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Bill George is a celebrated leader who served as Chair and CEO of Medtronic, the world's leading medical technology company. He is an executive fellow at Harvard Business School, where he has taught leadership since 2004, and is the bestselling author of many books, including Discover Your True North. Bill also served as a director at Goldman Sachs, ExxonMobil, Novartis, Target, the Mayo Clinic, and World Economic Forum USA. In this episode of ⁠the Elevate Podcast⁠, Bill joins host Robert Glazer to discuss his leadership career, the importance of purpose-driven leadership, and more. To learn more about core values, check out The Compass Within. Thank you to the sponsors of The Elevate Podcast Mizzen & Main: ⁠⁠mizzenandmain.com⁠⁠ (Promo Code: elevate20) Shopify: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠shopify.com/elevate⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Indeed: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠indeed.com/elevate⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Masterclass: ⁠⁠masterclass.com/elevate⁠⁠ Found: ⁠⁠found.com/elevate Learn more about your ad choices. Visit megaphone.fm/adchoices

Dr. Monty Pal and Dr. Matteo Lambertini discuss a compelling global study on the clinical behavior of breast cancer in young BRCA1 and BRCA2 carriers, the association of pre-diagnostic awareness of BRCA status with prognosis, and the importance of identifying healthy people who are at risk of carrying the BRCA1/2 pathogenic variants. TRANSCRIPT Dr. Monty Pal: Well, hello everyone, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of medical oncology at the City of Hope Comprehensive Cancer Center in Los Angeles. Now, when we think about genetic testing, whether for patients diagnosed with breast cancer or for other family members of them, it seems to be widely underutilized. Today, we're going to be discussing a recently published study in the Journal of Clinical Oncology that reported on the clinical behavior of breast cancer and specifically young BRCA1 and BRCA2 carriers, and the association of pre-diagnostic awareness of BRCA status with prognosis. I thought this was just a fascinating piece, and I honestly couldn't wait to have this conversation. It's a really compelling paper that highlights the importance of identifying healthy people who are at risk of carrying the BRCA1/2 pathogenic variants, and really the need for genetic counseling and testing to inform people about early detection that could lead to a better prognosis. I'm really delighted to welcome the study's lead author, Dr. Matteo Lambertini. He really needs no introduction. He's very well known in the breast cancer world for his amazing contributions to fertility in the context of breast cancer, to pregnancy in the context of breast cancer, and genetic testing. He's an associate professor at the University of Genova, and a breast cancer medical oncologist at the San Martino Polyclinic Hospital in Genova, Italy.  Dr. Lambertini, thank you so much for joining us today. Dr. Matteo Lambertini: Thank you very much, Dr. Pal. It's a great pleasure. Dr. Monty Pal: Oh, thanks. And just FYI, if you're listening in and you want to hear our disclosures, they're all listed at the transcript of this podcast.  So, I poured through this paper [Clinical Behavior of Breast Cancer in Young BRCA Carriers and Prediagnostic Awareness of Germline BRCA Status] yesterday, Dr. Lambertini, and first of all, congratulations on this study. This was a huge international multicenter effort, 4,752 patients. How did you pool all these patients with young breast cancer? Dr. Matteo Lambertini: Thanks a lot for the question. Yes, this was an effort made by several centers all over the world. The main idea behind the creation of this network that we have named as BRCA BCY Collaboration, was to get as many data as possible in a sort of niche patient population in the breast cancer field, meaning women diagnosed with breast cancer at the age of 40 years or younger, and all of them being BRCA carriers. We know that around, in the Western world, around 5% of breast cancer cases are being diagnosed under the age of 40 years, and among them around 10-15% are BRCA carriers. So, I would say it's a relatively rare patient population where we did not have a lot of evidence to support our choices in terms of counseling on treatment, prevention, and oncofertility as well. That was the idea behind the creation of this network that includes many centers. Dr. Monty Pal: Yeah. You know, what's so interesting about this is that you sort of draw this line between patients who have BRCA testing at the time of diagnosis and then BRCA testing earlier in their course and then leading to a diagnosis perhaps. And I think that's where really sort of the dichotomy in outcome sits. Can you maybe elaborate on this and tell us about timing of genetic testing in this study and what that meant ultimately in terms of prognosis? Dr. Matteo Lambertini: In this specific analysis from this large network, including almost 5,000 women with breast cancer diagnosed at the age of 40 years or younger and being a BRCA carrier, we looked specifically into the timing of genetic testing because this is a retrospective study and the criteria for inclusion are those that I have just mentioned, so diagnosis at a young age plus carrying germline BRCA pathogenic or likely pathogenic variant. In this analysis, we have looked into the time the patient has got the genetic testing and particular we focused on two populations: those that were diagnosed, knowing already to be a BRCA carrier, and those that got tested after being diagnosed with breast cancer. And the main findings from this analysis have been that knowing to be a BRCA carrier was associated with a lower stage at the time of diagnosis, meaning more T1 tumors, so a tumor less than 2 cm, more node-negative disease, and this translated into less aggressive treatment, so less often axillary dissection, less often use of chemotherapy and anthracycline-based chemotherapy. And even more importantly, we have seen a better overall survival for those patients that were diagnosed already knowing to be BRCA carriers as compared to those tested after breast cancer diagnosis. These results after adjusting for all the confounding, stage, treatment and so on, there was not significant anymore, meaning that it's not the timing of test per se that is probably leading to a better survival, but it is the fact that knowing to be a BRCA carrier would likely translate into having access to all the preventive measures that we have in this setting and this will translate into an overall survival benefit, so in terms of saving more lives in young BRCA carriers. Dr. Monty Pal: I think it's such an important point, and it's one that I think might sound implicit, right, but it needs to be proven, I think, through a study like this. You know, the fact that finding this early, identifying the mutation, doing enhanced screening, and so forth, is really going to lead to superior clinical outcomes. One of the things that I think many people puzzle over, including myself, is what to do? I personally occasionally will see BRCA altered patients in the context of prostate cancer. But that's a very different population of individuals, right? Typically older men. In young females with BRCA mutation, I guess there's a specific set of considerations around reproductive health. You'd already highlighted preventive strategies, but what sorts of things should we be talking about in the clinics once a patient's diagnosed and once perhaps their breast cancer diagnosis is established? Dr. Matteo Lambertini: Yes, exactly. Knowing to be a BRCA carrier has a lot of implications from prevention to treatment to survivorship issues including reproductive counseling. And this is important not only for the patient that has been diagnosed with breast cancer but also for all the family members that will get tested and maybe identify with this sort of genetic alteration before diagnosis of cancer. Why this is important is because we have access to very effective preventive measures, a few examples: MRI screening, which starts at a very young age and normally young women don't have an effective screening strategy outside the BRCA field. Also, primary preventive measures, for example, risk-reducing surgery. These women are known to have a high risk of breast cancer and high risk of ovarian cancer. So the guidelines are suggesting to undergo risk-reducing salpingo-oophorectomy at a young age, so 35 to 40 years in BRCA1 carrier, 40 to 45 years in BRCA2 carrier. And also risk-reducing mastectomy should be discussed because it is a very effective way to prevent the occurrence of breast cancer. And in some situations, including the setting that we are talking about, so young women with breast cancer, BRCA carrier, also risk-reducing mastectomy has shown to improve overall survival.  On the other side, once diagnosed with breast cancer, nowadays knowing to be or not a BRCA carrier can make a difference in terms of treatment. We have PARP inhibitors in the early setting, in the adjuvant setting as well as in the metastatic setting. And in terms of survivorship implication, one of the critical aspects for young women is the oncofertility care which is even more complicated when we talk about BRCA carriers that are women candidates for gynecological surgery at a very young age. So this sort of counseling is even more complicated. Dr. Monty Pal: One of the other things, and this is subtle in your paper and I hope you don't mind me bringing it up, is the difference between BRCA1 and BRCA2. It really got me thinking about that because there are differences in phenotype and manifestation. Do you mind just expanding on that a little bit for the audience because I think that's a really important reminder that you brought up in the discussion? Dr. Matteo Lambertini: The difference between BRCA1 and BRCA2 carriers has been known that there are different phenotypes of breast cancer that are more often diagnosed in these two different populations. Normally BRCA1 carriers have a higher likelihood to develop a triple negative breast cancer as compared to BRCA2 carriers, more likely to develop a hormone receptor-positive HER2-negative disease. In this study, again, a specific population of young women with breast cancer, we have seen the same findings, mostly triple negative disease in BRCA1 carrier, mostly luminal-like disease in BRCA2 carrier. But what's novel or interesting from this study is to look also at the age at the time of diagnosis of this disease. And particularly in BRCA1 carriers, we should be sort of more careful about diagnosis of breast cancer and also other primary tumors including ovarian cancer because the risk of developing these malignancies is higher even at a younger age as compared to BRCA2 carriers. And this has implications also in the primary and secondary prevention that we were talking about earlier. Dr. Monty Pal: Oh, interesting. I guess the fundamental question then from your paper becomes, how do we get at the right patients for screening for BRCA1 and BRCA2? And I realize our audience here is largely oncologists who are going to be listening to this podcast, oncology providers, MDs, nurses, etc. But maybe speak for a moment to the general practitioner. Are there things that, for instance, a general practitioner should be looking for to say, “Wait a minute, this patient's high risk, we should consider BRCA1, BRCA2 testing or germline screening”? Dr. Matteo Lambertini: Yes, it's a very important question for the breast cancer community. After the updated ASCO guideline, the counseling is way easier because right now the age cutoff goes up to 65 years, meaning that all the patients diagnosed with breast cancer below the age of 65 years should be tested these days. And then above the age of 65, there are different criteria like triple-negative disease or family history. From a general practitioner standpoint, it's of course a bit more difficult, but knowing particularly the family history of the person that they have in front will be crucial to know if there are cases of breast cancer diagnosed at a young age, maybe triple-negative cases, knowing cases of ovarian cancer in first-degree relatives or pancreatic cancer in first-degree relatives, and of course cases of prostate cancer as well. So, I would say probably mostly the family side will be important from a general practitioner perspective.  From an oncology one, the other point that I think is important to stress also based on the data that we have shown in this publication is that having a case of breast cancer known to carry a BRCA pathogenic or likely pathogenic variant. It means that all the people around this case should get tested and if found to be BRCA carrier and healthy carrier, these people should also undergo the primary and secondary prevention strategies because this is very critical also to improve their outcomes and try to avoid the developing of breast or ovarian cancer, but also in the case of diagnosis of this disease, a diagnosis at an earlier stage, as we have seen in this paper. Dr. Monty Pal: Brilliant. I'm going to diverge from our list of questions here and close by asking a question that I have at the top of my mind. You're very young. I know our podcast listeners can't see you, but you're very, very young. Dr. Matteo Lambertini: Thank you. Thank you for that. Not so young but yeah. Dr. Monty Pal: You have nearly 300 papers. Your H-index is 67. You've already made these seminal contributions, as I outlined it from the outset, regarding fertility, regarding use of GnRH analogs, regarding pregnancy and breast cancer. What are you studying now? What are you really excited about right now that you're doing that you think might potentially be practice changing? Give us a little teaser. Dr. Matteo Lambertini: Yeah. Thanks a lot, Dr. Pal. Receiving this compliment from you is fantastic. So, thanks a lot for that. From my side, in terms of my research, I've been interested in the field of breast cancer in young women since the start of my training. I've had very good mentors from Italy, from Europe, from the U.S. I'm still interested in this field, so I think we still have a lot to learn to try to improve the care of young women with breast cancer. For example, the oncofertility care, which is something I worked a lot over the past years. Now with all the new treatment options, there's a sort of new chapter of oncofertility counseling. So, what's the impact of immunotherapy? What's the impact of the new targeted agents?  More on the genetic aspects, now we know that there's not only BRCA1 or BRCA2. There are a lot of other different genes that may increase the risk of breast cancer and other malignancies. And also for these genes, we really don't have a lot of evidence to counsel women on prognosis, treatment, prevention strategy. So we need to learn way more for this special patient population that are quite rare, and so we really need a multicenter academic effort to try to give some evidence in this field. Dr. Monty Pal: Yeah. It's tough because these are rare circumstances, but, you know, I think that you've done really well to sort of define some collective experiences that I think really define therapy. I mean, I just remember when I was in training 25 years ago, just reading through textbooks where all the experience around breast cancer and pregnancy was really just very sort of anecdotal almost, you know? And so it's great to see that the state of the science has moved forward.  Well, gosh, I really enjoyed our conversation today. I think your study really reminds us how powerful genetic information is in terms of improving outcomes. And, you know, hopefully this will lead some individuals to perhaps test more broadly in appropriate settings. So, thank you so much, Matteo, for joining us today with your fantastic insights on the ASCO Daily News Podcast. Dr. Matteo Lambertini: Thank you very much, Dr. Pal. It's a real pleasure. Dr. Monty Pal: And thanks to our listeners too. You'll find a link to Dr. Lambertini's study in the transcript of this episode. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks a ton. 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. Sumanta (Monty) Pal  @montypal  Dr. Matteo Lambertini @matteolambe   Follow ASCO on social media:     @ASCO on Twitter    ASCO on Bluesky   ASCO on Facebook     ASCO on LinkedIn     Disclosures:    Dr. Monty Pal:   Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview  Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical  Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Matteo Lambertini: Consulting or Advisory Role: Roche, Novartis, Lilly, AstraZeneca, Pfizer, MSD, Exact Sciences, Gilead Sciences, Seagen, Menarini, Nordic Pharma Speakers' Bureau: Takeda, Roche, Lilly, Novartis, Pfizer, Sandoz, Ipsen, Knight Therapeutics, Libbs, Daiichi Sankyo, Gilead Sciences, AstraZeneca, Menarini, AstraZeneca, Menarini Research Funding (Inst.): Gilead Sciences Travel, Accommodations, Expenses: Gilead Sciences, Daiichi Sankyo Europe GmbH, Roche

Aktien von Roche und Novartis legen zu, Oktoberfest München nach Bombendrohung wieder geöffnet, der Eigenmietwert ist abgeschafft – was nun?, Julie Andrews wird 90

In this JCO Article Insights episode, Dr. Ece Cal interviews Dr. Martin Wermke, author of the JCO article, "Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas." TRANSCRIPT The disclosures for guests on this podcast can be found in the transcript. Dr. Ece Cali: Welcome to this episode of JCO Article Insights. This is Dr. Ece Cali, JCO editorial fellow, and today I am joined by Dr. Martin Wermke, Professor for Experimental Cancer Therapy at Dresden University of Technology, to discuss the manuscript “Phase 1 Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-like T-Cell Engager Obrixtamig in Patients with DLL3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas.” Obrixtamig is a bispecific T-cell engager that binds to DLL3 on tumor cells and CD3 on T-cells. This manuscript presents the phase 1A dose escalation results of Obrixtamig in patients with DLL3+ small cell lung cancer and neuroendocrine carcinomas. In this study, 168 patients were treated with Obrixtamig across four different dosing regimens. 49% of the patients had small cell lung cancer, 42% had extrapulmonary neuroendocrine carcinoma, and 8% had large cell neuroendocrine carcinoma of the lung. Patients received a median of two prior lines of therapy. 33% of the patients had brain metastases at baseline. Of note, this trial did not mandate baseline brain imaging. Maximum tolerated dose was not reached. 88% of the patients experienced a treatment-related adverse event, however, only 3.6% of the patients had to discontinue treatment due to treatment-related AEs, and dose reduction due to treatment-related AEs was documented in 2.4% of the patient population. Similar to the other DLL3-targeted bi-therapies, the most common adverse events included CRS in 57%, dysgeusia in 23%, and pyrexia in 21% of the patients. CRS events were mostly mild. They occurred more frequently in the first two to three doses. 9% of the patients experienced ICANS, of which 3% were graded as Grade 3 or higher. And let's review the efficacy results. Responses were only seen in patients who received 90 microgram per kg or more once weekly or once every three weeks dosing. The objective response rate in patients who received an effective dose was 28%. If we review by tumor type, 21% of the small cell lung cancer patients, 27% of the extrapulmonary neuroendocrine carcinoma patients, and 70% of the large cell neuroendocrine carcinoma patients had objective response. Median duration of response was 8.5 months, though this data is immature due to short follow-up. Dr. Wermke, DLL3-targeted bispecific T-cell engagers are reshaping the treatment landscape of small cell lung cancer. This trial investigates Obrixtamig in other high-grade neuroendocrine tumors as well. Can you put this trial into context for us and explain why it may represent an important step forward? Dr. Martin Wermke: Yeah, thank you for providing me with the opportunity to discuss our data today. I think the data with Obrixtamig in small cell lung cancer are largely similar to what has been observed with other bispecific T-cell engagers such as tarlatamab with respect to the response rate and duration. It has, however, been to be mentioned that BI 1438001 had a bit more liberal inclusion criteria than other trials around. You already mentioned the fact that we allowed the inclusion of patients without mandatory brain imaging, which led to some patients having their brain mets been diagnosed during the treatment with obrixtamig and then adding to the progressive disease patients. That is something which was not the case with the tarlatamab trials where you really had to have a brain imaging before, and in the Phase 1 trial you were even required to treat the brain mets before you included the patient. So it is a bit different, more poorest patient population. I think the trial adds on existing data by being the first trial to also include non-SCLC neuroendocrine carcinoma of other origin, for example from the gastrointestinal tract, and also by including large cell neuroendocrine carcinoma of the lung, which is a really hard to treat pulmonary neoplasm which currently lacks any standardized treatment. So that is really a step forward which we will build on in the future. Dr. Ece Cali: And one thing I would note in this trial, only patients with tumor expressing DLL3 were enrolled. Can you tell us a little bit more about this target, DLL3 in the context of neuroendocrine tumors, and does DLL3 expression predict clinical outcomes after treatment with DLL3 BiTEs, or do we actually need other predictive biomarkers for these novel agents? Dr. Martin Wermke: Yeah, thank you. That's a pretty interesting question. First of all, DLL3 is an atypical notch ligand, which is expressed by the majority of neuroendocrine carcinomas, virtually absent on healthy adult tissues. Therefore, turning it really into a bona fide target for T-cell engaging therapies, pretty low risk for on-target off-tumor side effects. We found that in all the patients we screened, we had an expression rate of about 94% in small cell lung cancer, 80% of large cell neuroendocrine carcinoma of the lung were positive, and also about 80% of the extrapulmonary neuroendocrine carcinoma. So it's really a high prevalence. So the fact that we only included DLL3+ tumors still means we included most of the patients that presented with these diseases. I think at the moment there are no data suggesting a clear-cut association between DLL3 expression levels and outcome on DLL3 CD3 T-cell engagers. There's also not a lot published. If you want to find this out for tarlatamab, you have to look into their patent to really see the data, but it's not clear-cut and I'm sure we need other markers to complement that. And I think what probably plays a major role is intrinsic T-cell fitness. So the question how really diseased your T-cells are, how old you are, because age also correlates with the fitness of the immune system, and other patient characteristics such as tumor burden, we've seen all across the board that the higher the tumor burden, the lower the rate of prolonged response is in such trials. And I also think we need to focus on other components of the tumor microenvironment. So see how high the T-cell infiltration with obrixtamig is and how abundant suppressive elements like regulatory T-cells or myeloid-derived suppressive cells are. That is work which is currently being done. Data are emerging, but I don't think that at the moment we have any clear biomarker helping us to select who should not receive DLL3 T-cell engagers. Dr. Ece Cali: Those are great points and there is a lot we need to learn about how to use these novel agents in the future. I'd like to highlight the results in large cell neuroendocrine carcinoma of the lung. The response rate in this group was remarkably high at 70%. Though we should note the small sample size of only 14 patients in this trial. After first line chemoimmunotherapy, current approved options for this population have very modest clinical activity. Given these trial results, how do you envision the field moving forward for patients with large cell neuroendocrine carcinoma? Dr. Martin Wermke: Yeah, I think LCNEC is really an area which urgently needs further improvement of therapeutic standards. At the moment, as I said, there is no real standard. We are usually extrapolating from results we have in small cell lung cancer or non-small cell lung cancer, but I don't think we have too many prospective trials really informing this. Of course, 14 patients is a small sample size, but I think it's still fair to say that we can claim that DLL3 T-cell engagers are not doing worse in LCNEC than they do in SCLC. And that's why I think we really need to move forward clinical trials that are specifically targeting this population. Although I fear a bit that, given the rareness of this disease and the aggressiveness of its phenotype, that this is probably not the main focus of the pharmaceutical industry. So I think it's up to us academic investigators to really come up with investigator-initiated trials trying to fill the knowledge gaps we have here. Dr. Ece Cali: And one more thing that I want to talk about is the accessibility for these drugs. These novel agents are showing real promise in improving outcomes for patients with high-grade neuroendocrine tumors, an area where progress has been limited until very recently. However, as DLL3 BiTEs become more widely used, issues of logistics and access come into sharper focus. With unique toxicities and the specialized monitoring, their use is restricted to certain centers. Looking ahead, what kinds of strategies could help mitigate some of these adverse events or make these treatments more broadly available? Dr. Martin Wermke: Yeah, I think if you look at countries like the United States where tarlatamab has already been approved, we can see how the management strategies are evolving. I've heard about a colleague equipping their patients with thermometers and a pill of Dexamethasone, alongside with a temperature control protocol and clearly instructing them, "If you measure a temperature above a certain level then start taking the Dexamethasone and come back to our office and we're going to take care of you." I think that's one way to move forward. I think we are lucky in a way that CRS usually manifests within the first 24 hours. This was the same in our study, like in the tarlatamab studies. So we really know when the time of trouble is for our patients. And in this time, I think we need to instruct the patients to stay close to the hospital. I don't think we need to hospitalize all of them, but we probably need them to stay in a nearby hotel to be able to reach the emergency room if needed in a short period of time. And I think we can also learn in this strategy how to manage bispecific antibodies from the experience our colleagues in hematology had because they have been using bispecific T-cell engagers for quite some years right now and they developed strategies and networks that were able to successfully treat these patients also on an outpatient basis. And I think that is clearly an experience we need to follow, acknowledging that we are talking about diseases which are much more frequent than the standard hematology indications. Dr. Ece Cali: Thank you so much, Dr. Wermke, for this informative discussion and for sharing your perspective on this evolving field. Dr. Martin Wermke: Yeah, thank you for providing me with the opportunity to talk about data. It was really great being able to share that, and I really think that we are just at the beginning of a new exciting area for the treatment of neuroendocrine carcinomas, and I think much improvement is yet to come for our patients. Dr. Ece Cali: Yes, that's really exciting. And thank you everyone for listening to JCO Article Insights. Please come back for more interviews and article summaries and be sure to leave us a rating and review so others can find our show. For more podcasts and episodes from ASCO, please visit asco.org/podcasts. 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 this 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. Dr. Martin Wermke's Disclosures Honoraria: Lilly, Boehringer Ingelheim, SYNLAB, Janssen, Merck Serono, GWT, Amgen, Novartis, Pfizer,  BMS GmbH & Co. KG, Regeneron, MJH/PER, Takeda Consulting or Advisory Role: Bristol-Myers Squib, Novartis, Lilly, Boehringer Ingelheim, ISA Pharmaceuticals, Amgen, immatics, Bayer, ImCheck therapeutics, AstraZeneca, Tacalyx, Regeneron, Daiichi Sankyo Europe GmbH, Zymeworks, PharmaMar, Iovance Biotherapeutics, T-Knife, Genentech Research Funding: Roche Patents, Royalties, Other Intellectual Property Travel, Accommodations, Expenses: Pfizer, Bristol-Myers Squibb, AstraZeneca,  Amgen,  GEMoaB, Sanofi/Aventis, immatics,  Merck Serono, Janssen Oncology, Iovance Biotherapeutics, Daiichi Sankyo Europe GmbH"

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Marchés en mode montagnes russes : euphorie, panique éclair, et retour à l'euphorie comme si rien ne s'était passé. L'IA qui s'emballe, l'inflation qui s'incruste, et Trump qui déraille… bienvenue dans la semaine la plus surréaliste de septembre. Je te raconte tout ça dans ce Swiss Bliss : une fête foraine version marchés financiers.

Trump verhängt 100-Prozent-Zölle auf importierte Medikamente. Novartis sieht sich dank US-Investitionen nicht betroffen. Die Schweizer Pharmabranche bleibt dennoch unter Druck. Ausserdem: · Baselbieter Gemeinden fordern finanzielle Entlastung · Live-Interview mit SVP-Kandidatin Caroline Mall

Host: Susanna Price Guest: Robert Storey Want to watch that extended interview? Go to: https://esc365.escardio.org/event/2092?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. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, 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. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi.  Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Robert Storey has declared to have potential conflicts of interest to report: research grants and personal fees from AstraZeneca and Cytosorbents, and personal fees from Abbott, Afortiori Development/Thrombolytic Science, Boehringer Ingelheim/Lilly, Bristol Myers Squibb/Johnson & Johnson, Chiesi, Idorsia/Viatris, Novo Nordisk, PhaseBio and Tabuk. 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 Strategic decisions in valvular heart disease Optimising drug therapy in chronic coronary syndromes Mythbusters: Does wearing a white coat make you smarter? Host: Susanna Price Guests: John-Paul Carpenter, Fabien Praz, Robert Storey Want to watch that episode? Go to: https://esc365.escardio.org/event/2092 Want to watch that extended interview on Optimising drug therapy in chronic coronary syndromes ? Go to: https://esc365.escardio.org/event/2092?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. The ESC is not liable for any translated content of this video. The English-language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Nicolle Kraenkel, Fabien Praz 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. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder Mycardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Bristol Myers Squibb, Daiichi Sankyo, Sanofi Aventis, Novo Nordisk, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Robert Storey has declared to have potential conflicts of interest to report: research grants and personal fees from AstraZeneca and Cytosorbents, and personal fees from Abbott, Afortiori Development/Thrombolytic Science, Boehringer Ingelheim/Lilly, Bristol Myers Squibb/Johnson & Johnson, Chiesi, Idorsia/Viatris, Novo Nordisk, PhaseBio and Tabuk. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

In this episode of the Scrum.org Community Podcast, Patricia Kong hosts a discussion with Elaine Lin Hering, author of  USA Today Best Selling Book "Unlearning Silence," and Ravi Verma, a Professional Scrum Trainer. They examine how workplace culture and cultural norms influence who speaks up and why intentional communication matters.Elaine explains that silence can be strategic or damaging, depending on context, and emphasizes the need for leaders to create environments where all voices are heard. Ravi shares his experiences with reactive versus reflective decision-making and the importance of transparency. They discuss practical strategies for encouraging voice and the significance of designing inclusive meeting practices.Tune in to this inspiring episode that anyone can relate to!Get more insights about Unlearning Silence in this article on the Professional Scrum Unlocked Substack!About Elaine Lin Hering:Elaine Lin Hering a facilitator, writer, and speaker. She works with organizations and individuals to build skills in communication, collaboration, and conflict management. She has worked on six continents and facilitated executive education at Harvard, Dartmouth, Tufts, UC Berkeley, and UCLA. She is the former Advanced Training Director for the Harvard Mediation Program and a Lecturer on Law at Harvard Law School. She has worked with coal miners at BHP Billiton,micro-finance organizers in East Africa, mental health professionals in China, and senior leadership at the US Department of Commerce. Her clients include American Express, Chevron, Google, Nike, Novartis, PayPal, Pixar, and the Red Cross. She is the author of the USA Today Bestselling book Unlearning Silence: How to Speak Your Mind, Unleash Talent, and Live More Fully (Penguin, 2024).About Ravi Verma:Ravi Verma is a Public Speaker, Agile Coach, Scrum.org Professional Scrum Trainer, Evidence Based Management Consultant and Blogger with a passion for helping teams recapture the magic of making I.T. As the Founder and Chief Org Whisperer at The Org Whisperers, Ravi blends ideas from the world of Technology, Entrepreneurship and Organizational Development to develop strong teams and inspiring leaders at all levels of an organization. He recently co-founded his second startup - Al Dente, a platform that helps Agile Coach's and organizations empirically improve business outcomes in tandem with Agile delivery frameworks like Scrum. 

Navigating MS Together: A Patient's Journey and Her Neurologist's Insight - Episode 191 - Transcript In this episode, we explore what it's really like to be newly diagnosed with MS through the personal story of Fran Peed, who went from MS advocate to MS patient. Fran reflects on the first two years of living with MS — a period of uncertainty, adjustment, and learning how to manage both the medical and emotional sides of the diagnosis. Joining her is Dr. Michelle Betz, Fran's neurologist and a specialist in multiple sclerosis at Sentara Neurology Specialists. Together, they reflect on building a trusting care relationship, navigating the early decisions after diagnosis, and learning how to live well with MS — not just manage it. Whether you're newly diagnosed or supporting someone who is, this conversation offers honesty, support, and hope. This podcast episode was created in collaboration with Novartis. Disclaimer: This podcast provides general educational information. Can Do MS does not endorse, promote, or recommend any product or service associated with the content of this program.

The FDA is working to reapprove GSK's long-dormant drug Wellcovorin (leucovorin) for cerebral folate deficiency, which the agency linked to “developmental delays with autistic features.” This immediately followed a much-anticipated press conference in which President Donald Trump, flanked by Health Secretary Robert F. Kennedy Jr and other healthcare administrators, linked the use of Tylenol during pregnancy to rising rates of autism.  Meanwhile, Pfizer woke us all up Monday with the news that it had acquired breakout obesity rockstar Metsera for $4.9B. The deal should pump new life into Pfizer's portfolio, which over the last two years has suffered three discontinued assets. Bite-sized deals—or those at or below the $5 billion mark—have defined biopharma recently, with Roche picking up metabolic dysfunction-associated steatohepatitis biotech 89bio for a potential $3.5 billion last week and Novartis putting another $5.7 billion on the line with partner Monte Rosa Therapeutics in a second molecular glue agreement.  Another therapeutic space primed for M&A action is psychedelics. After AbbVie bought Gilgamesh Pharmaceuticals' lead depression asset for $1.2B last month, BioSpace spoke sought opinions from experts on who might be next to take the plunge. A few potential names included Eli Lilly, Bristol Myers Squibb and Merck.  On the policy front, the CDC's revamped vaccine advisory committee convened for their first meeting to discuss COVID-19, MMRV and hepatitis B vaccine schedules. Industry watchers who spoke to BioSpace commented on the “lack of knowledge” and dearth of previous experience on the committee. And while the advisors ultimately voted to change the schedule for the MMRV vaccine, it appears unlikely to significantly affect manufacturers' bottom lines. Finally, in rare disease, Stealth BioTherapeutics secured its long-sought approval for elamipretide—now Forzinity—in Barth syndrome—a disorder that would fall under the purview of the FDA's new Rare Disease Evidence Principles framework for ultra rare diseases affecting less than 1,000 people in the U.S. And we said “Bye Bye Bluebird,” as the famed gene therapy biotech—which was recently bought out by two private equity firms—returned to its original moniker, Genetix Biotherapeutics.  Lastly, make sure to sign up for Biopharm Executive here for access to a special deep dive into China biopharma.  

In this episode of the Investing in Integrity podcast, Ross Overline, CEO and co-founder of Scholars of Finance, welcomes Bill George, Legendary Business leader and former CEO of Medtronic, Harvard Business School professor, and board member at Goldman Sachs, for a candid conversation on authentic leadership in finance. Drawing on decades of executive and boardroom experience, Bill highlights why integrity, emotional intelligence, and purpose-driven decision-making are vital in today's financial landscape. Together, they discuss strategies for combating greed, building sustainable long-term value, and staying true to one's moral compass even in high-stakes environments. The discussion also explores navigating ethical challenges in the age of AI and ensuring finance remains a force for good. Whether you're an aspiring finance professional or a seasoned investor, this episode offers valuable insights on leading with character and transforming business through values-based leadership.Meet Bill George:Bill George is an Executive Education Fellow at Harvard Business School and former chairman and CEO of Medtronic, where he led from 1991 to 2001. Earlier in his career, he held senior roles at Honeywell, Litton Industries, and the U.S. Department of Defense. A prolific author, Bill has written several influential books on authentic leadership, including True North. He has served on the boards of Goldman Sachs, ExxonMobil, Novartis, Target, and the Mayo Clinic. Recognised with honors such as the Bower Award for Business Leadership, Bill is widely respected for advancing values-driven leadership in business and society.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a comeback in the obesity market with the acquisition of Metsera for $4.9 billion, rejuvenating its portfolio after facing challenges with three discontinued assets. Meanwhile, Stealth BioTherapeutics has received expedited FDA approval for the first-ever treatment for Barth syndrome, and Sanofi's decision on their oral multiple sclerosis drug has been postponed to December. The ACIP committee has expressed concerns about a lack of knowledge and experience within the reconstituted committee. Biotility offers industry-recognized credentials to advance bioscience careers, Novartis is exploring ways to reduce drug costs in the US, and Merck has received approval for a subcutaneous formulation of Keytruda. Stay tuned for more updates on the psychedelics space, rare disease treatments, and other developments in the biopharmaceutical industry.

US-Zölle & Schweiz: Bernecker ordnet Trumps Zollpolitik ein: Goldverarbeitung, Pharma und Uhren seien die Hauptthemen. Die Schweiz setze auf reziproke Lösungen und Deals; große Konzerne wie Roche, Novartis oder ABB würden Investitionen in den USA prüfen. Produktion könne teils in die EU verlagert werden. Zinsen & Wall Street: "The Federal Reserve writes the stock market letter." Mit weiteren Senkungen in Richtung 3 bis 3,5 rechnet Bernecker - die Börse preise das vorweg. Thieme kritisiert Wunsch nach 1 %-Zinsen als politisch motiviert. Marktausblick: Bernecker sieht "drei Spieltische": Trump, Deutschland, Ukraine/Russland. China erst später entscheidend. Thieme: Korrekturen von 5 bis 10 % möglich, zum Jahresende aber höhere Kurse. Empfehlung: 10 bis 20 % Liquidität, Gewinne absichern, nicht nur auf Nvidia setzen; Chancen auch bei Titeln wie Infineon. Einzeltitel & Deals: Nvidia/Intel als strategisch klug, HP im Blick. Continental fokussiert sich nach dem Spin-off wieder auf Reifen - "konstruktive Firmenstrategie". Kernaussage: Thieme betont den Faktor Geopolitik: "Frieden ist die wichtigste Zutat für jede Börsenstrategie." Bücher am Rande: Berneckers "60 Jahre Börse" und Thiemes neues Praxisbuch werden signiert. https://www.heiko-thieme.club/link-sammlung-buch/

US-Zölle & Schweiz: Bernecker ordnet Trumps Zollpolitik ein: Goldverarbeitung, Pharma und Uhren seien die Hauptthemen. Die Schweiz setze auf reziproke Lösungen und Deals; große Konzerne wie Roche, Novartis oder ABB würden Investitionen in den USA prüfen. Produktion könne teils in die EU verlagert werden. Zinsen & Wall Street: "The Federal Reserve writes the stock market letter." Mit weiteren Senkungen in Richtung 3 bis 3,5 rechnet Bernecker - die Börse preise das vorweg. Thieme kritisiert Wunsch nach 1 %-Zinsen als politisch motiviert. Marktausblick: Bernecker sieht "drei Spieltische": Trump, Deutschland, Ukraine/Russland. China erst später entscheidend. Thieme: Korrekturen von 5 bis 10 % möglich, zum Jahresende aber höhere Kurse. Empfehlung: 10 bis 20 % Liquidität, Gewinne absichern, nicht nur auf Nvidia setzen; Chancen auch bei Titeln wie Infineon. Einzeltitel & Deals: Nvidia/Intel als strategisch klug, HP im Blick. Continental fokussiert sich nach dem Spin-off wieder auf Reifen - "konstruktive Firmenstrategie". Kernaussage: Thieme betont den Faktor Geopolitik: "Frieden ist die wichtigste Zutat für jede Börsenstrategie." Bücher am Rande: Berneckers "60 Jahre Börse" und Thiemes neues Praxisbuch werden signiert. https://www.heiko-thieme.club/link-sammlung-buch/

Host Gil Bashe welcomes Milind Kamkolkar a globally recognized healthcare & life sciences technology executive and venture leader with over two decades of experience building and scaling companies and market-leading capabilities at the intersection of life sciences, healthcare, and deep tech. He has co-founded and incubated multiple breakthrough startups—including ventures at Flagship Pioneering, RA Capital, Arch, and General Catalyst—raising nearly $500M in funding. As the first Chief Data Officer in global pharma (Sanofi) and a senior executive at Novartis, Milind pioneered enterprise AI transformations and forged strategic alliances with Apple, AWS, Microsoft, and Google. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen

La Fed a baissé ses taux comme un vaccin miracle… sauf que ça ne guérit pas l'économie, mais ça fait grimper Wall Street. UBS menace de déménager son siège aux États-Unis si Berne lui serre trop la vis côté capital. Et Trump ? Il taxe les visas H-1B, fait pression sur la Fed, et censure les médias qui se moquent de lui. Ajoutez TikTok coincé entre Washington et Pékin, Nvidia et Intel qui s'allient dans l'IA, et quelques secousses sur le marché suisse (Roche, Novartis, SIG…) : bienvenue dans le Swiss Bliss du 20 septembre 2025.

On this week's episode, Daphne Zohar, Josh Schimmer, Luba Greenwood and Matt Gline open with a look at overall market sentiment, spotlighting Stifel's bullish report on the biotech sector's nice recovery since April's “liberation day” with the XBI up over 40%, the recent wave of M&A activity, and the Biotech Winter. The co-hosts then highlight recent deals, including Roche's $3.5 billion acquisition of 89Bio and Novartis's $5.7 billion licensing agreement with Monte Rosa Therapeutics. In data news, the group overviews aTyr Pharma's Phase 3 results in pulmonary sarcoidosis, with Matt Gline sharing perspective on the therapeutic area after Roivant's similar fate. Next, long-versus-short dynamics around biotech data readouts are highlighted, along with positive data sets from Areteia and Apollo. Matt also details Roivant's positive Phase 3 results in dermatomyositis. The conversation then turns to big pharma's exodus from the UK, as several companies including Merck, AstraZeneca, and Eli Lilly scale back large investments. The co-hosts explore possible causes for the pullback, such as heavy regulation and tax incentives holding back innovation. Michal Preminger joins the discussion to share her unique insights on UK and US biotech hubs and draws attention to the Massachusetts paradox and the impact on the biopharma industry. *This episode aired on September 19, 2025

When people get hives or swelling, they often think it's caused by an allergy. But in the case of chronic spontaneous urticaria (CSU), the culprit is often your own immune system. CSU isn't your typical allergic reaction, instead, it's frequently an autoimmune condition, where the immune system misfires and activates mast cells without any external trigger. In this episode, Dr. Payel Gupta and Kortney unpack what it means for CSU to be autoimmune and autoallergic. They explain how IgE and IgG antibodies can trigger histamine release, leading to hives and swelling. You'll also learn why allergy testing isn't useful for diagnosing CSU, and how tests like IgG food sensitivity panels can do more harm than good by leading to unnecessary food avoidance and confusion. What we cover in our episode about autoimmune CSU and chronic hives: Is CSU an allergy? Why CSU is often mistaken for an allergic reaction—and why standard allergy tests rarely provide helpful answers. How the immune system works in CSU: What mast cells are, how they release histamine, and their central role in chronic spontaneous urticaria. Understanding autoimmune CSU: Learn how the immune system can trigger hives from within, including the roles of IgE and IgG antibodies. Autoimmune hives explained: We explore how CSU can be autoimmune, why the immune system may attack itself, and what Type I and Type IIb autoimmune CSU really mean. ____ Made in partnership with The Allergy & Asthma Network. Thanks to Novartis for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 12, 2025. In this episode: Novo Nordisk cuts 9,000 jobs; deals freshen up Novartis's cardio franchise; J&J's Inlexto approval; Summit's ivonescimab challenges; and FDA's DTC ad crackdown. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XQF6667ICBDMTFBCUCNYBZUJZY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

September 16, 2025 | With the rise of AI and automation, what is the core human skill in drug discovery that is and will be valuable in the future? Derek Lowe, director of Chemical Biology Therapeutics at Novartis and author of the In the Pipeline blog, discusses the impact of AI—and non-AI technologies—on the business of drug making. With host Christopher Bahl, cofounder and CEO of AI Proteins, their conversation covers the value of a PhD in the tech world today, the long-term impacts of knowledge creation in US leadership positions, how the industry can navigate a biotech winter, and more. Links from this episode:  AI Proteins Novartis In the Pipeline 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novartis and Monte Rosa have entered into their second molecular glue deal worth up to $5.7 billion, with Novartis putting $120 million upfront for more of the biotech's AI-discovered degraders. The myasthenia gravis market, once sparse, is now flourishing with new treatments approved and promising late-stage trial results from companies like Argenx and Regeneron. In other news, AstraZeneca has suspended its $270 million commitment in the UK, the FDA has flip-flopped on scrapping advisory committee meetings, and Sino Biological has developed a high-throughput platform for AI-driven antibody discovery. The myasthenia gravis space is heating up with targeted therapies, with several companies releasing promising late-stage trial results. Biogen is developing a pipeline for lupus, with investors showing interest in their programs. The FDA has several actions scheduled for September, including Merck's proposed subcutaneous formulation of Keytruda. Eli Lilly's obesity pill, Orforglipron, is in focus at the European Association for the Study of Diabetes meeting. In the cancer news, Merck's Keytruda challenger faces consistency problems, while other companies like Daiichi Sankyo and Biontech report positive data. Capsida reports a patient death in a gene therapy trial, while Alkermes shows promise in narcolepsy treatment. FDA is looking to streamline the development of non-opioid painkillers. Various webinars and events are upcoming in the pharma industry. Job opportunities are available at companies like Moderna, Abbvie, and Regeneron. Overall, the biopharma industry is seeing advancements and progress in various therapeutic areas.

The accredited CME program highlights the latest clinical research about iTTP, a rare thrombotic disorder. Led by Shruti Chaturvedi, MD, this activity provides a summary of clinically relevant data presented at the International Society of Thrombosis and Haemostatis Congress (ISTH 2025) that can enhance the care of patients with iTTP. This program is supported by an educational grant from Sanofi.To receive CME credit, go to https://checkrare.com/learning/p-isth2025-module3-immune-thrombotic-thrombocytopenic-purpura-ittp-clinical-research-highlights/Target AudienceThis activity has been designed to meet the educational needs of physicians specializing in iTTP. Other members of the care team may also participate.Learning ObjectivesAfter participating in the activity, learners should be better able to:Describe the latest research being presented to better manage individuals with iTTP and its clinical relevance. Shruti Chaturvedi, MDAssistant Professor of MedicineJohns Hopkins Disclosure StatementAccording to the disclosure policy of the Academy, all faculty, planning committee members, editors, managers and other individuals who are in a position to control content are required to disclose any relationships with any ineligible company(ies). The existence of these relationships is not viewed as implying bias or decreasing the value of the activity. Clinical content has been reviewed for fair balance and scientific objectivity, and all of the relevant financial relationships listed for these individuals have been mitigated. Disclosure of relevant financial relationships are as follows:Faculty Educator/PlannerDr. Chaturvedi discloses the following relevant financial relationships with ineligible companies:Scientific Advisory Board/Consultant: Sanofi, Takeda, Sobi, argenx, Star Pharma, RallyBio, Novartis, AlexionGrant/Research Support: Sanofi, Sobi, argenx Other Planners for this activity have no relevant financial relationships with any ineligible companies. This activity will review off-label or investigational information. The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy or CheckRare CE. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information. Accreditation and Credit DesignationIn support of improving patient care, this activity has been planned and implemented by American Academy of CME, Inc. and CheckRare CE. American Academy of CME, Inc. 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.PhysiciansAmerican Academy of CME, Inc., designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Other HCPsOther members of the care team will receive a certificate of participation. There are no fees to participate in the activity. Participants must review the activity information including the learning objectives and disclosure statements, as well as the content of the activity. To receive CME credit for your participation, please complete the pre and post-program assessments. Your certificate will be emailed to you within 30 days. PrivacyFor more information about the American Academy of CME privacy policy, please access http://www.academycme.org/privacy.htm  For more information about CheckRare's privacy policy, please access https://checkrare.com/privacy/ContactFor any questions, please contact: CEServices@academycme.orgCopyright© 2025. This CME-certified activity is held as copyrighted © by American Academy of CME and CheckRare CE. Through this notice, the Academy and CheckRare CE grant permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Trump is considering exempting certain "non-patented" pharmaceuticals from tariffs, although specific guidelines have not yet been released. The Intercept has withdrawn a liver drug from the US market, and Ocaliva, approved for primary biliary cholangitis in 2016, did not receive full approval last year. Merck is cutting 125 employees in the UK as it ends R&D work. AbbVie has extended exclusivity for its drug Rinvoq until 2037 with a generics settlement. Novo's headcount has increased by 81% in five years as revenue climbed. The FDA is reportedly preparing an order restricting Chinese drug licensing deals. Capsida has reported a patient death in a gene therapy trial. Novartis' BD team is busy with bolt-on deal promises for 2025. That's all for today's news in the Pharma and Biotech world. Thank you for listening!

This accredited CME program highlights the latest clinical research about immune thrombocytopenia (ITP), a rare thrombotic disorder. Led by Shruti Chaturvedi, MD, this program provides a summary of clinically relevant data presented at the International Society of Thrombosis and Haemostatis Congress (ISTH 2025) that can enhance the care of patients with ITP. This program is supported by an educational grant from Sanofi.To receive CME credit, go to https://checkrare.com/learning/p-isth2025-module2-immune-thrombocytopenia-clinical-research-highlights/Target AudienceThis activity has been designed to meet the educational needs of physicians specializing in ITP. Other members of the care team may also participate.Learning ObjectivesAfter participating in the activity, learners should be better able to:Describe the latest research being presented to better manage individuals with ITP and its clinical relevance.FacultyShruti Chaturvedi, MDAssistant Professor of Medicine,Johns Hopkins Disclosure StatementAccording to the disclosure policy of the Academy, all faculty, planning committee members, editors, managers and other individuals who are in a position to control content are required to disclose any relationships with any ineligible company(ies). The existence of these relationships is not viewed as implying bias or decreasing the value of the activity. Clinical content has been reviewed for fair balance and scientific objectivity, and all of the relevant financial relationships listed for these individuals have been mitigated. Disclosure of relevant financial relationships are as follows:Faculty Educator/PlannerDr. Chaturvedi discloses the following relevant financial relationships with ineligible companies:Scientific Advisory Board/Consultant: Sanofi, Takeda, Sobi, argenx, Star Pharma, RallyBio, Novartis, AlexionGrant/Research Support: Sanofi, Sobi, argenx Other Planners for this activity have no relevant financial relationships with any ineligible companies. This activity will review off-label or investigational information. The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy or CheckRare CE. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information.Accreditation and Credit DesignationIn support of improving patient care, this activity has been planned and implemented by American Academy of CME, Inc. and CheckRare CE. American Academy of CME, Inc. 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.PhysiciansAmerican Academy of CME, Inc., designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Other HCPsOther members of the care team will receive a certificate of participation. There are no fees to participate in the activity. Participants must review the activity information including the learning objectives and disclosure statements, as well as the content of the activity. To receive CME credit for your participation, please complete the pre and post-program assessments. Your certificate will be emailed to you within 30 days. PrivacyFor more information about the American Academy of CME privacy policy, please access http://www.academycme.org/privacy.htm  For more information about CheckRare's privacy policy, please access https://checkrare.com/privacy/ContactFor any questions, please contact: CEServices@academycme.orgCopyright© 2025. This CME-certified activity is held as copyrighted © by American Academy of CME and CheckRare CE. Through this notice, the Academy and CheckRare CE grant permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).

Detecting the Often Undetectable One family's insight into ovarian and uterine cancer, finding support, cherishing family and making change through philanthropy. Diane Trounson-Chaiken, PsyD Diane was born and raised in Long Island City, NY and as a true New Yorker did all of her schooling in NYC. She received her BA in Psychology and Education from Barnard College, Columbia University in 1988 then traveled downtown to New York University where she received her MA and Doctor of Psychology in Child Clinical Psychology in 1994. For many years she worked in early intervention with developmentally delayed preschoolers and their families. She also taught psychology graduate courses to Masters and Doctoral students at several universities, most notably Philadelphia College of Osteopathic Medicine.  Diane met her husband Warren in 1989. They were married in 1993 and moved to the Philadelphia area in 1994. They have two sons, Ben (27 years) and Josh (23 years). Ben graduated from Colgate University in 2020 and lives in Manhattan. Josh graduated from Wake Forest University in 2024 and currently lives in Chicago. Spending time with her husband and sons is what Diane loves most in life. Whether traveling the world, a passion they all share, or sitting on the beach at the Jersey shore, it's all about being together. In April 2023, Diane was diagnosed with Stage 3B Clear Cell Ovarian Cancer & Stage 1 Uterine Cancer. She is treated at Fox Chase Cancer Center in Philadelphia, recognized as a nationally leading cancer center for both clinical care and research. After surgery and chemotherapy Diane achieved remission in October 2023. A year later in November 2024 she suffered a recurrence that resulted in surgery.  Again, this summer in June 2025 she had a more significant recurrence with several areas of metasteses. Diane is currently undergoing chemotherapy which will be followed by surgery and continued chemo. She has learned that this journey is not a sprint but much more of a marathon and is so grateful for the love and support of  her family and many dear friends.  Following are several organizations and programs the Chaiken family supports philanthropically.  -Fox Chase Cancer Center, Ovarian cancer research -Unite for Her, a national organization that provides free services and support for breast and ovarian cancer patients -We Are Wake, a campus wide program at Wake Forest University that supports students' mental health. -Her Health Compass -Crohn's & Colitis Foundation of America  Warren Chaiken is a seasoned executive with over two decades of experience leading complex organizations and driving growth through strategic innovation, operational excellence, and customer-centric leadership. Most recently, Warren served as President & CEO of Almo Corporation, a leading national distributor of appliances, consumer electronics, and professional A/V equipment. Under his leadership, Almo experienced significant expansion, culminating in its successful acquisition by DCC Technology, a division of DCC plc. Warren began his career in accounting and finance before joining Almo, where he held progressive leadership roles across operations, logistics, and sales. As CEO, he championed a culture of service, integrity, and continuous improvement while fostering key partnerships and launching new business units, including Almo Professional A/V. His functional expertise spans strategic planning, mergers and acquisitions, supply chain management, and go-to-market strategy. He is also recognized for his ability to build high-performing teams, guide family-owned businesses through transformational growth, and lead with vision in dynamic markets. Warren and Diane Chaiken are committed philanthropists. Together, they support the Philadelphia Board of the Crohn's & Colitis Foundation of America, Unite for HER, Committee to Benefit the Children, and Swim With Purpose. They also endowed The Chaiken Family Ovarian Cancer Visiting Professorship at Fox Chase Cancer Center. In addition, they founded the Chaiken Cares Foundation to promote health and provide assistance for a variety of children's needs. Their past involvement includes serving on the Parents Committees of both Wake Forest University and Colgate University. Warren and Diane have been married for 32 years and are proud parents of two sons—Ben, 27, and Josh, 23. Warren holds a B.A. from Lafayette College and an MBA from Penn State University. He currently advises companies in the distribution and technology sectors. Sue Weldon, Founder/Chief Executive Officer of Unite for HER, founded the organization in 2009 following her breast cancer diagnosis at age 39. Her vision for accessible integrative cancer care has transformed the organization from serving 23 patients to helping thousands annually. A nationally recognized leader in health equity, Sue serves as a patient advocate advisor to the American Cancer Society, Lilly, AstraZeneca, Deloitte, Daiichi-Sankyo, Pfizer, Novartis, and AbbVie. She holds a BA from West Chester University and has received numerous honors, including AstraZeneca's Catalyst for Care Award and West Chester University's Distinguished Alumni Award. She has three grown children, Taylor, Evan and Corrine and resides with her husband, Chip in West Chester, PA Find Yonni & Heather here https://www.herhealthcompass.com/

Antonio Aspas, socio-director de Buy & Hold Gestión de Activos analiza valores como Euronext, Teleperformance, Ryanair, Novartis o Vallourec

On this week's episode, Chris Garabedian, Tess Cameron, EricSchmidt, Sam Fazeli, and Brad Loncar open with a look at the market environment as biotech sees its first IPO since February -- LB Pharma -- and financings, including Maze's $150M PIPE and Rapport's $250M follow-on. The co-hosts discuss improving sentiment around rates, the $XBI, and insights from conversations at the HC Wainwright conference. Novartis' $1.4B acquisition of Tourmaline Bio and broader deal-making dynamics are also highlighted. On thepolicy front, the group examines the latest China biotech news, including a draft executive order from the Trump Administration. The co-hosts debate access, geopolitical concerns, and the FDA's slower trial-startup process. Indata news, the co-hosts examine Revolution Medicines' pancreatic cancer therapy, emerging small-cell lung cancer data from the World Conference on Lung Cancer, Summit's mixed readout and market reaction, and promising newnarcolepsy data from Takeda and Alkermes. Dianthus' positive generalized myasthenia gravis results are also highlighted. Regulatory and safety updates cover the FDA's withdrawal of Intercept's liver drug, a patient death in Capsida's gene therapy trial, Soleno's FAERS-related stock drop, SEC action on Fibrogen data manipulation, and cancellations of several FDA ad comms raising transparency questions. The episode concludes with a discussion on BridgeBio accusing Alnylam and Pfizer of aggressive tactics in the ATTR-CM market, Arena Bioworks appointing veteran Harvey Berger as CEO, and Novo Nordisk's 11% workforce reduction. *This episode aired on September 12, 2025.

In this episode of The Tech Leader's Playbook, Avetis Antaplyan sits down with Susan Ruediger, Founder and Chief Mission Officer of the CMT Research Foundation (CMTRF), and Laura MacNeill, the organization's CEO. Together, they explore how patient-led research is revolutionizing drug development and catalyzing billion-dollar outcomes. Susan shares the remarkable story of CMTRF's $128,000 seed investment in DTX Pharma that led to a $1 billion Novartis acquisition — a masterclass in strategic risk-taking and venture philanthropy. Laura explains how CMTRF's unique “go-out-of-business” mission drives urgency, focus, and impact, while also inspiring other nonprofits to adopt similar models. The conversation dives deep into storytelling's role in galvanizing donors, the importance of milestones and reinvestment, and how rare disease foundations can unlock breakthroughs for broader neurodegenerative diseases like ALS, Parkinson's, and Alzheimer's. Whether you're a biotech leader, investor, or nonprofit executive, this episode offers actionable lessons on focus, partnerships, and creating outsized impact with limited resources.TakeawaysPatient-led research can de-risk and accelerate drug development.$128K seed funding led to a $1B Novartis acquisition.CMTRF uses a venture-philanthropy model with milestone-based funding.Mission: fund treatments, find a cure, close the foundation.Storytelling drives awareness, donations, and partnerships.Early investments keep promising science alive.Biotech partnerships share risk and leverage expertise.Novartis validated CMT as a major market opportunity.Rare disease focus offers faster FDA pathways.Staying laser-focused means saying no to distractions.Chapters00:00 Intro & Guest Welcome01:20 From Grassroots Donations to Billion-Dollar Deals02:30 Understanding CMT and Its Impact05:00 Finding the Right Delivery Vehicle for Drugs07:40 The $128K Bet That Changed Everything09:50 Other Success Stories & Market Signaling13:00 The Venture-Philanthropy Model Explained16:30 The Power of Milestones and Flexibility18:45 Reinvestment and Sustainable Funding21:30 Role of Storytelling and Strategy in Movement Building26:10 Velocity Campaign & Raising $20M27:25 Why Biotechs Care About Rare Diseases31:50 CMT as a Gateway Indication for Neurodegenerative Disease33:30 Staying Focused and Saying No38:30 The Drug Development Lifecycle and Staying Mission-Aligned42:10 How to Get Involved and Follow CMTRF's Work45:10 Personal & Business Advice for Leaders48:30 Favorite Books and Final Thoughts52:00 Closing Remarks and Call to ActionSusan Ruediger's Social Media Links:https://www.linkedin.com/in/susan-ruediger/Laura MacNeill's Social Media Links:https://www.linkedin.com/in/laura-macneill-m-b-a-97633732/CMT Research Foundation's Website:https://cmtrf.org/Resources and Links:https://www.hireclout.comhttps://www.podcast.hireclout.comhttps://www.linkedin.com/in/hirefasthireright

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novo Nordisk has cut 9,000 jobs worldwide and reduced its 2025 profit growth guidance. The new CEO is fulfilling a cost reallocation promise, leading to a decrease in operating profit growth projection from 10% to 16% down to 4% to 10%. The company's restructuring efforts are aimed at increasing efficiency and reducing costs. In other news, the ousted CDC director Susan Monarez will testify in front of the Senate, and a recent report from the Maha commission emphasizes chronic diseases and potential vaccine reform.Biotechs are using contingent value rights (CVRs) to close the gap between buyer and seller expectations in transactions amid a down market. Novartis is actively pursuing acquisitions, particularly in the cardiovascular space, while Novo Nordisk is restructuring and cutting costs, impacting profit growth projections. Amgen is looking beyond the scrutiny of one obesity asset to focus on a fuller portfolio. Trilink Biotechnologies offers process development services for nucleic acid therapeutic development. In other news, LB Neuroscience files for a $228 million IPO, Novartis acquires Tourmaline for $1.4 billion, and Hengrui licenses a heart disease drug to a US startup for up to $1 billion. The FDA debuts a consumer 'green list' instead of addressing the GLP-1 compounding fight. Thank you for tuning in to Pharma and Biotech daily.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. Novartis recently acquired Tourmaline for $1.4 billion, continuing its investment in cardiovascular treatments. The company has also made other partnerships in the cardiovascular space this year. Biogen is preparing to release new data on its lupus treatments, with analysts praising the company's pipeline. Novartis has been active in mergers and acquisitions, putting over $17 billion into deals this year. The biotech industry is also seeing some activity, with LB filing for a $228 million IPO to support its phase III plans. Overall, companies like Novartis and Biogen are focusing on expanding their portfolios and developing innovative treatments for various diseases.

The Make America Healthy Again Commission released itssecond report Tuesday, recommending, among other efforts, an investigation into a possible link between vaccines and the uptick in chronic disease. At a livestreamed MAHA commission meeting, Health Secretary Robert F. Kennedy painted a dire picture of the country's health, saying the U.S. now has “the highest chronic disease burden of any country in the world.” Looking back to last week, all eyes were on HealthSecretary Robert F. Kennedy Jr.'s appearance before the Senate Finance Committee. The combative showdown amounted to little more than political theater, according to industry watchers, with Kennedy accusing former CDC Director Susan Monarez of lying in an op-ed published in the Wall Street Journal about his alleged request that she approve vaccine advisors' recommendations in advance of their meeting later this month.Over at the FDA, BioSpace combed through the latest cache of publicized complete response letters (CRLs), including one for Lykos' MDMA-based therapeutic for post-traumatic stress disorder. Going forward, the agency has promised to release CRLs in real time. The greater transparency could help companies spinning on a carousel of confusion caused by all the recent regulatory change. In other FDA news, we take a deep dive into new expert panels, which some commentators view as one-sided, and into the new rare disease approval framework, which one critic called “all wrapper and no gift.” And in the weight loss space, the FDA debuted a consumer “green list” for GLP-1 ingredients. Meanwhile, at the World Conference on Lung Cancer inBarcelona, several data readouts caught our attention. In particular, Summit Therapeutics released disappointing data for its PD-L1/VEGFa bispecific antibody ivonescimab in Western populations—a finding some analysts said could have readthroughs to Bristol Myers Squibb/BioNTech's first ever global data readout for its L1/VEGFa bispecific.Finally, in Biopharm Executive this week, check out features on contingent value rights, which have been getting tacked on to biopharma deals more and more, Amgen's pipeline beyond the obesity drug MariTide and Novartis' recent deal spree, which included the $1.4B acquisition of Tourmaline on Tuesday.

Vistazo a Anglo American, Monte dei Paschi di Siena, Unilever, ASML o Novartis con Josep Prats, gestor de fondos de Abante Asesores.

Dr. Pedro Barata and Dr. Rana McKay discuss the integration of innovative advances in molecular imaging and therapeutics to personalize treatment for patients with renal cell and urothelial carcinomas. TRANSCRIPT Dr. Pedro Barata: Hello, I'm Dr. Pedro Barata, your guest host of By the Book, a podcast series featuring insightful conversations between authors and editors of the ASCO Educational Book. I'm a medical oncologist at University Hospitals Seidman Cancer Center and an associate professor of medicine at Case Western Reserve University in Cleveland, Ohio. I'm also an associate editor of the ASCO Educational Book. Now, we all know the field of genitourinary cancers (GU) is evolving quite rapidly, and we have new innovations in molecular imaging as well as targeted therapeutics. Today's episode will be exploring novel approaches that are transforming the management of renal cell and urothelial carcinomas and also their potential to offer a more personalized treatment to patients. For that, joining for today's discussion is Dr. Rana McKay, a GU medical oncologist and professor at University of California San Diego. Dr. McKay will discuss her recently published article titled, “Emerging Paradigms in Genitourinary Cancers: Integrating Molecular Imaging, Hypoxia-Inducible Factor-Targeted Therapies, and Antibody-Drug Conjugates in Renal Cell and Urothelial Carcinomas.”  Our full disclosures are available in the transcript of this episode.  And with that, Rana McKay, great to have you on the podcast today. Dr. Rana McKay: Oh, thank you so much, Dr. Barata. It's really wonderful to be here with you. So, thanks for hosting. Dr. Pedro Barata: No, thanks for taking the time, and I'm looking forward to this conversation. And by the way, let me start by saying congrats on a great article in the Educational Book. Really super helpful paper. I'm recommending it to a lot of the residents and fellows at my own institution. I would like to first ask you to kind of give our listeners some context of how novel approaches in the molecular imaging as well as targeted therapeutics are actually changing the way we're managing patients with GU, but specifically with renal cell carcinoma and urothelial carcinoma. So, what are the areas you would call out as like being big areas for innovation in this context, and why are they important? Dr. Rana McKay: Very good question. And I think this is really what this article highlights. It highlights where are we going from an imaging diagnostics standpoint? Where are we going from a therapeutic standpoint? And I think if we have to step back, from the standpoint of diagnostics, we've seen PET imaging really transform diagnostics in prostate cancer with the advent of PSMA PET imaging, and now PSMA PET imaging is used as a biomarker for selection for theranostics therapy. And so, we're starting to see that enter into the RCC landscape, enter into the urothelial cancer landscape to a lesser extent. And I think it's going to potentially be transformative as these tools get more refined. I think when we think about therapeutics, what's been transformative most recently in the renal cell carcinoma landscape has been the advent of HIF2α inhibition to improve outcomes for patients. And we have seen the approval of belzutifan most recently that has reshaped the landscape. And now there's other HIF2α inhibitors that are being developed that are going to be further important as they get refined. And lastly, I think when we think about urothelial carcinoma, the greatest transformation to treatment in that context has been the displacement of cisplatin and platinum-based chemotherapy as a frontline standard with the combination of enfortumab vedotin plus pembrolizumab. And we've seen antibody-drug conjugates really reshape treatment and tremendously improve outcomes for patients. So, I think those are the three key areas of interest. Dr. Pedro Barata: So with that, let's focus first on the imaging and then we'll get to the therapeutic area. So, we know there's been a paradigm shift, really, when prostate-specific targets emerged as tracers for PET scanning. And so, we now commonly use prostate-specific membrane antigen, or PSMA-based PET scanning, and really transform how we manage prostate cancer. Now, it appears that we're kind of seeing a similar wave in renal cell carcinoma with the new radiotracer against the target carbonic anhydrase IX. What can you tell us about this? And is this going to be available to us anytime soon? And how do you think that might potentially change the way we're managing patients with RCC today? Dr. Rana McKay: First, I'll step back and say that in the context of PSMA PET imaging, we have actually been able to better understand RCC as well. So, we know that PSMA is expressed in the neovasculature of tumors, and it can actually be used to detect renal cell carcinoma tumors. It has a detection rate of about 84% when used for detection. And so, you know, I don't think it's just restricted to carbonic anhydrase IX, but we will talk about that. So, PSMA expressed in the neovasculature has a detection rate of around 84%, particularly if we're looking at clear cell RCC. CAlX is overexpressed in clear cell RCC, and it's actually used in diagnosing renal cell carcinoma when we think of CAlX IHC for diagnosing clear cell RCC. And now there are CAlX PET tracers. The first foray was with the ZIRCON study that was actually an interestingly designed study because it was designed to detect the likelihood of PET imaging to identify clear cell RCC. So, it was actually used in the early diagnostics setting when somebody presents with a renal mass to discriminate that renal mass from a clear cell versus a non-clear cell, and it was a positive study. But when I think about the potential application for these agents, you know, I think about the entire landscape of renal cell carcinoma. This is a disease that we do treat with metastasis-directed therapy. We have certainly seen patients who've undergone metastasectomy have long, durable remissions from such an approach. And I think if we can detect very early onset oligometastatic disease where a metastasis-directed therapy or SABR could be introduced - obviously tested in a trial to demonstrate its efficacy - I think it could potentially be transformative. Dr. Pedro Barata: Wonderful. It's a great summary, and I should highlight you are involved in some of those ongoing studies testing the performance of this specific PET scanning for RCC against conventional imaging, right? And to remind the listeners, thus far, for the most part, we don't really do FDG-PET for RCC. There are some specific cases we do, but in general, they're not a standard scanning. But maybe that will change in the future. Maybe RCC will have their own PSMA-PET. And to your point, there's also emerging data about the role of PSMA-PET scanning in RCC as well, as you very elegantly summarized. Wonderful. So, let me shift gears a little bit because you did, in your introduction, you did highlight a novel MOA that we have in renal cell carcinoma, approved for use, initially for VHL disease, and after that for sporadic clear cell renal cell carcinoma. We're talking about hypoxia-inducible factor 2-alpha inhibitors, or HIF2α inhibitors, such as belzutifan. But there's also others coming up. So, as a way to kind of summarize that, what can you tell us about this breakthrough in terms of therapeutic class, this MOA that got to our toolbox of options for patients with advanced RCC? Tell us a little bit what is being utilized currently in the management of advanced RCC. And where do you see the future going, as far as, is it moving early on? Is it getting monotherapy versus combinations? Maybe other therapies? What are your thoughts about that? What can you tell us about it? Dr. Rana McKay: Belzutifan is a first-in-class HIF2α inhibitor that really established clinical validation for HIF2α as a therapeutic target. When we think about the activity of this agent, the pivotal LITESPARK-005 trial really led to the approval of belzutifan in patients who were really heavily pretreated. It was patients who had received prior IO therapy, patients who had received prior VEGF-targeted therapy. And in the context of this study, we saw a median PFS of 5.6 months, and there did seem to be a tail on the curve when you looked at the 12-month PFS rate with belzutifan. It was 33.7% compared to 17.6% with everolimus. And then when we look at the response rate, it was higher with belzutifan on the order of 22-23%, and very low with everolimus, as we've previously seen. I think one of the Achilles heels of this regimen is the primary PD rate, which was 34% when used in later line. There are multiple studies that are testing belzutifan in combination across the treatment landscape. So, we have LITESPARK-011, which is looking at the combination of belzutifan plus lenvatinib in the second-line setting. We've got the MK-012 [LITESPARK-012] study, which is looking at belzutifan in various combinations in the frontline setting. So there is a combination with IO plus belzutifan. And so this is also being looked at in that context. And then we also have the LITESPARK-022 study, which is looking at pembrolizumab with belzutifan in the adjuvant setting. So there's a series of studies that will be exploring belzutifan really across the treatment landscape. Many of these studies in combination. Additionally, there are other HIF2α inhibitors that are being developed. We have casdatifan, which is another very potent HIF2α inhibitor. You know, I think pharmacologically, these are different agents. There's a different half-life, different dosing. What is going to be the recommended phase 3 dose for both agents, the EPO suppression levels, the degree of EPO suppression, and sustainability of EPO suppression is very different. So, I think we've seen data from casdatifan from the ARC-20 trial from monotherapy with a respectable response rate, over 30%, primary PD rate hovering just around 10%.  And then we've also seen data of the combination of casdatifan with cabozantinib as well that were recently presented this year. And that agent is also being tested across the spectrum of RCC. It's being looked at in combination with cabozantinib in the PEAK-1 study, and actually just at the KCRS (Kidney Cancer Research Summit), we saw the unveiling of the eVOLVE-RCC trial, which is going to be looking at a volrustomig, which is a PD-1/CTLA-4 inhibitor plus casdatifan compared to nivo-ipi in the frontline setting.  So, we're going to see some competition in this space of the HIF2α inhibitors. I think when we think of mechanism of action in that these are very potent, not a lot of off-target activity, and they target a driver mutation in the disease. And that driver mutation happens very early in the pathogenesis. These are going to be positioned much earlier in the treatment landscape. Dr. Pedro Barata: All these studies, as you're saying, look really promising. And when we talk about them, you mentioned a lot of combinations. And to me, when I think of these agents, it makes a lot of sense to combine because there's not a lot of overlapping toxicities, if you will. But perhaps for some of our listeners, who have not used HIF2α inhibitors in practice yet, and they might be thinking about that, what can you tell us about the safety profile? How do you present it to your patients, and how do you handle things like hypoxia or anemia? How do you walk through the safety profile and tolerability profile of those agents like belzutifan? Dr. Rana McKay: I think these drugs are very different than your traditional TKIs, and they don't cause the classic symptoms that are associated with traditional TKIs that many of us are very familiar with like the rash, hand-foot syndrome, hypertension, diarrhea. And honestly, these are very nuanced symptoms that patients really struggle with the chronicity of being on a chronic daily TKI. The three key side effects that I warn patients about with HIF2α inhibitors are: (1) fatigue; (2) anemia; and (3) hypoxia and dysregulation in the ability to sense oxygen levels. And so, many of these side effects - actually, all of them - are very dose-dependent. They can be very well-managed. So, we can start off with the anemia. I think it's critically important before you even start somebody on belzutifan that you are optimizing their hemoglobin and bone marrow function. Make sure they don't have an underlying iron deficiency anemia. Make sure they don't have B12 or folate deficiency. Check for these parameters. Many patients who have kidney cancer may have some hematuria, other things where there could be some low-level blood loss. So, make sure that those are resolved or you're at least addressing them and supplementing people appropriately. I monitor anemia very closely every 3 to 4 weeks, at least, when people start on these medications. And I do initiate EPO, erythropoietin, should the anemia start to worsen. And I typically use a threshold of around 10g/dL  for implementing utilization of an EPO agent, and that's been done very safely in the context of the early studies and phase 3 studies as well. Now, with regards to the hypoxia, I think it's also important to make sure that you're selecting the appropriate individual for this treatment. People who have underlying COPD, or even those individuals who have just a very high burden of disease in their lung, lymphangitic spread, pleural effusions, maybe they're already on oxygen - that's not an ideal candidate for belzutifan. Something that very easily can be done in the clinic before you think about initiating somebody on this treatment, and has certainly been integrated into some of the trials, is just a 6-minute walk test. You know, have the patient walk around the clinic with one of the MAs, one of the nurses, put the O2 sat on [measuring oxygen saturation], make sure they're doing okay. But these side effects, like I said, are very dose-dependent. Typically, if a patient requires, if the symptoms are severe, the therapy can be discontinued and dose reduced. The standing dose is 120 mg daily, and there's two dose reductions to 80 mg and 40 mg should somebody warrant that dose modification. Dr. Pedro Barata: This is relatively new, right? Like, it was not that we're used to checking oxygen levels, right? In general, we're treating these patients, so I certainly think there's a learning curve there, and some of the points that you highlight are truly critical. And I do share many of those as well in our practice. Since I have you, I want to make sure we touch base on antibody-drug conjugates as well. It's also been a hot area, a lot of developments there. When I think of urothelial carcinoma and renal cell carcinoma, I see it a little bit different. I think perhaps in urothelial carcinoma, antibody-drug conjugates, or ADCs, are somewhat established already. You already mentioned enfortumab vedotin. I might ask you to expand a little bit on that. And then in renal cell carcinoma, we have some ADCs as well that you include in your chapter, and that I would like you to tell us what's coming from that perspective. So, tell us a little bit about how do you see ADCs in general for GU tumors, particularly UC and RCC? Tell us a little bit about the complexity or perhaps the challenges you still see. At the same time, tell us about the successes. Dr. Rana McKay: Stepping back, let's just talk about like the principles and design of ADCs. So, most ADCs have three components. There's a monoclonal antibody that typically targets a cell surface antigen, which is conjugated by a linker, which is the second component, to a payload drug. And typically, that payload drug has been chemotherapy, whether it be topoisomerase or whether it be MMAE or other chemotherapeutic. We can start in the RCC space. There's been multiple antibody-drug conjugates that have been tested. There's antibody-drug conjugates to CD70, which is expressed on clear cell RCC. There's been antibody-drug conjugates to ENPP3, which is also expressed on RCC. There's antibody-drug conjugates to CDH6. And they have different payloads, like I said, whether it be topoisomerase I or other microtubule inhibitors. Now, when we think about kidney cancer, we don't treat this disease with chemotherapy. This disease is treated with immunotherapy. It is treated with treatments that target the VEGF pathway and historically has not been sensitive to chemo. So, I think even though the targets have been very exciting, we've seen very underwhelming data regarding activity, and in some context, seen increased toxicity with the ADCs. So, I think we need to tread lightly in the context of the integration and the testing of ADCs in RCC. We just came back from the KCRS meeting, and there was some very intriguing data about a c-Kit ADC that's being developed for chromophobe RCC, which is, you know, a huge unmet need, these variant tumors that really lack appropriate therapeutics. But I just caution us to tread lightly around how can we optimize the payload to make sure that the tumor that we're treating is actually sensitive to the agent that's targeting the cell kill. So, that's a little bit on the ADCs in RCC. I still think we have a long way to go and still in early testing. Now, ADCs for UC are now the standard of care. I think the prototypical agent, enfortumab vedotin, is a nectin-4-directed ADC that's conjugated to an MMAE payload and was the first ADC approved for advanced urothelial, received accelerated approval following the EV-201 trial, which was basically a multicenter, single-arm study that was investigating EV in cisplatin-ineligible patients with advanced urothelial carcinoma, and then ultimately confirmed in the EV-301 study as well. And so, that study ended up demonstrating the support superiority of EV from an overall survival standpoint, even PFS standpoint. Building on that backbone is the EV-302 study, which tested EV in combination with pembrolizumab versus platinum-based chemotherapy in the frontline setting. And that was a pivotal, landmark study that, like I said, has displaced platinum therapy as a frontline treatment for people with advanced urothelial carcinoma. And when we think about that study and the median overall survival and just how far we've come in urothelial cancer, the median OS with EV-pembro from that trial was 31 and a half months. I mean, that's just incredible. The control arm survival was 16 and a half months. The hazard ratio for OS, 0.47. I mean this is why when this data was presented, it was literally a standing ovation that lasted for several minutes because we just haven't seen data that have looked that good. And there are other antibody-drug conjugates that are being tested. We've all been involved in the saga with sacituzumab govitecan, which is a trophoblast cell surface antigen 2 (Trop-2) targeted ADC with a topoisomerase I payload. It was the second ADC to receive approval, but then that approval was subsequently withdrawn when the confirmatory phase 3 was negative, the TROPiCS-04 trial. So, approval was granted based off of the TROPHY-U-01, single-arm, phase 2 study, demonstrating a response rate of around 28% and a PFS of, you know, about 5 and a half months. But then failure to show any benefit from an OS standpoint. And I think there's a lot of controversy in the field around whether this agent still has a role in advanced urothelial carcinoma. And I think particularly for individuals who do not have molecular targets, like they're not HER2-amplified or have HER2-positivity or FGFR or other things like that. Dr. Pedro Barata: Fantastic summary, Rana. You were talking about the EV, and it came to mind that it might not be over, right, for the number of ADCs we use in clinical practice in the near future. I mean, we've seen very promising data for ADC against the HER2, right, and over-expression. It also can create some challenges, right, in the clinics because we're asking to test for HER2 expression. It's almost like, it's not exactly the same to do it in breast cancer, but it looks one more time that we're a little bit behind the breast cancer field in a lot of angles. And also has vedotin as a payload. Of course, I'm referring to disitamab vedotin, and there's very elegant data described by you in your review chapter as well. And it's going to be very interesting to see how we sequence the different ADCs, to your point as well. So, before we wrap it up, I just want to give you the opportunity to tell us if there's any area that we have not touched, any take-home points you'd like to bring up for our listeners before we call it a day. Dr. Rana McKay: Thank you so much. I have to say, you know, I was so excited at ASCO this year looking at the GU program. It was fantastic to see the progress being made, novel therapeutics that really there's a tremendous excitement about, not just in RCC and in UC, but also in prostate cancer, thinking about the integration of therapies, not just for people with refractory disease that, even though our goal is to improve survival, our likelihood of cure is low, but also thinking about how do we integrate these therapies early in the treatment landscape to enhance cure rates for patients, which is just really spectacular. We're seeing many of these agents move into the perioperative setting or in combination with radiation for localized disease. And then the special symposium on biomarkers, I mean, we've really come a long, long way. And I think that we're going to continue to evolve over the next several years. I'm super excited about where the field is going in the treatment of genitourinary malignancies. Dr. Pedro Barata: Oh, absolutely true. And I would say within the Annual Meeting, we have outstanding Educational Sessions. And just a reminder to the listeners that actually that's where the different teams or topics for the Educational Book chapters come from, from actually the educational sessions from ASCO. And your fantastic chapter is an example of that, right, focusing on advanced GU tumors. So, thank you so much, Rana, for taking the time, sharing your insights with us today on the podcast. It was a fantastic conversation as always. Dr. Rana McKay: My pleasure. Thanks so much for having me, Dr. Barata. Dr. Pedro Barata: Of course.  And thank you to our listeners for your time today. You will find the link to the article discussed today in the transcript of this episode. I also encourage you to check out the 2025 ASCO Educational Book. You'll find an incredible wealth of information there. It's free, available online, and you'll find, hopefully, super, super important information on the key science and issues that are shaping modern oncology, as we've heard from Dr. McKay and many other outstanding authors. So, thank you, everyone, and I hope to see you soon. 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. Pedro Barata @PBarataMD Dr. Rana McKay @DrRanaMcKay Follow ASCO on social media:        @ASCO on X (formerly Twitter)        ASCO on Bluesky       ASCO on Facebook        ASCO on LinkedIn        Disclosures:     Dr. Pedro Barata: Stock and Other Ownership Interests: Luminate Medical Honoraria: UroToday Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Merck, Ipson, Astellas Medivation, Novartis, Dendreon Speakers' Bureau: AstraZeneca, Merck, Caris Life Sciences, Bayer, Pfizer/Astellas Research Funding (Inst.): Exelixis, Blue Earth, AVEO, Pfizer, Merck  Dr. Rana McKay: Consulting or Advisory Role: Janssen, Novartis, Tempus, Pfizer, Astellas Medivation, Dendreon, Bayer, Sanofi, Vividion, Calithera, Caris Life Sciences, Sorrento Therapeutics, AVEO, Seattle Genetics, Telix, Eli Lilly, Blue Earth Diagnostics, Ambrx, Sumitomo Pharma Oncology, Esiai, NeoMorph, Arcus Biosciences, Daiichi Sankyo, Exelixis, Bristol Myers Squibb, Merck, Astrazeneca, Myovant Research Funding (Inst.): Bayer, Tempus, AstraZeneca, Exelixis, Bristol Myers Squibb, Oncternal Therapeutics, Artera    

For the first time, Donald Trump publicly questioned Operation Warp Speed and mRNA shots during the pandemic. “Many people think they are a miracle that saved Millions of lives. Others disagree!” writes the President. “I hope OPERATION WARP SPEED was as “BRILLIANT” as many say it was. If not, we all want to know about it, and why???” “To date I have seen no evidence that any manufacturer of these magic potions consistently produces what they claim they produce,” says Sasha Latypova. Sasha Latypova is a retired pharma R&D executive with 25 years of experience. She managed contract research organizations, working with over 60 pharma companies, including Pfizer and Novartis. She specialized in cardiovascular safety and interacted with the FDA. Follow at https://x.com/sasha_latypova⠀Chloe Carmichael, Ph.D., is a clinical psychologist and USA Today bestselling author. She serves on the Women's Health Magazine Advisory Board and is a fellow at the Independent Women's Forum. She authored “Can I Say That?” and “Nervous Energy.” Learn more at https://drchloe.com 「 SUPPORT OUR SPONSORS 」 Find out more about the brands that make this show possible and get special discounts on Dr. Drew's favorite products at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://drdrew.com/sponsors⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠  ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠• FATTY15 – The future of essential fatty acids is here! Strengthen your cells against age-related breakdown with Fatty15. Get 15% off a 90-day Starter Kit Subscription at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://drdrew.com/fatty15⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ • PALEOVALLEY - "Paleovalley has a wide variety of extraordinary products that are both healthful and delicious,” says Dr. Drew. "I am a huge fan of this brand and know you'll love it too!” Get 15% off your first order at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://drdrew.com/paleovalley⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ • VSHREDMD – Formulated by Dr. Drew: The Science of Cellular Health + World-Class Training Programs, Premium Content, and 1-1 Training with Certified V Shred Coaches! More at https://drdrew.com/vshredmd • THE WELLNESS COMPANY - Counteract harmful spike proteins with TWC's Signature Series Spike Support Formula containing nattokinase and selenium. Learn more about TWC's supplements at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://twc.health/drew⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ 「 MEDICAL NOTE 」 Portions of this program may examine countervailing views on important medical issues. Always consult your physician before making any decisions about your health. 「 ABOUT THE SHOW 」 Ask Dr. Drew is produced by Kaleb Nation (⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://kalebnation.com⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠) and Susan Pinsky (⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://twitter.com/firstladyoflov⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠e⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠). This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. Learn more about your ad choices. Visit megaphone.fm/adchoices

Unser Partner Scalable Capital ist der einzige Broker, den du brauchst. Inklusive Trading-Flatrate, Zinsen und Portfolio-Analysen. Alle weiteren Infos gibt's hier: scalable.capital/oaws. Aktien + Whatsapp = Hier anmelden. Lieber als Newsletter? Geht auch. Das Buch zum Podcast? Jetzt lesen. Der Kalender zum Podcast? Jetzt kaufen. Figma & Salesforce mit eher schwachen Zahlen. Alphabet mit Chips. Macy's und Campbell feiern Legenden-Comeback. Novartis macht China-Deal. Alphabet ist auf einmal großer KI-Profiteur. Denn wegen KI muss es Chrome nicht verkaufen und darf Apple Milliarden zahlen. Wir erklären die Hintergründe. In Boom-Zeiten soll man in die Schaufelverkäufer investieren. Aber wer verdient mit denen, die im Boom reich geworden sind? In der Kryptowelt könnten das Lindblad Expeditions (WKN: A14WKW) oder Mandarin Oriental (WKN: 872956) sein. Apropos reich: Südkoreaner kaufen Bitmine statt Tesla. Die Trump-Familie verkauft den World Liberty Financial Coin. Und sie gehen mit American Bitcoin an die Börse. Diesen Podcast vom 04.09.2025, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novartis has increased its commitment to its partnership with Argo BioPharma by an additional $5.2 billion, focusing on RNAi agreements targeting cardiovascular diseases. This highlights the ongoing advancements and challenges in the biopharmaceutical industry. Biotechs are turning to special purpose acquisition companies (SPACs) as a way to go public amid the IPO freeze. Gene therapy, with its potential to cure deadly diseases, is still facing challenges in terms of insurance coverage in the U.S. The industry is seeing a shift with some of the biggest biotech SPACs from the 2021 bubble no longer on the market. Meanwhile, Cytokinetics' cardiac myosin inhibitor, aficamten, has shown promising results in a phase III study for patients with obstructive hypertrophic cardiomyopathy. RFK Jr. has announced plans to reorganize chronic disease programs in the US to address high COVID-19 death rates. Companies like Novartis and Arrowhead are making significant commitments to various programs, while Trump's efforts to shore up the pharma supply chain with U.S. API are being questioned. Novartis continues its cutting spree with layoffs in New Jersey.These developments shed light on the evolving landscape of the biopharmaceutical industry.

Addressing Swallowing Difficulties and Nutritional Deficiencies in MS - Episode 190 Swallowing issues and nutrition changes are common in MS but often overlooked. Host Stephanie Buxhoeveden is joined by speech-language pathologist Dr. Corinne Jones and dietitian Carla Cos to explore how MS affects eating—and what you can do about it. Learn practical strategies to stay safe, eat well, and adapt to changing symptoms without giving up the joy of food. Thank you to the generous support of our sponsors of this podcast episode, including Kathleen C Moore Foundation, Genentech, and Novartis. Disclaimer: This podcast provides general educational information. Can Do MS does not endorse, promote, or recommend any product or service associated with the content of this program.   Additional Resources: National Foundation of Swallowing Disorders IDDSI - International Dysphagia Diet Standardization Initiative

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo Nordisk's drug Wegovy has successfully reduced cardiovascular risk by 57% compared to tirzepatide. Eli Lilly has terminated two mid-stage trials for a second obesity asset, while Vertex Pharmaceuticals and Enlaza Therapeutics have formed a potential $2 billion partnership to develop drugs for autoimmune diseases. Biogen and Eisai have received FDA approval for the subcutaneous maintenance formulation of Leqvembi. Arrowhead Pharmaceuticals has secured a commitment of up to $2 billion from Novartis for an siRNA Parkinson's program. The FDA's new radiopharma guidance is expected to accelerate the space, and Teva has launched the first generic version of Novo Nordisk's obesity drug Saxenda. The pharmaceutical industry is navigating uncertainty during turbulent times, with companies focusing on innovation and new partnerships to drive progress.The FDA has issued new radiopharma guidance, which former FDA Commissioner Stephen Hahn believes is crucial for cancer therapy. Despite recent investments in radiopharmaceutical therapeutics by big pharma, the FDA's approval of updated COVID-19 vaccines with restrictions contradicts the medical freedom promised by health secretary Robert F. Kennedy Jr. Rare diseases secured four FDA firsts in August, including a win for Novo Nordisk's glp-1 drug WeGovy. Investment in new ALS therapies signals progress after setbacks, with new biotechs and collaborative initiatives showing promise at Bio2025. Other news includes the closure of Appia, Senate summons of Kennedy, updates on COVID-19 vaccines, and Lilly's obesity pill heading to the FDA. Thank you for listening to Pharma and Biotech daily.

Are you ready for some football?The 2025 NFL season kicks off this week with the defending champion Philadelphia Eagles hosting the Dallas Cowboys on Thursday night.The highest linear TV ratings are usually delivered by live sports broadcasts and no entity is a more reliable generator for eyeballs than the NFL.It should then come as no surprise that drugmakers want to intensify their relationship with the league.Take, for example, Novartis was named the first-ever corporate pharmaceutical partner of the NFL in March.The announcement came one month after the Swiss pharma giant ran its first Super Bowl ad to raise awareness for breast cancer.While Novartis receives top billing as the lead pharma sponsor for the NFL, there are other health brands pursuing opportunities with players and franchises across the league.This week, we're joined by Stacia Garner, VP of marketing at Edwards Lifesciences, to discuss the company's partnership with the Los Angeles Rams to raise awareness of heart valve failure.-TRENDSAnd for our Trends segment, we welcome back Steven Madden to MM+M and dive into the ongoing turmoil at the CDC.  Music: “Deep Reflection” by DP and Triple Scoop Music. Step into the future of health media at the MM+M Media Summit on October 30th, 2025 live in NYC! Join top voices in pharma marketing for a full day of forward-thinking discussions on AI, streaming, retail media, and more. Explore the latest in omnichannel strategy, personalization, media trust, and data privacy—all under one roof. Don't wait—use promo code PODCAST for $100 off your individual ticket. Click here to register! AI Deciphered is back—live in New York City this November 13th.Join leaders from brands, agencies, and platforms for a future-focused conversation on how AI is transforming media, marketing, and the retail experience. Ready to future-proof your strategy? Secure your spot now at aidecipheredsummit.com. Use code POD at check out for $100 your ticket! Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music.

We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex's new pact with Enlaza for autoimmune disease—which the Casgevy maker hopes could ease conditioning for the sickle cell/beta thalassemia gene therapy—and Novartis' agreement with Arrowhead for neurodegenerative diseases such as Parkinson's.  But as we look ahead, Thursday's Senate Finance Committee will be the focus this week, as Health and Human Services Secretary Robert F. Kennedy Jr. will answer questions after the ousting of CDC Director Susan Monarez. Her departure is reportedly linked to changes to the regulation of COVID-19 vaccines, for which the FDA last week issued restricted approvals to Moderna, Pfizer/BioNTech and Novavax and rescinded the emergency use authorizations. The next ACIP meeting—where COVID-19 vaccines will be on the agenda—is set for Sept. 18 and 19.   In the weight loss arena, Novo Nordisk presented results from a real-world study this weekend at the European Society of Cardiology Congress in Madrid showing that Wegovy cut the risk of heart attack, stroke or death by 57% compared to Eli Lilly's tirzepatide in people with obesity and cardiovascular disease. The company also continues to throw money into the space, last week inking a $550 million deal with Replicate for RNA-based treatments for obesity and diabetes. Meanwhile, Lilly is dropping studies of one oral obesity candidate as another nears a regulatory filing. Finally, the FDA greenlit the first GLP-1 generic for obesity.   We also discuss reactions to the FDA's new guidance on radiopharma drug development, four recent approvals for rare diseases, and everything you ever wanted to know about SPACs. 

In a world where marketing agencies are racing to keep up with rapid change, how do you grow faster without losing your people, your culture, or your edge? In this episode of Leader Generation, Mod Op's new COO, Stuart Goldstein, joins Tessa Burg to share his playbook for scaling agencies. With years of experience leading firms through mergers, digital transformations, and process overhauls, Stuart reveals why the real challenge isn't the technology or the tools—it's bringing people along for the ride. Listeners will get an inside look at why Mod Op is uniting specialized agencies under one platform to offer clients deep expertise without the coordination headaches of managing multiple vendors. Listeners will get an inside look at why Mod Op is uniting specialized agencies under one platform, how to turn skeptics into champions, and the leadership moves that make change stick. From integrating AI across disciplines to avoiding the “shiny object” trap, he offers candid advice and relatable stories that apply to any leader facing transformation. This conversation delivers practical ways to align people, processes, and platforms—to keep your team motivated and your clients happy. Leader Generation is hosted by Tessa Burg and brought to you by Mod Op.  About Stuart Goldstein: As an experienced operations leader with over 20 years of success, Stuart can captain any ship. From start-up to heavyweight, Stuart has helped agencies and organizations pave their path to greatness. His expertise has been instrumental in driving growth and fame for renowned clients such as Johnson & Johnson, Oreo, Coca-Cola, American Express, Novartis, Diageo, eBay, GlaxoSmithKline, Time Warner, and Marvel, among others. And somehow, he still finds a way to drop a joke and take life one day at a time as long as it fits the brief. About Tessa Burg: Tessa is the Chief Technology Officer at Mod Op and Host of the Leader Generation podcast. She has led both technology and marketing teams for 15+ years. Tessa initiated and now leads Mod Op's AI/ML Pilot Team, AI Council and Innovation Pipeline. She started her career in IT and development before following her love for data and strategy into digital marketing. Tessa has held roles on both the consulting and client sides of the business for domestic and international brands, including American Greetings, Amazon, Nestlé, Anlene, Moen and many more. Tessa can be reached on LinkedIn or at Tessa.Burg@ModOp.com.  

Shea Belsky shares his top do's and don'ts for managing neurodiversity in the workplace.— YOU'LL LEARN — 1) Why neurodivergency is unavoidable at work2) The unique strengths and struggles of autistic people3) When and how to discuss neurodiversity at workSubscribe or visit AwesomeAtYourJob.com/ep1087 for clickable versions of the links below. — ABOUT SHEA — Shea Belsky is an autistic self-advocate. He is a Tech Lead II at HubSpot, and the former Chief Technology Officer of Mentra. Having been the manager of neurodivergent & neurotypical employees, he brings many unique perspectives on neurodiversity in the workplace. Shea has championed neurodiversity for organizations like Novartis, the Kennedy Krieger Institute, Northeastern University, in addition to being featured in Forbes and the New York Post.• LinkedIn: Shea Belsky• Podcast: Autistic Techie• Website: SheaBelsky.com— RESOURCES MENTIONED IN THE SHOW — • Book: Radical Candor: Be a Kick-Ass Boss Without Losing Your Humanity by Kim Scott• Past episode: 150: Expressing Radical Candor with Kim Scott• Past episode: 860: The Science of Compelling Body Language with Richard Newman• Past episode: 1049: What Dyslexia Can Teach Us About Creativity, Problem Solving, and Critical Thinking with Kate Griggs• Past episode: 1070: An ADHD Strategist's Pro Tips for Staying Motivated and Productive When You Can't Focus with Skye Waterson• Past episode: 1085: How to Find More Fun at Work Every Day with Bree Groff— THANK YOU SPONSORS! — • Strawberry.me. Claim your $50 credit and build momentum in your career with Strawberry.me/Awesome• LinkedIn Jobs. Post your job for free at linkedin.com/beawesome• Quince. Get free shipping and 365-day returns on your order with Quince.com/Awesome• Square. See how Square can transform your business by visiting Square.com/go/awesomeSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

US-Präsident Trump will tiefere Medikamentenpreise und droht mit Zöllen. Nutzen Roche, Novartis und Co. den US-Markt aus? Und, warum fällt es der Branche so schwer Preise zu senken, angesichts der hohen Gewinne und Gehälter? Kritische Fragen an Interpharma-Geschäftsführer René Buholzer. Ergänzend zum Tagesgespräch finden Sie jeden Samstag in unserem Kanal die aktuelle Samstagsrundschau. Die Schweizer Pharma-Industrie steht gleich unter mehrfachem Druck aus den USA: einerseits soll sie die Preise senken für Medikamente in den USA und vermehrt im Land produzieren. Die Industrie hat Milliardeninvestitionen angekündigt, doch dem US-Präsidenten reicht das nicht. Bis Ende September soll die Industrie darlegen, wie sie die Medikamentenpreise, die teilweise ein Mehrfaches über denjenigen in Europa inklusive der Schweiz liegen, senken will. Gelingt das nicht drohen der Branche hohe Zölle. Die Hälfte aller Schweizer Pharma-Exporte gehen in die USA. Wie konnte die Branche so abhängig werden von einem Markt? Warum soll es trotz der hohen Margen im Geschäft nicht möglich sein, die Preise in den USA zu senken, ohne sie in Europa anzuheben? Was hat die Schweiz von Roche, Novartis und Co. tatsächlich? Und, nutzt die Branche die aktuelle Situation, um alte Forderungen nach weniger Regulierung durchzubringen? René Buholzer, der Chef von Interpharma, dem Verband der forschenden Pharmafirmen in der Schweiz, nimmt Stellung in der Samstagsrundschau bei Klaus Ammann.

Send us a textJennifer Garvey Berger designs and teaches leadership programs, coaches senior leaders and their teams, and supports new ways of thinking about strategy and people. In her four highly acclaimed books, Unleash Your Complexity Genius (co-authored with Carolyn Coughlin), Unlocking Leadership Mindtraps, Simple Habits for Complex Times (co-authored with Keith Johnston), and Changing on the Job, Jennifer builds on deep theoretical knowledge to offer practical ways to make leaders' organizations more successful, their work more meaningful, and their lives more gratifying. Jennifer has worked with senior leaders in the private, non-profit, and government sectors worldwide (like Novartis, Google, KPMG, Intel, Microsoft, Wikimedia, and the New Zealand Department of Conservation).Jennifer is a co-founder and CEO of Cultivating Leadership. She has a masters and a doctorate from Harvard University. Formerly an associate professor at George Mason University, Jennifer learned about deep change more than a decade ago when she turned down the tenure offer and moved to a small seaside village in New Zealand with her husband, two kids, and the family dog. While she still considers herself a Kiwi by choice, you can find her in the French countryside, where she has bought a house with eleven friends who live in community and try to keep the dog from terrifying the cats.A Quote From This Episode“My job is to admire that meaning system and hold space for that meaning system to grow a little bit. My job is not to fix it…”Resources Mentioned in This Episode 

As summer winds down and September approaches, many people with asthma notice their symptoms getting worse. This is no coincidence as more asthma triggers appear during this time of year, from pollen and viruses to stress and weather changes. This combination peaks during Asthma Peak Week, a time when asthma attacks and ER visits spike across the country. Allergist Dr. Kristin Sokol joins us to discuss seasonal asthma triggers, why fall can be especially risky, and how you can prepare to keep your asthma under control. You'll learn how to identify your personal triggers, steps to reduce your exposure, and why staying consistent with your medication routine is critical. We also cover tools like an asthma action plan, preparing for school, and making sure caregivers and teachers know how to respond to an asthma flare. What we cover in our episode about managing asthma triggers during the fall: Understanding asthma: learn why even mild asthma should be reviewed before the fall. Identifying triggers: from indoor allergens to seasonal pollen and surprising emotional triggers, know what can set off your asthma. Preparing for Asthma Peak Week: discover how viruses, ragweed pollen, and stress combine into a dangerous flare period and how to get ahead of it. Staying in control: strategies to avoid or reduce asthma trigger exposure, prepare for school, and keep your asthma action plan up to date. Supporting everyone with asthma: special considerations for adults, caregivers, and teachers to stay healthy and ready year-round. More episodes about asthma Ep. 81: Why asthma attacks rise in September peak week Ep. 58: What is controlled Asthma? - Everything you need to know! Ep. 117: As-Needed Albuterol–Budesonide in Mild Asthma (BATURA Trial) Made in partnership with The Allergy & Asthma Network. Thanks to Novartis for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

As AI continues to reshape everything from medicine to flight decks, the question isn't whether it's coming to your organization; it's whether leaders are ready for it.  The future belongs to executives who can blend critical thinking with adaptive leadership, who can shed old assumptions and operate ahead of the curve.  According to psychologist and organizational strategist Eric Olson, the most crucial skill for tomorrow's leaders is resilience rooted in clarity, connection, and courageous action. What's driving this leadership revolution isn't just digital disruption; it's cognitive disruption. Across industries, AI is exposing the limits of traditional thinking and highlighting the cost of bias, rigidity, and ego-driven leadership. In this high-stakes environment, emotional intelligence, adaptability, and mission-first thinking are no longer soft skills; they're survival tools. Eric Olson, PhD, is the founder of EMO Advisors and a trusted advisor to leaders at Microsoft, Hawaiian Airlines, Ford, and Spirit Airlines. In this episode, we unpack the emerging playbook for 21st-century leadership, from the cockpit to the boardroom.  You'll hear how elite teams regulate for excellence, and what over 1,000 pilots revealed about what makes teams thrive under pressure.  You'll also learn: Why past performance fails in AI-disrupted environments, and what to assess instead The surprising truth about pilot personalities  How Microsoft is reengineering its executive ranks to lead in an AI-first world What the Norwegian Sovereign Fund did to eliminate bias and boost performance Why effective leaders must press pause during crises to regain clarity How self-regulation and cross-functional trust reduce catastrophic errors in high-stakes teams The hidden costs of amygdala-driven leadership, and how to train for resilience How Delta Airlines is using AI to extract more wallet share, and why that's just the beginning The “Olson Resilience Model” that Fortune 50 teams use to perform under pressure   Guest Bio Eric Olson, PhD, is the founder of EMO Advisors. He develops leaders and management teams to improve business performance through a growth mindset. He builds resilience with senior teams using strategic planning offsites, culture change, innovation labs, team coaching, and other methods. Eric's client list includes Microsoft, Hawaiian Airlines, Ford, GitHub, IBM, The Coca-Cola Company, Disney, and Novartis, among many others. He works in the digital transformation space (Cloud + AI, mixed reality, engineering, UX, devices, etc.). Eric coaches leaders to build highly engaging cultures through a blend of financial, organizational, and psychological insights. Connect with Eric on LinkedIn.  About Your Host Craig Picken is an Executive Recruiter, writer, speaker and ICF Trained Executive Coach. He is focused on recruiting senior-level leadership, sales, and operations executives in the aviation and aerospace industry. His clients include premier OEMs, aircraft operators, leasing/financial organizations, and Maintenance/Repair/Overhaul (MRO) providers and since 2008, he has personally concluded more than 400 executive-level searches in a variety of disciplines. Craig is the ONLY industry executive recruiter who has professionally flown airplanes, sold airplanes, and successfully run a P&L in the aviation industry. His professional career started with a passion for airplanes. After eight years' experience as a decorated Naval Flight Officer – with more than 100 combat missions, 2,000 hours of flight time, and 325 aircraft carrier landings – Craig sought challenges in business aviation, where he spent more than 7 years in sales with both Gulfstream Aircraft and Bombardier Business Aircraft. Craig is also a sought-after industry speaker who has presented at Corporate Jet Investor, International Aviation Women's Association, and SOCAL Aviation Association.    Check out this episode on our website, Apple Podcasts, or Spotify, and don't forget to leave a review if you like what you heard. Your review feeds the algorithm so our show reaches more people. Thank you! 

Host: Emer Joyce Guest: Tim Chico Want to watch that extended interview on smartwatch, heart rate and ECG? Go to: https://esc365.escardio.org/event/1811?resource=interview Want to watch that episode? Go to: https://esc365.escardio.org/event/1811   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, 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. Tim Chico has declared to have potential conflicts of interest to report: research funding from Google. 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.

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 8, 2025. In this episode: Trump ups pressure on MFN pricing; Pfizer says pharma working with Trump on direct sales; Sanofi says direct sales worth considering: Aurigene Oncology CEO on biotech valuations and more; and Novartis progresses pipeline-in-a-product assets. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RCXSH2B5EVCC3IIK35GXUSNZVA/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things