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This week, we interviewed Jeremy Laynor, the Senior Vice President of Sales at Providence Medical Technology. We discussed his book The Point Guard Approach. Jeremy offers some insight into what it takes to be a leader at work and at home. Jeremy has a strong track record of success in medical device sales leadership, with specific experience in the spinal implant market. He most recently served as Vice President of Sales at Paradigm Spine, where he was instrumental in growing their commercial effort since 2013. Jeremy held sales leadership positions at Medtronic and previously at Salient Surgical, where he helped the market development of their advanced energy platform to the standard of care for many common orthopedic and spine procedures. He began his healthcare career with Cardinal Health, where he specialized in cultivating national sales teams for new pharmaceutical, biotech, or medical technologies. Jeremy graduated from Slippery Rock University in Pennsylvania, where he played point guard for the men's basketball team. He is a husband and proud father of four children, and the family currently lives in Dallas, Texas.
Hospitals today face rising drug costs, workforce shortages, supply chain disruptions and tightening reimbursement, making financial sustainability increasingly difficult to achieve. In this episode of Healthcare Insider, Cardinal Health's Mike Brown, R.Ph, vice president of managed services, and Michelle Dalton, PharmD, regional director of account management and operations, discuss how a strategic approach to pharmacy management can help hospitals of all sizes reduce costs, optimize operations and unlock new revenue streams. They also share how one Southeastern health system kept $3 million in clinical savings in one year by transforming pharmacy operations. Listen to learn how your organization can tap into the pharmacy's full potential to drive financial resilience and growth across your system.
Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements.00:00 Introduction and Guest Introduction00:37 The Importance of Documentation in Quality Systems01:30 Hierarchy and Structure of Documentation02:44 Standard Operating Procedures (SOPs) vs. Work Instructions11:22 Document Control and Change Management15:52 Roles and Responsibilities in Quality Systems18:20 RACI Matrix and Its Importance20:47 Common Issues in Documentation and Training25:25 Conclusion and Where to Find More InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
Blake Squires began his journey in the mid-90s in Los Angeles, capitalizing early on the convergence of technology and media. He soon returned to his hometown of Cleveland to co-found Everstream with Steve McHale (episode 196) and Charlie Lougheed (episode 42, and also my co-founder at Axuall). Blake served as COO until Everstream's acquisition by Concurrent Computer Corp in 2005.Next, he co-founded Findaway, a global leader in digital audiobook distribution and creators of PLAYAWAY, a line of preloaded audiobook devices and products. Findaway was acquired by Spotify in 2022—a story shared by co-founder Mitch Kroll (episode 128) and early team member Mike Belsito (episode 52).In 2011, Blake launched Movable, a software and wearable platform built to "inspire movement." He also founded DoctorsOrders, an e-scripting tool for medical suppliers, which was acquired by Cardinal Health in 2018.Blake later partnered with inventor John Osher (of SpinBrush fame) to develop the Stubl/Shadow manual razor, acquired by Edgewell for its Schick brand. The duo also created a unique toothbrush licensed to Waken in the UK.In 2022, Blake co-founded Bloomfilter, an AI-powered process intelligence platform optimizing the product and software development lifecycle. We've heard Bloomfilter's story from his co-founder Andrew Wolfe on episode 134.By 2024, Blake had become a board partner at Greycroft and a “Fellow” at global design firm IDEO, recognized for his work supporting VCs and early-stage startups. Blake also serves as a founding advisor to the Ohio Angel Collective.As I mentioned up top, Blake's story truly is a Lay of The Land of Lay of The Land. He's deeply connected with Northeast Ohio's startup ecosystem—through this episode alone, we'll hear links to Lee Zapis (episode 7), John Knific (episode 199), David Levine (episode 132), AC Evans (episode 39), Ray Leach (episode 69), and many more.More than just well-connected, Blake is a visionary builder, inspiring leader, and accomplished serial entrepreneur with a rare ability to scale products, teams, and brands.00:00:00 - The Entrepreneurial Journey Begins 00:12:17 - Passion and the Intersection of Art and Business 00:15:09 - Defining Core Values in Entrepreneurship 00:18:27 - The Evolution of Big Mama Music 00:21:09 - Navigating Course Corrections in Business 00:23:23 - Finding the Next Problem to Solve 00:26:25 - Building a Values-Driven Company 00:28:09 - The Shift to Audiobooks and Market Insights 00:33:35 - The Role of Storytelling in Business 00:41:23 - Learning from Failure and Pivoting Strategies 00:43:22 - Scaling and Growth in Libraries 00:48:47 - Building a Strong Company Culture 00:49:08 - Lessons from Movable and the Importance of Partnerships 00:54:55 - Navigating the Healthcare Market 00:55:42 - Universal Truths in Entrepreneurship 01:01:07 - Transitioning to Advisory Roles and New Ventures 01:04:20 - Hidden Gem -----LINKS:https://www.linkedin.com/in/blakesquires/-----SPONSOR:Roundstone InsuranceRoundstone Insurance is proud to sponsor Lay of The Land. Founder and CEO, Michael Schroeder, has committed full-year support for the podcast, recognizing its alignment with the company's passion for entrepreneurship, innovation, and community leadership.Headquartered in Rocky River, Ohio, Roundstone was founded in 2005 with a vision to deliver better healthcare outcomes at a more affordable cost. To bring that vision to life, the company pioneered the group medical captive model — a self-funded health insurance solution that provides small and mid-sized businesses with greater control and significant savings.Over the past two decades, Roundstone has grown rapidly, creating nearly 200 jobs in Northeast Ohio. The company works closely with employers and benefits advisors to navigate the complexities of commercial health insurance and build custom plans that prioritize employee well-being over shareholder returns. By focusing on aligned incentives and better health outcomes, Roundstone is helping businesses save thousands in Per Employee Per Year healthcare costs.Roundstone Insurance — Built for entrepreneurs. Backed by innovation. Committed to Cleveland.-----Stay up to date by signing up for Lay of The Land's weekly newsletter — sign up here.Past guests include Justin Bibb (Mayor of Cleveland), Pat Conway (Great Lakes Brewing), Steve Potash (OverDrive), Umberto P. Fedeli (The Fedeli Group), Lila Mills (Signal Cleveland), Stewart Kohl (The Riverside Company), Mitch Kroll (Findaway — Acquired by Spotify), and over 200 other Cleveland Entrepreneurs.Connect with Jeffrey Stern on LinkedIn — https://www.linkedin.com/in/jeffreypstern/Follow Lay of The Land on X @podlayofthelandhttps://www.jeffreys.page/
The Cardinal Health Retail Business Conference (RBC) is an annual celebration recognizing independent pharmacies and their unwavering commitment to comprehensive patient care in their community. Join us for a deep dive into RBC with pharmacist Joan R. Wissinger, a 25-year RBC veteran! In this episode, Joan shares her insights on why RBC is a must-attend event for independent pharmacists, highlighting the networking opportunities, continuing education courses, and the invaluable experience of connecting with peers.
The Cardinal Health Retail Business Conference (RBC) is an annual celebration recognizing independent pharmacies and their unwavering commitment to comprehensive patient care in their community. Join us for a deep dive into RBC with pharmacist Joan R. Wissinger, a 25-year RBC veteran! In this episode, Joan shares her insights on why RBC is a must-attend event for independent pharmacists, highlighting the networking opportunities, continuing education courses, and the invaluable experience of connecting with peers.
Columbus appears to be on track to keep an important promise: The Columbus Promise. The innovative education partnership launched in 2021 with the goal of sending more Columbus City School graduates to college, boosting their own life trajectories and helping Central Ohio supercharge its workforce. The Columbus Promise lets any graduate of Columbus City Schools attend Columbus State Community College at no cost for six semesters and provides a $500 stipend each semester plus academic support. Now the Promise is no longer just a pilot. The program's key partners – the City of Columbus, Columbus City Schools, I Know I Can, and Columbus State – and an array of private backers – have all recently recommitted to launching a new phase of the program, with more than half of a new $25 million goal already raised. With a panel of leaders, we unpack the Columbus Promise, explore its origins and impact, and get an inside look at what happens next. Featuring Dr. Angela Chapman, Superintendent/CEO, Columbus City Schools Janelle Coleman, Vice President, Community Engagement & Corporate Philanthropy and President, AEP Foundation Shannon Hardin, President, Columbus City Council Dr. Desiree Polk-Bland, Senior Vice President for Student Success, Columbus State Community College The moderator is Colleen Marshall, News Anchor, NBC4, and host of "NBC4's The Spectrum." This presenting sponsor of this forum was The Columbus Foundation. This forum was also sponsored by Cardinal Health and American Electric Power. The presenting sponsor of the CMC livestream was The Center for Human Kindness at the Columbus Foundation. CMC's livestream partner was The Columbus Dispatch. This forum was also supported by The Ellis. This forum was recorded before a live audience at The Ellis in Columbus' historic Italian Village on April 9, 2025.
Specialty medication spending is projected to rise sharply through 2026, intensifying pressure on health systems to control costs while improving patient outcomes. In this episode of Healthcare Insider, Cardinal Health's Mike Brown, vice president of managed services, and Naveen Mansukhani, director of specialty and ambulatory pharmacy solutions, break down the critical role specialty pharmacies play in managing spend, capturing revenue and retaining patients within the care continuum. They share real-world examples of how hospitals large and small are benefiting from tailored pharmacy models and discuss how to overcome common challenges such as labor shortages, compliance and ongoing accreditation requirements. Listen to learn how your organization can build a scalable, compliant specialty pharmacy strategy that supports value-based care and long-term success.
On this episode of the Counter Talk™ Podcast host Jason Callori speaks with Jeff Harrell, PharmD, CEO of Cascadia, a network of over 30 independent pharmacies in the Pacific Northwest region. Jeff shares his journey from basketball player to successful pharmacy owner. He discusses how he built his network and the challenges independent pharmacists are facing today in a competitive market. This episode highlights the opportunities to grow through clinical services, medical synchronization, and more.
On this episode of the Counter Talk™ Podcast host Jason Callori speaks with Jeff Harrell, PharmD, CEO of Cascadia, a network of over 30 independent pharmacies in the Pacific Northwest region. Jeff shares his journey from basketball player to successful pharmacy owner. He discusses how he built his network and the challenges independent pharmacists are facing today in a competitive market. This episode highlights the opportunities to grow through clinical services, medical synchronization, and more.
What if you could transform your supply chain to run smarter, faster, and safer—all while reducing manual touches? On this episode of Power Supply, we welcome Peter Bennett, Senior VP of Global Supply Chain at Cardinal Health, to explore the revolutionary impact of automation in healthcare logistics. From robotics that bring goods to people, to AI-driven planning systems, Pete shares how these technologies are reducing manual touches while improving safety and accuracy. Whether you're interested in emerging technologies or discovering how automation can benefit your organization, this episode offers valuable insights into the future of healthcare supply chain operations. Tune in today to discover how automation is reshaping the way products move through the healthcare ecosystem! Once you complete the interview, jump on over to the link below to take a short quiz and download your CEC certificate for 0.5 CEC! – https://www.flexiquiz.com/SC/N/ps13-07 #PowerSupply #Podcast #AHRMM #HealthcareSupplyChain #Automation #SupplyChainTechnology #HealthcareInnovation
Dr. John Sweetenham and Dr. James Foran discuss the evolving treatment landscape in acute myeloid leukemia, including new targeted therapies, advances in immunotherapy, and the current role for allogeneic transplantation. TRANSCRIPT Dr. John Sweetenham: Hello, I'm Dr. John Sweetenham, the host of the ASCO Daily News Podcast. There has been steady progress in the therapies for acute myeloid leukemia (AML) in recent years, largely based on an increasing understanding of the molecular mechanisms which underlie the disease. On today's episode, we'll be discussing the evolving treatment landscape in AML. We'll explore risk group stratification, new targeted therapies, advances in immunotherapy for AML, and also a little about the current role for allogenic transplantation in this disease. I'm delighted to welcome Dr. James Foran to this discussion. Dr. Foran is a professor of medicine and chair of the Myeloid Malignancies and Blood and Marrow Transplant Disease Group at the Mayo Clinic Comprehensive Cancer Center. He's based in Jacksonville, Florida. Our full disclosures are available in the transcript of this episode. James, it's great to have you join us on the podcast today, and thanks so much for being here. Dr. James Foran: I'm delighted and thank you for the invitation. Thank you very much. Dr. John Sweetenham: Sure, James, let's get right into it. So, our understanding of the molecular mechanisms underlying AML has resulted not only in new methods for risk stratification in this disease, which have added refinement to cytogenetics, but also has resulted in the development of many new targeted agents. Understanding that this is a complex area of investigation, and our time is somewhat limited, can you give us a high-level update on the current state of the art in terms of how risk factors are being used for treatment selection now? Dr. James Foran: Absolutely. I think in the past, you know, we had things broken down pretty simply into make a diagnosis based on morphology, do cytogenetics, break patients into the groups of those who were more likely to benefit from therapy – so-called favorable risk – those where the intensive therapies were less likely to work – so-called poor adverse risk, and then this large intermediate group that really had variable outcomes, some better, some worse. And for a long time, the progress was in just identifying new subtle cytogenetic risk groups. And then, late 1990s, we began to understand that FLT3 mutations or NRAS mutations may be more adverse than others that came along. In the first part of this millennium, in the, you know, 2000-2010 range, a lot of work was being done to understand better or worse risk factors with single genes. The ability to do multiplex PCR, and then more recently NGS platforms, have allowed us to really look at many genes and identify many mutations in patients. At the beginning that was used just to sort of refine – who did a little better, who did a little worse with intensive therapy – helped us decide who may benefit more from an allogeneic transplanter for whom that would not be necessary. But the good news is that really, we're now starting to target those mutations. One of the first molecularly targeted treatments in leukemia was FLT3 mutations, where we knew they were adverse. Then along came targeted treatments. I was involved in some of those early studies looking at sunitinib, sorafenib, more recently midostaurin, now quizartinib, FDA approved, and gilteritinib in the relapse refractory setting. So we're moving into a state where we're not just refining prognosis, we're identifying targets. You know, it's been slow progress, but definite incremental progress in terms of outcomes by looking for FLT3 mutations, then looking for IDH mutations, and more recently, mutations involving NPM1 or rearrangement of what we used to call the MLL gene, now the lysine methyltransferase 2A or KMT2A rearrangement, where we now have targets. And it's not just for refinement of prognosis, but now we're identifying therapeutic targets for patients and ways to even look for measurable residual disease which is impacting our care. Dr. John Sweetenham: That's great, James. And I'm going to expand on that theme just a little bit and perhaps ask you to elaborate a little bit more on how the introduction of these new therapies have specifically impacted frontline therapy. And a couple of ancillary questions maybe to go along with that: First of all, is ‘7+3' a standard therapy for anybody in 2025? And maybe secondly, you know, could you comment also maybe briefly on older patients with AML and how you think maybe the treatment landscape is changing for them compared with, say, 5 or 10 years ago? Dr. James Foran: I'll start with the therapy and then work my way back. So we've had ‘7+3' cytarabine daunorubicin or cytarabine anthracycline since 1976, and we're still using it as the backbone of our intensive therapy. There is still an important role for it, particularly in younger or fitter patients, and particularly for those with intermediate or favorable risk genetic groups or cytogenetic risk groups just because we achieve high rates of remission. Our 30-day induction mortality rates are lower now than they were 10 and 20 years ago. Our supportive care is better. And we still have a busy inpatient hospital service here at Mayo Florida and my colleagues in Rochester and Arizona as well giving intensive therapy. So that remains the backbone of curative therapy for younger adults. We are trying to be a little more discriminating about who we administer that to. We are trying to add targeted agents. We know from, now, two different randomized trials that the addition of a FLT3 inhibitor, either midostaurin or more recently quizartinib, has a survival advantage in patients with a FLT3 mutation, or for quizartinib, a FLT3/ITD mutation. And so yes, ‘7+3' remains important. Off protocol for somebody who just comes in with acute leukemia in a 40-year-old or 30-year-old or even early 60s and fit, we would still be considering ‘7+3' therapy and then waiting for an expedited gene mutation panel and an expedited cytogenetics panel to come back to help us discriminate is that a patient for whom we should be giving a FLT3 inhibitor? I think there's a little more nuance about when we do a day 14 bone marrow, do they really matter as much anymore? I still do them. Some of my colleagues find them less important. But we're still giving intensive therapy. We're still giving high-dose ARA-C consolidation for younger patients who achieve complete remission. In older adults, it's a different story. You know, it was only in the early part of the 2000s – 2004, 2007 range – where we really got buy-in from randomized studies that low-dose therapy was better than no therapy. There was a lot of nihilism before then about therapy for older adults, especially over age 75. We know that low-dose ARA-C is better than nothing. It looked like azacitidine was better than ARA-C or at least equivalent or slightly better. But with the advent of venetoclax it was a game changer. I ran a national randomized study of intensive therapy in AML. It was the last national randomized study of intensive therapy in older patients right before venetoclax got approved. And we were very excited about our results, and we thought we had some really interesting clinical results. And suddenly that's a little bit obsolete in patients over 70 and particularly over age 75 because of the high remission rates with azacytidine venetoclax or hypomethylating agents, so-called HMAs and venetoclax and the survival advantage. Now, it's not a home run for everybody. We quote 60% to 70% remission rates, but it's a little different based on your cytogenetics and your mutation profile. You have to continue on therapy so it's continuous treatment. It's not with curative intent, although there are some people with long-term remission in it. And the median survival went from 10 months to 15 months. So home run? No, but definitely improved remissions, meaningful for patients off transfusions and better survival. So right now it's hard to find an older adult who you wouldn't give azacitidine and venetoclax or something similar, decitabine, for instance, and venetoclax, unless somebody really was moribund or had very poor performance status or some reason not to. And so ‘7+3' is still relevant in younger adults. We're trying to get better results with ‘7+3' by adding targeted agents and azacitine and venetoclax in older adults. I think the area of controversy, I guess there are two of them, is what to do in that overlap age between 60 and 75. Should people in that age still get intensive therapy, which we've used for years – the VIALE-A trial of aza-venetoclax was age 75 plus – or with cardiac comorbidities? And I think if you're 68 or 72, many of us are starting to bias towards aza-venetoclax as generally being better tolerated, generally being more outpatient, generally being slow and steady way to get a remission. And it doesn't stop you from going to transplant for somebody who might still be a candidate. The other area of controversy is somebody under 60 who has adverse cytogenetics where we don't do very well with ‘7+3,' we still give it and we might do just as well with decitabine venetoclax. A lot of us feel that there's equipoise in the 60 to 75 group where we really can ask a question of a randomized study. Retrospective studies might suggest that intensive therapy is a little better, but there are now a couple of randomized studies happening saying, “Can we replace ‘7+3' in that intermediate age with aza-venetoclax?” And for younger adults similarly, we're looking to see how we apply that technology. Those are the areas where we're really trying to investigate what's optimal for patients and that's going to require randomized trials. Dr. John Sweetenham: Oh, that's great, thank you. And I'll just extend that question a little bit more, particularly with respect to the new targeted therapies. How much are they impacting the treatment of these patients in the relapse and refractory setting now? Dr. James Foran: Oh, they're definitely impacting it. When I trained and probably when you trained, AML was still a medical emergency. But that was the thing that you admitted to the hospital immediately, you started therapy immediately. The rule was always that's the one thing that brings the fellow and the consultant in at night to see that new patient on a Friday or Saturday. Now, we'll still admit a patient for monitoring, but we try not to start therapy for the first three or five or seven days if they're stable, until we get those genetics and those genomics back, because it helps us discriminate what therapy to pursue. And certainly, with FLT3 mutations, especially FLT3/ITD mutations, we're adding FLT3 inhibitors and we're seeing a survival advantage. Now, on the surface, that survival advantage is in the range of 7% or 10%. But if you then pursue an allogeneic transplant in first remission, you're taking disease where we used to see 30%, 40% long-term survival, maybe less, and you're pushing that to 60%, 70% in some studies. And so we're now taking a disease that– I don't want to get off topic and talk about Ph+ ALL. But that's a disease where we're actually a little excited. We have a target now, and it used to be something really adverse and now we can do a lot for it and a lot about it. The other mutations, it's a little more subtle. Now, who knew until 2010 that a mutation in a sugar metabolism gene, in isocitrate dehydrogenase, or IDH was going to be so important, or even that it existed. We know that IDH1 and IDH2 mutations are still a minority of AML, certainly less than 10% to 15%, maybe overall. But we're able to target those with specific IDH1 and IDH2 inhibitors. We get single-agent responses. There are now two approved IDH1 inhibitors on the market. We don't yet have the randomized data that adding those to intensive therapy is better, but we're getting a very strong hint that it might be better in older adults who have an IDH mutation, maybe adding those is helpful and maybe adding those to low-intensity therapy is helpful. Those studies are ongoing, and we're also trying with low-intensity treatments to add these agents and get higher remission rates, deeper remissions, longer remissions. I think a lot of work has to be done to delineate the safety of that and the long-term efficacy. But we're getting hints it's better, so I think it is impacting. The other area it's impacting is when you pick up adverse mutations and those have crept into our classification systems like an ASXL1 mutation or RUNX1 mutation for instance, or some of the secondary AML mutations like BCOR and others, where that's helping us discriminate intermediate-risk patients who we think aren't going to do as well and really helping us select a group who's more likely to get benefit from allogeneic transplant or for whom at least our cure rates without allo transplant are low. And so I think it's impacting a lot. Dr. John Sweetenham: Great. And I'm going to pick up now, if I may, on a couple of things that you've just mentioned and continue the theme of the relapsed and refractory setting. We've started to see some reports which have looked at the role of immune strategies for patients with AML, in particular CAR T or NK cells. Can you comment a little on this and let us know whether you think either these two strategies or other immune strategies are likely to have a significant role in AML in the future? Dr. James Foran: They are, but I think we're still a step behind finding the right target or the right way to do it. If you think of allogeneic transplantation as the definitive immune therapy, and we know for adverse AML we can improve survival rates and cure rates with an allotransplant, then we know inherently that immune therapy matters. And so how do we do what they've done in large cell lymphoma or in CD19 targeting for B cell malignancies? How do we bring that to acute myeloid leukemia? There have been a number of efforts. There have been at least 50 trials looking at different targets. CD33, CD123, CD7, others, CLL-1. So, there have been a number of different trials looking at how to bind a CAR T or a CAR T construct that can be active. And we have hints of efficacy. There was kind of a provocative paper in the New England Journal of Medicine a year ago in April of last year from a Chinese group that looked at a CD7-based CAR T and it was 10 patients, but they used CD7 positive acute leukemia, AML or ALL and had a CD7-targeted CAR T and they actually incorporated that with a haploidentical transplant and they had really high remission rates. People tolerated it quite well. It was provocative. It hasn't yet been reproduced on a larger scale, but the strong hints that the strategy is going to work. Now, CD33 is a little tricky to have a CAR T when CD33 is expressed on normal hematopoietic cells. CD123 likewise. That's been something where there's, I think, still promise, but we've struggled to find the trials that make that work. Right now, there's a lot of interest in leveraging NK cells and looking, for a couple of reasons, but NK cells are attractive and NK cell markers might be attractive targets. NK cells might have similar degrees of immune efficacy. It's speculative, but they are likely to have less cytokine release syndrome and less neurotoxicity than you see with CAR T. And so it's kind of attractive to leverage that. We have had some ongoing trials looking at it with bispecifics and there certainly are trials looking at it with CAR NK-based strategies. One of the antigens that people looked at is the NK group 2D. NK group 2D or NKG2D is overexpressed in AML and its ligands overexpressed. And so that's a particular potential target. So, John, it's happening and we're looking for the hints of efficacy that could then drive a pivotal trial to get something approved. One of the other areas is not restricting yourself just to a single antigen. For instance, there is a compound that's looking at a multi-tumor-associated antigen-specific T-cell therapy, looking at multiple antigens in AML that could be overexpressed. And there were some hints of activity and efficacy and actually a new trial looking at a so-called multi-tumor associated antigen-specific T cell therapy. So without getting into specific conflicts of interest or trials, I do think that's an exciting area and an evolving area, but still an investigational area. I'll stop there and say that we're excited about it. A lot of work's going there, but I'm not quite sure which direction the field's going to pivot to there. I think that's going to take us some time to sort out. Dr. John Sweetenham: Yeah, absolutely. But as you say, exciting area and I guess continue to watch this space for now. So you've mentioned allogeneic stem cell transplants two or three times during this discussion. Recognizing that we don't have an imatinib for AML, which has kind of pushed transplant a long way further back in the treatment algorithm, can you comment a little on, you know, whether you think the role of stem cell transplantation is changing in AML or whether it remains pretty much as it was maybe 10 years ago? Dr. James Foran: By the way, I love that you use imatinib as an introduction because that was 6 TKIs ago, and it tells you the evolution in CML and you know, now we're looking at myristoyl pocket as a target, and so on. That's a great way to sort of show you the evolution of the field. Allogeneic transplant, it remains a core treatment for AML, and I think we're getting much smarter and much better about learning how to use it. And I'm just going to introduce the topic of measurable residual disease to tell you about that. So I am a little bit of a believer. Part of my job is I support our allogeneic transplant program, although my focus is acute myeloid leukemia, and I've trained in transplant and done it for years and did a transplant fellowship and all that. I'm much more interested in finding people who don't need a transplant than people who do. So I'm sort of looking for where can we move away from it. But it still has a core role. I'll sidestep and tell you there was an MDS trial that looked at intermediate or high-risk MDS and the role of allogeneic transplant that shows that you about double your survival. It was a BMT CTN trial published several years ago that showed you about double your three-year survival if you can find a donor within three months and get to a transplant within six months. And so it just tells you the value of allotransplant and myeloid malignancy in general. In AML we continue to use it for adverse risk disease – TP53 is its own category, I can talk about that separately – but adverse risk AML otherwise, or for patients who don't achieve a really good remission. And I still teach our fellows that an allotransplant decreases your risk of relapse by about 50%. That's still true, but you have to have a group of patients who are at high enough risk of relapse to merit the non-relapse mortality and the chronic graft versus host disease that comes with it. Now, our outcomes with transplant are better because we're better at preventing graft versus host disease with the newer strategies such as post-transplant cyclophosphamide. There are now new FDA-approved drugs for acute and chronic graft versus host disease, ruxolitinib, belumosudil, axatilimab now. So we have better ways of treating it, but we still want to be discriminating about who should get it. And it's not just a single-minded one-size-fits-all. We learned from the MORPHO study that was published in the JCO last year that if you have FLIT3-positive AML, FLIT3/IDT-positive AML, where we would have said from retrospective studies that your post-transplant survival is 60% give or take, as opposed to 15% or 20% without it, that we can discriminate who should or shouldn't get a transplant. Now that trial was a little bit nuanced because it did not meet its primary endpoint, but it had an embedded randomization based upon MRD status and they used a very sensitive test of measurable residual disease. They used a commercial assay by Invivoscribe that could look at the presence of a FLT3/ITD in the level of 10 to the minus 5th or 10 to the minus 6th. And if you were MRD-negative and you went through a transplant, you didn't seem to get an advantage versus not. That was of maintenance with gilteritinib, I'll just sort of put that on there. But it's telling us more about who should get a transplant and who shouldn't and who should get maintenance after transplant and who shouldn't. A really compelling study a year ago from I don't know what to call the British group now, we used to call them the MRC and then the NCRI. I'm not quite sure what to call their studies at the moment. But Dr. Jad Othman did a retrospective study a year ago that looked at patients who had NPM1 mutation, the most common mutation AML, and looked to see if you were MRD positive or MRD negative, what the impact of a transplant was. And if you're MRD negative there was not an advantage of a transplant, whereas if you're MRD positive there was. And when they stratified that by having a FLT3 mutation that cracked. If you had a FLT3 mutation at diagnosis but your NPM1 was negative in remission, it was hard to show an advantage of a transplant. So I think we're getting much more discriminating about who should or should not get a transplant by MRD testing for NPM1 and that includes the patients who have a concomitant FLT3 mutation. And we're really trying to learn more and more. Do we really need to be doing transplants in those who are MRD-negative? If you have adverse risk genetics and you're MRD-negative, I'll really need good data to tell me not to do a transplant, but I suspect bit by bit, we'll get that data. And we're looking to see if that's really the case there, too. So measurable residual disease testing is helping us discriminate, but there is still a core role of allogeneic transplant. And to reassure you, compared to, I think your allotransplant days were some time ago if I'm right. Dr. John Sweetenham: Yes. Dr. James Foran: Yeah. Well, compared to when you were doing transplants, they're better now and better for patients now. And we get people through graft versus host disease better, and we prevent it better. Dr. John Sweetenham: That's a great answer, James. Thanks for that. It really does help to put it in context, and I think it also leads us on very nicely into what's going to be my final question for you today and perhaps the trickiest, in a way. I think that everything you've told us today really emphasizes the fact that the complexity of AML treatment has increased, primarily because of an improved understanding of the molecular landscape of the disease. And it's a complicated area now. So do you have any thoughts on what type of clinical environment patients with AML should be evaluated and treated in in 2025? Dr. James Foran: Yeah, I want to give you a kind of a cautious answer to that because, you know, I'm a leukemia doctor. I work at a leukemia center and it's what we focus on. And we really pride ourselves on our outcomes and our diagnostics and our clinical trials and so on. I am very aware that the very best oncologists in America work in private practice and work in community practice or in networks, not necessarily at an academic site. And I also know they have a much harder job than I have. They have to know lung cancer, which is molecularly as complicated now as leukemia, and they have to know about breast cancer and things that I don't even know how to spell anymore. So it's not a question of competence or knowledge. It's a question of infrastructure. I'll also put a little caveat saying that I have been taught by Rich Stone at Dana-Farber, where I did a fellowship a long time ago, and believe Rich is right, that I see different patients than the community oncologists see with AML, they're seeing different people. But with that caveat, I think the first thing is you really want to make sure you've got access to excellence, specialized hematopathology, that you can get expedited cytogenetics and NGS testing results back. There was a new drug, approved just a few months ago, actually, for relapsed AML with a KMT2A rearrangement, revumenib. We didn't talk about the menin inhibitors. I'll mention them in just a second. That's a huge area of expansion and growth for us. But they're not found on NGS platforms. And normal cytogenetics might miss a KMT2A-rearrangement. And we're actually going back to FISH panels, believe it or not, on AML, to try to identify who has a KMT2A-rearrangement. And so you really want to make sure you can access the diagnostic platforms for that. I think the National Referral Labs do an excellent job. Not always a really fast job, but an excellent job. At my institution, I get NGS results back within three days or four days. We just have an expedited platform. Not everybody has that. So that's the key, is you have to be able to make the diagnosis, trust the pathologist, get expedited results. And then it's the question of trying to access the targeted medications because a lot of them are not carried in hospital on formulary or take time to go through an insurance approval process. So that's its own little headache, getting venetoclax, getting gilteritinib, getting an IDH1 inhibitor in first line, if that's what you're going for. And so I think that requires some infrastructure. We have case managers and nurses who really expedite that and help us with it, but that's a lot of work. The other piece of the puzzle is that we're still with AML in the first month and maybe even the second month. We make everybody worse before we make them better. And you have to have really good blood bank support. I can give an outpatient platelet transfusion or red cell transfusion seven days a week. We're just built for that. That's harder to do if you're in a community hospital and you have to be collaborating with a local blood bank. And that's not always dead easy for somebody in practice. So with those caveats, I do find that my colleagues in community practice do a really good job making the diagnosis, starting people on therapy, asking for help. I think the real thing is to be able to have a regional leukemia center that you can collaborate with, connect with, text, call to make sure that you're finding the right patients who need the next level of diagnostics, clinical trial, transplant consults, to really get the best results. There was some data at ASH a couple of years ago that looked at – the American Society of Hematology and ASCOs had similar reports – that looked at how do we do in academic centers versus community practice for keeping people on therapy. And on average, people were more likely to get six cycles of therapy instead of three cycles of therapy with azacitidine venetoclax at an academic center. Now, maybe it's different patients and maybe they had different cytogenetics and so on, but I think you have to be patient, I think you have to collaborate. But you can treat those patients in the community as long as you've got the infrastructure in place. And we've learned with virtual medicine, with Zoom and other platforms that we can deliver virtual care more effectively with the pandemic and beyond. So I think we're trying to offer virtual consults or virtual support for patients so they can stay in their home, stay in their community, stay with their oncologists, but still get access to excellent diagnostics and supportive care and transplant consults, and so on. I hope that's a reasonable answer to that question. It's a bit of a nuanced answer, which is, I think there's an important role of a leukemia center, and I think there's a really fundamental role of keeping somebody in the community they live in, and how we collaborate is the key to that. And we've spent a lot of time and effort working with the oncologists in our community to try to accomplish that. John, I want to say two other things. I didn't mention in the molecular platforms that NPM1 mutations, we can now target those on clinical trials with menin inhibitors. We know that NPM1 signals through the Hoxa9/Meis1 pathway. We know that similar pathways are important in KMT2A rearrangements. We know that there are some other rare leukemias like those with NUP98 rearrangement. We can target those with menin inhibitors. The first menin inhibitor, revuminib, was approved by the FDA for KMT2A. We have others going to the FDA later this year for NPM1. There are now pivotal trials and advanced expanded phase 1/2 studies that are showing 30% response rates. And we're looking to see can we add those into the first-line therapy. So, we're finding more targets. I'll say one last thing about molecular medicine. I know I'm a little off topic here, but I always told patients that getting AML was kind of like being struck by lightning. It's not something you did. Now, obviously, there are risk factors for AML, smoking or obesity or certain farm environments, or radioactive exposures and so on. But bit by bit, we're starting to learn about who's predisposed to AML genetically. We've identified really just in the last five or eight years that DDX41 mutations can be germline half the time. And you always think germline mutations are going to cause AML in a younger patient, but the median age is 60 to 70 just like other AMLs. They actually might do pretty well once they get AML. We've reported that in several papers. And so we're trying to understand who that has a RUNX1 mutation needs germline testing, who with a DDX41 needs germline testing. And we're trying to actually come up with a cleaner pathway for germline testing in patients to really understand predisposition, to help with donor selection, to help with family counseling. So I think those are other areas where a leukemia center can contribute for somebody in who's community practice to understand genomic or genetic complexity in these patients. And we're starting to develop the databases that support that. Dr. John Sweetenham: Yeah, great. Thanks, James. I loved your answer about the clinical environment too. And I know from a patient-centric perspective that I know that patients would certainly appreciate the fact that we're in a situation now where the folks taking care of them will make every effort to keep them close to home if they possibly can. I want to thank you, James, for an incredible review of a very complex subject and I think you did a great job. I think we all will have learned a lot. And thanks again for being willing to share your insights with us today on the ASCO Daily News Podcast. Dr. James Foran: John, it's my pleasure. And as you know, I'll do anything for a latte, so no problem at all. Dr. John Sweetenham: Okay. I owe you one, so thank you for that. And thank you to our listeners for your time today. You'll find links to the studies we've discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. John Sweetenham Dr. James Foran 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. James Foran: Stock and Other Ownership Interests: Aurinia Pharmaceuticals Consulting or Advisory Role: Peerview, CTI BioPharma Corp, Remix Therapeutics, Cardinal Health, Medscape, Syndax, Autolus Therapeutics Research Funding (Inst.): Chordia Therapeutics, Abbvie, Actinium Pharmaceuticals, Kura Oncology, Sellas Life Sciences, Novartis, Roivant, Celgene/Bristol-Myers Squibb, Astellas Pharma, SERVIER Travel, Accommodations, Expenses: Peerview
In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
Concerned about VTE prevention in your facility? This episode explores how standardized protocols and technology can improve patient outcomes and operational efficiency. Join Dr. Parth Rali as he shares his experience at Temple University Hospital, including the creation of their Anticoagulation Stewardship Committee. You'll learn how standardizing care can lead to better decision-making and better results for patients. See References & Disclaimers.This episode is sponsored by Cardinal Health.
Patricia Kienle, Cardinal Health, and Mike Ganio , ASHP , join us to discuss the compounding educational line up at the ASHP Pharmacy Futures meeting in June and explain the unique opportunity to participate in the Designated Person Program that offers a live skills workshop on Wednesday June 11th. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
Join Jason Callori and special guest Kim Stokell, Director of Consumer Health Marketing at Cardinal Health, as they dive deep into front-end optimization. This episode explores the importance of a well-designed and merchandised front-end space, how to identify your customer base and their health priorities, and the role of private label products in driving sales. Kim shares valuable insights on how to create a high-performing front end that enhances patient care, boosts profits, and positions your pharmacy as a trusted resource in your community. Learn about the latest trends in customer buying habits, the importance of community engagement, and how to achieve front-end success.
Join Jason Callori and special guest Kim Stokell, Director of Consumer Health Marketing at Cardinal Health, as they dive deep into front-end optimization. This episode explores the importance of a well-designed and merchandised front-end space, how to identify your customer base and their health priorities, and the role of private label products in driving sales. Kim shares valuable insights on how to create a high-performing front end that enhances patient care, boosts profits, and positions your pharmacy as a trusted resource in your community. Learn about the latest trends in customer buying habits, the importance of community engagement, and how to achieve front-end success.
Dr. Shaalan Beg and Dr. David Wang discuss key abstracts in GI cancers from the 2025 ASCO Gastrointestinal Cancers Symposium, including major advances in CRC, neoadjuvant approaches in esophageal cancer, and innovative studies on ctDNA. TRANSCRIPT Dr. Shaalan Beg: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Shaalan Beg. I'm a medical oncologist and an adjunct associate professor at UT Southwestern Medical Center in Dallas. Today, we're bringing you some key highlights from the 2025 ASCO Gastrointestinal Cancers Symposium, and I'm delighted to be joined by the chair of GI25, Dr. David Wang. Dr. Wang is a GI medical oncologist at the University of Michigan. Our full disclosures are available in the transcript of this episode. Dr. Wang, thanks for coming on the podcast today. Dr. David Wang: Well, thank you. It's a pleasure to be here. Dr. Shaalan Beg: GI25 featured major therapeutic advances across the spectrum of GI malignancies, and it was exciting to hear about innovations and novel approaches that are shaping the future of our field. Before we start talking about specific abstracts, could you share some of your key highlights from the meeting? Dr. David Wang: Sure. Our theme this year was “Breaking Boundaries to Enhance Patient Centered Care.” Past years' themes have focused more on precision oncology, but we wanted to broaden our focus on patients and to be more holistic, which kind of led us into some of the Intersection [sessions] that we had. Each day started with a different Intersection. The first one was “Emerging Therapies in GI Cancers”, where invited speakers talked about bispecific antibody drug conjugates, theranostics, CAR T and other cell-based therapies. The second day was on “Personalized Risk Assessment for GI Cancers,” and this included looking at polygenic risk scores for colorectal cancer, microRNAs and liquid biopsies such as exosomes and pancreatic cancer and non-endoscopic screening modalities in esophageal cancer. And on our final day, we wanted to talk about “Integrative Oncology and Integrative Medicine,” looking at evidence-based uses of acupuncture and supplements in patients who are receiving treatment for cancer, mindfulness-based practices and exercise. And of course, we had a fantastic keynote talk by Dr. Pamela Kunz from the Yale School of Medicine titled, “Disrupting Gastrointestinal Oncology: Shattering Barriers with Inclusive Science.” She highlighted the intersection of science, patient care, and health and gender equity. And I would encourage your podcast listeners to access the lecture in ASCO's Meeting Library if they haven't yet had a chance to hear Dr. Kunz's wonderful lecture. We were really happy this year because the attendance hit a new record. We had over 5,000 people attend either in person or virtually from their home or office, and we had almost 1,000 abstracts submitted to the meeting, so these were either record or near record numbers. We offered a lot of different networking opportunities throughout the meeting, and attending found these to be incredibly rewarding and important and this will continue to be an area of emphasis in future meetings. Dr. Shaalan Beg: Let's take a deeper dive into the exciting studies presented at GI25. The late breaking abstract LBA143 was CheckMate-8HW. This was the first results of NIVO + IPI versus NIVO monotherapy for MSI-high metastatic colorectal cancer. What are your thoughts about this study? Dr. David Wang: Yeah, so we know that colorectal cancer patients with MSI-high tumors don't necessarily respond well to chemotherapy. And we were fortunate because last year CheckMate-8HW actually looked at two different arms – so this was NIVO + IPI compared to standard of care chemotherapy and showed its very significant improvement in median progression-free survival. And that was actually published in the New England Journal of Medicine back in November of 2024. This year's presentation actually focused now on NIVO + IPI versus NIVO monotherapy. And as you know IPI+NIVO can be quite toxic. So this was an important analysis to be done. So we know that NIVO is definitely more easily tolerated. So what was interesting was that the 2-year and 3-year progression-free survival not surprisingly favored IPI+NIVO and this was statistically significant. And the overall response rate was also better with IPI+NIVO versus NIVO alone. I know we're always concerned about toxicities and there were higher grade 3 and 4 toxicity incidences in the combination arm versus the monotherapy arm, but overall, only about 28 additional events in several hundred patients treated. So I think that's well-tolerated. Our discussant Dr. Wells Messersmith actually said that, with this new data, he would consider doing combination immunotherapy in any patient that presented in the front line with MSI-high or deficient mismatch repair colorectal cancer that was metastatic. Dr. Shaalan Beg: One of the focuses for directing first-line therapy for colorectal cancer has been right and left sided colon cancer because we know these are two different cancers with their own unique molecular subtypes. We heard on Abstract 17, the DEEPER trial, the final analysis of modified FOLFOXIRI plus cetuximab versus bevacizumab for RAS wild-type and left sided metastatic colorectal cancer. How do you summarize the findings of this study and what should our readers be aware of? Dr. David Wang: Interestingly, this was a phase 2 study and the emphasis of the abstract was actually a subgroup analysis of those patients with RAS wild-type and BRAF wild-type as well as left sided cancers. So, I think the entire study enrolled 359 patients, but the analysis that was discussed at the meeting really focused on 178 patients that fit that characteristic. Very similar to what we've seen in prior studies, left-sided tumors have better response to cetuximab versus bevacizumab. And if you flip it so that you now are looking at right sided tumors, targeting EGFR is actually detrimental. The depth of response was better with cetuximab in these left sided RAS and BRAF mutant tumors. And so the lead author actually suggested that this could be a new first-line standard of care. And the question is, is there a benefit of doing this triple agent regimen with modified FOLFIRINOX? We know there's a lot more toxicity with that. Not clear that there's a benefit for that over FOLFOX, maybe in younger patients that could tolerate it. When our discussant, again Dr. Wells Messersmith, spoke about this, he said that, in his practice he would, again, favor cetuximab over bevacizumab in combination with chemo, these left-sided RAS and BRAF wild-type tumors, but that he would actually prefer a doublet versus a triplet chemo regimen, and that is consistent with the current NCCN guidelines. Dr. Shaalan Beg: Another area where colorectal cancer has been a wonderful model to study new technology has been in the area of circulating tumor DNA (ctDNA). And the BESPOKE CRC trial is looking to see if ctDNA can inform adjuvant treatment decisions for stage II and III colorectal cancer. And in Abstract 15, we heard final results of the BESPOKE CRC sub-cohort. What were the findings there? Dr. David Wang: BESPOKE CRC is another one of these important ctDNA studies. It was an observational study, not a randomized trial, but it did provide a lot of different insights to us. We know that there were over 1,700 patients enrolled, and so it was reported that this is the largest ctDNA study in colorectal cancer performed in the United States. And they were able to analyze over 1,100 patients. Some of the key findings were that postoperative adjuvant therapy management decisions actually changed in 1 out of 6 patients, so that's pretty significant. In terms of surveillance, we know that patients who have ctDNA positivity, this is prognostic of recurrence. In terms of patients who have positive ctDNA post-surgery, it looked like, at least in this observational study, the majority of patients who received any benefit were those who had positive ctDNA. So adjuvant therapy, even in stage II and stage III patients seemed to only benefit those patients who have positive ctDNA. I think that does raise the question, and this also was brought up in the discussion, which is “Can we de-escalate adjuvant therapy in terms of patients who are ctDNA-negative post-op?” And Dr. Richard Kim from Moffitt felt that we are not yet there. Obviously, we need randomized control trials where we are taking ctDNA results and then randomizing patients to receive adjuvant or non-adjuvant to really know the difference. Other questions that come up with use of ctDNA include: What do you do with these patients who turn positive? This study for BESPOKE actually followed patients out to two years after surgery. So what you do with a positive ctDNA result wasn't really clear. It seems to suggest that once you turn positive, patients go on to more intensive surveillance. You know, again as an observation, patients who did turn positive were able to go to metastasis-directed therapy much more quickly. And again, this was supposedly to improve their curative intent therapy. And I think the other question that has been brought up all the time is, is this really cost effective? Patients want to know, and we want to give patients that information, but I think we're still stuck with what to do with a positive ctDNA level in a patient that's on surveillance because no randomized control studies have actually suggested that we need to start systemic therapy right away. Dr. Shaalan Beg: Yeah. And I guess in terms of practice informing or practice changing, these results may not give us a clear answer. But because a lot of patients are asking for these tests, it does give us some real world experiences on what to expect in terms of conversion of these positive into negative and the outcome so we can have a shared decision making with our patients in the clinic and then come up with a determination on whether ctDNA for molecular residual disease is something which would be worthwhile for the care of our patient. But more to come, I guess, in coming years to answer different problems around this challenge. Dr. David Wang: Yes, I agree. Dr. Shaalan Beg: The BREAKWATER trial looked at the use of encorafenib, cetuximab and chemotherapy for BRAF V600E-mutant metastatic colorectal cancer. We've covered this combination for a second- third-line treatment in metastatic colorectal cancer previously. Abstract 16 from GI25 was evaluating the use of this regimen in the first-line space. Everyone was looking forward to these results, and what did the investigators present? Dr. David Wang: I think this is, as you mentioned, a nice follow up to later lines of therapy where Dr. Kopetz from MD Anderson pioneered use of encorafenib, cetuximab and binimetinib in the BEACON trial. Everybody was kind of curious what would happen now if you use encorafenib plus cetuximab plus chemotherapy in the first-line setting. And so this is an interim analysis that was pre-planned in the phase 3 open label BREAKWATER trial. And even though there were three arms, and so the three arms were encorafenib plus cetuximab, encorafenib plus cetuximab plus FOLFOX, or standard of care chemo, only two arms were presented in the abstract. So basically looking at encorafenib plus cetuximab and FOLFOX-6 versus standard of care therapy, and the overall response rate was statistically significant with a 60.9% overall response rate encorafenib plus cetuximab plus chemo arm versus standard of care chemo was only 40%. The interim overall survival also was different. It was 92% versus 87% at 6 months and 79% versus 66% at 12 months, again favoring the chemotherapy plus encorafenib plus cetuximab. In terms of the statistics, the p was 0.0004. However, the pre-plan analysis required the p-value to be 1x10 to the -8. And so even though this looks really good, it hasn't quite met its pre-specified significance level. The good thing is that this is only interim analysis and the study is ongoing with future analysis planned. So the real question is: Does it matter when we actually use this regimen? We know that the regimen's approved in the second third-line setting. What about in the first line? And there was some preclinical data that the discussant reviewed that shows that patients actually benefit if this is done in the first-line setting. For example, there was some preclinical data showing that even FOLFIRI, for example, can upregulate RAS, which would make tumors more resistant to this combination. This was thought to be practice-changing in a patient that has B600E showing up treatment naive that we should probably consider this regimen. And actually this did receive accelerated FDA approval about a month ago. Dr. Shaalan Beg: Yeah, and for what it's worth, I put up a Twitter poll asking my Twitter followers on how the BREAKWATER trial results will change their approach for newly diagnosed BRAF mutated colorectal cancer. We got 112 responses; 72% said that they will incorporate encorafenib, cetuximab, FOLFOX for their frontline BRAF mutated patients. But 23% said that they would like to wait for overall survival results. Dr. David Wang: Wow, that's interesting. They really want that 1x10 to the -8. Dr. Shaalan Beg: I guess so. All right. Let's change gears and talk about esophageal cancer. LBA329 was the SCIENCE study which presented preliminary results from a randomized phase 3 trial comparing sintilimab and chemoradiotherapy plus sintilimab versus chemoradiotherapy for neoadjuvant resectable locally advanced squamous esophageal cancer. Where are we in this space? Dr. David Wang: Okay. So, yeah, this was an interesting trial. Again, just to set the context, esophageal squamous cell carcinoma is more prevalent in Asia. And the study sites as well as the patients were mostly from Asia. So this was again a phase 3 trial with interim results. They only rolled 146 out of the planned 420 for this interim analysis. And yeah, they're using immune checkpoint inhibitor that we don't use in the United States, sintilimab, combined with their two standards of neoadjuvant therapy, either chemotherapy, which is more common in Asia, or or chemoradiation, which is more common in the US and Western Europe, versus chemoradiation. And so they actually had two primary endpoints, but only were reporting one. So their two primary endpoints were pathCR and the other one was event-free survival. The event-free survival, again, was not reported at the meeting. What they found was that in terms of pathCR rate, if you take the two arms that are really informative about that, chemoradiation plus sintilimab versus chemoradiation alone, the pathCR rate was 60% versus 47%. We know that chemo alone doesn't induce as much of a pathCR rate, and that was 13%. So it was found that the delta in terms of pathCR between the chemoradiation arms, one with sintilimab and one without, was significant. And this actually confirms data again from Asia, like for the ESCORT-NEO trial where it used another immune checkpoint inhibitor pembrolizumab in addition to neoadjuvant chemo. So as our discussant for this abstract said, yes, we know that radiation combined with chemotherapy improves pathCR rates, but we have recent data from the ESOPEC trial, we don't know that that necessarily will translate to overall survival. So again, waiting for additional enrollments and longer term follow up before incorporating this into clinical care here. Dr. Shaalan Beg: So David, how do the results of the SCIENCE trial compare with our practice in the United States and ongoing studies asking questions for neoadjuvant therapy for esophageal carcinoma in the United States? Dr. David Wang: I think obviously immune checkpoint inhibitor in the new adjuvant setting is important. Jennifer Eads at UPenn is running that EA2174 which is looking at chemoradiation plus or minus nivolumab, and then in non-pathCR responders randomized to adjuvant nivolumab per CheckMate 577 or nivolumab with intensification adding ipilimumab. We know that the ESOPEC trial just came out, and was published actually during the meeting, and that really focuses on adenocarcinomas. So adenocarcinomas of the GE junction, distal esophagus, now, we would probably treat very similarly to gastric using perioperative FLOT. However, the standard in the US for esophageal squamous cell carcinoma remains neoadjuvant chemoradiation. We know that squamous cell carcinomas are more exquisitely sensitive to radiotherapy. And then obviously in those patients who don't achieve a pathologic complete response, the expectation would be that they would go on to receive nivolumab per CheckMate 577. Again, the thought is that these tumors are more sensitive to immunotherapy given their higher incidences of mutational changes. And so again, this kind of goes along with the positive results seen in the SCIENCE trial that we just discussed with sintilimab but also EFFECT-neo with pembrolizumab. Obviously, we await the results of Jennifer's trial. Dr. Shaalan Beg: And the last abstract I was hoping we could get your perspective on was Abstract 652, which is a Phase 3 study of everolimus plus lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumors, the STARTER-NET trial. What were the results of this study? Dr. David Wang: So, I just want to give a shout out because we did have a session at this year's GI ASCO that looked at more rare tumors. So appendiceal tumors, neuroendocrine tumors, those kinds of things. So again, I would encourage your listeners to listen to that session if they have interest in that. Another type of rare tumor was adenosquamous tumors. But in terms of the STARTER-NET trial, this was again an interim analysis of his phase 3trial and it was looking at combining everolimus plus lanreotide versus everolimus. So we know that in pancreatic-gastric neuroendocrine tumors, if you have low Ki-67, a well differentiated tumor, that the standard of care really is a somatostatin analog, and sometimes if they're more aggressive, we kind of consider molecular targeted therapy with everolimus. This was asking the question of whether we should do the combination on the frontline. And what was interesting is in this study, the patients were actually more of a poor prognostic set. So they had Ki-67 up to 20% or these were patients that actually had multiple liver lesions. And what they found was a median for progression free survival was improved with a combination out to 29.7 months versus 11.5 months with the somatostatin analog alone, and that the overall response rate was 23% versus 8.3%, again, favoring the combination. If you looked at subgroup analysis, it was actually those patients who had Ki-67 greater than 10%, so the more aggressive tumors, or those with diffuse liver lesions that had the most benefit. So I think that would be the patient population I would consider this new combination with using would be those patients again with poorer prognosis neuroendocrine tumor phenotype. Dr. Shaalan Beg: Thank you very much, Dr. Wang, for sharing your insights with us today and your great work to build a robust GI Cancers Symposium this year. Dr. David Wang: Well, thank you. I mean that really is a cooperative effort. We appreciate all the members of the GI25 Program Committee as well as the ASCO staff that just made it an outstanding meeting. Dr. Shaalan Beg: And thank you to all our listeners for your time today. You'll find links to the abstracts discussed today on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. Shaalan Beg @ShaalanBeg Dr. David Wang Follow ASCO on social media: @ASCO on Twitter @ASCO on BlueSky ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Shaalan Beg: Employment: Science 37 Consulting or Advisory Role: Ipsen, Array BioPharma, AstraZeneca/MedImmune, Cancer Commons, Legend Biotech, Foundation Medicine Research Funding (Inst.): Bristol-Myers Squibb, AstraZeneca/MedImmune, Merck Serono, Five Prime Therapeutics, MedImmune, Genentech, Immunesensor, Tolero Pharmaceuticals Dr. David Wang: Honoraria: Novartis Consulting or Advisory Role: Novartis, Cardinal Health, Bristol-Myers Squibb, BeiGene, Eisai
Every February, families of patients and survivors come together during Feeding Tube Awareness Week to celebrate the positive impact of feeding tubes and challenge the associated stigma. Cardinal Health is proud to join this important conversation by sharing our latest podcast episode, hosted by Christina Rollins, a registered dietitian and nutrition support clinician. In this episode, Christina is joined by Catherine Bennett, a pediatric nutrition expert, who shares her experiences with blenderized tube feeding (BTF). Catherine discusses her journey, the benefits of BTF, and offers practical tips for patients and caregivers. • Benefits of BTF: Improved feeding tolerance and quality of life. • Daily Routines and Methods: Practical tips for patients and caregivers. • Risks and Education: Preventing deficiencies through proper education. • Advice for Clinicians: Managing BTF effectively.
Every February, families of patients and survivors come together during Feeding Tube Awareness Week to celebrate the positive impact of feeding tubes and challenge the associated stigma. Cardinal Health is proud to join this important conversation by sharing our latest podcast episode, hosted by Christina Rollins, a registered dietitian and nutrition support clinician. In this episode, Christina is joined by Katherine Bennett, a pediatric nutrition expert, who shares her experiences with blenderized tube feeding (BTF). Katherine discusses her journey, the benefits of BTF, and offers practical tips for patients and caregivers. • Benefits of BTF: Improved feeding tolerance and quality of life. • Daily Routines and Methods: Practical tips for patients and caregivers. • Risks and Education: Preventing deficiencies through proper education. • Advice for Clinicians: Managing BTF effectively.
Mark T. Hebner is the founder and CEO of Index Fund Advisors, Inc., (IFA), author of the highly regarded book Index Funds: The 12-Step Recovery Program for Active Investors, focused on investor education. Mark's current book and previous editions received praise from financial industry experts and academic luminaries, including John Bogle, David Booth, Burton Malkiel, and Nobel Laureates Harry Markowitz and Paul Samuelson. The book has been nominated as one of the three all-time greatest investment books, along with the writings of John Bogle and Warren Buffett. This book details the possible perils associated with stock picking, mutual fund manager picking, market timing, and other wealth-depleting behaviors. Hebner's 12-Step Program teaches the differences between active and passive investing, explains the emotional triggers that impact investment decisions, and offers an enlightening education on evidence-based investing that may forever change the way an investor perceives the stock market. Hebner is a respected speaker, frequent news contributor and authority on investing. His life's mission is to “change the way the world invests by replacing speculation with education.” Hebner is especially knowledgeable about index funds, portfolio construction and the research indexes designed by Nobel Laureate Eugene Fama and Kenneth French. These indexes provide the building blocks for the prudent evidence-based investment strategies that Hebner implements for his IFA clients. Mark is a Wealth Advisor (Series 65) and has an MBA from the University of California, Irvine and a Bachelor's in Nuclear Pharmacy from the University of New Mexico. He was a member of the Young Presidents' Organization for over 20 years and is currently a member of the World Presidents' Organization and the Chief Executives Organization. Prior to founding Index Fund Advisors in 1999, Mark was President, CEO and co-Founder of Syncor International (previously a public company - SCOR) from 1975 to 1985. In Jan. 2003, Cardinal Health acquired Syncor for approximately $850 million. As a division of Cardinal Health, it is the world's leading provider of nuclear pharmacy services. -- Critical Mass Business Talk Show is Orange County, CA's longest-running business talk show, focused on offering value and insight to middle-market business leaders in the OC and beyond. Hosted by Ric Franzi, business partner at REF Orange County.
Optimal Health Series Central Ohio is growing rapidly, and the region's four major hospital systems are following suit. Each of Columbus' “Big Four” systems – OhioHealth, The Ohio State University Wexner Medical Center, Mount Carmel Health System, and Nationwide Children's Hospital – are expanding rapidly, constructing new facilities and scrambling to hire legions of qualified healthcare professionals. With the region's population expected to grow by 30% in the next 25 years, that may translate into 730,000 new residents – all of whom will require access to healthcare. Can Central Ohio's biggest healthcare players keep pace with demand? This forum features an extraordinary panel featuring the CEOs of all four of the region's major hospital systems for an in-depth exploration of the present and future of healthcare in Central Ohio. Featuring panelists: Dr. Stephen Markovich, President and Chief Executive Officer, OhioHealth Timothy Robinson, Chief Executive Officer, Nationwide Children's Hospital Dr. John Warner, Chief Executive Officer, The Ohio State University Wexner Medical Center and Executive Vice President, The Ohio State University Tauana McDonald, President and Chief Executive Officer, Mount Carmel Health System The host is Greg Moody, Director of Professional Development and the State of Ohio Leadership Institute, John Glenn College of Public Affairs, The Ohio State University. The presenting sponsors of CMC's long-running Optimal Health Series are The Ohio State University Wexner Medical Center, OhioHealth, and Nationwide Children's Hospital. This forum was also sponsored by AstraZeneca, Cardinal Health, Fifth Third Bank, The Healthcare Career Collaborative of Central Ohio Powered by Aspyr, Mount Carmel Health System, and CK Construction. The presenting sponsor of the CMC livestream was The Center for Human Kindness at the Columbus Foundation. CMC's livestream partner was The Columbus Dispatch. This forum was also supported by Vue Columbus. This forum was recorded before a live audience at Vue Columbus in Columbus, Ohio's historic Brewery District on January 22, 2025.
Rashmi Airan is a captivating and motivational speaker, consultant, and catalyst for transformation with a mission to foster organizational cultures centered around authenticity. Her powerful story transcends the pitfalls of making a life-altering decision; it's a tale of leadership, core values, and decision-making, capable of creating a safe haven for courageous and often challenging conversations. As a first-generation immigrant of Indian descent raised with lofty expectations, Rashmi excelled as a lawyer, graduating with honors from Columbia Law School. After gaining experience at major corporations, she embarked on an independent law practice in Miami. During the housing boom, she developed an ethical blind spot collaborating with a real estate developer engaged in questionable practices. Driven by her desire for success to provide for her children, Rashmi refrained from questioning her client's actions despite her inner voice urging caution. This led to a federal prison sentence for bank fraud. During her six months in federal prison, Rashmi found inner peace and self-forgiveness. This humbling yet invaluable experience made her realize that while living with remorse is one thing, allowing it to define one's identity is another. Now a "recovering lawyer and investment banker," female leader, and community entrepreneur, Rashmi is an internationally recognized keynote speaker and TEDx presenter. With over thirty years of real-world experience in finance, business and law, Rashmi Airan intimately understands the complexities modern leaders face. Her expertise is bolstered by years of research in behavioral psychology and collaborations with renowned global brands like Coca-Cola, Cardinal Health, Merck, Comcast, Sotheby's, and Hershey's. Deloitte has recognized the transformative power and relatability of Rashmi's journey, which spans from an Ivy League education to federal prison.
What if you could uncover hidden cost savings throughout your healthcare supply chain? This week on Power Supply, Iliana Isherwood, Supply Chain Sales Executive at Cardinal Health, joins us to reveal proven strategies for identifying and capturing often-overlooked savings opportunities. From streamlining processes to optimizing vendor partnerships, Iliana shares how organizations can build a sustainable pipeline of value-driven initiatives. Whether you're looking to enhance purchased services or improve vendor relationships, this episode offers valuable approaches for achieving measurable results. Tune in today to discover how your team can transform small opportunities into significant wins! Once you complete the interview, jump on over to the link below to take a short quiz and download your CEC certificate for .5 CECs! – https://www.flexiquiz.com/SC/N/ps12-07 #PowerSupply #Podcast #AHRMM #HealthcareSupplyChain #CostSavings #SupplyChainOptimization #VendorPartnerships
In this insightful episode of 10x Your Team with Cam & Otis, Gary Smith joins the discussion to explore the intricacies of strategic planning and its impact on team success. Gary shares his expertise on aligning team efforts with organizational goals, emphasizing the importance of clear communication and adaptability in achieving desired outcomes. The conversation delves into practical strategies for effective leadership, fostering a culture of continuous improvement, and the role of resilience in navigating challenges. Whether you're a leader aiming to enhance your team's performance or a team member seeking to contribute more effectively, this episode offers valuable insights and actionable advice.More About Gary:Gary J. Smith has spent over 30 years in Human Resources, concentrating in the areas of Recruitment, Employee Relations, Training, and Organizational Development and Effectiveness. He has held positions such as: Director of Staffing with Pepsi Cola International; Director, Human Resources with A.O. Smith Corporation; and, Manager of Human Resources with American Hospital Supply Corporation (now Cardinal Health, Inc.) and Pullman, Inc. Prior to forming Smith, Scott & Associates in 1989, Smith was Managing Director for Chicago operations, at the nation's largest search firm specializing in Information Technology recruitment. He has been an active member of the adjunct faculty at DePaul University's Graduate School of Business since 1991. In 2005, Smith also joined the faculty of the University of Colorado as an adjunct lecturer in the College of Business.#10xyourteam #LeadershipStrategies #TeamSucces #StrategicPlanning #EffectiveLeadership #ContinuousImprovement #TeamPerformance #AdaptableLeadership #ResilienceInLeadership #TeamCulture #BusinessInsights #LeadershipDevelopment #OrganizationalGoals #LeadershipPodcast #TeamAlignment #GrowthMindsetChapters:Introduction and Gary's BackgroundTime: 00:00 - 05:00Description: Opening remarks and introduction of Gary Smith, highlighting his journey and expertise in strategic planning.The Importance of Strategic PlanningTime: 05:01 - 15:00Description: Discussion on how strategic planning aligns team efforts with organizational goals.Effective Communication in LeadershipTime: 15:01 - 25:00Description: Gary shares insights on the role of clear communication in achieving team success.Adaptability and ResilienceTime: 25:01 - 35:00Description: Exploring the importance of adaptability and resilience in navigating challenges.Fostering a Culture of ImprovementTime: 35:01 - 45:00Description: Strategies for creating a culture of continuous improvement within teams.Closing Thoughts and Key TakeawaysTime: 45:01 - EndDescription: Final reflections on the discussion and key takeaways for listeners to apply in their own contexts.Gary Smithhttps://www.linkedin.com/in/smithgaryj/https://www.linkedin.com/company/smith-scott&associates/
The health-care logistics market is growing at a faster pace than the general freight market and has become an attractive vertical for providers of freight transportation services. The inherently complex nature of these supply chains due to cargo temperature requirements and safety concerns can warrant higher margins relative to other end markets. In this Talking Transports podcast, Joel Wayment, vice president of 3PL services at Cardinal Health, joins Lee Klaskow, Bloomberg Intelligence senior transportation and logistics analyst, to share his insights about the challenges and opportunities facing health-care supply chains. Wayment also provided his insights into technology innovations, regulations, fraud prevention and how the winner of the Super Bowl could affect the flow of critical goods.See omnystudio.com/listener for privacy information.
What's the true cost of medical supply waste in your facility? On this episode of Power Supply Season 12, Christina Tosto, VP & GM for WaveMark™ Solutions at Cardinal Health, joins us to reveal the true impact of supply waste in our healthcare systems. From leveraging visibility and data to implementing effective communication strategies, Christina shares proven strategies for identifying and eliminating costly waste in healthcare supply chains. Whether you're battling expired supplies or seeking to optimize your operational efficiencies, this episode offers actionable solutions for turning waste reduction into measurable improvements. Tune in now to discover how small inventory management changes can deliver lasting results to your bottom line and patient care outcomes! Once you complete the interview, jump on over to the link below to take a short quiz and download your CEC certificate for .5 CECs! – https://www.flexiquiz.com/SC/N/ps12-04 #PowerSupply #Podcast #AHRMM #HealthcareSupplyChain #WasteReduction #SupplyChainOptimization #PatientCare #CostContainment
S&P futures are down (0.06%), hinting at a flat open. Both the Asian and European markets are down for the day. Asia top stories highlight fears over ongoing economic weakness in China and the impact of Trump's appointment of China hawks. European top stories note the increase in UK unemployment amidst steady wage growth, German CPI, and political tensions with calls for an earlier election in Germany. Companies Mentioned: Coca-Cola, Cardinal Health, Endeavor Group, GE Vernova, Baidu, Amazon
Join special guest host Adam Robinson, Owner of Save-Rite Drugs in Lexington, Kentucky on a multi-episode journey recapping all things Retail Business Conference! Listen in for highlights of Cardinal Health customers, employees, services and solutions offered at RBC 2024! This episode's topic includes Dispill®-USA. This discussion will highlight benefits such as building patient loyalty, medication syncing, and supporting caregivers and patients.
Join special guest host Adam Robinson, Owner of Save-Rite Drugs in Lexington, Kentucky on a multi-episode journey recapping all things Retail Business Conference! Listen in for highlights of Cardinal Health customers, employees, services and solutions offered at RBC 2024! This episode's topic includes Dispill®-USA. This discussion will highlight benefits such as building patient loyalty, medication syncing, and supporting caregivers and patients.
On this episode of the Counter Talk™ Podcast, host Jason Callori speaks with Jerrica Mathis, Vice President of Government Relations, and Bryan Lowe, Director of Government Relations. This episode will explore the perspectives of state and federal government, latest developments in PBM reform and the potential impact of the upcoming election on the pharmaceutical industry.
On this episode of the Counter Talk™ Podcast, host Jason Callori speaks with Jerrica Mathis, Vice President of Government Relations, and Bryan Lowe, Director of Government Relations. This episode will explore the perspectives of state and federal government, latest developments in PBM reform and the potential impact of the upcoming election on the pharmaceutical industry.
Plus: Amazon shares rise after the tech giant reported strong cloud revenue. Cardinal Health shares increase after the drug distributor said the greater use of anti-obesity drugs fueled a double-digit quarterly sales increase. J.R. Whalen reports. Sign up for the WSJ's free What's News newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices
Join special guest host Adam Robinson, Owner of Save-Rite Drugs in Lexington, Kentucky on a multi-episode journey recapping all things Retail Business Conference! Listen in for highlights of Cardinal Health customers, employees, services and solutions offered at RBC 2024! This episode's topic includes Cardinal Health™ Reconciliation. Learn how this solution can provide clear visibility into your pending claims, as well as total reconciled claims.
European bourses are entirely in the green alongside modest strength in US futures following post-earning strength in Amazon/Intel & ultimately outmuscling losses in Apple.Dollar is firmer, CHF sinks after the region's inflation data and JPY pares recent strength.Gilts continue to underperform with benchmarks generally softer pre-Payrolls.Crude is lower as risk-premium returns into the weekend though participants have NFP to navigate first.Looking ahead, US NFP, ISM Manufacturing PMI, Earnings from Ares Management, Dominion Energy, Charter Communications, Imperial Oil, LyondellBasell, Cardinal Health & Cboe Global Markets.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk
Each year, the National Community Pharmacists Association (NCPA), in partnership with Cardinal Health, publishes the NCPA Digest, a comprehensive analysis quantifying and profiling the state of independent community pharmacy. The Digest is designed to help pharmacy owners better manage their business and provide elected officials with data to inform policymaking. Cardinal Health has been a proud sponsor of this annual report since 2008, reiterating our commitment to independent pharmacies and their ongoing success as community healthcare destinations. In this episode, Doug Hoey, CEO of NCPA, and Lisa Schwartz, NCPA's senior director of professional affairs, discuss findings from the 2024 edition of the NCPA Digest with Brad Cochran, executive vice president, pharmaceutical and specialty distribution at Cardinal Health. From patient care services and technological trends to economic impacts and the importance of advocacy, Doug, Lisa and Brad explain how the 2024 NCPA Digest can help independent pharmacists benchmark current business performance and adopt new strategies. Access the Digest here or log in to your NCPA member profile. In this episode, Doug Hoey, CEO of NCPA, and Lisa Schwartz, NCPA's senior director of professional affairs, discuss findings from the 2024 edition of the NCPA Digest with Brad Cochran, executive vice president, pharmaceutical and specialty distribution at Cardinal Health. From patient care services and technological trends to economic impacts and the importance of advocacy, Doug, Lisa and Brad explain how the 2024 NCPA Digest can help independent pharmacists benchmark current business performance and adopt new strategies. Access the Digest here or log in to your NCPA member profile.
This week on the AHRMM Subject Matter Expert Podcast, Pete Bennett, Senior Vice President of Global Supply Chain at Cardinal Health, joins Justin Poulin LIVE during the AHRMM24 Conference in Columbus, OH. Pete discusses his passion for supply chain resiliency, breaking down critical factors like people, processes and tech footprints that keep organizations resilient amid disruptions. He also shares a surprising backstory on his initial healthcare reluctance before recognizing the vital patient impact. Tune in today and discover why supply chain resiliency is critical for safeguarding healthcare and enhancing patient care! #PowerSupply #AHRMM #Podcast #HealthcareSupplyChain #SupplyChainResiliency
“What does my preference card say?” How many times have we been asked that question? How often have our preference cards not been up-to-date and we've pulled the wrong instrument, medication, or supply? Preference cards are a often a source of frustration in our Operating Rooms, but they don't have to be! In today's interview, we dive into the details of preference cards with Jen Nichols, Senior Clinical Consultant at Cardinal Health. Tune in to find out how many different departments one preference card can affect, and be reminded of the one person most affected by accurate or inaccurate preference cards. Don't miss this interview! Love our show? Download our First Case mobile app on:
Join special guest host Adam Robinson, Owner of Save-Rite Drugs in Lexington, Kentucky on a multi-episode journey recapping all things Retail Business Conference! Listen in for highlights of Cardinal Health customers, employees, services and solutions offered at RBC 2024! This episode's topic includes Women in Pharmacy. It will discuss industry insights that are relevant to women pharmacists to help them become more confident, visionary and supportive to other women leaders in the pharmacy industry.
In this podcast, we spoke with Fran Gregory, Vice President of Emerging Therapies at Cardinal Health about the cell and gene therapy landscape, innovative solutions to reduce cost, the regulatory environment, and reimbursement. Fran Gregory brings extensive experience in the biologic drug sector. As a pharmacist, she has worked across various areas, including payer PBM, pharmaceutical manufacturing, and now at Cardinal Health. Gregory oversees the advanced therapy solutions and biosimilars business units, which focus on cell and gene therapies and cost-saving biologics, respectively. Cell and Gene Therapy Landscape In the cell and gene therapy landscape, there are about 25 FDA-approved products in the U.S., split into 35% cell therapies and 65% gene therapies (at the time of the interview, now 38). This field has rapidly evolved since the approval of the first CAR-T cell therapies in 2017, and the FDA continues to support innovation, with a pipeline of around 1,500 products under development. The agency aims to approve over 100 products by 2030, potentially benefiting more than 100,000 patients. Therapeutic areas include oncology, hematology, neurology, diabetes, and even conditions affecting vision and hearing. Gregory notes the unique challenges in this field, such as conducting clinical trials with small patient populations, complex manufacturing processes, and stringent cold chain logistics for distribution. The high cost of these therapies also poses a challenge, as some treatments can cost millions. However, opportunities abound as the healthcare system innovates to improve regulatory processes, distribution methods, and patient experiences. Reducing Cost She explains that the high cost of cell and gene therapies is due to the intensive research, development, and manufacturing requirements, particularly for treatments targeting rare diseases. Although the upfront cost is high, these therapies can offer long-term savings by reducing ongoing medical expenses for patients. New payment models, such as outcomes-based agreements, annuities, and warranties, are being developed to increase patient access and manage costs. One innovative approach is the Cell and Gene Therapy Access Model, inspired by President Biden's 2022 executive order on lowering prescription costs. This model enables CMS to negotiate with manufacturers on behalf of states, enhancing access for patients and encouraging manufacturer participation. The first products under this model, aimed at sickle cell disease, are expected to launch in early 2025. Gregory expresses optimism about the future of these therapies and their potential to drive further healthcare innovation. Regulatory Environment The regulatory environment for cell and gene therapies is evolving quickly as the FDA is committed to expediting the market availability of these products. The agency offers pathways like accelerated approval, where manufacturers can bring products to market based on indicative clinical outcomes and continue gathering real-world evidence post-approval. The FDA's regenerative medicine advanced therapy (RMAT) designation also addresses the small patient populations in cell and gene therapy trials, focusing less on traditional statistical significance. Looking ahead, the FDA will increasingly emphasize outcome measures and closely monitor manufacturing processes to ensure safety and efficiency as technologies evolve. Reimbursement Organizations like the Institute for Clinical and Economic Review (ICER) will also play a significant role in evaluating both clinical and economic outcomes, influencing pricing and reimbursement discussions between manufacturers, governments, and insurers. As the landscape grows, these evaluations will guide not only regulatory decisions but also payment models, ensuring that gene therapies offer value and affordability. Cardinal Health is deeply involved in the commercialization of cell and gene therapies,
Join special guest host Adam Robinson, Owner of Save-Rite Drugs in Lexington, Kentucky on a multi-episode journey recapping all things Retail Business Conference! Listen in for highlights of Cardinal Health customers, employees, services and solutions offered at RBC 2024!
On #TWIRx "This Week in Pharmacy" --we start out with the WORLD WIDE Celebration of Pharmacists, World Pharmacist Day 2024, thank you to all the 4-Million Pharmacists on planet Earth. On September 25, 2024, the global community came together to celebrate World Pharmacists Day, shining a spotlight on the invaluable role pharmacists play in safeguarding public health. (Shout out to Katrina Azer & Anisha Patel) HARMACY Film -- huge announcement from Dr. Anaïs Webster- Mennuti, Dr. Kristin Speer, and Marie Wilda! Go to HarmacyFilm.com Thank you Josh Kent from Cannabis Pharmacy, forwarding education, programs to support independent pharmacy businesses, and delivering highest quality products, check them out CannabisPharmacy.com -- and the Education leaders from the Answer Page with Dr. Stephen Corn, M.D. and Dr. Meredith Fisher-Corn, M.D, they joined the Pharmacy Podcast Network for reliable education for healthcare providers. Thank you Sykes & Company for your services for Pharmacy Owners and accounting management to 'Master the Margins' of your businesses. The Road-Trip Guy is back with another 'Pharmacy CrossRoads' host Bruce Kneeland. This episode is about growing your compounding pharmacy business. We're proud of the Pediatirc Pharmacist leaders, 'Perfecting Peds' and their latest podcast episode on CFTR (Cystic fibrosis), take a listen! Cardinal Health is focused on 'Why Independent Pharmacy' with Barry Christensen on 'Counter Talk' podcast --this is a great podcast about why it's time to build your community pharmacy, Cardinal Health is ready help build your pharmacy in 2025. What's QHIN and how is Surescripts leading the way in 'qualified health information networks' will impact healthcare. We had a wonderful discussion lead by Dr. Simi Burn, PharmD, with special guests Ashton S. Maaraba, J.D. with IPC and Ritesh Patel with FINN Partners for being part of this discussion about #DigitalHealth inside Community Pharmacy today. The 50 Most Influential People in Pharmacy Awards are getting ready to launch! Who do you think is an influential leader in Pharmacy Care? We're so proud to be launching the 4th #Pharmacy50 Awards in October 2024. Shout Out to the # 1 for 2023, Dr. Nadia Ahmad, PharmD --with Walgreens. Thank you Nadia for a special recognition of my work in pharmacy, thank you. First featured guest today on TWIRx is a specialty pharmacy 'Slayer of Healthcare Barriers' Jennifer Noonan, MSN, RN, with Accessia Health, helping patients find funding for their medications when all hope seems lost, this company fights for the patient's pharmacy care. Perigon Pharmacy 360, President Dr. Chris Antypas, PharmD., will be featured at the NASP Annual Event on the PPN's PRess coverage of the conference and he's here with us on TWIRx. Chris shares about how his specialty pharmacy is combining technology, pharmacy care plans, specialty & rare disease specialty pharmacists to innovate pharmacy care. Shaun Jensen with JB Consulting will be at NASP ready to talk about helping Specialty Pharmacies build custom systems, software programs, and APIs to make your workflow, your mobile apps, and how to best leverage A.I. to help dial into your specialty pharmacy operations on another level. Shaun and his team build powerful programs specific to your operations needs. We can't wait to talk with Shaun in Nashville. Thank you Shelia Arquette, CEO of the NASP for your unwavering support of Specialty Pharmacy excellence. Your impact on specialty care has been incredible. See everyone in Nashville.
With the complexity of drug pricing and the evolving healthcare industry, independent pharmacist are able to understand the impact of advocacy within their local, regional and national communities. Pharmacist are taking the initiative to become members of their state legislation and keeping-up-to-date with industry trends. Barry Christensen's, RPh, owner of Island Pharmacy in Ketchikan, Alaska shares the history of his family business and how advocacy can drive the future of the pharmacy profession. Given Island Pharmacy's longstanding history in Ketchikan, and the unpredictable nature of the healthcare industry, Christensen learned early in his career that it's imperative to advocate for the role of independent pharmacists to local, regional and national policymakers. Listen to Barry Christensen's journey of towards advocacy within his community.
Have you ever considered the impact that your choice of surgical gloves can have on your day-to-day work and hand health? In this new First Case Vendor SpotlightTM, Dr. Rosemary Babeaux, the Global Medical Science Lead for the United States at Cardinal HealthTM, returns to discuss the latest advancements in surgical gloves, including the patented Neu-TheraTM moisturizing coating for ProtexisTM Surgical Gloves. Operating room professionals rely on their hands as their primary tools, and choosing the right gloves can significantly enhance their well-being and efficiency. Today's discussion will highlight hand health, and we'll learn about polyisoprene gloves. Join us as we discover how polyisoprene gloves are specifically designed to offer comfort, fit naturally, and reduce skin irritation. Plus, uncover the key ingredients that are carefully chosen to provide a comfortable fit and overall hand well-being. Cardinal HealthTM ProtexisTM Surgical Gloves are the #1 market leader for surgical gloves in the United States. As a premium brand with a comprehensive, quality portfolio, their on-site clinical team, self-manufacturing process, and quality product differentiates them from the competition and demonstrates their commitment to the safety and care of both healthcare providers and patients. For more information, contact Cardinal Health or talk to your local Cardinal Health representative.
Ashling Dunne, SIPTU Organiser, on the risk to jobs at medical device manufacturer, Cardinal Health, in Co.Offaly.
Aisling Dunne, SIPTU representative at Cardinal Health told reporters the news was a big shock & Tony McCormack, Chair of the Offaly Co Co
Maryland Democrats were on the mainstage at this week's Democratic National Convention with speeches from Governor Wes Moore, Congressman Jamie Raskin and Prince George's County Executive and Senate candidate Angela Alsobrooks. Josh Kurtz, founding editor of Maryland Matters joins Midday to reflect on Maryland's impact in Chicago. Then, Baltimore City recently settled for $152 million with Cardinal Health for their role in the opioid crisis. This large amount follows $45 million settlements with CVS and Allergan earlier this year. WYPR health reporter Scott Maucione joins Midday to explain the details of the settlement and how the funds will be used.Email us at midday@wypr.org, tweet us: @MiddayWYPR, or call us at 410-662-8780.
In this episode, we break down how to optimize the pharmaceutical supply chain. Our guest, Joel Wayment, vice president 3PL services and packaging solutions at Cardinal Health helps break down where some help in the pharma supply chain is needed. For more information subscribe to Running on Ice the newsletter or podcast. Follow the Running on Ice Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices
How can perioperative clinicians and supply chain work together to optimize supply consumption and documentation to support enhanced patient care? Find out in today's Vendor Spotlight™ featuring Jen Nichols, BSN, RN, Clinical Consultant for Cardinal Health™ Presource® Solutions and Debbie Davis, Vice President of Product and Marketing Strategy for Cardinal Health™ WaveMark™ Solutions. We'll highlight the common challenges associated with procedure cards and uncover the ways that procedure cards and custom packs can be optimized to eliminate waste, increase efficiencies, and drive savings. As health systems seek ways to reduce waste, manage supply expenses, and ensure product availability, hear Cardinal Health™ Presource® and WaveMark™ Solutions experts share how perioperative leaders are empowered to work alongside Supply Chain to: Help identify process improvements and ensure safety standard compliance Consolidate procedural supplies, maximizing case pick process efficiency Optimize packs and align with changing procedural needs Generate insights with advanced analytics to optimize procedure cards Reach out to your Cardinal Health™ representative for additional solutions to help drive efficiencies and innovation in the OR, or request more information on their website. #operatingroom #ornurse #scrubtech #vendorspotlight #cardinalhealth #supplychain #efficiency #productivity
With the scope of services and treatments expanding in their stores, independent pharmacies are realizing their ability to significantly impact the communities they serve. Pharmacists are now taking on more responsibilities beyond traditional roles and extending their services into their communities. Erik Hudson, pharmacy manager of Western Medical Equipment and Drug in Woodward, Oklahoma, not only shares his journey into pharmacy but also addresses what he's doing to encourage his seven pharmacies, five medical supply locations and over 90 employees to meet their community members where they are: in nonprofits, food banks and long-term care facilities. For Hudson, being a successful independent pharmacy means getting involved in the communities he serves, and success to him means he's effectively reaching and treating them. Listen to Erik Hudson's inspirational story today.