Podcasts about Jazz Pharmaceuticals

You asked, we answered! Well, actually Janet Greenwood answered! On this first episode of a special two-part feature, Greg sits down with epilepsy hero Janet Greenwood of Keck Medicine of USC. Janet is a Physician's Assistant for the epilepsy doctors at Keck, and she just so happens to be the primary clinician overseeing the care of Greg's son Jake for many years, so they have a wonderful history together. In this two-part episode, Greg asks Janet a series of FAQ's about epilepsy, from living with epilepsy, to being a caregiver, to treatment options. They cover a LOT of ground in these episodes, so be sure to get out a pen and take some notes! You won't want to miss what Janet has to say. Talk About It with Greg Grunberg is excited to be sponsored by Neurelis and by Jazz Pharmaceuticals.

Dr. John Sweetenham and Dr. Erika Hamilton highlight key abstracts that were presented at ASCO25, including advances in breast and pancreatic cancers as well as remarkable data from the use of structured exercise programs in cancer care. Transcript Dr. Sweetenham: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. John Sweetenham. Today, we'll be discussing some of the key advances and novel approaches in cancer care that were presented at the 2025 ASCO Annual Meeting. I'm delighted to be joined again by the chair of the Meeting's Scientific Program, Dr. Erika Hamilton. She is a medical oncologist and director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute in Nashville, Tennessee.  Our full disclosures are available in the transcript of this episode. Dr. Hamilton, congratulations on a fantastic meeting. From the practice-changing science to the world-renowned speakers at this year's Meeting, ASCO25 really reflected the amazing progress we're seeing in oncology today and the enormous opportunities that lie ahead of us. And thanks for coming back on to the podcast today to discuss some of these advances. Dr. Hamilton: Thanks, Dr. Sweetenham. I'm happy to join you today. It really was an impactful ASCO Annual Meeting. I probably am biased, but some great research was presented this year, and I heard lots of great conversations happening while we were there. Dr. Sweetenham: Yeah, absolutely. There was a lot of buzz, as well as a lot of media buzz around the meeting this year, and I think that's probably a good place to start. So I'd like to dive into abstract number LBA3510. This was the CHALLENGE trial, which created a lot of buzz at the meeting and subsequently in the media. This is the study that was led by the NCI Canada Clinical Trials Group, which was the first randomized phase 3 trial in patients with stage III and high-risk stage II colon cancer, which demonstrated that a post-treatment structured exercise program is both feasible and effective in improving disease-free survival in this patient group. The study was performed over a long period of time and in many respects is quite remarkable. So, I wonder if you could give us your thoughts about this study and whether you think that this means that our futures are going to be full of structured exercise programs for those patients who may benefit. Dr. Hamilton: It's a fantastic question. I think that this abstract did create a lot of buzz. We were very excited when we read it. It was highlighted in one of the Clinical Science Symposium sessions. But briefly, this was a phase 3 randomized trial. It was conducted at 55 centers, so really a broad experience, and patients that had resected colon cancer who completed adjuvant therapy were allowed to participate. There were essentially 2 groups: a structured exercise program, called ‘the exercise group,' or health education materials alone, so that was called just ‘the health education group.' And this was a 3-year intervention, so very high quality. The primary end point, as you mentioned, was disease-free survival. This actually accrued from 2009 to 2024, so quite a lift, and almost 900 patients underwent randomization to the exercise group or the health education group. And at almost 8 years of follow-up, we saw that the disease-free survival was significantly longer in the exercise group than the health education group. This was essentially 80.3% of patients were disease-free in exercise and 73.9% in the health education group. So a difference of over 6 percentage points, which, you know, at least in the breast cancer world, we make decisions about whether to do chemotherapy or not based on these kind of data. We also looked at overall survival in the exercise group and health education group, and the 8-year overall survival was 90.3% in the exercise group and 83.2% in the health education group. So this was a difference of 7.1%. Still statistically significant. I think this was really a fantastic effort over more than a decade at over 50 institutions with almost 900 patients, really done in a very systematic, high-intervention way that showed a fantastic result. Absolutely generalizable for patients with colon cancer. We have hints in other cancers that this is beneficial, and frankly, for our patients for other comorbidities, such as cardiovascular, etc., I really think that this is an abstract that deserved the press that it received. Dr. Sweetenham: Yeah, absolutely, and it is going to be very interesting, I think, over the next 2 or 3 years to see how much impact this particular study might have on programs across the country and across the world actually, in terms of what they do in this kind of adjuvant setting for structured exercise. Dr. Hamilton: Absolutely.  So let's move on to Abstract 3006. This was an NCI-led effort comparing genomic testing using ctDNA and tissue from patients with less common cancers who were enrolled in but not eligible for a treatment arm of the NCI-MATCH trial. Tell us about your takeaways from this study. Dr. Sweetenham: Yeah, so I thought this was a really interesting study based, as you said, on NCI-MATCH. And many of the listeners will probably remember that the original NCI-MATCH study screened almost 6,000 patients to assess eligibility for those who had an actionable mutation. And it turned out that about 60% of the patients who went on to the study had less common tumors, which were defined as anything other than colon, rectum, breast, non–small cell lung cancer, or prostate cancer. And most of those patients lacked an eligible mutation of interest and so didn't get onto a trial therapy. But with a great deal of foresight, the study group had actually collected plasma samples from these patients so that they would have the opportunity to look at circulating tumor DNA profiles with the potential being that this might be another way for testing for clinically relevant mutations in some of these less common cancer types. So initially, they tested more than 2,000 patients, and to make a somewhat complicated story short, there was a subset of five histologies with a larger representation in terms of sample size. And these were cholangiocarcinoma, small cell lung cancer, esophageal cancer, pancreatic, and salivary gland cancer. And in those particular tumors, when they compared the ctDNA sequencing with the original tumor, there was a concordance there of around 84%, 85%. And in the presentation, the investigators go on to list the specific mutated genes that were identified in each of those tumors. But I think that the other compelling part of this study from my perspective was not just that concordance, which suggests that there's an opportunity there for the use of ctDNA instead of tumor biopsies in some of these situations, but what was also interesting was the fact that there were several clinically relevant mutations which were detected only in the circulating tumor DNA. And a couple of examples of those included IDH1 for cholangiocarcinoma, BRAF and p53 in several histologies, and microsatellite instability was most prevalent in small cell lung cancer in the ctDNA. So I think that what this demonstrates is that liquid biopsy is certainly a viable screening option for patients who are being assessed for matching for targeted therapies in clinical trials. The fact that some of these mutations were only seen in the ctDNA and not in the primary tumor specimen certainly suggests that there's some tumor heterogeneity. But I think that for me, the most compelling part of this study was the fact that many of these mutations were only picked up in the plasma. And so, as the authors concluded, they believe that a comprehensive gene profiling with circulating tumor DNA probably should be included as a primary screening modality in future trials of targeted therapy of this type. Dr. Hamilton: Yeah, I think that that's really interesting and mirrors a lot of data that we've been seeing. At least in breast cancer, you know, we still do a biopsy up front to make sure that our markers, we're still treating the right disease that we think we are. But it really speaks to the utility of using ctDNA for serial monitoring and the emergence of mutations. Dr. Sweetenham: Absolutely. And you mentioned breast cancer, and so I'd like to dwell on that for a moment here because obviously, there was a huge amount of exciting breast cancer data presented at the meeting this year. And in particular, I'd like to ask you about LBA1008, the DESTINY-Breast09 clinical trial, which I think has the potential to establish a new first-line standard of care for metastatic HER2+ breast cancer. And that's an area where we haven't seen a whole lot of innovation for around a decade now. So can you give us some of the highlights of this trial and what your thinking is, having seen the results? Dr. Hamilton: Yeah, absolutely. So this was a trial in the first-line metastatic HER2 setting. So this was looking at trastuzumab deruxtecan. We certainly have had no shortage of reports around this drug, initially approved for later lines. DESTINY-Breast03 brought it into our second-line setting for HER2+ disease and we're now looking at DESTINY-Breast09 in first-line. So this actually was a 3-arm trial where patients were randomized 1:1:1 against standard taxane/trastuzumab/pertuzumab in one arm; trastuzumab deruxtecan with pertuzumab in another arm; and then a third arm, trastuzumab deruxtecan alone. And what we did not see reported was that trastuzumab deruxtecan-alone arm. But we did have reports from the trastuzumab deruxtecan plus pertuzumab versus the chemo/trastuzumab/pertuzumab. And what we saw was a statistically significant improvement in median progression-free survival, 26.9 months up to 40.7, so an improvement of 13.8 months, over a year in PFS. Not to mention that we're now in the 40-month range for PFS in first-line disease. Really, across all subgroups, we really weren't able to pick out a subset of patients that did not benefit. We did see about a 12% ILD rate with trastuzumab deruxtecan. That really is on par with what we've seen in other studies, around 10%-15%. I think that this is going to become a new standard of care in the first-line. I think it did leave some unanswered questions. We saw some data from the PATINA trial this past San Antonio Breast, looking at the addition of endocrine therapy with or without a CDK4/6 inhibitor, palbociclib, for those patients that also have ER+ disease, after taxane has dropped out in the first-line setting. So how we're going to kind of merge all this together is, I suspect that there are going to be patients that we or they just don't have the appetite to continue 3 to 4 years of trastuzumab deruxtecan. And so we're probably going to be looking at a maintenance-type strategy for them, maybe integrating the PATINA data there. But how we really put this into practice in the first-line setting and if or when we think about de-escalating down from trastuzumab deruxtecan to antibody therapy are some lingering questions. Dr. Sweetenham: Okay, so certainly is going to influence practice, but watch this space for a little bit longer, it sounds as though that's what you're saying. Dr. Hamilton: Absolutely.  So let's move on to GI cancer. Abstract 4006 reported preliminary results from the randomized phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel versus the chemo gemcitabine/nab-paclitaxel alone in patients with previously untreated metastatic pancreatic cancer. Can you tell us more about this study? Dr. Sweetenham: Yeah, absolutely. As you mentioned, elraglusib is actually a first-in-class inhibitor of GSK3-beta, which has multiple potential actions in pancreatic cancer. But the drug itself may be involved in mediating drug resistance as well as in some tumor immune response modulation. Some of that's not clearly understood, I believe, right now. But certainly, preclinical data suggests that the drug may be effective in preclinical models and may also be effective in combination with chemotherapy and potentially with immune-modulating agents as well. So this particular study, as you said, was an open-label, randomized phase 2 study in which patients with pancreatic cancer were randomized 2:1 in favor of the elraglusib plus GMP—gemcitabine and nab-paclitaxel—versus the chemotherapy alone. And upon completion of the study, which is not right now, median overall survival was the primary end point, but there are a number of other end points which I'll talk about in just a moment. But the sample size was planned to be around 207 patients. The primary analysis included 155 patients in the combination arm versus 78 patients in the gemcitabine/nab-paclitaxel arm. Overall, the 1-year overall survival rate was 44.1% for the patients in the elraglusib-containing arm versus 23.0% in the patients receiving gemcitabine/nab-paclitaxel only. When they look at the median overall survival, it was 9.3 months for the experimental arm versus 7.2 months for chemotherapy alone. So put another way, there's around a 37% reduction in the risk of death with the use of this combination arm. The treatment was overall well-tolerated. There were some issues with grade 1 to 2 transient visual impairment in a large proportion of the patients. The most common treatment-related adverse effects with the elraglusib/GMP combination was transient visual impairment, which affected around 60% of the patients. Most of the more serious treatment-related adverse events included neutropenia, anemia, and fatigue in 50%, 25%, and 16% of the patients, respectively. So the early results from this study show a significant benefit for 1-year overall survival and for median overall survival with, as I mentioned above, a significant reduction in the risk of death. The authors went on to mention that the median overall survival for the control arm in this study is somewhat lower than in other comparable trials, but they think that this may be related to a more advanced disease burden in this particular study. Of interest to me was that right now: there is no apparent difference in progression-free survival between the 2 arms of this study. The authors described this as potentially indicating that this may be related in some way to immune modulation and immune effects on the tumor, which, if I'm completely honest, I don't totally understand. And so, the improvement in overall survival, as far as I can see at the moment, is not matched by an improvement in progression-free survival. So I think we probably need to wait for more time to elapse to see what happens with the study. And so, I think it certainly is an interesting study, and the results are intriguing, but I think it's probably a little early for it to actually shift the treatment paradigm in this disease. Dr. Hamilton: Fantastic. I think we've been waiting for advances in pancreatic cancer for a long time, but this, not unlike others, we learn more and then learn more we don't realize, so. Dr. Sweetenham: Right. Let's shift gears at this point and talk about a couple of other abstracts in kind of a very different space. Let's start out with symptom management for older adults with cancer. We know that undertreated symptoms are common among the older patient population, and Abstract 11002 reported on a randomized trial that demonstrated the effects of remote monitoring for older patients with cancer in terms of kind of symptoms and so on. Can you tell us a little bit about this study and whether you think this approach will potentially improve care for older patients? Dr. Hamilton: Yeah, I really liked this abstract. It was conducted through the Veterans Affairs, and it was based in California, which I'm telling you that because it's going to have a little bit of an implication later on. But essentially, adults that were 75 years or older who were Medicare Advantage beneficiaries were eligible to participate. Forty-three clinics in Southern California and Arizona, and patients were randomized either into a control group of usual clinic care alone, or an intervention group, which was usual care plus a lay health worker-led proactive telephone-based weekly symptom assessment, and this was for 12 months using the validated Edmonton Symptom Assessment System. So, there was a planned enrollment of at least 200 patients in each group. They successfully met that. And this lay health worker reviewed assessments with a physician assistant, who conducted follow-up for symptoms that changed by 2 points from a prior assessment or were rated 4 or greater. So almost a triage system to figure out who needed to be reached out to and to kind of work on symptoms. What I thought was fantastic about this was it was very representative of where it enrolled. There were actually about 50% of patients enrolled here that were Hispanic or Latinos. So some of our underserved populations and really across a wide variety of tumor types. They found that the intervention group had 53% lower odds of emergency room use, 68% lower odds of hospital use than the control group. And when they translated this to actual total cost of care, this was a savings of about $12,000 U.S. per participant and 75% lower odds of a death in an acute care facility. So I thought this was really interesting for a variety of reasons. One, certainly health care utilization and cost, but even more so, I think any of our patients would want to prevent hospitalizations and ER visits. Normally, that's not a fantastic experience having to feel poorly enough that you're in the emergency room or the hospital. And really showing in kind of concrete metrics that we were able to decrease this with this intervention. In terms of sustainability and scalability, I think the question is really the workforce to do this. Obviously, you know, this is going to take dedicated employees to have the ability to reach out to these patients, etc., but I think in value-based care, there's definitely a possibility of having reimbursement and having the funds to institute a program like this. So, definitely thought-provoking, and I hope it leads to more interventions. Dr. Sweetenham: Yeah, we've seen, over several years now, many of these studies which have looked at remote symptom monitoring and so on in this patient population, and many of them do show benefits for that in kinds of end points, not the least in this study being hospitalization and emergency room avoidance. But I think the scalability and personnel issue is a huge one, and I do wonder at some level whether we may see some AI-based platforms coming along that could actually help with this and provide interactions with these patients outside of actual real people, or at least in combination with real people. Dr. Hamilton: Yeah, that's a fantastic point.  So let's talk a little bit about clinical trials. So eligibility assessment for oncology clinical trials, or prescreening, really relies on manual review of unstructured clinical notes. It's time-consuming, it's prone to errors, and Abstract 1508 reported on the final analysis of a randomized trial that looked at the effect of human-AI teams prescreening for clinical trial eligibility versus human-only or AI-only prescreening. So give us more good news about AI. What did the study find? Dr. Sweetenham: Yeah, this is a really, a really interesting study. And of course, any of us who have ever been involved in clinical trials will know that accrual is always a problem. And I think most centers have attempted, and some quite successfully managed to develop prescreening programs so that patients are screened by a health care provider or health care worker prior to being seen in the clinic, and the clinical investigator will then already know whether they're going to be eligible for a trial or not. But as you've already said, it's a slow process. It's typically somewhat inefficient and requires a lot of time on the part of the health care workers to actually do this in a successful way. And so, this was a study from Emory University where they took three models of ways in which they could assess the accuracy of the prescreening of charts for patients who are going to be considered for clinical trials. One of these was essentially the regular way of having two research coordinators physically abstract the charts. The second one was an AI platform which would extract longitudinal EHR data. And then the third one was a combination of the two. So the AI would be augmented by the research coordinator or the other way around. As a gold standard, they had three independent oncology reviewers who went through all of these charts to provide what they regarded as being the benchmark for accuracy. In a way, it's not a surprise to me because I think that a number of other systems which have used this combination of human verification of AI-based tools, it actually ultimately concluded that the combination of the two in terms of chart accuracy was for the most part better than either one individually, either the research coordinator or the AI alone. So I'll give you just a few examples of where specifically that mattered. The human plus AI platform was more accurate in terms of tumor staging, in terms of identifying biomarker testing and biomarker results, as well as biomarker interpretation, and was also superior in terms of listing medications. There are one or two other areas where either the AI alone was somewhat more accurate, but the significant differences were very much in favor of a combination of human + AI screening of these patient charts. So, in full disclosure, this didn't save time, but what the authors reported was that there were definite efficiency gains, and presumably this would actually become even more improved once the research coordinators were somewhat more comfortable and at home with the AI tool. So, I thought it was an interesting way of trying to enhance clinical trial accrual up front by this combination of humans and technology, and I think it's going to be interesting to see if this gets adopted at other centers in the future. Dr. Hamilton: Yeah, I think it's really fascinating, all the different places that we can be using AI, and I love the takeaway that AI and humans together are better than either individually. Dr. Sweetenham: Absolutely.  Thanks once again, Dr. Hamilton, for sharing your insights with us today and for all of the incredible work you did to build a robust program. And also, congratulations on what was, I think, a really remarkable ASCO this year, one of the most exciting for some time, I think. So thank you again for that. Dr. Hamilton: Thanks so much. It was really a pleasure to work on ASCO 2025 this year. Dr. Sweetenham: And thank you to our listeners for joining us today. You'll find links to all the abstracts we discussed today in the transcript of this episode. Be sure to catch up on all of our coverage from the Annual Meeting. You can catch up on my daily reports that were published each day of the Annual Meeting, featuring the key science and innovations presented. And we'll have wrap-up episodes publishing in June, covering the full spectrum of malignancies from ASCO25. If you value the insights you hear on the ASCO Daily News Podcast, please remember to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   More on today's speakers: Dr. John Sweetenham   Dr. Erika Hamilton @erikahamilton9   Follow ASCO on social media:  @ASCO on Twitter  ASCO on Bluesky  ASCO on Facebook   ASCO on LinkedIn     Disclosures:     Dr. John Sweetenham:     No relationships to disclose    Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson   Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics

In this episode of Talk About It, actor/ comedian/ influencer and good friend of the show Stanzi Potenza returns to talk about something that can cause both celebration and disappointment alike... milestones. Everybody naturally loves to celebrate milestones. They can motivate us to keep pushing or show us that our progress is leading to positive outcomes, whether they are for an addiction that you have overcome, professional progress, even time between seizures. But are they designed by default to lead us to disappointment when we don't reach the next one? In the case of seizures, there is inevitability that a breakthrough seizure may - and will - occur, so is this really a healthy thing for patients or caregivers to do? Greg chats with Stanzi, because she recently posted that she had her first seizure in almost two years, which lead to some feelings of disappointment. The call she has to make to her mom, telling her followers about it, even coming out of a postictal state and realizing what has just happened. It can be discouraging when your pride and self-fulfillment is attached to not having seizures. So what is the right thing to do? Greg also has another friend of the show, Jonathan Shapiro, on to briefly give some hopeful perspective about reframing how we think about milestones. This is something we all deal with, so you do not want to miss this episode! Talk About It with Greg Grunberg is excited to be sponsored by Neurelis and by Jazz Pharmaceuticals.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Roche and Jazz Pharmaceuticals presented data at ASCO showing that their drug combination improved survival in a phase III lung cancer trial, with analysts noting a strong treatment effect. Jazz has filed for FDA approval for the combination, which could provide an alternative to monotherapy treatments from Roche and AstraZeneca. Trump's tariffs could potentially endanger the rare disease space, according to industry experts. Other news includes Kymera's success with a protein degrader candidate, Amgen's IMDelltra boosting survival in small cell lung cancer, and concerns about the impact of FDA guidelines on nitrosamine testing. BioAgilytix will be at BIO International to discuss their drug production capabilities. Other news includes Kura's new data in acute myeloid leukemia, Keros' layoffs, Regeneron's investment in a Chinese obesity drug, and Sanofi's acquisition of Blueprint to expand their rare disease portfolio. Upcoming events include webinars on AI in life science R&D and the crisis facing the pharma industry. Job opportunities in clinical data management, regulatory affairs, and scientific roles are also highlighted.

The words of the week so far in biopharma are “deals” and “cancer”—or, more specifically, money being invested in cancer and other key therapeutic areas. With the American Society of Clinical Oncology's annual conference underway in Chicago, Bristol Myers Squibb got in the PD-1/PD-L1xVEGF game, paying potentially more than $11 billion to co-develop BioNTech's solid tumor bispecific BNT327. Elsewhere, Sanofi nabbed the year's second-biggest buyout, picking up Blueprint for $9.5 billion, expanding its rare disease portfolio. And Regeneron plunked down up to $2 billion to license a dual GLP-1/GIP receptor agonist from Chinese biopharma Hansoh Pharmaceuticals Group.  Back in Chicago, presentations by AstraZeneca, Gilead and Amgen drew rave reviews from investor analysts, while Pfizer and Arvinas elaborated on mixed data from a PROTAC that showed positive results in only a subsection of breast cancer patients, failing to impress Wall Street. Meanwhile, Bicara's solid survival stats in head and neck cancer weren't enough to clear the high bar set by rival Merus. At the meeting, BioSpace's own Dan Samorodnitsky sat down with Jazz Pharmaceuticals' CMO Rob Iannone to discuss the company's recently acquired pediatric glioma drug, and talked AI strategy with AstraZeneca's head of U.S. oncology for lung cancer Arun Krishna. Dan recaps his ASCO experience here.  Speaking of buzzy therapeutic spaces, there was more action on the vaccines front last week as Health and Human Services Secretary RFK Jr. announced that healthy children and healthy pregnant women would no longer be advised to get vaccinated against COVID-19. However, as of publication, the CDC still recommends a COVID vaccine for healthy children but instead of a universal recommendation advises that the decision should be made between parents and healthcare providers. Against this backdrop, the FDA signed off on Moderna's next-gen COVID-19 vaccine, mNEXSPIKE, for a limited population in line with its new guidelines. This was a much-needed win for Moderna, which last week had a $760 million-plus government contract for its mRNA-based bird flu vaccine terminated.  Also on the policy front, the Trump administration released its Make America Healthy Again report last week to much scrutiny after reports found studies and references that did not exist.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Regeneron's shares have dropped due to the failure of their dupixent follow-up drug, while Sanofi has acquired Blueprint for $9.5 billion to expand their rare disease portfolio. Bristol Myers Squibb is collaborating with Biontech on a bispecific antibody for solid tumors, and Amgen's imdelltra has shown a 40% increase in survival for small cell lung cancer at ASCO. Moderna has received FDA approval for their next-gen COVID-19 vaccine, and AstraZeneca is partnering with AI companies to stop cancer at all stages. Keros has cut 45% of its workforce along with a pulmonary hypertension drug, and Jazz has presented new cancer data at ASCO. FDA actions are pending for companies like Merck, Gilead, and Regeneron/Sanofi.The implications of the overturning of the FDA's lab-developed tests rule in a post-Chevron legal landscape are discussed, where power has shifted from federal agencies to the courts. Upcoming FDA decisions, including Gilead's HIV prophylaxis lenacapavir, are highlighted, along with new FDA guidelines on nitrosamine testing for the pharmaceutical industry. Jazz Pharmaceuticals is in the "goldilocks zone" with new cancer data at ASCO25, showcasing results from acquisitions made over the past five years. Zeiss introduces an AI-powered spatial biology solution for research labs. Other news includes updates from ASCO25, cell and gene therapy developments, and upcoming events in the biopharma industry.

Continuing our series on the Heroes of Epilepsy, Greg has his long-time friend Dr. Barry Gidal to talk about all things pharmaceutical on this episode! Dr. Gidal is a Professor of Pharmacy and past Chair of the Pharmacy Practice Division at the University of Wisconsin-Madison. Dr. Gidal talks about taking mystery and anxiety out of your experience with medicine and about talking with your pharmacist. They discuss the importance of checking your medications and journaling, differences between generic drugs, developments that Dr. Gidal is excited about, and so much more! This episode is not a tough pill to swallow, so don't miss it! Talk About It with Greg Grunberg is excited to be sponsored by Neurelis and by Jazz Pharmaceuticals 

On this episode of Talk About It, we break out the Gold Jacket to chat with Alan Faneca, retired NFL offensive lineman and NFL Hall of Fame Inductee! Alan and Greg have become friends through advocacy for epilepsy awareness over the years, because Alan was diagnosed with epilepsy when he was a teenager and played at the highest levels of football with the condition. He also has a daughter with a rare form of epilepsy, so this cause is really close to his heart. Ironically, Nick also has a connection to Alan through his time with the Pittsburgh Steelers and hosting events together, so this is really a friend reunion show! They discuss his diagnosis, how his family helps him deal with the condition, going through the process again with his daughter, and - of course - his induction into the NFL Hall of Fame in Canton, OH. This is an episode that you are seriously not going to want to miss! The Talk About It podcast is excited to be sponsored in part by Neurelis. The Talk About It podcast is excited to also be sponsored in part by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

Dr. John Sweetenham and Dr. Erika Hamilton discuss top abstracts that will be presented at the 2025 ASCO Annual Meeting, including research on tech innovations that could shape the future of oncology. Transcript Dr. John Sweetenham: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. John Sweetenham, and I'm delighted to be joined today by Dr. Erika Hamilton, a medical oncologist and director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute in Nashville, Tennessee. Dr. Hamilton is also the chair of the 2025 ASCO Annual Meeting Scientific Program, and she's here to tell us about some of the key abstracts, hot topics, and novel approaches in cancer care that will be featured at this year's Annual Meeting. Our full disclosures are available in the transcript of this episode. Dr. Hamilton, it's great to have you on the podcast today, and thanks so much for being here. Dr. Erika Hamilton: Thanks, Dr. Sweetenham. I'm glad to be here. Dr. John Sweetenham: Dr. Hamilton, the Presidential Theme of the Annual Meeting this year is ‘Driving Knowledge to Action: Building a Better Future,' and that's reflected in many of the sessions that will focus on action-oriented guidance to improve care for our patients. And as always, there'll be great presentations on practice-changing abstracts that will change treatment paradigms and transform care. Can you tell us about some of the hot topics this year and what you're particularly excited about? Dr. Erika Hamilton: You're right. Dr. Robin Zon's theme is ‘Driving Knowledge to Action: Building a Better Future,' and you're going to see that theme really interlaced throughout the ASCO program this year. We had a record number of submissions. Over 5,000 abstracts will be published, and there'll be about 3,000 presentations, either in oral format or poster presentations. We have 200 dynamic sessions. Many of the discussants will be highlighting key takeaways and how we can translate action-oriented guidance to better treat our patients to build a better future. Our state-of-the-art science will include a Plenary Session. This will feature presentations as well as discussion of each of the presentations for clinical late-breaking abstracts. We have Clinical Science Symposia that I'm particularly excited about this year. These will feature key abstracts as well as discussions and a foundational talk around the subject. We're covering novel antibody-drug conjugate targets, turning “cold” tumors “hot” to include CAR T, as well as the future of cancer detection. There'll be rapid oral abstracts, case-based panels, and this will also feature interactive audience polling and case discussions. I also want to highlight the community connection opportunities. There will be 13 Communities of Practice that will be meeting on-site during ASCO, and there's also really a plethora of networking opportunities for trainees and early-career professionals, a Women's Networking Center, a patient advocate space, and I'm happy to report there will also be live music out on the terrace this year at ASCO. Dr. John Sweetenham: Well, that's going to be a really great addition. I have to say, I think this is always a special time of year because excitement starts to mount as the meeting gets closer and closer. And once the abstracts are out there, I certainly personally feel that the excitement builds. Talking of abstracts, let's dive into some of the key abstracts for this year's meeting. I'd like to start out by asking you about Abstract 505. This reports on 15-year outcomes for women with premenopausal hormone receptor-positive early breast cancer in the SOFT and TEXT trials. It assesses the benefits of adjuvant exemestane and ovarian function suppression or tamoxifen and ovarian function suppression. So, could you talk us through this and tell us what you think the key takeaways from this abstract are? Dr. Erika Hamilton: Absolutely. This is essentially the SOFT and TEXT trials. They are trials that we've been following for quite some time, evidenced by the 15-year outcome. And I think it really answers two very important questions for us regarding adjuvant endocrine therapy for patients that are facing hormone receptor-positive disease. The benefit of ovarian function suppression for one, and then second, the benefit of exemestane over tamoxifen, which is our SERM [selective estrogen receptor modulator]. So, in terms of the SOFT trial, when we talk about distance recurrence-free interval, which I really think is probably the most meaningful because secondary cancers, et cetera, are not really what we're getting at here. But in terms of distant recurrence-free interval, certainly with tamoxifen, using tamoxifen plus ovarian function suppression adds a little bit. But where we really get additional benefits are by moving to exemestane, an aromatase inhibitor with the ovarian function suppression. So, for example, in SOFT, for distant recurrence-free interval for patients that have received prior chemotherapy, the distance recurrence-free interval was 73.5% with tamoxifen, bumped up just a tiny bit to 73.8% with ovarian function suppression. But when we used both ovarian function suppression and switched to that aromatase inhibitor, we're now talking about 77.6%. It may seem like these are small numbers, but when we talk about an absolute benefit of 4%, these are the type of decisions that we decide whether to offer chemotherapy based on. So, really just optimizing endocrine therapy really can provide additional benefits for these patients. Just briefly, when we turn to TEXT, similarly, when we look at distance recurrence-free interval for our patients that are at highest risk and receive chemotherapy, tamoxifen and ovarian function suppression, 79%; 81% with exemestane and ovarian function suppression. And when we talk about our patients that did not receive chemotherapy, it increased from 91.6% up to 94.6%—very similar that 3% to 4% number. So, I think that this is just very important information when counseling our patients about the decisions that they're going to make for themselves in the adjuvant setting and how much we want to optimize endocrine therapy. Dr. John Sweetenham: Thanks so much for your insight into that. Dr. Erika Hamilton: Yeah, absolutely. So, let's turn to hematologic malignancies. Abstract 6506 reports exciting results on the new agent ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukemia. This is a phase 1b clinical activity study and safety results. This was the pivotal KOMET-001 study. And my question is, will this new agent fulfill an unmet need in this NPM1 space? Dr. John Sweetenham: Yeah, great question. And I think the answer is almost certainly ‘yes'. So, just as some brief background, NPM1 mutation is known to be a driver of leukemogenesis in around 30% of patients with AML, and it's a poor prognostic factor. And typically, about 50% of these patients will relapse within a year of their first-line therapy, and only around 10% of them will get a subsequent complete remission with salvage therapy. Menin inhibitors, which disrupt the interaction between menin and KMT2A, are known to be active in NPM1-mutated as well as in KMT2A-rearranged AML. And ziftomenib is a selective oral menin inhibitor, which in this study was evaluated at a dose of 600 mg once a day, as you mentioned, a phase 1b/2 study, which is multicenter and presented by Dr. Eunice Wang from Roswell Park. It's a relatively large study of 112 patients who were treated with this standard dose with relatively short median follow-up at this time. The median age was 69 years, and median prior therapies were two, but with a range of one to seven. And I think very importantly, 60% of these patients had previously been treated with venetoclax, and 23% of them had had a prior transplant. Looking at the results overall for this study, the overall response rate was 35%, which is actually quite impressive. Specifically for those patients in the phase 2 part of the study, around 23% achieved a CR [complete remission] or CRh [complete remission with partial hematologic recovery]. What's very interesting in my mind is that the response rates were comparable in venetoclax-naive and venetoclax-exposed patients. And the drug was very well tolerated, with only 3% of patients having to discontinue because of treatment-related adverse events. And I think the authors appropriately conclude that, first of all, the phase 2 primary endpoint in the study was met, and that ziftomenib achieved deep and durable responses in relapsed and refractory NPM1-mutated AML, regardless of prior venetoclax, with good tolerance of the drug. And so, I think putting all of this together, undoubtedly, these data do support the potential use of this agent as monotherapy and as a new option for those patients who have relapsed or refractory NPM1-mutated acute myeloid leukemia. So, let's move on a little bit more now and change the subject and change gears completely and talk about circulating tumor DNA [ctDNA]. This has been a hot topic over a number of years now, and at this year's meeting, there are quite a few impactful studies on the use of ctDNA. We have time to focus on just one of these, and I wanted to get your thoughts on Abstract 4503. This is from the NIAGARA trial, which looks at ctDNA in patients with muscle-invasive bladder cancer who receive perioperative durvalumab. Could you tell us a little bit about this study? Dr. Erika Hamilton: So, this was the phase 3 NIAGARA trial, and this is literally looking for patients with muscle-invasive bladder cancer that are cisplatin-eligible, and the addition of durvalumab to neoadjuvant chemotherapy. So here, this is a planned exploratory analysis of ctDNA and the association with clinical outcomes from NIAGARA. So, this is really the type of study that helps us determine which of our patients are more likely to have a good outcome and which of our patients are more likely not to. There were 1,000 randomized patients in this study, and 462 comprised the biomarker-evaluable population. There were about half in the control arm and half in the durvalumab arm. And overall, the ctDNA-positive rate at baseline was about 57%, or a little over half, and that had decreased to about 22% after neoadjuvant treatment. ctDNA clearance rates from baseline to pre-radical cystectomy was about 41% among those with durvalumab and 31% among those in control. And the non-pCR rate was 97% among patients with pre-cystectomy ctDNA-positive status. So, this really gives us some information about predicting who is going to have better outcomes here. We did see a disease-free survival benefit with perioperative durvalumab, and this was observed in post-cystectomy ctDNA-positive as well as the ctDNA-negative groups. Shifting gears now to GI cancer, Abstract 3506 is a long-term safety and efficacy study of sotorasib plus panitumumab and FOLFIRI for previously treated KRAS G12C-mutated metastatic colorectal cancer. And this is the CodeBreaK-101 study. What are your thoughts on this study? Dr. John Sweetenham: Yeah, thanks. A very interesting study, and this abstract builds upon the phase 3 CodeBreaK-300 trial, which I think has just been published in the Journal of Clinical Oncology. This showed that the combination of sotorasib and panitumumab improved clinical outcomes in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer. The current abstract, as you mentioned, reports the CodeBreaK-101 trial. And this was a phase 1b trial where FOLFIRI therapy was added to sotorasib and panitumumab in previously treated patients with KRAS G12C-mutated metastatic colorectal cancer. The abstract reports the overall and progression-free survival results, as well as some updated safety and response data. So, in this study, patients with this particular mutation who had received at least one prior systemic treatment but were KRAS G12C inhibitor-naive were enrolled into an expansion cohort of the CodeBreaK-101 protocol. And these patients received what apparently now recommended as the standard phase 2 dose of sotorasib of 960 mg daily, plus panitumumab and a standard dose of FOLFIRI. And the primary endpoint of the study was safety, and secondary endpoints included confirmed response, overall response, and progression-free survival, as assessed by the investigator. And by November of last year, 40 patients had been enrolled into this study. Common treatment-related adverse events were cutaneous; some patients developed neutropenia, and stomatitis was fairly widespread. Discontinuation of sotorasib because of adverse events was only seen in 1% of patients, although patients did have to discontinue because of toxicity from some of the other agents in the combination. Looking at the results of this study, the updated objective response rate was 57.5%, and the disease control rate was estimated at 92%, going on 93%, with a median time to response of 1.6 months and a median response duration of 6 months. After a median follow-up of 29.2 months, the median progression-free survival was 8.2 months, and the overall survival 17.9 months. So, the authors have concluded that this combination, including sotorasib, panitumumab, and FOLFIRI, does appear to show quite promising long-term efficacy in pretreated patients with this specific mutation. The ongoing phase 3 study they mentioned, CodeBreaK-301, is aiming to evaluate this combination against the standard of care in the first-line setting for patients with KRAS G12C-mutated colorectal cancer. So, promising results, and we'd be very interested to see how this particular combination performs in the frontline. Dr. Erika Hamilton: Fantastic. Thanks so much for sharing that. Let's shift gears again and really talk about digital technology. I feel that we're all going to have to get much better with this, and really, there are a lot of promises for our patients coming here. There are a lot of abstracts at ASCO that are focusing on innovations in digital technology, including a really interesting psychosocial digital application for caregivers of patients that are undergoing hematopoietic stem cell transplantation. Can you tell us a little bit about this? It's Abstract 11000. Dr. John Sweetenham: Yeah, absolutely. This abstract certainly caught my eye, and I think it's intriguing for a number of reasons, partly because it's app-based, and partly also because it specifically addresses caregiver burden and caregiver needs in the oncology setting, which I think is especially important. And although the context, the clinical context of this study, is hematopoietic stem cell transplantation, I think it has potential applications way beyond that. We all know that caregivers of patients undergoing stem cell transplantation have significant quality-of-life struggles. They are well-documented to have significant psychological and emotional strain before, during, and after stem cell transplantation. And this abstract describes an application called BMT-CARE, which is aimed at improving caregivers' quality of life, caregiver burden, mood symptoms, and coping skills, and so on. So, this was a single-center, randomized trial from MGH [Massachusetts General Hospital] of this app for stem cell transplant caregivers, compared with usual care in those individuals. And the eligible patients, or eligible individuals, were adults caring for patients with heme malignancy undergoing either an autologous or an allogeneic stem cell transplant. Patients were randomly assigned either to use the app or for usual care. And the app itself—and I think it'll be interesting to actually see this at the meeting and visualize it and see how user-friendly and so on it is—but it comprises five modules, which integrate psychoeducation, behavior change, stress management, and they're delivered through a kind of interactive platform of educational games and videos. And then participants were self-reporting at baseline and then 60 days after transplant. So, around 125 patients were enrolled in this study, of around 174 who were initially approached. So, just over 70% uptake from caregivers, which is, I think, relatively high, and evenly distributed between the two randomized arms. And the majority of the participants were spouses. And at 60 days post-stem cell transplant, the intervention participants reported a better quality of life compared with those who received usual care. If you break this down a little bit more, these participants reported lower caregiving burden, lower incidence of depression, fewer PTSD symptoms, and overall better coping skills. So, the authors conclude that this particular app, a digital health intervention, led to pretty substantial improvements in quality of life for these caregivers. So, intriguing. As I said, it'll be particularly interesting to see how this thing looks during the meeting. But if these kind of results can be reproduced, I think this sort of application has potential uses way beyond the stem cell transplant setting. Dr. Erika Hamilton: Yeah, I find that just so fascinating and very needed. I think that the caregiving role is often underestimated in how important that is for the patient and the whole family, and really giving our caregivers more tools in their toolbox certainly is quite helpful. Dr. John Sweetenham: Absolutely. Well, the meeting is getting closer, and as I mentioned earlier, I think anticipation is mounting. And I wanted to say thanks so much to you for chatting with me today about some of the interesting advances in oncology that we're going to see at this year's meeting. There is a great deal more to come. Our listeners can access links to the studies we've discussed today in the transcript of this episode. I'm also looking forward, Dr. Hamilton, to having you back on the podcast after the Annual Meeting to dive into some of the late-breaking abstracts and some of the other key science that's captured the headlines this year. So, thanks once again for joining me today. Dr. Erika Hamilton: Thanks so much for having me. Pleasure. Dr. John Sweetenham: And thank you to our listeners for joining us today. Be sure to catch my “Top Takeaways from ASCO25.” These are short episodes that will drop each day of the meeting at 5:30 p.m. Eastern Time. So, subscribe to the ASCO Daily News Podcast wherever you prefer to listen, and join me for concise analyses of the meeting's key abstracts.   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.   More on today's speakers: Dr. John Sweetenham   Dr. Erika Hamilton @erikahamilton9   Follow ASCO on social media:  @ASCO on Twitter  ASCO on Bluesky  ASCO on Facebook   ASCO on LinkedIn     Disclosures:     Dr. John Sweetenham:     No relationships to disclose  Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson   Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics

Jazz Pharmaceuticals, Inc. v. Robert F. Kennedy Jr.

In V.E. Shwab's bestselling novel, A Conjuring of Light, she wrote, "Kings need not raise their voices to be heard." But on this episode of Talk About It, Greg talks to a King who is being heard not by raising his voice, but by writing a book of his own! That book is called Be There When I Return, and it is out NOW everywhere books are sold. Michael King seemed to have everything going his way as a young bartender in 1980's Los Angeles until his friends began to notice a bizarre quirk in his behavior, but he is not aware of it happening. After the closest people in his life convince him to see a doctor, he is hit with the reality of an epilepsy diagnosis and drags through years of not being able to control his seizures. He ends up becoming a candidate for an experimental surgery, but his family doesn't know if he will remember them when he wakes up. We'll let Michael fill in the rest of this story, but you don't want to miss this episode!  The Talk About It podcast is excited to be sponsored in part by Neurelis. The Talk About It podcast is excited to also be sponsored in part by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

Welcome to another episode of the Oncology Brothers podcast! In this episode, Drs. Rohit and Rahul Gosain, both practicing community medical oncologists, continue their discussion on HER2-positive biliary tract cancer. They are joined by Dr. Shubham Pant from MD Anderson, who shares his expertise on this rapidly evolving field. In this episode, we cover: •⁠  ⁠The importance of HER2 testing in biliary tract cancers, including intrahepatic and extrahepatic cholangiocarcinomas and gallbladder cancers. •⁠  ⁠Who should be tested for HER2 positivity and how to classify HER2-positive disease. •⁠  ⁠The role of next-generation sequencing (NGS) and immunohistochemistry (IHC) in determining HER2 status. •⁠  ⁠Current treatment options for HER2-positive biliary tract cancer, including the latest clinical trials and approved therapies like trastuzumab deruxtecan and zanidatamab. •⁠  ⁠The significance of patient-centered decision-making and managing side effects associated with these treatments. •⁠  ⁠Insights into the potential for brain metastases in biliary tract cancer and the importance of ongoing surveillance. Join us as we delve into the latest data and strategies for managing HER2-positive biliary tract cancer, and stay tuned for our next episode where we will discuss side effects and management of these therapies. Accreditation/Credit Designation Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians' Education Resource®, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Acknowledgment of Commercial Support This activity is supported by an educational grant from Jazz Pharmaceuticals, Inc. Link to gain CME credits from this activity: https://www.gotoper.com/courses/from-bench-to-bedside-paradigm-shifts-in-her2-metastatic-btc-treatment Follow us on social media: •⁠  ⁠X/Twitter: https://twitter.com/oncbrothers •⁠  ⁠Instagram: https://www.instagram.com/oncbrothers •⁠  Website: https://oncbrothers.com/ Don't forget to like, subscribe, and hit the notification bell for more updates from the Oncology Brothers!

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Ananda Pharma Plc finance director Jeremy Sturgess-Smith talked with Proactive's Stephen Gunnion about the appointment of Chris Tovey as a strategic advisor. Tovey brings significant experience from his time as chief operating officer at GW Pharmaceuticals and later Jazz Pharmaceuticals. According to Sturgess-Smith: “He's going to bring all that experience to Ananda,” helping guide the company through its regulatory path and corporate development. Sturgess-Smith also touched on Ananda securing ethics approval to begin its first human trial of MRX1, a key milestone for the company's therapeutic pipeline. He noted this was the first ethics approval of its kind for any Ananda trial, with recruitment expected to begin shortly in Australia. “It's very, very exciting to have that ethics approval in the bag,” he said. Looking ahead, the company also expects ethics approvals for studies into chemotherapy-induced peripheral neuropathy and endometriosis in the next six months. For more interviews and updates, visit Proactive's YouTube channel. Don't forget to like this video, subscribe, and hit the notification bell to stay informed.** #AnandaPharma #MRX1Trial #ClinicalTrials #CannabinoidMedicine #BiotechNews #PharmaceuticalInnovation #EthicsApproval #GWPharma #DrugDevelopment #Epidiolex #HealthInnovation #ProactiveInvestors

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD information, and to apply for credit, please visit us at PeerView.com/EEJ865. CME/NCPD credit will be available until April 19, 2026.A Roadmap for Managing Post-HCT VOD/SOS: Team-Based Guidance on Capturing, Assessing, and Managing Diverse Presentations[JAC_Logo] In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical education grant from Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD information, and to apply for credit, please visit us at PeerView.com/EEJ865. CME/NCPD credit will be available until April 19, 2026.A Roadmap for Managing Post-HCT VOD/SOS: Team-Based Guidance on Capturing, Assessing, and Managing Diverse Presentations[JAC_Logo] In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical education grant from Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD information, and to apply for credit, please visit us at PeerView.com/EEJ865. CME/NCPD credit will be available until April 19, 2026.A Roadmap for Managing Post-HCT VOD/SOS: Team-Based Guidance on Capturing, Assessing, and Managing Diverse Presentations[JAC_Logo] In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical education grant from Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/NCPD information, and to apply for credit, please visit us at PeerView.com/EEJ865. CME/NCPD credit will be available until April 19, 2026.A Roadmap for Managing Post-HCT VOD/SOS: Team-Based Guidance on Capturing, Assessing, and Managing Diverse Presentations[JAC_Logo] In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an independent medical education grant from Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This major social media influencer is talking about it in a HUGE WAY! Jamie Simpson is not afraid of showing it all when it comes to her epilepsy -- and she is encouraging all of us to be bold when sharing our story. From dating, to having seizures in public places and showing us, to her incredible service dog Echo, Jamie lays it all on the line to help others understand the world of epilepsy, from the point of view of someone who has the condition. All in this episode of TALK ABOUT IT with Greg Grunberg. The Talk About It podcast is excited to be sponsored in part by Neurelis. The Talk About It podcast is excited to also be sponsored in part by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

Ahhh, it's that time of the year! Pitchers and catchers report, spring training is underway, we buy hotdogs and beer from a guy yelling up the stairs, it's just perfection! Nobody loves the feeling of the start of baseball season more than Greg, maybe with the exception of this episode's guest. Greg sits down in studio with Joey Hanley, a former college player who has now devoted his life to coaching and training young-and-promising baseball players to achieve their dreams of playing in college and beyond. This success didn't come without struggle, however, but luckily Joey had the right mindset to take it head on. Joey was diagnosed with epilepsy after he hit his head in the bathroom following a seizure when he was younger, and he battled through this diagnosis to achieve success on and off the diamond. He isn't going to let epilepsy slow him down from anything that he wants to do, and neither should you. Don't miss this episode! The Talk About It podcast is excited to be sponsored in part by Neurelis. The Talk About It podcast is excited to sponsored in part by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

On this week's episode, Daphne Zohar, Eric Schmidt, Tess Cameron, Brian Skorney, and Yaron Werber discuss the state of the biotech market, emphasizing the resilience of the sector despite current downtowns. The IPO market also remains stagnant, with many companies trading below IPO prices.  The conversation shifts to notable deals, including Jazz Pharmaceuticals acquiring Chimerix for $935 million and AbbVie's move into the obesity space with its $350 million acquisition of Gubra. The group also discusses Pliant Therapeutics' discontinuation of its Phase 2b trial in idiopathic pulmonary fibrosis and Biohaven's promising results from its Phase 1 study of BHV-1300, a potential IgG degrader for autoimmune diseases. The conversation then covers BMS' decision to terminate MRTX1133, a G12D inhibitor from its $4.8bn acquisition of Mirati Therapeutics, and the challenges independent biotech companies face post-launch, including investor skepticism and long-term value pressure. In regulatory news, the group touches on FDA and NIH Senate hearings, vaccine policy debates, and concerns over the revolving door between industry and regulatory agencies, particularly with Pfizer's hire of former FDA director, Patrizia Cavazzoni. They also discuss the broader implications of scientific credibility and public trust in healthcare institutions. The episode concludes with insights on professional networking best practices, emphasizing clear and specific outreach strategies. *This episode aired on March 7, 2025.

S&P Futures are moving higher this morning as Commerce Sec indicated that the Trump Administration may announce a tariff reduction on Canada and Mexico today. European markets are displaying a strong upside move on new spending plans out of Germany. China talked stimulus action in the Two Sessions meeting. Trumps address to a joint session of Congress did not provide any new details of his economic plan and did not indicate a possible tariff reduction announcement on Canada and Mexico. CRWD earnings announcement disappointed the markets and shares are lower. After the bell today, MRVL, VEEV, ZS & MDB are scheduled to release. Jazz Pharmaceuticals to acquire Chimerix for $8.55 per share. evening. ECB rate announcement is scheduled for tomorrow. Congress remains challenged to advert a government shutdown next week as funding runs out on March 14th.

The Americans with Disabilities Act is unquestionably in the premiere class of landmark legislation in American History. On this episode, Greg sits down with the original author and co-sponsor of the ADA -- avid disability rights advocate, the Honourable Tony Coelho, former Representative from California. Tony first introduced the ADA alongside Senator Lowell Weicker in the 100th Congress in 1988 and battled the red tape, opposition and criticism to finally get the bill passed and signed into law by President George H.W. Bush in 1990.  Greg is joined by his Talk About It partner Ken Lowenberg to talk with Tony about his personal history with epilepsy, how the bill came into existence, the importance of enforcing the ADA by presidential administrations, and the dangers of stigma. This episode is so important to listen to, because it's easy to overlook how widespread the impact of the ADA is, touching every American in ways that might be subtle or even hidden. Don't miss it! The Talk About It podcast is excited to be sponsored in part by Neurelis. The Talk About It podcast is excited to sponsored in part by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AAJ865. CME/MOC/CE/AAPA/IPCE credit will be available until February 23, 2026.Accelerating Innovation In Biliary Tract Cancer: Restructuring Treatment Models With Immunotherapy & Targeted Platforms In Advanced Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Cholangiocarcinoma Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical education grants from AstraZeneca, Incyte Corporation, Jazz Pharmaceuticals, and Taiho Oncology, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AAJ865. CME/MOC/CE/AAPA/IPCE credit will be available until February 23, 2026.Accelerating Innovation In Biliary Tract Cancer: Restructuring Treatment Models With Immunotherapy & Targeted Platforms In Advanced Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Cholangiocarcinoma Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical education grants from AstraZeneca, Incyte Corporation, Jazz Pharmaceuticals, and Taiho Oncology, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AAJ865. CME/MOC/CE/AAPA/IPCE credit will be available until February 23, 2026.Accelerating Innovation In Biliary Tract Cancer: Restructuring Treatment Models With Immunotherapy & Targeted Platforms In Advanced Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Cholangiocarcinoma Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical education grants from AstraZeneca, Incyte Corporation, Jazz Pharmaceuticals, and Taiho Oncology, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AAJ865. CME/MOC/CE/AAPA/IPCE credit will be available until February 23, 2026.Accelerating Innovation In Biliary Tract Cancer: Restructuring Treatment Models With Immunotherapy & Targeted Platforms In Advanced Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Cholangiocarcinoma Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical education grants from AstraZeneca, Incyte Corporation, Jazz Pharmaceuticals, and Taiho Oncology, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AAJ865. CME/MOC/CE/AAPA/IPCE credit will be available until February 23, 2026.Accelerating Innovation In Biliary Tract Cancer: Restructuring Treatment Models With Immunotherapy & Targeted Platforms In Advanced Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Cholangiocarcinoma Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical education grants from AstraZeneca, Incyte Corporation, Jazz Pharmaceuticals, and Taiho Oncology, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/CE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/AAJ865. CME/MOC/CE/AAPA/IPCE credit will be available until February 23, 2026.Accelerating Innovation In Biliary Tract Cancer: Restructuring Treatment Models With Immunotherapy & Targeted Platforms In Advanced Disease In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Cholangiocarcinoma Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical education grants from AstraZeneca, Incyte Corporation, Jazz Pharmaceuticals, and Taiho Oncology, Inc.Disclosure information is available at the beginning of the video presentation.

Everybody needs a Jonathan Shapiro in their life. In this special season premiere of Talk About It, Greg sits down with his closest mensch and the other half of his party of two at the deli, Jonathan Shapiro. When life gets hard, Greg turns to him for sage advice and a nice bowl of matzoh ball soup. As you'll find out in this episode, Jonathan has quite a personal history, beginning his career as a federal prosecutor and eventually becoming... you guessed it... a television show writer and showrunner. (BOSTON LEGAL, THE PRACTICE, GOLIATH, THE BLACKLIST, among many others.)  Not only that, Jonathan has a deep personal connection to Greg because he is also the father of a son with epilepsy, the incredible Zeke Shapiro. The two mensches talk about Zeke's journey with his condition, and his abject bravery to perform stand up comedy and become a news anchor. They have always - and will continue to - lean on each other when times are really hard, or celebrate together when times are really great, and everything in between. All over a tuna melt on rye heels, of course. You don't want to miss this episode! The Talk About It podcast is excited to be sponsored in part by Neurelis. The Talk About It podcast is excited to sponsored in part by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.  

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC

In today's episode, supported by Jazz Pharmaceuticals, we had the pleasure of speaking with James J. Harding, MD, director of Early Drug Development at Memorial Sloan Kettering Cancer Center, about the FDA approval of zanidatamab-hrii (Ziihera) for patients with HER2-positive metastatic biliary tract cancer. In our exclusive interview, Dr Harding discussed the significance of this approval, marking the first HER2-targeted therapy specifically for biliary tract cancer. He highlighted findings from the pivotal HORIZON BTC-01 trial (NCT04466891), explored how zanidatamab fits into the treatment paradigm, and addressed the role of HER2 profiling in guiding patient selection. Dr Harding also detailed ongoing research into zanidatamab in earlier treatment settings and emphasized its potential to transform care for patients with this challenging disease.

Happy Holidays from the Talk About It Family! Let's take a trip down memory lane... on the very first episode of Talk About It, Greg sat down with filmmaker and epilepsy advocate Miles Levin to talk about a short film that he created called Under The Lights. That's why we are so excited about this month's episode, where we check back up on that short film because it is now in the process of being a full-blown, big time FEATURE, with a full-blown, big time cast! Greg sits down with actor Pearce Joza who you would recognize as being the lead in the short film, and now is the lead of the upcoming feature alongside a deep bench of great actors including Nick Offerman, Tanzyn Crawford, Randall Park, and Lake Bell. They talk about how this project grew into what it is now, tell some stories from set, and tease an upcoming documentary that Pearce and Greg are producing together. You don't want to miss this episode! The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

Wicked, Wicked, WICKED! Everyone is talking about Wicked! Well, do we here at Talk About It have news for you... there is a brand new musical playing in Los Angeles that is all the rage in the epilepsy community, and it will make you forget all about good witches or bad witches. That musical is "It's All Your Fault, Tyler Price" and it tells the story of a middle school boy whose younger sister has epilepsy and is being bullied, shining a light on the high and low moments of a family dealing with epilepsy, how it affects the parent, and the challenges they are forced to overcome. It's a fresh, honest perspective and a wonderful opportunity to highlight epilepsy awareness on the stage! Greg sits down with the show's creators, Emmy award-winning composer and songwriter Ben Decter and Tony-nominated director Kristin Hanggi, to tell the story of what inspired Ben to start writing this show, how he and Kristin developed the final iteration of the musical, and so, SO much more! Plus! You'll get a sneak peek of one of the numbers that they shot a music video for. This episode is so much fun, you do NOT want to miss it! The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals

This month, a very special guest with a very special mission joins Greg on the podcast from New York City, and we are going to get REAL. Anjalee Seneviratne began having seizures when she was growing up in Sri Lanka, and they discuss how a lack of awareness or education about epilepsy leads to people not doing the first thing to bring this condition into the light… talk about it. She is now living in New York City, and attempting to get a bunch of landmark buildings including the Empire State Building to light up for Purple Day on March 26. She has had some luck with World Trade Center and Bryant Park, but with more awareness there is certainly a way! Finally, they talk about a very serious subject that is often times not talked about openly due to its severity, and that is suicide. Anjalee had an episode this past year, but thankfully survived. She talks about how epilepsy and her medication side effects had an impact, and how people treated her after that event. If you or someone you know is suffering from suicidal thoughts, talk to somebody. Dial 988, or visit 988lifeline.org. The world is so much better with you here.   The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals

On this month's episode, Talk About It co-founder Ken Lowenberg brings along one of his good friends Jake Didinsky to talk all about autism. Jake is a proud business manager, community organizer, DJ, is LGBTQIA+ and non-binary, and is an all-around powerhouse who uses their life on the spectrum as an advantage and is proud and unapologetic about all of it. They are an inspiration to Greg and Ken, and should also be an inspiration to you and anyone you know living with autism! They discuss having episodes of being nonverbal and what to do when that happens, the unique challenges of autism, the difficulty of being diagnosed as an adult, living with depression, the importance of allyship, and how Jake advocates for local, state, and national governments to push for legislation - not just for autism, but for causes to help all kinds of marginalized communities. No matter what your condition is, don't be afraid to be proud and get involved!  The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals

At Talk About It, we cover topics that need more attention and need to be talked about more.   In this special episode, Greg's close friend and fellow actor/ bandmate Sarah Wayne Callies stops by the studio to talk about safety - both on set, and at home. After a brief session talking shop, they get into the substance of a cause so near and dear to Sarah and one that can be very difficult to talk about, domestic violence.   Sarah shares a personal and painful story about a good friend of hers who became isolated from relationships, including theirs, as her husband grew increasingly violent and threatening, leading to a podcast Sarah is producing called "Bitch is a Bad Word." It is so important to talk about this subject, and if you are feeling threatened or unsafe at home, do not hesitate. Talk About It.   The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Phil Jochelson, therapeutic head for Clinical Development Neuroscience at Jazz Pharmaceuticals, sat down to discuss the phase 4 XYLO study, a randomized controlled study evaluating the effects of switching from high-sodium to low-sodium oxybate on blood pressure in patients with narcolepsy. Jochelson gave some insight regarding the conduct of the trial, including end points, objectives, and patient demographics, as well as some of the benefits to studying blood pressure and cardiovascular risks. In addition, he discussed enhancements to narcolepsy care through low-sodium oxybate, the importance of unique studies like XYLO, and the need to educate clinicians on sodium load and its risks.  Looking for more sleep disorders discussion? Check out the NeurologyLive® sleep disorders clinical focus page. Episode Breakdown: 1:15 – Reasons behind the XYLO study and links between high sodium intake and cardiovascular risk 4:45 – Patient demographics; inclusion and exclusion criterias 6:40 – Neurology News Minute 9:25 – Overview of XYLO and determining what a successful study looks like 15:30 – Improved understanding of the benefits of low-sodium oxybate The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here: EU Regulatory Review Adopts Negative Opinion of Lecanemab as Treatment for Alzheimer Disease GLP-1 Agonist Liraglutide Shows Protective Effects on Alzheimer Disease in Phase 2 Trial FDA Approves Carbidopa/Levodopa ER Capsules Formulation IPX203 for Parkinson Disease Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Dr. Allison Zibelli and Dr. Erika Hamilton discuss the results of the DESTINY-Breast06 trial in HR+, HER2-low and HER2-ultralow metastatic breast cancer and the A-BRAVE trial in early triple-negative breast cancer, the results of which were both presented at the 2024 ASCO Annual Meeting. TRANSCRIPT Dr. Allison Zibelli: Hello, I'm Dr. Allison Zibelli, your guest host of the ASCO Daily News Podcast. I'm an associate professor of medicine and breast medical oncologist at the Sidney Kimmel Cancer Center of Jefferson Health in Philadelphia. My guest today is Dr. Erika Hamilton, a medical oncologist and director of breast cancer research at the Sarah Cannon Research Institute. We'll be discussing the DESTINY-Breast06 trial, which showed a progression-free advantage with the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) compared to chemotherapy in hormone receptor-positive HER2-low or HER2-ultralow metastatic breast cancer. We'll address the implications of this study for the community, including the importance of expanding pathology assessments to include all established subgroups with HER2 expression, and the promise of expanding eligibility for antibody-drug conjugates. We'll also highlight advances in triple-negative breast cancer, focusing on the A-BRAVE trial, the first study reporting data on an immune checkpoint inhibitor avelumab in patients with triple-negative breast cancer with invasive residual disease after neoadjuvant chemotherapy.  Our full disclosures are available in the transcript of this episode.  Erika, it's great to have you on the podcast today. Dr. Erika Hamilton: Thanks so much, Allison. Happy to join. Dr. Allison Zibelli: Antibody-drug conjugates are rapidly changing the treatment landscape in breast cancer. The data from the DESTINY-Breast06 trial suggests that trastuzumab deruxtecan may become a preferred first-line treatment option for most patients with HER2-low or HER2-ultralow metastatic breast cancer after progression on endocrine therapy. First, could you remind our listeners, what's the definition of HER2-ultralow and what were the findings of this trial? Dr. Erika Hamilton: Yeah, those are fantastic questions. Ultralow really has never been talked about before. Ultralow is part of a subset of the IHC zeros. So it's those patients that have HER2-tumor staining that's less than 10% and incomplete but isn't absolutely zero. It's even below that +1 or +2 IHC that we have classified as HER2-low. Now, I think what's important to remember about D-B06, if you recall, D-B04 (DESTINY-Breast04) was our trial looking at HER2-low, is that D-B06 now included HER2-low as well as this HER2-ultralow category that you asked about. And it also moved trastuzumab deruxtecan up into the frontline. If you recall, D-B04 was after 1 line of cytotoxic therapy. So now this is really after exhausting endocrine therapy before patients have received other chemotherapy. And what we saw was an improvement in progression-free survival that was pretty significant: 13.2 months versus 8.1 months, it was a hazard ratio of 0.62. And you can ask yourself, “well, was it mainly those HER2-low patients that kind of drove that benefit? What about the ultralow category?” And when we look at ultralow, it was no different: 13.2 months versus 8.3 months, hazard ratio, again, highly significant. So I think it's really encouraging data and gives us some information about using this drug earlier for our patients with hormone receptor-positive but HER2-negative disease.  Dr. Allison Zibelli: I thought this study was really interesting because it's a patient population that I find very difficult to treat, the hormone receptor-positive metastatic patient that's not responding to endocrine therapy anymore. But it's important to mention that T-DXd resulted in more serious toxicities compared to traditional chemotherapy in this study. So how do you choose which patients to offer this to? Dr. Erika Hamilton: Yeah, those are both great points. So you're right, this is after endocrine therapy. And in fact, about 85% of these patients had received at least 2 prior lines of endocrine therapy. So I have some people kind of asking, “Well, if endocrine therapy really isn't benefiting everyone in the second-line setting post-CDK, should we just move to the ADCs?” And, no, probably we should really make sure that we're exhausting endocrine therapies for those patients that are going to benefit. And once we determine somebody has endocrine-resistant disease, that's when we would think about switching. In terms of the side effects, I think you're right. It's mainly ILD that's probably the more serious side effect that we worry about a little bit with trastuzumab deruxtecan. The good news is, through multiple trials, we've gotten a little bit better at managing this. We've pretty much all but eliminated any fatal cases of ILD, definitely less than 1% now. ILD rates, depending on what study you look for, kind of ranges in that 10% to 15% range. Any grade ILD on D-B06 was 11.3%. So really kind of making sure that we look for ILD at scans, making sure that patients are educated to tell us about any new pulmonary symptoms: cough, exertional dyspnea, shortness of breath at rest, etc. But I think the most common side effects that we really deal with on a daily basis with trastuzumab deruxtecan, luckily, is nausea, which we've gotten better at managing with the 2- or 3-drug antiemetic regimen, and probably a little bit of fatigue as well. Dr. Allison Zibelli: Thank you. So, I think for most people in the community, the sticking point here will be expanding pathology assessments to include all of the subgroups, including the ultralow. Most patients in the community are not testing for HER2-low and HER2-ultralow now. Dr. Erika Hamilton: Historically, we kind of all did HER2 IHC, right? And then as FISH became available, there were a lot of institutions that moved to FISH and maybe didn't have IHC anymore. And now, at least in my institution, we do both. But I think it's a very important point that you made that IHC was really designed to pick out those patients that have HER2-high, the 3 pluses or the FISH amplified cases. It was not to tell the difference between a 1+ or a 2+ or a 0 that's not quite a 0 and a 1+. So I think you're right. I think this is tough. I probably have a little bit more of an interesting take on this than some people will. But data from ASCO, not this year but in 2023, there was actually a pretty eloquent study presented where they looked at serial biopsies in patients, and essentially, if you got up to 4 or 5 biopsies, you were guaranteed to have a HER2-low result. Now, this didn't even include ultralow, which is even easier. If we know we include ultralow, we're really talking about probably 85% to 90% of our patients now that have some HER2 expression. But if we biopsy enough, we're guaranteed to get a HER2 low.  And so I think the question really is, if we know IHC wasn't really designed to pick out these ultralows, and we know kind of greater than 90% of patients are going to have some expression, did we kind of develop this drug a little bit backwards? Because we thought we understood HER2, and the reality is this drug is a little bit more like a sacituzumab govitecan, where we don't test for the TROP2. Should we really be kind of serial biopsying these patients or should maybe most patients have access to at least trying this drug?  Dr. Allison Zibelli: So I don't think that most of my patients will really be happy to sign up for serial biopsies. Dr. Erika Hamilton: Agreed. Dr. Allison Zibelli: Do we have any emerging technologies for detecting low levels of HER2? You talked about how the IHC test isn't really designed to detect low levels of HER2. Do you think newer detection techniques such as immunofluorescence will make a difference, or will we have liquid biopsy testing for this? Dr. Erika Hamilton: Yeah, I think liquid biopsy may be a little bit hard, just because some of those circulating tumor cells are more of a mesenchymal-type phenotype and don't necessarily express all of the same receptors. Normally, if they're cytokeratin-positive, they do, but certainly there is a lot out there looking at more sensitive measures. You mentioned immunofluorescence, there are some even more quantitative measures looking at lower levels of HER2. I definitely think there will be. I guess, ultimately, with even the IHC zeros that are the less than 10% incomplete staining, having a PFS that was absolutely no different than the HER2 low, I guess the question is, how low can we really go? We know that even the IHC zeros doesn't mean that there's no HER2 expression on the cell surface. It just means that maybe there's a couple of thousand as opposed to 10,000 or 100,000 copies of HER2. And so it really appears that perhaps this drug really is wedded to having a lot of HER2 expression. So ultimately, I wonder how much we're going to have to use those tests, especially with what we know about tumor heterogeneity. We know that if we biopsy 1 lesion in the liver, biopsy a lymph node, or even another lesion in the liver, that the HER2 results can have some heterogeneity. And so ultimately, my guess is that most people have some HER2 expression on their breast cancer cells. Dr. Allison Zibelli: So maybe we're going to be using this for everybody in the future. Dr. Erika Hamilton: It certainly seems like we keep peeling back the onion and including more and more patients into the category that are eligible to receive this. I agree. Dr. Allison Zibelli: Let's move on to triple-negative breast cancer, namely the A-BRAVE trial. This was an interesting trial for patients that did not get neoadjuvant immunotherapy and testing 2 groups. The first group was those with residual disease after neoadjuvant conventional chemotherapy. The second group was people with high-risk disease identified upfront that had upfront surgery. The study found that adjuvant avelumab did not improve disease-free survival versus observation, which was the study's primary endpoint. But interestingly, there was a significant improvement in 3-year overall survival and distant disease-free survival. Can you give us your thoughts on that? Dr. Erika Hamilton: Yeah, I think this study was really interesting. Right now, the standard for our patients with larger or node-positive triple-negative cancers is KEYNOTE-522. It's a pretty tough regimen. It's kind of 2 sequential uses of 2 chemotherapies, so 4 chemotherapy agents total with pembrolizumab. But you're right, this study looked at those that had residual disease after neoadjuvant that didn't include immunotherapy, or those patients that didn't get neoadjuvant therapy, went to surgery, and then were receiving chemotherapy on the back end. I'm going to give you the numbers, because you're right. The 3-year disease-free survival rates were not statistically significant. It was 68.3% among those that had avelumab, 63.2% with those that had observation only. So the difference was 5.1% in favor of avelumab, but it wasn't statistically significant. A p value of 0.1, essentially. But when we looked at the 3-year overall survival rates, we saw the same pattern, those patients with the avelumab doing better, but it was 84.8% overall survival and not, unfortunately, dying, versus 76.3%. So the magnitude of benefit there was 8.5%, so about 3% higher than we saw for disease-free survival, and this was statistically significant.  So is this going to change practice for most patients? I probably don't think so. I think for our patients that have larger tumors that's recognized upfront or have node positivity, we're probably going to want to use neoadjuvant chemo. Being able to get a PCR is very prognostic for our patients and enables us to offer things on the back end, such as PARP inhibitors or further chemotherapy of a different type of chemotherapy. But for our patients that go to surgery and maybe the extent of their disease just isn't recognized initially, this could be an option. Dr. Allison Zibelli: I agree. I think this will be a really useful regimen for patients where we get the surprise lymph node that we weren't expecting, or somebody who comes to us, maybe without seeing the medical oncologist, who got upfront surgery. So I thought this was really interesting. What kind of translational studies do you think we're going to do to try and understand which patients would benefit from avelumab? Dr. Erika Hamilton: Yeah, I think that's a great question, and honestly, it's a question that we haven't really answered in the neoadjuvant setting either. Immunotherapy in breast cancer is just a little bit different than it is in some other diseases. We have a benefit for those patients that are PD-L1 positive in the first line. We really haven't seen benefit for metastatic outside of first line. And then in neoadjuvant, it was among all comers. We don't have to test for PD-L1. And now we have this avelumab data from A-BRAVE. I think the question is, is there's probably a subset of patients that are really getting benefit and a subset that aren't. And I don't know that PD-L1 testing is the right test. We know a lot of people are looking at TILs, so kind of lymphocytes that are infiltrating the tumor, a variety of other kind of immunologic markers. But my guess is that eventually we're going to get smart enough to tease out who actually needs the immunotherapy versus who isn't going to benefit. But we're not quite there yet. Dr. Allison Zibelli: Thank you, Erika, for sharing your valuable insights with us on the ASCO Daily News Podcast today. Dr. Erika Hamilton: Thanks so much for having me.  Dr. Allison Zibelli: And thank you to our listeners for joining us. You'll find the links to all the abstracts discussed today in the transcript of this episode. Finally, if you like this podcast and you value our insights, please take a moment to rate, review, and subscribe wherever you get your podcasts. It really helps other people to find us. So thank you very much for listening today.   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. Allison Zibelli Dr. Erika Hamilton @ErikaHamilton9   Follow ASCO on social media:  @ASCO on Twitter    ASCO on Facebook    ASCO on LinkedIn      Disclosures: Dr. Allison Zibelli:  None Disclosed   Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson   Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics

In this month's episode of Talk About It, Greg and his guest Craig Chambliss, CEO of Neurelis Inc, explore the importance of rescue therapies – or immediate use medications – in overall seizure treatment.  Talking to your health care team about whether immediate use medications is right for you is critical, even if your seizures are mostly under control.  The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals  

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/HXN865. CME/MOC/NCPD/AAPA/IPCE credit will be available until July 2, 2025.Achieving Optimal SCLC Care With Established and Innovative Therapies: Latest Evidence, Key Ongoing Trials, and Practical Considerations for Real-World Practice In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical educational grants provided by Amgen, AstraZeneca, Daiichi Sankyo, Inc., and Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/HXN865. CME/MOC/NCPD/AAPA/IPCE credit will be available until July 2, 2025.Achieving Optimal SCLC Care With Established and Innovative Therapies: Latest Evidence, Key Ongoing Trials, and Practical Considerations for Real-World Practice In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical educational grants provided by Amgen, AstraZeneca, Daiichi Sankyo, Inc., and Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/HXN865. CME/MOC/NCPD/AAPA/IPCE credit will be available until July 2, 2025.Achieving Optimal SCLC Care With Established and Innovative Therapies: Latest Evidence, Key Ongoing Trials, and Practical Considerations for Real-World Practice In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical educational grants provided by Amgen, AstraZeneca, Daiichi Sankyo, Inc., and Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/HXN865. CME/MOC/NCPD/AAPA/IPCE credit will be available until July 2, 2025.Achieving Optimal SCLC Care With Established and Innovative Therapies: Latest Evidence, Key Ongoing Trials, and Practical Considerations for Real-World Practice In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical educational grants provided by Amgen, AstraZeneca, Daiichi Sankyo, Inc., and Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/HXN865. CME/MOC/NCPD/AAPA/IPCE credit will be available until July 2, 2025.Achieving Optimal SCLC Care With Established and Innovative Therapies: Latest Evidence, Key Ongoing Trials, and Practical Considerations for Real-World Practice In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and LUNGevity Foundation. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent medical educational grants provided by Amgen, AstraZeneca, Daiichi Sankyo, Inc., and Jazz Pharmaceuticals.Disclosure information is available at the beginning of the video presentation.

Do your employee experience efforts cater to the diverse workforce that make up your organisation's ecosystem? This episode of the Digital HR Leaders podcast looks into this question through the lens of Heidi Manna, Chief People Officer at Jazz Pharmaceuticals. Through innovative employee listening strategies and data-driven approaches, Heidi has achieved great success creating an inclusive employee experience amongst the disparate teams at Jazz Pharmaceuticals. So tune in to learn more about: How Jazz Pharmaceuticals listens to its employees and crafts a clear value proposition to drive engagement and satisfaction The company's flexible work model and its approach towards intentional collaboration Insights into the metrics and methods used to evaluate the effectiveness of its flexible work model and employee experience strategies Strategies for constructing a compelling business case for flexible work models and gaining support from the C-suite How Jazz Pharmaceuticals ensures a positive experience for all employees, including those in on-site and customer-facing roles Heidi's key takeaways on maintaining clarity, adaptability and a growth mindset to foster a robust and inclusive workplace If you are an HR Leader looking to elevate your employee experience strategies, this episode promises to be an inspirational listen. Support from this podcast comes from HiBob, who brings us Bob, the most usable enterprise HCM according to Nucleus Research. Bob is rated the most useable HCM solution in Nucleus Research's 2024 Enterprise HCM Value Matrix. Bob delivers tangible results for organizations through ease of use and fast setup, like for this US-based CRM vendor that achieved a 228% ROI. Need proof? Read how Bob increased productivity and reduced software costs by downloading the Nucleus ROI study here.  Links to Resources: Heidi Manna on LinkedIn: Heidi Manna Jazz Pharmaceuticals: Jazz Pharmaceuticals HiBob Platform: HiBob MyHRFuture Academy: MyHRFuture Insight222: Insight222 Hosted on Acast. See acast.com/privacy for more information.

This month on Talk About It, we are cooling off the summer heat with some refreshing and delicious lemonade! Greg hosts three different interviews with people who are taking the sourest of lemons that life hands them and squeezing out incredible creative initiatives that make the world a much, MUCH better place. Up first is Landis Wiedner who developed epilepsy after a traumatic brain surgery to remove a tumor. She was disrupted by this sudden change in her adult life and realized that there weren't enough resources to help her deal with the struggles of "adulting" with epilepsy, so she started a podcast! The What the EF Podcast she started has now been on for five seasons and aims to be an outlet for those everyday conversations that aren't as accessible for adults in her situation. Way to go Landis! Then, Greg has some very special guests to the studio - his son Jake's girlfriend Morgan, and her incredible mom Karen and brother Kyle! Kyle was born with cerebral palsy, but Karen never let his condition affect his ability to play sports and enjoy recreational activities. In fact, she came on board the AYSO VIP Program for kids and helped to expand it to now host hundreds of special needs participants, from 4-year-olds to 40-year-olds! From basketball to soccer, Karen is leading the way to establish communities and provide a safe environment for individuals like Kyle to learn and grow through playing sports. Greg and Nick headed out to watch the basketball program in action, and we get a full recap of how incredible that experience was that is sure to pull on your heart strings! Finally, Greg talks with Sue Seserman, a writer and new author that harnesses her conditions and turns them into superpowers! Sue has epilepsy and type 1 diabetes, and has such a brilliant creative vision on how to use them for good. She has now released her new graphic novel Epilectra that centers around a woman who becomes a superhero by converting the electricity in her brain that causes seizures and uses them for super electric abilities! She is joined by a cast of characters - Team SEEZ - who all have a disability, but use them as “superabilities” to change the circumstances of their adversaries and save the day. She is a visionary, and we are so excited that this novel is finally here! Plus, we recap Greg's trip to the Epilepsy Walk at the Rose Bowl with some familiar faces and some new friends! Don't miss this episode! The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals

Some topics are so heavy they are difficult to discuss, but gun violence has become such a problem in America that it is vitally important for us to talk about it in order to bring change. In this special episode of Talk About It, Greg is joined in studio by some great new friends -- Mark Barden, founder of Sandy Hook Promise and co-founder of Artist for Action, and Matthew Reich and Neal Saini, co-founders of Artist for Action. Mark Barden experienced the unimaginable when his 7-year-old son Daniel was killed in the Sandy Hook massacre of 2012, an event that sent shockwaves throughout the country. Mark and his family continue to go through periodic episodes of depression, anger, hopelessness, and warding off bad actors who spread conspiracies. However, he has harnessed those emotions to start Sandy Hook Promise (SandyHookPromise.org) that works to educate communities and school districts about gun violence and notify law enforcement through a tip line when a student or school is in danger. The work he is doing is literally saving lives. Mark also co-founded Arist for Action with Matthew and Neil, an organization that platforms causes for artists to easily promote to fans. Together, they put on major events to promote gun reform and are producing a documentary feature with major musical stars attached. This episode is heavy, but this is a conversation that needs to be had.  The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

In this episode, Greg is joined by a fellow parent of a child with epilepsy, and that parent just so happens to be the incredibly talented and incredibly funny actress Lake Bell! Lake's daughter Nova was diagnosed with epilepsy at just five years old due to a genetic mutation commonly associated with Dravet Syndrome, a rare form of epilepsy. Greg and Lake talk about re-framing the condition to her daughter so that it is positive, taking away guilt or anxiety when she has a seizure. She has created a scenario in which after Nova has a seizure, she thinks of it as "sparkling" and is very brave and smart, like Joan of Arc who  is featured in the Frozen movie that her daughter loves and who also had epilepsy.   Lake is currently working on two projects that center around epilepsy - a book about the brain that she is announcing on this episode, and the feature film "Under the Lights" expanded from the short film written and directed by guest of the show Miles Levin and starring Greg, himself! What a small world it is in this community! The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.

Greg Grunberg (@greggrunberg) hosts Shawn Francis (@iamshawnfrancis) and Brian Altounian (@brianaltounian) of the Just Two Dads podcast about raising children with special needs. See Shawn and Brian every Wednesday @ 11AM PT Live on Facebook! The Talk About It podcast is sponsored by Seizures Are Signs — dedicated to educating families on the importance of early and specific diagnosis by providing an assessment to help get the conversation started, educational information, stories from families who have found a diagnosis, links to advocacy groups, and more. For more information, go to SeizuresAreSigns.com. Seizures are Signs is made available by Jazz Pharmaceuticals.