insights of this episode, consider leaving us a five-star review on Apple Podcasts, and let us know what you learned, found helpful, or liked most about this show!
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.
On this week's episode, Chris Garabedian, Paul Matteis, Mike Yee, and Sam Fazeli recap the 2026 J.P. Morgan Healthcare Conference, noting that the biotech outlook for 2026 is broadly positive. Investor sentiment is noted as healthy but not overheated, and from the specialist community, the outlook is similarly upbeat. On the venture side, the M&A landscape also looks strong, with one of the best pre‑JPM financing weeks in at least a decade. The conversation turns to company updates, with Alnylam's 2030 strategy as well as Moderna's cost-cutting initiatives and upcoming vaccine readouts. On the deal front, the group covers AbbVie's $650M partnership with China-based RemeGen on a next‑gen PD‑1/VEGF bispecific antibody. AI developments were another key theme at JPM, including Pfizer's claim that AI contributed to $5.6B in cost reductions. In regulatory news, FDA flexibility, new CMC guidance for cell and gene therapies, and updates on Dr. Makary's CNPVs are overviewed. Next, the co-hosts cover the latest obesity news, including new oral GLP-1s and potential competition from Pfizer and Amgen in the monthly injectables market, as well as BMS and AbbVie's interest in entering the space. The episode concludes with rapid‑fire round of data updates in DMD, gene therapy, myeloma, cystic fibrosis, and Alzheimer's prevention. *This episode aired on January 16, 2026.
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/PYJ865. CME/AAPA credit will be available until January 5, 2027.Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease 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 independent medical education grants from Amgen; Genentech, a member of the Roche Group; and Jazz Pharmaceuticals.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/PYJ865. CME/AAPA credit will be available until January 5, 2027.Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease 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 independent medical education grants from Amgen; Genentech, a member of the Roche Group; and Jazz Pharmaceuticals.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/PYJ865. CME/AAPA credit will be available until January 5, 2027.Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease 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 independent medical education grants from Amgen; Genentech, a member of the Roche Group; and Jazz Pharmaceuticals.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. This morning, we're diving into a series of fascinating updates that underline the vibrant and ever-changing landscape of our industry.The J.P. Morgan Healthcare Conference recently set the stage for some intriguing discussions, particularly from Novo Nordisk. The company is diversifying its metabolic drug development portfolio by exploring innovative avenues, reflecting a broader industry trend where firms seek to balance their core expertise with novel therapeutic areas. This strategic diversification is crucial as companies aim to address complex health issues with an expansive approach to innovation. Novo Nordisk's leadership emphasized this strategic pivot towards diversifying their innovation pipeline beyond traditional metabolic disorders, aiming to keep the company at the forefront of pharmaceutical advancements.Meanwhile, Takeda's R&D head, Andy Plump, brought attention to some challenges currently facing U.S. innovation. Despite a sluggish start at the conference, recent months have been buzzing with significant deal-making activities. This scenario highlights the delicate dance between maintaining steady innovation and navigating regulatory hurdles and economic pressures. However, optimism remains high, with strategic investments and collaborations seen as potential catalysts for rejuvenation in research.Amgen made waves by presenting promising results from an exploratory study of Maritide in weight loss maintenance. The study's outcomes signal a significant milestone in obesity management and set the stage for further clinical trials and potential approval processes. This advancement offers hope in addressing what remains a critical public health issue worldwide.A significant development at the National Institutes of Health (NIH) is the leadership change as Dr. Gary Gibbons steps down as Director of the Heart, Lung, and Blood Institute. This shift adds to a growing list of interim leadership roles across NIH's 27 institutes and centers, which could impact continuity in critical research projects and funding initiatives.On the corporate front, Sonoma Pharmaceuticals announced notable workforce reductions due to financial challenges, while Lyra Therapeutics decided to abandon its rhinosinusitis treatment project alongside laying off its entire team. These decisions highlight the financial volatility that smaller biotech firms face amid competitive pressures and regulatory complexities. In contrast, Pretzel Therapeutics has emerged successfully from turbulent times, demonstrating resilience and adaptability within the biotech sector. Strategic restructuring and leadership realignment have positioned Pretzel Therapeutics for future growth in therapeutic development.A major highlight involves AbbVie entering into an agreement with the White House to reduce Medicaid drug prices while committing a substantial $100 billion investment in U.S. R&D over the next decade. This aligns with broader efforts to make healthcare more affordable while encouraging domestic pharmaceutical investment. AbbVie's substantial commitment towards U.S. R&D speaks volumes about their strategy within TrumpRx program contexts that aim at enhancing market penetration while balancing innovation investment against cost management pressures.Medtronic has expressed readiness to engage in mergers and acquisitions, indicating that medtech companies are poised for expansion through strategic buyouts. This move reflects an industry-wide capacity for growth through consolidation and collaboration. As we look towards mergers and acquisitions within medtech highlighted by Medtronic's intentions, it's clear that strategic M&A activities remain vital for companies seeking to expand capabilities and market presence in this competitive landscape.The FDA has aSupport the show
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/PYJ865. CME/AAPA credit will be available until January 5, 2027.Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease 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 independent medical education grants from Amgen; Genentech, a member of the Roche Group; and Jazz Pharmaceuticals.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/PYJ865. CME/AAPA credit will be available until January 5, 2027.Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease 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 independent medical education grants from Amgen; Genentech, a member of the Roche Group; and Jazz Pharmaceuticals.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/PYJ865. CME/AAPA credit will be available until January 5, 2027.Innovation Takes the Lead in SCLC: Leveraging Evolving Advances to Drive Improved Outcomes in Limited- and Extensive-Stage Disease 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 independent medical education grants from Amgen; Genentech, a member of the Roche Group; and Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.
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
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world.The industry continues to navigate a dynamic landscape marked by significant scientific advancements, regulatory changes, and strategic shifts. Eli Lilly's acquisition of Ventyx Biosciences for $1.2 billion underscores Lilly's commitment to expanding its portfolio in inflammation-related therapeutics, particularly following promising readouts in Parkinson's and cardiovascular conditions. This acquisition exemplifies big pharma's strategy to bolster pipelines with promising biotechs, reflecting an industry-wide focus on innovation-driven growth. Concurrently, Lilly has partnered with InduPro in a potential $950 million deal to develop next-generation cancer treatments, highlighting the ongoing trend of leveraging innovative biotech approaches to address complex oncological challenges.In regulatory news, the FDA issued an untitled letter to Esperion Therapeutics concerning misleading claims in a commercial for its cholesterol-lowering drug, Nexlizet. This action highlights the FDA's continued vigilance over direct-to-consumer advertising practices, ensuring that pharmaceutical promotions remain accurate and evidence-based. Meanwhile, the FDA has also eased regulations on AI-enabled consumer wearables, allowing more devices to enter the market under the wellness category without full regulatory review. This shift may accelerate the adoption of digital health technologies, fostering innovation and potentially enhancing patient care through more personalized and accessible health monitoring solutions.Clinical trial and study findings continue to shape therapeutic strategies across various domains. Gilead Sciences reported that while HIV can develop resistance to its antiviral drug lenacapavir, this adaptation compromises the virus's replication capabilities. This finding underscores the ongoing challenges in antiviral therapy development and the need for continued research into resistance mechanisms. In obesity management, Viking Therapeutics is ramping up commercialization efforts to compete with major players like Amgen and Eli Lilly, while Novo Nordisk is engaging in public discourse to address weight stigma, emphasizing the multifaceted nature of obesity.The biosimilar sector is at a pivotal juncture as it confronts what some term a 'biosimilar void.' With key patents set to expire and evolving global policies, stakeholders are urged to reassess strategies to maintain momentum in this cost-reduction avenue for biologic therapies. This period presents opportunities for innovation in biosimilar development and commercialization strategies.In organizational updates, AstraZeneca appointed Rick Suarez as head of its U.S. biopharma unit, leading a $50 billion investment surge aimed at strengthening its foothold in the American market. Such strategic leadership appointments are crucial as companies navigate competitive landscapes and pursue ambitious growth targets.The industry's response to COVID-19 continues to evolve, with Inflarx adjusting its business strategy by reducing its workforce by 30% and reallocating resources from COVID-related projects to focus on its promising candidate for inflammatory conditions. This strategic pivot reflects broader industry trends where companies re-evaluate their portfolios post-pandemic to align with core strengths and emerging opportunities.Furthermore, partnerships remain integral to advancing therapeutic innovations. Lexeo Therapeutics has teamed up with Johnson & Johnson's Abiomed unit to explore heart pump technology as a delivery system for cardiac gene therapies. Such collaborations are instrumental in driving forward cutting-edge treatment modalities that could significantly impact patient outcomes in cardiology.The pharmaceutical and biotech sectors are witnessing significant financiSupport 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 groundbreaking advancements and strategic movements shaping the future of healthcare.The pharmaceutical and biotech sectors are undergoing significant transformations, driven by scientific breakthroughs, regulatory developments, and strategic shifts. At the forefront is Eli Lilly's impressive lineup of investigational cardiometabolic drugs, spotlighted in Clarivate's "Drugs to Watch in 2026" report. This signals a robust focus on combating cardiometabolic disorders, which have vast implications for global health due to their widespread prevalence. The report also highlights Johnson & Johnson's competitive position in this therapeutic area, indicating a dynamic landscape where innovation is key.In oncology, Jazz Pharmaceuticals is making waves with its bispecific antibody, Ziihera, positioning it as a preferred HER2-targeted therapy for stomach cancer. This development marks a shift towards precision medicine and targeted therapies, which are gradually supplanting traditional treatments like Herceptin. The promising efficacy of Ziihera could revolutionize treatment protocols for HER2-positive gastric cancer patients, enhancing survival outcomes and quality of life.Meanwhile, a legal confrontation has erupted between Bayer and leading COVID-19 vaccine developers such as Moderna, Johnson & Johnson, and Pfizer-BioNTech. Bayer alleges patent infringement on intellectual property developed years prior. This lawsuit underscores the intricate relationship between innovation and intellectual property rights in the pharmaceutical industry, especially poignant in the aftermath of the COVID-19 pandemic.Daiichi Sankyo's collaboration with Genesis to commercialize Vanflyta—an acute myeloid leukemia treatment—across 13 European countries highlights strategic movements in oncology. Approved in 2023, this partnership exemplifies Daiichi's commitment to expanding its European market presence and improving patient access to critical cancer therapies.GSK's promising Phase 3 results for its hepatitis B drug candidate represent a potential breakthrough as a "functional cure." Such advancements could redefine management strategies for hepatitis B, a chronic infection affecting millions worldwide. The positive trial outcomes pave the way for FDA submission, showcasing GSK's dedication to addressing unmet medical needs through innovative approaches.Amgen's strategic partnership with Disco Pharmaceuticals illustrates ongoing investment in oncology research. With a $618 million agreement focused on cancer target discovery, Amgen leverages Disco's expertise to fortify its oncology pipeline. This collaboration underscores the significance of cooperative innovation in drug development and enhancing therapeutic options.In gene therapy, Ikarovec and VectorBuilder are advancing eye disease treatments through an innovative partnership. Their $1 billion deal aims to make gene therapies more accessible by enabling administration outside specialized settings—a transformative approach that could democratize advanced treatments.Hope Biosciences' Phase 2 study results offer hope for Parkinson's disease patients through stem cell therapy improvements in motor function. Despite some data discrepancies, these findings set the stage for Phase 3 trials and underscore the potential of stem cell therapies in neurological disorders.The pharmaceutical industry also grapples with economic challenges as layoffs rise by 16% year-over-year in 2025. Concurrently, despite regulatory hurdles and macroeconomic uncertainties, the FDA approved 55 new treatments and vaccines—a testament to resilience and innovation within biopharma.In regulatory dynamics, GSK's Exdensur received approval in Japan for treating severe asthma and chronic rhinosinusitisSupport the show
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
Obesity titans Novo Nordisk and Eli Lilly characteristically kicked off 2026 in the headlines. After capping 2025 with the first-ever FDA approval of an oral GLP-1 for obesity, Novo launched its Wegovy pill on Monday, starting at $149 per month out of pocket for the lower doses. Meanwhile, all eyes are on Lilly, which expects a greenlight for orforglipron as early as March. The oral weight loss play is set to be a key aspect of a pivotal year for Lilly, which hopes to more than double its annual revenue in just a few years. Also pulling a rabbit out of a hat just before Christmas were nine drugmakers—including Amgen, Bristol Myers Squibb, Boehringer Ingelheim—which signed Most Favored Nation drug pricing agreements with the Trump administration, likely securing their businesses against the threat of tariffs. However, drug pricing will continue to be top of mind in 2026, experts told BioSpace, as only about half of Big Pharmas have signed a deal, and small and mid-sized companies haven't yet begun. Another area biopharma leaders are watching with bated breath is the FDA. The overwhelming consensus from experts who spoke with BioSpace is that last year was a disaster—particularly from a workforce standpoint. Still, the agency approved 56 novel drugs, down just a tick from 2024's 59. Advisory committees fell off considerably, in both number and concordance, however, according to a report by Jefferies, as these meetings came under scrutiny by FDA leadership. In 2026, will the unprecedented leadership turnover—especially at CDER—settle down? Will the new rare disease and cell and gene therapy policies bear first fruits? Also on the regulatory front, the CDC has already been busy this year, axing several childhood vaccines from its recommended schedule with potential implications for biopharma companies including Pfizer and Merck. And if there's one area biopharma watchers anticipate even more than regulatory action, it's M&A action. Last month, analysts shared their top targets with BioSpace, listing names like Summit Therapeutics, Apogee Therapeutics and Axsome Therapeutics. Here at BioSpace, we'll stick with Viking. Finally, don't forget to check out our NextGen Class of 2026—featuring 15 biotech startups whose mission and platforms cut through a challenging environment. And make sure to join us next week when senior editor Annalee Armstrong and news editor Dan Samorodnitsky will provide dispatches from the J.P. Morgan Healthcare Conference.
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This is the 70th episode in my drug pronunciation series. In this episode, I divide Corlanor and ivabradine into syllables, tell you which syllables to emphasize, and share my sources. The written pronunciations are below and in the show notes on https://www.thepharmacistsvoice.com. Note: we don't cover pharmacology in this series. Just pronunciations. ⭐️Sign up for The Pharmacist's Voice ® monthly email newsletter! https://bit.ly/3AHJIaF ⭐️ Corlanor = core-lan-ore Core, like an apple core (also, Cor in Latin translates to "heart" in English) lan, like lanai - a type of porch commonly associated with the state of Hawaii ore, as in iron ore comes from Michigan No syllable is emphasized in the literature, so give all three syllables equal emphasis. My two cents: when I say Corlanor, I emphasize the first syllable, "Core." Written pronunciation source: medication guide for Corlanor on Amgen's website. Spoken pronunciation examples: drugs.com and cardiologist Dr. Tara Narula says it on YouTube. ivabradine = eye-VAB-ra-deen eye, as in Eye of the Tiger (a famous song) https://bit.ly/49cTTRL VAB, which rhymes with "fab," (like the word, fabulous) ra, like rough - as in sandpaper feels rough deen, like the Dean of a college of pharmacy Written pronunciation sources: USP dictionary online, MedlinePlus.gov, and drugs.com. Spoken pronunciation example: drugs.com If you know someone who would like to learn how to say Corlanor and ivabradine, please share this episode with them. Subscribe for all future episodes. This podcast is on all major podcast players and YouTube. Popular links are below. ⬇️ Apple Podcasts https://apple.co/42yqXOG Spotify https://spoti.fi/3qAk3uY Amazon/Audible https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt Host Background: Kim Newlove has been an Ohio pharmacist since 2001 (BS Pharm, Chem Minor). Her experience includes hospital, retail, compounding, and behavioral health. She is also an author, voice actor (medical narrator and audiobook narrator), podcast host, and consultant (audio production and podcasting). Other episodes in this series The Pharmacist's Voice Podcast Episode 360, Pronunciation Series Episode 69 (Kisunla) The Pharmacist's Voice Podcast Episode 358, Pronunciation Series Episode 68 (Journavx) The Pharmacist's Voice Podcast Episode 356, Pronunciation Series Episode 67 (Zanaflex) The Pharmacist's Voice Podcast Episode 352, Pronunciation Series Episode 66 (Yescarta) The Pharmacist's Voice Podcast Episode 350, Pronunciation Series Episode 65 (Xarelto) The Pharmacist's Voice Podcast Episode 349, Pronunciation Series Episode 64 (acetaminophen) The Pharmacist's Voice Podcast Episode 348, Pronunciation Series Episode 63 (Welchol/colesevelam) The Pharmacist's Voice Podcast Episode 346, Pronunciation Series Episode 62 (valacyclovir) The Pharmacist's Voice Podcast Episode 343, Pronunciation Series Episode 61 (ubrogepant) The Pharmacist's Voice Podcast Episode 341, Pronunciation Series Episode 60 (topiramate) The Pharmacist's Voice Podcast Episode 339, Pronunciation Series Episode 59 (Suboxone) The Pharmacist's Voice Podcast Episode 337, Pronunciation Series Episode 58 (rosuvastatin) The Pharmacist's Voice Podcast Episode 335, Pronunciation Series Episode 57 (QVAR) The Pharmacist's Voice Podcast Episode 333, Pronunciation Series Episode 56 (pantoprazole) The Pharmacist's Voice Podcast Episode 330, Pronunciation Series Episode 55 (oxcarbazepine) The Pharmacist's Voice Podcast Episode 328, Pronunciation Series Episode 54 (nalmefene) The Pharmacist's Voice Podcast Episode 326, Pronunciation Series Episode 53 (Myrbetriq) The Pharmacist's Voice Podcast Episode 324, Pronunciation Series Episode 52 (liraglutide) The Pharmacist's Voice Podcast Episode 322, Pronunciation Series Episode 51 (ketamine) The Pharmacist's Voice Podcast Episode 320, Pronunciation Series Episode 50 (Jantoven) The Pharmacist's Voice Podcast Episode 318, Pronunciation Series Episode 49 (ipratropium) The Pharmacist's Voice Podcast Episode 316, Pronunciation Series Episode 48 (hyoscyamine) The Pharmacist's Voice Podcast Episode 313, Pronunciation Series Episode 47 (guaifenesin) The Pharmacist's Voice Podcast Episode 311, Pronunciation Series Episode 46 (fluticasone) The Pharmacist's Voice Podcast Episode 309, Pronunciation Series Episode 45 (empagliflozin) The Pharmacist's Voice Podcast Episode 307, Pronunciation Series Episode 44 (dapagliflozin) The Pharmacist's Voice Podcast Episode 304, Pronunciation Series Episode 43 (cetirizine) The Pharmacist's Voice Podcast Episode 302, Pronunciation Series Episode 42 (buspirone) The Pharmacist's Voice Podcast Episode 301, Pronunciation Series Episode 41 (azithromycin) The Pharmacist's Voice Podcast Episode 298, Pronunciation Series Episode 40 (umeclidinium) The Pharmacist's Voice Podcast Episode 296, Pronunciation Series Episode 39 (Januvia) The Pharmacist's Voice Podcast Episode 294, Pronunciation Series Episode 38 (Yasmin) The Pharmacist's Voice Podcast Episode 292, Pronunciation Series Episode 37 (Xanax, alprazolam) The Pharmacist's Voice Podcast Episode 290, Pronunciation Series Episode 36 (quetiapine) The Pharmacist's Voice Podcast Episode 287, pronunciation series ep 35 (bupropion) The Pharmacist's Voice Podcast Episode 285, pronunciation series ep 34 (fentanyl) The Pharmacist's Voice Podcast Ep 281, Pronunciation Series Ep 33 levothyroxine (Synthroid) The Pharmacist's Voice ® Podcast Ep 278, Pronunciation Series Ep 32 ondansetron (Zofran) The Pharmacist's Voice ® Podcast Episode 276, pronunciation series episode 31 (tocilizumab-aazg) The Pharmacist's Voice ® Podcast Episode 274, pronunciation series episode 30 (citalopram and escitalopram) The Pharmacist's Voice ® Podcast Episode 272, pronunciation series episode 29 (losartan) The Pharmacist's Voice Podcast Episode 269, pronunciation series episode 28 (tirzepatide) The Pharmacist's Voice Podcast Episode 267, pronunciation series episode 27 (atorvastatin) The Pharmacist's Voice Podcast Episode 265, pronunciation series episode 26 (omeprazole) The Pharmacist's Voice Podcast Episode 263, pronunciation series episode 25 (PDE-5 inhibitors) The Pharmacist's Voice Podcast Episode 259, pronunciation series episode 24 (ketorolac) The Pharmacist's Voice ® Podcast episode 254, pronunciation series episode 23 (Paxlovid) The Pharmacist's Voice ® Podcast episode 250, pronunciation series episode 22 (metformin/Glucophage) The Pharmacist's Voice Podcast ® episode 245, pronunciation series episode 21 (naltrexone/Vivitrol) The Pharmacist's Voice ® Podcast episode 240, pronunciation series episode 20 (levalbuterol) The Pharmacist's Voice ® Podcast episode 236, pronunciation series episode 19 (phentermine) The Pharmacist's Voice ® Podcast episode 228, pronunciation series episode 18 (ezetimibe) The Pharmacist's Voice ® Podcast episode 219, pronunciation series episode 17 (semaglutide) The Pharmacist's Voice ® Podcast episode 215, pronunciation series episode 16 (mifepristone and misoprostol) The Pharmacist's Voice ® Podcast episode 211, pronunciation series episode 15 (Humira®) The Pharmacist's Voice ® Podcast episode 202, pronunciation series episode 14 (SMZ-TMP) The Pharmacist's Voice ® Podcast episode 198, pronunciation series episode 13 (carisoprodol) The Pharmacist's Voice ® Podcast episode 194, pronunciation series episode 12 (tianeptine) The Pharmacist's Voice ® Podcast episode 188, pronunciation series episode 11 (insulin icodec) The Pharmacist's Voice ® Podcast episode 184, pronunciation series episode 10 (phenytoin and isotretinoin) The Pharmacist's Voice ® Podcast episode 180, pronunciation series episode 9 Apretude® (cabotegravir) The Pharmacist's Voice ® Podcast episode 177, pronunciation series episode 8 (metoprolol) The Pharmacist's Voice ® Podcast episode 164, pronunciation series episode 7 (levetiracetam) The Pharmacist's Voice ® Podcast episode 159, pronunciation series episode 6 (talimogene laherparepvec or T-VEC) The Pharmacist's Voice ® Podcast episode 155, pronunciation series episode 5 Trulicity® (dulaglutide) The Pharmacist's Voice ® Podcast episode 148, pronunciation series episode 4 Besponsa® (inotuzumab ozogamicin) The Pharmacist's Voice ® Podcast episode 142, pronunciation series episode 3 Zolmitriptan and Zokinvy The Pharmacist's Voice ® Podcast episode 138, pronunciation series episode 2 Molnupiravir and Taltz The Pharmacist's Voice ® Podcast episode 134, pronunciation series episode 1 Eszopiclone and Qulipta Kim's websites and social media links: ✅ Guest Application Form (The Pharmacist's Voice Podcast) https://bit.ly/41iGogX ✅ Monthly email newsletter sign-up link https://bit.ly/3AHJIaF ✅ LinkedIn Newsletter link https://bit.ly/40VmV5B ✅ Business website https://www.thepharmacistsvoice.com ✅ Get my FREE eBook and audiobook about podcasting ✅ The Pharmacist's Voice ® Podcast https://www.thepharmacistsvoice.com/podcast ✅ Drug pronunciation course https://www.kimnewlove.com ✅ Podcasting course https://www.kimnewlove.com/podcasting ✅ LinkedIn https://www.linkedin.com/in/kimnewlove ✅ Facebook https://www.facebook.com/kim.newlove.96 ✅ Twitter https://twitter.com/KimNewloveVO ✅ Instagram https://www.instagram.com/kimnewlovevo/ ✅ YouTube https://www.youtube.com/channel/UCA3UyhNBi9CCqIMP8t1wRZQ ✅ ACX (Audiobook Narrator Profile) https://www.acx.com/narrator?p=A10FSORRTANJ4Z ✅ Start a podcast with my coach, Dave Jackson from The School of Podcasting! *New 12-4-25* Click my affiliate link: https://community.schoolofpodcasting.com/invitation?code=G43D3G Thank you for listening to episode 362 of The Pharmacist's Voice ® Podcast. 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This episode explores the critical role of post-fracture care (PFC) in improving patient care and optimizing healthcare systems. Two program coordinators highlight real-world examples of how PFC can reduce the risk of subsequent fractures and lower healthcare costs. They also share actionable strategies for how to integrate PFC best practices into existing healthcare frameworks including aligning objectives with the organization's broader strategic goals and establishing and tracking against clear metrics.This episode is sponsored by Amgen.
This episode features Olivier Godement, Head of Product for Business Products at OpenAI, discussing the current state and future of AI adoption in enterprises, with a particular focus on the recent releases of GPT 5.1 and Codex. The conversation explores how these models are achieving meaningful automation in specific domains like coding, customer support, and life sciences: where companies like Amgen are using AI to accelerate drug development timelines from months to weeks through automated regulatory documentation. Olivier reveals that while complete job automation remains challenging and requires substantial scaffolding, harnesses, and evaluation frameworks, certain use cases like coding are reaching a tipping point where engineers would "riot" if AI tools were taken away. The discussion covers the importance of cost reduction in unlocking new use cases, the emerging significance of reinforcement fine-tuning (RFT) for frontier customers, and OpenAI's philosophy of providing not just models but reference architectures and harnesses to maximize developer success. (0:00) Intro(1:46) Discussing GPT-5.1(2:57) Adoption and Impact of Codex(4:09) Scientific Community's Use of GPT-5.1(6:37) Challenges in AI Automation(8:19) AI in Life Sciences and Pharma(11:48) Enterprise AI Adoption and Ecosystem(16:04) Future of AI Models and Continuous Learning(24:20) Cost and Efficiency in AI Deployment(27:10) Reinforcement Learning and Enterprise Use Cases(31:17) Key Factors Influencing Model Choice(34:21) Challenges in Model Deployment and Adaptation(38:29) Voice Technology: The Next Frontier(41:08) The Rise of AI in Software Engineering(52:09) Quickfire With your co-hosts: @jacobeffron - Partner at Redpoint, Former PM Flatiron Health @patrickachase - Partner at Redpoint, Former ML Engineer LinkedIn @ericabrescia - Former COO Github, Founder Bitnami (acq'd by VMWare) @jordan_segall - Partner at Redpoint
This podcast continues the important conversation on osteoporosis, shining a spotlight on how health systems can leverage features within their Electronic Health Record (EHR) systems to improve care for postmenopausal osteoporosis patients.Christen Buseman, Health Systems and Key Accounts Marketing Director at Amgen for the US bone health franchise speaks with Barry Wendt, MD, of St. Elizabeth Healthcare about how health systems can leverage Diagnosis-Aware Notes (DAN) within EHR systems to improve postmenopausal osteoporosis care. This episode is sponsored by Amgen and the participants have been compensated for their time.This episode is sponsored by Amgen.