Podcasts about Takeda

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 Big data in cardiology Measuring lipids: what clinicians need to know Milestones Host: Perry Elliott Guests: Carlos Aguiar, Karim Lekadir, Kostas Koskinas Want to watch that episode? Go to: https://esc365.escardio.org/event/1808 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  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, Nicolle Kraenkel and Karim Lekadir 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Perry Elliott has declared to have potential conflicts of interest to report: consultancies for Pfizer, BMS, Cytokinetics, AstraZeneca, Forbion. Kostas Koskinas has declared to have potential conflicts of interest to report: speaker fees / honoraria from MSD, Daiichi-Sankyo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Perry Elliott Guest: Karim Lekadir Want to watch that episode? Go to: https://esc365.escardio.org/event/1808?r Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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, Nicolle Kraenkel and Karim Lekadir 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Perry Elliott has declared to have potential conflicts of interest to report: consultancies for Pfizer, BMS, Cytokinetics, AstraZeneca, Forbion. 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."

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.

Dr. Diwakar Davar and Dr. Jason Luke discuss novel agents in melanoma and other promising new data in the field of immunotherapy that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Diwakar Davar: Hello. My name is Diwakar Davar, and I am welcoming you to the ASCO Daily News Podcast. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. Today, I'm joined by my colleague and good friend, Dr. Jason Luke. Dr. Luke is a professor of medicine. He is also the associate director of clinical research and the director of the Phase 1 IDDC Program at the University of Pittsburgh's Hillman Cancer Center. He and I are going to be discussing some key advancements in melanoma and skin cancers that were presented at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Jason, it is great to have you back on the podcast. Dr. Jason Luke: Thanks again so much for the opportunity, and I'm really looking forward to it. Dr. Diwakar Davar: Perfect. So we will go ahead and start talking a little bit about a couple of key abstracts in both the drug development immunotherapy space and the melanoma space. The first couple of abstracts, the first two, will cover melanoma. So, the first is LBA9500, which was essentially the primary results of RELATIVITY-098. RELATIVITY-098 was a phase 3 trial that compared nivolumab plus relatlimab in a fixed-dose combination against nivolumab alone for the adjuvant treatment of resected high-risk disease. Jason, do you want to maybe give us a brief context of what this is? Dr. Jason Luke: Yeah, it's great, thanks. So as almost all listeners, of course, will be aware, the use of anti–PD-1 immunotherapies really revolutionized melanoma oncology over the last 10 to 15 years. And it has become a standard of care in the adjuvant setting as well. But to review, in patients with stage III melanoma, treatment can be targeted towards BRAF with BRAF and MEK combination therapy, where that's relevant, or anti–PD-1 with nivolumab or pembrolizumab are a standard of care. And more recently, we've had the development of neoadjuvant approaches for palpable stage III disease. And in that space, if patients present, based on two different studies, either pembrolizumab or nivolumab plus ipilimumab can be given prior to surgery for somewhere in the 6- to 9-week range. And so all of these therapies have improved time-to-event endpoints, such as relapse-free or event-free survival. It's worth noting, however, that despite those advances, we've had a couple different trials now that have actually failed in this adjuvant setting, most high profile being the CheckMate-915 study, which looked at nivolumab plus ipilimumab and unfortunately was a negative study. So, with RELATIVITY-047, which was the trial of nivolumab plus relatlimab that showed an improvement in progression-free survival for metastatic disease, there's a lot of interest, and we've been awaiting these data for a long time for RELATIVITY-098, which, of course, is this adjuvant trial of LAG-3 blockade with relatlimab plus nivolumab. Dr. Diwakar Davar: Great. So with that, let's briefly discuss the trial design and the results. So this was a randomized, phase 3, blinded study, so double-blinded, so neither the investigators knew what the patients were getting, nor did the patients know what they were getting. The treatment investigational arm was nivolumab plus relatlimab in the fixed-dose combination. So that's the nivolumab standard fixed dose with relatlimab that was FDA approved in RELATIVITY-047. And the control arm was nivolumab by itself. The duration of treatment was 1 year. The patient population consisted of resected high-risk stage III or IV patients. The primary endpoint was investigator-assessed RFS. Stage and geography were the standard stratifying factors, and they were included, and most of the criteria were balanced across both arms. What we know at this point is that the 2-year RFS rate was 64% and 62% in the nivolumab and nivolumab-combination arms, respectively. The 2-year DMFS rate was similarly equivalent: 76% with nivolumab monotherapy, 73% with the combination. And similar to what you had talked about with CheckMate 915, unfortunately, the addition of LAG-3 did not appear to improve the RFS or DMFS compared to control in this patient population. So, tell us a little bit about your take on this and what do you think might be the reasons why this trial was negative? Dr. Jason Luke: It's really unfortunate that we have this negative phase 3 trial. There had been a lot of hope that the combination of nivolumab with relatlimab would be a better tolerated combination that increased the efficacy. So in the metastatic setting, we do have 047, the study that demonstrated nivolumab plus relatlimab, but now we have this negative trial in the adjuvant setting. And so as to why exactly, I think is a complicated scenario. You know, when we look at the hazard ratios for relapse-free survival, the primary endpoint, as well as the secondary endpoints for distant metastasis-free survival, we see that the hazard ratio is approximately 1. So there's basically no difference. And that really suggests that relatlimab in this setting had no impact whatsoever on therapeutic outcomes in terms of efficacy. Now, it's worth noting that there was a biomarker subanalysis that was presented in conjunction with these data that looked at some immunophenotyping, both from circulating T cells, CD8 T cells, as well as from the tumor microenvironment from patients who were treated, both in the previous metastatic trial, the RELATIVITY-047 study, and now in this adjuvant study in the RELATIVITY-098 study. And to briefly summarize those, what was identified was that T cells in advanced melanoma seemed to have higher expression levels of LAG-3 relative to T cells that are circulating in patients that are in the adjuvant setting. In addition to that, there was a suggestion that the magnitude of increase is greater in the advanced setting versus adjuvant. And the overall summary of this is that the suggested rationale for why this was a negative trial may have been that the target of LAG-3 is not expressed as highly in the adjuvant setting as it is in the metastatic setting. And so while the data that were presented, I think, support this kind of an idea, I am a little bit cautious that this is actually the reason for why the trial was negative, however. I would say we're not really sure yet as to why the trial was negative, but the fact that the hazard ratios for the major endpoints were essentially 1 suggests that there was no impact whatsoever from relatlimab. And this really makes one wonder whether or not building on anti–PD-1 in the adjuvant setting is feasible because anti–PD-1 works so well. You would think that even if the levels of LAG-3 expression were slightly different, you would have seen a trend in one direction or another by adding a second drug, relatlimab, in this scenario. So overall, I think it's an unfortunate circumstance that the trial is negative. Clearly there's going to be no role for relatlimab in the adjuvant setting. I think this really makes one wonder about the utility of LAG-3 blockade and how powerful it really can be. I think it's probably worth pointing out there's another adjuvant trial ongoing now of a different PD-1 and LAG-3 combination, and that's cemiplimab plus fianlimab, a LAG-3 antibody that's being dosed from another trial sponsor at a much higher dose, and perhaps that may make some level of difference. But certainly, these are unfortunate results that will not advance the field beyond where we were at already. Dr. Diwakar Davar: And to your point about third-generation checkpoint factors that were negative, I guess it's probably worth noting that a trial that you were involved with, KeyVibe-010, that evaluated the PD-1 TIGIT co-formulation of vibostolimab, MK-4280A, was also, unfortunately, similarly negative. So, to your point, it's not clear that all these third-generation receptors are necessarily going to have the same impact in the adjuvant setting, even if they, you know, for example, like TIGIT, and they sometimes may not even have an effect at all in the advanced cancer setting. So, we'll see what the HARMONY phase 3 trial, that's the Regeneron cemiplimab/fianlimab versus pembrolizumab control with cemiplimab with fianlimab at two different doses, we'll see how that reads out. But certainly, as you've said, LAG-3 does not, unfortunately, appear to have an impact in the adjuvant setting. So let's move on to LBA9501. This is the primary analysis of EORTC-2139-MG or the Columbus-AD trial. This was a randomized trial of encorafenib and binimetinib, which we will abbreviate as enco-bini going forward, compared to placebo in high-risk stage II setting in melanoma in patients with BRAF V600E or K mutant disease. So Jason, you know, you happen to know one or two things about the resected stage II setting, so maybe contextualize the stage II setting for us based on the trials that you've led, KEYNOTE-716, as well as CheckMate-76K, set us up to talk about Columbus-AD. Dr. Jason Luke: Thanks for that introduction, and certainly stage II disease has been something I've worked a lot on. The rationale for that has been that building off of the activity of anti–PD-1 in metastatic melanoma and then seeing the activity in stage III, like we just talked about, it was a curious circumstance that dating back about 7 to 8 years ago, there was no availability to use anti–PD-1 for high-risk stage II patients, even though the risk of recurrence and death from melanoma in the context of stage IIB and IIC melanoma is in fact similar or actually higher than in stage IIIA or IIIB, where anti–PD-1 was approved. And in that context, a couple of different trials that you alluded to, the Keynote-716 study that I led, as well as the CheckMate 76K trial, evaluated pembrolizumab and nivolumab, respectively, showing an improvement in relapse-free and distant metastasis-free survival, and both of those agents have subsequently been approved for use in the adjuvant setting by the US FDA as well as the European Medicines Agency.  So bringing then to this abstract, throughout melanoma oncology, we've seen that the impact of anti–PD-1 immunotherapy versus BRAF and MEK-targeted therapy have had very similar outcomes on a sort of comparison basis, both in frontline metastatic and then in adjuvant setting. So it was a totally reasonable question to ask: Could we use adjuvant BRAF and MEK inhibitor therapy? And I think all of us expected the answer would be yes. As we get into the discussion of the trial, I think the unfortunate circumstance was that the timing of this clinical trial being delayed somewhat, unfortunately, made it very difficult to accrue the trial, and so we're going to have to try to read through the tea leaves sort of, based on only a partially complete data set. Dr. Diwakar Davar: So, in terms of the results, they wanted to enroll 815 patients, they only enrolled 110. The RFS and DMFS were marginally improved in the treatment arm but certainly not significantly, which is not surprising because the trial had only accrued 16% to 18% of its complete accrual. As such, we really can't abstract from the stage III COMBI-AD data to stage II patients. And certainly in this setting, one would argue that the primary treatment options certainly remain either anti–PD-1 monotherapy, either with pembrolizumab or nivolumab, based on 716 or 76K, or potentially active surveillance for the patients who are not inclined to get treated.  Can you tell us a little bit about how you foresee drug development going forward in this space because, you know, for example, with HARMONY, certainly IIC disease is a part of HARMONY. We will know at least a little bit about that in this space. So what do you think about the stage IIB/C patient population? Is this a patient population in which future combinations are going to be helpful, and how would you think about where we can go forward from here? Dr. Jason Luke: It is an unfortunate circumstance that this trial could not be accrued at the pace that was necessary. I think all of us believe that the results would have been positive if they'd been able to accrue the trial. In the preliminary data set that they did disclose of that 110 patients, you know, it's clear there is a difference at a, you know, a landmark at a year. They showed a 16% difference, and that would be in line with what has been seen in stage III. And so, you know, I think it's really kind of too bad. There's really going to be no regulatory approach for this consideration. So using BRAF and MEK inhibition in stage II is not going to be part of standard practice moving into the future. To your point, though, about where will the field go? I think what we're already realizing is that in the adjuvant setting, we're really overtreating the total population. And so beyond merely staging by AJCC criteria, we need to move to biomarker selection to help inform which patients truly need the treatment. And in that regard, I don't think we've crystallized together as a field as yet, but the kinds of things that people are thinking about are the integration of molecular biomarkers like ctDNA. When it's positive, it can be very helpful, but in melanoma, we found that, unfortunately, the rates are quite low, you know, in the 10% to 15% range in the adjuvant setting. So then another consideration would be factors in the primary tumor, such as gene expression profiling or other considerations.  And so I think the future of adjuvant clinical trials will be an integration of both the standard AJCC staging system as well as some kind of overlaid molecular biomarker that helps to enrich for a higher-risk population of patients because on a high level, when you abstract out, it's just clearly the case that we're rather substantially overtreating the totality of the population, especially given that in all of our adjuvant studies to date for anti–PD-1, we have not yet shown that there's an overall survival advantage. And so some are even arguing perhaps we should even reserve treatment until patients progress. I think that's a complicated subject, and standard of care at this point is to offer adjuvant therapy, but certainly a lot more to do because many patients, you know, unfortunately, still do progress and move on to metastatic disease. Dr. Diwakar Davar: Let's transition to Abstract 2508. So we're moving on from the melanoma to the novel immunotherapy abstracts. And this is a very, very, very fascinating drug. It's IMA203. So Abstract 2508 is a phase 1 clinical update of IMA203. IMA203 is an autologous TCR-T construct targeting PRAME in patients with heavily pretreated PD-1-refractory metastatic melanoma. So Jason, in the PD-1 and CTLA-4-refractory settings, treatment options are either autologous TIL, response rate, you know, ballpark 29% to 31%, oncolytic viral therapy, RP1 with nivolumab, ORR about 30-ish percent. So new options are needed. Can you tell us a little bit about IMA203? Perhaps tell us for the audience, what is the difference between a TCR-T and traditional autologous TIL? And a little bit about this drug, IMA203, and how it distinguishes itself from the competing TIL products in the landscape. Dr. Jason Luke: I'm extremely enthusiastic about IMA203. I think that it really has transformative potential based on these results and hopefully from the phase 3 trial that's open to accrual now. So, what is IMA203? We said it's a TCR-T cell product. So what that means is that T cells are removed from a patient, and then they can be transduced through various technologies, but inserted into those T cells, we can then add a T-cell receptor that's very specific to a single antigen, and in this case, it's PRAME. So that then is contrasted quite a bit from the TIL process, which includes a surgical resection of a tumor where T cells are removed, but they're not specific necessarily to the cancer, and they're grown up in the lab and then given to the patient. They're both adoptive cell transfer products, but they're very different. One is genetically modified, and the other one is not. And so the process for generating a TCR-T cell is that patients are required to have a new biomarker that some may not be familiar with, which is HLA profiling. So the T-cell receptor requires matching to the concomitant HLA for which the peptide is bound in. And so the classic one that is used in most oncology practices is A*02:01 because approximately 48% of Caucasians have A*02:01, and the frequency of HLA in other ethnicities starts to become highly variable. But in patients who are identified to have A*02:01 genotype, we can then remove blood via leukapheresis or an apheresis product, and then insert via lentiviral transduction this T-cell receptor targeting PRAME. Patients are then brought back to the hospital where they can receive lymphodepleting chemotherapy and then receive the reinfusion of the TCR-T cells. Again, in contrast with the TIL process, however, these T cells are extremely potent, and we do not need to give high-dose interleukin-2, which is administered in the context of TIL. Given that process, we have this clinical trial in front of us now, and at ASCO, the update was from the phase 1 study, which was looking at IMA203 in an efficacy population of melanoma patients who were refractory at checkpoint blockade and actually multiple lines of therapy. So here, there were 33 patients and a response rate of approximately 50% was observed in this population of patients, notably with a duration of response approximately a year in that treatment group. And I realize that these were heavily pretreated patients who had a range of very high-risk features. And approximately half the population had uveal melanoma, which people may be aware is a generally speaking more difficult-to-treat subtype of melanoma that metastasizes to the liver, which again has been a site of resistance to cancer immunotherapy. So these results are extremely promising. To summarize them from what I said, it's easier to make TCR-T cells because we can remove blood from the patient to transduce the T cells, and we don't have to put them through surgery. We can then infuse them, and based on these results, it looks like the response rate to IMA203 is a little bit more than double what we expect from lifileucel. And then, whereas with lifileucel or TILs, we have to give high-dose IL-2, here we do not have to give high-dose IL-2. And so that's pretty promising. And a clinical trial is ongoing now called the SUPREME phase 3 clinical trial, which is hoping to validate these results in a randomized global study. Dr. Diwakar Davar: Now, one thing that I wanted to go over with you, because you know this trial particularly well, is what you think of the likelihood of success, and then we'll talk a little bit about the trial design. But in your mind, do you think that this is a trial that has got a reasonable likelihood of success, maybe even a high likelihood of success? And maybe let's contextualize that to say an alternative trial, such as, for example, the TebeAM trial, which is essentially a T-cell bispecific targeting GP100. It's being compared against SOC, investigator's choice control, also in a similarly heavily pretreated patient population. Dr. Jason Luke: So both trials, I think, have a strong chance of success. They are very different kinds of agents. And so the CD3 bispecific that you referred to, tebentafusp, likely has an effect of delaying progression, which in patients with advanced disease could have a value that might manifest as overall survival. With TCR-T cells, by contrast, we see a very high response rate with some of the patients going into very durable long-term benefit. And so I do think that the SUPREME clinical trial has a very high chance of success. It will be the first clinical trial in solid tumor oncology randomizing patients to receive a cell therapy as compared with a standard of care. And within that standard of care control arm, TILs are allowed as a treatment. And so it will also be the first study that will compare TCR-T cells against TILs in a randomized phase 3. But going back to the data that we've seen in the phase 1 trial, what we observe is that the duration of response is really connected to the quality of the response, meaning if you have more than a 50% tumor shrinkage, those patients do very, very well. But even in patients who have less than 50% tumor shrinkage, the median progression-free survival right now is about 4.5 months. And again, as we think about trial design, standard of care options for patients who are in this situation are unfortunately very bad. And the progression-free survival in that population is probably more like 2 months. So this is a trial that has a very high likelihood of being positive because the possibility of long-term response is there, but even for patients who don't get a durable response, they're likely going to benefit more than they would have based on standard chemotherapy or retreatment with an anti–PD-1 agent. Dr. Diwakar Davar: Really, a very important trial to enroll, a trial that is first in many ways. First of a new generation of TCR-T agents, first trial to look at cell therapy in the control arm, a new standard of efficacy, but potentially also if this trial is successful, it will also be a new standard of trial conduct, a new kind of trial, of a set of trials that will be done in the second-line immunotherapy-refractory space. So let's pivot to the last trial that we were going to discuss, which was Abstract 2501. Abstract 2501 is a first-in-human phase 1/2 trial evaluating BNT142, which is the first-in-class mRNA-encoded bispecific targeting Claudin-6 and CD3 in patients with Claudin-positive tumors. We'll talk a little bit about this, but maybe let's start by talking a little bit about Claudin-6. So Claudin-6 is a very interesting new target. It's a target that's highly expressed in GI and ovarian tumors. There are a whole plethora of Claudin-6-targeting agents, including T-cell bispecifics and Claudin-6-directed CAR-Ts that are being developed. But BNT142 is novel. It's a novel lipid nanoparticle LNP-encapsulated mRNA. The mRNA encodes an anti–Claudin-6 CD3 bispecific termed RiboMAB-021. And it then is administered to the patient. The BNT142-encoding mRNA LNPs are taken up by the liver and translated into the active drug. So Jason, tell us a little bit about this agent. Why you think it's novel, if you think it's novel, and let's talk a little bit then about the results. Dr. Jason Luke: So I certainly think this is a novel agent, and I think this is just the first of what will probably become a new paradigm in oncology drug development. And so you alluded to this, but just to rehash it quickly, the drug is encoded as genetic information that's placed in the lipid nanoparticle and then is infused into the patient. And after the lipid nanoparticles are taken up by the liver, which is the most common place that LNPs are usually taken up, that genetic material in the mRNA starts to be translated into the actual protein, and that protein is the drug. So this is in vivo generation, so the patient is making their own drug inside their body. I think it's a really, really interesting approach. So for any drug that could be encoded as a genetic sequence, and in this case, it's a bispecific, as you mentioned, CD3-Claudin-6 engager, this could have a tremendous impact on how we think about pharmacology and novel drug development moving into the future in oncology. So I think it's an extremely interesting drug, the like of which we'll probably see only more moving forward. Dr. Diwakar Davar: Let's maybe briefly talk about the results. You know, the patient population was heavily pretreated, 65 or so patients, mostly ovarian cancer. Two-thirds of the patients were ovarian cancer, the rest were germ cell and lung cancer patients. But let's talk a little bit about the efficacy. The disease control rate was about 58% in the phase 1 population as a whole, but 75% in the ovarian patient population. Now tell us a little bit about the interesting things about the drug in terms of the pharmacokinetics, and also then maybe we can pivot to the clinical activity by dose level. Dr. Jason Luke: Well, so they did present in their presentation at ASCO a proportionality showing that as higher doses were administered, that greater amounts of the drug were being made inside the patient. And so that's an interesting observation, and it's an important one, right? Suggesting that the pharmacology that we classically think of by administering drugs by IV, for example, would still be in play. And that did translate into some level of efficacy, particularly at the higher dose levels. Now, the caveat that I'll make a note of is that disease control rate is an endpoint that I think we have to be careful about because what that really means is sometimes a little bit unclear. Sometimes patients have slowly growing tumors and so on and so forth. And the clinical relevance of disease control, if it doesn't last at least 6 months, I think is probably pretty questionable. So I think these are extremely interesting data, and there's some preliminary sense that getting the dose up is going to matter because the treatment responses were mostly observed at the highest dose levels. There's also a caveat, however, that across the field of CD3 bispecific molecules like this, there's been quite a bit of heterogeneity in terms of the response rate, with some of them only really generating stable disease responses and other ones having more robust responses. And so I think this is a really interesting initial foray into this space. My best understanding is this molecule is not moving forward further after this, but I think that this really does set it up to be able to chase after multiple different drug targets on a CD3 bispecific backbone, both in ovarian cancer, but then basically across all of oncology. Dr. Diwakar Davar: Perfect. This is a very new sort of exciting arena where we're going to be looking at, in many ways, these programmable constructs, whether we're looking at in vivo-generated, in this case, a T-cell bispecific, but we've also got newer drugs where we are essentially giving drugs where people are generating in vivo CAR T, and also potentially even in vivo TCR-T. But certainly lots of new excitement around this entire class of drugs. And so, what we'd like to do at this point in time is switch to essentially the fact that we've got a very, very exciting set of data at ASCO 2025. You've heard from Dr. Luke regarding the advances in both early drug development but also in advanced cutaneous melanoma. And Jason, as always, thank you so much for sharing your very valuable and great, fantastic insights with us on the ASCO Daily News Podcast. Dr. Jason Luke: Well, thanks again for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for taking your time to listen today. You will find the links to the abstracts that we discussed today in the transcript of this episode. And finally, if you value the insights that you hear on 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. Diwakar Davar    @diwakardavar    Dr. Jason Luke @jasonlukemd Follow ASCO on social media:     @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn   Disclosures:     Dr. Diwakar Davar:      Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences     Consulting or Advisory Role: Instil Bio, Vedanta Biosciences     Consulting or Advisory Role (Immediate family member): Shionogi     Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences     Research Funding (Inst.): Zucero Therapeutics     Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy     Dr. Jason Luke:     Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX     Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine     Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure     Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)     Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

Dr. Neeraj Agarwal and Dr. Jeanny Aragon-Ching discuss important advances in the treatment of prostate, bladder, and kidney cancers that were presented at the 2025 ASCO Annual Meeting. TRANSCRIPT Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News Podcast. I am Dr. Neeraj Agarwal, your guest host of the ASCO Daily News Podcast today. I am the director of the Genitourinary Oncology Program and a professor of medicine at the University of Utah Huntsman Cancer Institute and editor-in-chief of the ASCO Daily News.  I am delighted to be joined by Dr. Jeanny Aragon-Ching, a GU medical oncologist and the clinical program director of the GU Center at the Inova Schar Cancer Institute in Virginia. Today, we will be discussing some key abstracts in GU oncology that were presented at the 2025 ASCO Annual Meeting.  Our full disclosures are available in the transcript of this episode.  Jeanny, it is great to have you on the podcast. Dr. Jeanny Aragon-Ching: Oh, thank you so much, Neeraj. Dr. Neeraj Agarwal: Jeanny, let's begin with some prostate cancer abstracts. Let's begin with Abstract 5017 titled, “Phase 1 study results of JNJ-78278343 (pasritamig) in metastatic castration-resistant prostate cancer.” Can you walk us through the design and the key findings of this first-in-human trial? Dr. Jeanny Aragon-Ching: Yeah, absolutely, Neeraj. So this study, presented by Dr. Capucine Baldini, introduces pasritamig, a first-in-class T-cell redirecting bispecific antibody that simultaneously binds KLK2 on prostate cancer cells and CD3 receptor complexes on T cells. KLK2 is also known as human kallikrein 2, which is selectively expressed in prostate tissue. And for reference, KLK3 is what we now know as the PSA, prostate-specific antigen, therefore making it an attractive and specific target for therapeutic engagement. Now, while this was an early, first-in-human, phase 1 study, it enrolled 174 heavily pretreated metastatic CRPC patients. So many were previously treated with ARPIs, taxanes, and radioligand therapy. So given the phase 1 nature of this study, the primary objective was to determine the safety and the RP2D, which is the recommended phase 2 dose. Secondary objectives included preliminary assessment of antitumor activity. So, pasritamig was generally well tolerated. There were no treatment-related deaths. Serious adverse events were rare. And in the RP2D safety cohort, where patients received the step-up dosing up to 300 mg of IV every 6 weeks, the most common treatment-related adverse events were low-grade infusion reactions. There was fatigue and grade 1 cytokine release syndrome, what we call CRS. And no cases of neurotoxicity, or what we call ICANS, the immune effector cell-associated neurotoxicity syndrome, reported. Importantly, the CRS occurred in just about 8.9% of patients. All were grade 1. No patients required tocilizumab or discontinued treatment due to adverse events. So, this suggests a favorable safety profile, allowing hopefully for outpatient administration without hospitalization, which will be very important when we're thinking about bispecifics moving forward. In terms of efficacy, pasritamig showed promising activity. About 42.4% of evaluable patients achieved a PSA50 response. Radiographic PFS was about 6.8 months. And among patients with measurable disease, the objective response rate was about 16.1% in those with lymph node or bone metastases, and about 3.7% in those with visceral disease, with a median duration of response of about 11.3 months. So, altogether, this data suggests that pasritamig may offer a well-tolerated and active new potential option for patients with metastatic CRPC.   Again, as a reminder, with the caveat that this is still an early phase 1 study. Dr. Neeraj Agarwal: Thank you, Jeanny. These are promising results for a bispecific T-cell engager, pasritamig, in prostate cancer. I agree, the safety and durability observed here stand out, and this opens the door for further development, possibly even in earlier disease settings.  So, shifting now from immunotherapy to the evolving role of genomics in prostate cancer. So let's discuss Abstract 5094, a real-world, retrospective analysis exploring the prognostic impact of homologous recombination repair gene mutations, especially BRCA1 and BRCA2 mutations, in metastatic hormone-sensitive prostate cancer. Can you tell us more about this abstract, Jeanny? Dr. Jeanny Aragon-Ching: Sure, Neeraj. So this study was presented by Dr. David Olmos, represents one of the largest real-world analyses we have evaluating the impact of homologous recombination repair, or what we would call HRR, alterations in metastatic hormone-sensitive prostate cancer. So, this cohort included 556 men who underwent paired germline and somatic testing. Now, about 30% of patients had HRR alterations, with about 12% harboring BRCA1 or BRCA2 mutations and 16% having alterations in other HRR genes. Importantly, patients were stratified via CHAARTED disease volume, and outcomes were examined across treatment approaches, including ADT alone, doublet therapy, and triplet therapy. The prevalence of BRCA and HRR alterations were about similar between the metastatic hormone-sensitive prostate cancer and the metastatic castrate-resistant prostate cancer, with no differences observed, actually, between the patients with high volume versus low volume disease.  So, the key finding was that BRCA and HRR alterations were associated with poor clinical outcomes in metastatic hormone-sensitive prostate cancer. And notably, the impact of these alterations may actually be even greater in metastatic hormone-sensitive prostate cancer than previously reported in metastatic CRPC. So, the data showed that when BRCA mutations are present, the impact of the volume of disease is actually limited. So, poor outcomes were observed across the board for both high-volume and low-volume groups. So, the analysis showed that patients with HRR alterations had significantly worse outcomes compared to patients without HRR alterations. Median radiographic progression-free survival was about 20.5 months for the HRR-altered patients versus 30.6 months for the non-HRR patients, with a hazard ratio of 1.6. Median overall survival was 39 months for HRR-altered patients compared to 55.7 months for the non-HRR patients, with a hazard ratio of 1.5. Similar significant differences were observed when BRCA-mutant patients were compared with patients harboring non-BRCA HRR mutations. Overall, poor outcomes were independent of treatment of ARPI or taxanes. Dr. Neeraj Agarwal: Thank you, Jeanny. So, these data reinforce homologous recombination repair mutations as both a predictive and prognostic biomarker, not only in the mCRPC, but also in the metastatic hormone-sensitive setting as well. It also makes a strong case for incorporating genomic testing early in the disease course and not waiting until our patients have castration-resistant disease. Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. And I think this really brings home the point and the lead up to the AMPLITUDE trial, which is LBA5006, a phase 3 trial that builds on this very concept of testing with a PARP inhibitor, niraparib, in the hormone-sensitive space. Can you tell us a little bit more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure. So, the AMPLITUDE trial, a phase 3 trial presented by Dr. Gerhardt Attard, enrolled 696 patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations. 56% of these patients had BRCA1 and BRCA2 mutations. Patients were randomized to receive abiraterone with or without niraparib, a PARP inhibitor. The majority of patients, 78% of these patients, had high-volume metastatic hormone-sensitive prostate cancer, and 87% of these patients had de novo metastatic HSPC. And 16% of these patients received prior docetaxel, which was allowed in the clinical trial. So, with a median follow-up of nearly 31 months, radiographic progression-free survival was significantly prolonged with the niraparib plus abiraterone combination, and median was not reached in this arm, compared to abiraterone alone, which was 29.5 months, with a hazard ratio of 0.63, translating to a 37% reduction in risk of progression or death. This benefit was even more pronounced in the BRCA1 and BRCA2 subgroup, with a 48% reduction in risk of progression, with a hazard ratio of 0.52. Time to symptomatic progression also improved significantly across all patients, including patients with BRCA1, BRCA2, and HRR mutations. Although overall survival data remain immature, early trends favored the niraparib plus abiraterone combination. The safety profile was consistent with prior PARP inhibitor studies, with grade 3 or higher anemia and hypertension were more common but manageable. Treatment discontinuation due to adverse events remained low at 11%, suggesting that timely dose modifications when our patients experience grade 3 side effects may allow our patients to continue treatment without discontinuation. These findings support niraparib plus abiraterone as a potential new standard of care in our patients with metastatic hormone-sensitive prostate cancer with HRR alterations, and especially in those who had BRCA1 and BRCA2 mutations. Dr. Jeanny Aragon-Ching: Thank you, Neeraj. This trial is especially exciting because it brings PARP inhibitors earlier into the treatment paradigm. Dr. Neeraj Agarwal: Exactly. And it is exciting to see the effect of PARP inhibitors in the earlier setting.  So Jeanny, now let's switch gears a bit to bladder cancer, which also saw several impactful studies. Could you tell us about Abstract 4502, an exploratory analysis from the EV-302 trial, which led to approval of enfortumab vedotin plus pembrolizumab for our patients with newly diagnosed metastatic bladder cancer? So here, the authors looked at the outcomes in patients who achieved a confirmed complete response with EV plus pembrolizumab. Dr. Jeanny Aragon-Ching: Sure, Neeraj. So, EV-302 demonstrated significant improvements in progression-free and overall survival for patients previously treated locally advanced or metastatic urothelial cancer, I'll just call it metastatic UC, as a frontline strategy, establishing EV, which is enfortumab vedotin, plus pembro, with pembrolizumab as standard of care in this setting.  So, this year at ASCO, Dr Shilpa Gupta presented this exploratory responder analysis from the phase 3 EV-302 trial. Among 886 randomized patients, about 30.4% of patients, this is about 133, in the EV+P arm, and 14.5% of the patients in the chemotherapy arm, achieved a confirmed complete response. They call it the CCR rates. So for patients who achieved this, median PFS was not reached with EV+P compared to 26.9 months with chemotherapy, with a hazard ratio of 0.36, translating to a 64% reduction in the risk of progression. Overall survival was also improved. So the median OS was not reached in either arm, but the hazard ratio favored the EV+P at 0.37, translating to a 63% reduction in the risk of death. The median duration of complete response was not reached with EV+P compared to 15.2 months with chemotherapy. And among those patients who had confirmed CRs at 24 months, 78% of patients with the EV+P arm remained progression-free, and around 95% of the patients were alive, compared to 54% of patients who were progression-free and 86% alive of the patients in the chemotherapy arm. Safety among responders were also consistent with prior reports. Grade 3 or higher treatment-related adverse events occurred in 62% of EV+P responders and 72% of chemotherapy responders. Most adverse events were managed with dose modifications, and importantly, no treatment-related deaths were reported among those who were able to achieve complete response.  So these findings further reinforce EV and pembro as the preferred first-line therapy for metastatic urothelial carcinoma, offering a higher likelihood of deep, durable responses with a fairly manageable safety profile. Dr. Neeraj Agarwal: Thank you for the great summary, Jeanny. These findings underscore the depth and durability of responses achievable with this combination and also suggest that achieving a response may be a surrogate for long-term benefit in patients with metastatic urothelial carcinoma.  So now, let's move to Abstract 4503, an exploratory ctDNA analysis from the NIAGARA trial, which evaluated perioperative durvalumab, an immune checkpoint inhibitor, in muscle-invasive bladder cancer. So what can you tell us about this abstract? Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. So, in NIAGARA, presented by Dr. Tom Powles, the addition of perioperative durvalumab to neoadjuvant chemotherapy, gem/cis, significantly improved event-free survival, overall survival, and pathologic complete response in patients with cisplatin-eligible muscle-invasive bladder cancer. Recall that this led to the U.S. FDA approval of this treatment regimen on March 28, 2025.  So, a planned exploratory analysis evaluated the ctDNA dynamics and their association with clinical outcomes, which was the one presented recently at ASCO. So, the study found that the incidence of finding ctDNA positivity in these patients was about 57%. Following neoadjuvant treatment, this dropped to about 22%, with ctDNA clearance being more common in the durvalumab arm, about 41%, compared to the chemotherapy control arm of 31%. Notably, 97% of patients who remained ctDNA positive prior to surgery failed to achieve a pathologic CR. So, this indicates a strong association between ctDNA persistence and lack of tumor eradication. So, postoperatively, only about 9% of patients were ctDNA positive. So, importantly, durvalumab conferred an event-free survival benefit regardless of ctDNA status at both baseline and post-surgery. Among patients who were ctDNA positive at baseline, durvalumab led to a hazard ratio of 0.73 for EFS. So, this translates to a 27% reduction in the risk of disease recurrence, progression, or death compared to the control arm. In the post-surgical ctDNA-positive group, the disease-free survival was also improved with a hazard ratio of 0.49, translating to a 51% reduction in the risk of recurrence.  So, these findings underscore the prognostic value of ctDNA and suggest that durvalumab provides clinical benefit irrespective of molecular residual disease status. So, the data also supports that ctDNA is a promising biomarker for future personalized strategies in the perioperative treatment of muscle-invasive bladder cancer. Dr. Neeraj Agarwal: Thank you, Jeanny. It is great to see that durvalumab is improving outcomes in these patients regardless of ctDNA status. However, based on these data, presence of ctDNA in our patients warrants a closer follow-up with imaging studies, because these patients with positive ctDNA seem to have a higher risk of recurrence. Dr. Jeanny Aragon-Ching: I agree, Neeraj.  Let's round out the bladder cancer discussion with Abstract 4518, which reported the interim results of SURE-02, which is a phase 2 study evaluating neoadjuvant sacituzumab govitecan plus pembrolizumab in cisplatin-ineligible muscle-invasive bladder cancer. Can you tell us more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure, Jeanny. So, Dr Andrea Necchi presented interim results from the SURE-02 trial. This is a phase 2 study evaluating neoadjuvant sacituzumab govitecan plus pembrolizumab, followed by a response-adapted bladder-sparing treatment and adjuvant pembrolizumab in patients with muscle-invasive bladder cancer.  So, in this interim analysis, 40 patients were treated and 31 patients were evaluable for efficacy. So, the clinical complete response rate was 38.7%. All patients achieving clinical complete response underwent bladder-sparing approach with a repeat TURBT instead of radical cystectomy. Additionally, 51.6% of patients achieved excellent pathologic response with a T stage of 1 or less after neoadjuvant therapy. The treatment was well tolerated, with only 12.9% of patients experiencing grade 3 or higher adverse events without needing dose reduction of sacituzumab. Molecular profiling, interestingly, showed that clinical complete response correlated with luminal and genomically unstable subtypes, while high stromal gene expression was associated with lack of response.  These results suggest that sacituzumab plus pembrolizumab combination has promising activity in this setting, and tolerability, and along with other factors may potentially allow a bladder preservation approach in a substantial number of patients down the line. Dr. Jeanny Aragon-Ching: Yeah, agree with you, Neeraj. And the findings are very provocative and support completing the full trial enrollment and further exploration of this strategy in muscle-invasive bladder cancer in order to improve and provide further bladder-sparing strategies. Dr. Neeraj Agarwal: Agree. So, let's now turn to the kidney cancer, starting with Abstract 4505, the final overall analysis from CheckMate-214 trial, which evaluated nivolumab plus ipilimumab, so dual checkpoint inhibition strategy, versus sunitinib in our patients with metastatic clear cell renal cell carcinoma. Dr. Jeanny Aragon-Ching: Yeah, absolutely, Neeraj. So, the final 9-year analysis of the phase 3 CheckMate-214 trial confirms the long-term superiority of nivolumab and ipilimumab over sunitinib for first-line treatment of advanced metastatic renal cell carcinoma. So, this has a median follow-up of 9 years. Overall survival remains significantly improved with the combination. So, in the ITT patient population, the intention-to-treat, the hazard ratio for overall survival was 0.71. So, this translates to a 29% reduction in the risk of death. 31% of patients were alive at this 108-month follow-up compared to 20% only in those who got sunitinib. So, similar benefits were observed in the intermediate- and poor-risk groups with a hazard ratio of 0.69, and 30% versus 19% survival at 108 months.  Importantly, a delayed benefit was also seen in those favorable-risk patients. So, the hazard ratio for overall survival improved from 1.45 in the initial report and now at 0.8 at 9 years follow-up, with 35% of patients alive at 108 months compared to 22% in those who got sunitinib. Progression-free survival also favored the nivo-ipi arm across all risk groups. At 96 months, the probability of remaining progression-free was about 23% compared to 9% in the sunitinib arm in the ITT patient population, 25% versus 9% in the intermediate- and poor-risk patients, and 13% compared to 11% in the favorable-risk patients. Importantly, at 96 months, 48% of patients in the nivo-ipi responders remained in response compared to just 19% in those who got sunitinib. And in the favorable-risk group, 36% of patients who responded remained in response, although data were not available for sunitinib in this subgroup.  So, this data reinforces the use of nivolumab and ipilimumab as a durable and effective first-line effective strategy for standard of care across all risk groups for advanced renal cell carcinoma. Dr. Neeraj Agarwal: Thank you, Jeanny. And of course, since ipi-nivo data were presented, several other novel ICI-TKI combinations have emerged. And I'm really hoping to see very similar data with TKI-ICI combinations down the line. It is really important to note that we are not seeing any new safety signals with the ICI combinations or ICI-based therapies, which is very reassuring given the extended exposure. Dr. Jeanny Aragon-Ching: Absolutely agree with you there, Neeraj.  Now, going on and moving on to Abstract 4514, which is the KEYNOTE-564 trial, and they reported on the 5-year outcomes of adjuvant pembrolizumab in clear cell RCC in patients who are at high risk for recurrence. Can you tell us a little bit more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure. So, the KEYNOTE-564 trial established pembrolizumab monotherapy as the first adjuvant regimen to significantly improve both disease-free survival and overall survival compared to placebo after surgery for patients with clear cell renal cell carcinoma. So, Dr Naomi Haas presented the 5-year update from this landmark trial.  A total of 994 patients were randomized to receive either pembrolizumab or placebo. The median follow-up at the time of this analysis was approximately 70 months. Disease-free survival remained significantly improved with pembrolizumab. The median DFS was not reached with pembrolizumab compared to 68.3 months with placebo, with a hazard ratio of 0.71, translating to a 29% reduction in risk of recurrence. At 5 years, 60.9% of patients receiving pembrolizumab remained disease-free compared to 52.2% with placebo. Overall survival also favored pembrolizumab. The hazard ratio for OS was 0.66, translating to a 34% reduction in risk of death, with an estimated 5-year overall survival rate of 87.7% with pembrolizumab compared to 82.3% for placebo. Importantly, these benefits were consistent across all key subgroups, including patients with sarcomatoid features. In addition, no new serious treatment-related adverse events have been reported in the 3 years since treatment completion.  So, these long-term data confirm pembrolizumab as a durable and effective standard adjuvant therapy for patients with resected, high-risk clear cell renal cell carcinoma. Dr. Jeanny Aragon-Ching: Thank you for that wonderful summary, Neeraj. Dr. Neeraj Agarwal: That wraps up our kidney cancer highlights. Any closing thoughts, Jeanny, before we conclude? Dr. Jeanny Aragon-Ching: It's been so wonderful reviewing these abstracts with you, Neeraj. So, the 2025 ASCO Annual Meeting showcased a lot of transformative data across GU cancers, from first-in-class bispecifics to long-term survival in RCC. And these findings are already shaping our clinical practices. Dr. Neeraj Agarwal: I agree. And we have covered a broad spectrum of innovations in GU cancers with strong clinical relevance.  So, thank you, Jeanny, for joining me today and sharing your insights.  And thank you to our listeners for joining us. You will find links to the abstracts discussed today in the transcript of this episode. If you find these conversations valuable, please take a moment to rate, review, and subscribe to the ASCO Daily News Podcast wherever you listen. Thank you so much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers:    Dr. Neeraj Agarwal     @neerajaiims     Dr. Jeanny Aragon-Ching   Follow ASCO on social media:       @ASCO on Twitter       ASCO on Bluesky   ASCO on Facebook       ASCO on LinkedIn       Disclosures:   Dr. Neeraj Agarwal:   Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences  Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas  Dr. Jeanny Aragon-Ching:   Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc., Pfizer/EMD Serono   Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant, Exelixis,    Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb, Astellas/Seattle Genetics

In this podcast episode, Miguel Regueiro, MD, discusses developing the medical home model for patients with IBD, technological advances for patients in GI and more. •    Intro :58 •    The interview/about Regueiro 1:03 •    Tell us about your family and where you grew up. 1:24 •    How did you get interested in medicine? 2:16 •    Who were your early influences?  4:18 •    What is the medical home? 5:57 •    How did you develop the idea to apply the medical home model to IBD? 7:45 •    Did you get any funding from the payers for this model to keep costs under control for this patient population? 10:57 •    Why hasn't this model become standard of care for patients with complex IBD? 14:13 •    What has worked, and what hasn't worked when it comes to adopting an integrative care medical home model? 18:15 •    Are there themes patients share as to why they wouldn't want to be enrolled in a medical home? 21:28 •    What motivated your change to go from UPMC to become the GI Chief of Cleveland Clinic? 23:09 •    What have you learned in this position at Cleveland Clinic? 25:23 •    Are you spending a lot of time on the business side of care as opposed to the patient side? 26:34 •    How would you recommend that people prepare for having a position like this? 27:34 •    Are you seeing a shift in excitement over taking on leadership roles outside of traditional academics? 30:02 •    With our clinical tool chest changing so rapidly, is there a common theme that you use to guide the strategy of the institute on what to invest in? 35:06 •    What are the challenges that you still see in the ways we are using telehealth? 39:05 •    What are some of the most exciting things you see on the horizon in the realm of IBD management? 40:26 •    Thank you, Miguel 42:55 •    Thanks for listening 45:11 Miguel Regueiro, MD, is the chief of the Digestive Disease Institute at Cleveland Clinic, and professor in the department of medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. We'd love to hear from you! Send your comments/questions to guttalkpodcast@healio.com. Follow us on X @HealioGastro @sameerkberry @umfoodoc. For more from Regueiro, follow @MRegueiroMD on X. Disclosures: Berry and Chey report no relevant financial disclosures. Regueiro reports being on the advisory boards of and consulting for Abavax, Abbvie, Amgen, Biocon, BMS, Boehringer Ingelheim Pharmaceuticals Inc. (BIPI), Celgene, Celltrion, Gilead, Genentech, Johnson and Johnson, Lilly, Merck, Organon, Pfizer, Prometheus, Roche, Salix, Sanofi, Takeda and UBC.

Description: 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 Anna Henderson, MD, a pediatric gastroenterologist at Northern Light Health in Maine, about bone mineral density in EoE patients. They discuss a paper she co-authored on the subject. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship that exists 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 the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, eosinophilic esophagitis (EoE), and bone density.   [1:22] Holly introduces today's guest, Dr. Anna Henderson, a pediatric gastroenterologist at Northern Light Health in Maine.   [1:29] During her pediatric and pediatric gastroenterology training at Cincinnati Children's Hospital, she took a special interest in eosinophilic esophagitis. In 2019, Dr. Henderson received APFED's NASPGHAN Outstanding EGID Abstract Award.   [1:45] Holly, a feeding therapist in Maine, has referred many patients to Dr. Henderson and is excited to have her on the show.   [2:29] Dr. Henderson is a wife and mother. She loves to swim and loves the outdoors. She practices general pediatric GI in Bangor, Maine, at a community-based academic center.   [2:52] Her patient population is the northern two-thirds of Maine. Dr. Henderson feels it is rewarding to bring her expertise from Cincinnati to a community that may not otherwise have access to specialized care.   [3:13] Dr. Henderson's interest in EoE grew as a GI fellow at Cincinnati Children's. Her research focused on biomarkers for disease response to dietary therapies and EoE's relationship to bone health.   [3:36] As a fellow, Dr. Henderson rotated through different specialized clinics. She saw there were many unanswered questions about the disease process, areas to improve treatment options, and quality of life for the patients suffering from these diseases.   [4:00] Dr. Henderson saw many patients going through endoscopies. She saw the social barriers for patients following strict diets. She saw a huge need in EoE and jumped on it.   [4:20] Ryan grew up with EoE. He remembers the struggles of constant scopes, different treatment options, and dietary therapy. Many people struggled to find what was best for them before there was a good approved treatment.   [4:38] As part of Ryan's journey, he learned he has osteoporosis. He was diagnosed at age 18 or 19. His DEXA scan had such a low Z-score that they thought the machine was broken. He was retested.   [5:12] Dr. Henderson explains that bone mineral density is a key measure of bone health and strength. Denser bones contain more minerals and are stronger. A low bone mineral density means weaker bones. Weaker bones increase the risk of fracture.   [5:36] DEXA scan stands for Dual Energy X-ray Absorptiometry scan. It's a type of X-ray that takes 10 to 30 minutes. A machine scans over their bones. Typically, we're most interested in the lumbar spine and hip bones.   [5:56] The results are standardized to the patient's height and weight, with 0 being the average. A negative number means weaker bones than average for that patient's height and weight. Anything positive means stronger bones for that patient's height and weight.   [6:34] A lot of things can affect a patient's bone mineral density: genetics, dietary history, calcium and Vitamin D intake, and medications, including steroid use. Prednisone is a big risk factor for bone disease.   [7:07] Other risk factors are medical and auto-immune conditions, like celiac disease, and age. Any patient will have their highest bone density in their 20s to 30s. Females typically have lower bone mineral density than males.   [7:26] The last factor is lifestyle. Patients who are more active and do weight-bearing exercises will have higher bone mineral density than patients who have more of a sedentary lifestyle.   [7:56] Ryan was told his bone mineral density issues were probably a side-effect of the long-term steroids he was on for his EoE. Ryan is now on benralizumab for eosinophilic asthma. He is off steroids.   [8:36] Dr. Henderson says the research is needed to find causes of bone mineral density loss besides glucocorticoids.   [8:45] EoE patients are on swallowed steroids, fluticasone, budesonide, etc. Other patients are on steroids for asthma, eczema, and allergic rhinitis. These may be intranasal steroids or topical steroids.   [9:01] Dr. Henderson says we wondered whether or not all of those steroids and those combined risks put the EoE population at risk for low bone mineral density. There's not a lot published in that area.   [9:14] We know that proton pump inhibitors can increase the risk of low bone mineral density. A lot of EoE patients are on proton pump inhibitors.   [9:23] That was where Dr. Henderson's interest started. She didn't have a great way to screen for bone mineral density issues or even know if it was a problem in her patients more than was expected in a typical patient population.   [9:57] Holly wasn't diagnosed with EoE until she was in her late 20s. She was undiagnosed but was given prednisone for her problems. Now she wonders if she should get a DEXA scan.   [10:15] Holly hopes the listeners will learn something and advocate for themselves or for their children.   [10:52] If a patient is concerned about their bone mineral density, talking to your PCP is a perfect place to start. They can discuss the risk factors and order a DEXA scan and interpret it, if needed.   [11:11] If osteoporosis is diagnosed, you should see an endocrinologist, specifically to discuss therapy, including medications called bisphosphonates.   [11:36] From an EoE perspective, patients can talk to their gastroenterologist about what bone mineral density risk factors may be and if multiple risk factors exist. Gastroenterologists are also more than capable of ordering DEXA scans and helping their patients along that journey.   [11:53] A DEXA scan is typically the way to measure bone mineral density. It's low radiation, it's easy, it's fast, and relatively inexpensive.   [12:10] It's also useful in following up over time in response to different interventions, whether or not that's stopping medications or starting medications.   [12:30] Dr. Henderson co-authored a paper in the Journal of Pediatric Gastroenterology and Nutrition, called “Prevalence and Predictors of Compromised Bone Mineral Density in Pediatric Eosinophilic Esophagitis.” The study looked at potential variables.   [12:59] The researchers were looking at chronic systemic steroid use. They thought it was an issue in their patients, especially patients with multiple atopic diseases like asthma, eczema, and allergic rhinitis. That's where the study started.   [13:22] Over the years, proton pump inhibitors have become more ubiquitous, and more research has come out. The study tried to find out if this was an issue or not. There weren't any guidelines for following these patients, as it was a retrospective study.    [13:42] At the time, Dr. Henderson was at a large institution with a huge EoE population. She saw that she could do a study and gather a lot of information on a large population of patients. Studies like this are the start of figuring out the guidelines for the future.   [14:34] Dr. Henderson wanted to determine whether pediatric patients with EoE had a lower-than-expected bone mineral density, compared to their peers. [14:44] Then, if there were deficits, she wanted to determine where they were more pronounced. Were they more pronounced in certain subgroups of patients with EoE?   [14:59] Were they patients with an elemental diet? Patients with an elimination diet? Were they patients on steroids or PPIs? Were they patients with multiple atopic diseases? Is low bone mineral density just a manifestation of their disease processes?   [15:14] Do patients with active EoE have a greater propensity to have low bone mineral density? The study was diving into see what the potential risk factors are for this patient population.   [15:45] The study was a retrospective chart review. They looked at patients aged 3 to 21. You can't do a DEXA scan on a younger patient, and 21 is when people leave pediatrics.   [16:03] These were all patients who had the diagnosis of EoE and were seen at Cincinnati Children's in the period between 2014 and 2017. That period enabled full ability for chart review. Then they looked at the patients who had DEXA scans.   [16:20] They did a manual chart review of all of the patients and tried to tease out what the potential exposures were. They looked at demographics, age, sex, the age of the diagnosis of EoE, medications used, such as PPIs, and all different swallowed steroids.   [16:44] They got as complete a dietary history as they could: whether or not patients were on an elemental diet, whether that was a full elemental diet, whether they were on a five-food, six-food, or cow's milk elimination diet.   [16:58] They teased out as much as they could. One of the limitations of a retrospective chart review is that you can't get some of the details, compared to doing a prospective study. For example, they couldn't tease out the dosing or length of therapy, as they would have liked.   [17:19] They classified those exposures as whether or not the patient was ever exposed to those medications, whether or not they were taking them at the time of the DEXA scan, or if they had been exposed within the year before the DEXA scan.   [17:40] They also looked at whether the patients had other comorbid atopic disorders, to see if those played a role, as well.   [18:03] The study found that there was a slightly lower-than-expected bone mineral density in the patients. The score was -0.55, lower than average but not diagnostic of a low bone mineral density, which would be -2 or below.   [18:27] There were 23 patients with low bone mineral density scores of -2 or below. That was 8.6% of the study patients. Typically, only 2.5% of the population would have that score. It was hard to tease out the specific risk factors in a small population of 23.   [18:57] They looked at what the specific risk factors were that were associated with low bone mineral density, or bone mineral density in general.   [19:12] After moving from Colorado, Holly has transferred to a new care team, and doctors wanted her baseline Vitamin D and Calcium levels. No one had ever tested that on her before. Dr. Henderson says it's hard because there's nothing published on what to do.   [19:58] The biggest surprise in the study was that swallowed steroids, or even combined steroid exposure, didn't have any effect on bone mineral density. That was reassuring, in light of what is known about glucocorticoid use.   [20:16] The impact of PPI use was interesting. The study found that any lifetime use of PPIs did seem to decrease bone mineral density. It was difficult to tease out the dosing and the time that a patient was on PPIs.   [20:34] Dr. Henderson thinks that any lifetime use of PPIs is more of a representation of their cumulative use of PPIs. At the time of the study, from 2014 to 2017, PPIs were still very much first-line therapy for EoE; 97% of the study patients had taken PPIs at some time.   [21:02] There are so many more options now for therapy when a patient has a new diagnosis of EoE, especially with dupilumab now being an option.   [21:11] Dr. Henderson speaks of patients who started on PPIs and have stayed on them for years. This study allows her to question whether we need to continue patients on PPIs. When do we discuss weaning patients off PPIs, if appropriate?   [22:05] Ryan says these podcasts are a great opportunity for the community at large and also for the hosts. He just wrote himself a note to ask his endocrinologist about coming off PPIs.   [22:43] Dr. Henderson says that glucocorticoid use is a known risk factor for low bone mineral density and osteoporosis. In the asthma population, inhaled steroids can slightly decrease someone's growth potential while the patient is taking them.   [23:10] From those two facts, it was thought that swallowed steroids would have a similar effect. But since they're swallowed and not systemic, maybe things are different.   [23:23] It was reassuring to Dr. Henderson that what her study found was that the swallowed steroid didn't affect bone mineral density. There was one other study that found that swallowed steroids for EoE did not affect someone's height.   [23:51] Dr. Henderson clarifies that glucocorticoids include systemic steroids like prednisone and hydrocortisone.     [23:57] Based on Dr. Henderson's retrospective study, fluticasone as a swallowed steroid did not affect bone mineral density. It was hard to tease out the dosing, but the cumulative use did not seem to result in a deficit for bone mineral density.   [24:16] Holly shared that when she tells a family of a child she works with that the child's gastroenterologist will likely recommend steroids, she will now give them the two papers Dr. Henderson mentioned. There are different types of steroids. The average person doesn't know the difference.   [25:15] Dr. Henderson thinks that for patients who have multiple risk factors for low bone mineral density, it is reasonable to have a conversation about bone health with their gastroenterologist to see whether or not a DEXA scan would be worth it.   [25:56] If low bone mineral density is found, that needs to be followed up on.   [26:03] There are no great guidelines, but this study is a good start on what these potential risk factors are. We need some more prospective studies to look at these risk factors in more detail than Dr. Henderson's team teased out in this retrospective study.   [26:23] Dr. Henderson tells how important it is for patients to participate in prospective longitudinal studies for developing future guidelines.   [26:34] Holly points out that a lot of patients are on restrictive diets. It's important to think about the whole picture if you are starting a medication or an elimination, or a restricted diet. You have to think about the impact on your body, overall.   [27:11] People don't think of dietary therapy as medication, but it has risks and benefits involved, like a medication.   [27:50] Dr. Henderson says, in general, lifestyle management is the best strategy for managing bone health. Stay as active as you can with weight-bearing exercises and eating a well-balanced diet. If you are on a restrictive diet, make sure it's well-balanced.   [28:12] Dr. Henderson says a lot of our patients have feeding disorders, so they see feeding specialists like Holly. A balanced diet is hard when kids are very selective in their eating habits.   [29:10] Dr. Henderson says calcium and Vitamin D are the first steps in how we treat patients with low bone mineral density. A patient who is struggling with osteoporosis needs to discuss it with their endocrinologist for medications beyond supplementation.   [29:31] Ryan reminds listeners who are patients always to consult with their medical team. Don't go changing anything up just because of what we're talking about here. Ask your care team some good questions.   [29:47] Dr. Henderson would like families to be aware, first, that some patients with EoE will have bone mineral density loss, especially if they are on PPIs and restrictive diets. They should start having those discussions with their providers.   [30:04] Second, Dr. Henderson would like families to be reassured that swallowed steroids and combined steroid exposure didn't have an impact on bone mineral density. Everyone can take that away from today's chat.   [30:18] Lastly, Dr. Henderson gives another plug for patient participation in prospective studies, if they're presented with the opportunity. It's super important to be able to gather more information and make guidelines better for our patients. [30:35] Holly thanks Dr. Henderson for coming on Real Talk — Eosinophilic Diseases and sharing her insights on bone mineral density, and supporting patients in Maine.   [30:57] Dr. Henderson will continue to focus on the clinical side. She loves doing outreach clinics in rural Maine. It's rewarding, getting to meet all of these patients and taking care of patients who would otherwise have to travel hours to see a provider.   [32:01] Ryan thinks the listeners got a lot out of this. 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.   [32:11] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [32:19] 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.   [32:28] Ryan thanks Dr. Henderson for joining us today for this great conversation. Holly also thanks APFED's Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Anna Henderson, MD, a pediatric gastroenterologist at Northern Light Health in Maine Cincinnati Children's “Prevalence and Predictors of Compromised Bone Mineral Density in Pediatric Eosinophilic Esophagitis.” Journal of Pediatric Gastroenterology and Nutrition   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, Sanofi, Regeneron, and Takeda.   Tweetables:   “DEXA scan stands for dual-energy X-ray absorptiometry scan. It's a type of X-ray where a patient lies down for 10 to 30 minutes. A machine scans over their bones. Typically, we're most interested in the lumbar spine and hip bones.” — Anna Henderson, MD   “We wondered whether or not all of those steroids and those combined risks even put our EoE population at risk for low bone mineral density. There's not a lot published in that area.” — Anna Henderson, MD   “If a patient is worried [about their bone mineral density], their PCP is a perfect place to start for that. They're more than capable of discussing the risk factors specific for that patient, ordering a DEXA scan, and interpreting it if need be.” — Anna Henderson, MD   “I think we need some more prospective studies to look at these risk factors in a little bit more detail than we were able to tease out in our retrospective review.” — Anna Henderson, MD   “Just another plug for the participation in prospective studies, if you're presented with the opportunity. It's super important to be able to gather more information and to be able to make guidelines better for our patients about these risks.” — Anna Henderson, MD

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Host: Susanna Price Guest: Sabiha Gati Want to watch that extended interview on LDL management? Go to: https://esc365.escardio.org/event/1809?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/1809   Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors.  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, Sabiha Gati, Nicolle Kraenkel and Susanna Price 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. 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 Heart disease risk: Framingham Heart Study insights Sudden death in female athletes Mythbusters: Owning a pet reduces the risk of heart disease Host: Susanna Price Guests: Carlos Aguiar, Sabiha Gati, Vasan Ramachandran Want to watch that episode? Go to: https://esc365.escardio.org/event/1809 Want to watch that extended interview on sudden death in athletes? Go to: https://esc365.escardio.org/event/1809?resource=interview   Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. The ESC is not liable for any translated content of this video.The English-language always prevails. 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.   Declarations of interests Stephan Achenbach, Sabiha Gati, Nicolle Kraenkel, Susanna Price and Vasan Ramachandran 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. 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.

In this CME podcast episode, Dr. Andrew Cutler interviews Dr. Phillip Coffin, Director of the Center on Substance Use and Health in San Francisco, CA, about the management of stimulant use disorders. They explore the challenges of treatment and highlight the importance of harm reduction strategies to enhance patients' quality of life.  CME credit is available to NEI Members only.   Target Audience: This activity has been developed for the healthcare team or individual prescriber specializing in mental health. All other healthcare team members interested in psychopharmacology are welcome for advanced study. Learning Objectives: After completing this educational activity, you should be better able to: Summarize pharmacologic and behavioral treatment strategies for stimulant use disorders, particularly methamphetamine and cocaine Evaluate the evidence base for current and investigational medications used in clinical trials and real-world settings Apply harm reduction principles and integrated care models to improve outcomes for patients with stimulant use disorders in diverse clinical settings Accreditation: In support of improving patient care, this activity has been planned and implemented by HMP Education and Neuroscience Education Institute (NEI). HMP Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.   Activity Overview: This activity is available with synchronized audio and is best supported via a computer or device with current versions of the following browsers: Mozilla Firefox, Google Chrome, or Safari. A PDF reader is required for print publications. A post-test score of 70% or higher is required to receive CME/CE credit.   Estimated Time to Complete: 1 hour Released: June 18, 2025*   Expiration: June 17, 2028 *NEI and HMP Education maintain a record of participation for six (6) years. CME/CE Credits and Certificate Instructions: After listening to the podcast, to take the optional posttest and receive CME/CE credit, click: https://nei.global/POD25-02.  Credit Designations: The following are being offered for this activity: Physician: ACCME AMA PRA Category 1 Credits™ HMP Education designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse: ANCC contact hours This continuing nursing education activity awards 1.00 contact hour. Provider approved by the California Board of Registered Nursing, Provider #18006 for 1.00 contact hour. Nurse Practitioner: ACCME AMA PRA Category 1 Credit™ American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credits™ from organizations accredited by the ACCME. The content in this activity pertaining to pharmacology is worth 1.00 continuing education hour of pharmacotherapeutics. Pharmacy: ACPE application-based contact hours This internet enduring, knowledge-based activity has been approved for a maximum of 1.00 contact hour (.10 CEU). The official record of credit will be in the CPE Monitor system. Following ACPE Policy, NEI and HMP Education must transmit your claim to CPE Monitor within 60 days from the date you complete this CPE activity and are unable to report your claimed credit after this 60-day period. Ensure your profile includes your DOB and NABP ID. Physician Associate/Assistant: AAPA Category 1 CME credits HMP Education has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credits for activities planned in accordance with the AAPA CME Criteria. This internet enduring activity is designated for 1.00 AAPA Category 1 credit. Approval is valid until June 17, 2028. PAs should only claim credit commensurate with the extent of their participation. Psychology: APA CE credits Continuing Education (CE) credits for psychologists are provided through the co-sponsorship of the American Psychological Association (APA) Office of Continuing Education in Psychology (CEP). The APA CEP Office maintains responsibility for the content of the programs. This activity awards 1.00 CE Credit. Social Work: ASWB-ACE CE credits As a Jointly Accredited Organization, HMP Education is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. Regulatory boards are the final authority on courses accepted for continuing education credit. Social workers completing this internet enduring course receive 1.00 general continuing education credit. Non-Physician Member of the Healthcare Team: Certificate of Participation HMP Education awards hours of participation (consistent with the designated number of AMA PRA Category 1 Credit™) to a participant who successfully completes this educational activity. Peer Review: The content was peer-reviewed by an MD, LFAPA specializing in psychiatry, forensic, addiction to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI and HMP Education takes responsibility for the content, quality, and scientific integrity of this CME/CE activity. Disclosures: All individuals in a position to influence or control content are required to disclose any relevant financial relationships. Any relevant financial relationships were mitigated prior to the activity being planned, developed, or presented. Disclosures are from the original live presentation, unless otherwise noted. Faculty Author / Presenter Andrew J. Cutler, MD Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences, Norton College of Medicine, State University of New York Upstate Medical University, Syracuse, NY Chief Medical Officer, Neuroscience Education Institute, Malvern, PA Consultant/Advisor: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Brii Biosciences, Cerevel, Corium, Delpor, Evolution Research, Idorsia, Intra-Cellular, Ironshore, Janssen, Jazz, Karuna, Lundbeck, LivaNova, Luye, MapLight Therapeutics, Neumora, Neurocrine, NeuroSigma, Noven, Otsuka, Relmada, Reviva, Sage Therapeutics, Sumitomo (Sunovion), Supernus, Takeda, Teva, Tris Pharma, VistaGen Therapeutics Speakers Bureau: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, BioXcel, Corium, Idorsia, Intra-Cellular, Ironshore, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Sumitomot (Sunovion), Supernus, Takeda, Teva, Tris Pharma, Vanda Data Safety Monitoring Board (DSMB): COMPASS Pathways, Freedom Biosciences Faculty Author / Presenter Phillip Coffin, MD, MIA Director of Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA No financial relationships to disclose. 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Ozlem Goker-Alpan, MD, Founder and President, Lysosomal & Rare Disorders Research & Treatment Center (LDRTC) and Ravi Kamath, MD, PhD, of Fairfax Radiological Consultants & Inova Health System and University of Virginia School of Medicine Fairfax, Virginia, USA discuss best practices to identify and treat bone problems associated with 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.This educational program is supported by an educational grant from Takeda and Ultragenyx.To obtain credit, visit https://checkrare.com/learning/p-skeletal-involvement-in-lysosomal-disorders/quizzes/evaluation-skeletal-involvement-in-lysosomal-disorders/ FacultyOzlem Goker-Alpan, MD, Founder and President, Lysosomal & Rare Disorders Research & Treatment Center (LDRTC), Fairfax, VA Ravi Kamath, MD, PhD,Fairfax Radiological Consultants & Inova Health System and the University of Virginia School of Medicine, Fairfax, VirginiaDisclosuresAffinityCE staff, LDRTC staff, CheckRare staff, planners, and reviewers, have no relevant financial interests to disclose. All faculty disclosures are listed below and are included in the beginning of each presentation.Dr. Goker-Alpan is on the Advisory Board/Consultant for Chiesi, Takeda, Sanofi, Prevail/Lilly, Sparks Therapeutics, Uniqure, Exegenesis, Astellas, Freeline, Team Sanfilippo. She receives grants/research support from Chiesi, Sanofi, Takeda, Prevail/Lilly, Spark Therapeutics, Amicus, Freeline, Sangamo, Cyclo, Odorsia, DMT, Homology, Protaliz. She is on the speaker bureau for Sanofi, Takeda, Amicus, ChiesiDr. Kamath is on the Advisory Board for Spur Therapeutics and Intrinsic Therapeutics. He is also a consultant for Sanofi, Shire and Takeda.  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. A non-conflicted reviewer resolved conflicts of interest for presenting faculty with relevant financial interests through peer review of content.Learning ObjectivesDescribe the role of the orthopedic surgeon in the team approach to careDescribe best practices to monitor bone abnormalities in persons with LDsDescribe best practices to treat bone abnormalities in persons with LDsDescribe research trends in bone abnormalities in persons with LDsPhysiciansThis 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 AssistantsThis 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™. Physician Assistants should claim only the credit commensurate with the extent of their participation in the activity.NursesContinuing Nursing Education is provided for this program through the joint providership of AffinityCE and the LDRTC. AffinityCE 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 PractitionersThis 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™. Nurse practitioners should claim only the credit commensurate with the extent of their participation in the activity.Genetic CounselorsCategory 2 CEUThis 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 Credit™. 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.Commercial Support Support for this educational activity was provided by Takeda and Ultragenyx. Participation CostsThere is no cost to participate in this activity.CME InquiriesFor all CME policy-related inquiries, please contact us at ce@affinityced.com.Send customer support requests to cds_support+ldrtc@affinityced.com.

VOV1 - Hưởng ứng Ngày ASEAN phòng chống sốt xuất huyết, ngày 14/06, tại Hà Nội, Báo Sức khỏe và Đời sống (Bộ Y tế) phối hợp với Công ty dược phẩm Takeda tổ chức cuộc tọa đàm trực tuyến với chủ đề "Hướng tới không còn ca tử vong do sốt xuất huyết: Hiệp lực phòng bệnh bằng giải pháp tích hợp."

Nach einer Blutkrebserkrankung wie Leukämie oder Multiplem Myelom kann ein sogenannter SID – ein sekundärer Immundefekt – zurückbleiben. Er schwächt das Immunsystem und macht Betroffene anfälliger für Infektionen. Was genau dahintersteckt und wie man wieder zu mehr Lebensqualität findet, erklärt Prof. Frank Stenner vom Universitätsspital Basel in dieser Folge.Diese Folge unseres Podcasts wurde ermöglicht durch die Unterstützung von Takeda.  Die Mitarbeiter und Mitarbeiterinnen bei Takeda verbinden Forschung und Entwicklung, um schnell die Bedürfnisse der Krebsgemeinschaft zu erfüllen und innovative Medikamente bereitzustellen. Mehr Infos zum Engagement von Takeda: www.takeda.ch Wir freuen uns sehr über Rückmeldungen, Ideen und Themenvorschläge für unseren Podcast. Schreib uns gerne auf Instagram (@lebenmitkrebs_ch), Facebook (@LebenmitKrebsSchweiz) oder via E-Mail auf info@lebenmitkrebs.ch. Alles Liebe Nadine & Sandra Disclaimer:Gekennzeichnete Folgen wurden mit finanzieller Unterstützung der jeweiligen Unternehmen erstellt. Die Unternehmen haben keinen Einfluss auf den finalen Inhalt der Folgen. Die Unternehmen sowie die Produzentin übernehmen keine Verantwortung für wiedergegebenen Meinungen und Aussagen von Interviewpartnern in den jeweiligen Folgen. Die unterstützenden Unternehmen und die Redaktion geben ebenso wenig individuelle Empfehlungen in Bezug auf die Diagnose oder den Behandlungsplan von Patienten und Patientinnen. Diese Fragen sind mit den behandelnden Ärzt*innen zu besprechen.

Where's the greatest impact: Culture or Code?Let's discuss! We're thrilled to invite you to yet another Disruption Talk this time with Nishtha Jain, Head of Innovation & Digital Technology at TakedaQuestions tackled:How does the third largest pharmaceutical company in Asia approach GenAI?How to boost the right mindset to make the most of the latest tech?How does Head of Innovation at Takeda ensure the right balance between present delivery and future vision?Join us for a deep dive into AI & Culture in Pharma.Host: Agnieszka Hyla-Pochrzęst, Delivery Lead at Netguru

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.

Today's guest is Damion Nero, Head of Data Science at Takeda Pharmaceuticals. With over 15 years of experience applying AI, machine learning, and real-world data to drug development and precision medicine, Damion joins Emerj Managing Editor Matthew DeMello to explore the evolving role of AI in drug development and supply chain management. He breaks down how AI is currently streamlining administrative and regulatory tasks, improving efficiency across clinical trials, and saving valuable time for healthcare professionals. Damion also discusses why broader, transformative supply chain efficiencies are still on the horizon, as AI continues to evolve and scale in the pharmaceutical industry. This episode is sponsored by Arkestro. Learn more about Arkestro's upcoming Advisory Council event here. Find out more about sponsored content and how to engage with the Emerj audience at emerj.com/ad1.

This episode covers:  Cardiology this Week: A concise summary of recent studies Coronary sinus reducer: promise in refractory angina Best strategies to reach LDL cholesterol goals in high-risk patients Snapshots Host: Susanna Price Guests: Carlos Aguiar, Rasha Al-Lamee, J. Wouter Jukema, Steffen Petersen Want to watch that episode? Go to: https://esc365.escardio.org/event/1807 Want to watch that extended interview on LDL management? Go to: https://esc365.escardio.org/event/1807?resource=interview Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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. Declarations of interests Stephan Achenbach, Nicolle Kraenkel and Susanna Price have declared to have no potential conflicts of interest to report. 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. 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. J. Wouter Jukema has declared to have potential conflicts of interest to report: J. Wouter Jukema/his department has received research grants from and/or was speaker (CME accredited) meetings sponsored/supported by Abbott, Amarin, Amgen, Athera, Biotronik, Boston Scientific, Dalcor, Daiichi Sankyo, Edwards Lifesciences, GE Healthcare Johnson and Johnson, Lilly, Medtronic, Merck-Schering-Plough, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi Aventis, Shockwave Medical, the Netherlands Heart Foundation, CardioVascular Research the Netherlands (CVON), the Netherlands Heart Institute and the European Community Framework KP7 Programme. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Susanna Price Guest: J. Wouter Jukema Want to watch that extended interview on LDL management? Go to: https://esc365.escardio.org/event/1807?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/1807 Disclaimer ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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. Declarations of interests Stephan Achenbach, Nicolle Kraenkel and Susanna Price 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. J. Wouter Jukema has declared to have potential conflicts of interest to report: J. Wouter Jukema/his department has received research grants from and/or was speaker (CME accredited) meetings sponsored/supported by Abbott, Amarin, Amgen, Athera, Biotronik, Boston Scientific, Dalcor, Daiichi Sankyo, Edwards Lifesciences, GE Healthcare Johnson and Johnson, Lilly, Medtronic, Merck-Schering-Plough, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi Aventis,Shockwave Medical, the Netherlands Heart Foundation, CardioVascular Research the Netherlands (CVON), the Netherlands Heart Institute and the European Community Framework KP7 Programme. 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.

In this energizing episode of The Athletics of Business, Ed Molitor welcomes Molly Painter, Vice President of Sales and Strategic Accounts at Takeda. Molly leads Takeda's U.S. Plasma-Derived Therapies business unit and is renowned for her rare blend of strategic clarity and deeply human-centered leadership. Together, they explore what it takes to lead authentically in high-stakes environments, build trust through vulnerability, and drive results without losing sight of people. Molly shares personal stories from her career, her family, and her life-long belief that leadership should be rooted in purpose, agility, and heart. Our Guest Molly Painter is a seasoned executive across both biotech and biopharma, known for her ability to lead with clarity, conviction, and a calm, commanding presence. With deep expertise in rare disease and neuroscience, she has a proven track record of building, launching, and scaling organizations—from early-stage biotech startups to global pharmaceutical business units. Currently Vice President of Sales & Strategic Accounts at Takeda, Molly leads the U.S. Plasma-Derived Therapies Business Unit, driving growth, alignment, and performance across one of the company's most strategic portfolios. She previously served as President of U.S. Orphazyme, where she built a scalable commercial organization from the ground up in just nine months, and as President of Vifor Pharma Group, where she drove topline U.S. sales growth and positioned the company as a leader in the nephrology and cardio-renal therapy space. Molly brings a rare combination of strategic precision and human-centered leadership. She thrives in complex, high-stakes environments and is deeply skilled in interpreting trends, aligning cross-functional teams, and creating cultures of accountability and ambition. She has led all facets of drug company development—from pipeline strategy to in-line commercialization—and is known for her ability to articulate value, influence stakeholders, and accelerate market uptake both domestically and globally. A strong advocate for agile leadership and inclusive growth, Molly holds an MBA from Northwestern University in Management & Organization with an emphasis on Health Enterprise Management. She also serves on several executive boards, including Big Brothers Big Sisters Chicago, the Joffrey Women's Board, and the Healthcare Businesswomen's Association (HBA).   What You'll Learn in This Episode Why the combination of strategy and heart is so rare and so powerful The art of having crucial conversations while building psychological safety How to lead with agility in the face of constant change and ambiguity Why vulnerability is a superpower in leadership, not a liability How Molly's mom, mentors, and real-world reps shaped her coaching style What “air cover” means and why it's critical for team decision-making How to balance elite performance with empathy, trust, and authenticity The importance of mentoring both inside and outside your company Why being “real” is the key to building loyalty and driving results How to juggle leadership, parenting, volunteer work, and still show up 100 percent Resources & Links Molly Painter LinkedIn Instagram Takeda Pharmaceuticals  Ed Molitor LinkedIn Website

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.

Description: 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 Bethany Doerfler, MS, RDN, a clinical research dietician specializing in lifestyle management of digestive diseases at Northwestern Medicine. Ryan and Holly discuss managing nutritional deficiencies in patients with non-EoE EGIDs and a study Bethany worked on. Disclaimer: The information provided in this podcast is designed to support, not replace the relationship that exists 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 the episode, brought to you thanks to the support of Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:17] Holly introduces today's topic, common nutritional deficiencies that affect those with eosinophilic gastrointestinal diseases that occur in the GI tract lower than the esophagus (non-EoE EGIDs).   [1:31] Holly introduces today's guest, Bethany Doerfler, a clinical research dietician specializing in lifestyle management of digestive diseases, including gastroesophageal reflux disease, motility disorders, and eosinophilic diseases.   [1:45] Bethany currently practices as part of a multi-disciplinary team in a digestive health institute at Northwestern Medicine.   [2:03] Bethany began working with this disorder almost 20 years ago. She worked with Dr. Gonsalves and Dr. Hirano at Northwestern. Dr. Gonsalves invited her to work with EoE patients. Bethany had not heard of EoE.   [2:59] Bethany says the lens that we've used to look at food as the trigger and also a therapeutic agent in the esophagus, we're looking at in non-EoE EGIDs as well; at the same time, trying to make sure that we're honoring the other parts of our patient's lives.   [3:27] Before Bethany started working in GI at Northwestern, she worked in the Wellness Institute, doing nutrition for patients at Northwestern. Bethany has a research background in epidemiology and she wanted to see better nutrition research in GI.   [3:56] Through a friend, Bethany connected with the Chief of GI at that point. Northwestern had never had a dietician working in GI.   [4:08] Bethany is pleased to see a trend in healthcare of thinking about the patient as a whole person, including diet, psychological wellness, physical health, exercise, sleep, and more. Bethany wanted to see more research on GI disorders.   [4:38] Bethany says that eosinophils in the esophagus indicate that something is irritating the tissues, such as reflux, food triggers, aeroallergens, and other things.   [4:58] Eosinophils do belong in the stomach, the small intestine, and the colon. The challenge for researchers has been, how many, where are they supposed to live, and what are they supposed to look like.   [5:10] There is eosinophilic gastritis, where eosinophils can infiltrate the stomach, causing a lot of inflammatory responses that make patients sick. We see that in all parts of the small intestine and less commonly, in the colon, as well.   [5:32] It's a good reminder for listeners that eosinophils are white blood cells. When they're in the tissues, they can swell things up and cause the body to have this inflammatory response in these lower GI tract organs.   [5:49] The symptoms patients can experience are vomiting, diarrhea, and abdominal pain, among other things.   [6:14] The nomenclature for this subset of eosinophil-associated diseases has changed and Bethany says to hang tight, there is lots of work underway to nail this down further in the next couple of months to a year.   [6:29] The last guidelines were published by a Delphi Consensus in 2022. The experts in the field got together and voted on the scientific accuracy of certain statements to develop cut points for how to grade.   [6:48] The experts are asking questions like: What counts as eosinophilic gastritis? What do we think are some of the symptoms and the clinical findings so that we all are looking at things through the same lens?   [7:02] To get to these consensus statements, there's a lot of discussion, agreement, and good collegial discussions about making sure that we're looking at this accurately.   [7:12] We're trying to give the right names to the right disorders and give clear diagnostic criteria, so that we're helping our patients get a diagnosis, and we're not labeling something incorrectly and sticking someone with an inaccurate diagnosis.   [7:36] The proper terminology is eosinophilic gastritis in the stomach, eosinophilic enteritis in the small intestine, eosinophilic colitis in the colon, and eosinophilic gastroenteritis where the stomach and the small bowel are involved.   [7:53] There's more to come on the clinical criteria of what makes that diagnosis but we're getting the names and the numbers right.   [8:03] Holly agrees that having the symptoms given a named diagnosis is important to patients, knowing that researchers are looking into their illness.   [9:00] Bethany notes that the diagnosis also means that there are opportunities for medical therapy, cut points for which medicines or therapies work or not, and billing codes. If we can't bill insurance companies, patients might not get certain services.    [9:28] Ryan tells how beneficial it was for him to have access to multi-disciplinary teams and see specialists he might not have seen without the proper diagnosis and just thought it was a GI issue. He was fortunate to see a dietician and start dietary therapy.   [9:53] Bethany says the dietician's priority is the patient's health and wellness.   [10:13] These disorders carry clinical non-gastrointestinal manifestations: fatigue, concern over what to eat, food access issues, family support, and other food allergies. These are important things for a dietician to consider.   [10:37] Are patients growing as they should? Do they feel like they have enough to eat? Do they feel excluded in social settings? There's a list of important things that we want to be looking at. That's why it's important to have a multi-disciplinary approach.   [11:07] First, Bethany wants to see that her patients are physically and nutritionally well. That's a priority if we're going to try to get rid of some of the food triggers that could be exacerbating the disease.   [11:20] Before Bethany takes anything out of someone's diet, she wants to make sure that they're getting enough of the good stuff to help them feel good and grow.   [11:29] From a diet therapy perspective, Bethany is trying to apply a food removal or substitution protocol to other spots outside the esophagus. They're seeing that some of the triggers are very similar, both in the stomach and small intestine.   [12:09] Dr. Gonsalves, Dr. Hirano, and Bethany did a study, The Elemental Study, where they wanted to uncover if food proteins carried the same trigger risk in the stomach and small intestine as they do in the esophagus.   [12:35] They put their patients on a hypoallergenic elemental formula for a period, followed up, and looked at their biopsies of the stomach and small intestine. Fifteen wonderful patients made it through the trial.   [12:56] One hundred percent of the patients achieved disease remission and felt better. There were some genetic alterations in the patients. Then they started the process of reintroducing foods over the year.   [13:15] That was not part of the original grant but was the team's clinical interest to see what it is that people are allergic to. Some of the common suspects: wheat, dairy, eggs, soy, and nuts, were found to be very common triggers for EoG and EoN, as well.   [13:47] The benefit of working with a dietician as part of your team is, first, we can remediate things the disease has caused nutritionally, and second, we can think about how diet can be a therapeutic tool to use with medications or instead of medication.   [14:15] If you want to use nutrition therapeutically, you don't have to stay there if it's not the right time to be taking things out of your diet. We have some good, safe, medical therapies. You can find your food triggers but you don't have to pick that lane forever.   [14:42] Holly and Ryan relate their experiences with traveling abroad and going on medical therapies when they can't stay on their diets.   [15:57] Bethany says low levels of vitamins and minerals in the blood can be caused by a disorder or an elimination diet. In the U.S., dairy is the biggest source of protein for young kids. It's also the biggest source of calcium and vitamin D.   [16:22] Dieticians often say, if we are going to use dietary therapy for EoE or non-EoE EGIDs, we have to think of this as a substitution diet. If we remove something, we have to replace it with something equally nutrient-dense.   [16:39] Bethany and her group look at serum values of Vitamin D, B12, and iron they assess for patients. For kids, instead of drawing blood, they piece together what they're taking against what they need and see if there are gaps to fill with food or supplements.   [17:32] In patients with non-EoE EGIDs, Bethany says we see the disease intersect with the food supply. When we take milk out, we're cutting the biggest source of calcium and Vitamin D. We have to replace calcium and Vitamin D.   [17:55] In the 1950s, a public health law allowed wheat to be enriched with folic acid and other B vitamins and iron. When we cut out wheat, our patients aren't getting enough iron or B vitamins. We have to replace those.   [18:16] For patients who have eosinophils in their stomach and small intestine, their absorption in the small bowel may be directly impacted.   [18:26] People can have low levels of protein in their blood, maybe because they're eating insufficient protein or maybe because the disease doesn't allow them to absorb protein sufficiently when there's swelling in the small intestine.   [18:44] There are other nutrients, like zinc, for people who have diarrhea, and magnesium if you can't eat a lot of whole grains and nuts, There are quite a few nutrients that Bethany is broadly looking at.   [18:54] Based on the absorption in the small intestine, patients' doctors need to look at their B12, folic acid, iron levels, and Vitamin D.   [19:12] Holly loves Bethany's terminology of replacing, not just eliminating, foods. She will use that terminology with her patients to make it feel more supportive for them.   [20:40] A lot of people want to get all their nutrients through their food. That's not always practical. Vitamin D is hard to get exclusively in your diet if you're not drinking milk or eating wild-caught fish. You have to rely on fortified foods or add supplements.   [21:15] One, we want to take a look at your diet and ask how are your calories. We want to make sure you're eating enough. Two, if we suspect there are some vitamin deficiencies, we check your blood or just empirically supplement you.   [21:36] Supplementation should be done carefully. There are some vitamins where you can get too much of a good thing. Vitamins stored in the fat need to be at levels sufficient for repletion, dictated by age and gender. Dieticians know what to recommend.   [22:19] For patients who have non-EoE EGIDs, some have tentative swallowing, so Bethany tries to do as many liquid or chewable safe options for supplements as possible.   [23:46] Holly works with patients who have feeding difficulty, so she appreciates the liquid and chewable supplements for easier swallowing and quicker absorption.    [24:08] Bethany mentions that some fortified oat, corn, and rice breakfast cereals are highly enriched with B vitamins and iron. Look at the labels. It can be a way to layer in more vitamins without purchasing a supplement.   [25:24] Holly doesn't think patients understand how valuable a good dietician can be. She had one patient with celiac who was taking a supplement with gluten in it! She reminds listeners to always consult your care team before making any changes to your treatment plan.   [25:59] Bethany's favorite thing to talk about is foods and where to find what. If listeners have questions, she is happy to post answers on the website.   [26:25] The American Academy of Pediatrics says a cup of vitamin-fortified juice a day is not too much sugar and is a good source of Vitamin C and other nutrients. The calcium and Vitamin D you get from a cup of fortified juice is very value-available.   [26:46] In the non-dairy drink world, some are nicely fortified and some are not. If you make your almond milk, you're missing out on the fortifications.   [27:11] Bethany likes some of the fortified juices and some of the enriched non-dairy milk options. Those are the best ways to get calcium and Vitamin D for people who need calories. Instead of water with meals, substitute an enriched drink with meals.   [27:33] Some people struggle with protein, probably because of their level of food restriction. The typical animal proteins are great. If you can do soy, a cup of soy milk has eight grams of protein. Soy is a complete protein that mimics animal proteins.   [28:04] Cook your cereal in soy milk. Use it as the base of a smoothie. This is before getting into protein powders. Try legume-based proteins, if you can handle legumes. Your supplements have to be personalized. That's the tricky part.   [28:30] If you have a lot of food allergies or intolerances, it may be worth talking to your gastroenterologist, allergist, or dietician about adding elemental formula as a supplement. Bethany uses it often with food allergy patients as a safe supplement.   [29:31] Bethany primarily treats adults but also young adults transitioning from the pediatric side into the adult world. Sometimes a feeding difficulty follows patients into adult treatment. We need everyone at the table to treat this immune-mediated disease.   [30:32] Patient advocacy groups like APFED have ways to help you find dieticians. Also, the Academy of Nutrition and Dietetics has “Find a Specialist” on their website. Eatright.org. Dieticians can do telehealth if you are not near one.   [31:45] If the practice that you're in doesn't have a dietician, you could gently suggest they have one join the practice, or consult with the practice. Patient advocacy is strong.   [33:12] Bethany talks about getting an appointment with a dietician. On the pediatric side, it has to do with the billing code. Ask your insurance if they cover medical nutrition therapy, Billing Code 97802, and for which diseases. Insurance may have stipulations.   [34:14] If medical nutrition therapy is not a covered benefit, ask the dietician if they can do a sliding scale. Holly says she has seen plans in several states where the patient can use the HSA or FSA card to pay for medical nutrition therapy.   [34:49] Bethany believes in the pediatric world, where growth and development are concerns, there's a little bit better coverage.   [34:59] On the adult side, if Bethany has other diagnoses, like high blood pressure, or diabetes, she is also billing for those because she makes sure what she recommends is also in line with what is good for their heart and wellness in general.   [35:55] Bethany was intrigued to learn food proteins do trigger disease activity for our patients in the stomach and small intestine, just as in the esophagus.   [36:20] In the Elemental Trial, they were surprised to learn people with non-EoE EGIDs had more allergies than expected. They were more likely to have more than just one or two. They were also more likely to have rare food allergies like legumes or grains.   [36:43] A patient may want to learn all their food triggers, but they may be a highly allergic person and it may not be worth trying to remove all their food triggers.   [37:06] Bethany wants to remind listeners that the diet approach should be a substitution diet. If you take things out, you've got to replace them with other plants.   [37:18] There's great crossover nutrition between fruits and vegetables. Seeds are great as a fill-in for nuts. There are plenty of other whole grains out there besides wheat. There are lots of good ways to get that nutritional balance into your diet.   [37:31] For anyone who's eliminating a food group, even if you're substituting it, it's a good idea to talk to your doctor about filling in with a good multivitamin, multimineral supplement.   [37:59] Bethany says it's fun working with colleagues to look for other ways to look at this nutrition lens for patients with Non-EoE EGIDs.   [38:14] They are looking at noninvasive ways to find eosinophils to go faster with helping people find their food triggers without having to scope them.   [38:28] Bethany is hoping with that research to be able to help people learn how they can cheat, like having pizza once a month if they are allergic to dairy. That's a question for your care team, but we don't have a great science-based way to answer that.   [38:53] As we study more noninvasive ways to get at eosinophilic activity, we can give patients a little bit more freedom and quality of life. That's what Bethany is working on next.   [39:58] Holly thanks Bethany Doerfler for joining us on Real Talk — Eosinophilic Diseases. For our listeners, to learn more about eosinophilic disorders, please visit APFED.org and check out the links in the show notes.   [40:11] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at APFED.org/specialist.   [40:21] 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.   [40:34] Holly thanks Bethany for joining us today. Holly also thanks APFED's Education Partners Bristol Myers Squibb, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Bethany Doerfler, MS, RD, Clinical Research Dietician specializing in lifestyle management of digestive diseases at Northwestern Medicine Dr. Nirmala Gonsalves Dr. Ikuo Hirano (In Memoriam) The Elemental Study, Gonsalves, Doerfler, Hirano Academy of Nutrition and Dietetics   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of Bristol Myers Squibb, Sanofi, Regeneron, and Takeda.   Tweetables:   “The lens that we've used to look at food as the trigger and also a therapeutic agent in the esophagus, we're doing that in non-EoE EGIDs as well, and at the same time, trying to make sure that we're honoring the other parts of our patient's lives.” — Bethany Doerfler, RD   “We are trying to give the right names to the right disorders and give clear diagnostic criteria so that we're helping our patients get a diagnosis, and we're not labeling something incorrectly and sticking someone with a diagnosis that isn't accurate.” — Bethany Doerfler, RD   “The diagnosis also means that there are opportunities for medical therapy, cut points for which we decide if medicines or other therapies work or not, and billing codes. If we can't bill insurance companies, patients may not be privy to certain services.” — Bethany Doerfler, RD   “Look at the [fortified cereal] labels. You'd be surprised how much they look like a multivitamin, not only for B vitamins but for iron. … It can be a fantastic way to layer in more vitamins without having to think about purchasing a supplement.” — Bethany Doerfler, RD   “There's great crossover nutrition between fruits and vegetables. Seeds are great as a fill-in for nuts. There are plenty of other whole grains out there besides wheat. There are lots of good ways for us to get that nutritional balance into your diet.” — Bethany Doerfler, RD

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 The role of cardiac magnetic resonance in myocardial disease Air pollution and heart disease Statistics Made Easy: Quasi-experimental study designs Host: Rick Grobbee Guests: Carlos Aguiar, Steffen Petersen, Mark Miller Want to watch that episode? Go to: https://esc365.escardio.org/event/1806 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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. Declarations of interests: Stephan Achenbach, Rick Grobbee, Nicolle Kraenkel and Mark Miller 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Rick Grobbee Guest: Steffen Petersen Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1806?r Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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. Declarations of interests: Stephan Achenbach, 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. 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.

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 podcast episode, Ryan Stidham, MD, discusses the evolution and development of digital imaging and AI in the GI space, how AI can revolutionize stages within the clinical trials and practices and more. •    Intro :24 •    The interview/about Stidham :36 •    Tell us about your family and where you grew up. 1:14 •    How did you embrace changes in technology growing up? 3:07 •    What was the seminal moment that got you to move from being a consumer of information to being a producer and innovator?  6:05 •    What ignited you to start commercializing and patenting your ideas, and operationalizing them into a company? How did that evolution occur? 8:32 •    Can you give a quick overview of what these tools and technologies entail?  12:52 •    What got you interested in inflammatory bowel disease, and how did your childhood interest in coding shift to artificial intelligence? 18:12 •    Where did your interest in AI come about? 20:26 •    You recently published a review on how AI will revolutionize the conduct of clinical trials in inflammatory bowel disease […] Will AI remove the need for central reading in IBD trials in the future? 23:58 •    How do we change the way we train GI doctors, and should we start making these changes today? 26:38 •    With AI rapidly changing the landscape, are we spending enough time educating our fellows in how to adapt to changes and communicate with patients? 32:33 •    What do you think will change in IBD and gastroenterology in the near term as a result of AI? 35:06 •    What is it that we really need in terms of health care access, and how can AI technology assist these needs? 38:39 •    Thank you, Ryan 44:04 •    Thanks for listening 44:20 Ryan Stidham, MD, MS, AGAF, is a translational scientist caring exclusively for patients with inflammatory bowel disease. He is an associate professor in the department of medicine and the department of computational medicine and bioinformatics where he serves as the associate chair of translational research. His research focus is the use of artificial intelligence to improving measurement of IBD and other gastrointestinal diseases, developing new interpretations of cross-sectional imaging, endoscopy, medical text, and other electronic data.  We'd love to hear from you! Send your comments/questions to guttalkpodcast@healio.com. Follow us on X @HealioGastro @sameerkberry @umfoodoc. For more from Stidham, follow @CrohnsDoc on X. Disclosures: Berry and Chey report no relevant financial disclosures. Stidham reports consulting or on advisory boards for AbbVie, Bristol Myers Squibb, CorEvitas, Eli Lilly, Exact Sciences, Gilead, Janssen, Merck, Pfizer, and Takeda. Stidham holds intellectual property and equity on medical imaging and endoscopic analysis technologies licensed by the University of Michigan to PreNovo, LLC, AMI, LLC and PathwaysGI, Inc.

This Oncology PER®Spectives™ podcast explores the role of EZH2 in metastatic castration-resistant prostate cancer (mCRPC) progression and its synergy with androgen receptor inhibitors. In this podcast, experts Neeraj Agarwal, MD, FASCO; Himisha Beltran, MD; and Maha Hussain, MD, FACP, FASCO, discuss the management of mCRPC. Acknowledgment of Educational Grant Support This activity is supported by an educational grant from Pfizer Inc. Accreditation/Credit Designation Physicians' Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians' Education Resource®, LLC, designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians' Education Resource®, LLC is approved by the California Board of Registered Nursing, Provider #16669, for 1.5 Contact Hours. Instructions on How to Receive Credit Listen to this podcast in its entirety. Go to gotoper.com/credit and enter code: 6947 Answer the evaluation questions. Request credit using the drop-down menu. You may immediately download your certificate. Today's faculty are: Neeraj Agarwal, MD, FASCO Professor of Medicine Senior Director for Clinical Research HCI Presidential Endowed Chair of Cancer Research Director, Center of Investigational Therapeutics Director, Genitourinary Oncology Program Huntsman Cancer Institute, University of Utah (NCI-CCC) Salt Lake City, UT Disclosures: Grant/Research Support (paid to institution): Arvinas, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Calithera, Celldex, Clovis, Crispr, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, GlaxoSmithKline, Immunomedics, Janssen, Lava, Merck, Nektar, Neoleukin, Novartis, Oric, Pfizer, Roche, Sanofi, Seagen, Takeda, Tra-con Himisha Beltran, MD Associate Professor of Medicine Director of Translational Research Within Medical Oncology Harvard Medical School Lank Center for Genitourinary Oncology and the Division of Molecular and Cellular Oncology Dana Farber Cancer Institute Boston, MA Disclosures: Grant/Research Support: Circle Pharma, Daiichi Sankyo, Novartis; Adviser: Amgen, AstraZeneca, Daiichi Sankyo, Novartis Maha Hussain, MD, FACP, FASCO Genevieve E. Teuton Professor of Medicine Professor, Medicine (Hematology/Oncology) Deputy Director Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine Chicago, IL Disclosures: Advisory Board: AstraZeneca, Bayer, Convergent Therapeutics, Honoraria: AstraZeneca, Bayer The staff of Physicians' Education Resource®, LLC, have no relevant financial relationships with ineligible companies. PER® mitigated all COI for faculty, staff, and planners prior to the start of this activity by using a multistep process. Off-Label Disclosure and Disclaimer This activity may or may not discuss investigational, unapproved, or off-label use of drugs. Learners are advised to consult prescribing information for any products discussed. The information provided in this accredited activity is for continuing education purposes only and is not meant to substitute for the independent clinical judgment of a health care professional relative to diagnostic, treatment, or management options for a specific patient's medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER® or any company that provided commercial support for this activity. Release Date May 14, 2025 Expiration Date May 14, 2026

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Bayer has announced a restructuring that will result in 2,000 job cuts and a reduction in management layers. CEO Bill Anderson believes Trump's most favored nations policy could provide an opportunity for European countries to contribute more to biopharma innovation. Galapagos has abandoned plans for a spinout and cell therapy, causing a stir in the industry. Trump's most favored nation policy has led to a sell-off of PBMs, but analysts believe it may not have a significant impact without further congressional action. Sino Biological offers solutions for autoimmune diseases, with reagents for nearly 50 different conditions. In other news, CMS is preparing for a new cycle of drug negotiations, Azafaros has raised $150 million for rare neuro-metabolic diseases, and Roche's Genentech is investing $700 million in a North Carolina plant. 10x Genomics has cut 8% of its workforce, and there are upcoming webinars on biotech downturns and AI in life science R&D. Job opportunities include positions at 4D Molecular Therapeutics, Takeda, and Regeneron Pharmaceuticals.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The White House has announced a new drug pricing policy that includes the revival of the most favored nations rule and extends to the private markets, leveraging the patent system, drug importation, and more. Meanwhile, Lilly's Zepbound has been found to have a superior benefit-risk ratio compared to Novo's Wegovy, BMS and Sanofi settle a Plavix lawsuit with Hawaii for $700 million, and biopharma companies are focusing on developing a cure for HIV as federal funding for related research is being cut. Sino Biological offers comprehensive solutions for autoimmune diseases, and Roche promises a $300 million investment in China production after a multibillion-dollar investment in the US. On the other hand, Lexeo and IGM have both announced significant layoffs. Novartis CEO has expressed concerns about Trump's pricing controls.Funding for HIV-related research and infrastructure is being cut by the Trump administration, leading biopharma companies like Gilead and Immunocore to focus on finding a cure for HIV. In the field of neurology, there is a need for more precise diagnostic tools to effectively treat neurodegenerative conditions. The new HHS vaccine requirement has been criticized by leading vaccine physician Paul Offit as potentially being anti-vaccine activism disguised as policy. Companies like Novartis, Bayer, and AstraZeneca are exploring new indications and innovations in radiopharmaceuticals, hoping to capitalize on a market that could reach $16 billion by 2033. The FDA has faced delays in reviewing certain drugs, while biotech stocks have fallen after the appointment of Vinay Prasad to succeed Marks at CBER. Vertex has decided to abandon AAV in the gene therapy space.Upcoming events include a webinar on surviving and thriving in the biotech downturn. Job opportunities in the biopharma industry include positions at Takeda, Daiichi Sankyo, and AbbVie. Heather McKenzie, senior editor at BioSpace, is open to suggestions for future coverage topics in neuroscience, oncology, cell & gene therapy, metabolic, or other areas.

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.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Takeda's $30 billion investment in the U.S. is making headlines, along with their opposition to Trump's proposal on drug prices. The FDA's appointment of Vinay Prasad is stirring up mixed reactions within the industry. On another note, Lilly's legal victory against compounders, Novavax's growing sales, and Gilead's significant investment in U.S. manufacturing are all key developments. The FDA vaccine advisors are gearing up for a meeting to discuss COVID-19 updates, while Vor Bio is seeking an exit due to funding challenges. Biotech stocks took a hit following Prasad's appointment to lead CBER, highlighting the industry's current challenges including vaccine hesitancy and job market struggles.

This episode covers: Cardiology This Week: A concise summary of recent studies Colchicine for secondary prevention An algorithmic approach to the workup of syncope Milestones: CIBIS II Host: Rick Grobbee Guests: Carlos Aguiar, Sanjit Jolly, Michele Brignole Want to watch that episode? Go to: https://esc365.escardio.org/event/1805 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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. Declarations of interests: Stephan Achenbach, Michele Brignole, Diederick 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Sanjit Jolly has declared to have potential conflicts of interest to report: grant support from Boston Scientific, honorarium from Boston Scientific, Shockwave, Abiomed, SIS, and Teleflex.  Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Rick Grobbee Guest: Michele Brignole Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1805?r  Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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. Declarations of interests: Stephan Achenbach, Michele Brignole, Diederick 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. 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.

Today's guest is Damion Nero, Head of Data Science at Takeda Pharmaceuticals. With over 15 years of experience applying AI, machine learning, and real-world data to drug development and precision medicine, Damion joins Emerj Managing Editor Matthew DeMello to explore the evolving role of AI in drug development and supply chain management. He breaks down how AI is currently streamlining administrative and regulatory tasks, improving efficiency across clinical trials, and saving valuable time for healthcare professionals. Damion also discusses why broader, transformative supply chain efficiencies are still on the horizon, as AI continues to evolve and scale in the pharmaceutical industry. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on Emerj's flagship ‘AI in Business' podcast!

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.

Although East Asians make up a significant share of entry-level roles in U.S. biopharma, few have risen to senior leadership positions. That disparity is what inspired the launch of ElevAAte—a new nonprofit founded this year to support and grow East Asian American leadership in the industry. In this week’s episode of "The Top Line," Fierce Pharma Deputy Editor Angus Liu speaks with two of ElevAAte’s co-founders: Architect Therapeutics CEO Angie You and Candid Therapeutics CEO Ken Song. The veteran biotech leaders discuss why a group like ElevAAte is needed and how East Asian Americans can harness their collective strength to build the next generation of biopharma executives. You and Song—who led Amunix’s $1.2 billion sale to Sanofi and RayzeBio’s $4.1 billion acquisition by Bristol Myers Squibb, respectively—also share insights from their dealmaking careers and offer advice for young professionals entering the field. To learn more about the topics in this episode: Though prevalent in the lab and middle management, East Asian Americans are underrepresented in biopharma C-suites: report Candid's T-cell engager shopping spree rolls on with WuXi Biologics pact worth up to $925M A reason to fight: Former FDA leader Janet Woodcock inspires 3rd Biotech Sisterhood summit Takeda taps Julie Kim to take over for retiring CEO Christophe Weber This episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

AI is revolutionizing healthcare innovation, from drug discovery and clinical trials to leveraging wearables for patient care and collaborating with regulatory bodies. In this episode, Leo Barella, Chief Technology Officer at Takeda, discusses how AI is transforming healthcare. Barella highlights AI's potential in drug discovery, clinical trials, and wearable technology, drawing inspiration from SpaceX and Tesla's data-driven approaches. He emphasizes the importance of collaboration with regulatory bodies to integrate consumer health data and improve patient understanding in clinical trials. Barella envisions AI's role in healthcare evolving towards a future of improved efficiency and patient outcomes, similar to advancements in autonomous driving. Tune in to discover how AI is transforming healthcare innovation at Takeda, from enhancing drug discovery and clinical trials to leveraging wearables for better patient outcomes. Resources: Connect with and follow Leo Barella on LinkedIn. Follow Takeda on LinkedIn and visit their website.

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 Hypertension in the elderly The digital twin in cardiology Snapshots Host: Emer Joyce Guests: Carlos Aguiar, Gianfranco Parati, Nico Bruining, Joost Lumens Want to watch that episode? Go to: https://esc365.escardio.org/event/1804 Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsors. 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. Declarations of interests: Stephan Achenbach, Nico Bruining, Emer Joyce 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Joost Lumens has declared to have potential conflicts of interest to report: research grants from Medtronic (all grants paid to institute, Maastricht University). Gianfranco Parati has declared to have potential conflicts of interest to report: honoraria for lectures by Omron, Merck, Viatris, Somnomedics. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Host: Emer Joyce Guests: Joost Lumens and Nico Bruining Want to watch that extended interview? Go to: https://esc365.escardio.org/event/1804?resource=interview Disclaimer: ESC TV Today is supported by Bristol Myers Squibb and Novartis. This scientific content and opinions expressed in the programme have not been influenced in any way by its sponsor. 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.  Declarations of interests: Stephan Achenbach, Nico Bruining, Emer Joyce 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. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Joost Lumens has declared to have potential conflicts of interest to report: research grants from Medtronic (all grants paid to institute, Maastricht University). 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.

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.

在生技藥廠中，研發和臨床試驗部門經常是大家關注的焦點，但你知道嗎？即使一款藥物在臨床上證明有效，若無持續且穩定量產高品質藥物的能力，它也難以真正廣泛的造福病患。本集節目帶你走進藥廠中極少被提及，卻舉足輕重的部門——Process & Global Manufacture。 相信大家記憶中，都曾有一間從小吃到大的街角麵攤，韶光荏苒，熟習的味道和帶來的感動卻始終不變。仔細想想，這真的是一件很不容易的事。當麵店的規模放大千倍萬倍，來到工業規模時，一點點原料的批次差異 (lot-to-lot variation)，到製造時冷藏環境的些微變化，每個在上游微不足道的細節差異，在經過重重關卡後都可能被放大成不可忽視的嚴重問題，所有細節都可能影響成敗。 究竟藥廠是如何克服重重困難，在兼顧量及品質的情況下穩定把藥物送到市場上呢？本集我們邀請到目前在 Takeda 製造流程部門擔任經理的韓子強博士，分享他在製造領域的深耕經驗與有趣故事，並與我們探討職涯的更多可能性。  

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 of Yet Another Value Podcast, host Andrew Walker returns for a solo discussion on Keros Therapeutics (KROS), a biotech firm navigating a dramatic fall from grace. Once buoyed by hopes for its leading drug Cybo (KER-012), KROS is now reeling from halted trials and a steep drop in share price. Andrew lays out the case for why this company, despite setbacks, may still hold considerable value. He explores KROS's licensing deal with Takeda, their significant cash reserves, and questions surrounding its future direction. Calling on shareholder alignment and corporate governance, Andrew challenges listeners to consider whether KROS is veering into zombie biotech territory—or poised for a smart pivot.Stat+ article on zombie biotechs and Sutro: https://www.statnews.com/2025/03/19/sutro-bio-biotech-luvelta/Chapters:[00:00:00] Sponsor and Intro[00:03:00] Recap of Sage Pharmaceuticals as a case study in shareholder value.[00:04:48] Introduction to KROS and its recent setbacks, including Cybo's trial halt.[00:05:05] Defining the “zombie biotech” phenomenon and why it matters.[00:08:21] Misaligned incentives between management and shareholders in troubled biotechs.[00:10:04] Why KROS's partnership with Takeda could be its most valuable asset.[00:13:14] Review of KROS's three main drugs: Cybo, 065, and 050 (licensed to Takeda).[00:14:55] Risk-adjusted value potential of KROS's royalties from Takeda deal.[00:17:01] Mixed data from 065 and skepticism from analysts.[00:18:09] Potential but doubtful value remaining in Cybo post-trial shutdown.[00:18:40] KROS's massive cash balance vs. market cap and implications for shareholder returns.[00:20:05] Breakdown of 2023 overhead and burn rate concerns.[00:21:53] Call for drastic cost cuts and corporate reevaluation.[00:23:36] Analysis of board alignment and concern over lack of urgency.[00:25:44] Why KROS no longer needs a science-heavy board.[00:28:44] Shareholder engagement as a tool to prevent value destruction.[00:31:33] Encouragement for listeners to contact the board and advocate for value-maximizing outcomes.Links:See our legal disclaimer here: https://www.yetanothervalueblog.com/p/legal-and-disclaimer

In this special pop-up episode of the Bloodstream Podcast, host Patrick James Lynch discusses the discontinuation of two Takeda bleeding disorder products with Anthea Cherednichenko, Takeda's VP Franchise Head Hematology and Transplant. Additionally, the 'I'm Fine' segment, sponsored by Sanofi, explores why people cling to the notion of being 'fine' and the importance of embracing vulnerability for true resilience.   I'm Fine is presented by @SanofiUS   Presenting Sponsor: Takeda, visit bleedingdisorders.com to learn more.   Show Notes: Subscribe: The BloodStream Podcast   Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on X/Twitter   

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.

Today's guest is Nishtha Jain, Head of Innovation and Digital Technology at Takeda Pharmaceuticals. Nistha returns to the program to discuss the transformative impact of AI across the pharmaceutical value chain. She and Emerj Editorial Director Matthew DeMello explore how AI is improving drug development efficiency, addressing data challenges, and overcoming regulatory hurdles. She highlights key breakthroughs like Google DeepMind's AlphaFold and AI-assisted clinical trial optimization, emphasizing the potential for faster, more cost-effective drug development. The discussion also covers the challenges of AI adoption, including data accessibility, regulatory compliance, and ethical considerations like bias in AI models. If you've enjoyed or benefited from some of the insights of this episode, consider leaving us a five-star review on Apple Podcasts, and let us know what you learned, found helpful, or liked most about this show!

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.