Podcasts about AstraZeneca

In this podcast episode, Rami Komrokji, MD, reviews data from select presentations in myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPNs) presented at the ASH 2025 Annual Meeting and shares expert perspectives on the clinical implications of these findings, including:Abstract 910: MANIFEST-2 96-Wk Update: Ruxolitinib + Pelabresib or Placebo in Patients With JAK Inhibitor–Naive MFAbstract 1024: Phase I Trial of INCA033989, a First-in-Class Antibody Targeting Mutant Calreticulin: Safety and Efficacy in Essential ThrombocythemiaAbstract 484: Preliminary Results From 2 Phase I Trials Exploring the Mutant Calreticulin-Specific mAb INCA033989 ± Ruxolitinib in Patients With MFAbstract 235: VERONA: Subgroup Analyses of Venetoclax or Placebo Combined With Azacitidine in Treatment-Naive Higher-Risk MDSAbstract 490: IMerge Post Hoc Analysis: Treatment-Emergent Cytopenias and Response With Imetelstat in Patients With Lower-Risk MDSAbstract 487: Randomized Phase II Trial of Reduced Treatment Durations of Hypomethylating Agents for Lower-Risk MDSPresenter: Rami Komrokji, MDSenior Member, Vice ChairSection Head – Leukemia and MDSDepartment of Malignant HematologyH. Lee Moffitt Cancer CenterProfessor of Oncologic SciencesUniversity of South FloridaTampa, FloridaContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program: https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KFF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 21, 2026.Turning the Tide in Gastric Cancer Management: Integrating Modern Systemic Therapies Across the Disease Continuum for Community-Based Clinicians In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KFF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 21, 2026.Turning the Tide in Gastric Cancer Management: Integrating Modern Systemic Therapies Across the Disease Continuum for Community-Based Clinicians In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KFF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 21, 2026.Turning the Tide in Gastric Cancer Management: Integrating Modern Systemic Therapies Across the Disease Continuum for Community-Based Clinicians In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KFF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 21, 2026.Turning the Tide in Gastric Cancer Management: Integrating Modern Systemic Therapies Across the Disease Continuum for Community-Based Clinicians In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KFF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 21, 2026.Turning the Tide in Gastric Cancer Management: Integrating Modern Systemic Therapies Across the Disease Continuum for Community-Based Clinicians In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KFF865. CME/MOC/NCPD/AAPA/IPCE credit will be available until December 21, 2026.Turning the Tide in Gastric Cancer Management: Integrating Modern Systemic Therapies Across the Disease Continuum for Community-Based Clinicians In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Disclosure information is available at the beginning of the video presentation.

Welcome back to the Ultimate Guide to Partnering® Podcast. AI agents are your next customers. Subscribe to our Newsletter: https://theultimatepartner.com/ebook-subscribe/ Check Out UPX:https://theultimatepartner.com/experience/ https://youtu.be/vEdq8rpBM3I In this data-rich keynote, Jay McBain deconstructs the tectonic shifts reshaping the $5.3 trillion global technology industry, arguing that we are entering a new 20-year cycle where traditional direct sales models are obsolete. McBain explains why 96% of the industry is now surrounded by partners and how successful companies must pivot from “flywheels and theory” to a granular strategy focused on the seven specific partners present in every deal. From the explosion of agentic AI and the $163 billion marketplace revolution to the specific mechanics of multiplier economics, this discussion provides a roadmap for navigating the “decade of the ecosystem” where influence, trust, and integration—not just product—determine winners and losers. Key Takeaways Half of today's Fortune 500 companies will likely vanish in the next 20 years due to the shift toward AI and ecosystem-led models. Every B2B deal now involves an average of seven trusted partners who influence the decision before a vendor even knows a deal exists. Microsoft has outpaced AWS growth for 26 consecutive quarters largely because of a superior partner-led geographic strategy. Marketplaces are projected to grow to $163 billion by 2030, with nearly 60% of deals involving partner funding or private offers. The “Multiplier Effect” is the new ROI, where partners can make up to $8.45 for every dollar of vendor product sold. Future dominance relies on five key pillars: Platform, Service Partnerships, Channel Partnerships, Alliances, and Go-to-Market orchestration. If you're ready to lead through change, elevate your business, and achieve extraordinary outcomes through the power of partnership—this is your community. At Ultimate Partner® we want leaders like you to join us in the Ultimate Partner Experience – where transformation begins. Keywords: Jay McBain, Canalys, partner ecosystem, channel chief, agentic AI, marketplace growth, multiplier economics, B2B sales trends, tech industry forecast, service partnerships, strategic alliances, Microsoft vs AWS, distribution transformation, managed services growth, SaaS platforms, customer journey mapping, 28 moments of truth, future of reselling, technology spending 2025, ecosystem orchestration, partner multipliers. T Transcript: Jay McBain WORKFILE FOR TRANSCRIPT [00:00:00] Vince Menzione: Just up from, did you Puerto Rico last night? Puerto Rico, yes. Puerto Rico. He dodged the hurricane. Um, you all know him. Uh, let him introduce himself for those of you who don’t, but just thrilled to have on the stage, again, somebody who knows more about what’s going on in, in the, and has the pulse on this industry probably than just about anybody I know personally. [00:00:21] Vince Menzione: J Jay McBain. Jay, great to see you my friend. Alright, thank you. We have to come all the way. We live, we live uh, about 20 minutes from each other. We have to come all the way to Reston, Virginia to see each other, right? That’s right. Very good. Well, uh, that’s all over to you, sir. Thank you. [00:00:35] Jay McBain: Alright, well thank you so much. [00:00:36] Jay McBain: I went from 85 degrees yesterday to 45 today, but I was able to dodge that, uh, that hurricane, uh, that we kind of had to fly through the northern edge of, uh, wanna talk today about our industry, about the ultimate partner. I’m gonna try to frame up the ultimate partner as I walk through the data and the latest research that, uh, that we’ve been doing in the market. [00:00:56] Jay McBain: But I wanted to start here ’cause our industry moves in 20 year cycles, and if you look at the Fortune 500 and dial back 20 years from today, 52% of them no longer exist. As we step into the next 20 year AI era, half of the companies that we know and love today are not gonna exist. So we look at this, and by the way, if you’re not in the Fortune 500 and you don’t have deep pockets to buy your way outta problems, 71% of tech companies fail over the course of 10 years. [00:01:30] Jay McBain: Those are statistics from the US government. So I start to look at our industry and you know, you may look at the, you know, mainframe era from the sixties and seventies, mini computers, August the 12th, 1981, that first IBM, PC with Microsoft dos, version one, you know, triggered. A new 20 year era of client server. [00:01:51] Jay McBain: It was the time and I worked at IBM for 17 years, but there was a time where Bill Gates flew into Boca Raton, Florida and met with the IBM team and did that, you know, fancy licensing agreement. But after, you know, 20 years of being the most valuable company in the world and 13 years of antitrust and getting broken up, almost like at and TIBM almost didn’t make payroll. [00:02:14] Jay McBain: 13 years after meeting Bill Gates. Yeah, that’s how quickly things change in these eras. In 1999, a small company outta San Francisco called salesforce.com got its start. About 10 years later, Jeff Bezos asked a question in a boardroom, could we rent out our excess capacity and would other companies buy it? [00:02:35] Jay McBain: Which, you know, most people in the room laughed at ’em at the time. But it created a 20 year cloud era when our friends, our neighbors, our family. Saw Chachi PT for the first time in March of 2023. They saw the deep fakes, they saw the poetry, they saw the music. They came to us as tech people and said, did we just light up Skynet? [00:02:58] Jay McBain: And that consumer trend has triggered this next 20 years. I could walk through the richest people in the world through those trends. I could walk through the most valuable companies. It all aligns. ’cause by the way, Apple’s no longer at the top. Nvidia is at the top, Microsoft. Second, things change really quickly. [00:03:17] Jay McBain: So in that course of time, you start to look at our industry and as people are talking about a six and a half or $7 trillion build out of ai, that’s open AI and Microsoft numbers, that is bigger than our industry that’s taken over 50 years to build. This year, we’re gonna finish the year at $5.3 trillion. [00:03:36] Jay McBain: That’s from the smallest flower shop to the biggest bank. Biggest governments that Caresoft would, uh, serve biggest customer in the world is actually the federal government of the us. But you look at this pie chart and you look at the changes that we’re gonna go through over the next 20 years, there’s about a trillion dollars in hardware. [00:03:54] Jay McBain: There’s about a trillion dollars in software. If you look forward through all of the merging trends, quantum computing, humanoid robots, all the things that are coming that dollar to dollar software to hardware will continue to exist all the way through. We see services making up almost two thirds of this pie. [00:04:13] Jay McBain: Yesterday I was in a telco conference with at and t and Verizon and T-Mobile and some of the biggest wireless players and IT services, which happen to be growing faster than products. At the moment, there is more work to be done wrapping around the deal than the actual products that the customer is buying. [00:04:32] Jay McBain: So in an industry that’s growing at 7%. On top of the world economy that’s grown at 2.2. This is the fastest growing industry, and it will be at least for the next 10 years, if not 2070 0.1% of this entire $5 trillion gets transacted through partners. While what we’re talking to today about the ultimate partner, 96% of this industry is surrounded by partners in one way or another. [00:05:01] Jay McBain: They’re there before the deal. They’re there at the deal. They’re there after the deal. Two thirds of our industry is now subscription consumption based. So every 30 days forever, and a customer for life becomes everything. So if every deal in medium, mid-market, and higher has seven partners, according to McKinsey, who are those seven people trying to get into the deal? [00:05:25] Jay McBain: While there’s millions of companies that have come into tech over the last 10 to 20 years. Digital agencies, accountants, legal firms, everybody’s come in. The 250,000 SaaS companies, a million emerging tech companies, there’s a big fight to be one of those seven trusted people at the table. So millions of companies and tens of millions of people our competing for these slots. [00:05:49] Jay McBain: So one of the pieces of research I’m most proud of, uh, in my analyst career is this. And this took over two years to build. It’s a lot of logos. Not this PowerPoint slide, but the actual data. Thousands of people hours. Because guess what? When you look at partners from the top down, the top 1000 partners, by capability and capacity, not by resale. [00:06:15] Jay McBain: It’s not a ranking of CDW and insight and resale numbers. It is the surrounding. Consulting, design, architecture, implementations, integrations, managed services, all the pieces that’s gonna make the next 20 years run. So when you start to look at this, 98% of these companies are private, so very difficult to get to those numbers and, uh, a ton of research and help from AI and other things to get this. [00:06:41] Jay McBain: But this is it. And if you look at this list, there’s a thousand logos out of the million companies. There’s a thousand logos that drive two thirds of all tech services in the world. $1.07 trillion gets delivered by a thousand companies, but here’s where it gets fun. Those companies in the middle, in blue, the 30 of them deliver more tech services than the next 970. [00:07:08] Jay McBain: Combined the 970 combined in white deliver more tech services. Then the next million combined. So if you think we live in an 80 20 rule or maybe a 99, a 95 5 rule, or a 99 1 rule, we actually live in a 99.9 0.1 parallel principle. These companies spread around the world evenly split across the uh, different regions. [00:07:35] Jay McBain: South Africa, Latin America, they’re all over. They split. They split among types. All of the Venn diagram I just showed from GSIs to VARs to MSPs, to agencies and other types of companies. But this is a really rich list and it’s public. So every company in the world now, if you’re looking at Transactable data, if you’re looking at quantifiable data that you can go put your revenue numbers against, it represents 70 to 80% of every company in this room’s Tam. [00:08:08] Jay McBain: In one piece of research. So what do you do below that? How do you cover a million companies that you can’t afford to put a channel account manager? You can’t afford to write programs directly for well after the top down analysis and all the wallet share and you know exactly where the lowest hanging fruit is for most of your tam. [00:08:28] Jay McBain: The available markets. The obtainable markets. You gotta start from the community level grassroots up. So you need to ask the question for the million companies and the maybe a hundred thousand companies out there, partner companies that are surrounding your customer. These are the seven partners that surround your customer. [00:08:48] Jay McBain: What do they read, where do they go, and who do they follow? Interestingly enough, our industry globally equates to only a thousand watering holes, a thousand companies at the top, a thousand places at the bottom. 35% of this audience we’re talking. Millions of people here love events and there’s 352 of them like this one that they love to go to. [00:09:13] Jay McBain: They love the hallway chats, they love the hotel lobby bar, you know, in a time reminded by the pandemic. They love to be in person. It’s the number one way they’re influenced. So if you don’t have a solid event strategy and you don’t have a community team out giving out socks every week, your competitors might beat you. [00:09:31] Jay McBain: 12% of this audience loves podcasts. It’s the Joe Rogan effect of our industry. And while you know, you may not think the 121 podcasts out there are important, well, you’re missing 12% of your audience. It’s over a million people. If you’re not on a weekly podcast in one of these podcasts in the world, there’s still people that read one of the 106 magazines in the world. [00:09:55] Jay McBain: There are people that love peer groups, associations, they wanna be part of this. There’s 15 different ways people are influenced. And a solid grassroots strategy is how you make this happen. In the last 10 years, we’ve created a number of billionaires. Bottom up. They never had to go talk to la large enterprise. [00:10:15] Jay McBain: They never had to go build out a mid-market strategy. They just went and give away socks and new community marketing. And this has created, I could rip through a bunch of names that became unicorns just in the last couple of years, bottoms up. You go back to your board walking into next year, top down, bottom up. [00:10:34] Jay McBain: You’ve covered a hundred percent of your tam, and now you’ve covered it with names, faces, and places. You haven’t covered it with a flywheel or a theory. And for 44 years, we have gone to our board every fourth quarter with flywheels and theory. Trust me, partners are important. The channel is key to us. [00:10:57] Jay McBain: Well, let’s talk at the point of this granularity, and now we’re getting supported by technology 261 entrepreneurs. Many of them in the room actually here that are driving this ability to succeed with seven partners in every deal to exchange data to be able to exchange telemetry of these prospects to be able to see twice or three times in terms of pipeline of your target addressable market. [00:11:26] Jay McBain: All these ai, um, technologies, agentic technologies are coming into this. It’s all about data. It’s all about quantifiable names, faces, and places. Now none of us should be walking around with flywheels, so let’s flip the flywheels. No. Uh, so we also look at, and I sold PCs for 17 years and that was in the high times of 40% margins for partners. [00:11:55] Jay McBain: But one interesting thing when you study the p and l for broad base of partners around the world, it’s changed pretty significantly in this last 20 year era. What the cloud era did is dropped hardware from what used to be 84% plus the break fix and things that wrap around it of the p and l to now 16% of every partner in the world. [00:12:16] Jay McBain: 84% of their p and l is now software and services. And if you look at profitability, it’s worse. It’s actually 87% is profitability wise. They’ve completely shifted in terms of where they go. Now we look at other parts of our market. I could go through every part of the pie of the slide, but we’re watching each of the companies, and if you can see here, this is what we want to talk about in terms of ultimate partner. [00:12:43] Jay McBain: Microsoft has outgrown AWS for 26 straight quarters. They don’t have a better product. They don’t have a better price, they don’t have better promotion. It’s all place. And I’ll explain why you guess here in the light green line. Exactly. The day that Google went a hundred percent all in partner, every deal, even if a deal didn’t have a partner, one of the 4% of deals that didn’t have a partner, they injected a partner. [00:13:09] Jay McBain: You can see on the left side exactly where they did it. They got to the point of a hundred percent partner driven. Rebuilt their programs, rebuilt their marketplace. Their marketplace is actually larger than Microsoft’s, and they grew faster than Microsoft. A couple of those quarters. It is a partner driven future, and now I have Oracle, which I just walked by as I walked from the hotel. [00:13:31] Jay McBain: Oracle with their RPOs will start to join. Maybe the list of three hyperscalers becomes the list of four in future slides, but that’s a growth slide. Market share is different. AWS early and commanding lead. And it plays out, uh, plays out this way. But we’re at an interesting moment and I stood up six years ago talking about the decade of the ecosystem after we went through a decade of sales starting in 1999 when we all thought we were born to be salespeople. [00:14:02] Jay McBain: We managed territories with our gut. The sales tech stack would have it different, that sales was a science, and we ended the decade 2009, looking at sales very differently in 2009. I remember being at cocktail parties where CMOs would be joking around that 50% of their marketing dollars were wasted. They just didn’t know which 50%. [00:14:23] Jay McBain: And I’ll tell you, that was really funny. In 2009 till every 58-year-old CMO got replaced by a 38-year-old growth hacker who walked in with 15,348 SaaS companies in their MarTech and ad tech stack to solve the problem, every nickel of marketing by 2019 was tracked. Marketo, Eloqua, Pardot, HubSpot, driving this industry. [00:14:50] Jay McBain: Now, we stood up and said the 28 moments that come before a sale are pretty much all partner driven. In the best case scenario, a vendor might see four of the moments. They might come to your website, maybe they read an ebook, maybe they have a salesperson or a demo that comes in. That’s four outta 28 moments. [00:15:10] Jay McBain: The other 24 are done by partners. Yeah, in the worst case scenario and the majority scenario, you don’t see any of the moments. All 28 happen and you lose a deal without knowing there ever was a deal. So this is it. We need to partner in these moments and we need to inject partners into sales and marketing, like no time before, and this was the time to do it. [00:15:33] Jay McBain: And we got some feedback in the Salesforce state of sales report, which doesn’t involve any partnerships or, or. Channel Chiefs or anything else. This is 5,500 of the biggest CROs in the world that obviously use Salesforce. 89% of salespeople today use partners every day. For the 11% who don’t, 58% plan two within a year. [00:15:57] Jay McBain: If you add those two numbers together, that’s magically the 96% number. They recognize that every deal has partners in it. In 2024, last year, half of the salespeople in the world, every industry, every country. Miss their numbers. For the minority who made their numbers, 84 point percent pointed to partners as the reason why they made their numbers. [00:16:21] Jay McBain: It was the cheat code for sales, so that modern salesperson that knows how to orchestrate a deal, orchestrate the 28 moments with the seven partners and get to that final spot is the winning formula. HubSpot’s number in separate research was 84% in marketing. So we’re starting to see partners in here. We don’t have to shout from the mountaintops. [00:16:44] Jay McBain: These communities like ultimate Partner are working and we’re getting this to the highest levels in the board. And I’ll say that, you know, when 20 years from now half of the companies we know and love fail after we’re done writing the book and blaming the CEO for inventing the thing that ended up killing them, blaming the board for fiduciary responsibility and letting it happen. [00:17:06] Jay McBain: What are the other chapters of the book? And I think it’s all in one slide. We are in this platform economy and the. [00:17:31] Jay McBain: So your battery’s fine. Check, check, check, check. Alright, I’ll, I’ll just hold this in case, but the companies that execute on all five of these areas, well. Not only today become the trillion dollar valued companies, but they become the companies of tomorrow. These will be the fastest growing companies at every level. [00:17:50] Jay McBain: Not only running a platform business, but participating in other platforms. So this is how it breaks out, and there are people at very senior levels, at very big companies that have this now posted in the office of the CEO winning on integrations is everything. We just went through a demographic shift this year where 51% of our buyers are born after 1982. [00:18:15] Jay McBain: Millennials are the number one buyer of the $5 trillion. Their number one buying criteria is not service. Support your price, your brand reputation, it’s integrations. The buy a product, 80% is good as the next one if it works better in their environment. 79% of us won’t buy a car unless it has CarPlay or Android Auto. [00:18:34] Jay McBain: This is an integration world. The company with the most integrations win. Second, there are seven partners that surround the customer. Highly trusted partners. We’re talking, coaching the customer’s, kids soccer team, having a cottage together up at the lake. You know, best men, bate of honors at weddings type of relationships. [00:18:57] Jay McBain: You can’t maybe have all seven, but how does Microsoft beat AWS? They might have had two, three, or four of them saying nice things about them instead of the competition. Winning in service partnerships and channel partnerships changes by category. If you’re selling MarTech, only 10% of it today is resold, so you build more on service partnerships. [00:19:18] Jay McBain: If you’re in cybersecurity today, 91.6% of it is resold. Transacted through partners. So you build a lot of channel partnerships, plus the service partnerships, whatever the mix is in your category, you have to have two or three of those seven people. Saying nice things about you at every stage of the customer journey. [00:19:38] Jay McBain: Now move over to alliances. We have already built the platforms at the hyperscale level. We’ve built the platforms within SaaS, Salesforce, ServiceNow, Workday, Marketo, NetSuite, HubSpot. Every buyer has a set of platforms that they buy. We’ve now built them in cybersecurity this year out of 6,500 as high as cyber companies, the top five are starting to separate. [00:20:02] Jay McBain: We built it in distribution, which I’ll show in a minute. We’re building it in Telco. This is a platform economy and alliances win and you have alliances with your competitors ’cause you compete in the morning, but you’re best friends by the afternoon. Winning in other platforms is just as important as driving your own. [00:20:20] Jay McBain: And probably the most important part of this is go to market. That sales, that marketing, the 28 moments, the every 30 days forever become all a partner strategy. So there’s still CEOs out there that believe platform is a UI or UX on a bunch of disparate products and things you’ve acquired. There’s still CFOs out there that Think platform is a pricing model, a bundle model of just getting everything under one, you know, subscription price or consumption price. [00:20:51] Jay McBain: And it’s not, platforms are synonymous with partnerships. This is the way forward and there’s no conversation around ai. That doesn’t involve Nvidia over there, an open AI over here and a hyperscaler over there and a SaaS company over here. The seven layer stack wins every single time, and the companies that get this will be the ones that survive this cycle. [00:21:16] Jay McBain: Now, flipping over to marketplaces. So we had written research that, um, about five years ago that marketplaces were going to grow at 82% compounded. Yeah, probably one of the most accurate predictions we ever made, because it happened, we, we predicted that, uh, we were gonna get up to about $85 billion. Well, now we’ve extended that to 2030, so we’re gonna get up to $163 billion, and the thing that we’re watching is in green. [00:21:46] Jay McBain: If 96% of these deals are partner assisted in some way, how is the economics of partnering going to work? We predicted that 50% of deals by 2027. Would be partner funded in some way. Private offers multi-partner offers distributor sellers of record, and now that extends to 59% by 2030, the most senior leader of the biggest marketplace AWS, just said to us they’re gonna probably make these numbers on their own. [00:22:14] Jay McBain: And he asked what their two competitors are doing. So he’s telling us that we under called this. Now when you look at each of the press releases, and this is the AWS Billion Dollar Club. Every one of the companies on the left have issued a press release that they’re in the billion dollar club. Some of them are in the multi-billions, but I want you to double click on this press release. [00:22:35] Jay McBain: I’m quoted in here somewhere, but as CrowdStrike is building the marketplace at 91% compounded, they’re almost doubling their revenue every single year. They’re growing the partner funding, in this case, distributor funding by 3548%. Almost triple digit growth in marketplace is translating into almost quadruple digit growth in funding. [00:23:01] Jay McBain: And you see that over and over again as, as Splunk hit three, uh, billion dollars. The same. Salesforce hit $2 billion on AWS in Ulti, 18 months. They joined in October 20, 23, and 18 months later, they’re already at $2 billion. But now you’re seeing at Salesforce, which by the way. Grew up to $40 billion in revenue direct, almost not a nickel in resell. [00:23:28] Jay McBain: Made it really difficult for VARs and managed service providers to work with Salesforce because they couldn’t understand how to add services to something they didn’t book the revenue for. While $40 billion companies now seeing 70% of their deals come through partners. So this is just the world that we’re in. [00:23:44] Jay McBain: It doesn’t matter who you are and what industry you’re in, this takes place. But now we’re starting to see for the first time. Partners join the billion dollar club. So you wonder about partnering and all this funding and everything that’s working through Now you’re seeing press releases and companies that are redoing their LinkedIn branding about joining this illustrious club without a product to sell and all the services that wrap around it. [00:24:10] Jay McBain: So the opening session on Microsoft was interesting because there’s been a number of changes that Microsoft has done just in the last 30 days. One is they cut distribution by two thirds going from 180 distributors to 62. They cut out any small partner lower than a thousand dollars, and that doesn’t sound like a lot, but that’s over a hundred thousand partners that get deed tightening the long tail. [00:24:38] Jay McBain: They we’re the first to really put a global point system in place three years ago. They went to the new commerce experience. If you remember, all kinds of changes being led by. The biggest company for the channel. And so when we’re studying marketplaces, we’re not just studying the three hyperscalers, we’re studying what TD Cynic is doing with Stream One Ingram’s doing with Advant Advantage Aerosphere. [00:25:01] Jay McBain: Also, we’re watching what PAX eight, who by the way, is the 365 bestseller for Microsoft in the world. They are the cybersecurity leader for Microsoft in the world and the copilot. Leader in the world for Microsoft and Partner of the Year for Microsoft. So we’re watching what the cloud platforms are doing, watching what the Telco are doing, which is 25 cents out of every dollar, if you remember that pie chart, watching what the biggest resellers are converting themselves into. [00:25:30] Jay McBain: Vince just mentioned, you know, SHI in the changes there watching the managed services market and the leaders there, what they’re doing in terms of how this industry’s moving forward. By the way, managed services at $608 billion this year. Is one and a half times larger than the SaaS industry overall. [00:25:48] Jay McBain: It’s also one and a half times larger than all the hyperscalers combined. Oracle, Alibaba, IBM, all the way down. This is a massive market and it makes up 15 to 20 cents of every dollar the customer spend. We’re watching that industry hit a trillion dollars by the end of the decade, and we’re watching 150 different marketplace development platforms, the distribution of our industry, which today is 70.1% indirect. [00:26:13] Jay McBain: We’re starting to see that number, uh, solidify in terms of marketplaces as well. Watching distributors go from that linear warehouse in a bank to this orchestration model, watching some of the biggest players as the world comes around, platforms, it tightens around the place. So Caresoft, uh, from from here is the sixth biggest distributor in the world. [00:26:40] Jay McBain: Just shows you how big the. You know, biggest client in the world is that they serve. But understand that we’re publishing the distributor 500 list, but it’ll be the same thing. That little group in blue in the middle today, you know, drives almost two thirds of the market. So what happens in all this next stage in terms of where the dollars change hands. [00:27:07] Jay McBain: And the economics of partnering themselves are going through the most radical shift that we’ve seen ever. So back to the nineties, and, and for those of you that have been channel chiefs and running programs, we went to work every day. You know, everything’s on fire. We’re trying to check hundred boxes, trying to make our program 10% better than our competitors. [00:27:30] Jay McBain: Hey, we gotta fix our deal registration program today, and our incentives are outta whack or training programs or. You know, not where they need to be. Our certification, you know, this was the life of, uh, of a channel chief. Everybody thought we were just out drinking in the Caribbean with our best partners, but we were under the weight of this. [00:27:49] Jay McBain: But something interesting has happened is that we turned around and put the customer at the middle of our programs to say that those 28 moments in green before the sale are really, really important. And the seven partners who participate are really important. Understanding. The customer’s gonna buy a seven layer stack. [00:28:09] Jay McBain: They’re gonna buy it With these seven partners, the procurement stage is much different. The growth of marketplaces, the growth of direct in some of these areas, and then long term every 30 days forever in a managed service, implementations, integrations, how you upsell, cross-sell, enrich a deal changes. So how would you build a program that’s wrapped around the customer instead of the vendor? [00:28:35] Jay McBain: And we’re starting to hear our partners shout back to us. These are global surveys, big numbers, but over half of our partners, regardless of type, are selling consulting to their customer. Over half are designing architecting deals. A third of them are trying to be system integrators showing up at those implementation integration moments. [00:28:55] Jay McBain: Two thirds of them are doing managed services, but the shocking one here is 44% of our partners, regardless of type, are coding. They’re building agents and they’re out helping their customer at that level. So this is the modern partner that says, don’t typecast me. You may have thought of me in your program. [00:29:14] Jay McBain: You might have me slotted as a var. Well, I do 3.2 things, and if I don’t get access to those resources, if you don’t walk me to that room, I’m not gonna do them with you. You may have me as a managed service provider that’s only in the morning. By the afternoon I’m coding, and by the next morning I’m implementing and consulting. [00:29:33] Jay McBain: So again, a partner’s not a partner. That Venn diagram is a very loose one now, as every partner on there is doing 3.2 different business models. And again, they’re telling us for 43 years, they said, I want more leads this year it changed. For the first time, I want to be recognized and incentivized as more than just a cash register for you. [00:29:57] Jay McBain: I want you to recognize when I’m consulting, when I’m designing, when you’re winning deals, because of my wonderful services, by the way, we asked the follow up question, well, where should we spend our money with you? And they overwhelmingly say, in the consulting stage, you win and lose deals. Not at moment 28. [00:30:18] Jay McBain: We’re not buying a pack of gum at the gas station. This is a considered purchase. You win deals from moment 12 through 16 and I’m gonna show you a picture of that later, and they say, you better be spending your money there, or you’re not gonna win your fair share or more than your fair share of deals. [00:30:36] Jay McBain: The shocking thing about this is that Microsoft, when they went to the point system, lifted two thirds of all the money, tens of billions of dollars, and put it post-sale, and we were all scratching our heads going. Well, if the partners are asking for it there, and it seems like to beat your biggest competitors, you want to win there. [00:30:54] Jay McBain: Why would you spend the money on renewal? Well, they went to Wall Street and Goldman Sachs and the people who lift trillions of dollars of pension funds and said, if we renew deals at 108%, we become a cash machine for you. And we think that’s more valuable than a company coming out with a new cell phone in September and selling a lot of them by Christmas every year. [00:31:18] Jay McBain: The industry. And by the way, wall Street responded, Microsoft has been more valuable than Apple since. So we talk in this now multiplier language, and these are reports that we write, uh, at AMIA at canals. But talking about the partner opportunity in that customer cycle, the $6 and 40 cents you can make for every dollar of consumption, or the $7 and 5 cents you can make the $8 and 45 cents you can make. [00:31:46] Jay McBain: There’s over 24 companies speaking at this level now, and guess what? It’s not just cloud or software companies. Hardware companies are starting to speak in this language, and on January 25th, Cisco, you know, probably second to Microsoft in terms of trust built with the channel globally is moving to a full point system. [00:32:09] Jay McBain: So these are the changes that happen fast. But your QBR with your partners now less about drinking beers at the hotel lobby bar and talking dollar by dollar where these opportunities are. So if you’re doing 3.2 of these things, let’s build out a, uh, a play where you can make $3 for every dollar that we make. [00:32:28] Jay McBain: And you make that profitably. You make it in sticky, highly retained business, and that’s the model. ’cause if you make $3 for every dollar. We make, you’re gonna win Partner of the year, and if you win partner of the year, that piece of glass that you win on stage, by the time you get back to your table, you’re gonna have three offers to buy your business. [00:32:51] Jay McBain: CDW just bought a w. S’s Partner of the Year. Insight bought Google’s eight time partner of the year. Presidio bought ServiceNow’s, partner of the year over and over and over again. So I’m at Octane, I’m at CrowdStrike, I’m at all these events in Vegas every week. I’m watching these partners of the year. [00:33:05] Jay McBain: And I’m watching as the big resellers. I’m watching as the GSIs and the m and a folks are surrounding their table after, and they’re selling their businesses for SaaS level valuations. Not the one-to-one service valuation. They’re getting multiples because this is the new future of our industry. This is platform economics. [00:33:25] Jay McBain: This is winning and platforms for partners. Now, like Vince, I spent 20 minutes without talking about ai, but we have to talk about ai. So the next 20 years as it plays out is gonna play out in phases. And the first thing you know to get it out of the way. The first two years since that March of 23, has been underwhelming, to say the least. [00:33:47] Jay McBain: It’s been disappointing. All the companies that should have won the biggest in AI have been the most disappointing. It’s underperformed the s and p by a considerable amount in terms of where we are. And it goes back to this. We always overestimate the first two years, but we underestimate the first 10. [00:34:07] Jay McBain: If you wanna be the point in time person and go look at that 1983 PC or the 1995 internet or that 2007 iPhone or that whatever point in time you wanna look at, or if you want to talk about hallucinations or where chat chip ET version five is version, as opposed to where it’s going to be as it improves every six months here on in. [00:34:30] Jay McBain: But the fact of the matter is, it’s been a consumer trend. Nvidia got to be the most valuable company in the world. OpenAI was the first company to 2 billion users, uh, in that amount of speed. It’s the fastest growing product ever in history, and it’s been a consumer win this trillions of dollars to get it thrown around in the press releases. [00:34:49] Jay McBain: They’re going out every day, you know, open ai, signing up somebody new or Nvidia, investing in somebody new almost every single day in hundreds of billions of dollars. It is all happening really on the consumer side. So we got a little bit worried and said, is that 96% of surround gonna work in ag agentic ai? [00:35:10] Jay McBain: So we went and asked, and the good news is 88% of end customers are using partners to work through their ag agentic strategy. Even though they’re moving slow, they’re actually using partners. But what’s interesting from a partner perspective, and this is new research that out till 2030. This is the number one services opportunity in the entire tech or telco industry. [00:35:34] Jay McBain: 35.3% compounded growth ending at $267 billion in services. Companies are rebuilding themselves, building out practices, and getting on this train and figuring out which vendors they should hook their caboose to as those trains leave the station. But it kind of plays out like this. So in the next three to five years, we’re in this generative, moving into agentic phase. [00:36:01] Jay McBain: Every partner thinks internally first, the sales and marketing. They’re thinking about their invoicing and billing. They’re thinking about their service tickets. They’re thinking about creating a business that’s 10% better than their competitors, taking that knowledge into their customers and drive in business. [00:36:17] Jay McBain: But we understand that ag agentic AI, as it’s going to play out is not a product. A couple of years ago, we thought maybe a copilot or an agent force or something was going to be the product that everybody needed to buy, and it’s not a product, it’s gonna show up as a feature. So you go back in the history of feature ads and it’s gonna show up in software. [00:36:38] Jay McBain: So if you’re calling in SMB, maybe you’re calling on a restaurant. The restaurant isn’t gonna call OpenAI or call Microsoft or call Nvidia directly. They’re running their restaurant. And they may have chosen a platform like Toast Square, Clover, whatever iPads people are running around with, runs on a platform that does everything in their business, does staffing, does food ordering, works with Uber Eats, does everything end to end? [00:37:08] Jay McBain: They’re gonna wait to one of those platforms, dries out agent AI for them, and can run the restaurant more effectively, less human capital and more consistently, but they wait for the SaaS platform as you get larger. A hundred, 150 people. You have vice presidents. Each of those vice presidents already have a SaaS stack. [00:37:28] Jay McBain: I talked about Salesforce, ServiceNow, Workday, et cetera. They’ve already built that seven layer model and in some cases it’s 70 layers. But the fact is, is they’re gonna wait for those SaaS layers to deliver ag agentic to them. So this is how it’s gonna play out for the next three and a half, three to five years. [00:37:45] Jay McBain: And partners are realizing that many of them were slow to pick up SaaS ’cause they didn’t resell it. Well now to win in this next three to half, three to five years, you’re gonna have to play in this environment. When you start looking out from here, the next generation, you know, kind of five through 15 years gets interesting in more of a physical sense. [00:38:06] Jay McBain: Where I was yesterday talking about every IOT device that now is internet access, starts to get access to large language models. Every little sensor, every camera, everything that’s out there starts to get smart. But there’s a point. The first trillionaire, I believe, will be created here. Elon’s already halfway there. [00:38:24] Jay McBain: Um, but when Bill Gates thought there was gonna be a PC in every home, and IBM thought they were gonna sell 10,000 to hobbyists, that created the richest person in the world for 20 years, there will be a humanoid in every home. There’s gonna be a point in time that you’re out having drinks with your friends, and somebody’s gonna say, the early adopter of your friends is gonna say. [00:38:46] Jay McBain: I haven’t done the dishes in six weeks. I haven’t done the laundry. I haven’t made my bed. I haven’t mowed the lawn. When they say that, you’re gonna say, well, how? And they’re gonna say, well, this year I didn’t buy a new car, but I went to the car dealership and I bought this. So we’re very close to the dexterity needed. [00:39:05] Jay McBain: We’ve got the large language models. Now. The chat, GPT version 10 by then is going to make an insane, and every house is gonna have one of the. [00:39:17] Jay McBain: This is the promise of ai. It’s not humanoid robots, it’s not agents. It’s this. 99% of the world’s business data has not been trained or tuned into models yet. Again, this is the slow moving business. If you want to think about the 99% of business data, every flight we’ve all taken in this room sits on a saber system that was put in place in 1964. [00:39:43] Jay McBain: Every banking transaction, we’ve all made, every withdrawal, every deposit sits on an IBM mainframe put in place in the sixties or seventies. 83% of this data sits in cold storage at the edge. It’s not ready to be moved. It’s not cleansed, it’s not, um, indexed. It’s not in any format or sitting on any infrastructure that a large language model will be able to gobble up the data. [00:40:10] Jay McBain: None of the workflows, none of the programming on top of that data is yet ready. So this is your 10 to 20 year arc of this era that chat bot today when they cancel your flight is cute. It’s empathetic, it feels bad for you, or at least it seems to, but it can’t do anything. It can’t book you the Marriott and get you an Uber and then a 5:00 AM flight the next morning. [00:40:34] Jay McBain: It can’t do any of that. But more importantly, it doesn’t know who you are. I’ve got 53 years of flights under my belt and they, I’m the person that get me within six hours of my kids and get me a one-way Hertz rental. You know, if there’s bad weather in Miami, get me to Tampa, get me a Hertz, I’m driving home, I’m gonna make it home. [00:40:56] Jay McBain: I’m not the 5:00 AM get me a hotel person. They would know that if they picked up the flights that I’ve taken in the past. Each of us are different. When you get access to the business data and you become ag agentic, everything changes. Every industry changes because of this around the customers. When you ask about this 35% growth, working on that data, working in traditional consulting and design and implementation, working in the $7 trillion of infrastructure, storage, compute, networking, that’s gonna be around, this is a massive opportunity. [00:41:30] Jay McBain: Services are gonna continue to outgrow products. Probably for the next five to 10 years because of this, and I’m gonna finish here. So we talked a lot about quantifying names, faces, places, and I think where we failed the most as ultimate partners is underneath the tam, which every one of our CEOs knows to the decimal point underneath the TAM that our board thinks they’re chasing. [00:41:59] Jay McBain: We’ve done a very poor job. Of talking about the available markets and obtainable markets underneath it, we, we’ve shown them theory. We’ve shown them a bunch of, you know, really smart stuff, and PowerPoint slides up the wazoo, but we’ve never quantified it for them. If they wanna win, if they want to get access, if they want to double their pipeline, triple their pipeline, if they wanna start winning more deals, if they wanna win deals that are three times larger, they close two times faster. [00:42:31] Jay McBain: And they renew 15% larger. They have to get into the available and obtainable markets. So just in the last couple weeks I spoke at Cribble, I spoke at Octane, I spoke at CrowdStrike Falcon. All three of those companies at the CEO level, main stage use those exact three numbers, three x, two x, 15%. That’s the language of platforms, and they’re investing millions and millions and millions of dollars on teams. [00:42:59] Jay McBain: To go build out the Sam Andal in name spaces and places. So you’ve heard me talk about these 28 moments a lot. They’re the ones that you spend when you buy a car. Some people spend one moment and they drive to the Cadillac dealership. ’cause Larry’s been, you know, taking care of the family for 50 years. [00:43:18] Jay McBain: Some people spend 50 moments like I do, watching every YouTube video and every, you know, thing on the internet. I clear the internet cover to cover. But the fact is, is every deal averages around these 28 moments. Your customer, there’s 13 members of the buying committee today. There’s seven partners and they’re buying seven things. [00:43:37] Jay McBain: There’s 27 things orchestrating inside these 28 moments. And where and how they all take place is a story of partnering. So a couple of years ago, canals. Latin for channel was acquired by amia, which is a part of Informa Tech Target, which is majority owned by Informa. All that being said, there’s hundreds of magazines that we have. [00:44:00] Jay McBain: There’s hundreds of events that we run. If somebody’s buying cybersecurity, they probably went to Black Hat or they probably went to GI Tech. One of these events we run, or one of the magazines. So we pick up these signals, these buyer intent signals as a company. Why did they wanna, um, buy a, uh, a Canals, which was a, you know, a small analyst firm around channels? [00:44:22] Jay McBain: They understood this as well. The 28 moments look a lot like this when marketers and salespeople are busy filling in the spots of every deal. And by the way, this is a real deal. AstraZeneca came in to spend millions of dollars on ASAP transformation, and you can start to see as the customer got smart. [00:44:45] Jay McBain: The eBooks, they read the podcasts, they listened to the events they went to. You start to see how this played out over the long term. But the thing we’ve never had in our industry is the light blue boxes. This deal was won and lost in December. In this particular case, NTT software won and Yash came in and sold the customer five projects. [00:45:07] Jay McBain: The millions of dollars that were going to be spent were solved here. The design and architecture work was all done here. A couple of ISVs You see in light blue came in right at the end, deal was closed in April. You see the six month cycle. But what if you could fill in every one of the 28 boxes in every single customer prospect that your sales and marketing team have? [00:45:30] Jay McBain: But here’s the brilliance of this. Those light blue boxes didn’t win the deals there. They won the deals months before that. So when NTT and Software one walked into this deal. They probably won the deal back in October and they had to go through the redlining. They had to go through the contracting, they had to go through all the stuff and the Gantt chart to get started. [00:45:54] Jay McBain: But while your CMO is getting all excited about somebody reading an ebook and triggering an MQL that the sales team doesn’t want, ’cause it’s not qualified, it’s not sales qualified, you walk in and say, no, no. This is a multimillion deal, dollar deal. It’s AstraZeneca. I know the five partners that are coming in in December to solidify the seven layers, and you’re walking in at the same time as the CMOs bragging about an ebook. [00:46:21] Jay McBain: This changes everything. If we could get to this level of data about every dollar of our tam, we not only outgrow our competitors, we become the platforms of the next generation. Partnering and ultimate partnering is all here. And this is what we’re doing in this room. This is what we’re doing over these couple of days, and this is what, uh, the mission that Vince is leading. [00:46:43] Jay McBain: Thank you so much. [00:46:47] Vince Menzione: Woo. Day in the house. Good to see you my friend. Good to see you. Oh, we’re gonna spend a couple minutes. Um, I’m put you in the second seat. We’re gonna put, we’re gonna make it sit fireside for a minute. Uh, that was intense. It was pretty incredible actually, Jay. And so I’m, I think I wanna open it up ’cause we only have a few minutes just to, any questions? [00:47:06] Vince Menzione: I’m sure people are just digesting. We already have one up here. See, [00:47:09] Question: Jay knows I’m [00:47:10] Vince Menzione: a question. I love it. We, I don’t think we have any I can grab a mic, a roving mic. I could be a roving mic person. Hold on. We can do this. This is not on. [00:47:25] Vince Menzione: Test, test. Yes it is. Yeah. [00:47:26] Question: Theresa Carriol dared me to ask a question and I say, you don’t have to dare me. You know, I’m going to Anyway. Um, so Jay, of the point of view that with all of the new AI players that strategic alliances is again having a moment, and I was curious your point of view on what you’re seeing around this emergence and trend of strategic alliances and strategic alliance management. [00:47:52] Question: As compared to channel management. And what are you seeing in terms of large vendors like AWS investing in that strategic alliance role versus that channel role training, enablement, measurement, all that good stuff? [00:48:06] Jay McBain: Yeah, it’s, it’s a great question. So when I told the story about toast at the restaurant or Square or Clover, they’re not call, they’re not gonna call open AI or Nvidia themselves either. [00:48:17] Jay McBain: When you look out at the 250,000 ISVs. That make up this AI stack, there is the layers that happen there. So the Alliance with AWS, the alliance they have with Microsoft or Google is going to be how they generate agent AI in their platforms. So when I talk about a seven layer stack, the average deal being seven layers, AI is gonna drive this to nine, and then 11, then probably 13. [00:48:44] Jay McBain: So in terms of how alliances work, I had it up there as one of the five core strategies, and I think it’s pretty even. You can have the best alliances in the world, but if the seven partners trusted by the customer don’t know what that alliance is and the benefits to the customer and never mention it, it’s all for Naugh. [00:49:00] Jay McBain: If you’re go-to market, you’re co-selling, your co-marketing strategies are not built around that alliance. It’s all for naught. If the integration and the co-innovation, the co-development, the all the co-creation work that’s done inside these alliances isn’t translated to customer outcomes, it’s all for naugh. [00:49:17] Jay McBain: These are all five parallel swim lanes. All five are absolutely critically needed. And I think they’re all five pretty equally weighted in terms of needing each other. Yes. To be successful in the era of platforms. Yeah. [00:49:32] Vince Menzione: And the problem is they’re all stove pipe today. If, if at all. Yeah. Maintained, right. [00:49:36] Vince Menzione: Alliances is an example. Channels and other example. They don’t talk to one another. Judge any, we’ve got a mic up here if anybody else has. Yep. We have some questions here, Jacqueline. [00:49:51] Question: So when we’re developing our channel programs, any advice on, you know, what’s the shift that we should make six months from now, a year from now? The historical has been bronze, silver, gold, right? And you’ve got your deal registration, but what’s the future look like? [00:50:05] Jay McBain: Yeah, so I mean, the programs are, are changing to, to the point where the customer should be in the middle and realizing the seven partners you need to win the deal. [00:50:15] Jay McBain: And depending on what category of product you’re in, security, how much you rely on resell, 91.6%. You know, the channel partners are gonna be critical where the customer spends the money. And if you’re adding friction to that process, you’re adding friction in terms of your growth. So you know, if you’re in cybersecurity, you have to have a pretty wide open reseller model. [00:50:39] Jay McBain: You have to have a wide open distribution model, and you have to make sure you’re there at that point of sale. While at the same time, considering the other six partners at moment 12 who are in either saying nice things about you or not, the customer might even be starting with you. ’cause there is actually one thing that I didn’t mention when I showed the 28 moments filled in. [00:51:00] Jay McBain: You’ll notice that the customer went to AWS twice direct. AWS lost the deal. Microsoft won the deal software. One is Microsoft’s biggest reseller in the world. They just acquired crayon. NTT who, who loves both had their Microsoft team go in. [00:51:18] Question: Mm. [00:51:19] Jay McBain: So I think that they went to AWS thinking it was A-W-S-S-A-P, you know, kind of starting this seven layer stack. [00:51:25] Jay McBain: I think they finished those, you know, critical moments in the middle looking at it. And then they went back to AWS kind of going probably WWTF. Yeah. What we thought was happening isn’t actually the outcome that was painted by our most trusted people. So, you know, to answer your question, listen to your partners. [00:51:43] Jay McBain: They want to be recognized for the other things they’re doing. You can’t be spending a hundred percent of the dollars at the point of sale. You gotta have a point of system that recognizes the point of sale, maybe even gold, silver, bronze, but recognizing that you’re paying for these other moments as well. [00:51:57] Jay McBain: Paying for alliances, paying for integrations and everything else, uh, in the cyber stack. And, um, you know, recognizing also the top 1000. So if I took your tam. And I overlaid those thousand logos. I would be walking into 2026 the best I could of showing my company logo by logo, where 80% of our TAM sits as wallet share, not by revenue. [00:52:25] Jay McBain: Remember, a million dollar partner is not a million dollar partner. One of them sells 1.2 million in our category. We should buy them a baseball cap and have ’em sit in the front row of our event. One of them sells $10 million and only sells our stuff if the customer asks. So my company should be looking at that $9 million opportunity and making sure my programs are writing the checks and my coverage. [00:52:48] Jay McBain: My capacity and capability planning is getting obsessed over that $9 million. My farmers can go over there, my hunters can go over here, and I should be submitting a list of a thousand sorted in descending order of opportunity. Of where my company can write program dollars into. [00:53:07] Vince Menzione: Great answer. All right. I, I do wanna be cognizant of time and the, all the other sessions we have. [00:53:14] Vince Menzione: So we’ll just take one other question if there are any here and if not, we’ll let I know. Jay, you’re gonna be mingling around for a little while before your flight. I’m [00:53:21] Jay McBain: here the whole day. [00:53:22] Vince Menzione: You, you’re the whole day. I see that Jay’s here the whole day. So if you have any other questions and, and, uh, sharing the deck is that. [00:53:29] Vince Menzione: Yep. Alright. We have permission to share the deck with the each of you as well. [00:53:34] Jay McBain: Alright, well thank you very much everyone. Jay. Great to have you.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the significant events of 2025, a year marked by pivotal scientific breakthroughs, regulatory changes, and industry trends that have reshaped drug development and patient care.One of the standout advancements was Novo Nordisk gaining FDA approval for an oral version of Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist for obesity management. This marks a notable shift in treatment accessibility, as it provides an easier alternative to injectables for those managing weight and cardiovascular risks. This development could significantly enhance patient adherence and broaden access to this critical therapy.However, not all news was positive. Pfizer faced a challenging situation when a patient death occurred in the extension of their Hympavzi hemophilia study. Such incidents highlight the intrinsic risks of clinical trials, especially within gene therapy realms where safety monitoring is paramount. These events remind us of the delicate balance between innovation and patient safety in advanced biologic therapies.In legal news, Johnson & Johnson was ordered by a Baltimore jury to pay $1.56 billion in a talc-related cancer case. This ruling underscores heightened scrutiny on product safety and consumer protection within the pharmaceutical industry, potentially influencing future litigation and regulatory measures.Clinical trial outcomes also presented mixed results. Neurocrine Biosciences' Ingrezza did not meet efficacy endpoints in its phase 3 trial for cerebral palsy-related dyskinesia. Although it is approved for other movement disorders, this setback reflects the complexities involved in expanding drug indications. Such challenges highlight ongoing hurdles in translating preclinical successes into clinical realities.Despite geopolitical tensions, particularly between China and the U.S., Chinese biotech firms thrived, maintaining robust deal activity. China's continued growth as an innovation hub is driven by strategic investments and collaborations that bolster global drug development efforts, underscoring its increasing influence in life sciences.Regulatory landscapes also shifted with proposals from the Center for Medicare & Medicaid Innovation to align U.S. drug prices with international rates under Medicare Parts B and D. These proposed models could significantly impact pricing strategies and market dynamics within the U.S., requiring pharmaceutical companies to adapt while ensuring equitable access to medications.Ethical challenges surfaced as six individuals were charged with insider trading involving biotech stocks. Such incidents highlight the necessity for stringent ethical standards and regulatory oversight to maintain investor confidence and market integrity.Meanwhile, AstraZeneca's extended partnership with Niowave for actinium-225 supply reflects an interest in radiopharmaceuticals as targeted cancer therapies. This collaboration highlights the potential of radiopharmaceuticals in oncology, opening promising avenues for precision medicine approaches.As 2025 closes, it's clear that this year has been one of both triumphs and trials for the pharmaceutical and biotech industries. Scientific innovations like Novo Nordisk's oral GLP-1 receptor agonist offer new hope for patients, yet challenges such as clinical trial setbacks and legal battles indicate ongoing hurdles in drug development and commercialization. These developments will likely influence industry strategies and regulatory policies as we advance into 2026.The sustained momentum of China's biotech industry amid global trade tensions remains notable. This trend reflects China's strategic investments in biotech capabilities and its growing role in global markets despite geopolitical frictions.In clinical research, Hope BioscienceSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world.In a dynamic landscape marked by both advancements and challenges, the pharmaceutical and biotech sectors continue to evolve with notable scientific, regulatory, and strategic updates. Ipsen's recent $1 billion acquisition of Simcere's preclinical LRRC15-targeting asset underscores a growing focus on antibody-drug conjugates (ADCs). These conjugates leverage the targeted action of antibodies combined with the cytotoxic effects of drugs, representing a promising approach to cancer treatment by potentially minimizing systemic toxicity. Ipsen's strategic move reflects its commitment to expanding its oncology portfolio and staying competitive within the rapidly advancing ADC landscape.AstraZeneca has been active in its pursuit of innovative cancer treatments. The company has invested $100 million in Jacobio's clinical-stage pan-KRAS inhibitor, a promising development targeting KRAS mutations prevalent in various cancers. This investment aligns with AstraZeneca's strategy to tackle challenging oncogenic targets. However, their efforts faced a setback as their Phase 3 trial for ceralasertib, an ATR inhibitor for lung cancer, failed to meet its primary endpoint. Despite this setback, AstraZeneca maintains confidence by investing significantly in promising areas like KRAS inhibitors, highlighting the inherent risks involved in pioneering novel therapeutic strategies, particularly those aiming to overcome resistance mechanisms in immuno-oncology.BioMarin has quietly discontinued its liver disease candidate amid a $4.8 billion deal with Amicus. This decision points to the complex nature of pipeline prioritization and resource allocation within high-stakes financial environments. The company's strategic shifts reflect ongoing evaluations of their development priorities in light of evolving market demands.Boehringer Ingelheim has demonstrated a commitment to renal therapeutics with a $448 million investment in Rectify Pharmaceuticals for a preclinical chronic kidney disease program. This partnership seeks to address significant unmet medical needs within kidney disease treatment. Meanwhile, Gilead Sciences has entered into a $35 million licensing agreement with Assembly Biosciences for herpes simplex virus (HSV) assets, diversifying its infectious disease portfolio and expanding its reach within antiviral therapies.Novo Holdings-backed Windward Bio's acquisition of rights to Qyun's clinical-stage immunology bispecifics for $700 million highlights robust activity in the immunology space. Bispecific antibodies are gaining traction due to their ability to target two antigens simultaneously, offering enhanced therapeutic efficacy. This acquisition illustrates ongoing interest in this area as companies seek innovative solutions to complex immunological challenges.The broader industry is also witnessing strategic partnerships such as Aditum Bio's launch of a new biotech venture with Fosun Pharma. This collaboration aims to foster novel therapies through a synergistic blend of biotechnology innovation and pharmaceutical expertise. These alliances reflect an industry trend towards collaborative efforts that leverage diverse strengths to advance therapeutic development.In regulatory news, nine major pharmaceutical companies have reached agreements with the U.S. government to lower certain drug prices in exchange for tariff relief. This development signals ongoing negotiations aimed at balancing drug affordability with industry sustainability amid growing scrutiny over pricing practices.In December 2025, significant developments emerged, impacting scientific innovation, regulatory approvals, mergers, and strategic partnerships across the industry. Notably, the U.S. Food and Drug Administration (FDA) granted early approval to Cytokinetics' MyqorzSupport the show

For episode 659 of the BlockHash Podcast, host Brandon Zemp is joined by Vijit Katta, CEO & Co-founder of Tria. Vijit Katta is the CEO and Co-founder of Tria, with over a decade of experience across entrepreneurship, commercial strategy, and early-stage investing. He built Polygon's in-house accelerator, funding early-stage projects; founded a healthtech startup in Austria, and led commercial strategy for multiple 9-figure portfolios at GSK and AstraZeneca; he holds a CS degree from BITS Pilani and an MBA from INSEAD. Tria is a self-custodial neobank that unifies spending, trading, and earning across all chains — without bridges, gas, or custodians. Built for both humans and AI, Tria makes money programmable, enabling anyone or any agent to transact natively on-chain. Powered by its interoperability layer, BestPath AVS, Tria abstracts away the complexity of crypto to deliver instant, global, and autonomous finance. 

Returning guest Dean McAlister, EVP, Inizio Biotech, has spent over 35 years in Fortune 500 pharma leadership, including nearly 3 decades at AstraZeneca. Hear how to prepare to lead in an uncertain environment, how to develop conscious competence as a leadership skill, how to become more adaptable as a leader, how to stop your ego from getting in the way as a leader, and how to build the courage to say what needs to be said in meetings. Connect with Shirley at ShirleyKavanagh.com and on LinkedIn, and Dean on LinkedIn

Pablo García, director general de Divacons-Alphavalue, repasa lo más destacado en Europa: Rheinmetall, Astrazeneca, Telecom Italia y la industria automovilística.

Guest: Gerard A. Silvestri MD, MS, Master FCCP Guest: Adam H. Fox, MD, MSc Guest: Anurag Singh, MD, PhD From updated surveillance strategies to evolving biopsy techniques and treatment advances, recent findings presented at 2025 conferences are reshaping non-small cell lung cancer management. Dr. Gerard Silvestri speaks with Drs. Adam Fox and Anurag Singh to explore key data influencing diagnostic decisions, patient-centered care, and multidisciplinary treatment planning across stages. Dr. Silvestri is a pulmonologist and the Hillenbrand Professor of Thoracic Oncology at the Medical University of South Carolina. Dr. Fox is a pulmonologist and Assistant Professor of Medicine at the Medical University of South Carolina. Dr. Singh is a Professor of Radiation Oncology and the Director of Radiation Research at the Roswell Park Cancer Center in New York. This program is produced in partnership with the American College of Chest Physicians and is sponsored by AstraZeneca.

Guest: Gerard A. Silvestri MD, MS, Master FCCP Guest: Mariam Alexander, MD, PhD Guest: Jessica S. Donington, MD, MSCR The 2025 European Society for Medical Oncology Congress and World Conference on Lung Cancer revealed significant updates in non-small cell lung cancer care. Learn more as Drs. Gerard Silvestri, Mariam Alexander, and Jessica Donington review new data on EGFR- and ROS1-targeted therapies, perioperative immunotherapy, and multidisciplinary strategies to expand resectability in stage III non-small cell lung cancer. Dr. Silvestri is a pulmonologist and the Hillenbrand Professor of Thoracic Oncology at the Medical University of South Carolina. Dr. Alexander is an Assistant Professor of Medical Oncology at the Medical University of South Carolina. Dr. Donington is a Professor in Surgery and Chief of the Section of Thoracic Surgery at the University of Chicago. This program is produced in partnership with the American College of Chest Physicians and is sponsored by AstraZeneca.

This podcast brings you highlights from Scrip Awards 2025, including wins for AstraZeneca, Syndax, Akeso and Summit Therapeutics and the Lifetime Achievement Award for Flagship Pioneering's Noubar Afeyan.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of groundbreaking advancements, revealing a landscape rich with scientific innovation and strategic maneuvers poised to impact patient care and the drug development pipeline.Let's start with Johnson & Johnson's recent FDA approval for a subcutaneous version of Rybrevant, their lung cancer medication. This new formulation offers a more convenient administration method compared to AstraZeneca's Tagrisso, intensifying competition in the non-small cell lung cancer market. The shift towards more patient-friendly delivery systems underscores the industry's commitment to enhancing treatment adherence and convenience. In contrast, Insmed faced a setback with its phase 2 trial for Brinsupri in treating chronic rhinosinusitis without nasal polyps. The discontinuation of this program highlights the unpredictable nature of clinical trials and emphasizes the need for rigorous scientific validation before advancing therapeutic candidates.Meanwhile, Lilly has shown promising results with its oral obesity pill, marking significant progress in weight management therapies. Patients transitioning from injectable GLP-1 therapies to Lilly's oral drug candidate maintained substantial weight loss, positioning Lilly favorably against Novo Nordisk's Wegovy. The potential for oral formulations to revolutionize treatment paradigms in chronic conditions cannot be understated. Lilly's progress in obesity treatment with its oral medication orforglipron further cements its competitive edge. Participants in their Phase III clinical trial maintained weight loss after switching from Wegovy or Zepbound to orforglipron, suggesting an efficacious oral alternative to injectable treatments and potentially enhancing patient adherence.On the regulatory front, the Biosecure Act's progression within a major defense spending bill could impose new challenges for life sciences companies with Chinese affiliations. This legislative shift reflects geopolitical tensions impacting global pharmaceutical collaborations and underscores the importance of regulatory compliance in international partnerships. Similarly, Intercept Pharmaceuticals' restructuring following the withdrawal of Ocaliva from the U.S. market is indicative of strategic pivots in response to regulatory hurdles and evolving market dynamics.In dermatology, Takeda's successful phase 3 trials for Zasocitinib highlight the competitive nature of drug development as multiple players vie for market share within therapeutic areas. Their anticipated 2026 FDA filing underscores the prolonged timelines involved in bringing novel therapies to market despite successful clinical outcomes.Public-private collaborations continue to play a crucial role in vaccine development, as evidenced by Moderna's pandemic influenza vaccine advancement into phase 3 trials with support from the Coalition for Epidemic Preparedness Innovations (CEPI). This $54 million investment illustrates ongoing efforts to bolster pandemic preparedness through innovative mRNA technologies. Meanwhile, Moderna's $54 million funding from CEPI to advance its bird flu vaccine highlights resilience amidst fluctuating governmental support. This endeavor leverages Moderna's mRNA technology platform, emphasizing mRNA's versatility across various infectious diseases.Shifting our focus slightly, medical groups have expressed opposition to changes in hepatitis B vaccination recommendations by the CDC for newborns. Such policy debates have significant implications for public health strategies and highlight ongoing discussions within medical communities regarding optimal vaccination protocols.GSK's strategic collaboration with Camp4 Therapeutics marks another key industry development. With an investment exceeding $400 million, GSK aims to Support the show

In this podcast episode, Jeremy S. Abramson, MD, MMSc, reviews data from select presentations in lymphomas at the ASH 2025 Annual Meeting and provides perspectives on the clinical implications of these data for patients with chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL), including:CLL17: randomized phase III trial of continuous ibrutinib vs fixed-duration venetoclax plus obinutuzumab or venetoclax plus ibrutinib for untreatedCLL BRUIN CLL-313: randomized phase III trial of pirtobrutinib vs BR for previously untreated patients with CLLBRUIN CLL-314: pirtobrutinib vs ibrutinib in treatment-naive and BTKi-naive R/R CLL/SLL EPCORE-FL-1: randomized phase III trial of epcoritamab with rituximab and lenalidomide vs rituximab and lenalidomide for R/R FLSTARGLO: 3-year follow-up data from the randomized phase III trial of glofitamab plus GemOx vs rituximab plus GemOx for patients with R/R DLBCLPresenter: Jeremy S. Abramson, MD, MMScProfessor of MedicineHarvard Medical SchoolDirector, Center for LymphomaMass General Brigham Cancer InsBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/4aqMobZ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Today's guest is Robert Wenier, Global Head of Cloud and Infrastructure at AstraZeneca. Robert leads enterprise cloud, infrastructure, and platform strategy across a highly regulated, data-intensive global organization. Robert joins Emerj CEO and Head of Research Daniel Faggella to discuss how enterprise data and AI architectures are shifting from service-oriented and microservice models toward emerging agentic architectures that prioritize end-to-end business outcomes over stepwise technical execution. The conversation explores why AI is moving from a supporting role to a direct driver of competitive advantage, and how this changes expectations for infrastructure, data strategy, and leadership ownership. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the 'AI in Business' podcast! If you've enjoyed or benefited from some of the insights of this episode, consider leaving us a five-star review on Apple Podcasts, and let us know what you learned, found helpful, or liked most about this show! Watch Daniel and Robert's conversation on our new YouTube Channel: youtube.com/@EmerjAIResearch.

“People are not looking for a perfect, polished answer. They're looking for a human to speak to them like a human,” says Jessica Malaty Rivera, an infectious disease epidemiologist and one of the most trusted science communicators in the U.S. to emerge from the COVID-19 pandemic. That philosophy explains her relatable, judgement-free approach to communications which aims to make science more human, more accessible and less institutional. In this wide-ranging Raise the Line discussion, host Lindsey Smith taps Rivera's expertise on how to elevate science understanding, build public trust, and equip people to recognize disinformation. She is also keen to help people understand the nuances of misinformation -- which she is careful to define – and the emotional drivers behind it in order to contain the “infodemics” that complicate battling epidemics and other public health threats. It's a thoughtful call to educate the general public about the science of information as well as the science behind medicine. Tune in for Rivera's take on the promise and peril of AI-generated content, why clinicians should see communication as part of their professional responsibility, and how to prepare children to navigate an increasingly complex information ecosystem.Mentioned in this episode:de Beaumont Foundation If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/podcast

In this episode, Hanny Al-Samkari, MD, gives his thoughts on 5 key presentations from ASH 2025, and provides perspectives on the clinical implications of these data for patients with nonmalignant hematologic disorders such as ITP and vWD, including: LBA-2: Primary results from VAYHIT2, a randomized, double-blind, phase III trial of ianalumab plus eltrombopag vs placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatmentAbstract 844: Secondary analysis results from VAYHIT3, a phase II study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least 2 lines of therapyAbstract 5: Deciphering the dilemma: intravenous (IV) iron use in iron deficiency anemia during acute infectionsAbstract 308: Subcutaneous, every-4-week maintenance dosing of a novel protein S antibody is well tolerated and substantially reduces bleeding rates: results from a phase I/II multidose study of VGA039 in patients with von Willebrand diseaseAbstract 841: Immune thrombocytopenia in patients treated with immune checkpoint inhibitorsPresenter:Hanny Al-Samkari, MDThe Peggy S. Blitz Endowed Chair in Hematology/OncologyCo-Director, Hereditary Hemorrhagic Telangiectasia Center of ExcellenceMassachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant updates that are shaping the future of healthcare, patient care, and drug development.The U.S. Food and Drug Administration has been particularly active recently, granting Johnson & Johnson a National Priority Review Voucher for its multiple myeloma drug combination. This move highlights the importance of J&J's treatment in addressing unmet needs within oncology, a field continuously striving for innovative solutions. These vouchers expedite the review process, reflecting a broader commitment to accelerating the availability of critical therapies for patients who need them most.Continuing with regulatory advancements, AstraZeneca and Daiichi Sankyo's Enhertu, in combination with Roche's Perjeta, has gained FDA approval as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. This breakthrough is supported by late-stage study results demonstrating a 44% reduction in disease progression or death compared to standard care. The approval signifies not only progress in breast cancer therapeutics but also underscores the potential benefits of strategic collaborations in drug development. Such partnerships are increasingly vital as they aim to optimize therapeutic efficacy through shared expertise and resources.In contrast to these advancements, Pfizer is facing financial recalibrations with projected revenues for 2026 estimated to decline due to diminishing COVID-19 vaccine sales and patent expirations. This situation reflects broader industry challenges as companies navigate post-pandemic market dynamics and patent cliffs, forcing reevaluations of long-term strategies.On another front, Gilead Sciences continues to push boundaries in HIV treatment with a promising single-tablet regimen combining bictegravir and lenacapavir. This innovation targets underserved segments within the HIV market, offering streamlined treatment options that could enhance patient adherence and outcomes significantly.Shifting focus to obesity management, Novo Nordisk's oral semaglutide is emerging as a highly anticipated medication among primary care providers. This trend highlights a growing preference for oral GLP-1 therapies as convenient alternatives to injectable formulations, marking a shift in how obesity—a major public health concern—is managed.The importance of regulatory compliance remains evident as Novo Nordisk received an FDA warning letter concerning manufacturing issues at an Indiana site previously owned by Catalent. This incident underscores the necessity for rigorous quality control in pharmaceutical manufacturing, which can have far-reaching implications on operational dynamics and supply chains.The FDA is also pioneering efforts to incorporate real-world evidence into medical device submissions by opening pathways for extensive deidentified datasets from sources like national cancer registries and electronic health records. This policy shift aims to integrate diverse data sources into the evidentiary foundation for medical device evaluations, potentially fostering innovation within this sector.In line with collaborative efforts, Genentech has partnered with Caris Life Sciences in a multi-year agreement valued at up to $1.1 billion, emphasizing the strategic importance of integrating diagnostic advancements with therapeutic developments to achieve precision medicine goals.Meanwhile, Yarrow Bioscience has acquired an autoimmune thyroid disease drug from China's Gensci, exemplifying a growing trend of cross-border collaborations aimed at leveraging global innovation ecosystems to address diverse therapeutic areas. This acquisition is part of a $1.37 billion deal, reinforcing the globalization of biotech partnerships as companies seek access to novel therapeutics andSupport the show

JCO PO author Dr. Shilpa Gupta at Cleveland Clinic Children's Hospital shares insights into her article, "Fibroblast Growth Factor Receptor 3 (FGFR3) Alteration Status and Outcomes on Immune Checkpoint Inhibitors (ICPI) in Patients with Metastatic Urothelial Carcinoma". Host Dr. Rafeh Naqash and Dr. Gupta discuss how FGFR3 combined with TMB emerged as a biomarker that may be predictive for response to ICPI in mUC. TRANSCRIPT Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, podcast editor for JCO Precision Oncology and Associate Professor at the OU Health Stephenson Cancer Center. Today I am excited to be joined by Dr. Shilpa Gupta, Director of Genitourinary Medical Oncology at the Cancer Institute and co-leader of the GU Oncology Program at the Cleveland Clinic, and also lead author of the JCO PO article titled "Fibroblast Growth Factor Receptor 3 Alteration Status and Outcomes on Immune Checkpoint Inhibitors in Patients With Metastatic Urothelial Carcinoma." At the time of this recording, our guest's disclosures will be linked in the transcript. Shilpa, welcome again to the podcast. Thank you for joining us today. Dr. Shilpa Gupta: Thank you, Rafeh. Honor to be here with you again. Dr. Rafeh Naqash: It is nice to connect with you again after two years, approximately. I think we were in our infancy of our JCO PO podcast when we had you first time, and it has been an interesting journey since then. Dr. Shilpa Gupta: Absolutely. Dr. Rafeh Naqash: Well, excited to talk to you about this article that you published. Wanted to first understand what is the genomic landscape of urothelial cancer in general, and why should we be interested in FGFR3 alterations specifically? Dr. Shilpa Gupta: Bladder cancer or urothelial cancer is a very heterogeneous cancer. And while we find there is a lot of mutations can be there, you know, like BRCA1, 2, in HER2, in FGFR, we never really understood what is driving the cancer. Like a lot of old studies with targeted therapies did not really work. For example, we think VEGF can be upregulated, but VEGF inhibitors have not really shown definite promise so far. Now, FGFR3 receptor is the only therapeutic target so far that has an FDA approved therapy for treating metastatic urothelial cancer patients, and erdafitinib was approved in 2019 for patients whose tumors overexpressed FGFR3 mutations, alterations, or fusions. And in the landscape of bladder cancer, it is important because in patients with non-muscle invasive bladder cancer, about 70 to 80% patients can have this FGFR3. But as patients become metastatic, the alterations are seen in, you know, only about 10% of patients. So the clinical trials that got the erdafitinib approved actually used archival tumor from local cancer. So when in the real world, we don't see a lot of patients if we are trying to do metastatic lesion biopsies. And why it is important to know this is because that is the only targeted therapy available for our patients right now. Dr. Rafeh Naqash: Thank you for giving us that overview. Now, on the clinical side, there is obviously some interesting data for FGFR3 on the mutation side and the fusion side. In your clinical practice, do you tend to approach these patients differently when you have a mutation versus when you have a fusion? Dr. Shilpa Gupta: We can use the treatment regardless of that. Dr. Rafeh Naqash: I recently remember I had a patient with lung cancer, squamous lung cancer, who also had a synchronous bladder mass. And the first thought from multiple colleagues was that this is metastatic lung. And interestingly, the liquid biopsy ended up showing an FGFR3-TACC fusion, which we generally don't see in squamous lung cancers. And then eventually, I was able to convince our GU colleagues, urologists, to get a biopsy. They did a transurethral resection of this tumor, ended up being primary urothelial and synchronous lung, which again, going back to the FGFR3 story, I saw in your paper there is a mention of FGFR3-TACC fusions. Anything interesting that you find with these fusions as far as biology or tumor behavior is concerned? Dr. Shilpa Gupta: We found in our paper of all the patients that were sequenced that 20% had the pathognomonic FGFR3 alteration, and the most common were the S249C, and the FGFR3-TACC3 fusion was in 45 patients. And basically I will say that we didn't want to generate too much as to fusion or the differences in that. The key aspect of this paper was that historically there were these anecdotal reports saying that patients who have FGFR alterations or mutations, they may not respond well to checkpoint inhibitors because they have the luminal subtype. And these were backed by some preclinical data and small anecdotal reports. But since then, we have seen that, and that's why a lot of people would say that if somebody's tumor has FGFR3, don't give them immunotherapy, give them erdafitinib first, right? So then we had this Phase 3 trial called the THOR trial, which actually showed that giving erdafitinib before pembrolizumab was not better. That debunked that myth, and we are actually reiterating that because in our work we found that patients who had FGFR3 alterations or fusions, and if they also have TMB-high, they actually respond very well to single agent immunotherapy. And that is, I think, very important because it tells us that we are not really seeing that so-called potential of resistance to immunotherapy in these patients. So to answer your question, yeah, we did see those differences, but I wouldn't say that any one marker is more prominent. Dr. Rafeh Naqash: The analogy is kind of similar to what we see in lung cancer with these mutations called STK11/KEAP1, which are also present in some other tumors. And one of the questions that I don't think has been answered is when you have in lung cancer, if you extrapolate this, where doublet or single agent immunotherapy doesn't do as well in tumors that are STK11 mutated. But then if you have a high TMB, question is does that TMB supersede or trump the actual mutation? Could that be one reason why you see the TMB-high but FGFR3 altered tumors in your dataset responding or having better outcomes to immunotherapy where potentially there is just more neoantigens and that results in a more durable or perhaps better response to checkpoint therapy? Dr. Shilpa Gupta: It could be. But you know, the patients who have FGFR alterations are not that many, right? So we have already seen that just patients with TMB-high respond very well to immunotherapy. Our last podcast was actually on that, regardless of PD-L1 that was a better predictor of response to immunotherapy. So I think it's not clear if this is adding more chances of response or not, because either way they would respond. But what we didn't see, which was good, that if they had FGFR3, it's not really downplaying the fact that they have TMB-high and that patients are not responding to immunotherapy. So we saw that regardless, and that was very reassuring. Dr. Rafeh Naqash: So if tomorrow in your clinic you had an individual with an FGFR3 alteration but TMB-high, I guess one could be comfortable just going ahead with immunotherapy, which is what the THOR trial as you mentioned. Dr. Shilpa Gupta: Yes, absolutely. And you know, when you look at the toxicity profiles of pembrolizumab and erdafitinib, really patients really struggle with using the FGFR3 inhibitors. And of course, if they have to use it, we have to, and we reserve it for patients. But it's not an easy drug to tolerate. Currently the landscape is such that, you know, frontline therapy has now evolved with an ADC and immunotherapy combinations. So really if patients progress and have FGFR3 alterations, we are using erdafitinib. But let's say if there were a situation where a patient has had chemotherapy, no immunotherapy, and they have FGFR3 upregulation and TMB-high, yes, I would be comfortable with using only pembrolizumab. And that really ties well together what we saw in the THOR trial as well. Dr. Rafeh Naqash: Going to the clinical applications, you mentioned a little bit of this in the manuscript, is combination therapies. You alluded to it a second back. Everything tends to get combined with checkpoint therapy these days, as you've seen with the frontline urothelial, pembrolizumab with an ADC. What is the landscape like as far as some of these FGFR alterations are concerned? Is it reasonable to combine some of those drugs with immune checkpoint therapy? And what are some of the toxicity patterns that you've potentially seen in your experience? Dr. Shilpa Gupta: So there was indeed a trial called the NORSE trial. It was a randomized trial but not a comparative cohort, where they looked at FGFR altered patients. And when they combined erdafitinib plus cetrelimab, that did numerically the response rates were much higher than those who got just erdafitinib. So yeah, the combination is definitely doable. There is no overlapping toxicities. But unfortunately that combination has not really moved forward to a Phase 3 trial because it's so challenging to enroll patients with such kind of rare mutations on large trials, especially to do registration trials. And since then the frontline therapy has evolved to enfortumab vedotin and pembrolizumab. I know there is an early phase trial looking at a next generation FGFR inhibitor. There is a triplet combination looking in Phase 1 setting with a next generation FGFR inhibitor with EV-pembro. However, it's not a randomized trial. So you know, I worry about such kinds of combinations where we don't have a path for registration. And in the four patients that have been treated, four or five patients in the early phase as a part of basket trial, the toxicities were a lot, you know, when you combine the EV-pembro and an FGFR3 inhibitor, we see more and more toxicity. So the big question is do we really need the "kitchen sink" approach when we have a very good doublet, or unless the bar is so high with the doublet, like what are we trying to add at the expense of patient toxicity and quality of life is the big question in my mind. Dr. Rafeh Naqash: Going back to your manuscript specifically, there could be a composite biomarker. You point out like FGFR in addition to FGFR TMB ends up being predictive prognostic there. So that could potentially be used as an approach to stratify patients as far as treatment, whether it's a single agent versus combination. Maybe the TMB-low/FGFR3 mutated require a combination, but the TMB-high/FGFR mutated don't require a combination, right? Dr. Shilpa Gupta: No, that's a great point, yeah. Dr. Rafeh Naqash: But again, very interesting, intriguing concepts that you've alluded to and described in this manuscript. Now, a quick take on how things have changed in the bladder cancer space in the last two years. We did a podcast with you regarding some biomarkers as you mentioned two years back. So I really would like to spend the next minute to two to understand how have things changed in the bladder cancer space? What are some of the exciting things that were not there two years back that are in practice now? And how do you anticipate the next two years to be like? Maybe we'll have another podcast with you in another two years when the space will have changed even more. Dr. Shilpa Gupta: Certainly a lot has happened in the two years, you know. EV-pembro became the universal frontline standard, right? We have really moved away from cisplatin eligibility in metastatic setting because anybody would benefit from EV-pembro regardless of whether they are candidates for cisplatin or not, which historically was relevant. And just two days ago, we saw that EV-pembro has now been approved for localized bladder cancer for patients who are cisplatin ineligible or refusing. So, you know, this very effective regimen moving into earlier setting, we now have to really think of good treatment options in the metastatic setting, right? So I think that's where a lot of these novel combinations may come up. And what else we've seen is in a tumor agnostic trial called the DESTINY-PanTumor trial, patients who had HER2 3+ on immunohistochemistry, we saw the drug approval for T-DXd, and I think that has kind of reinvigorated the interest in HER2 in bladder cancer, because in the past targeting HER2 really didn't work. And we still don't know if HER2 is a driver or not. And at ESMO this year, we saw an excellent study coming out of China with DV which is targeting HER2, and toripalimab, which is a Chinese checkpoint inhibitor, showing pretty much similar results to what we saw with EV-pembro. Now, you know, not to do cross-trial comparisons, but that was really an amazing, amazing study. It was in the presidential session. And I think the big question is: does that really tell us that HER2-low patients will not benefit? Because that included 1+, 2+, 3+. So that part we really don't know, and I think we want to study from the EV-302 how the HER2 positive patients did with EV and pembro. So that's an additional option, at least in China, and hopefully if it gets approved here, there is a trial going on with DV and pembro. And lastly, we've seen a very promising biomarker, like ctDNA, for the first time in bladder cancer in the adjuvant setting guiding treatment with adjuvant atezolizumab. So patients who were ctDNA positive derived overall survival and recurrence-free survival benefit. So that could help us select moving forward with more studies. We can spare unnecessary checkpoint inhibitors in patients who are not going to benefit. So I think there is a lot happening in our field, and this will help do more studies because we already have the next generation FGFR inhibitors which don't have the toxicities that erdafitinib comes with. And combining those with these novel ADCs and checkpoint inhibitors, you know, using maybe TMB as a biomarker, because we really need to move away from PD-L1 in bladder cancer. It's shown no utility whatsoever, but TMB has. Dr. Rafeh Naqash: Well, thank you so much, Shilpa, for that tour de force of how things have changed in bladder cancer. There used to be a time when lung and melanoma used to lead this space in terms of the number of approvals, the biomarker development. It looks like bladder cancer is shifting the trend at this stage. So definitely exciting to see all the new changes that are coming up. I'd like to spend another minute and a half on your career. You've obviously been a leader and example for many people in the GU space and beyond. Could you, for the sake of our early career especially, the trainees and other listeners, describe how you focused on things that you're currently leading as a leader, and how you shaped your career trajectory over the last 10 years? Dr. Shilpa Gupta: That's a really important question, Rafeh, and you and I have had these discussions before, you know, being an IMG on visas like you, and being in different places. I think I try to make the most of it, you know, instead of focusing on the setbacks or the negative things. Like tried to grab the opportunities that came along. When I was at Moffitt, got to get involved with the Phase 1 trial of pembrolizumab in different tumor types. And just keeping my options open, you know, getting into the bladder cancer at that time when I wanted to really do only prostate, but it was a good idea for me to keep my options open and got all these opportunities that I made use of. I think an important thing is to, like you said, you know, have a focus. So I am trying to focus more on biomarkers that, you know, we know that 70% patients will respond to EV-pembro, right? But what about the remaining 30%? Like, so I'm really trying to understand what determines hyperprogressors with such effective regimens who we really struggle with in the clinic. They really don't do well with anything we give them after that. So we are doing some work with that and also trying to focus on PROs and kind of patient-reported outcomes. And a special interest that I've now developed and working on it is young-onset bladder cancer. You know, the colorectal cancer world has made a lot of progress and we are really far behind. And bladder cancer has historically been a disease of the elderly, which is not the case anymore. We are seeing patients in their 30s and 40s. So we launched this young-onset bladder cancer initiative at a Bladder Cancer Advocacy Network meeting and now looking at more deep dive and creating a working group around that. But yeah, you know, I would say that my philosophy has been to just take the best out of the situation I'm in, no matter where I am. And it has just helped shape my career where I am, despite everything. Dr. Rafeh Naqash: Well, thank you again. It is always a pleasure to learn from your experiences and things that you have helped lead. Appreciate all your insights, and thank you for publishing with JCO PO. Hopefully we will see more of your biomarker work being published and perhaps bring you for another podcast in a couple of years. Dr. Shilpa Gupta: Yeah, thank you, Rafeh, for the opportunity. And thanks to JCO PO for making these podcasts for our readers. So thanks a lot. Dr. Rafeh Naqash: Thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcast. 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. DISCLOSURES Dr. Shilpa Gupta Stock and Other Ownership Interests: Company: BioNTech SE,  Nektar Consulting or Advisory Role: Company: Gilead Sciences, Pfizer, Merck, Foundation Medicine, Bristol-Myers Squibb/Medarex, Natera, Astellas Pharma, AstraZeneca, Novartis, Johnson & Johnson/Janssen Research Funding: Recipient: Your Institution Company: Bristol Myers Squibb Foundation, Merck, Roche/Genentech, EMD Serono, Exelixis, Novartis, Tyra Biosciences, Pfizer, Convergent Therapeutics, Acrivon Therapeutics, Flare Therapeutics, Amgen Travel, Accommodations, Expenses: Company: Pfizer, Astellas Pharma, Merck    

This week on Careers in Discovery, we're joined by Peter Hamley, Founder and CEO of Scripta Therapeutics.  Peter didn't follow the typical founder path. After a long and successful career in big pharma R&D and business development, he made the leap into Biotech with a mission: to unlock the potential of transcription factors in treating neurodegenerative diseases. What followed was a complete mindset shift - from structure and scale to agility and risk.  In this episode, Peter shares the thinking behind Scripta's unique approach to drug discovery, how his experience at Sanofi and AstraZeneca shaped his leadership style, and why failure, iteration, and clarity of purpose are more important now than ever. 

In this podcast episode, Amir T. Fathi, MD, reviews data from select presentations in leukemias at the ASH 2025 Annual Meeting, and provides perspectives on the clinical implications of these data for patients with acute myeloid leukemia (AML) or chronic myeloid leukemia (CML), including:Abstract 6: Phase II PARADIGM trial of azacitidine and venetoclax vs conventional intensive chemotherapy for fit patients with newly diagnosed AMLAbstract 47: Phase I/II SAVE trial of revumenib plus decitabine/cedazuridine and venetoclax in the cohort of patients with newly diagnosed AMLAbstract 766: Phase Ib KOMET-007 trial of ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-mutant AMLAbstract 654: Phase I/II VICEROY trial of venetoclax and azacitidine + gilteritinib in patients with newly diagnosed FLT3-mutated AML ineligible for intensive induction chemotherapyAbstract 903: 3-Yr Update of the phase II FASCINATION trial of asciminib and conventional BCR::ABL1 inhibitors in newly diagnosed CMLAbstract 906: Phase II ASC2ESCALATE trial of asciminib in patients with chronic-phase CML after 1 prior TKIPresenter:Amir T. Fathi, MDDirector, Leukemia ProgramMassachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MassachusettsContent based on an online CME program supported by educational grants from AstraZeneca, BeOne Medicines, Genentech, Geron Corporation, Incyte, Johnson & Johnson, Lilly, and Novartis Pharmaceuticals Corporation.Link to full program:https://bit.ly/48Ye45N Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China's OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity.   Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots.   Pfizer CEO Albert Bourla, for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration's sentiment on vaccines, Bourla prominsed Pfizer's continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus.  The FDA has also granted several approvals in the past week, to Amgen, Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo. USAntibiotics also snagged a greenlight, for Augmentin XR, the first approval to be given under the agency's new Commissioner's National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data.   In ClinicaSpace this week, we highlighted 5 of 2025's Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025. This past week provided a few more on each front. In the winner's circle, Immunome's desmoid tumor drug and and Kyverna's CAR T for stiff person syndrome both aced pivotal trials, while Sanofi's MS drug tolebrutinib and Gilead and Arcus' TIGIT therapy domvanalimab each failed Phase III tests.   And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma's Next M&A Target, and more M&A predictions for 2026.  

“Delivering a baby one day and holding a patient's hand at the end of life literally the next day...that continuity is very powerful,” says Dr. Jen Brull, board chair of the American Academy of Family Physicians (AAFP). And as she points out, that continuity also builds trust with patients, an increasingly valuable commodity when faith in medicine and science is declining. As you might expect given her role, Dr. Brull believes strengthening family medicine is the key to improving health and healthcare. Exactly how to do that is at the heart of her conversation with host Lindsey Smith on this episode of Raise the Line, which covers ideas for payment reform, reducing administrative burdens, and stronger support for physician well-being. And with a projected shortage of nearly forty thousand primary care physicians, Dr. Brull also shares details on AAFP's “Be There First” initiative which is designed to attract service-minded medical students – whom she describes as family physicians at heart -- early in their educational journey. “I have great hope that increasing the number of these service-first medical students will fill part of this gap.”Tune-in for an informative look at a cornerstone of the healthcare system and what it means to communities of all sizes throughout the nation.  Mentioned in this episode:AAFP If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/podcast

Send us a textWhat if the biggest transformation in digital pathology this year had nothing to do with new hardware—and everything to do with how we think about value, workflow, and readiness?In this year-end recap livestream from the 11th Digital Pathology & AI Congress in London, I break down what truly mattered in 2025. Instead of focusing on buzzwords or hype cycles, this episode highlights the practical advances shaping diagnostics, patient care, and drug development—and the mindset shift our field must embrace to move forward.Digital pathology is no longer “early adoption.” It's becoming essential infrastructure. And yet the biggest barrier isn't scanners or algorithms—it's the knowledge and confidence needed to use them well.Key Highlights & Timestamps0:00 — Setting the Stage from LondonAn overview of the forces that shaped digital pathology in 2025: workflow integration, clinical readiness, and the move from theory to operational reality.1:45 — Leica's Expanded Portfolio & FDA-Cleared CollaborationsA look at Leica's updated scanner lineup and co-developed, FDA-cleared solutions with Indicollabs. These launches reflect a broader industry trend toward highly specialized, clinically validated digital tools designed for end-to-end workflows.4:12 — The Acceleration of Companion DiagnosticsFrom Artera's de novo–approved prostate prognostic test to AstraZeneca's TROP2 scoring efforts, 2025 pushed computational pathology directly into therapeutic decision-making.6:20 — Why Workflow Integration Became the Theme of 2025Partnerships like BioCare + Hamamatsu + Visgen and Zeiss + MindPeak show where the field is heading: full-stack solutions, not isolated tools. Labs want interoperability, reliability, and simplified digital workflows.9:10 — Adoption Challenges: ROI, Education & AI UncertaintyWe explore the realities slowing digital transformation: – ROI is real, but requires workflow change – AI anxiety persists among clinicians and patients – Education is still the strongest driver of adoption12:00 — 2025's Innovation HighlightsBreakthroughs shaping the next phase of digital pathology include: – emerging agentic AI platforms – voice-enabled image management systems – improved multiplexing technologies like Hamamatsu's Moxiplex15:40 — The Growing Intersection of Pathology & GenomicsAI models predicting genomic alterations from H&E images gained traction, especially for cases with minimal tissue. Tempus acquiring Paige signals the deepening connection between digital workflows and molecular data.18:30 — What 2026 Will RequirePriorities for the coming year include: – building agentic AI solutions capable of real workflow orchestration – strengthening validation and QC – sharing real-world deployment case studies – expanding training and hands-on learningRESOURCES:1. The Lucerne Toolbox 3: digital health and artificial intelligence to optimise the patient journey in early breast cancer-a multidisciplinary consensus2. Artificial intelligence (AI) molecular analysis tool assists in rapid treatment decision in lung cancer: a case reportSupport the showGet the "Digital Pathology 101" FREE E-book and join us!

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of transformative events shaping the future of drug development, patient care, and global healthcare strategies.**Johnson & Johnson's Multiple Myeloma Advances** Johnson & Johnson has made significant strides in the treatment of multiple myeloma with their bispecific antibody, Tecvayli. In recent trials, Tecvayli has shown remarkable promise when used in combination therapies as a second-line treatment. This development is noteworthy as it could potentially challenge the dominance of CAR-T cell therapies like J&J's Carvykti by offering a more accessible and less complex alternative. For patients, this means potentially fewer logistical hurdles and a more straightforward therapeutic option, which could drastically improve patient care standards.**Regulatory Scrutiny on RSV Vaccines** Turning to regulatory news, the U.S. FDA has intensified its scrutiny of respiratory syncytial virus (RSV) vaccines developed by pharmaceutical giants such as Merck, AstraZeneca, and Sanofi for infants. This increased oversight follows reports linking some COVID-19 vaccines to adverse effects in children. The FDA's actions highlight the ongoing necessity for vigilant safety monitoring in vaccine development, especially for vulnerable populations like infants. This is a crucial step in ensuring that vaccines designed for our youngest population are both safe and effective.**Eli Lilly's Strategic Moves in Oncology and Beyond** Eli Lilly is making waves in oncology with its BTK inhibitor, Jaypirca. Despite strong phase 3 results that support its use as a first-line treatment for chronic lymphocytic leukemia (CLL), Lilly is focusing on its application as a second-line therapy. This strategic choice reflects an astute understanding of market dynamics and therapeutic niches where Jaypirca can provide substantial benefits despite competition from established first-line treatments. Additionally, Eli Lilly continues to leverage its financial success from its weight loss drug Tirzepatide to position itself as a central player in global pharmaceutical innovation. The company's strategic investments are likely to catalyze advancements across various therapeutic areas, reinforcing its role as a key contributor to medical breakthroughs.**Legislative Impact on Biopharma** In legislative news, the Biosecure Act's incorporation into the U.S. National Defense Authorization Act marks a strategic shift towards tightening regulations on Chinese biopharma entities regarding federal contracts by 2026. This move could have profound implications for international collaborations and competition within biotechnology innovation and drug development sectors. It signals a broader trend of increased scrutiny on foreign entities in sensitive industries like biopharmaceuticals.**China's Healthcare Transformation** China's healthcare landscape is undergoing significant transformation with the inclusion of drugs from companies like Pfizer, Lilly, and J&J into its first private insurance formulary. This development could enhance access to innovative medications within China, potentially improving health outcomes and influencing global pricing strategies in the pharmaceutical industry.**Gamida Cell's Milestone in Cell Therapies** In a major milestone for cell therapies, Gamida Cell has secured a second FDA approval for its stem cell therapy Omisirge. Initially approved to reduce infection risk during hematopoietic stem cell transplantations in blood cancer patients, Omisirge's expanded indication to treat severe aplastic anemia underscores the potential of cell therapies in addressing diverse hematologic conditions.**CSL Seqirus' New Facility in Australia** In Australia, CSL Seqirus has opened a $1 billion facility dedicated to producing cell-baSupport the show

Send us a textHave you ever thought, “Digital pathology sounds amazing, but without a scanner, what's the point of learning it now?” If so, this episode will change how you see your role in the future of pathology.In this talk, I challenge one of the most persistent myths in our field: the belief that you need expensive hardware before you can begin your digital pathology journey. Through personal experience and the remarkable story of another pathologist who started with even less, I show why knowledge—not infrastructure—is what truly opens doors.Highlights and Key Themes0:00 – The Limiting BeliefI open with the core misconception I hear from pathologists worldwide: “I need a scanner before I can start.” I explain why hesitation, not lack of equipment, is the real barrier—and why waiting for perfect conditions keeps many people stuck.2:24 – My Early Digital Pathology StoryI describe my residency in 2013, when a single scanner was “off limits” to trainees. Faced with a research project requiring consistent cell counting, I improvised using a microscope camera and Microsoft Paint. It wasn't sophisticated, but it was digital, consistent, and reproducible. This experience taught me a foundational lesson: if you can measure something, measure it; don't rely on visual estimation.7:01 – How This Led to My First Digital Pathology JobThat basic Paint-and-dots project became my gateway to working at Definiens (now part of AstraZeneca). I wasn't hired for computational expertise; I was hired because I understood tissue, biology, and the value of quantifying what we see. Working alongside image analysis scientists showed me the exponential power of combining tissue knowledge with computational tools.10:03 – Dr. Talat Zehra's StoryI share the inspiring journey of Dr. Talat Zehra from Karachi, Pakistan, who began with no access to scanners and only a microscope camera. During COVID shutdowns, she taught herself the foundations of digital pathology, joined global organizations, conducted a nationwide survey, and contacted AI vendors for access to platforms. After many rejections, one vendor offered a trial account. In just six weeks, she completed three AI projects using microscope camera images—each one published in a peer-reviewed journal. Her story highlights a universal truth: starting with curiosity and persistence matters far more than having perfect tools.14:14 – Two Paths After a ConferenceI explain the difference between the “forgetting loop” and the “learning path.” Many attendees leave inspired but slip back into routine. Others commit to one consistent learning habit—journal clubs, vendor webinars, DigiPath Digest sessions—and return a year later with clarity, confidence, and momentum. These individuals become the people others seek out for guidance in digital pathology.18:04 – Where to BeginYou don't need a scanner or an institutional budget to start. What you need is structured knowledge. I introduce my book, Digital Pathology One on One, and encourage listeners to choose one learning habit to build on after the episode. The only wrong choice is choosing nothing.19:06 – Final MessageKnowledge drives adoption, not infrastructure.Scanners, AI tools, and computational platforms already exist. What's missing are people who understand how to interpret tissue digitally, collaborate with computational teams, and bridge biology with technology. You haveSupport the showGet the "Digital Pathology 101" FREE E-book and join us!

JCO Editor-in-Chief Dr. Jonathan Friedberg is joined by colleagues Dr. Jennifer Woyach, Dr. Wojciech Jurczak, and Dr. Matthew Davids to discuss simultaneous publications presented at ASH 2025 on pertibrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. TRANSCRIPT The disclosures for guests on this podcast can be found in the show notes. Dr. Jonathan Friedberg: I'm Jonathan Friedberg, editor of Journal of Clinical Oncology, and welcome to JCO After Hours, where we are covering two manuscripts that were presented at the American Society of Hematology meeting 2025 in Orlando, Florida. I am delighted to be joined by colleagues on this call to discuss these pivotal manuscripts which cover the topic of pirtobrutinib, a new upfront treatment option for patients with chronic lymphocytic leukemia. I will first just introduce our guests, Dr. Woyach. Dr. Jennifer Woyach: Hi, my name is Jennifer Woyach. I am from the Ohio State University. Dr. Wojciech Jurczak: Hello, I am Wojciech Jurczak, working at the National Research Institute of Oncology in Krakow, Poland. Dr. Matthew Davids: Hi, I am Matthew Davids from Dana-Farber Cancer Institute in Boston. Dr. Jonathan Friedberg: We are going to start by just learning a little bit about these two trials that were both large, randomized phase 3 studies that I think answered some definitive questions. We will start with your study, Jennifer. If you could just describe the design of your study and the patient population. Dr. Jennifer Woyach: Absolutely. So this is the BRUIN CLL-314 study, and this is a phase 3 randomized trial of pirtobrutinib versus ibrutinib in patients with CLL or SLL who had not previously been treated with a covalent BTK inhibitor. The patients were both treatment-naive and relapsed/refractory, about one-third of the patients treatment-naive, the rest relapsed/refractory, and they were stratified based upon 17p deletion and the number of prior lines of therapy. The primary objective was looking at non-inferiority of overall response rate over the entire treated population as well as the relapsed/refractory patient population. Key secondary objectives included progression-free survival in the intention-to-treat and the smaller relapsed/refractory and treatment-naive populations. Dr. Jonathan Friedberg: And just comment a little bit on the risk of the patients. Dr. Jennifer Woyach: This study was fairly typical of this cohort of patients. Within the relapsed/refractory patient population, there was a median of one prior line of therapy in each of the groups, up to nine prior lines of therapy in the patients included on the study. For the overall cohort, about two-thirds of the patients were IGHV unmutated, about 15% had 17p deletion, 30% had TP53 mutations, and about 35% to 40% had a complex karyotype, which is three or more abnormalities. Dr. Jonathan Friedberg: And what were your findings? Dr. Jennifer Woyach: Regarding the primary outcome, which is the focus of the publication, we did find that pirtobrutinib was indeed non-inferior and actually superior to ibrutinib for overall response rate throughout the entire patient population and in both the relapsed/refractory and treatment-naive cohorts. PFS is a little bit immature at this time but is trending towards also being significantly better in pirtobrutinib-treated patients compared with ibrutinib-treated patients. Probably most significantly, we found this to be the case in the treatment-naive cohort where there was a striking trend to an advantage of pirtobrutinib versus ibrutinib. Dr. Jonathan Friedberg: And the follow-up that you have on that progression-free survival? Dr. Jennifer Woyach: So we have about 18 months follow-up on progression-free survival. Dr. Jonathan Friedberg: The second study, Wojciech, can you just go through the design and patient population that you treated? Dr. Wojciech Jurczak: Thank you, Dr. Friedberg, for this question. So the BRUIN CLL-313 study was, in fact, the first phase 3 study with pirtobrutinib in exclusively untreated CLL patients. It was a randomized study where we challenged pirtobrutinib versus bendamustine-rituximab. At the time we designed the protocol, bendamustine-rituximab was an option as a standard of care, and Bruton tyrosine kinase monotherapy was used far more commonly than nowadays. The primary target of the study was progression-free survival. We took all untreated patients except for those with 17p deletions. Therefore, it is a good representation for intermediate risk. We had about 60% of the population, 56 to be precise, which was unmutated, evenly distributed into two treatment arms. 17p deleted cases were excluded, but we had about 7% and 8% of TP53 mutated patients as well as about 11% and 7%, respectively, in the pirtobrutinib and bendamustine-rituximab arm of patients with complex karyotype. The progression-free survival was in favor of pirtobrutinib and was assessed by an independent review committee. What is important is that the progression-free survival of the bendamustine-rituximab arm was actually similar to the other studies addressing the same questions, like the comparison with ibrutinib in the ALLIANCE study or zanubrutinib in the SEQUOIA study. What was different was the hazard ratio. In our study, it was 0.20. It was one of the longest effect sizes noted in the frontline BTK study. It represented an 80% reduction in progression-free survival or death. If we compare it to ibrutinib or zanubrutinib, it was 0.39 and 0.42 respectively. Presumably, this great effect contributed towards a trend of overall survival difference. Although survival data are not mature enough, there is a clear trend represented by three patients we lost in the pirtobrutinib arm versus 10 patients lost in the bendamustine-rituximab arm. This trend in overall survival is becoming statistically significant despite the fact that there was a possibility of crossover, and effectively 52.9 patients, which means 18 out of 34 patients relapsing in the bendamustine-rituximab arm, were treated by pirtobrutinib. Dr. Jonathan Friedberg: I am going to turn it over to Matt. The question is: why study pirtobrutinib in this patient population? And then with these two studies, how do you find the patients that were treated, are they representative of people who you see? And do you see this maybe being approved and more widely available? Dr. Matthew Davids: I think in terms of the first question, why study this in a frontline population, we have seen very impressive data with pirtobrutinib in a very difficult-to-treat population of CLL patients. This was from the original BRUIN phase 1/2 study where most of the patients had at least two or three lines of therapy, often both a covalent BTK inhibitor and the BCL2 inhibitor venetoclax, and yet they were still responding to pirtobrutinib. The drug was also very well tolerated in that early phase experience. And actually, we have seen phase 3 data from the BRUIN 321 study comparing pirtobrutinib to bendamustine and rituximab in a relapse population as well. So I think that really motivated these studies to look at pirtobrutinib as a first therapy. You know, often in other cancers of course, we want to use our best therapy first, and I think these studies are an initial step at looking at that. In terms of the second question around the patient population, these are pretty representative patient populations, I would say, for most frontline CLL studies. We see patients who are a bit younger and fitter than sort of the general population of CLL patients who are treated in clinical practice, and I think that is true here as well. Median age in the sort of mid-60s here is a bit younger than the typical patients we are treating in practice. But that is not different from other CLL frontline studies that we have seen recently, so I think it makes it a little bit easier as we kind of think across studies to feel comfortable that these are relatively similar populations. Dr. Jonathan Friedberg: How do you see this either getting regulatory approval or potentially being used compared to current standard of care options? Dr. Matthew Davids: So my understanding is that both of these trials were designed with registrational intent in the frontline setting, and they are both positive studies. That is certainly very encouraging in terms of the potential for an approval here. We have seen in terms of the FDA recently some concerns around the proportion of patients who are coming from North America, and my understanding is that is relatively low on these two studies. But nonetheless, the datasets are very impressive, and so I think it is certainly supportive of regulatory approval for frontline pirtobrutinib. Dr. Jonathan Friedberg: I will ask Jennifer a question. The control arm in your study was ibrutinib, and I think many in the audience may recognize that newer, second-generation BTK inhibitors like acalabrutinib and zanubrutinib are more frequently used now if monotherapy is decided. How do you respond to that, and how would you put your results in your pirtobrutinib arm in context with what has been observed with those agents? Dr. Jennifer Woyach: Yeah, that is a great question. Even though in the United States we are predominantly using acalabrutinib or zanubrutinib when choosing a monotherapy BTK inhibitor, this is actually not the case throughout the entire world where ibrutinib is still used very frequently. The head-to-head studies of both acalabrutinib and zanubrutinib compared to ibrutinib have shown us pretty well what the safety profile and efficacy profile of the second-generation BTK inhibitors is. So even though we do not have a head-to-head study of acalabrutinib or zanubrutinib versus pirtobrutinib, I think, given the entirety of data that we have with all of the covalent BTK inhibitors, I think we can safely look at the pirtobrutinib arm here, how the ibrutinib arm compares or performs in context with those other clinical trials. And though we really can not say anything about pirtobrutinib versus acalabrutinib or zanubrutinib, I think we can still get a good idea of what might be the clinical scenarios in which you might want to choose pirtobrutinib. Dr. Jonathan Friedberg: And Wojciech, do you agree with that? Obviously, I think you have acknowledged that chemoimmunotherapy is rarely used anymore as part of upfront treatment for CLL. So, I guess a similar question. If you were to put the pirtobrutinib result in your study in context with, I guess, more contemporary type controls, would you agree that it is competitive? Dr. Wojciech Jurczak: Well, I think that that was the last study ever where bendamustine-rituximab was used as a comparator arm. So we should notice that smashing difference. Because if we look at the progression-free survival at two years, we have 93.4% in pirtobrutinib arm versus 70.7% in bendamustine-rituximab arm. Bendamustine-rituximab arm did the same as in the other trials, like ALLIANCE or SEQUOIA. Pirtobrutinib did exceptionally well, as pirto is not just the very best BTK inhibitor overcoming the resistance, but perhaps even more important for the first line, it is very well tolerated and is a very selective drug. Now, if we look at treatment-related adverse events, the discontinuation rate, they were hardly ever seen. If we compared the adverse events in exposure-adjusted incidence, literally all adverse events were two or three times higher in bendamustine-rituximab arm except for the bleeding tendency, which however was predominantly in CTCAE grade 1 and 2 with just 0.7% of grade 3 hemorrhage. Therefore, I think that we should actually put the best and the safest drugs upfront if we may, and pirtobrutinib is, or should be, the first choice if we choose monotherapy. Now, I understand that we are not presenting you the data of pirtobrutinib in combination with anti-CD20 or with BCL2 inhibitors, but that is to come. Dr. Jonathan Friedberg: Matt, how would you envision, were regulatory approval granted and this were an option, using this in the upfront patient population? Is there anybody who you would preferentially use this or start on this treatment? Or would this be something that you would tend to reserve for second line? Dr. Matthew Davids: So I would say that in general for most of my patients who would want to start with a continuous BTK inhibitor, I would still use a covalent BTK inhibitor, and I say that for a couple of reasons despite the very promising data from these studies. The first is that the follow-up for both of these phase 3 trials is still quite short, in the range of a median 18 to 24 months. And we know that CLL is a marathon, not a sprint, and these patients are going to probably be living for a very long time. And we do have much longer follow-up from the covalent BTK inhibitors, median of 10-year follow-up with ibrutinib and five to six years with zanubrutinib and acalabrutinib respectively. And you know, I do not think that the pirtobrutinib is going to fall off a cliff after two years, but on the other hand, I think there is a lot of value to long-term data in this disease, and that is why I think for most of my patients I would stick with covalent BTK inhibitors. But the other important factor that we need to consider is patients who are younger and may have many different CLL treatments over the years. We have to be very careful, I think, about how we sequence these drugs. We know right now that we can start with covalent BTK inhibitors and then subsequently patients will respond well to the non-covalent inhibitor pirtobrutinib in later lines of therapy. But right now we do not have prospective data the other way around. So how will the patients on these studies who progress on pirtobrutinib respond to covalent BTK inhibitors? We do not know yet. There have not been a lot of progression events, which is great, but we would like to see some data in that respect to feel more comfortable with that sequence. Now, I do think that particularly for older patients and those who have significant cardiovascular comorbidities, if they wanted to go on a continuous BTK inhibitor, I do think these data really strongly support using pirtobrutinib as the BTK inhibitor of choice in that population. In particular, the cardiovascular risks with pirtobrutinib seem to be quite low. I was very struck in the comparison with BR that the rate of AFib was equivalent between the two arms of the study. And that is really the first time we have seen that with any of these BTK inhibitors, no elevated risk of AFib in a randomized study. I think that is the population where it will get the most traction first, is the upfront, sort of older patient with significant cardiovascular comorbidities. And as the data from these studies mature, I think that we will start to see more widespread use of pirtobrutinib in the frontline setting. Dr. Jonathan Friedberg: Jennifer, I am just curious if you have any personal experience or heard anecdotally about after progression on pirtobrutinib the use of other BTK inhibitors and whether there is a growing experience there. Dr. Jennifer Woyach: I do not think that there is much clinical experience, you know, as Matt alluded to, it certainly has not been tested yet. There has been some data in relapsed CLL suggesting that in people who have resistance mutations to covalent BTK inhibitors after treatment with pirtobrutinib, sometimes those mutations go away. I think most of us are concerned that they are probably not actually gone but maybe in compartments that we just have not sampled, suggesting that sort of approach where you might sequence a covalent inhibitor after a non-covalent in somebody who had already been resistant probably would not work that well. But, you know, in this setting where people had never been exposed to a covalent BTK inhibitor before, we really have no idea what the resistance patterns are going to be like. We assume they will be the same as what we have seen in relapsed CLL, but I think we just need some longer follow-up to know for sure. Dr. Wojciech Jurczak: If I may confront Dr. Davids about the use of covalent BTK inhibitors upfront, well, I think that we should abandon the idea of using the first and the second and the third generation, at least if we don't have medical lines. If we endlessly block the same pathway, it is not going to be effective. So if pirtobrutinib gets approval in first, second line, we do not necessarily have to use it in the first line. I am not here in a position to defend that we should treat patients with pirtobrutinib upfront and not BCL2 time-limited regimen. However, the way I look at CLL patients when choosing therapy is not just how should I treat them now, but what would be the best regimen in 5, 10 years if I have to re-treat them. And in some instances, the idea may be that in this setting we would like to have a BTK inhibitor upfront to have a BCL2 inhibitor later to make it time-limited. Although I understand and I agree with Matthew that if we have an elderly, fragile population, then the charm of having a drug taken once a day in a tablet with literally few cardiovascular adverse events might be an option. Dr. Jonathan Friedberg: And I will give Matt the last word whether he wants to respond to that, and also just as a forward-looking issue, I know both investigators have implied that there will be future studies looking at combinations with pirtobrutinib, and if you have any sense as to what you would be looking for there. Dr. Matthew Davids: The field really is heading toward time-limited therapy for most patients, I would say. There is a bit of a discrepancy right now in the field between sort of what we are doing in academic practice and what is done sort of more widely in community practice. And so right now we are going to see evolving datasets comparing these approaches. We are already seeing data now from the CLL17 study with ibrutinib comparing continuous to time-limited venetoclax-based therapy, and we are seeing similar efficacy benefits from these time-limited therapies without the need for continuous treatment. And so that is where I think some of the future studies with pirtobrutinib combining it with venetoclax and other partners are so important. Fortunately, several of these studies are already ongoing, including a phase 3 trial called CLL18, which is looking at pirtobrutinib with venetoclax, comparing that to venetoclax and obinutuzumab. So I am optimistic that we are going to be developing these very robust datasets where we can actually use pirtobrutinib in the frontline setting as a time-limited therapy as a component of a multi-drug regimen. So far, those early data are very promising. Dr. Wojciech Jurczak: Perhaps last but not least, in a single center we have treated over 300 patients with pirtobrutinib. So eventually some of them relapsed. And I must say that our experience on BCL2 inhibitors, not just venetoclax but including sonrotoclax, are appealingly good. Therefore, by using pirtobrutinib even earlier, we do not block the efficacy of other compounds. Dr. Jonathan Friedberg: All right. Well, I want to thank all of our speakers. I also want to congratulate our two guests who presented these very influential papers at the ASH Annual Meeting, and chose to publish them in JCO, so we thank you for that, and Dr. Davids for your commentary - really appreciated. That is this episode of JCO After Hours. Thank you for your attention. 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.   Disclosures Dr. Wojciech Jurczak Consulting or Advisory Role: BeiGene, Lilly, Abbvie/Genentech, Takeda, Roche, AstraZeneca Research Funding: Roche, Takeda, Janssen-Cilag, BeiGene, AstraZeneca, Lilly, Abbvie/Genentech Dr. Jennifer Woyach Consulting or Advisory Role: Pharmacyclics, Janssen, AstraZeneca, Beigene, Loxo, Newave Pharmaceutical, Genentech, Abbvie, Merck Research Funding: Company name: Janssen, Schrodinger, beone, Abbvie, Merck, Loxo/Lilly Dr. Matthew Davids Honoraria: Curio Science, Aptitude Health, Bio Ascend, PlatformQ Health, Plexus Consulting or Advisory Role: Genentech, Janssen, Abbvie, AstraZeneca, Adaptive Biotechnologies, Ascentage Pharma, BeiGene, Lilly, Bristol-Myers Squibb, Genmab, Merck, MEI Pharma, Nuvalent, Inc., Galapagos NV, Schroedinger Research Funding: Ascentage Pharma, Novartis, MEI Pharma, AstraZeneca  

Dr. Pedro Barata and Dr. Ravin Garg discuss strategies to increase trial representation, including leveraging trial navigators and prioritizing pragmatic trial models, as featured in the ASCO Educational Book article, "Practical Guide to Clinical Trial Accessibility: Making Trial Participation a Standard of Care." TRANSCRIPT Dr. Pedro Barata: Hello, and welcome to By the Book, a podcast from ASCO featuring compelling perspectives from authors and editors of the ASCO Educational Book. I'm Dr. Pedro Barata. I am a medical oncologist at University Hospital Seidman Cancer Center and an associate professor of medicine at Case Western Reserve University in Cleveland, Ohio. I am also the associate editor of the ASCO Educational Book. We know that in recent years, the oncology community has increasingly prioritized the need to modernize clinical trial eligibility, reduce patient burden, and enhance diversity in trial participation. On that note, today we will be speaking about ways to enhance access to clinical trials with Dr. Ravin Garg. He is a hematologist oncologist at Maryland Oncology Hematology and also an assistant professor of oncology at Johns Hopkins Hospital in Baltimore. Dr. Garg is also the co-author of a fantastic paper in the ASCO Educational Book titled, "Practical Guide to Clinical Trial Accessibility: Making Trial Participation a Standard of Care."  Dr. Garg, welcome. Thanks for being here, and congrats on your paper. Dr. Ravin Garg: Thank you for having me, Pedro. I am excited to be here. Dr. Pedro Barata: [KI1]  Your paper is a wonderful, multidisciplinary piece that actually features perspectives from the different stakeholders, right? The patient advocacy, industry, community practice, and academia about these challenges in making trials more available. This podcast is a wonderful platform. It reaches out to a lot of folks within our community. So, I will start by asking you the obvious. Why do you think it is a must read for our community, for our listeners? Dr. Ravin Garg: So Pedro, thanks again for inviting me. You do a great job with these podcasts.  So, I think first and foremost, oncologists right now are under a lot of stress, just in terms of clinical volume. There is concern for research money, and how we get the best care for our patients. So I think this article is very important because it helps bring together, as you had mentioned, the stakeholders throughout academic to community practice and everywhere in between, and try to find how, as a team with different oncologists who partake in different aspects of oncology, can come together to streamline the process to try to get our patients on trials, or certainly have them have availability of trials, just if they are interested in going on them. Being in practice, we have had several challenges that we can talk about throughout this podcast, but I think it is a very important paper because it recognizes that at the end of the day, it takes a team effort for all of us in academics, community, industry, and pharmaceuticals to really come together as a team to really help put forth the trials for our patients. Dr. Pedro Barata: So, from the perspective of a community oncologist, how do you put together, or maybe you can describe some of the challenges that you see to increase trial participation in the community? Dr. Ravin Garg: Yes, Pedro, that is a great question, and it is something that I keep on thinking about and trying to find ways to be better at it myself. But I will say some of the challenges as a community doctor that I have seen for myself and talking to other colleagues. Number one, I do think there is a lot of stress on doctors in the community in general, Pedro. Oftentimes we are tasked to see a wide smorgasbord of patients, so we may not have the luxury of being a specialist in any particular tumor subtype. Like oftentimes, we will have to see lung cancer, the next one will be breast cancer, the next one could be CML, the next one could be thrombocytopenia. And as you know better than I do, Pedro, the field in each one of these disciplines is changing so rapidly: molecular genomics, radioligand treatments, different imaging tests, MRD testing for some of our hematologic malignancies. And I think one challenge we have in community is just keeping up with the basics of Oncology 101. In the process of doing that, it can be very difficult to sometimes remember that we have very exciting trials available for our patients. So, I think a lot of it is the day in and day out of being an oncologist is so taxing at times that oftentimes a research trial is not the first thing in our head space when we see a patient. I think number two, Pedro, at least in the community, and perhaps this is with academics too, is that we are bombarded, I would say, by a lot of messaging these days. We have in-baskets to go through, labs to go through, things of that nature. And in the process of a patient visit, seeing them, doing an exam, taking a history, trying to go over the NCCN guidelines on best practice for how to manage their care, at least for me at times, it is very hard to remember, "Hey, there might be a great trial available, whether within our network or maybe partnering with an academic center." So getting through a day can be fraught with a lot of peril and just difficulties, I would say. And I would say number three, Pedro, at least as, you know, I am in a private practice where I do see a wide range of benign and malignant hematology and solid tumors, so I would not call myself a specialist. And I think the challenge with that, at least for trials, Pedro, is that when you are a specialist or perhaps you are focusing on a couple of disease subtypes, you become more of an authoritative voice in those types of tumors, and you might be more aware of the trials within your network or perhaps in proxy with an academic center that you can offer your patient. So I think when sometimes we spread ourselves too thin, it can be very hard to be a thought leader, if you will, in a particular subtype of a malignancy, let's say, and maybe not be aware of a trial that could be really well-suited for your patient. In terms of ideas that myself and colleagues have had in terms of helping mitigate against some of these, I would say, setbacks or issues in the practice for trial enrollment, some of the things we have talked about, Pedro, is, number one, is we do partner with academic centers. So we live here in Maryland. We have several really fantastic academic centers. So, you know, oftentimes, not just within our practice of Maryland Oncology Hematology, we have a lot of great trials available here too, for certain, but in addition to that, we will often times work with doctors at Georgetown, Johns Hopkins, and Maryland if they have a compelling trial that we do not have within our network. It is really of the patient's interest, Pedro, to reach out to them in a collaborative manner to see if they have a trial that might be really compelling for your patient. So I do find myself collaborating a lot with colleagues in, like talented like yourself in academics. You know, I think you do a lot of GU malignancies. So as an example, like partnering with colleagues who are GU experts and say, "Hey, we have a patient with stage IV renal cell. These are the standard options I know, but are there any trials that you might have available?" I think the other thing that has been very helpful for us is having navigators within research, Pedro. Like as an example, what has really helped the uptake of trial enrollment for our center in Annapolis is having a research navigator because often times what they can do is, a priori, Pedro, before you see the patient and you are kind of formulating a standard of care treatment plan perhaps, they might tug you on the shirt and say, "Hey, we have a great trial here through Sarah Cannon, or there might be something else out there." And being aware of that when you go into a patient's room really provides a nice arena, if you will, to go and say, "The standard of care is here, but hey, we have a trial option that might be well suited for you, maybe perhaps even better, that we can talk about, too." So having research support in the community is really a huge boon, I think, Pedro, for us to really increase our enrollment for patients onto trials. Dr. Pedro Barata: Yes, I really love that, Ravin. So, let me switch gears a bit. I would love for you to talk a little bit about patient advocacy because they do play a huge role in cancer, and they address many barriers. How do you think we should leverage the patient advocacy groups to reduce patient burden and maybe have them really leverage patient advocacies to improve representation in clinical trials? What do we think we can do more? Dr. Ravin Garg: Oh, Pedro, I think they are very critically important. As a clinical oncologist now, and I would say this is for anyone in the field of medicine, you are exactly right. I think patients are bombarded by information. There are a lot of things online, whether it be TikTok, Facebook, Google, Yahoo, and people really just have a lot of information given to them. And some of it is fact driven, and some of it is not, Pedro. And oftentimes, I do think there can be at times a mistrust with some medical personnel. I think we are in an era where we are seeing that to some degree with some attributes of medicine. And I think of it as an opportunity for education for the patient and for myself as a physician. And I think patient advocates, to your point, which was well taken, serve as a bridge to both. And what I mean is that, you know, patient advocates are wonderful. They are, I think, outstanding communicators. They almost are a neutral party, Pedro, where many patients feel that they are an independent source of information that is free of bias, if you will. They are there to provide support, emotional support, scientific support for patients so they can make an informed decision. So, in terms of our practice right now, patient advocates is something that we are evolving in that capacity, I would say, Pedro. I think now more than ever, having more people as bridges of communication with care providers along with patients is of critical importance. And I would venture a guess, and I think this has been published, where patient advocates really can help tremendously in familiarizing patients with trials and what they are all about and maybe clear up some misconceptions of what trials, what the mission of trials are. Because I do think some patients, at least I have had a few over the years, where when they hear the term trial, they almost think they are being experimented upon, when, in point of fact, they could really help advance their care. That messaging along the way for some can may be mixed up a little bit. And so I think patient advocates is a really great way to offer more information for patients with a source they find very independent and trustworthy, if you will. And it can really help expedite, and I think make a more fruitful conversation for care providers, whether academic or community, and they might be more open-minded in terms of enrolling onto a trial. Dr. Pedro Barata: Wonderful. Yes, I agree. I agree with you completely.  So let's focus a little bit now on the folks designing the studies. We usually call them the sponsors. It might be an academic sponsorship, if you will, but we can also have pharma being the sponsor of a study. The angle from an academic design, it is not necessarily the same as what happens when we have pharma. And from that angle, how do you think a more inclusive research can be promoted? Dr. Ravin Garg: Oftentimes with trials, I think keeping them simple, as simple as we can. And what I mean by that is, often times for trials, Pedro, even for care providers who are enrolling, it can be daunting when there are a lot of different things involved, particularly, let's say, for investigator sponsored, which are incredibly brilliant science, incredible, but it can be a little bit daunting for patients and even the referring physician to talk about getting translational specimens, imaging, traveling to certain centers to get scans and biopsies and even different diagnostic testing like PSMA testing for, you know, prostate cancer. And it can, I think, be very intimidating for patients in terms of what might be required of him or her to enter onto a trial. Like, "This is not what I signed up for. This is laborious. This is a full time job for me. Do I have to pay for parking to go to a city? Do I have to pay for these imaging tests? And do I have to stay in a place for my family to enroll onto a trial?" So I think keeping trials as simple as possible, but yet cull the data we need as investigators where we can really advance the care, hopefully get approval for a drug, but also learn more about the medication and how it works for our patients. So I think simplifying language for trial is very important. I know when I have gone over studies for patients, Pedro, if it is a voluminous amount of information, they can right away get very intimidated. "Like, oh my goodness, this is like a term paper for college again," you know? I am joking, but you know, keeping language simplified is very important, I think, number one. And I feel that sometimes when they are asked to do a lot of different diagnostic testing, which is very important for translational work, I 100% understand, but I do think sometimes patients can get a little bit off put, if you will, and frustrated with the whole process of doing it. The second thing for our patients, Pedro, that they have mentioned to us when we put them on trials, not just within our own site but elsewhere, is that it takes a lot of time in terms of collecting information, perhaps a washout period from their last standard of treatment prior to enrollment onto a study. Many patients, Pedro, as you know better than I do, are in maybe crisis in terms of their health and their cancer might be growing, promulgating out of control, and they worry about not being able to expeditiously start onto a treatment, onto a trial. So that can lead to a lot of frustration. And one thing that you brought up, which was outstanding for me, is the enrollment criterion for some of our patients is felt to be somewhat strict. We have had some patients who may have had a remote history of a stage I malignancy that was by all accounts in remission, you know, let's say 4 or 5 years in the past, and the risk of recurrence at this point would be incredibly low, but they may not be able to enter onto a study because of some stringent criterion put forth. And that can be a little bit frustrating. In fact, I have had one or two patients who, as an example, with kidney issues, but the GFR was about 60, like right near a cutoff that oftentimes, as you know, we use where you can get into trial or not. And you know, if they are at 58, as an example, and otherwise they are a picture of health, a great candidate for a trial that will likely advance their care, and if the entry criterion is too stringent, that might be a lost opportunity for all parties involved, all stakeholders, if you will. I do appreciate the criterion for entry onto studies cannot be too liberalized. You have to have a certain baseline, but there is a little bit of a gray area and tension, of sorts, if you will, where the patient has a comorbid illness that is a disqualifying offense, but in practicality, perhaps it shouldn't be, especially if they are motivated and there is an opportunity to really advance their care. We have run into, not often, but sometimes in the past, I should say, where patients have been very off put because we try to get them onto a study and there may have been a particular feature or attribute in their underlying care that they couldn't get onto it. So I think having a little bit more thoughtfulness, perhaps, in terms of entry criterion and practicality, if you will, I think would really help enrollment onto studies. Dr. Pedro Barata: Really well said. Is there anything else that you would like to tell our listeners before we wrap up the podcast today? Dr. Ravin Garg: I would say just macroscopically speaking, it is really an honor to be an oncologist. I think I speak for both of us. Anyone listening who is thinking about the field, it is tremendous. Just the research, the bravery of our patients, and the thoughtfulness of our scientists like Pedro and translationalists and clinical trialists is really awe inspiring. So I have really loved this field. I will say from a trial perspective, we really need to enter as many patients as we can onto trials because the science is so brilliant now, the genomic underpinnings of the tumor, we are making great strides as a team of clinicians and scientists, translationalists. So the more that we can get people onto trials and get approved drugs, it is going to help them out in the end. So I think it is such an important time for all of us to come together as a community, find the best way to help our patients out. And clinical trials have to be at the forefront of how we can continue to advance care for our patients. Dr. Pedro Barata: Yeah, no Ravin, I really agree with you. We really need to increase access to clinical studies, and actually your paper is a great step in that direction by raising awareness, bringing up solutions, and again, collaboration, collaboration, collaboration is really a multidisciplinary effort to accomplish that.  Thank you so much for sharing your fantastic thoughts and insights with us. Dr. Ravin Garg: Thank you, Pedro. I am- you do a wonderful job with these podcasts. I am really honored to meet you and to be part of this. Dr. Pedro Barata: And thank you to our listeners for your time today. I encourage you to check out Dr. Garg's article in the 2025 ASCO Educational Book. We will post a link to the paper in our show notes. And please join us again next month on By the Book for more insights on key advances and innovations that are shaping modern oncology. Thank you for your attention. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:          Dr. Pedro Barata   @PBarataMD    Dr. Ravin Garg Follow ASCO on social media:          @ASCO on X      ASCO on Bluesky     ASCO on Facebook       ASCO on LinkedIn       Disclosures:       Dr. Pedro Barata:   Stock and Other Ownership Interests: Luminate Medical   Honoraria: UroToday   Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Merck, Ipson, Astellas Medivation, Novartis, Dendreon   Speakers' Bureau: AstraZeneca, Merck, Caris Life Sciences, Bayer, Pfizer/Astellas   Research Funding (Inst.): Exelixis, Blue Earth, AVEO, Pfizer, Merck    Dr. Ravin Garg: Patents, Royalties, Other Intellectual Property: Creator, editor, and writer of hemeoncquestions.com  

On Wednesday November 19 2025, the European Commission unveiled its Digital Omnibus Package, which was basically split in two proposals: a proposed Regulation on simplification for AI rules; and a proposed Regulation on simplification of the digital legislation. We will tackle the first one today.Today we are reviewing that AI-related block with Oliver Patel, who is AI Governance Lead at the global pharma and biotech company AstraZeneca, where he helps implement and scale AI governance worldwide. He also advises governments and international policymakers as a Member of the OECD's Expert Group on AI Risk and Accountability.References:* Oliver Patel, “Fundamentals of AI Governance” (now available for pre-order)* Enterprise AI Governance, a newsletter by Oliver Patel* Oliver Patel on LinkedIn* Oliver Patel: How could the EU AI Act change?* EU proposal for a Regulation on simplification for AI rules (EU Commission, covered today)* EU proposal for a Regulation on simplification of the digital legislation (EU Commission, not covered today)* Europe's digital sovereignty: from doctrine to delivery (Politico). This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mastersofprivacy.com/subscribe

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, the landscape of the pharmaceutical and biotech industries is marked by groundbreaking scientific advancements, regulatory shifts, and strategic collaborations that promise to reshape patient care and drug development significantly.A controversy has emerged in the wake of proposed changes to U.S. vaccine regulations by Dr. Vinay Prasad, a senior FDA official. This proposal has sparked considerable opposition from 12 former FDA commissioners who argue that these regulatory overhauls could potentially undermine public trust in vaccines. Former leaders from both the CDC and FDA have expressed concerns over these proposed vaccine policy changes during an ACIP meeting, discussions that could influence future public health strategies and vaccine trust. At a time when vaccine confidence is crucial, maintaining the integrity of regulatory processes is vital to public health efforts.Leadership changes are also afoot within the FDA, as Dr. Tracy Beth Hoeg steps into the role of acting director for the Center for Drug Evaluation and Research. Her appointment signals a shift towards leaders with direct experience in public health crises. This comes amidst further internal restructuring at the FDA, including the transfer of Theresa Michele, long-standing director of the Office of Nonprescription Drugs, indicating dynamic changes within the agency.In the realm of oncology, Eli Lilly's progress with its Bruton's tyrosine kinase inhibitor, Jaypirca, is noteworthy. The drug's expanded label now includes earlier treatment stages for chronic lymphocytic leukemia and small lymphocytic lymphoma. This expansion underscores the therapeutic potential of non-covalent BTK inhibitors and may significantly improve patient outcomes by offering earlier intervention options.Geopolitical challenges are impacting the industry as WuXi AppTec, a major China-based biopharmaceutical contractor, faces scrutiny from the Pentagon amid concerns about its potential ties with the Chinese military. This development highlights the complex interplay between global security concerns and international biotech collaborations. The intersection of global security concerns continues to impact biopharmaceutical supply chains as WuXi AppTec faces increased scrutiny from U.S. authorities.On the manufacturing front, Quvara Medical's emergence as a new contract development and manufacturing organization following Buckland Group's acquisition of a Becton Dickinson facility in the UK reflects industry trends toward consolidating manufacturing capabilities to meet growing biopharmaceutical demand efficiently.AstraZeneca is enhancing its pipeline through a renewed partnership with Neurimmune for an amyloidosis asset. This collaboration, potentially worth up to $780 million, highlights AstraZeneca's strategic focus on rare diseases and underscores their commitment to expanding their therapeutic portfolio through successful alliances.Regulatory updates from the FDA propose reductions in user fees for early-stage clinical trials conducted domestically while considering additional fees for overseas developments. This initiative aims to incentivize research activities within the U.S., potentially accelerating drug discovery timelines and fostering domestic innovation.In surgical technology advancements, Medtronic's Hugo surgical robot has secured FDA clearance for procedures involving prostate, kidney, and bladder removal. This marks a significant advancement in robotic-assisted surgeries and could enhance patient outcomes across approximately 230,000 surgeries annually in the U.S.As we explore more about financial maneuvers within this sector, Royalty Pharma's $275 million financing deal for Denali Therapeutics' Hunter syndrome drug reflects confidence in Denali's pipeline pendinSupport the show

  In Part 3, Carol Pitcher-Towner, Alnylam Pharmaceuticals, explores how the pharmaceutical industry can become part of the solution. She highlights why leadership diversity matters, how trial design still excludes too many women and why embedding sex- and gender-aware science from day one could accelerate fairer, more effective care for everyone. Speaker bio Carol Pitcher-Towner is Senior Vice President and Head of Development Programs at Alnylam Pharmaceuticals. Since joining the company in 2014 as one of its first European regulatory leaders, she has gone on to oversee patient safety, risk management and Alnylam's global development portfolio. With more than 20 years of experience, including roles at AstraZeneca, Carol brings deep expertise across regulatory affairs and clinical development. She holds a PhD in Biological Sciences from the University of Warwick and was named an HBA Luminary in 2022 for her commitment to inclusive, patient-focused innovation. This content was reviewed by Alnylam UK Ltd for compliance with regulations applicable to the pharmaceutical industry only.

“This is a time to reimagine public health and public health/healthcare system integration,” says Dr. Deb Houry, the former chief medical officer for the US Centers for Disease Control and Prevention. In this thoughtful Raise the Line conversation, Dr. Houry reflects on unprecedented federal action in vaccine guidance and other issues since her noteworthy resignation from the CDC in August, and sees a more decentralized landscape emerging where states and localities play a larger role in providing public health recommendations. And while she acknowledges upsides to this shift, she's also concerned what the absence of a national consensus on health standards could mean. “Diseases don't recognize borders, and it's also important that people have equitable access to preventative services, vaccines, and other things,” she tells host Lindsey Smith. Tune in for Dr. Houry's seasoned perspective on this consequential moment in public health, and her encouraging message for learners and early career providers considering a career in the sector.Mentioned in this episode:DH Leadership & Strategy Solutions If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/podcast

Dr. Monty Pal and Dr. Jason Westin discuss the federal funding climate for cancer research and the persistent problem of drug shortages, two of the major concerns facing the oncology community in 2026. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I am your host, Dr. Monty Pal. I am a medical oncologist and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. There are always multiple challenges facing oncologists, and today, we discuss two of them that really stand out for 2026: threats to federal funding for cancer research and the persistent problem of drug shortages. I am thrilled to welcome Dr. Jason Westin, who believes that one way to meet these challenges is to get oncologists more involved in advocacy, and he will share some strategies to help us meet this moment in oncology. Dr. Westin is a professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, but he actually wears a lot of hats within ASCO. He is a member of the Board of Directors and has also previously served as chair of ASCO's Government Relations Committee. And he is also one of the inaugural members of ASCO's Political Action Committee, or PAC. He has testified before Congress about drug shortages and many other issues. Dr. Westin, I am really excited to have you on the podcast today and dive into some of these elements that will really impact our community in 2026. Thanks so much for joining us today. Dr. Jason Westin: Thank you for having me. Dr. Monty Pal: You've had such a range of experience. I already alluded to you testifying before Congress. You've actually run for office before. You wear so many different hats. I'm used to checking my PubMed every other day and seeing a new paper out from you and your group, and you publish in the New England Journal [of Medicine] on practice-setting standards and the diseases that you treat. But you've also done all this work in the domain of advocacy. I can't imagine that balancing that is easy. What has sort of motivated you on the advocacy front? Dr. Jason Westin: Advocacy to me is another way to apply our skills and help more people than just those that you're sitting across from at the time. Clinical research, of course, is a tool to try and take what we know and apply it more broadly to people that you'll never meet. And advocacy, I think, can do the same thing, where you can have a conversation with a lawmaker, you can advocate for a position, and that hopefully will help thousands or maybe even more people down the road who you'd never get to directly interact with. And so, I think it's a force multiplier in the same way that research can be. And so, I think advocacy is a wonderful part of how doctors care for our patients. And it's something that is often difficult to know where to start, but once people get into advocacy, they can see that the power, the rewarding nature of it is attractive, and most people, once they get going, continue with that through the rest of their career. Dr. Monty Pal: So, I'll ask you to expand on that a little bit. We have a lot of our younger ASCO members listening to this podcast, folks that are just starting out their careers in clinical practice or academia. Where does that journey begin? How do you get to the point that you're testifying in front of Congress and taking on these bigger sort of stances for the oncology community? Dr. Jason Westin: Yeah, with anything in medicine and in our careers, you have to start somewhere. And often you start with baby steps before you get in front of a panel of senators or other high-profile engagement opportunities. But often the first setting for junior colleagues to be engaged is doing things – we call them "Hill Days" – but basically being involved in kind of low-stakes meetings where you're with a group of peers, some of whom have done this multiple times before, and can get engaged talking to members of representatives' offices, and doing so in a way where it's a natural conversation that you're telling a story about a patient in your clinic, or that you're telling a personal experience from a policy that impacted your ability to deliver optimal care. It sounds stressful, but once you're doing it, it's not stressful. It's actually kind of fun. And it's a way that you can get comfort and skill with a group of peers who are there and able to help you. And ASCO has a number of ways to do that, both at the federal level, there's the Hill Day where we each April have several hundred ASCO members travel to Capitol Hill. There's also state engagement that can be done, so-called visiting at home, when representatives from the U.S. Congress or from state legislators are back in district. You can meet with your own representatives on behalf of yourself, on behalf of your organization, and advocate for policies in a way that can be beneficial to your patients. But those initial meetings that are in the office often they're low stakes because you could be meeting not with the representative but with their staff. And that staff sometimes is as young or even younger than our junior colleagues. These sometimes can be people in their 20s, but they're often extremely knowledgeable, extremely approachable, and are used to dealing with people who are new to advocacy. But they actually help make decisions within the office. So it's not a waste of time. It's actually a super useful way to engage. So, it's that first step of anything in life. The activation energy is always high to do something new. But I'd encourage people who are listening to this podcast already having some level of interest about it to explore ways that they could engage more. Dr. Monty Pal: You know, I have to tell you, I'm going to riff on what you just said for a second. ASCO couldn't make it any easier, I think, for folks to participate and get involved. So, if you're listening to this and scratching your head and thinking, "Well, where do I begin? How do I actually sign on for that meeting with a local representative?" Go to the ASCO ACT Network website. And I'll actually talk to our producer, Geraldine, to make sure we've got a link to that somewhere associated with this podcast after it's published, Jason, but I actually keep that on my browser and it's super easy. I check in there every now and then and see if there's any new policy or legislation that ASCO, you know, is sort of taking a stance on, and it gives me some fodder for conversation with my local representatives too. I mean, it's just an awesome, awesome vehicle. I'm going to segue right from there right to the issues. So, you and I are both at academic centers. You know, I think this is something that really pervades academia and enters into implications for general clinical practice. There's been this, you know, massive sort of proposal for decreased funding to the NCI and to the NIH and so forth. Tell us what ASCO is doing in that regard, and tell us perhaps how our community can help. Dr. Jason Westin: We live in interesting times, and I think that may be an understatement x 100. But obviously investments in research are things that when you're at an academic center, you see and feel that as part of your daily life. Members of Congress need to be reminded of that because there's a lot of other competing interests out there besides investing in the future through research. And being an elected representative is a hard job. That is something where you have to make difficult choices to support this, and that may mean not supporting that. And there's lots of good things where our tax dollars could be spent. And so, I'm sympathetic to the idea that there's not unlimited resources. However, ASCO has done an excellent job, and ASCO members have led the charge on this, of stating what research does, what is the benefit of research, and therefore why should this matter to elected representatives, to their staff, and to those people that they're elected to serve. And ASCO has led with a targeted campaign to basically have that message be conveyed at every opportunity to elected representatives. And each year on Hill Day, one of the asks that we have is to continue to support research: the NCI, NIH, ARPA-H, these are things that are always in the asks to make sure that there's appropriate funding. But effectively playing offense by saying, "It's not just a number on a sheet of paper, this is what it means to patients. This is what it means to potentially your loved ones in the future if you are in the opposite situation where you're not on the legislative side, but you're in the office receiving a diagnosis or receiving a difficult piece of news." We only have the tools we have now because of research, and each breakthrough has been years in the making and countless hours spent funded through the engine of innovation: clinical research and translational research. And so ASCO continues to beat that drum. You mentioned earlier the ACT Network. Just to bring that back again is a very useful, very easy tool to communicate to your elected representatives. When you sign up on the ASCO ACT website, you get emails periodically, not too much, but periodically get emails of, "This is a way you can engage with your lawmakers to speak up for this." And as you said, Monty, they make it as easy as possible. You click the button, you type in your address so that it figures out who your elected representatives are, and then it will send a letter on your behalf after like five clicks to say, "I want you to support research. I want you to vote for this particular thing which is of interest to ASCO and by definition to members of ASCO." And so the ACT Network is a way that people listening can engage without having to spend hours and significant time, but just a few clicks can send that letter to a representative in Congress. And the question could be: does that matter? Does contacting your senator or your elected representative do anything? If all they're hearing is somebody else making a different argument and they're hearing over and over again from people that want investments in AI or investments in something else besides cancer research, whatever it is, they may think that there's a ground shift that people want dollars to be spent over here as opposed to at the NIH or NCI or in federally funded research. It is important to continue to express the need for federal funding for our research. And so, it really is important for folks to engage. Dr. Monty Pal: 100%. One of the things that I think is not often obvious to a lot of our listeners is where the support for clinical trials comes from. You know, you've obviously run the whole gamut of studies as have I. You know, we have our pharmaceutical company-sponsored studies, which are in a particular bucket. But I would say that there's a very important and critical subset of studies that are actually government funded, right? NCI-funded clinical trials. If you don't mind, just explain to our audience the critical nature of the work that's being done in those types of studies and if you can, maybe compare and contrast the studies that are done in that bucket versus perhaps the pharmaceutical bucket. Dr. Jason Westin: Both are critical, and we're privileged that we have pharma studies that are sponsored and federally funded clinical research. And I think that part of a healthy ecosystem for us to develop new breakthroughs has a need for both. The pharma sponsored studies are done through the lens of trying to get an approval for an agent that's of interest so that the pharma company can then turn around and use that outside of a clinical trial after an FDA approval. And so those studies are often done through the lens of getting over the finish line by showing some superiority over an existing treatment or in a new patient population. But they're done through that lens of kind of the broadest population and sometimes relatively narrow endpoints, but to get the approval so that then the drug can be widely utilized. Clinical trials done through cooperative groups are sometimes done to try and optimize that or to try and look at comparative things that may not be as attractive to pharma studies, not necessarily going for that initial approval, but the fine tuning or the looking at health outcomes or looking at ensuring that we do studies in representative populations that may not be as well identified on the pharma sponsored trials, but basically filling out the gaps in the knowledge that we didn't gain from the initial phase 3 trial that led to the approval. And so both are critical. But if we only do pharma sponsored trials, if we don't fund federally supported research and that dries up, the fear I have, and many others have, is that we're going to be lacking a lot of knowledge about the best ways to use these great new therapies, these new immune therapies, or in my team, we do a lot of clinical trials on CAR T-cell therapies. If we don't have federally funded research to do the important clinical studies, we'll be in the dark about the best ways to use these drugs, and that's going to be a terrible shame. And so we really do need to continue to support federal research. Dr. Monty Pal: Yeah, there are no softball questions on this podcast, but I think everybody would be hard pressed to think that you and I would come on here and say, "Well, no, we don't need as much money for clinical trials and NCI funding" and so forth. But I think a really challenging issue to tackle, and this is something we thought to ask you ahead of the podcast, is what to do about the general climate of, you know, whether it's academic research or clinical practice here that seems to be getting some of our colleagues thinking about moving elsewhere. I've actually talked to a couple of folks who are picking up and moving to Europe for a variety of considerations, other continents, frankly. The U.S. has always been a leader when it comes to oncology research and, one might argue, research in general. Some have the mindset these days that we're losing that footing a little bit. What's your perspective? Are you concerned about some of the trends that you're seeing? What does your crystal ball tell you? Dr. Jason Westin: I am highly concerned about this. I think as you said, the U.S. has been a leader for a long time, but it wasn't always. This is not something that's preordained that the world-leading clinical research and translational research will always be done in the United States. That is something that has been developed as an ecosystem, as an engine for innovation and for job development, new technology development, since World War II. That's something that through intentional investments in research was developed that the best and brightest around the world, if they could choose to go anywhere, you wanted them to come to work at universities and academic places within the United States. And I think, as you said, that's at risk if you begin to dry up the investment in research or if you begin to have less focus on being engaged in research in a way that is forward thinking, not just kind of maintaining what we do now or only looking at having private, for profit sponsored research. But if you don't have the investment in the basic science research and the translational research and the forward-thinking part of it, the fear is that we lose the advantage and that other countries will say, "Thank you very much," and be happy to invest in ways to their advantage. And I think as you mentioned, there are people that are beginning to look elsewhere. I don't think that it's likely that a significant population of researchers in the U.S. who are established and have careers and families – I don't think that we're going to see a mass exodus of folks. I think the real risk to me is that the younger, up-and-coming people in undergraduate or in graduate school or in medical school and are the future superstars, that they could either choose to go into a different field, so they decide not to go into what could be the latest breakthroughs for cancer patients but could be doing something in AI or something in a different field that could be attractive to them because of less uncertainty about funding streams, or they could take that job offer if it's in a different country. And I think that's the concern is it may not be a 2026 problem, but it could be a 2036 or a 2046 problem that we reap what we sow if we don't invest in the future. Dr. Monty Pal: Indeed, indeed. You know, I've had the pleasure of reviewing abstracts for some of our big international meetings, as I'm sure you've done in the past too. I see this trend where, as before, we would see the preponderance of large phase 3 clinical trials and practice setting studies being done here in the U.S., I'm seeing this emergence of China, of other countries outside of the U.S. really taking lead on these things. And it certainly concerns me. If I had to sort of gauge this particular issue, it's at the top of my list in terms of what I'm concerned about. But I also wanted to ask you, Jason, in terms of the issues that are looming over oncology from an advocacy perspective, what else really sort of keeps you up at night? Dr. Jason Westin: I'm quite concerned about the drug shortages. I think that's something that is a surprisingly evergreen problem. This is something that is on its face illogical that we're talking about the greatest engine for research in the world being the United States and the investment that we've made in drug development and the breakthroughs that have happened for patients all around the world, many of them happen in the United States, and yet we don't necessarily have access to drugs from the 1970s or 1980s that are cheap, generic, sterile, injectable drugs. This is the cisplatins and the vincristines and the fludarabine type medications which are not the sexy ones that you see the ads in the magazine or on TV at night. These are the backbone drugs for many of our curative intent regimens for pediatrics and for heme malignancies and many solid tumors. And the fact that that's continuing to be an issue is, in my opinion, a failure to address the root causes, and those are going to require legislative solutions. The root causes here are basically a race to the bottom where the economics to invest in quality manufacturing really haven't been prioritized. And so it's a race to the cheapest price, which often means you undercut your competitor, and when you don't have the money to invest in good manufacturing processes, the factory breaks down, there's no alternative, you go into shortage. And this has been going on for a couple of decades, and I don't think there's an end in sight until we get a serious solution proposed by our elected officials. That is something that bothers me in the ways where we know what we should be doing for our patients, but if we don't have the drugs, we're left to be creative in ways we shouldn't have to do to figure out a plan B when we've got curative intent therapies. And I think that's a real shame.  There's obviously a lot of other things that are concerning related to oncology, but something that I have personally had experience with when I wanted to give a patient a CAR T-cell, and we don't have a supply of fludarabine, which is a trivial drug from decades ago in terms of the technology investments in genetically modified T-cells, to not then have access to a drug that should be pennies on the dollar and available at any time you want it is almost like the Air Force investing in building the latest stealth bomber, but then forgetting to get the jet fuel in a way that they can't use it because they don't have the tools that they need. And so I think that's something that we do need to have comprehensive solutions from our elected officials. Dr. Monty Pal: Brilliantly stated. I like that analogy a lot. Let's get into the weeds for a second. What would that proposal to Congress look like? What are we trying to put in front of them to help alleviate the drug shortages? Dr. Jason Westin: We could spend a couple hours, and I know podcasts usually are not set up to do that. And so I won't go through every part. I will direct you that there have been a couple of recent publications from ASCO specifically detailing solutions, and there was a recent white paper from the Senate Finance Committee that went through some legislative solutions being explored. So Dr. Gralow, ASCO CMO, and I recently had a publication in JCO OP detailing some solutions, more in that white paper from the Senate Finance. And then there's a working group actually going through ASCO's Health Policy Committee putting together a more detailed proposal that will be published probably around the end of 2026. Very briefly, what needs to happen is for government contracts for purchasing these drugs, there needs to be an outlay for quality, meaning that if you have a manufacturing facility that is able to deliver product on time, reliably, you get a bonus in terms of your contract. And that changes the model to prioritize the quality component of manufacturing. Without that, there's no reason to invest in maintaining your machine or upgrading the technology you have in your manufacturing plant. And so you have bottlenecks emerge because these drugs are cheap, and there's not a profit margin. So you get one factory that makes this key drug, and if that factory hasn't had an upgrade in their machines in 20 years, and that machine conks out and it takes 6 months to repair or replacement, that is an opportunity for that drug to go into shortage and causes a mad dash for big hospitals to purchase the drug that's available, leaving disparities to get amplified. It's a nightmare when those things happen, and they happen all the time. There are usually dozens, if not hundreds, of drugs in shortage at any given time. And this has been going on for decades. This is something that we do need large, system-wide fixes and that investment in quality, I think, will be a key part. Dr. Monty Pal: Yeah, brilliantly said. And I'll make sure that we actually include those articles on the tagline for this podcast as well. I'll talk to our producer about that as well.  I'm really glad you mentioned the time in your last comment there because I felt like we just started, but in fact, I think we're right at our close here, Jason, unfortunately. So, I could have gone on for a couple more hours with you. I really want to thank you for these absolutely terrific insights and thank you for all your advocacy on behalf of ASCO and oncologists at large. Dr. Jason Westin: Thank you so much for having me. I have enjoyed it. Dr. Monty Pal: Thanks a lot. And many thanks to our listeners too. You can find more information about ASCO's advocacy agenda and activities at asco.org. Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Thanks so much. ASCO Advocacy Resources: Get involved in ASCO's Advocacy efforts: ASCO Advocacy Toolkit Crisis of Cancer Drug Shortages: Understanding the Causes and Proposing Sustainable Solutions, JCO Oncology Practice 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. Monty Pal   @montypal   Dr. Jason Westin @DrJasonWestin   Follow ASCO on social media:      @ASCO on X     ASCO on Bluesky    ASCO on Facebook      ASCO on LinkedIn      Disclosures:     Dr. Monty Pal:    Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview   Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical   Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis   Dr. Jason Westin: Consulting or Advisory Role: Novartis, Kite/Gilead, Janssen Scientific Affairs, ADC Therapeutics, Bristol-Myers Squibb/Celgene/Juno, AstraZeneca, Genentech/Roche, Abbvie, MorphoSys/Incyte, Seattle Genetics, Abbvie, Chugai Pharma, Regeneron, Nurix, Genmab, Allogene Therapeutics, Lyell Immunopharma Research Funding: Janssen, Novartis, Bristol-Myers Squibb, AstraZeneca, MorphoSys/Incyte, Genentech/Roche, Allogene Therapeutics

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

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Holger Zschäpitz über das Microsoft-Barometer und seine Folgen, das Inditex-Luxusproblem und gute Stimmung bei Salesforce. Außerdem geht es um Eli Lilly, AbbVie, Johnson & Johnson, Novo Nordisk, AstraZeneca, Abbott Laboratories, UnitedHealth Group, Bristol Myers Squibb, Dexcom, Align Technology, ResMed, Hims & Hers, JD Health International, iRhythm Technologies, Pro Medicus, Oscar Health, Xtrackers MSCI World Health Care (WKN: A113FD), Amundi S&P World Health Care Screened (WKN: A3DSTC), Franklin Future of Health and Wellness (WKN A3EFKW), Global X Telemedicine & Digital Health (WKN A2QKQ1), Xtrackers MSCI Genomic Healthcare Innovation (WKN: DBX0R2), Agilent, Roche, Vertex, Microsoft, Meta, Alphabet, Amazon, Nvidia, Salesforce, SAP, Snowflake, Inditex, H&M, Next, LVMH, Hermès, Aumovio, TKMS, Hellofresh, Gerresheimer, Ottobock, Tonies, PSI Software, Verbio, LPKF, Stratec, Thyssenkrupp Nucera, Procredit, Amadeus Fire, Bayer, BASF, Corteva, Syngenta, Formycon und PNE. Die aktuelle "Alles auf Aktien"-Umfrage findet Ihr unter: https://www.umfrageonline.com/c/mh9uebwm Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

In Part 2, Carol Pitcher-Towner, Alnylam Pharmaceuticals, breaks down the systemic forces driving inequity, from diagnostic bias to the lack of women in key specialties like cardiology, and explains how historical clinical trial exclusion continues to skew the science. Discover why representation isn't just a workforce issue: it's a scientific necessity, and the first barrier we must dismantle to ensure better care for everyone. Speaker bio Carol Pitcher-Towner is Senior Vice President and Head of Development Programs at Alnylam Pharmaceuticals. Since joining the company in 2014 as one of its first European regulatory leaders, she has gone on to oversee patient safety, risk management and Alnylam's global development portfolio. With more than 20 years of experience, including roles at AstraZeneca, Carol brings deep expertise across regulatory affairs and clinical development. She holds a PhD in Biological Sciences from the University of Warwick and was named an HBA Luminary in 2022 for her commitment to inclusive, patient-focused innovation. This content was reviewed by Alnylam UK Ltd for compliance with regulations applicable to the pharmaceutical industry only.

Show Notes In this episode of Develop This!, host Dennis Fraise sits down with Jason El Koubi, President and CEO of the Virginia Economic Development Partnership (VEDP), to explore how Virginia has earned — and maintained — its reputation as one of the best states for business. Jason shares how Virginia's nonpartisan approach to economic development ensures continuity, focus, and accountability. He dives deep into the Virginia Talent Accelerator Program, a national model for workforce training that has helped attract global leaders like AstraZeneca and Eli Lilly. From site readiness to speed-to-market, Virginia's economic playbook emphasizes agility, collaboration, and long-term talent development. Jason also discusses how the state is positioning itself for the industries of the future — including pharmaceutical manufacturing and artificial intelligence — all while doubling down on its goal to be America's Top State for Talent. If you're passionate about strategic, results-driven economic development, this episode offers a rare look inside a state model that works — and what other regions can learn from it.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAD865. CME/MOC/AAPA credit will be available until November 20, 2026.Harnessing the Power of ADCs in Gynecologic Cancers: Expert Insights for Practice Integration In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure information is available at the beginning of the video presentation.

This week, Isabel sits down with Carol Pitcher-Towner, Senior Vice President and Head of Development Programmes, Alnylam Pharmaceuticals, to unpack the gender inequities that continue to tarnish modern healthcare. Together, they explore the realities behind unequal outcomes and the steps needed to build a more inclusive future for patients. In Part 1, Carol eveals the personal experiences that made gender inequity impossible to ignore and uncovers where today's biggest gaps still exist. From disease areas where women are routinely misdiagnosed to the persistent blind spots shaping clinical practice, this episode exposes the uncomfortable truths that are still costing lives, and why fixing them can no longer be optional. Speaker bio Carol Pitcher-Towner is Senior Vice President and Head of Development Programs at Alnylam Pharmaceuticals. Since joining the company in 2014 as one of its first European regulatory leaders, she has gone on to oversee patient safety, risk management and Alnylam's global development portfolio. With more than 20 years of experience, including roles at AstraZeneca, Carol brings deep expertise across regulatory affairs and clinical development. She holds a PhD in Biological Sciences from the University of Warwick and was named an HBA Luminary in 2022 for her commitment to inclusive, patient-focused innovation. This content was reviewed by Alnylam UK Ltd for compliance with regulations applicable to the pharmaceutical industry only.

In this episode of AUANews Inside Tract, we celebrate 50 years of research support in urology. Since 1975, the AUA and the Urology Care Foundation have awarded nearly $40 million to over 1,000 researchers, driving innovation and improving care for millions of patients. Host Dr. Damara Kaplan sits down with Dr. Glenn Preminger, a distinguished AUA Research Scholar alumnus and pioneer in kidney stone management and minimally invasive surgery, to reflect on the legacy of AUA research, explore his groundbreaking career, and look ahead to the future of urologic innovation. Independent support for this podcast provided by AstraZeneca.  

What if the secret to transformation success isn't more budget but strong, built-in accountability?In this week's episode of the Only Constant, our guest Zee Amin discusses with Nellie Wartoft how flipping the traditional funding model transforms the transformation office into a high-impact internal consultancy. They explore co-investment strategies, building trust through realistic business cases, and why being brave enough to challenge the status quo matters more than having a mandate.Connect with:⁠⁠⁠⁠⁠⁠⁠⁠Nellie Wartoft⁠⁠⁠⁠⁠⁠⁠⁠CEO of ⁠⁠⁠⁠⁠⁠⁠⁠Tigerhall⁠⁠⁠⁠⁠⁠⁠⁠Chair of the ⁠⁠⁠⁠⁠⁠⁠⁠Executive Council for Leading Change (ECLC)⁠⁠⁠⁠⁠⁠⁠⁠nellie@tigerhall.com

Secretary Juan Pablo Segura joins BioTalk for a conversation about Virginia's growing position in the biohealth economy and the statewide strategy behind it. He outlines the significance of the new partnership with AstraZeneca, Lilly, and Merck, including up to $120 million in private investment to create a workforce development center and expand the Commonwealth's life sciences capacity. Segura talks through how Virginia approaches company recruitment, what investors are responding to, and why the state is seeing increased interest from biomanufacturing and advanced R&D companies. He also discusses Virginia's use of public-private partnerships to accelerate industry growth, strengthen the talent pipeline, and support emerging hubs across the Commonwealth. The conversation closes with a look at Virginia's role in the BioHealth Capital Region and how the regional identity helps amplify the state's message as it continues building a competitive biohealth ecosystem.   Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com). Juan Pablo Segura is the Secretary of Commerce and Trade for the Commonwealth of Virginia. He leads 13 agencies focused on economic growth, business development, and industry expansion across the state. Before entering public service, Segura spent his career building companies in the digital health sector, most notably as a founder of Babyscripts, a widely adopted maternity care platform. His work has been recognized by Startup Health, CTIA, EY, and the White House. He is a CPA and a graduate of the University of Notre Dame, and he lives in Henrico, Virginia with his family.

From pandemic-speed vaccine deployment to AI-powered process control, what separates hype from real manufacturing transformation?The biotech industry faces a fundamental challenge: how do you maintain rigorous quality standards while accelerating development timelines, personalizing therapies, and adopting transformative technologies? The answer isn't found in chasing every innovation trend, it's in understanding which changes create genuine value and when to implement them across the product lifecycle.Irina Ramos brings a perspective earned through high-stakes execution. After leading the global technology transfer of AstraZeneca's COVID-19 vaccine, a project that compressed typical timelines while maintaining uncompromising quality standards, she's applying those lessons to the industry's next wave of challenges: phase-appropriate CMC strategy, the practical realities of AI integration, and building teams that bridge generational experience gaps in an era of rapid technological change.This conversation cuts through the noise. Irina discusses when continuous processing actually makes strategic sense (hint: it's not always the right answer), why AI in bioprocessing requires more human expertise rather than less, and the collaborative frameworks that enabled one of the fastest vaccine rollouts in history—lessons directly applicable to your current CMC challenges.Episode highlights:How the biotech community is constantly changing, and the importance of adaptability for future scientists (00:00)Navigating phase-appropriate CMC strategy: What to focus on in early clinical phases and which decisions set the foundation for compliance (02:36)Scenarios for switching from batch to continuous processing, including barriers and benefits for early-stage vs. established products (02:58)Lessons from leading AstraZeneca's COVID-19 vaccine technology transfer: Collaboration, rapid regulatory communication, and mission-driven teams (05:20)Adapting lessons from the pandemic for ongoing drug development—balancing speed and risk while maintaining quality (08:24)Realistic perspectives on integrating AI in bioprocessing: demystifying its applications, emphasizing human-critical oversight, and practical use cases in manufacturing (10:40)Key skills for scientists in a biotech world shaped by AI—why foundational understanding and strong mentorship matter (13:51)Bridging experience gaps: How to foster collaboration and creativity between new and established professionals in regulated environments (15:45)Final takeaway: Start small, remain mission-driven, and remember that one size does not fit all in continuous manufacturing (17:15)Whether you're evaluating process platform decisions for Phase I programs, building cross-functional teams for tech transfer, or determining which digital tools deserve investment beyond the buzzword, this episode provides decision frameworks grounded in real-world execution at global scale.Connect with Irina Ramos:LinkedIn: www.linkedin.com/in/irinaramosNext step:Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-foundersBook a 20-minute call to help you get s

On Friday's Mark Levin Show, WJNO's Brian Mudd fills in for Mark. It's chilling that anti-American Senate Democrats voted against pay for military and essential workers amid the 31-day government shutdown. These Democrats are making them political pawns. President ​Trump ​is doing what he can - he ​ordered ​​all ​available ​funds ​to ​be ​identified ​and ​allocated ​to ​cover ​the ​$5.3 ​billion ​​payday. The average American hasn't felt this shutdown and Republican polling has surged during it. This ​is ​the ​second ​longest shutdown, ​closing ​in ​on ​those ​35 ​days ​of ​the ​longest ​that ​we ​had ​back ​in ​2019 ​during ​Trump's ​first ​term. ​You ​don't ​even ​remember ​that and 2019 was a great year. Later, two federal judges expect the Trump administration wave a magic wand and come up with money to pay SNAP, which expires Saturday. It's also chilling that Jack Smith weaponized the DOJ by issuing 197 subpoenas to 34 individuals and 163 businesses, targeting records of over 430 Republicans and entities creating an "enemies list.” This government overreach against political opposition is unsurprising after the Trump-Russia hoax and impeachments. Afterward, in the past 31 days, Trump has neutralized nearly a third of drug-running boats entering the US, secured $5 billion in tariffs and most-favored-nation status, negotiated AstraZeneca's prescription drug pricing to save Americans over $15 billion annually while attracting $50 billion in domestic R&D investments, finalized a Chinese trade deal ending the US soybean embargo and promising a fentanyl crackdown, and lifted the estimated economic growth rate to 3.9% per the Atlanta Fed GDP tracker. What have the Democrats done? Learn more about your ad choices. Visit podcastchoices.com/adchoices