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Dr. Monty Pal and Dr. Vamsi Velcheti discuss the evolving treatment landscape in EGFR-mutated non-small cell lung cancer, including landmark trials like FLAURA2, novel drug therapies, and the growing importance of ctDNA and MRD testing. TRANSCRIPT Dr. Monty Pal: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist and professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, I'm truly delighted to introduce Dr. Vamsi Velcheti, who's a professor of medicine and the chief of hematology-oncology at the Mayo Clinic in Jacksonville, Florida. We'll be discussing the expanding treatment landscape in EGFR-positive lung cancer and how to navigate the challenges of balancing treatment efficacy, toxicity, and patient quality of life in the EGFR-positive space.  Just FYI, our full disclosures are available in the transcript of this episode.  Vamsi, it's so great to have you on the podcast. Thank you so much for being here. Dr. Vamsi Velcheti: Thank you, Monty. It's a pleasure to be here with you. It's a really exciting topic and there are a lot of updates in the EGFR space. Dr. Monty Pal: So, I'm going to need your help with this because I'll be honest with you, I see very little lung cancer, if any, in my practice. I'm pretty much exclusively kidney cancer these days. I'm coming on 20 years at City of Hope now, and I still remember when trials like ECOG 1599 were presented with, you know, platinum doublets. And, of course, the field has changed a lot since then. But tell us a little bit about the first-line landscape, and I think just for the sake of time, we're going to stick with EGFR-positive disease here. What does it look like these days? Dr. Vamsi Velcheti: Monty, the foundation of care remains the third-generation EGFR inhibitors. These are selective EGFR inhibitors, like osimertinib. We've had an evolution of the development of these TKIs. Like, you know, we had the first-generation, second-generation, not-so-selective EGFR inhibitors. Now we have mutant-selective EGFR inhibitors in the clinic, and they're doing a really good job. And these are quite effective in patients who have classical activating mutations. But the reality is that these have not been transformative. These agents have fundamentally changed the response patterns, excellent CNS penetration, and very good tolerability profile. However, we don't see a lot of durability in terms of the response. So, what's different today is now there have been several trials in combination with these third-generation EGFR inhibitors that have really laid the foundation of how we kind of think about EGFR-positive disease. At the high level, there are a lot of challenges to selecting the patients for these combination-based modalities. I'm assuming we'll be talking more about these different trials and different approaches. Some of these combination-based strategies have really moved the needle in terms of improving overall survival and really improving long-term outcomes and durability in our patients. Dr. Monty Pal: And we are going to get into the weeds on this in just a moment. But I did kick off this podcast talking about chemotherapy, ECOG 1599. It does seem as though chemotherapy is still a component of management in advanced non-small cell lung cancer. So, can you tell us about, perhaps first, you mentioned osimertinib, you know, some of these next-generation EGFR inhibitors. Tell us about the role of chemo plus osimertinib. Dr. Vamsi Velcheti: That's exactly where I was going with the combination-based strategies. You know, we first started off with our earlier trials in the EGFR space evaluating the question of, are targeted therapies, are these highly effective, third-generation, EGFR-selective inhibitors, superior to platinum-doublet chemotherapy? And we've had multiple trials demonstrating that, like the FLAURA trial and in the past with second-generation EGFR inhibitors like erlotinib and gefitinib and afatinib. So, we know that these TKIs actually perform better than platinum-doublet chemotherapy. Now, we have a large, global, phase 3 trial data from the FLAURA2 trial, which looks at the question, "Hey, you know, osimertinib is better than chemotherapy, platinum-doublet chemotherapy. Can we do even better by combining osimertinib with platinum-doublet chemotherapy?" So, FLAURA2 answered that question. This is a large, phase 3 trial, and it's a positive trial with improved durability of disease control and improving overall survival with combination with chemotherapy. So, it's a very important and landmark trial, and essentially combining osimertinib with a platinum-based chemotherapy improved responses, deepened responses, and improved overall survival and really changing the disease trajectory. And this strategy is definitely compelling, especially in patients who have certain clinical high-risk features like, you know, patients who have high disease burden or patients who are sometimes having rapid disease progression early on osimertinib, especially with patients who have a lot of visceral disease burden. So, intensifying treatments up front could alter the natural trajectory of the disease. Dr. Monty Pal: So, you sort of alluded to this in that last part there, but is that kind of how you in clinical practice select? Is it based on, you know, visceral involvement? Is it based on rapidity of disease where you think about adding chemotherapy to osimertinib? Maybe you can give us the corollary. Which patients do you just use osimertinib alone in, for instance? Dr. Vamsi Velcheti: Definitely, there are some patients who have low disease burden and they have the classical mutations, like an exon 19 deletion. And these patients, especially if they don't have a lot of disease burden, they don't have CNS involvement, there may be a subset of patients who could just do fine on osimertinib of course, with close monitoring of the disease. I guess we'll get into that later, how do we do that with either ctDNA or like closer imaging or both. So, there may be some opportunity to kind of escalate patients' treatments based on certain clinical characteristics or radiographic characteristics or certain biological characteristics informed by ctDNA or other approaches. Dr. Monty Pal: No, that's interesting. And you're right, we will chat about ctDNA in just a bit. But before we get there, I think one of the big agents that has really sort of come to the fore in advanced non-small cell lung cancer is amivantamab. I've heard a lot about this in the context of even kidney cancer because in certain subsets, I'm interested in MET-directed therapies and so forth, right? So maybe tell us a little bit about the mechanism of amivantamab first, and then maybe tell us about this pivotal MARIPOSA trial where it's combined with lazertinib. Dr. Vamsi Velcheti: So, the MARIPOSA trial compared lazertinib alone with amivantamab plus lazertinib. And this trial demonstrated overall survival advantage, and there were key differences in terms of tolerability and the safety of amivantamab, which is an EGFR and MET bispecific, and there were certain kind of unique toxicity profiles that make it a little different than the intensification approach with chemotherapy through the FLAURA2 trial. So, there's a trade-off in terms of the toxicity profile. It's a different agent and a different management protocol in terms of dermatological toxicity management that clinicians need to be comfortable with. And also, there are certain unique issues in terms of amivantamab; there's a higher rate of infusion-related reactions, there's an increased risk for edema and VTEs because of amivantamab. Certainly a different toxicity profile, different management paradigm there in terms of longitudinal care of these patients requiring dermatological care and like, you know, close monitoring and prophylaxis VTEs. But having said that, definitely it's a different strategy, and it kind of changes the biology and the natural history of the cancers, and we do see some durability of responses that we see with the MARIPOSA. So, it's certainly a great alternative, at least for some patients. Dr. Monty Pal: That was a great overview of MARIPOSA. Now comes the really difficult question, which is, how do you choose between the two? You have these two great options, right, for EGFR-positive patients. You've already highlighted some of the distinctions in terms of toxicity. I think the audience is well aware of the side effects of chemo-doublet, perhaps even the EGFR-based therapies. Amivantamab is quite new. Give us a sense of how you in clinical practice decide between the two potential options here. Dr. Vamsi Velcheti: Yeah, I think that's the big challenge. I think these are two independent strategies that have evolved through the phase 3, and both of them have demonstrated overall survival benefit. So, the way I think about this is in three dimensions, right? Like, the disease biology, the patient priorities, and feasibility of care delivery. So, when I talk about the disease biology, you know, the mechanism is very different, and MET is a very dominant driver of disease in EGFR-altered patients and it's a significant mechanism of resistance, acquired resistance to TKIs. So, certainly I think there's a patient population that could benefit from a MET-directed therapy up front. However, we don't have great data to kind of really demonstrate how using amivantamab in the front line is going to change that. And are there like perhaps like some patients who we could identify who would benefit from such a strategy? Very recently, there have been some approvals in the second-line setting in lung cancer, not in the EGFR space, but like in generally in lung cancer, with the MET ADCs, and those drugs are approved with a companion diagnostic, which requires MET IHC testing. So, what has happened, at least in large academic practices and also I think in the community now, they have been checking for MET IHC expression more routinely in lung cancer. What we have been doing in our institution is we have been doing MET IHC as a reflex for all patients with EGFR, not just EGFR, but all non-small cell lung cancer patients. What that has done is now, like, we have been increasingly testing patients with EGFR for MET. And there's clearly a subset of patients who have de novo MET expression and a high MET expression. And those patients, I've been kind of like preferentially treating them with the MARIPOSA regimen. But again, I have to caution the audience that we still don't have data that MET IHC is going to help us make those decisions, whether it's better than like a FLAURA2 regimen. But however, in the second-line setting in the CHRYSALIS trial, we know that MET is a very powerful predictor of response to amivantamab. We really need more data there, but that's what I have been doing in my practice. But also, there's a lot of patient preference here. Like, there are some patients who don't want chemotherapy, and they want a non-chemotherapy approach. So, certainly there are some patients who prefer to have amivantamab. And now with the amivantamab, the subcutaneous version, the infusion reactions and the logistics of actual administration of amivantamab are more favorable with the subcutaneous approval. So, those are some of the elements that we need to take into account. Dr. Monty Pal: Well, I want to hone in on that because this subcutaneous administration route has been a big debate that I've seen on social media. Tell us, how much easier does it actually make the amivantamab experience? Does it cut down on the rash? Is it just infusion reactions? What's been your clinical experience? Vamsi Velcheti, MD: So, the subcutaneous administration of amivantamab has definitely improved the infusion reaction issue. Very rarely patients have infusion reaction now with the subcutaneous injections. And also, the infusion time is much, much shorter. Like we don't need a lot of infusion time, which is sometimes a challenge in busy infusion clinics. We need to take that into account. As far as the impact of the subcutaneous formulation on dermatological toxicity, we haven't really seen significant difference in terms of the intensity or rates of dermatological toxicity with subcutaneous. The benefits are really with the infusion reaction, the ease of administration. And interestingly, in the PALOMA trial, it also seems to be, even though this was not the primary endpoint of the study, there seems to be some suggestion that the subcutaneous amivantamab seems to have improved OS compared to the IV amivantamab. We don't really understand why, but that's a finding from the trial that's very intriguing. Dr. Monty Pal: That is really fascinating. I'm kind of curious to see how that's going to pan out. I'm going to shift gears a little bit here. And, you know, as we sort of close, I wanted to talk a little bit about biomarkers. I mean, this is obviously not a lung cancer-specific issue. It's something we think about across the board. But what I will say is that there are certain commonalities, and in bladder cancer, we think a lot now about ctDNA. But you've been way ahead of the game in lung cancer. Tell us how you guys use ctDNA, maybe both from the standpoint of monitoring for mutational status, but if you can, maybe offer some insights into some of these new MRD tests that are available too. Dr. Vamsi Velcheti: Yeah, it's rapidly evolving. Certainly, I think in the lung cancer space, you know, this has really kicked off in the lung cancer space with incorporating ctDNA into the workflow. Of course, you know, like baseline evaluation, we still kind of heavily rely on tissue genomic sequencing. But as you know, with targeted therapy, a lot of these patients have disease that evolves over time, and changes in terms of mutational pattern driving acquired resistance is a major issue across different molecular subtypes. And especially so in EGFR, when there are certain actionable opportunities associated with that transformation. So, we need to kind of have like a longitudinal snapshot of how we monitor these patients. So, the ctDNA has come to be like a tool that has now come to the forefront of clinical workflow, and almost all my patients who are having disease progression have ctDNA for kind of evaluating for resistance and informing treatment decisions, especially in EGFR. But having said that, there are a lot of challenges in terms of using ctDNA as a tool for monitoring. There are a lot of different types of assays and different platforms, and being able to use this as a quantitative tool that would be used along with the CT scans that we routinely use in clinical practice has been a challenge. And I think I would love to hear your perspectives as well, Monty, about how you're thinking about that in bladder and other disease contexts. But having said that, I think there's a lot of opportunity to incorporate ctDNA and MRD assays into clinical decision-making. Right now, in terms of clinical trials and clinical development, there have been some very interesting trials that are currently ongoing, especially in the EGFR space. We know that patients who clear ctDNA, based on some retrospective data and also like some retrospective-prospective data from trials that have already read out, that patients who clear ctDNA early with target therapy tend to do much better. They have a longer durability of response. There may be a subset of patients who have, even though they're having radiographic response, they have persistent ctDNA after a certain time point of initiation of targeted therapy. Those patients may require escalation of therapy. We don't yet know. I can't recommend that as a standard right now because we don't have clinical evidence to support that. But however, some of the clinical trials, like the ELIOS trial that's being done right now, that's actually completed enrollment, we'll hopefully see the results very soon. So, there is an emerging thought that instead of intensifying treatment for all patients with EGFR, there may be a population that may be just fine with frontline osimertinib monotherapy and introducing the intensification strategy at the time of emergence of MRD or progression on ctDNA before radiographic progression. So, there are a lot of adaptive molecular response criteria that we are kind of exploring in clinical trials that could inform how the future is going to look like for EGFR and other perhaps targeted therapies as well. So, it's fascinating, and I think there's a lot of opportunity there. Dr. Monty Pal: You know, you asked for my perspective. I actually think that what you highlighted there is the most interesting opportunity for ctDNA: the ability to de-escalate therapy. In terms of drug development, we've done so much to bring new therapies to patients, and now it's a bit of an embarrassment of riches, but the downside is that I feel like we tend to overtreat a lot of patients in the clinic. So, I definitely view MRD, you know, some of these other ctDNA techniques with methylation and so forth that may not be sort of tumor-dependent or bespoke could be incredibly, incredibly helpful. You touched on sort of the future, right, in this last section here with biomarkers. But give us a sense now in terms of novel drug therapies in the EGFR space. What are you most excited about moving forward in 2026 and beyond? Dr. Vamsi Velcheti: Yeah, I think there's a lot going on in this space, and not just this space, but across lung cancer and others as well. Like looking at the next generation of targets for ADCs. And I think a lot of these have to do with…so far in the drug development space, as you know, the improvements in clinical outcomes has been very incremental. So, we really need to make that big leap. And I think the big leap is not going to come from, in my opinion, from the next ADC, but it's going to come from how we tailor treatments and how we monitor disease better and how do we kind of incorporate the next treatment earlier and not wait for the radiographic progression. So, there's a lot of opportunity there to integrate biomarkers and dynamic biomarkers into clinical trial design and incorporating the recent advances in terms of drug design. You know, we have a lot of assets in the EGFR space, the next-generation EGFR inhibitors that are kind of designed with resistance in mind and rational combination, knowing when to introduce those combinations is also equally important. So, there's a lot going on, really exciting times to be in drug development. The one thing that I really hope will come to the forefront in drug development, not just for lung cancer, but all disease groups, is to kind of really be thoughtful about how we incorporate these really cool molecular monitoring tools and creating a composite score with imaging to be able to like really design the next generation of clinical trials. Dr. Monty Pal: You're so spot-on with that. I definitely think that we're getting to this point where, you know, we could think about the next BiTE, the next CAR-T, the next ADC. But, you know, maybe it's time for us to start really honing in on appropriate applications of these drugs, honing in on the right dose and what have you, because I definitely see some issues there.  Vamsi, this has just been terrific. I really want to thank you so much for sharing your fantastic insights with us today on the ASCO Daily News Podcast, and I really appreciate all your efforts to move the field of lung cancer forward. Dr. Vamsi Velcheti: Thanks, Monty. I really enjoyed the conversation. Dr. Monty Pal: Yeah, this was terrific.  And thanks to our listeners as well. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. 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. Monty Pal   @montypal  Dr. Vamsi Velcheti @VamsiVelcheti Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Vamsi Velcheti:   Honoraria: Galvanize Therapeutics  Consulting or Advisory Role: Bristol-Myers Squibb, Merck, AstraZeneca/MedImmune, GSK, Amgen, Taiho Oncology, Novocure, Regeneron, Takeda, Janssen Oncology, Picture Health Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline

This Special Episode on Atrial Fibrillation covers: Cardiology this Week: A concise summary of recent studies Atrial fibrillation burden: clinical relevance of a new outcome Pulsed field ablation: game changer? Drug treatment following atrial fibrillation ablation Spotlight: Holiday Heart Syndrome Host: Rick Grobbee Guests: Rick Grobbee, Konstantinos Koskinas, Jason Andrade, Arian Sultan, Michiel Rienstra Want to watch that special episode? Go to: https://esc365.escardio.org/event/2549 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, Jason Andrade, Yasmina Bououdina, Rick Grobbee 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. 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.  Michiel Rienstra has declared to have potential conflicts of interest to report: consultancy fees from Bayer (OCEANIC-AF national PI) , InCarda Therapeutics (RESTORE-SR national PI), Novartis to the institution. Speaker fee from Daiichi-Sankyo, Pfizer to the institution. Unrestricted research grant from the Dutch Heart Foundation and is conducted in collaboration with and supported by the Dutch CardioVascular Alliance, 01-002-2022-0118 EmbRACE. Unrestricted research grant from ZonMW and the Dutch Heart Foundation; DECISION project 848090001. Unrestricted research grants from the Netherlands Cardiovascular Research Initiative: an initiative with support of the Dutch Heart Foundation; RACE V (CVON 2014–9), RED-CVD (CVON2017-11). Unrestricted research grant from Top Sector Life Sciences & Health to the Dutch Heart Foundation (PPP Allowance; CVON-AI (2018B017). Unrestricted research grant from the European Union's Horizon 2020 research and innovation programme under grant agreement; EHRA-PATHS (945260). This research is funded by the Dutch Heart Foundation and is conducted in collaboration with and supported by the Dutch CardioVascular Alliance, 01 -002 -2022 -0118 EmbRACE.  Emma Svennberg has declared to have potential conflicts

Enterprises are operationalizing artificial intelligence at scale, moving from experimentation to accountability. Gabriele Ricci of Takeda and Board Director Karenann Terrell discuss how leaders can embed AI into core operations, address unfinished digital foundations, and measure success by outcomes—not through pilots.

Host: Sabiha Gati Guest: Thomas F. Luescher Want to watch that extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2556 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, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology this Week: A concise summary of recent studies The future of guidelines in an era of big data and AI Exercise in hypertrophic cardiomyopathy Snapshots Host: Sabiha Gati Guests: Kostas Koskinas, Thomas F. Luescher, Michael Papadakis, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2556 Want to watch the extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?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, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher 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.

Dans ce nouvel épisode de Cheminements, enregistré en live lors de la Journée Patient & Pharma, nous explorons les coulisses d'une collaboration fructueuse entre le monde associatif et l'industrie pharmaceutique. Loin des postures de principe, nos invitées nous expliquent comment elles ont bâti une relation durable pour répondre aux enjeux critiques des déficits immunitaires primitifs (DIP). De la lutte contre l'errance diagnostique à la sécurisation de l'accès aux immunoglobulines, découvrez comment l'écoute du "savoir expérientiel" des patients transforme concrètement le développement des solutions de santé et influence les politiques publiques.Les intervenants :Virginie Milière : déléguée générale de l'association IRIS (représentation et accompagnement des personnes atteintes de déficits immunitaires primitifs).Tania Aydenian : directrice du département Value-Based Partnerships chez Takeda.Les sujets abordés dans l'épisode :La genèse et l'évolution de la relation de confiance entre IRIS et Takeda malgré les restructurations industrielles.Les défis spécifiques des DIP : une errance diagnostique de 6 ans en moyenne et une dépendance aux médicaments dérivés du plasma.La différence entre un simple changement de conditionnement et une réelle innovation améliorant la qualité de vie des patients.L'importance de la transparence : savoir se dire les choses, même quand elles sont difficiles, pour avancer vers un objectif commun.La création de l'Alliance Plasma : un plaidoyer unique regroupant industriels et associations pour peser sur les décisions publiques.L'engagement humain au-delà du cadre professionnel, illustré par la participation des collaborateurs aux événements associatifs.Crédits :Écriture : Marguerite de RodellecProduction : MedShake StudioCet épisode à été enregistré durant la première édition de la Journée Patients & Pharma, un événement pour créer un véritable espace de dialogue entre représentants de patients et industrie qui a eu lieu le 4 décembre 2025, à la Maison A. Trocadéro. Chers auditeurs, je vous informe que d'autres épisodes exclusifs du podcast Cheminements ont été enregistrés en direct, pour donner la parole à des binômes patients / laboratoires qui sont venus raconter leurs collaborations, leurs défis, et parfois même… leurs histoires d'amour professionnelles. Alors si ce sujet vous parle, rejoignez-nous.Ressources :https://patientspharma.com/En ouvrant le dictionnaire, on apprend que "cheminement" désigne une progression graduelle, un mouvement, une avance graduelle.➡ Retrouvez tous les épisodes sur https://www.cheminements.co/❤️ Soutenez-nous gratuitement :Abonnez-vous !Laissez 5 étoiles et un avis sur Apple Podcasts ou Spotify ⭐Cheminements, le podcast santé des femmes, dans vos oreilles chaque semaine.Hébergé par Ausha. Visitez ausha.co/politique-de-confidentialite pour plus d'informations.

Episode 103 features Coach Chijo Takeda! Coach Chijo is a volleyball coach, educator, and content creator known for teaching the fundamentals of indoor volleyball with clarity, articulation, and energy. Through his online platforms, he has built a rapidly growing community of youth athletes and coaches who value skill development, confidence-building, and culture-driven leadership. In addition to coaching on the court, Chijo shares in-depth volleyball insights on YouTube and Instagram, regularly hosting IG Lives to answer questions and support coaches around the world. He also offers an online membership community designed to help coaches grow their knowledge, leadership, and impact. Coach Chijo is passionate about developing not just better players, but better people through the game of volleyball. Coach Chijo's Links: Website: https://coachchijo.com/ Youtube Channel: https://www.youtube.com/@CoachChijo Instagram: https://www.instagram.com/coachchijo/ Tik Tok: https://www.tiktok.com/@coachchijo In this episode we discuss: • Building real confidence in young athletes • Creating a culture that develops leaders • Coaching without ego • The mindset behind elite performance • What the next generation of volleyball truly needs This conversation is for players, coaches, and parents who want more than just skill development, they want growth from the inside out. Coach Chijo shares what it really takes to develop inspired, confident, resilient athletes in today's game. If you're serious about volleyball and personal growth, this episode is for you.

HOST:  Hildy Grossman, CO-HOST: Jordan Rich GUEST: Sumati Ram-Mohan, Vice President of Upstage Lung Cancer Why did singer and cabaret performer Hildy Grossman launch Upstage Lung Cancer 18 years ago? In this episode, Hildy describes how a fluke accident resulted in early detection of her lung cancer and put her on a life-changing path. When faced with an early diagnosis, Hildy didn't just ask "Why me?"—she asked, "What now?" She realized that while anyone with lungs can get lung cancer, not everyone has a stage to fight it. Thus, Upstage Lung Cancer was created as the only lung cancer organization to exclusively produce concerts and the performing arts to raise awareness, reduce stigma and fund cutting edge medical research. In a meeting of Art & Science, our guest, Sumati Ram-Mohan, a scientist and dancer, shares her story of how and why she reached out to Hildy. Now the Vice President of Upstage Lung Cancer, Sumati discusses how her experience in lung research and her passion for the stage help move this organization forward. Among other things, this podcast series, now ranked in the top 5 out of 40 lung cancer podcasts, was created to be both engaging, enjoyable and informative. They discuss almost two decades of outreach and impact, ending with a look ahead to this year's Fall Concert – an evening of joy aimed at this difficult disease. We thank our sponsors Lilly, Bristol Meyers Squibb, Revolution Medicines, Boehringer Ingelheim, and Takeda for their generous support of our podcast series Backstage @ Upstage.

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 some pivotal advancements and strategic shifts within the industry, highlighting how these changes are shaping the future of patient care and drug development.Let's start with Bristol Myers Squibb, which has been making headlines with its latest success in the realm of antibody-drug conjugates (ADCs). The company's ADC has reached an important milestone in a Phase 3 breast cancer trial conducted in China. This study successfully met its dual primary survival endpoints, affirming the company's significant $800 million investment in this promising drug candidate. The potential of ADCs in oncology cannot be overstated; they offer a remarkable combination of targeted therapy by harnessing the specificity of antibodies alongside the cytotoxic power of traditional chemotherapy. This approach not only enhances precision in treatment but also minimizes collateral damage to healthy tissues, showcasing the transformative potential of ADCs in cancer therapy.On the regulatory front, there are ongoing discussions about the impact of political decisions on drug pricing and innovation. The Trump administration's Most Favored Nation drug pricing policy has stirred significant concern within the biotech sector. In response, ten midsize biotech firms have united to form the Midsized Biotech Alliance of America to challenge this policy. They argue that such pricing strategies could hinder innovation by enforcing restrictive pricing models, potentially stalling the development pipeline for new therapies that address unmet medical needs.In terms of strategic corporate movements, Boehringer Ingelheim has entered into a $500 million partnership with a British biotech firm aimed at developing an oral therapy for autoimmune diseases. This collaboration is part of a broader trend towards precision medicine which focuses on modulating specific immune cells to improve treatment outcomes while minimizing unwanted side effects. It's a clear indication that companies are increasingly investing in targeted therapies that promise better efficacy and patient safety. Additionally, Boehringer Ingelheim's partnership with Sitryx underscores another trend: strategic partnerships aimed at innovative research endeavors with substantial investment commitments—potentially exceeding $500 million—to explore immune response modulation.The acquisition landscape is also seeing dynamic shifts. Asahi Kasei's acquisition of Germany's AiCuris for $920 million marks a strategic move to enhance its R&D capabilities, specifically focusing on antiviral therapies for immunocompromised patients. This acquisition aligns with growing global attention towards infectious disease research, especially in a post-pandemic era where preparedness and rapid response capabilities have become paramount.Meanwhile, Sarepta Therapeutics is undergoing a significant leadership change as CEO Doug Ingram announces his retirement. Ingram's leadership was characterized by notable advancements in treatments for Duchenne muscular dystrophy (DMD), although it wasn't without its share of challenges regarding regulatory and pricing debates. As Sarepta continues to expand its gene therapy pipeline, this leadership transition comes at a crucial juncture, potentially setting new directions for the company's future.Accent Therapeutics' recent decision to halt its solid tumor trial due to adverse events exemplifies the risks inherent in drug development. The company is now redirecting its focus towards other cancer programs, illustrating how adaptability remains key in navigating clinical setbacks.Protagonist Therapeutics has made a strategic choice by accepting a $400 million payment from Takeda instead of sharing profits from its hematology asset rusfertide. This decision may provideSupport the show

In the industry news section of this week's episode, we kick things off with Tamarind Bio's efforts to develop user-friendly artificial intelligence tools for science researchers. Then we examine the impact of the U.S. Food and Drug Administration's reversal on its earlier refusal to review Moderna's mRNA vaccine for the flu, discuss Gilead's acquisition of Arcellx to expand its cancer therapy pipeline, and dive into Takeda's investment in Vir Biotech's prostate cancer candidate. Then on the research front, we get into the science behind new protein-like polymers engineered to target and degrade some of cancer's most challenging driver proteins. And we discuss a potential control switch for CAR T cells that could make these immunotherapies much safer. Join GEN editors Corinna Singleman, PhD, Fay Lin, PhD, Uduak Thomas and Alex Philippidis for a discussion of the latest biotech and biopharma news. Listed below are links to the GEN stories referenced in this episode of Touching Base: Tamarind Bio Secures $13.6M Series A to Make AI More Accessible for BiologyBy Fay Lin, PhD, GEN Edge, February 24, 2026 StockWatch: FDA Reversal Boosts Moderna, But Not Other Vaccine CompaniesBy Alex Philippidis, GEN Edge, February 21, 2026Gilead to Acquire Arcellx for $7.8B, Adding Anito-Cel to Cancer PipelineBy Alex Philippidis, GEN Edge, February 23, 2026Astellas, Vir Biotechnology Launch Up-to-$1.7B Prostate Cancer CollaborationBy Alex Philippidis, GEN, February 26, 2026New Protein-Like Polymers Target, Degrade “Undruggable” Proteins Driving CancerGEN, February 11, 2026Drug-Controlled CAR T Cells May Enable Safer ImmunotherapyGEN, February 23, 2026Touching Base Podcast Hosted by Corinna Singleman, PhD Behind the Breakthroughs Hosted by Jonathan D. Grinstein, PhD Hosted on Acast. See acast.com/privacy for more information.

In this episode, we hear from Tina S., an individual living with HAE and an adult recipient of the Pam King HAEA Scholarship. Tina shares her journey, the impact of the scholarship, and how educational support can make a difference for individuals affected by HAE, regardless of age or stage of life. Learn more about the HAEA Scholarships by visiting: https://www.haea.org/pages/p/scholarshipsThank you to our 2026 sponsors: BioCryst, CSL Behring, IONIS Pharmaceuticals, and Takeda.

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Jessica Grady, a patient advocate living with EoE. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:50] Co-host Ryan Piansky introduces this episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:13] Holly introduces today's topic — eosinophilic esophagitis and life transitions — and today's guest, Jessica Grady, a patient advocate living with EoE.   [1:35] Jessica is a mom who was diagnosed with EoE in her 20s, after years of unexplained symptoms: acid reflux, GERD, food impaction, and anxiety around food. For about six years, Jessica searched for answers while dealing with these issues.   [2:00] Since then, Jessica has tried PPIs, steroids, and two clinical trials. She was always interested in the research, so being part of it has been valuable to her. There's a lot of work involved in clinical trials, and it's not easy.   [2:29] Jessica is managing her condition and has hit her second endoscopy with remission, with dupilumab. That's exciting, after her long journey. It has taught her the importance of advocating for yourself and staying hopeful with a chronic condition.   [3:01] After college, Jessica was going out with friends, and had pain almost like ulcers in her stomach. She thought maybe she was going out too much.   [3:20] One day at lunch, water got stuck. Jessica says it was like gargling; it wouldn't go down. Finally, it went down, and she took a bite of food, and that got stuck. That was her first episode. After that, Jessica has had food impactions as her main symptom.   [3:54] Jessica says it's quite a reality check when you're choking on water. How is that even possible? Once that happened, Jessica kicked herself into gear and had an endoscopy.   [4:12] Food impaction is Jessica's number one symptom. She has been to dinners where it happened, and she calmly excused herself from the table until she could finally get the food to go down.   [4:34] As Jessica aged, her food impactions started getting longer. That was terrifying, especially as a Mom needing to take care of her baby.   [4:52] Holly shares how she had symptoms from infancy and all the way through her childhood, and it was diagnosed as anxiety, until she started working in an EoE clinic and recognized her symptoms. Getting an EoE diagnosis is often very challenging.   [5:40] Jessica went to three different hospitals in her area. She didn't know what kind of doctor to look for. She went to a GI, got an endoscopy, and woke up with a fat lip. The doctor told her not to have caffeine and start on PPIs.   [6:11] There was no mention of a biopsy or EoE. She was told she had bad acid reflux and ulcers.   [6:35] The PPIs didn't help. She still had acid reflux and impactions. She was still uncomfortable.   [6:47] Jessica switched to another healthcare system and got closer to the answer, with more endoscopies and testing, but there was no research with it.   [7:02] Finally, Jessica switched to where she is today. There is a doctor and research. They run clinical trials. She gets the latest and greatest updates. She feels like it has helped her get to where she is today.   [7:21] Jessica said the doctor knew what to look for. The moment she described her symptoms, the doctor said it would need to be confirmed with a biopsy, but she has EoE. Jessica asked what now?    [7:34] Ryan says, we hear a lot of difficulty with diagnosis because not all doctors know what to look for. If they see ulcers or other common symptoms that people with EoE have, they can very easily misdiagnose. It's a tricky diagnosis to make.   [8:03] Jessica says that before her EoE diagnosis, doctors told her she had GERD, acid reflux, ulcers, and anxiety around food. They asked what her food choices were and if she was taking too big bites.   [8:12] Jessica asked the doctors why she always needs to have a bottle of water with her, and why she feels panic if there's something like a soft pretzel. They told her she was hyperactive and had anxiety. Jessica felt that that was not making sense.   [8:40] That is why Jessica feels it is so important to advocate. There's a lot of time involved when you're misdiagnosed. You get your hopes up and have lots of highs and lows. It's exhausting.   [8:53] Ryan says that when you do get diagnosed, you can start to treat the underlying condition properly, make progress, feel better, and feel like you're being listened to.   [9:30] Jessica's current course of treatment is PPIs and dupilumab. She's learned her food triggers. Being on the biologic means she doesn't have to worry as much about her triggers, but they can still cause symptoms. She doesn't eat nuts or pineapple.   [10:16] Jessica used to eat cottage cheese if she had acid reflux, but now she knows dairy is one of the worst things to have. She does her best to be mindful. She's really thankful that she's in remission now and can be like everyone else at the dinner table.   [11:04] Holly mentions that there are many trigger foods. It's patient-dependent. Dairy is the number one trigger, but we all have different little triggers, like pineapple. Holly's EoE is triggered by any melon. Ryan's EoE is triggered by apples and rice.   [11:48] Holly avoids all trigger foods for fear of an impaction or throwing up.   [12:27] Jessica says, if she wants to have an ice cream cone and live her life like everyone else, she will, but then she has guilt and wonders if it will do something to her later. She limits the high-allergy foods. If she has ice cream, she won't have cheese.   [13:06] Jessica monitors her food as much as possible. Her GI tells her that, since she's in remission, she doesn't need to be that careful. But she has anxiety because you never know if she will have a problem.   [13:21] Since Jessica has been in remission, she has recently gone from weekly to bi-weekly injections. But she is now hyper-vigilant for symptoms and starts each day with a sip of water to see how it goes down and if there are any bumps in the road.   [14:21] Jessica's GI had told her that she was only allergic to a few nuts and she could try other kinds of nuts. She tried cashews once and had a reaction. She reported it to her GI, and then he told her to avoid all nuts.   [14:47] Jessica recently went to her allergist to be retested for common allergies. The tests came back negative for every allergy. She doesn't know if that was because of being on the biologic treatment.   [16:01] Jessica's profession is clinical trial technology. That helped her to understand what a clinical trial is, how to enroll, and patient recruitment. When she went to a hospital with GI research, she asked about it. They had openings, and she enrolled.   [16:33] Jessica was interested in clinical trials because she was desperate for options and answers. Also, the cost of endoscopies adds up. Clinical trials are free. Sometimes you get paid. That was a big win for Jessica.   [17:09] When there was an option for a new treatment, she jumped at it both times. She participated in two trials. She didn't make it through them.   [17:21] In the first trial, Jessica's biopsies had two out of three criteria the trial was looking for, although she had active EoE.   [17:33] In the second trial, Jessica had a provision device she used to write a daily diary entry in. She was pretty far in, but then she had tech issues and emailed for help. That's not part of the protocol. If your diary is not logged correctly, you are out of the trial.   [17:57] That trial was an oral medication. She doesn't know if she was on the placebo or not. Jessica is always open to trials. She thinks they are very beneficial.   [18:46] After leaving the first trial, when Jessica's biopsies didn't meet the criteria, Jessica asked the clinical research nurse to keep her in mind for future trials, so she learned of the second trial.    [19:07] Jessica says she put a lot of time and effort into the second trial, with check-ins and multiple endoscopies, until she was dropped from it. It was challenging and very disappointing when she was dropped from the second trial. She was hopeful.   [19:40] At that point, Jessica changed course and started corticosteroid treatment. The inhaler didn't work. Then she did the slurry mix, and that didn't work, and then she did the injections.   [20:09] Ryan notes that Real Talk has talked to many researchers who have run clinical trials. Every time, they say they are so grateful for the community volunteering their time.   [20:21] They're very aware that some difficulties and challenges come up. Not all patients can make it to the end of the trial, whether that's on the research side or on the patient side.   [20:34] Ryan says the eosinophilic-associated disorder community, in general, is so willing to volunteer their time and participate in these things, and further research for the overall community. Ryan says it's good to hear that Jesica tried to participate.   [21:01] Jessica says she thinks it's valuable. She recommends that anyone who is interested should look into it, especially if you know you have something that's for the rest of your life. What do you have to lose?   [21:12] Jessica says she has something that can't be cured, so what is she going to do? She wants to be the tester. She wants to find something to help her. She doesn't want to choke anymore.   [21:29] Jessica wasn't a mom when she started in these clinical trials. Now she is a mother of two; she explains what conditions she would require to participate in another trial. She wants the opportunity for telemedicine visits except for when she needs a test.   [23:43] There are a lot of challenges. Jessica says that's why she is so passionate about patients and getting therapies to them. It's hard to try to do it all.   [24:24] Jessica was able to get off dupilumab when she was pregnant. She had acid reflux but no other symptoms, choking episodes, or food impactions during her pregnancy.   [25:05] Three months post-partum, it came back with a vengeance. Jessica had her first food impaction that was over 40 minutes. Earlier food impactions had been for seconds or a few minutes. It was terrifying.   [25:27] At three months post-partum, Jessica had to go back on dupilumab. No one could tell her it was safe for her child while breastfeeding. The doctor said it should be digested. It should be OK. "Should" is hard for a post-partum new mother to hear.   [26:08] In Jessica's second pregnancy, she confidently got off dupilumab again, and everything was great. Exactly three months after the birth of the second baby, she had a 45-minute food impaction.   [26:24] She thought she had to go to the ER. She was at the sink trying to get the food up, while her husband took care of the children. Finally, she recovered from the food impaction.   [27:12] Jessica had some spare dupilumab in the refrigerator from before her pregnancy. She called her GI, said she needed to go back on the dupilumab, and started it that day. On dupilumab, she hasn't had a food impaction since.   [27:52] Jessica looks at dupilumab as her lifeline. She gets to be like everybody else when she's on it. She is blessed and thankful for it. It wasn't approved for EoE until 2022. It has been a long ride to figure out how not to choke.   [28:12] Now that Jessica knows she has something that's saving her, changing from weekly to bi-weekly dupilumab injections is scary. If I don't do it this week, are we sure I'm not going to start choking again? Jessica thinks the next impaction will last an hour.   [29:06] Jessica advises people starting a family to make sure they have a care plan in place. Your doctors, family, and others need to be aware of and understand what's going on with you.    [29:19] Make sure that you're communicating. This is especially important for a woman with a GI and an OB. Make sure everyone's speaking the same language. When it comes to GI and allergy, Jessica wants to ask if they can get together on a call.   [29:41] Prepare safe and easy foods for post-partum. People may be dropping off food. Be mindful of what is safe for you to eat. Ask for a lot of help and try to have your care plan together.   [29:57] Jessica was having calls with her GI doctor when she was planning, once she was pregnant, during pregnancy, and post-partum. There was never a time when she wasn't doing check-ins to primary care, allergy, and GI.   [30:14] Have a care plan and know your trends. Jessica didn't realize the post-partum choking episode would repeat after the second birth. She thought it was a one-off. [30:38] If you have an episode, your body is telling you something. Follow the protocol you made for yourself.   [30:47] Once that food impaction happened the second time, Jessica knew exactly what to do because it had happened before. The problem was that she hadn't been proactive in starting on dupilumab before the food impaction happened.   [31:03] Jessica says her first dilation could only get to 12, so she had to have a second dilation to get to a normal 15.    [31:29] Jessica says she thought she was immortal. It only happened once; she supposed it wouldn't happen again.   [32:16] Holly says she loves to travel. When she travels, she brings along a medical emergency kit. The quality of life matters.   [32:36] Jessica watches for signs of EoE in her children. They're not showing signs of it. Anything could happen, and she takes it day by day. If the time comes and it happens, Jessica will know what to do, rather than going in clueless.   [34:44] Ryan says his parents didn't believe he had EoE before he was diagnosed.   [35:08] Jessica's last words: I would say the most challenging part of living with EoE is the unpredictability and not knowing, and the lifelong illness with that. You've got to be comfortable in the unknown.   [35:23] There's a lot of innovation and research right now, so I think more answers are coming. Be aware. See what's going on. Be more in tune with yourself. If you feel like things are happening, be mindful of that. Be comfortable knowing that it's unpredictable.   [35:50] That's the most challenging part of having EoE. Always trust your gut. Advocate for yourself. It took me years to get answers, but persistence is what got me there.   [36:05] Ryan says, that's a great outlook. Keep looking for new answers. Take it one step at a time. Be mindful and on the lookout.   [36:14] Ryan thanks Jessica for joining us today and sharing about your experience and your journey with EoE. I think this will be a super helpful conversation for our listeners.   [36:22] For our listeners who would like to learn more about eosinophilic disorders, please visit apfed.org and check out the links in the show notes.   [36:29] If you're looking to find a specialist who treats eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [36:37] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at APFED.org/connections.    [36:48] Ryan thanks Jessica for joining us today. This was a great conversation. Jessica thanks Ryan and Holly for having her on.   [36:59] Holly thanks Jessica and also thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode:   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast Apfed.org apfed.org/specialist apfed.org/connections apfed.org/research/clinical-trials   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "I'm managing my condition and have hit my second endoscopy with remission, with dupilumab." — Jessica Grady   "It's quite a reality check when you're choking on water. How is that even possible? Once that happened, I kicked myself into gear and had an endoscopy." — Jessica Grady   "If I want to have an ice cream cone and live my life like everyone else, I will, but then I have guilt and wonder if it will do something to me later." — Jessica Grady   "I advise people starting a family to make sure they have a care plan in place. Your doctors, family, and others need to be aware of and understand what's going on with you." — Jessica Grady   "I would say the most challenging part of living with EoE is the unpredictability and not knowing, and the lifelong illness with that. You've got to be comfortable in the unknown." — Jessica Grady   "There's a lot of innovation and research right now, so I think more answers are coming. Be aware. See what's going on. Be more in tune with yourself. If you feel like things are happening, be mindful of that. Be comfortable knowing that it's unpredictable." — Jessica Grady   Guest Bio: Jessica Grady, Patient Advocate

In this week's episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Andrea Wilkinson, Global Head of Patient Engagement & Advocacy, Epilepsy & Neuromuscular at UCB, a company dedicated to developing solutions for autoimmune and neurological conditions, including epilepsy. The company has a growing commitment to addressing unmet needs in rare neurological diseases and underserved patient populations. With fewer than 5% of clinical trials including pregnant women, major knowledge gaps persist, particularly for women with epilepsy. In this episode, we look at new research that used social media listening across several countries to uncover treatment fears, uncertainty and barriers women face during pregnancy and motherhood, and what must change to better support informed decision-making. While epilepsy is not considered a rare disease, epilepsy in pregnancy represents a small, clinically complex population that faces unique risks and persistent care gaps. Andrea is a biotech and health tech executive who has led strategic product launches for over 30 breakthrough biopharmaceutical therapies. Focused on improving outcomes for patients, particularly in rare diseases, she has worked with early- to late-stage launch teams at AstraZeneca/MedImmune, Takeda and Sanofi Pasteur. She develops platform tools, stakeholder roadmaps and patient-centered advocacy campaigns to support first-in-class medicines and address access, reimbursement, regulatory and commercial barriers. Andrea is also an angel investor with Pipeline Angels and serves on the boards of Project Open Hand and the HBA Pacific Region. She holds a BA from Louisiana Tech University. Tune in to learn more about the unmet needs, challenges and advancements in the rare disease and epilepsy spaces. 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

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

WBZ NewsRadio's James Rojas has more.See omnystudio.com/listener for privacy information.

This episode, we talk about two monumental projects that were started in this reign.  One was the historiographical project that likely led to the creation of the Kojiki and the Nihon Shoki.  And then there was the start of the first permanent capital city:  the Fujiwara Capital. Listen to the episode and find more on our website:  https://sengokudaimyo.com/podcast/episode-143   Rough Transcript   Welcome to Sengoku Daimyo's Chronicles of Japan.  My name is Joshua and this is Episode 143: Temmu's Monumental Projects     Ohoama sat astride his horse and looked out at the land in front of him.   He could still see the image of the rice fields, now long fallow, spreading out on the plain.  To the north, east, and west, he could see the mountains that would frame his vision.  As his ministers started to rattle off information about the next steps of the plan, Ohoama began to smile.  He thought of the reports his embassies to the Great Tang had brought back, about the great walled cities of the continent.  In his mind's eye, Ohoama envisioned something similar, rising up on the plain in front of him. There would be an earth and stone wall, surrounding the great city.  The gates would be grand, much like the temples, but on an even greater scale.  Houses would be packed in tight, each within their own walled compounds.  In the center painted red and white, with green accents, would be a palace to rival any other structure in the archipelago.  The people would stream in, and the city would be bustling with traffic. This was a new center, from which the power of Yamato would be projected across the islands and even to the continent.   Greetings everyone, and welcome back.  This episode we are still focused on the reign of Ohoama, aka Temmu Tennou, between the years 672 and 686. Last episode we talked about the Four Great Temples—or the Four National Temples.  Much of this episode was focused on the rise and spread of Buddhism as we see in the building of these national temples, but also on the changes that occurred as the relationship between Buddhism and the State evolved.  This was part of Ohoama's work to build up the State into something beyond what it had been in the past—or perhaps into something comparable to what they believed it to have been in the past.  After all, based on the size of the tomb mounds in the kofun period, it does seem that there was a peak of prosperity in the 5th century, around the time of Wakatakeru, aka Yuryaku Tennou, and then a decline, to the point that the lineage from Wohodo, aka Keitai Tennou, seemed to have come in during a time when they were rebuilding Yamato power and authority. This episode we are going to talk about two projects that Ohoama kicked off during his reign.  He wouldn't see the completion of either one, since both took multiple decades to complete, but both focused on linking the past and the future.  The first we'll talk about is a new attempt to gather historical documents and records—the last time that was done was in the time of Kashikiya Hime, over 50 years ago.  That was during the height of Soga power.  Since then a lot had changed, and presumably there were even more stories and records that had been written down.  Plus the tide had changed.  So they needed to update—and maybe even correct—the historical record. But beyond that, there was a greater goal: Ohoama and his court also needed to make sure that the past was something that they wanted to go back to, among other things. The other thing we are going to discuss is the start of a project to build a brand new capital city.  And when we talk a bout city, we really mean a city.  This was a massive undertaking, likely unlike anything that we've seen so far.  Sure, there had been monumental building projects, but this was something that was going to take a lot more work - how much more monumental could you get than a new city?  And it would create a physical environment that would be the embodiment of the new centralization of power and authority, and the new state that Ohoama was building, with his administration—and Yamato—at the center.   Let's start with the big ones.  First and foremost, we have the entry from the 17th day of the 3rd month of the 681.  Ohoama gave a decree from the Daigokuden to commit to writing a Chronicle of the sovereigns and various matters of high antiquity.  Bentley translates this as saying that they were to record and confirm the Teiki, which Aston translated as the Chronicle of the Sovereigns, and various accounts of ancient times.  This task was given out to a slew of individuals, including the Royal Princes Kawashima and Osakabe; the Princes Hirose, Takeda, Kuwada, and Mino; as well as Kamitsukenu no Kimi no Michichi, Imbe no Muraji no Kobito, Adzumi no Muraji no Inashiki, Naniwa no Muraji no Ohogata, Nakatomi no Muraji no Ohoshima, and Heguri no Omi no Kobito.  Ohoshima and Kobito were specifically chosen as the scribes for this effort.  We aren't told what work was started at this time.  Aston, in his translation of the Nihon Shoki, assumes that this is the start of the Kojiki.  Bentley notes that this is the first in a variety of records about gathering the various records, including gathering records from the various families, and eventually even records from the various provinces.  And I think we can see why.  Legitimizing a new state and a new way of doing things often means ensuring that you have control of the narrative.  Today, that often means doing what you can to control media and the stories that are in the national consciousness.  In Ohoama's day, I'd argue that narrative was more about the various written sources, and how they were presented.  After all, many of the rituals and evidence that we are looking at would rely on the past to understand the present.  The various family records would not only tell of how those families came to be, but would have important information about what else was going on, and how that was presented could determine whether something was going to be seen as auspicious, or otherwise.  Even without getting rid of those records, it would be important to have the official, State narrative conform to the Truth that the state was attempting to implement. Ultimately, there is no way to know, exactly, how everything happened.  If the Nihon Shoki had a preface, it has been lost.  The Kojiki, for its part, does have a preface, and it points to an origin in the reign of Ohoama—known as the sovereign of Kiyomihara.  In there we are told that the sovereign had a complaint—that the Teiki and Honji, that is the chronicles of the sovereigns and the various other stories and legends, that had been handed down by various houses had come to differ from the truth.  They said they had many falsehoods, which likely meant that they just didn't match the Truth that the State was trying to push.  Thus  they wanted to create a so-called "true" version to pass down. This task was given to 28 year old Hieda no Are.  It says they were intelligent and had an incredible memory.  They studied all of the sources, and the work continued beyond the reign of Ohoama.  Later, in 711 CE, during the reign of Abe, aka Genmei Tennou, Oho no Yasumaro was given the task of writing down everything that Hieda no Are had learned.  The astute amongst you may have noticed that this mentions none of the individuals mentioned in the Nihon Shoki.  Nor does the Nihon Shoki mention anything about Hieda no Are.  So was this a separate effort, or all part of the same thing?  Was Are using the materials collected by  the project? As you may recall, we left the Kojiki behind some time ago, since it formally ends with the reign of Kashikiya hime, aka Suiko Tennou, but realistically it ended with Wohodo, aka Keitai Tennou—after that point there are just lists of the various heirs.  As such, there is some speculation that this was originally built off of earlier histories, perhaps arranged during the Soga era. The general explanation for all of this is that Hieda no Are memorized the poems and stories, and then Yasumaro wrote them down.  Furthermore, though the language in the Kojiki does not express a particular gender, in the Edo period there was a theory that Hieda no Are was a woman, which is still a popular theory. Compare all of that to the Nihon Shoki.  Where the Kojiki was often light on details and ends with Suiko Tennou, the Nihon Shoki often includes different sources, specifically mentions some of them by name, and continues up through the year 697.  Furthermore, textual analysis of the Nihon Shoki suggests that it was a team effort, with multiple Chroniclers, and likely multiple teams of Chroniclers.   I have to admit, that sounds a lot more like the kind of thing that Ohoama was kicking off. We have an entry in the Shoku Nihongi, the work that follows the Nihon Shoki, that suggests 720 for the finished compilation of the Nihon Shoki.  So did it take from 681 to 720 to put together?  That is a really long project, with what were probably several generations of individuals working on it. Or should this be read in a broader sense?  Was this a historiographical project, as Bentley calls it, but one that did not, immediately, know the form it would take?  It isn't the first such project—we have histories of the royal lineage and other stories that were compiled previously—much of that attributed to Shotoku Taishi, but likely part of an earlier attempt by the court.  In fact, given that the Kojiki and Sendai Hongi both functionally end around the time of Kashikiya hime, that is probably because the official histories covered those periods.  Obviously, though, a lot had happened, and some of what was written might not fit the current narrative.  And so we see a project to gather and compile various sources.  While this project likely culminated in the projects of the Kojiki and the Nihon Shoki, I doubt that either work was necessarily part of the original vision.  Rather, it looks like the original vision was to collect what they could and then figure things out. It would have been after they started pulling the accounts together, reading them, and noticing the discrepancies that they would have needed to then edit them in such a way that they could tell a cohesive story.  That there are two separate compilations is definitely interesting.  I do suspect that Oho no Yasumaro was working from the efforts of Hieda no Are, either writing down something that had been largely captured in memory or perhaps finishing a project that Are had never completed.  The Nihon Shoki feels like it was a different set of teams, working together, but likely drawing from many of the same sources. And as to why we don't have the earlier sources?  I once heard it said that for books to be forgotten they didn't need to be banned—they just needed to fall out of circulation and no longer be copied anymore.  As new, presumably more detailed, works arose, it makes sense that older sources would not also be copied, as that information was presumably in the updated texts, and any information that wasn't brought over had been deemed counterfactual.  Even the Nihon Shoki risked falling into oblivion; the smaller and more digestible Kojiki was often more sought after.  The Kojiki generally presents a single story, and often uses characters phonetically, demonstrating how to read names and places.  And it just has a more story-like narrative to it.  The Nihon Shoki, comparatively, is dense, written in an old form of kanbun, often relying more on kanbun than on phonetic interpretations.  It was modeled on continental works, but as such it was never going to be as easy to read.  And so for a long time the Kojiki seems to have held pride of place for all but the most ardent scholars of history. Either way, I think that it is still fair to say that the record of 681 was key to the fact that we have this history, today, even if there was no way for Ohoama, at the time, to know just what form it would take. Another ambitious project that got started under Ohoama was the development of a new and permanent capital city. Up to this point we've talked about the various capitals of Yamato, but really it was more that we were talking about the palace compounds where the sovereign lived.  From the Makimuku Palace, where either Mimaki Iribiko or possibly even Himiko herself once held sway, to the latest palace, that of Kiyomihara, the sovereigns of Yamato were known by their palaces.  This is, in part, because for the longest time each successive sovereign would build a new palace after the previous sovereign passed away.  There are various reasons why this may have been the case, often connected to insular concepts of spiritual pollution brought on by the death of an individual, but also the practical consideration that the buildings, from what we can tell, were largely made of untreated wood.  That made them easier to erect, but also made them vulnerable to the elements, over time, and is probably one of the reasons that certain shrines, like the Shrine at Ise, similarly reconstitute themselves every 20 years or so. Furthermore, we talk about palaces, but we don't really talk about cities.  There were certainly large settlements—even going back to the Wei chronicles we see the mention of some 70 thousand households in the area of Yamateg.  It is likely that the Nara basin was filled with cultivated fields and many households.  Princes and noble households had their own compounds—remember that both Soga no Umako and Prince Umayado had compounds large enough that they could build temples on the compounds and have enough left over for their own palatial residences, as well.  However, these compounds were usually distributed in various areas, where those individuals presumably held some level of local control. It is unclear to me how exactly the early court functioned as far as housing individuals, and how often the court was "in session", as it were, with the noble houses.  Presumably they had local accommodations and weren't constantly traveling back and forth to the palace all the time.  We know that some houses sent individuals, men and women, to be palace attendants, even though they lived some distance away.  This was also likely a constraint on the Yamato court's influence in the early days. We do see the sovereign traveling, and various "temporary" palaces being provided.  I highly doubt that these were all built on the spot, and were likely conversions of existing residences, and similar lodging may have been available for elites when they traveled, though perhaps without such pomp and circumstance. What we don't really see in all of this, are anything resembling cities.  Now, the term "city" doesn't exactly have a single definition, but as I'm using it, I would note that we don't see large, permanent settlements of significant size that demonstrate the kind of larger civil planning that we would expect of such a settlement.  We certainly don't have cities in the way of the large settlements along the Yangzi and Yellow rivers. We talked some time back about the evolution of capital city layouts on the continent.  We mentioned that the early theoretical plan for a capital city was based on a square plan, itself divided into 9 square districts, with the central district constituting the palace.  This design works great on paper, but not so much in practice, especially with other considerations, such as the north-south orientation of most royal buildings.  And then there are geographic considerations.  In a place like Luoyang, this square concept was interrupted by the river and local topography.  Meanwhile, in Chang'an, they were able to attain a much more regular rectangular appearance.  Here, the court and the palace were placed in the center of the northernmost wall.  As such, most of the city was laid out to the south of the palace. In each case, however, these were large, planned cities with a grid of streets that defined the neighborhoods.  On each block were various private compounds, as well as the defined markets, temples, et cetera. The first possible attempt at anything like this may have been with the Toyosaki palace, in Naniwa.  There is some consideration that, given the size of the palace, there may have been streets and avenues that were built alongside it, with the intention of having a similar city layout.  If so, it isn't at all clear that it was ever implemented, and any evidence may have been destroyed by later construction on the site.  Then we have the Ohotsu palace, but that doesn't seem to be at the same scale as the Toyosaki palace—though it is possible that, again, we are missing some key evidence.  Nonetheless, the records don't really give us anything to suggest that these were large cities rather than just palaces. There is also the timeline.  While both the Toyosaki palace and the Ohotsu palace took years to build, they did not take the time and amount of manpower that would be needed to create a true capital city.  We can judge this based on what it took to build the new capital at Nihiki. This project gets kicked off in the 11th month of 676.  We are told that there was an intent to make the capital at Nihiki, so all of the rice-fields and gardens within the precincts, public and private property alike, were left fallow and became totally overgrown. This likely took some time.  The next time we see Nihiki is in the 3rd month of 682, when Prince Mino, a minister of the Household Department, and others, went there to examine the grounds.  At that point they apparently made the final decision to build the capital there.  Ohoama came out to visit later that same month. However, a year later, in the 12th month of 683, we are told that there was a decree for there to be multiple capitals and palaces in multiple sites, and they were going to make the Capital at Naniwa one of those places.  And so public functionaries were to go figure out places for houses.  So it wasn't just that they wanted to build one new, grand capital.  It sounds like they were planning to build two or three, so not just the one at Nihiki.  This is also where I have to wonder if the Toyosaki Palace was still being used as an administrative center, at the very least.  Or was it repurposed, as we saw that the Asuka palaces had been when the court moved to Ohotsu? This is further emphasized a few months later, when Prince Hirose and Ohotomo Yasumaro, at the head of a group of clerks, officials, artisans, and yin yang diviners were sent around the Home Provinces to try and divine sites suitable for a capital.  In addition, Prince Mino, Uneme no Oni no Tsukura, and others were sent to Shinano to see about setting up a capital there as well.  Perhaps this was inspired by the relationship between the two Tang capitals of Chang'an and Luoyang.  Or perhaps it was so that if one didn't work out another one might. Regardless, Nihiki seemed to be the primary target for this project, and in the third lunar month of 684 Ohoama visited the now barren grounds and decided on a place for the new palace.  A month later, Prince Mino and others returned with a map of Shinano, but there is no indication of where they might want to build another capital. After that, we don't hear anything more of Shinano or of a site in the Home Provinces.  We do hear one more thing about Naniwa, which we mentioned a couple of episodes back, and that is that in 686 there was a fire that burned down the palace at Naniwa, after which they seem to have abandoned that as a palace site.  And so we are left with the area of Nihiki. This project would take until the very end of 694 before it was ready.  In total, we are looking at a total of about 18 years—almost two decades, to build a new capital.  Some of this may have been the time spent researching other sites, but there also would have been significant time taken to clear and level.  This wasn't just fields—based on what we know, they were even taking down old kofun; we are later told about how they had to bury the bodies that were uncovered.  There was also probably a pause of some kind during the mourning period when Ohoama passed away.  And on top of it, this really was a big project.  It wasn't just building the palace, it was the roads, the infrastructure, and then all of the other construction—the city gates, the various private compounds, and more.  One can only imagine how much was being invested, especially if they were also looking at other sites and preparing them at the same time.  I suspect that they eventually abandoned the other sites when they realized just how big a project it really was that they were undertaking. Today we know that capital as Fujiwara-kyo, based on the name of the royal palace that was built there, and remarkably, we know where it was.  Excavations have revealed the site of the palace, and have given us an idea of the extent of the city:  It was designed as a square, roughly 5.3 kilometers, or 10 ri, on each side.  The square itself was interrupted by various terrain features, including the three holy mountains.  Based on archaeological evidence, the street grid was the first thing they laid out, and from what we can tell they were using the ideal Confucian layout as first dictated in the Zhouli, or Rites of Zhou.  This meant a square grid, with the palace in the center. Indeed, the palace was centered, due south of Mt. Miminashi, and you can still go and see the palace site, today.  When they went to build the palace, they actually had to effectively erase, or bury, the roads they had laid out.  They did the same thing for Yakushi-ji, or Yakushi-temple, when they built it as part of the city; one of the reasons we know it had to have been built after the roads were laid out.  We will definitely talk about this more when we get to that point of the Chronicles, but for now, know that the Fujiwara palace itself, based on excavations of the site, was massive.  The city itself would surpass both Heijo-kyo, at Nara, and Heian-kyo, in modern Kyoto.  And the palace was like the Toyosaki Naniwa palace on steroids.  It included all of the formal features of the Toyosaki Palace for running the government, but then enclosed that all in a larger compound with various buildings surrounding the court itself.  Overall, the entire site is massive.  This was meant as a capital to last for the ages. And yet, we have evidence that it was never completed.  For one thing, there is no evidence that a wall was ever erected around it—perhaps there was just no need, as relations with the mainland had calmed down, greatly.  But there is also evidence that parts of the palace, even, were not finished at the time that they abandoned it.  Fujiwara-kyo would only be occupied for about 16 years before a new capital was built—Heijo-kyo, in Nara.  There are various reasons as to why they abandoned what was clearly meant to be the first permanent capital city, and even with the move to a new city in Nara it would be clear that it was going to take the court a bit of time before they were ready to permanently settle down—at least a century or so. Based on all the evidence we have, and assuming this was the site of the eventual capital, Nihiki was the area of modern Kashihara just north of Asuka, between—and around—the mountains of Unebi, Miminashi, and Kagu.  If these mountains are familiar, they popped up several times much earlier in the Chronicles--Mostly in the Age of the Gods and in the reign of the mythical Iware-biko, aka Jimmu Tennou.  Yet these three mountains help to set out the boundaries of the capital city that was being built at this time. There is definitely some consideration that they were emphasized in the early parts  of the Chronicles—the mythical sections, which were bolstering the story of Amaterasu and the Heavenly Grandchild, setting up the founding myths for the dynasty.  Even though the Chronicles  were not completed until well after the court had moved out, the Fujiwara capital is the climax of the Nihon Shoki, which ends in 697, three years into life at the new palace.  And so we can assume that much of the early, critical editing of the Kojiki and Nihon Shoki were done with the idea that this would be the new capital, and so it was woven into the histories, and had it continued as the capital, the very landscape would have recalled the stories of the divine origins of the Royal family and the state of Yamato itself.  This was the stage on which Ohoama's state was built.  He, and his successors, didn't just change the future path of the Yamato government.  They rearranged the physical and temporal environment, creating a world that centered them and their government.  I suspect that Ohoama didn't originally consider that these wouldn't be finished during his reign.  That said, he came to power in his 40s, only slightly younger than his brother, who had just died.  He would live to be 56 years old—a respectable age for male sovereigns, around that time.  From a quick glance, Naka no Oe was about 45 or 46 years old, while Karu lived to about 57 or 58.  Tamura only made it to 48.  The female sovereigns seem to have lasted longer, with Ohoama's mother surviving until she was 66 or 67 years old, and Kashikiya Hime made it to the ripe old age of 74.  That said, it is quite likely that he thought he would make it longer.  After all, look at all the merit he was accruing!  Still, he passed away before he could see these projects fully accomplished.  That would have to be left for the next reign—and even that wasn't enough.  The Fujiwara Capital would only be occupied for a short time before being abandoned about two reigns later, and the histories as we know them wouldn't be complete for three more reigns.  So given all of this, let's take another quick look at Ohoama himself and where he stands at this pivotal moment of Yamato history.When we look at how he is portrayed, Ohoama is generally lionized for the work he is said to have accomplished.  I would argue that he is the last of three major figures to whom are attributed most of the changes that resulted in the sinification of the Yamato government.  The first is prince Umayado, aka Shotoku Taishi, who is said to have written the 17 article constitution, the first rank system, and the introduction of Buddhism.  To be fair, these things—which may not have been exactly as recorded in the Chronicles—were likely products of the court as a whole.  Many people attribute more to Kashikiya Hime, aka Suiko Tennou, as well as Soga no Umako.  Of course, Soga no Umako wasn't a sovereign, or even a member of the royal family, and Kashikiya Hime, aka Suiko Tennou, seems to have likewise been discounted, at least later, possibly due to the fact that she is thought to have come to power more as a compromise candidate than anything else—she was the wife of a previous sovereign and niece to Soga no Umako.  Many modern scholars seem to focus more on the agency of Kashikiya Hime and suggest that she had more say than people tend to give her credit for.  That said, Shotoku Taishi seems to have been the legendary figure that was just real enough to ascribe success to.  That he died before he could assume the throne just meant that he didn't have too many problematic decisions of his own to apparently work around. The next major figure seems to be Naka no Oe, aka Tenji Tennou.  Naka no Oe kicks off the period of Great Change, the Taika era, and is credited with a lot of the changes—though I can't help but notice that the formal sovereign, Naka no Oe's uncle, Karu, seems to have stuck with the new vision of the Toyosaki Palace and the administrative state while Naka no Oe and his mother moved back to the traditional capital.  And when Naka no Oe moved the capital to Ohotsu, he once again built a palace more closely aligned to what we see in Asuka than the one in Naniwa, which brings some questions about how the new court was operating.  But many of his reforms clearly were implemented, leveraging the new concepts of continental rulership to solidify the court's hegemony over the rest of the archipelago. Ohoama, as represented in the Chronicles, appears to be the culmination of these three.  He is building on top of what his brother had implemented through the last three reigns.  Some of what he did was consolidate what Naka no Oe had done, but there were also new creations, for which Ohoama is credited, even if most of the work was done outside of Ohoama's reign, but they were attributed to Ohoama, nonetheless.  Much of this was started later in Ohoama's reign, and even today there seem to be some questions about who did what.  Nonetheless, we can at least see how the Chroniclers were putting the story together. There are a lot of scholars that point to the fact that the bulk of the work of these projects would actually be laid out in the following reigns, and who suggest that individuals like the influential Uno no Sarara, who held the control of the government in Ohoama's final days, may have had a good deal more impact on how things turned out, ultimately.  In fact, they might even have been more properly termed her projects—there are some that wonder if some of the attributions to Ohoama were meant to bolster the authority of later decrees, but I don't really see a need for that, and it seems that there is enough evidence to suggest that these projects were begun in this period. All of this makes it somewhat ironic that by the time the narrative was consolidated and published to the court, things were in a much different place—literally.  The Fujiwara capital had been abandoned.  The court, temples, and the aristocracy had picked up stakes and moved north.  Fujiwara no Fuhito had come on the scene, and now his family was really taking off.  This was not the same world that the Chronicles had been designed around. And yet, that is what was produced.  Perhaps there is a reason that they ended where they did. From that point on, though, there were plenty of other projects to record what was happening.  Attempts to control the narrative would need to do a lot more.  We see things like the Sendai Kuji Hongi, with its alternative, and perhaps even subversive, focus on the Mononobe family.  And then later works like the Kogoshui, recording for all time the grievances of the Imbe against their rivals—for all the good that it would do.  With more people learning to write, it was no longer up to the State what did or did not get written down. But that has taken us well beyond the scope of this reign—and this episode, which we should probably be bringing to a close.  There are still some things here and there that I want to discuss about this reign—so the next episode may be more of a miscellany of various records that we haven't otherwise covered, so far.  Until then if you like what we are doing, please tell your friends and feel free to rate us wherever you listen to podcasts.  If you feel the need to do more, and want to help us keep this going, we have information about how you can donate on Patreon or through our KoFi site, ko-fi.com/sengokudaimyo, or find the links over at our main website,  SengokuDaimyo.com/Podcast, where we will have some more discussion on topics from this episode. Also, feel free to reach out to our Sengoku Daimyo Facebook page.  You can also email us at the.sengoku.daimyo@gmail.com.  Thank you, also, to Ellen for their work editing the podcast. And that's all for now.  Thank you again, and I'll see you next episode on Sengoku Daimyo's Chronicles of Japan.  

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

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.

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!

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant announcements and strategic initiatives that are shaping the landscape of drug development and patient care.Starting with a notable investment move, Eli Lilly has announced a $3.5 billion manufacturing facility in Pennsylvania, marking a significant milestone in their "Lilly in America" initiative. This facility is set to focus on injectables and devices, reinforcing Lilly's dedication to expanding its manufacturing capabilities within the United States. These types of investments are increasingly crucial as they aim to enhance supply chain resilience and support the production of complex biologics and innovative therapies—a step that could prove pivotal in maintaining a competitive edge in the global pharmaceutical market.Meanwhile, Regeneron's Eylea franchise is encountering challenges with declining sales, even with the introduction of Eylea HD. This situation highlights the difficulties companies face in maintaining market share amidst fierce competition and evolving treatment paradigms in ophthalmology. It underscores the importance of continuous innovation and effective lifecycle management strategies to sustain product competitiveness in a rapidly changing industry environment.Takeda is also navigating turbulent waters with its ADHD medication Vyvanse facing generic competition. Despite this, Takeda maintains an optimistic outlook for future growth by narrowing the revenue gap between declining Vyvanse sales and contributions from new products. This transition is reflective of a broader industry trend where companies pivot towards novel therapeutics to offset revenue losses from patent expirations, exemplifying strategic adaptation in response to market dynamics.AstraZeneca's ambitious $18.5 billion obesity deal with China's CSPC exemplifies the growing focus on metabolic disorders driven by rising global obesity rates. This partnership not only reinforces AstraZeneca's expansion strategy into China but also highlights the increasing importance of addressing obesity—a major public health challenge with significant healthcare cost implications. The deal marks a strategic push to leverage advanced therapeutic approaches, particularly targeting GLP-1 and GIP receptors with long-acting dual agonists. Additionally, AstraZeneca's further $15 billion pledge for investments in Chinese cell therapies and radiopharmaceuticals is expected to enhance its capabilities in personalized medicine and expand its global presence across key therapeutic areas—a reflection of a broader industry trend towards asset-centric deals prioritizing targeted acquisitions over traditional mergers.Novo Nordisk's ongoing legal challenge against drug pricing provisions in the Inflation Reduction Act (IRA) is gaining momentum, with support from the U.S. Chamber of Commerce urging the Supreme Court to review the case. This legal battle underscores ongoing tensions between pharmaceutical companies and regulatory frameworks aimed at controlling drug prices, reflecting broader debates on healthcare affordability and access—a critical issue that continues to shape policy discussions across the industry.Across the Atlantic, CDMO Vetter's €480 million investment in a new plant in Germany signals robust growth in contract development and manufacturing services. This expansion aligns with increasing demand for outsourcing solutions in biopharmaceutical production, driven by complex manufacturing processes and capacity constraints faced by many biotech firms. Such investments are pivotal as they aim to enhance production capabilities and meet growing demands for innovative biologics.Quince Therapeutics recently experienced a setback with its steroid delivery technology for ataxia-telangiectasia, illustrating the Support the show

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

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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're delving into the dynamic landscape of scientific breakthroughs, regulatory shifts, and strategic business maneuvers that are shaping the future of healthcare.The pharmaceutical industry is currently abuzz with discussions surrounding Pfizer's leadership, which has taken a firm stance against anti-vaccine narratives, particularly those propagated by figures like Robert F. Kennedy Jr. This critique highlights ongoing tensions between pharmaceutical companies and public health narratives that can significantly impact vaccine distribution and uptake. This situation underscores the crucial role of public trust in the industry's efforts to efficiently manage public health crises and ensure vaccine accessibility.Johnson & Johnson has projected its 2026 revenue to exceed $100 billion, largely driven by the success of its oncology treatment, Darzalex. This strategic focus on cancer therapies not only highlights J&J's commitment to expanding its oncology portfolio but also reflects broader industry trends where targeted cancer therapies are becoming pivotal revenue drivers due to their high efficacy and growing demand.Meanwhile, Takeda is navigating the challenges associated with patent expirations for its depression drug Trintellix. The anticipated patent cliff has led to a reduction of 243 positions within its U.S. neuroscience field force. This scenario emphasizes the ongoing importance of strategic planning around drug lifecycle management as companies strive to sustain revenue streams amidst patent expirations.Curia Global is also undergoing restructuring as it closes its Massachusetts plant, resulting in 81 job cuts. This move aligns with a broader trend in the industry aimed at optimizing operational efficiencies in response to shifting market demands and cost pressures.Advancements in rare disease treatments are making headlines with Intrabio's Aqneursa achieving Phase 3 success for ataxia-telangiectasia and receiving EU approval for Niemann-Pick disease Type C. These milestones underscore the critical role of rare disease research in expanding therapeutic options and highlight the potential for orphan drugs to offer substantial clinical benefits alongside commercial opportunities.In a significant collaboration, GSK has licensed Alteogen's enzyme to develop a subcutaneous form of Jemperli, a promising cancer medication. This partnership exemplifies the industry's focus on enhancing drug delivery technologies to improve patient compliance and therapeutic outcomes.Regulatory developments continue to unfold with notable approvals such as Ionis and Otsuka's hereditary angioedema drug receiving EU approval. Such milestones are indicative of the regulatory momentum that can facilitate market entry and expand access to innovative treatments across different geographies.Novo Nordisk's strategic shift away from cell therapy assets marks another noteworthy development within the industry. By divesting these assets, Novo Nordisk illustrates a broader reevaluation concerning investments in emerging technologies versus more traditional therapeutic areas.Turning our attention to financial strategies, Roche has made headlines with a substantial $2 billion investment in North Carolina aimed at supporting obesity-related drug production. This expansion underscores the critical role of manufacturing infrastructure in meeting rising global demand for innovative therapies—particularly in addressing conditions like obesity.The integration of AI into clinical improvements continues to gain traction in the biotech sector, with reports indicating higher success rates in clinical trials due to enhanced data analytics capabilities. This technological integration represents a paradigm shift in how clinical trials are designed and executedSupport the show

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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most significant events shaping the industry, from innovative drug formulations and regulatory challenges to the dynamic IPO landscape and clinical trial outcomes.Starting with Novo Nordisk, their oral formulation of Wegovy is witnessing substantial uptake, showcasing a strong demand for novel obesity treatments. This rapid adoption underscores a competitive environment where companies like Eli Lilly, with its Zepbound launch, are vying for market share. The introduction of innovative delivery methods in obesity management not only drives immediate commercial success but also highlights a critical area of therapeutic advancement due to the rising global prevalence of obesity.From a regulatory perspective, alignment with bodies like the FDA remains crucial. Companies such as Beam Therapeutics and Cabaletta Bio emphasize this at events like the J.P. Morgan Healthcare Conference, highlighting the importance of clear regulatory pathways in ensuring the successful approval of promising therapies. Conversely, Atara Biotherapeutics' recent setback with an unexpected FDA rejection demonstrates the unpredictability inherent in regulatory processes, which can significantly impact drug development timelines.The IPO market in biotech remains vibrant despite broader market uncertainties. Noteworthy are Agomab Therapeutics and Spyglass Pharma, each preparing for substantial public offerings. Agomab focuses on ALK5 inhibitors for inflammatory diseases, while Spyglass advances drug delivery implants for chronic eye conditions. This wave of IPOs highlights investor confidence in innovative therapies that address unmet medical needs and reflects a broader trend toward precision medicine and novel treatment modalities.In clinical research, AbbVie and Genmab faced a setback when their bispecific antibody failed to meet a crucial endpoint in a Phase III lymphoma study. Such challenges underscore the high stakes involved in oncology drug development, where successes can significantly alter treatment paradigms, yet failures remind us of the inherent risks.Turning to Alzheimer's disease, there is palpable excitement around next-generation treatments under investigation. These candidates promise to reshape the landscape by offering new hope in a field where effective therapies are desperately needed. This is complemented by advancements in manufacturing capabilities recognized as essential to strategic planning beyond 2026, ensuring that production processes can scale efficiently to meet global demands.On the workforce front, Takeda's decision to reduce its U.S. headcount, impacting its neurology teams, reflects industry trends where resource allocation is increasingly focused on core growth areas. Such strategic recalibrations are part and parcel of navigating competitive pressures and evolving market demands.In another realm, ImmunityBio's Phase 1 results for its CD19 CAR-NK cell therapy offer promising insights into innovative oncology approaches. The use of natural killer cells engineered with chimeric antigen receptors could revolutionize cancer treatment by providing targeted therapeutic options for hematological malignancies and potentially solid tumors.Regulatory approvals also continue to shape industry dynamics. SOBI's Aspaveli receiving EU approval for rare kidney diseases marks significant progress in complement inhibition therapies. Meanwhile, Bayer's Eylea approval for retinal vein occlusion-related visual impairment reinforces the vital role of VEGF inhibitors in ophthalmology.Strategic collaborations are also making headlines, as seen with Abelzeta and AstraZeneca's expanded partnership on GPC3 CAR-T therapy through an acquisition focused on China rights. This move illustrates the global interest inSupport the show

The sun rises over the misty fields near Nagashino, glinting off armour and steel. The Takeda banners flap in the wind, a warning to the Tokugawa warriors holding the hilltops. Every decision counts, every step could tip the balance of power. As the leader of your clan, Takeda, you are seeking to reclaim glory and lead your samurai through the chaos. Now is the time to win this sandwich chess, this Hasami Shogi from Lemery Games.Read the full review here: https://tabletopgamesblog.com/2026/01/17/hasami-shogi-saturday-review/Useful LinksHasami Shogi: https://lemerygames.com/products/hasami-shogi-deluxe-ludos-asia-collectionRulebook: https://drive.google.com/file/d/1yE2AF-jA-YLBe8G2LDwYoYJ01j62IXxr/view?usp=drive_linkLemery Games: https://lemerygames.com/BGG listing: https://boardgamegeek.com/boardgame/13716/hasami-shogiBagh Chal review: https://tabletopgamesblog.com/2023/05/13/bagh-chal-saturday-review/MusicIntro Music: Bomber (Sting) by Riot (⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/audiolibrary/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠)Music: Battlefield 6 Streaming Music Vol. 16 [Sneaky Sniper]Produced by Sascha EndeLink: https://ende.app/en/song/13090-battlefield-6-streaming-music-vol-16-sneaky-sniperMusic: World Of War (instrumental)Produced by Sascha EndeLink: https://ende.app/en/song/147-world-of-war-instrumentalSupportIf you want to support this podcast financially, please check out the links below:Ko-Fi: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://ko-fi.com/TabletopGamesBlog⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Patreon: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.patreon.com/tabletopgamesblog⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Website: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://tabletopgamesblog.com/support/⁠

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

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

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

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the ever-evolving landscape of pharmaceuticals and biotechnology, a series of strategic transactions and scientific advancements are reshaping the industry.BioMarin's acquisition of Amicus Therapeutics for $4.8 billion is a significant highlight, marking the company's largest transaction to date. This move signifies a strategic pivot towards enhancing its capabilities in the rare disease sector, leveraging Amicus's expertise and robust pipeline to potentially improve patient outcomes in this highly specialized area. This acquisition is expected to enrich BioMarin's portfolio significantly with promising assets from Amicus, reflecting a strategic shift under new leadership towards rare disease treatments.Regulatory affairs have seen considerable activity as well, with the FDA raising concerns over manufacturing practices at Catalent's gene therapy facility. These issues, documented in a Form 483 following inspections, particularly pertain to the production of Elevidys. Such regulatory scrutiny emphasizes the critical importance of maintaining compliance with manufacturing standards in gene therapy—a burgeoning field within biotech that holds immense promise for treating genetically-driven conditions.The FDA's oversight extends beyond manufacturing practices to advertising, as evidenced by an untitled letter issued to Bristol Myers Squibb regarding their Cobenfy TV ad. This action is part of the FDA's broader initiative to ensure that direct-to-consumer marketing materials accurately portray drug benefits and risks, thereby protecting public health.In another strategic move, Alvotech and Teva are gearing up for the 2026 U.S. launch of an Eylea biosimilar following a settlement with Regeneron. This development highlights the competitive dynamics within the biosimilar market—a segment poised for growth as patents on major biologics expire, offering more cost-effective alternatives and expanding treatment access.Meanwhile, Clovis Oncology has achieved a milestone with Rubraca, which transitioned from accelerated approval to full FDA endorsement for prostate cancer treatment after five years. This progression underscores Rubraca's demonstrated efficacy and safety profile in addressing advanced prostate cancer—a notable achievement amid an increasingly competitive oncology market.Policy changes proposed by Health and Human Services Secretary Robert F. Kennedy Jr. could have profound implications by disrupting funding streams for hospitals providing gender-affirming care to minors. The potential impact on healthcare providers and patients who rely on these services is significant.Turning to clinical trials, Daiichi Sankyo has seen success with Enhertu receiving FDA approval for first-line HER2-positive breast cancer treatment. Nonetheless, challenges persist as a separate phase 3 trial for another antibody-drug conjugate was paused due to unexpected patient deaths. Meanwhile, Takeda plans to seek FDA approval for its TYK2 inhibitor following successful phase 3 trials in psoriasis—indicating promising potential in autoimmune disease therapies.Strategic shifts are evident across organizations as well, highlighted by Kathy Fernando's departure from Pfizer to join Replicate Bioscience as Chief Business Officer. Her new role focuses on advancing Replicate's self-replicating RNA technology platform—an area gaining traction due to its implications for vaccine development and therapeutic applications.On the clinical trials front, Altimmune reported encouraging results from a 48-week study on metabolic dysfunction-associated steatohepatitis (MASH). Their GLP-1/glucagon dual receptor agonist demonstrated sustained weight loss and improvements in non-invasive liver fibrosis measures—offering new hope for MASH patients who face limited treSupport 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, revealing a landscape rich with scientific innovation and strategic maneuvers poised to impact patient care and the drug development pipeline.Let's start with Johnson & Johnson's recent FDA approval for a subcutaneous version of Rybrevant, their lung cancer medication. This new formulation offers a more convenient administration method compared to AstraZeneca's Tagrisso, intensifying competition in the non-small cell lung cancer market. The shift towards more patient-friendly delivery systems underscores the industry's commitment to enhancing treatment adherence and convenience. In contrast, Insmed faced a setback with its phase 2 trial for Brinsupri in treating chronic rhinosinusitis without nasal polyps. The discontinuation of this program highlights the unpredictable nature of clinical trials and emphasizes the need for rigorous scientific validation before advancing therapeutic candidates.Meanwhile, Lilly has shown promising results with its oral obesity pill, marking significant progress in weight management therapies. Patients transitioning from injectable GLP-1 therapies to Lilly's oral drug candidate maintained substantial weight loss, positioning Lilly favorably against Novo Nordisk's Wegovy. The potential for oral formulations to revolutionize treatment paradigms in chronic conditions cannot be understated. Lilly's progress in obesity treatment with its oral medication orforglipron further cements its competitive edge. Participants in their Phase III clinical trial maintained weight loss after switching from Wegovy or Zepbound to orforglipron, suggesting an efficacious oral alternative to injectable treatments and potentially enhancing patient adherence.On the regulatory front, the Biosecure Act's progression within a major defense spending bill could impose new challenges for life sciences companies with Chinese affiliations. This legislative shift reflects geopolitical tensions impacting global pharmaceutical collaborations and underscores the importance of regulatory compliance in international partnerships. Similarly, Intercept Pharmaceuticals' restructuring following the withdrawal of Ocaliva from the U.S. market is indicative of strategic pivots in response to regulatory hurdles and evolving market dynamics.In dermatology, Takeda's successful phase 3 trials for Zasocitinib highlight the competitive nature of drug development as multiple players vie for market share within therapeutic areas. Their anticipated 2026 FDA filing underscores the prolonged timelines involved in bringing novel therapies to market despite successful clinical outcomes.Public-private collaborations continue to play a crucial role in vaccine development, as evidenced by Moderna's pandemic influenza vaccine advancement into phase 3 trials with support from the Coalition for Epidemic Preparedness Innovations (CEPI). This $54 million investment illustrates ongoing efforts to bolster pandemic preparedness through innovative mRNA technologies. Meanwhile, Moderna's $54 million funding from CEPI to advance its bird flu vaccine highlights resilience amidst fluctuating governmental support. This endeavor leverages Moderna's mRNA technology platform, emphasizing mRNA's versatility across various infectious diseases.Shifting our focus slightly, medical groups have expressed opposition to changes in hepatitis B vaccination recommendations by the CDC for newborns. Such policy debates have significant implications for public health strategies and highlight ongoing discussions within medical communities regarding optimal vaccination protocols.GSK's strategic collaboration with Camp4 Therapeutics marks another key industry development. With an investment exceeding $400 million, GSK aims to Support the show

The last time Yamato was heavily involved on the continent, they were defeated militarily, and they returned to fortify their islands.  So how are things looking, now? This episode we will talk about some of what has been going on with Tang and Silla, but also touch on the Mishihase, the Hayato, the people of Tamna and Tanegashima, and more! For more information and references, check out:  https://sengokudaimyo.com/podcast/episode-140   Rough Transcript   Welcome to Sengoku Daimyo's Chronicles of Japan.  My name is Joshua and this is episode 140: Improving Diplomatic Ties Garyang Jyeongsan and Gim Hongsye looked out from the deck of their ship, tossing and turning in the sea.  The waves were high, and the winds lashed at the ship, which rocked uncomfortably beneath their feet.  Ocean spray struck them from below while rain pelted from above. Through the torrential and unstable conditions, they looked out for their sister ship.  It was their job to escort them, but in these rough seas, bobbing up and down, they were at the mercy of the elements.  One minute they could see them, and then next it was nothing but a wall of water.  Each time they caught a glimpse the other ship seemed further and further away.  They tried calling out, but it was no use—even if they could normally have raised them, the fierce winds simply carried their voices out into the watery void.  Eventually, they lost sight of them altogether. When the winds died down and the seas settled, they looked for their companions, but they saw nothing, not even hints of wreckage on the ocean.  They could only hope that their fellow pilots knew where they were going.  As long as they could still sail, they should be able to make it to land—either to the islands  to which they were headed, or back to the safety of the peninsula. And so the escort ship continued on, even without a formal envoy to escort.  They would hope for the best, or else they would explain what would happen,  and hope that the Yamato court would understand. The seas were anything but predictable, and diplomacy was certainly not for the faint of heart.   We are going through the period of the reign of Ohoama, aka Temmu Tennou.  It started in 672, with the death of his brother, Naka no Oe, remembered as the sovereign Tenji Tenno, when Temmu took the throne from his nephew, Ohotomo, aka Kobun Tenno, in what would become known as the Jinshin no Ran.  From that point, Ohoama continued the work of his brother in creating a government based on a continental model of laws and punishments—the Ritsuryo system.  He accomplished this with assistance from his wife, Uno, and other members of the royal family—his own sons, but also nephews and other princes of the time.  And so far most of our focus has been on the local goings on within the archipelago. However, there was still plenty going on in the rest of the world, and though Yamato's focus may have been on more local affairs, it was still engaged with the rest of the world—or at least with the polities of the Korean Peninsula and the Tang Dynasty.  This episode we are going to look at Yamato's foreign relations, and how they were changing, especially as things changed on the continent. Up to this point, much of what had been happening in Yamato had been heavily influenced by the mainland in one way or another.  And to begin our discussion, we really should backtrack a bit—all the way to the Battle of Baekgang in 663, which we discussed in Episode 124.  That defeat would lead to the fall of Baekje, at the hands of the Silla-Tang alliance.  The loss of their ally on the peninsula sent Yamato into a flurry of defensive activity.  They erected fortresses on Tsushima, Kyushu, and along the Seto Inland Sea.  They also moved the capital up to Ohotsu, a more easily defended point on the shores of Lake Biwa, and likewise reinforced various strategic points in the Home Provinces as well.  These fortresses were built in the style and under the direction of many of the Baekje refugees now resettled in Yamato. For years, the archipelago braced for an invasion by the Silla-Tang alliance.  After all, with all that Yamato had done to support Baekje, it only made sense, from their perspective, for Silla and Tang to next come after them.  Sure, there was still Goguryeo, but with the death of Yeon Gaesomun, Goguryeo would not last that long.  With a unified peninsula, then why wouldn't they next look to the archipelago? And yet, the attack never came.  While Yamato was building up its defenses, it seems that the alliance between Silla and Tang was not quite as strong as their victories on the battlefield may have made it seem.  This is hardly surprising—the Tang and Silla were hardly operating on the same scale.  That said, the Tang's immense size, while bringing it great resources, also meant that it had an extremely large border to defend.  They often utilized alliances with other states to achieve their ends.  In fact, it seems fairly common for the Tang to seek alliances with states just beyond their borders against those states that were directly on their borders.  In other words, they would effectively create a pincer maneuver by befriending the enemy of their enemy.  Of course.  Once they had defeated said enemy well, wouldn't you know it, their former ally was now their newest bordering state. In the case of the Silla-Tang alliance, it appears that at the start of the alliance, back in the days of Tang Taizong, the agreement, at least from Silla's perspective, was that they would help each other against Goguryeo and Baekje, and then the Tang dynasty would leave the Korean peninsula to Silla.  However, things didn't go quite that smoothly.  The fighting against Goguryeo and Baekje can be traced back to the 640s, but Tang Taizong passed away in 649, leaving the throne to his heir, Tang Gaozong.  The Tang forces eventually helped Silla to take Baekje after the battle of Baekgang River in 663, and then Goguryeo fell in 668, but the Tang forces didn't leave the peninsula.  They remained in the former territories of Baekje and in Goguryeo, despite any former agreements.  Ostensibly they were no doubt pointing to the continuing revolts and rebellions in both regions.  While neither kingdom would fully reassert itself, it didn't mean that there weren't those who were trying.  In fact, the first revolt in Goguryeo was in 669.  There was also a revolt each year until 673.  The last one had some staying power, as the Goguryeo rebels continued to hold out for about four years. It is probably worth reminding ourselves that the Tang dynasty, during this time, had reached out on several occasions to Yamato, sending diplomatic missions, as had Silla.  While the Yamato court may have been preparing for a Tang invasion, the Tang perspective seems different.  They were preoccupied with the various revolts going on, and they had other problems.  On their western border, they were having to contend with the kingdom of Tibet, for example.  The Tibetan kingdom had a powerful influence on the southern route around the Taklamakan desert, which abuts the Tibetan plateau.   The Tang court would have had to divert resources to defend their holdings in the western regions, and it is unlikely that they had any immediate designs on the archipelago, which I suspect was considered something of a backwater to them, at the time.  In fact, Yamato would have been much more useful to the Tang as an ally to help maintain some pressure against Silla, with whom their relationship, no longer directed at a common enemy, was becoming somewhat tense. In fact, just before Ohoama came to the throne, several events had occurred that would affect the Silla-Tang alliance. The first event is more indirect—in 670, the Tibetan kingdom attacked the Tang empire.  The fighting was intense, and required serious resources from both sides.  Eventually the Tibetan forces were victorious, but not without a heavy toll on the Tibetan kingdom, which some attribute to the latter's eventual demise.  Their pyrrhic victory, however, was a defeat for the Tang, who also lost troops and resources in the fighting.  Then, in 671, the Tang empire would suffer another loss as Silla would drive the Tang forces out of the territory of the former kingdom of Baekje. With the Baekje territory under their control, it appears that Silla was also working to encourage some of rebellions in Goguryeo.  This more than irked the Tang court, currently under the formal control of Tang Gaozong and the informal—but quite considerable—control of his wife, Wu Zetian, who some claim was the one actually calling most of the shots in the court at this point in time.  Silla encouragement of restoration efforts in Goguryeo reached the Tang court in 674, in and in 675 we see that the Tang forces were sent to take back their foothold in the former Baekje territory.  Tang defeated Silla at Gyeonggi, and Silla's king, Munmu, sent a tribute mission to the Tang court, apologizing for their past behavior. However, the Tang control could not be maintained, as they had to once again withdraw most of their troops from the peninsula to send them against the Tibetan kingdom once more.  As soon as they did so, Silla once again renewed their attacks on Tang forces on the peninsula.  And so, a year later, in 676, the Tang forces were back.  They crossed the Yellow Sea to try and take back the Tang territories on the lower peninsula, but they were unsuccessful.  Tang forces were defeated by Silla at Maeso Fortress in modern day Yeoncheon.  After a bit more fighting, Silla ended up in control of all territory south of the Taedong River, which runs through Pyongyang, one of the ancient capitals of Goguryeo and the capital of modern North Korea.  This meant that the Tang dynasty still held much of the territory of Goguryeo under their control. With everything that was going on, perhaps that explains some of the apparently defensive measures that Yamato continued to take.  For example, the second lunar month of 675, we know that Ohoama proceeded to Takayasu castle, likely as a kind of formal inspection.  Then, in the 10th lunar month of 675 Ohoama commanded that everyone from the Princes down to the lowest rank were to provide the government with weapons.  A year later, in the 9th month of 676, the Princes and Ministers sent agents to the capital and the Home Provinces and gave out weapons to each man.  Similar edicts would be issued throughout the reign.  So in 679 the court announced that in two years time, which is to say the year 681, there would be a review of the weapons and horses belonging to the Princes of the Blood, Ministers, and any public functionaries.  And in that same year, barrier were erected for the first time on Mt. Tatsta and Mt. Afusaka, along with an outer line of fortifications at Naniwa. While some of that no doubt also helped to control internal movements, it also would have been useful to prepare for the possibility of future invasions.  And the work continued.  In 683  we see a royal command to all of the various provinces to engage in military training.  And in 684 it was decreed at that there would be an inspection in the 9th month of the following year—685—and they laid out the ceremonial rules, such as who would stand where, what the official clothing was to look like, etc.  Furthermore, there was also an edict that all civil and military officials should practice the use of arms and riding horses.  They were expected to supply their own horses, weapons, and anything they would wear into battle. If they owned horses, they would be considered cavalry soldiers, while those who did not have their own horse would be trained as infantry.  Either way, they would each receive training, and the court was determined to remove any obstacles and excuses that might arise.   Anyone who didn't comply would be punished.  Non compliance could mean refusing to train, but it could also just mean that they did not provide the proper horses or equipment, or they let their equipment fall into a state of disrepair.  Punishments could range from fines to outright flogging, should they be found guilty.  On the other hand, those who practiced well would have any punishments against them for other crimes reduced by two degrees, even if it was for a capital crime.  This only applied to previous crimes, however—if it seemed like you were trying to take advantage of this as a loophole to be able to get away with doing your own thing than the pardon itself would be considered null and void. A year later, the aforementioned inspection was carried out by Princes Miyatokoro, Hirose, Naniwa, Takeda, and Mino.  Two months later, the court issued another edict demanding that military equipment—specifically objects such as large or small horns, drums, flutes, flags, large bows, or catapults—should be stored at the government district house and not kept in private arsenals.  The "large bow" in this case may be something like a ballista, though Aston translates it to crossbow—unfortunately, it isn't exactly clear, and we don't necessarily have a plethora of extant examples to point to regarding what they meant.  Still, these seem to be focused on things that would be used by armies—especially the banners, large bows, and catapults.  The musical instruments may seem odd, though music was often an important part of Tang dynasty military maneuvers.  It was used to coordinate troops, raise morale, provide a marching rhythm, and more.  Granted, much of this feels like something more continental, and it is unclear if music was regularly used in the archipelago.  This could be more of Yamato trying to emulate the Tang dynasty rather than something that was commonplace on the archipelago.  That might also explain the reference to the Ohoyumi and the catapults, or rock throwers. All of this language having to do with military preparations could just be more of the same as far as the Sinicization of the Yamato government is concerned; attempts to further emulate what they understood of the civilized governments on the mainland—or at least their conception of those governments based on the various written works that they had imported.  Still, I think it is relevant that there was a lot of uncertainty regarding the position of various polities and the potential for conflict.  Each year could bring new changes to the political dynamic that could see military intervention make its way across the straits.  And of course, there was always the possibility that Yamato itself might decide to raise a force of its own. Throughout all of this, there was continued contact with the peninsula and other lands.  Of course, Silla and Goguryeo were both represented when Ohoama came to the throne—though only the Silla ambassador made it to the ceremony, apparently.  In the 7th lunar month of 675, Ohotomo no Muraji no Kunimaro was sent to Silla as the Chief envoy, along with Miyake no Kishi no Irishi.  They likely got a chance to witness first-hand the tensions between Silla and the Tang court.  The mission would return in the second lunar month of the following year, 676.  Eight months later, Mononobe no Muarji no Maro and Yamashiro no Atahe no Momotari were both sent.  That embassy also returned in the 2nd lunar month of the following year. Meanwhile, it wasn't just Yamato traveling to Silla—there were also envoys coming the other way.  For example, in the 2nd lunar month of 675 we are told that Silla sent Prince Chyungweon as an ambassador.  His retinue was apparently detained on Tsukushi while the actual envoy team went on to the Yamato capital.  It took them about two months to get there, and then they stayed until the 8th lunar month, so about four months in total. At the same time, in the third month, Goguryeo and Silla both sent "tribute" to Yamato.  And in the 8th month, Prince Kumaki, from Tamna, arrived at Tsukushi as well.  Tamna, as you may recall, refers to nation on the island known today as Jeju.  The late Alexander Vovin suggested that the name originated from a proto-Japonic cognate with "Tanimura", and many of the names seem to also bear out a possible Japonic influence on the island nation. Although they only somewhat recently show up in the Chronicles from our perspective, archaeological evidence suggests that they had trade with Yayoi Japan and Baekje since at least the first century.  With the fall of Baekje, and the expansion of Yamato authority to more of the archipelago, we've seen a notable uptick in the communication between Tamna and Yamato noted in the record.  A month after the arrival of Prince Kumaki in Tsukushi, aka Kyushu, it is noted that a Prince Koyo of Tamna arrived at Naniwa.  The Tamna guests would stick around for almost a year, during which time they were presented with a ship and eventually returned in the 7th lunar month of the following year, 676.   Tamna envoys, who had also shown up in 673, continued to be an annual presence at the Yamato court through the year 679, after which there is an apparent break in contact, picking back up in 684 and 685. 676 also saw a continuation of Silla representatives coming to the Yamato court, arriving in the 11th lunar month.  That means they probably passed by the Yamato envoys heading the other way.  Silla, under King Mumnu, now had complete control of the Korean peninsula south of the Taedong river.  In the same month we also see another mission from Goguryeo, but the Chronicle also points out that the Goguryeo envoys had a Silla escort, indicating the alliance between Silla and those attempting to restore Goguryeo—or at least the area of Goguryeo under Tang control.  The Tang, for their part, had pulled back their commandary to Liaodong, just west of the modern border between China and North Korea, today.  Goguryeo would not go quietly, and the people of that ancient kingdom—one of the oldest on the peninsula—would continue to rise up and assert their independence for years to come. The chronicles also record envoys from the somewhat mysterious northern Mishihase, or Sushen, thought to be people of the Okhotsk Sea culture from the Sakhalin islands.  There were 11 of them, and they came with the Silla envoys, possibly indicating their influence on the continent and through the Amur river region.  Previously, most of the contact had been through the regions of Koshi and the Emishi in modern Tohoku and Hokkaido.  This seems to be their only major envoy to the Yamato court recorded in this reign. Speaking of outside groups, in the 2nd lunar month of 677 we are told that there was an entertainment given to men of Tanegashima under the famous Tsuki tree west of Asukadera.  Many people may know Tanegashima from the role it played in the Sengoku Period, when Europeans made contact and Tanegashima became a major hub of Sengoku era firearm manufacturing.  At this point, however, it seems that it was still a largely independent island in the archipelago off the southern coast of Kyushu.  Even southern Kyushu appears to have retained some significant cultural differences at this time, with the "Hayato" people being referenced in regards to southern Kyushu—we'll talk about them in a bit as they showed up at the capital in 682.  Tanegashima is actually closer to Yakushima, another island considered to be separate, culturally, from Yamato, and could be considered the start of the chain of islands leading south to Amami Ohoshima and the other Ryukyuan islands.  That said, Tanegashima and Yakushima are much closer to the main islands of the archipelago and show considerable influence, including Yayoi and Kofun cultural artifacts, connecting them more closely to those cultures, even if Yamato initially saw them as distinct in some way. A formal Yamato envoy would head down to Tanegashima two years later, in the 11th lunar month of 679.  It was headed up by Yamato no Umakahibe no Miyatsuko no Tsura and Kami no Sukuri no Koukan.  The next reference to the mission comes in 681, when the envoys returned and presented a map of the island.  They claimed that it was in the middle of the ocean, and that rice was always abundant. With a single sowing of rice it was said that they could get two harvests.  Other products specifically mentioned were cape jasmine and bulrushes, though they then note that there were also many other products that they didn't bother to list.  This must have been considered quite the success, as the Yamato envoys were each awarded a grade of rank for their efforts.   They also appear to have returned with some of the locals, as they were entertained again in Asuka—this time on the riverbank west of Asukadera, where various kinds of music were performed for them. Tanegashima and Yakushima would be brought formally under Yamato hegemony in 702 with the creation of Tane province, but for now it was still considered separate.  This was probably just the first part of the efforts to bring them into Yamato, proper. Getting back to the Silla envoys who had arrived in 676, they appear to have remained for several months.  In the third lunar month of 677 we are told that they, along with guests of lower rank—thirteen persons all told—were invited to the capital.  Meanwhile, the escort envoys and others who had not been invited to the capital were entertained in Tsukushi and returned from there. While this was going on, weather out in the straits drove a Silla boat to the island of Chikashima.  Aboard was a Silla man accompanined by three attendants and three Buddhist priests.  We aren't told where they were going, but they were given shelter and when the Silla envoy, Kim Chyeonpyeong, returned home he left with those who had been driven ashore, as well. The following year, 678, was not a great one for the Silla envoys.  Garyang Jyeongsan and Gim Hongsye arrived at Tsukushi, but they were just the escorts.  The actual envoys had been separated by a storm at sea and never arrived.  In their place, the escort envoys were sent to the capital, probably to at least carry through with the rituals of diplomacy.  This was in the first month of the following year, 679, and given when envoys had previously arrived, it suggests to me that they waited a few months, probably to see if the envoys' ship eventually appeared and to give the court time to figure out what to do.  A month later, the Goguryeo envoys arrived, still being accompanied by Silla escorts, also arrived. Fortunately the Yamato envoys to Silla and elsewhere fared better.  That year, 679, the envoys returned successfully from Silla, Goguryeo, and Tamna.  Overall, though, I think it demonstrates that this wasn't just a pleasure cruise.  There was a very real possibility that one could get lost at sea.  At the same time, one needed people of sufficient status to be able to carry diplomatic messages and appropriately represent the court in foreign lands.  We often seen envoys later taking on greater positions of responsibility in the court, and so you didn't have to go far to find those willing to take the risk for later rewards. That same year, another tribute mission from Silla did manage to make the crossing successfully.  And in this mission we are given more details, for they brought gold, silver, iron, sacrificial cauldrons with three feet, brocade, cloth, hides, horses, dogs, mules, and camels.  And those were just the official gifts to the court.  Silla also sent distinct presents for the sovereign, the queen, and the crown prince, namely gold, silver, swords, flags, and things of that nature. This appears to demonstrate increasingly close ties between Silla and Yamato. All of that arrived in the 10th lunar month of 679, and they stayed through the 6th lunar month of 680—about 7 to 9 months all told, depending on if there were any intercalary months that year.  In addition to entertaining the Silla envoys in Tsukushi—it is not mentioned if they made it to the capital—we are also told that in the 2nd lunar month, halfway through the envoys' visit, eight labourers from Silla were sent back to their own country with gifts appropriate to their station. Here I have to pause and wonder what exactly is meant by this.  "Labourer" seems somewhat innocuous.  I suspect that their presence in Yamato may have been less than voluntary, and I wonder if these were captured prisoners of war who could have been in Yamato now for over a decade.  If so, this could have been a gesture indicating that the two sides were putting all of that nastiness with Baekje behind them, and Yamato was accepting Silla's new role on the peninsula.  Or maybe I'm reading too much into it, but it does seem to imply that Silla and Yamato were growing closer, something that Yamato would need if it wanted to have easy access, again, to the wider world. Speaking of returning people, that seems to have been something of a common thread for this year, 680, as another mission from Goguryeo saw 19 Goguryeo men also returned to their country.  These were condolence envoys who had come to mourn the death of Takara Hime—aka Saimei Tennou.  They must have arrived in the midst of all that was happening peninsula, and as such they were detained.  Their detention is somewhat interesting, when you think about it, since technically Baekje and Goguryeo—and thus Yamato—would have been on the same side against the Silla-Tang alliance.  But perhaps it was just considered too dangerous to send them home, initially, and then the Tang had taken control of their home.  It is unclear to me how much they were being held by Yamato and how much they were just men without a country for a time.  This may reflect how things on the mainland were stabilizing again, at least from Yamato's perspective.  However, as we'll discuss a bit later, it may have also been another attempt at restoring the Goguryeo kingdom by bringing back refugees, especially if they had connections with the old court.  The Goguryeo envoys—both the recent mission and those who had been detained—would remain until the 5th lunar month of 681, when they finally took their leave.  That year, there were numerous mission both from and to Silla and Goguryeo, and in the latter part of the year, Gim Chyungpyeong came once again, once more bearing gives of gold, silver, copper, iron, brocade, thin silk, deerskins, and fine cloth.  They also brought gold, silver, flags of a rosy-colored brocade and skins for the sovereign, his queen, and the crown prince. That said, the 681 envoys also brought grave news:  King Munmu of Silla was dead.  Munmu had reigned since 661, so he had overseen the conquest of Silla and Goguryeo.  His regnal name in Japanese might be read as Monmu, or even "Bunbu", referencing the blending of literary and cultural achievements seen as the pinnacle of noble attainment.  He is known as Munmu the Great for unifying the peninsula under a single ruler—though much of the Goguryeo territory was still out of reach.  Indeed he saw warfare and the betterment of his people, and it is no doubt significant that his death is recorded in the official records of the archipelago.   He was succeeded by his son, who would reign as King Sinmun, though the succession wasn't exactly smooth. We are told that Munmu, knowing his time was short, requested that his son, the Crown Prince, be named king before they attended to Munmu's own funerary arrangements, claiming that the throne should not sit vacant.  This may have been prescient, as the same year Munmu died and Sinmun ascended to the throne there was a revolt, led by none other than Sinmun's own father-in-law, Kim Heumdol.  Heumdol may, himselve, have been more of a figurehead for other political factions in the court and military.  Nonetheless, the attempted coup of 681 was quickly put down—the envoys in Yamato would likely only learn about everything after the dust had settled upon their return. The following year, 682, we see another interesting note about kings, this time in regards to the Goguryeo envoys, whom we are told were sent by the King of Goguryeo.  Ever since moving the commandery to Liaodong, the Tang empire had claimed dominion over the lands of Goguryeo north of the Taedong river.  Originally they had administered it militarily, but in 677 they crowned a local, Bojang as the "King of Joseon", using the old name for the region, and put him in charge of the Liaodong commandery.  However, he was removed in 681, and sent into exile in Sichuan, because rather than suppressing revolt, he had actually encouraged restoration attempts, inviting back Goguryeo refugees, like those who had been detained in Yamato.  Although Bojang himself was sent into exile, his descendants continued to claim sovereignty, so it may have been one of them that was making the claim to the "King of Goguryeo", possibly with Silla's blessing. Later that year, 682, we see Hayato from Ohosumi and Ata—possibly meaning Satsuma—the southernmost point of Kyushu coming to the court in 682.  They brought tribute and representatives of Ohosumi and Ata wrestled, with the Ohosumi wrestler emerging victorious.  They were entertained west of Asukadera, and various kinds of music was performed and gifts were given. They were apparently quite the sight, as Buddhist priests and laiety all came out to watch. Little is known for certain about the Hayato.  We have shields that are attributed to them, but their association may have more to do with the fact that they were employed as ceremonial guards for a time at the palace.  We do know that Southern Kyushu had various groups that were seen as culturally distinct from Yamato, although there is a lot of overlap in material culture.  We also see early reports of the Kumaso, possibly two different groups, the Kuma and So, in earlier records, and the relationship between the Kumaso and the Hayato is not clearly defined. What we do know is that southern Kyushu, for all that it shared with Yamato certain aspects of culture through the kofun period, for example, they also had their own traditions. For example, there is a particular burial tradition of underground kofun that is distinct to southern Kyushu.  A great example of this can be found at the Saitobaru Kofun cluster in Miyazaki, which contains these unique southern Kyushu style burials along with more Yamato style keyhole shaped and circular type kofun.  Miyazaki sits just north of the Ohosumi peninsula, in what was formerly the land of Hyuga, aka  Himuka.  This is also where a lot of the founding stories of the Heavenly grandchild were placed, and even today there is a shrine there to the Heavenly Rock Cave.  In other words there are a lot of connections with Southern Kyushu, and given that the Chronicles were being written in the later 7th and early 8th centuries, it is an area of intense interest when trying to understand the origins of Yamato and Japanese history. Unfortunately, nothing clearly tells us exactly how the Hayato were separate, but in the coming century they would both come under Yamato hegemony and rebel against it, time and again.  This isn't the first time they are mentioned, but it may be the first time that we see them as an actual people, in a factual entry as earlier references in the Chronicles are suspect. Continuing on with our look at diplomacy during this period, the year 683 we see a continuation of the same patterns, with nothing too out of the ordinary.  Same with most of 684 until the 12th lunar month.  It is then that we see a Silla ship arrive with Hashi no Sukune no Wohi and Shirawi no Fubito no Hozen.  They had both, previously been to the Tang empire to study, though we don't have a record of them leaving for that or any other purpose.  They are accompanied by Witsukahi no Muraji no Kobito and Tsukushi no Miyake no Muraji no Tokuko, both of whom had apparently been captured and taken by the Tang dynasty during the Baekje campaign.  Apparently they had all traveled back from the Tang empire together to Silla, who then provided them passage to Yamato. The timing of this suggests it may have had something to do with the changes going on in the Tang empire—changes that I desperately want to get into, but given that we are already a good ways into this current episode, I think I will leave it for later.  But I will note this:  Emperor Gaozong had passed away and his wife, Empress Wu Zetian, was now ruling as regent for her sons.  Wu Zetian is probably the most famous empress in all of Chinese history, and while she held de facto power as a co-regent during her husband's reign and as a regent during her sons' reigns, she would actually ascend the throne herself in 690.  Her reign as a woman during a time of heightened patriarchal tradition is particularly of note, and it leads us to wonder about the vilification that she received by the men who followed her rule.  And I really want to get into all of that but, thematically, I think it better to wait.  Those of you reading ahead in the syllabus—which is to say the Chronicles—probably know why.  So let us just leave it there and say that the Tang was going through a few things, and that may explain why students were returning back in the company of former war captives. A few months later, the Silla escort, Gim Mulyu, was sent home along with 7 people from Silla who had been washed ashore—presumably during a storm or other such event, again illustrating the dangers of taking to the ocean at this time.  Perhaps related to that theme is the entry only a month later, which merely stated that Gim Jusan of Silla returned home.  Gim Jusan was an envoy sent to Yamato in the 11th lunar month of 683.  He was entertained in Tsukushi, and we are told that he returned to his own country on the 3rd month of 684.  Now we are seeing an entry in the 4th month of 685 that this same person apparently returned home. It is possible that something got mixed up, and that the Chroniclers were dealing with a typo in the records that made it seem like this took place a year later than it did.  This was certainly an issue at this time, given all the math one had to do just to figure out what day it was.  There is also the possibility that he returned on another embassy, but just wasn't mentioned for some reason.  The last possible explanation is that he somehow got lost and it took him a year to find his way back.  Not entirely impossible back then, though I am a bit skeptical.  Among other things, why would that note have found its way into the Chronicles in Yamato?  While they were certainly using some continental sources, this seems like something they were talking about as far as him leaving the archipelago, rather than discussion of something happening elsewhere. Speaking of happening elsewhere, I'm wondering about another event that happened around this time as well.  In fact, it was while Gim Mulyu was still in the archipelago.  For some reason the Yamato court granted rank to 147 individuals from Tang, Baekje, and Goguryeo.  Interestingly, they don't mention Silla.  Furthermore, there is no real mention of any Tang envoys during this reign.  In fact, there is hardly mention of the Tang dynasty at all.  There is a mention of some 30 Tang men—captives, presumably—being sent to the Yamato court from Tsukushi.  Those men were settled in Toutoumi, so there were men of Tang in the archipelago.  But beyond that, there are only three other mentions of the Tang dynasty.  One was when the students and war captives came back.  Another was this note about giving rank to 147 individuals.  Finally there is a similar record in 686, at the very end of the reign, where it is 34 persons who were given rank.  This time it was to carpenters, diviners, physicians, students from Tang—possibly those who had just come back a year or so earlier.  So if there weren't envoys from Tang, Goguryeo, and Baekje, who were these people and why were they being granted Yamato court rank?  My assumption is that it was foreigners living in the archipelago, and being incorporated into the Yamato court system.  Still, it is interesting that after the overtures by the Tang in the previous reign we have heard virtually nothing since then.  Again, that is likely largely due to the conflicts between Tang and Silla, though now, things seem to be changing.  The conflicts have settled down, and new rulers are in place, so we'll see how things go. Speaking of which, let's finish up with the diplomatic exchanges in this reign.  I'm only hitting some of the highlights here.  First is the return from Silla, in the 5th month of 685, of Takamuku no Asomi no Maro and Tsuno no Asomi no Ushikahi.  They had traveled to Silla in 684, and they did not come back emptyhanded.  The new King of Silla presented them with gifts, including 2 horses, 3 dogs, 2 parrots, and 2 magpies.  They also brought back the novice monks Kanjou and Ryoukan.  Not bad, overall. Then, 6 months later, another tribute mission came, but this one has an interesting—if somewhat questionable—note attached to it.  It is said that the envoys Gim Jisyang and Gim Geonhun were sent to request "governance" and to bring tribute.  This certainly go the court's attention.  They didn't bring the envoys all the way to the capital, but they did send to them, in Tsukushi, Prince Kawachi, Ohotomo no Sukune no Yasumaro, Fujiwara no Asomi no Ohoshima, and Hodzumi no Asomi no Mushimaro. About three months later they send the musical performers from Kawaradera to provide entertainment during a banquet for the Silla envoy, and in payment some 5,000 bundles of rice rom the private lands attached to the queen's palace were granted to the temple in gratitude. The Silla tribute was then brought to the capital from Tsukushi.  This time it was more than 100 items, including one fine horse, one mule, two dogs, a gold container inlaid with some kind of design, gold, silver, faint brocade, silk gauze, tiger and leopard skins, and a variety of medicines.  In addition, as was now common, the envoys, Gim Jisyang and Gim Geonhun, apparently had personal gifts to give in the form of gold, silver, faint brocade, silk gauze, gold containers, screens, saddle hides, silk cloth, and more medicine.  There were also gifts specifically for the sovereign, the queen, the Crown Prince, and for the various princes of the blood. The court returned this favor with gifts to the envoys, presented at a banquet just for them, before sending them on their way. A couple of notes.  First off, it is interesting that they are entertained at Tsukushi rather than being invited to the capital, and I wonder if this was because the sovereign, Ohoama, wasn't doing so well.  This was all happening in 685 and 686, and the sovereign would pass away shortly afterwards.  So it is possible that Ohoama just was not up to entertaining visitors at this time.  Of course, the Chronicles often don't tell us exactly why a given decision was made, only that it was.  And sometimes not even that. The other thing that seems curious is the mention of a request for governance.  That almost sounds like Silla was asking to come under Yamato hegemony, which I seriously doubt.  It may be that they were asking something along the lines of an alliance, but it is also possible that the scribes recording things for Yamato heard what they wanted to hear and so wrote it down in the light most favorable to Yamato laying claim to the peninsula. Or perhaps I'm misunderstanding exactly what they were asking for.  Maybe "governance" here means something else—perhaps just some kind of better relationship. And with that, we'll leave it for now.  There is more developing in the next reign, but I think we want to wait until we get there.  There are still a lot more things to cover in this reign before we move on—we haven't even touched on the establishment of the new capital, on the various court events, not to mention some of the laws and punishments that this period is named for.  And there is the minor issue of a rebellion.  All of that will be dealt with.  And then, after that, we get to the final reign of the Chronicles: the reign of Jitou Tennou.  From there?  Who knows. It is the winter holiday season, so I hope everyone is enjoying themselves.  Next episode will be the New Year's recap, and then we should finish with this reign probably in January or early February. Until then, if you like what we are doing, please tell your friends and feel free to rate us wherever you listen to podcasts.  If you feel the need to do more, and want to help us keep this going, we have information about how you can donate on Patreon or through our KoFi site, ko-fi.com/sengokudaimyo, or find the links over at our main website,  SengokuDaimyo.com/Podcast, where we will have some more discussion on topics from this episode. Also, feel free to reach out to our Sengoku Daimyo Facebook page.  You can also email us at the.sengoku.daimyo@gmail.com.  Thank you, also, to Ellen for their work editing the podcast. And that's all for now.  Thank you again, and I'll see you next episode on Sengoku Daimyo's Chronicles of Japan.

温かさと厳しさを併せ持つ武田鉄矢が毎週テーマに添ってさまざまな語りを展開。どんな話題でも美味しくさばいて見せマス！さらに、Podcastでは配信されていない2006年以降の音源をお楽しみいただけるサービスが「QloveR」にて展開中！毎週月曜日に1週間分ずつアーカイブ音源が更新され、掲載されている音源は何度でも聴き放題です！ぜひご登録の上お楽しみください。登録はこちら→https://qlover.jp/takeda [毎週月曜更新]See omnystudio.com/listener for privacy information.

In this episode, Brad W. Minton speaks with Melissa Grabiner about leveraging LinkedIn for early career professionals. They discuss the importance of having an optimized LinkedIn profile, engaging with the platform, and networking effectively to enhance job search success. Melissa shares practical tips on how to stand out to recruiters, the significance of being proactive in job searching, and the value of building connections. The conversation emphasizes the need for young professionals to take charge of their career paths and utilize LinkedIn as a powerful tool for growth and opportunity.Key takeawaysLinkedIn is essential for job seekers, especially young professionals.Engagement on LinkedIn can significantly increase visibility to recruiters.A strong profile photo and personalized banner are crucial for attracting attention.Using keywords in your profile can help recruiters find you more easily.Networking is often more effective than applying to job postings.Reaching out to decision-makers can lead to job opportunities that aren't advertised.Being proactive in your job search can set you apart from other candidates.Utilizing LinkedIn Learning can enhance your skills and profile.It's important to share your personal story in your LinkedIn profile.Life is too short to be unhappy at work; seek a fulfilling career.Guest Info:With more than two decades of experience in Human Resources and Talent Acquisition, Melissa Grabiner is widely recognized as a leading strategist and thought leader in the field. She has built a strong reputation for her expertise in Talent Acquisition and has cultivated a LinkedIn following of over 470,000 professionals. Melissa is ranked the #2 Female LinkedIn Creator globally and the #1 HR Creator in the United States.In the past year, her content has generated over 100 million post impressions and almost 2 million post engagements, underscoring her influence as a top voice in the HR and TA spaces. Her thought leadership extends beyond social media, with features in prominent publications including Market Watch, Fast Company, Harvard Business Review, and Indeed Business. She is also a sought-after podcast guest and frequently hosts LinkedIn Live sessions. Her expertise has been spotlighted twice on the iconic Times Square Billboard in New York City.Melissa spent 18 years at Baxter Healthcare, where she led Talent Acquisition for the company's largest global business unit—later acquired by Takeda Pharmaceuticals. Under her leadership, Melissa and her team received numerous awards, including recognition as the highest-performing global HR team at both Baxter and Takeda.Beyond her corporate achievements, Melissa is a passionate Job Search Coach, helping professionals enhance their resumes, optimize LinkedIn profiles, and refine their job search strategies, with perfect testimonials and ratings from every client (over 500). Melissa also works as a Talent Acquisition consultant for companies in the biotechnology and pharmaceutical industries and serves as a Business Advisor to three startup organizations.Melissa holds a bachelor's degree from the University of Illinois at Urbana-Champaign and is a certified yoga instructor and fitness enthusiast. She lives in Chicago with her husband and their two sons.Website: https://topmate.io/melissagrabinerLinkedIn: https://www.linkedin.com/in/melissa-grabiner/This podcast is brought to you by Mint To Be Career. www.minttobecareer.com

温かさと厳しさを併せ持つ武田鉄矢が毎週テーマに添ってさまざまな語りを展開。どんな話題でも美味しくさばいて見せマス！さらに、Podcastでは配信されていない2006年以降の音源をお楽しみいただけるサービスが「QloveR」にて展開中！毎週月曜日に1週間分ずつアーカイブ音源が更新され、掲載されている音源は何度でも聴き放題です！ぜひご登録の上お楽しみください。登録はこちら→https://qlover.jp/takeda [毎週月曜更新]See omnystudio.com/listener for privacy information.

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

It seems like it's time once more to grab some Japanese film. Especially after the passing of Tatsuya Nakadai. This gives us an excuse to go grab one of his films. So let's grab the three hour Akira Kurosawa film, Kagemusha: The Shadow Warrior(1980). Set before the unification of Japan, we have Tatsuya playing Shingen Takeda and his perfect double. Shingen's regular body double found a criminal that looks like Shingen's twin. A good thing too as lord Takeda get's mortally wounded and begs his generals and the other double to keep the peace for at least three years. This is to keep Oda Nobunaga from becoming emboldened. Spoiler from … Continue reading "Popcorn Pulse 254: Shadow War"

Description: Psoriatic disease affects far more than just the skin. Hear leading dermatologist Dr. April Armstrong and Dr. Benoît Guérrette discuss this and more with Jensen, a patient advocate. Psoriatic disease affects not only the skin but it can impact confidence, emotional and social well-being, and daily life. In this episode, join moderator Dr. Guy Eakin, Chief Scientific and Medical Officer at NPF, as we explore the disconnect between clinical classifications of psoriasis and what patients experience in real-life with leading dermatologist Dr. April Armstrong, Dr. Benoît Guérrette, Vice President of Dermatology & Rheumatology at Takeda, and Jensen, a NPF patient advocate and former Lead Youth Ambassador. Listen as we address the need for a more nuanced approach to classifying disease severity that accounts for the holistic needs of psoriatic disease, as well as share insights into how advocacy and awareness can drive change in treatment access and care standards.  The intent of this episode is to identify how clinical severity classifications of psoriasis are evolving to meet the needs of those who live with the disease and how that change impacts overall management. This episode is sponsored by Takeda. Timestamps: (0:00) Intro to Psoriasis Uncovered and guest welcome to dermatologist Dr. April Armstrong, Vice President of Takeda, Dr. Benoît Guérette, and patient advocate Jensen, who discuss the unmet needs of people with moderate psoriasis and how as a community we can better serve those living with the disease. 2:22 How health care providers and the biopharmaceutical industry are coming together to address systemic eligibility and the unmet needs of people living with psoriasis. 4:25 Quality of life should be included when assessing clinical severity in psoriasis and identification of appropriate treatment choices. 6:52 The impact of misdiagnosis, inappropriate treatment, and effect on high impact sites can be life- altering. 8:30 How appropriate treatment and knowledge can make all the difference when diagnosed with plaque psoriasis.  9:40 Views on the psoriasis disease classification system and how it's evolving to include real life impact from physical and emotional needs, to more personalized care for those living with psoriasis, even when small body surface areas are involved. Severity isn't defined by skin coverage alone. 12:38 What's needed to prioritize the care and outcomes of people living with psoriasis. 14:18  The future of management and care for psoriatic disease. 15:53  "My skin tells a story." Wisdom from what I wish I had known previously. 16:52  Moving closer to care that truly reflects the lives and needs of those who live with psoriasis. Key Takeaways: ·       Severity of psoriasis isn't defined by skin coverage or body surface area (BSA) alone. The impact on quality of life should also be considered in the assessment, selection of treatment, and management of the disease.  ·       The psoriasis disease classification system is evolving to be more of a patient centered approach.  Many clinicians are now using the International Psoriasis Council (IPC) or 2 bucket approach to identify whether someone should receive a topical or systemic treatment based on location and response to treatment, as well as impact on quality of life.  ·       With continued research and  development, the next 5 to 10 years could see a shift in effective treatment options while also treating sooner to initiate better outcomes for people living with psoriasis and psoriatic arthritis. Guest Bios:   April Armstrong, M.D., M.P.H. is an internationally renowned dermatologist and clinical researcher who is a Professor and Chief of Dermatology at the University of California Los Angeles (UCLA) where she specializes in inflammatory skin diseases such as psoriasis, atopic dermatitis, and hidradenitis suppurativa (HS). Dr. Armstrong is also the Co-Director for Network Resources at the UCLA Clinical and Translational Research Institute. She has conducted over 150 clinical trials and published over 350 high impact articles in scientific journals. Dr. Armstrong holds multiple leadership positions including the immediate Past Chair of the National Psoriasis Foundation Medical Board, Co-President of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), councilor for the International Psoriasis Council, and board member for the International Dermatology Outcome Measures and the American Academy of Dermatology.  Benoît Guérette, Ph.D. is an accomplished leader in medical affairs with extensive experience across academia and the pharmaceutical industry. Since March 2025, Dr. Guérette has served as Vice President of Dermatology and Rheumatology US Medical Affairs at Takeda Pharmaceutical. Prior to joining Takeda, he held several strategic and leadership roles at various pharmaceutical companies, including overseeing clinical development, global and U.S. medical affairs, global access & pricing, translational sciences and more. Before transitioning to the industry, Dr. Guérette was an Associate Professor of Immunology at Laval University, leading research in cancer immunology. He holds a Ph.D. in Medicine, Microbiology, and Immunology from Laval University and completed postdoctoral studies in Inflammation and Immunology at  Harvard Medical School.  Jensen is a volunteer and former Lead Youth Ambassador for the National Psoriasis Foundation. Jensen developed psoriasis at age 7 but wasn't formally diagnosed until age 14 being misdiagnosed along the way, trying different management approaches that were ineffective. She was a competitive swimmer from elementary through high school and in the last 2 years of high school played lacrosse. Upon finishing high school she attended college becoming a registered nurse in an intensive care unit. Jensen wants "youth living with psoriatic disease to feel a  community that is behind them and with them every step of the way. I really want to be able to make a difference in a way that would've helped me as a child when I was diagnosed." Resources: Ø  "Reassessing Psoriasis Severity" Advance Online, National Psoriasis Foundation. H. Onorati. January 16, 2024,  https://www.psoriasis.org/advance/psoriasis-severity-high-impact-sites/   Ø  "Psoriasis Involving Special Areas is Associated with Worse Quality of Life, Depression, and Limitations in the Ability to Participate in Social Roles and Activities". Blauvelt, A., Strober, B., Gondo, G., Journal of Psoriasis and Psoriatic Arthritis Volume 8, Issue 3.  https://journals.sagepub.com/doi/full/10.1177/24755303231160683

温かさと厳しさを併せ持つ武田鉄矢が毎週テーマに添ってさまざまな語りを展開。どんな話題でも美味しくさばいて見せマス！さらに、Podcastでは配信されていない2006年以降の音源をお楽しみいただけるサービスが「QloveR」にて展開中！毎週月曜日に1週間分ずつアーカイブ音源が更新され、掲載されている音源は何度でも聴き放題です！ぜひご登録の上お楽しみください。登録はこちら→https://qlover.jp/takeda [毎週月曜更新]See omnystudio.com/listener for privacy information.

温かさと厳しさを併せ持つ武田鉄矢が毎週テーマに添ってさまざまな語りを展開。どんな話題でも美味しくさばいて見せマス！さらに、Podcastでは配信されていない2006年以降の音源をお楽しみいただけるサービスが「QloveR」にて展開中！毎週月曜日に1週間分ずつアーカイブ音源が更新され、掲載されている音源は何度でも聴き放題です！ぜひご登録の上お楽しみください。登録はこちら→https://qlover.jp/takeda [毎週月曜更新]See omnystudio.com/listener for privacy information.

Research shows that women remain woefully underrepresented at the highest levels of leadership in the life sciences industry. Those who have broken through that glass ceiling, however, are not only doing groundbreaking work in pharma, biotech, medtech and beyond but also reframing what it means to be a leader in the sector—as evidenced by the often-unconventional career paths and management philosophies of the 10 women featured in this year’s Fiercest Women in Life Sciences report. In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, highlighting several honorees’ paradigm-busting approaches to leadership, mentorship and building inclusive teams. To learn more about the topics in this episode: 2025's Fiercest Women in Life Sciences 4 reasons life sciences still fail women at the top, despite a female-majority workforce: report GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels Merck KGaA, grappling with geopolitical tensions, ⁠reveals CEO transition Takeda taps Julie Kim to take over for retiring CEO Christophe Weber See omnystudio.com/listener for privacy information.

You're in the thick of it. An accident just happened while you were out climbing, and now you have to decide: do I self-rescue, or do I call for outside help? In this episode of the podcast, we dive into that moment of decision, and provide a series of questions that you can use as a matrix to help you decide what to do next. Our guests, Accidents Editor Pete Takeda, and IFMGA/AMGA Guide and Search and Rescue volunteer, Jason Antin, weigh in. Pete reflects on accident reports from ANAC where individuals have self-rescued, called SAR, or had to do a little of both. We break down a few of these case studies to explore what circumstances caused the accident victims to make the decisions they did to initiate rescue. Then, Jason shares what happens behind the scenes when you call Search and Rescue for help, and how self-rescue techniques can supplement a SAR team's mission and help SAR get to an injured party faster. Dive in to help prepare yourself, in case you ever find yourself in that moment of decision on how to respond to an accident. *** If you believe conversations like this matter, a donation to the AAC helps us continue sharing stories, insights, and education for the entire climbing community. Donate today at americanalpineclub.org/donate

温かさと厳しさを併せ持つ武田鉄矢が毎週テーマに添ってさまざまな語りを展開。どんな話題でも美味しくさばいて見せマス！さらに、Podcastでは配信されていない2006年以降の音源をお楽しみいただけるサービスが「QloveR」にて展開中！毎週月曜日に1週間分ずつアーカイブ音源が更新され、掲載されている音源は何度でも聴き放題です！ぜひご登録の上お楽しみください。登録はこちら→https://qlover.jp/takeda [毎週月曜更新]See omnystudio.com/listener for privacy information.

The best biotech and pharmaceutical innovations mean nothing if they can't be protected—and protected fast. Our next guest, Josh Goldberg, is solving this challenge as co-managing partner at Nath, Goldberg & Meyer, the #1 ranked patent law firm for biotech and pharmaceutical technologies. With nearly three decades of IP law experience and a unique background as a lab researcher, Josh brings an insider's understanding of how innovation actually happens. He's helped industry leaders like Amgen, Takeda, and GlaxoSmithKline turn breakthrough treatments into patent-protected portfolios—often in under a year instead of the typical four-year timeline. Driven by a passion for focus and strategic IP timing, Josh shares his pioneering approach to biotech and pharmaceutical patent prosecution. Join us to discover how smart IP strategy drives licensing power, regulatory success, and company valuation. Let's go!Episode Highlights:Focus drives success – Companies fail by trying to do everything at once; staying deliberate and focused is key to making real impactOne-year patent timelines vs. four years – Josh uses USPTO's Track 1 program to secure patents in record time, improving fundraising and M&A positioningClient-centered approach wins – Listening to unique client needs instead of one-size-fits-all strategies earned the firm its #1 rankingDiagnostic patents are back – New USPTO Director signals the patent office is "open for business" again after a decade of restrictionsScientist turned patent attorney – Josh's lab background gives him insider understanding of how innovation actually happensAbout our Guest: Joshua is the patent attorney innovation-driven pharmaceutical companies call when they need to turn complicated technologies into protected assets in record time.As co-managing partner at Nath, Goldberg & Meyer—the #1 ranked patent law firm for biotech and pharmaceutical technologies in both 2024 and 2025—Joshua leads IP efforts across industries like biotech, pharma, agriculture, renewable energy, and advanced materials. Whether it's a blockbuster acne treatment like DUAC, a vitamin D analog lotion like Sorilux, OTC solutions like Salonpas and Germagic, or a leading drug used to reduce stomach acid and treat conditions like GERD, ulcers, and heartburn—like Protonix—Joshua helps turn high-stakes R&D into patent-protected portfolios, often in under a year instead of the typical four-year timeline.Though his climate and agricultre IP expertise has made him famous as the “green patent guy,” Joshua moves between disciplines skillfully and has helped industry leaders like Amgen, Takeda, Guilford Pharmaceuticals, Mayne, and Stiefel Laboratories (which was acquired by GlaxoSmithKline) build pharma portfolios that hold up under investor, acquirer, and FDA scrutiny.His journey didn't begin in IP law, but in the lab, researching experimental pharmaceutical delivery systems. It gave him an edge most attorneys don't have: understanding how innovation actually happens, and how to protect it without slowing a business down. Links Supporting This Episode: Nath, Goldberg & Meyer Website: CLICK HEREJoshua Goldberg LinkedIn page: CLICK HERENath, Goldberg & Meyer LinkedIn: CLICK HEREMike Biselli LinkedIn page: CLICK HEREMike Biselli Twitter page:...

The orexin receptor agonists are coming. After years of managing narcolepsy with stimulants, sodium oxybate, and wake-promoting agents, we soon will have medications that target the root cause of the disorder: the loss of orexin signaling. These new drugs—developed by Takeda, Alkermes, and Centessa—aren't just incremental improvements. They represent a genuine shift in how we understand and treat hypersomnolence disorders. In this episode, we will:Define what orexin is and why losing it destabilizes wakefulness, REM boundaries, muscle tone, and cognitionLearn how orexin agonists work—not as stimulants, but as replacement therapy for a missing neurotransmitterFind out why OX2R is the key receptor, and how selective agonists restore stable wakefulness, reduce cataplexy, and normalize attentionReview the available clinical data from the new wave of programs: oveporexton (Takeda), alixorexton (Alkermes), and ORX750 (Centessa)See what makes these drugs different from modafinil, amphetamines, solriamfetol, and oxybate therapiesLearn why Phase 1, Phase 2, and Phase 3 trials matter—with quick insights on how these drugs reached such strong resultsConsider safety and side effects, including what Hy's Law means and why regulators watch liver signals so closelyLook ahead to what these medications may mean for NT1, NT2, IH, and other hypersomnolence disorders in the coming yearsSpeculate why this class represents one of the most exciting moments in modern sleep medicineProduced by: Maeve WinterMore Twitter: @drchriswinter IG: @drchriwinter Threads: @drchriswinter Bluesky: @drchriswinter The Sleep Solution and The Rested Child Thanks for listening and sleep well!

Tyler and Konnery are joined by Tecate-drinking, elf-smashing companion Cameron Takeda to wrap out Guillermo del Toro's horror action duology with "Hellboy II: The Golden Army"! Together they discuss Guillermo's post Pan's Labyrinth acclaim, the incredible creature and set designs, this second film's strength at standing on its own story, dive deep into each other's histories with comic books, and so much more on this Barry Manilow-sing-along episode of The Friendchise Podcast! What's New: Konnery: Dungeon Crawler Carl Book: The Butcher's Masquerade by Matt Dinniman Tyler: Chapterhouse Dune by Frank Herbert (Libby), Perfect Blue (4K Restoration In Theaters) Cameron: Megazone 23 and Megazone 23 Pt II (Prime Video, Tubi)

温かさと厳しさを併せ持つ武田鉄矢が毎週テーマに添ってさまざまな語りを展開。どんな話題でも美味しくさばいて見せマス！さらに、Podcastでは配信されていない2006年以降の音源をお楽しみいただけるサービスが「QloveR」にて展開中！毎週月曜日に1週間分ずつアーカイブ音源が更新され、掲載されている音源は何度でも聴き放題です！ぜひご登録の上お楽しみください。登録はこちら→https://qlover.jp/takeda [毎週月曜更新]See omnystudio.com/listener for privacy information.

温かさと厳しさを併せ持つ武田鉄矢が毎週テーマに添ってさまざまな語りを展開。どんな話題でも美味しくさばいて見せマス！さらに、Podcastでは配信されていない2006年以降の音源をお楽しみいただけるサービスが「QloveR」にて展開中！毎週月曜日に1週間分ずつアーカイブ音源が更新され、掲載されている音源は何度でも聴き放題です！ぜひご登録の上お楽しみください。登録はこちら→https://qlover.jp/takeda [毎週月曜更新]See omnystudio.com/listener for privacy information.