Podcasts about cdmos

Amid ongoing geopolitical uncertainty, regional manufacturing initiatives, and evolving supply chain risks reshaping the pharmaceutical industry, manufacturers are rethinking how biologics are produced and delivered around the world. Rather than relying on centralized production models, many organizations are expanding regional manufacturing footprints and developing more integrated production networks designed to improve resilience, reduce operational risk, and support long-term supply continuity.  In this episode of Off Script, we spoke with Jeff Mason, VP and head of the New Jersey Sales Office at Samsung Biologics, about how CDMOs are adapting to this changing landscape. The discussion follows Samsung Biologics establishing its first U.S. manufacturing presence through the acquisition of GSK's biologics facility in Rockville, Maryland, reflecting the broader industry shift toward regional manufacturing capacity. The conversation explores the growing importance of regional manufacturing strategies, why customers are increasingly seeking manufacturing redundancy from the outset of commercialization, how vertically integrated service models can simplify complex supply chains, and what the next generation of global manufacturing ecosystems could look like as companies balance efficiency with resilience.

The radiopharmaceutical sector is in the midst of a transformative year in 2026, with significant developments and challenges, including policy and reimbursement, increasing demand and growth within precision oncology and molecular imaging, and the need for specialised CDMOs when it comes to the intricate nature of radiopharmaceutical manufacturing. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Dr Andrew Cavey, CEO of ITM, about current and future radiopharmaceutical trends. Dr Cavey discusses the evolution of radiopharma, beyond the original “two pillars” of GEP-NETs and PSMA, including the move towards a multi-isotope model, as well as ITM's pipeline and the potential growth of the broader radiopharma ecosystem going forward. You can listen to episode 263 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.

As biopharma pipelines become more complex and market conditions continue to evolve, manufacturers are rethinking how they scale capacity, deploy capital, and build supply chains. The industry's focus is increasingly shifting toward developing the flexibility, resilience, and specialized capabilities needed to support rapidly evolving therapeutic modalities. At the same time, regionalization efforts, supply chain pressures, and changing sponsor expectations are prompting both CDMOs and drug developers to reassess long-term manufacturing strategies. In this episode of Off Script, we spoke with Sebastián Arana, executive vice president and global head of process solutions at MilliporeSigma, about the forces reshaping the biopharma CDMO landscape. The conversation explores the industry's shift from a capacity-driven market to a capability-driven one, how sponsors' expectations around speed and flexibility are changing manufacturing partnerships, and why process characterization, tech transfer, and supply chain coordination remain persistent scaling challenges. Arana also discusses the growing trend toward retrofitting existing facilities for multi-modality production, the rise of region-for-region manufacturing strategies, and more.

AI is moving incredibly fast across the life sciences sector, but many organizations still struggle to build systems that deliver real operational value. In this episode, tech leader Rose LaRocca-Fisch explains why strong data governance and business alignment must come before chasing software trends. Please visit our website to get more information: https://swangroup.net/ Rose shares her practical leadership experience guiding pharmaceutical companies, CDMOs, and global biotech organizations through massive growth. The discussion breaks down why high-profile tech implementations collapse and outlines the exact steps needed to prepare your infrastructure for enterprise-grade tools.Key themes covered in this conversation:Why does advanced software amplify existing operational flaws instead of fixing themThe OASIS framework for sustainable and scalable IT transformationHow data readiness directly impacts clinical trial success and manufacturing yieldsReal-world applications using platforms like Databricks to speed up patient enrollmentThe shift toward AI-assisted work and managing data integrity risksLinks from this episode:Get to know more about Steven Swan: https://www.linkedin.com/in/swangroup Get to know more about Rose LaRocca-Fisch: https://www.linkedin.com/in/rose-larocca-fisch 

“When your patient is your priority—getting them safe, highly pure, quality medicine—you're aligned with the health agency. That alignment and engagement really help.”Manda Pasarkar, Global Head of Regulatory Affairs CMC at Sanofi, has spent over 20 years mastering the intersection of chemistry and compliance—a rare combination that positions her at the forefront of pharmaceutical regulatory strategy.Pasarkar progressed from scientist roles at Teva through regulatory positions at Bayer, and now leads regulatory strategy for Sanofi's multi-billion dollar portfolio across biologics and small molecules, securing numerous drug marketing approvals in the US, EU, Japan, and China. She's also a Distinguished Toastmaster (DTM)—a designation fewer than 1% of Toastmasters International members achieve.In a recent PharmaSource podcast episode, Manda shared insights on navigating complex global regulatory landscapes, building productive agency relationships, leveraging ICH guidelines, working with CDMOs, and preparing for AI's impact on regulatory CMC.Read more.

As the industry reaches the mid-point in 2026, how are CDMOs of small-molecule drugs faring? The larger scale CDMOs with late-phase and/or commercial-scale capabilities are faring well while smaller and mid-sized CDMOs specializing in early-stage development and clinical-scale capabilities are facing some headwinds from more challenging trends in biotech financing, but opportunities lie ahead. Brian Scanlan, Managing Partner, Freedom Bioscience Partners, a strategic advisory firm to CROs, CDMOs, and investors, provides the latest insights.Support the show

As peptide therapeutics become larger, more complex, and increasingly purity-sensitive, manufacturers are confronting a new layer of execution challenges. Long-chain peptides introduce compounding scale-up inefficiencies, increasingly fragile purification requirements, and impurity profiles that become more difficult to characterize and control at commercial scale. At the same time, growing dependence on specialized amino acids, tightly specified reagents, and globally distributed supply chains are forcing developers and CDMOs to think more strategically about how process design decisions made early in development can ultimately determine long-term manufacturability and program risk. In this episode of Off Script, we continued our conversation with Dr. Sharadsrikar Venkatesan Kotturi, chief scientific officer at Neuland Laboratories, about the operational and technical realities shaping modern peptide manufacturing. The discussion explores why long-chain and high-purity peptides become increasingly difficult to scale reproducibly, how aggregation, impurity control, and analytical sensitivity compound across larger sequences, and why process robustness ultimately determines whether peptide programs can succeed commercially. We also examine the growing intersection between process design and supply chain resilience, including how early route selection decisions can amplify sourcing risk for protected amino acids and specialized reagents.

"Strategic partnerships — what a buzzword this has become in our industry." Kaan Fabian-Kekec and Clarita Havermeier at Simon-Kucher, unveiled exclusive new research at the start of CDMO Live Europe 2026.The research by Simon-Kucher and PharmaSource draws on 120+ senior executives across pharma and CDMOs globally. It reveals many areas of goal alignment, but highlights an execution gap as late-phase CDMOs are meeting established pharma's expectations just 44% of the time. The widest gaps are not quality or timelines. It's pricing and supply resilience.Listen to this recording from CDMO Live Europe 2026 and read the article

As peptide pipelines continue expanding globally, pharmaceutical companies are increasingly turning to CDMOs earlier in the lifecycle to help manage growing technical and operational complexity. Outsourcing partners are being leaned on to support process development, analytical strategy, scale-up, and regulatory readiness from the earliest stages of a program. At the same time, rising demand for peptide therapeutics is placing new pressure on manufacturing capacity, raw material availability, and technical expertise across the industry. In this episode of Off Script, we spoke with Dr. Sharadsrikar Venkatesan Kotturi, chief scientific officer at Neuland Laboratories, about how peptide development is reshaping relationships between sponsors and CDMOs. The conversation explores why pharmaceutical companies are engaging outsourcing partners earlier in the process, the growing execution challenges associated with peptide scale-up and impurity control, and how analytical complexity, raw material sourcing, and manufacturing scalability increasingly intersect across peptide programs. Kotturi also discusses the strain these shifting expectations are placing on both sponsors and service providers, along with the operational realities of supporting early-stage peptide development.

As drug development grows increasingly complex, CDMOs are exploring new ways to streamline the path from early-stage formulation through commercial manufacturing. Rather than operating in isolated segments of the development lifecycle, some outsourcing partners are beginning to form more integrated collaborations designed to reduce handoffs, improve coordination, and simplify the client experience across multiple stages of manufacturing. In this episode of Off Script, we spoke with David Leroux-Petersen, CEO of Corealis Pharma, and Jean-Baptiste (JB) Agnus, CCO of the CDMO division at Bora Pharmaceuticals, about the emerging role of CDMO-to-CDMO collaboration through the lens of a new partnership between their companies. The conversation explores how integrated outsourcing models can help reduce development risk and accelerate timelines, what operational alignment looks like across organizations with complementary capabilities, and why client-centricity, governance, and transparent communication are essential in complex manufacturing partnerships.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Daniel Hurni, Supply Chain Enterprise Capability Lead at Roche.   Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Dan, covering:   Why working all over the world was a key competent in building his confidence, and his understanding of people and perspectives from different cultures. The value of doing an MBA as a technician, and the need to master yourself and becoming the boss of yourself before leading others. A behind the scenes peek of CDMO sourcing and selection at small and a big pharma across different modalities.... and the importance of relationship building. Taking on a global supply chain lead at big pharma, and the job of navigating risk... and why you can only plan so much. How he's excited by, and thinking about AI with respect to supply chain, and why he will only apply it where it makes sense. Why listening, empathy, mentorship and networking are vital for survival and growth in a big pharma company. Top tips for large and specialist CDMOs.   With over 20 years of experience driving operational transformation in the life sciences sector, Daniel has established a reputation for optimizing end-to-end supply chains and navigating the complexities of the global pharma and biotech landscape. Throughout his career, he has successfully led high-stakes initiatives—ranging from aseptic Tech Transfers for sterile drug products to large-scale M&A integrations—consistently delivering cost reductions and scalable, patient-centric solutions within complex matrix environments. In small and large pharmaceutical companies.   Daniel specializes in bridging the gap between digital innovation and physical operations, leveraging AI, data integration, and advanced analytics to enhance S&OP and network design. Beyond his technical leadership in manufacturing and supplier management, he is a seasoned change management architect, adept at aligning functional priorities with enterprise strategy to drive operational agility. Daniel is also a frequent collaborator and thought leader who focuses on mentoring cross-functional teams and influencing stakeholders at all levels to build the intelligent, resilient supply chains of the future.     Molecule to Market is also sponsored by Bora Pharmaceuticals and supported by Lead Candidate. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!

Spencer Jones, Founder of XO Medtech and MedtechVendors.com, shares how frontline nursing experiences led him to patent vascular access innovations and ultimately take devices from idea to FDA clearance and product launch. Spencer walks through learning business fundamentals through accelerators, raising early funding, and building sales and distribution networks, then explains why launching a digital-first, AI-native ecosystem has enabled faster, leaner execution than traditional medtech pathways. Spencer also discusses leadership, clear communication, and why AI adoption is essential to accelerate and de-risk early-stage medtech.  Guest links: https://www.linkedin.com/in/medtech-innovation/ | www.xomedtech.com | https://medtechvendors.com/  Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 080 - Spencer Jones [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and today I'm delighted to welcome to the show Spencer Jones. Spencer is the founder at XO Medtech and MedTechvendors.com. He is an RN, MedTech entrepreneur with 12 years of med device leadership. He's a two time med device CEO with 10 plus patents under his belt and has taken devices from idea to FDA clearance and product launch. Spencer has built sales and distribution networks, led product development teams, and raised over 10 million in VC and Angel Capital. Spencer founded XO MedTech in 2024 to create a digital first medtech ecosystem, deploy AI native tools for medtech operators through medtechvendors.com and cultivate the next generation of medtech innovators. All right, Spencer, welcome to the podcast. Thanks for being here. [00:01:43] Spencer Jones: Thank you for having me, Lindsey. I'm very, very excited to be here. Like it's, it's always more fun to be a guest than it is to host the pod, so absolutely thrilled to be a guest on the pod. Thank you for having me. [00:01:54] Lindsey Dinneen: Of course. Absolutely. Well, yeah, let's just, if you won't, don't mind just sharing a little bit about yourself, your background and what led you to medtech. [00:02:04] Spencer Jones: Yeah. Born and raised in Arkansas. I've lived, I traveled a ton and lived in Memphis and whatnot, but grew up in a healthcare household. Dad did anesthesia for, what was it, 36 years or something at the same place. So I thought I was gonna be a CRNA, like actually started pre-med. Took chemistry my freshman year while I was, you know, it was just, I got a C and I was like, maybe, maybe med school's not for me. But but anyways, did the nursing school thing, got out, started working, pretty quickly, knew if you've ever spent any amount of time in frontline healthcare, you just kind of get, it's like a barrage of things that suck. It's just, especially nursing, the devices you're using are commoditized. Like just the workflows are bad. You know, people, it's, healthcare is very broken. Every, it's no secret. Everybody says that. Everybody knows that. So anyways, I noticed pretty quickly that hey, like why isn't this better? Why can't this be like this? And, you know, kind of had that mindset. And before I could even go through like critical care enough to apply to a CRNA school, ended up patenting some devices in the vascular access space. Really leveraged accelerator programs and the entrepreneurial support organizations that were in my area, in my region to, I call it that get that dirt money, which is like the before the seed, you know, your pre kind of, your pre-seed /seed you know, before the pre-seed money. And, and also like the business training, right? Like I wasn't formally trained on business stuff like that. So did that. Did the venture capital hamster wheel a little bit, took a, you know, device through class two de novo clearance. Was doing ride-alongs training, sales reps, doing marketing stuff, you know, managing our ip, managing clinical you know, 300 patient RCT that we had to do in the middle of COVID, launched the product and then past couple years, I left, left that company in 2022. Products still on the market and they got, you know, clearance in, in Europe now and et cetera, et cetera. But just been working more in laparoscopic spine or laparoscopic surgery orthopedic spine and then doing some like consulting projects and, and things like that. And then yeah, XO Medtech and Medtech Vendors that's been. You know, for the past two years, like a big focus. And I know we're gonna talk more about that, but yeah. So it's just been, it's been a great journey. Medtech is one of my --I love it and hate it at the same time, but I wouldn't wanna be doing anything else, frankly. So. [00:04:17] Lindsey Dinneen: Awesome. That's a great intro. Okay. You were, I really, I enjoyed how you sort of went straight from okay, so, so "I, you know, started the career, started in the industry, and then I, I, you know, got a bunch of patents." What were the ideas for the patents? Where did those come from? If we could just go back, how did that, what was that inspiration like? [00:04:39] Spencer Jones: Yeah. So I was night shift, med-surg, big, pretty big hospital in Little Rock. It was like one of the, one of the bigger ones in Little Rock, St. Vincent's, which is like CHI, St. Vincent, et cetera. And like one of my patients --well the, the very first one was a dual lumen peripheral IV. A patient has a peripheral IV in, I need to get a blood draw. They're like, "Go stick his other arm." I'm like, "Why can't we get it out of his, you know, IV that's in his, that's in his forearm?" And, and they were like, "Well, you, you know, you don't want to contaminate, you know, the thing." And I was like, "Oh, okay. That kind of makes sense." And I was like, well, PICC lines have two lumens. So you know, I was like, why couldn't, you know, why couldn't we just have a second lumen on, you know? And I was like, do those exist? And they didn't really exist. There was kind of one that existed, but it was more of like a longer extended dwell peripheral and you know, you kind of needed ultrasound to place it. You didn't really place, you know, normal nurses on the floor weren't gonna place it. And so I kind of, that one was just sheer-- I experienced something that I was like, "Dude, you're kidding me. There's gotta be a better way to do this." You know what I mean? And you know, kind of similar approach in that one. We, you know, that was the very first one so I was like doing these drawings on note cards and then like meeting with a patent attorney and I was like, did that provisional filing and wrote the patent myself and the claims and all this stuff. And the guy thought I was like, just " Okay, yeah, I'll, I'll file the provisional for you, bro, whatever." Filed the provisional, you know, ended up like going to a different attorney 'cause that guy was kind of just not taking me seriously. And so, ended up going to a different person, filed a non-pro provisional, started raising all this money, and that original attorney reached out later, was like, "Oh, so glad, glad to see blah, blah, blah." I was like, "Yeah, yeah, whatever." But then the second one, I, which was Safe Break Vascular, had the, it's kind of similar. Patient was like, had patients pulling out their IVs, pulling out lines, you know, and it's a million things. It's, it's walkie talkie, so like Alzheimer's, dementia, memory care type stuff. You, it's TBIs, it's agitation, sundowners. It's, you're coming off medication, you're drowsy, you forget, you're hooked up. You need to go to the bathroom. You trip on it. The nurse trips on the tubing. There's like a million reasons how, you know. Where mechanical force can get applied to an IV line. And same thing, I was just like, man, like this, it, it feels holding on for dear life is like the wrong approach because skin is only so strong. You get skin tears. Adhesives, you only want them to be so, you know, so, so strong. And it just, you know, it, wrapping it up, then you can't assess the site, you can get infiltration. So it didn't feel like any of the options we had were great. That one, I started to do patent research literally on the floor at the hospital. Like that night. I was like, I, 'cause I knew enough then found someone that had patented it. Like same exact concept. It was a nurse. And design was bad. Like the design, it had springs in it and it was just like not manufacturable and not a good design, but there were like conceptually it was like spot on. And then there were some elements of it that I was like, this would be very useful to have if I was gonna like actually do this. So me and somebody I'd met, and in accelerator program, we bought the patent from 'em for 20 grand which was a steal of a deal. It was like 10K up front, 10K after 18 months. And yeah. And then we turned around and raised a, you know, million dollar seed round within like, within nine months after acquiring the patent, got into an accelerator, ZeroTo510, shout out to them. But acquired the patent in February. Got it, or March, got into ZeroTo510, April. Went there in May, closed our seed round of a million in December, so it was like a nine month, yeah, ordeal. [00:08:03] Lindsey Dinneen: Wow. That's okay. That's awesome. I love the story. I love the fact that it was from boots on the ground going, "Okay, I see this problem. There's gotta be a better solution." That's super cool. So. All right, so you have these patents, you're going and you're working with accelerators. Can you tell us a little bit about what that experience was like, especially since you mentioned, you know, you didn't necessarily have the business background, so there was, there was probably a bit of a learning curve to that whole, you know, how do you get your idea from your, your note card drawing to commercialization. So I'd just love to hear about your experience. [00:08:35] Spencer Jones: Yeah. The, so I did one accelerator before ZeroTo510. It, I basically did two within about a year, a year of each other. It was like back to back to back. But the first one I did, it was industry agnostic. So it was just a lot of like mentorship and lean canvas startup methodology kind of business practice stuff like accounting 101, you know, building financial forecasts and models and like all of that stuff. So I really learned a ton about kind of just non device specific stuff there. Obviously I was learning a ton about device stuff along the way, but then once I got to ZeroTo510, that's when things kind of like really, you know-- and I had, I had won, I won that first accelerator. It was like a competition, and so I had 150K. And I was like, "Oh wow. So maybe, maybe this is gonna be a career path," 'cause I was still working full-time as a nurse and then I got into the second one. ZeroTo510 was amazing. Allan Daisley was running it. James Bell was like the co-director, I think, and it was like bootcamp. It was like, you know, 8:00 AM to 5:00 PM. It was like sessions and mentor hours and office hours and " Alright, we're done with that. You guys work on this for an hour and a half, we're gonna come back and talk about like the finished product and you better have it done." You know what I mean? And it was every day. I lived up at this building. It was amazing sponge mode. You know, it was one of those environments where you're just like constantly soaking it in and learning and learning and like you can feel your brain expanding like every day. You know, you wake up excited. And that one was amazing. Met a ton of people that I still work with today. You know, met my co-founder at XO Medtech. Met him at that accelerator. But yeah, it was just, that one was amazing. I was like, life changing. Came back from that and I was like, "This is what I was meant to do." I felt like I you know, found my calling. And so, yeah, shout out to the people there that you know, we're a part of that. [00:10:20] Lindsey Dinneen: Love it. Excellent. So, okay, so you found your co-founder for XO Medtech, and this is great because I wanted to dive into that. So, so you've, you've now successfully taken like several products to market and of course you have a lot of other great industry experience. What was, how was it different starting XO Medtech and Medtech Vendors than perhaps other things that you'd done in the past? [00:10:47] Spencer Jones: Yeah. You know, I'm gonna say it was way easier just to be honest. I mean, I mean, you know, I think we, we were doing a lot. We started building XO Medtech in 2022, 2023, and at that time a lot of it was like, it was really focused on the community and the training platform and the resources and kind of all the videos and things that we put in there. Which I still like to this day, will stand on it, that like there, if you're an early stage innovator and you're, you wanna like kind of internally like level yourself up, right? There's no better place than like XO Medtech and the training and inside there to do that, right? But, but yeah, it was we started doing it at a time when AI was starting to become, like Chat GBT, what was it, four was coming out or whatever. So we started it kind of before the wave and then as we were continuing to build it in like 2023 which was like the meat of us building it. It was like kind of starting to become more of a thing, but we still weren't really using it that much. But then as we really went into kind of like launch and growth mode in 2024, it was just like a huge tailwind and like being able and, and it continues to be. But like not having to raise, you know, three, four, $5 million to get a business off the ground and to get to a point where you can start selling something is just incredible. I mean, like we are, we are so agile and can move so quickly and, you know, we don't have any investors. We don't want any investors. So like our speed at which we can move is unbelievable. And coming from somewhere where it's " Oh, you wanna put out something for marketing? Route it through the quality management system and like maybe it goes out in two weeks." You know, we can go from like idea to feature in a week. You know what I mean, you know, let alone like idea to like press release, right? That's 10 minutes if we want to be, right? So really it's just, it's a lot easier and this takes nothing away. There's some incredibly rewarding parts of kind of my, like my medtech journey and stuff like that, like the day we got FDA clearance and, and X, Y, and z whatever date, you know, first sale and getting our first GPO contract. But it's, it's definitely more I would say day to day, just like the exhilarating agility, excitement type stuff that you like, don't really get with with me. And I'm not, I'm not taking anything away from, I'm still a medtech person through and through and I'm sure at some at some point I'll you know, do another device. We're developing another device at Lapovations, so, in combo spine. So my hands are still in it, but I love, love, love what we do at XO Medtech. It's so much fun. [00:13:11] Lindsey Dinneen: Awesome. Well, I love hearing that. So tell us a little bit about both XO Medtech and Medtech Vendors and yeah, their, their focuses. [00:13:21] Spencer Jones: Yeah. So I think, you know, like I said, we started XO Medtech and it's, it's a online community. So think like Skool, like S-K-O-O-L School or Circle, or there's some other Mighty Networks, like one of the-- we use Circle-- but you know, it's whether you're ideation or just like curious about medtech all the way through like series A really, you know, we've got, you know, there's community feed, people are posting. I mean, we posted you know, Project Medtech, you know, event stuff, discounts a lot of exclusive stuff where, I think we added, it was like three or $4,000 worth of discounts. Like just for being like once you join XO Medtech. But then there's that primary feed people, it's like a massive exchange of value and it's it's not like LinkedIn. There's no promotion. Like we base, we will take your post down if you're like nakedly promoting your own stuff or your services, whatever. The whole point of it is to be massive exchange of value. So you know, "Hey, we did some like really cool testing, ETO sterilization testing on coil tubing to see how it retained its memory. Here's what we found, your pictures," you know what I mean? Just stuff like that where it's like kind of giving people behind the, behind the curtain peaks at your own organizations or that kind of, those, those moments of alpha, those nuggets that you've found and just sharing it so you can have you know, and they're doing the same and everybody's better for it. But then we have a training course and then some other like mini courses, probably a couple dozen downloadable resources. So these are like, you know, prebuilt, proformas, budget forecasts, you know, IP stuff, due diligence type stuff, like stuff to help you with, get your data room beef, you know, beefed up and looking good. And we do videos. There's some live events every now and then. So, so that was very focused on the founder side, you know what I mean, like the entrepreneur side. We, you know, my co-founder used to run a med device, venture studio, so like doing like business engineering, business development, engineering, you know, kind of market related stuff for like early stage, largely like clinician and inventors and stuff like that. He used to run a, a, a group that did that. And we knew we wanted to kind of start to do more offerings that kind of for that side of the table, like the CDMO contract manufacturer design and development group side of the table. So we launched, we started building MedTechVendors.com and launched it in 2025, February, 2025. And then did kinda a relaunch with adding some like agentic AI features in I think at the end of the summer last year. But it, but at its core, I always say this analogy, it's like Angie's List, right? You know, Angie's List, what do they do? Well, it connects people with local pros. Allows them to like, evaluate, engage them really easily, you know, get, get their stuff done quickly from trusted people. You know what I mean? So we have the same approach. We help device teams, and that could be device teams at large, medium, small, or startup organizations or tech transfer offices, whoever we help those device teams find, evaluate, and engage contract manufacturers, CDMOs testing facilities, design and development groups, one man band engineers, whatever through the platform. We have an an ag agentic AI chat. So like it'll ask you questions about your device. It'll start recommending, "Hey, do you need this? Do you need these types of services? Are you looking for this type of vendor? This type of vendor?" It pre-populates forms. It generates matches for you. You can review each vendor's profile, one click get email intros or request quotes, and we're adding some some really cool additional features around some different like skills that you can run. So, think like a reimbursement skill or market a, you know, different predicate device selection skill, whatever. And so those are all gonna be like linked up to the to this kind of AI agent. I don't wanna say too much 'cause we're still building it. I'm like really excited about, but there's other things that we're adding to it. The ability to do quote, visualization you know, and trying to make it kind of a, you know, a home away from home, a hub where you can track execution, get things done, engage vendors, and kind of evolve it more laterally in kind of the lifecycle journey. Not just " Hey, I'm looking for a vendor," 'cause that's a very acute point in time in a, you know, in a person's journey. But trying to expand it out to say the period of time when you're doing X and Y and Z and looking for a vendor so we can get some really was sticky, more sticky use and add more value. So, that was that. And we've started really focusing on some more like intimate, I would say, engagements with CDMOs contract manufacturers focused on giving their sales and marketing teams massive, massive leverage using AI and ai, AI native tools. [00:17:35] Lindsey Dinneen: Awesome. That's really cool. Yeah. Okay, so going back a little bit to the, to XO Medtech, I know you know you, you mentioned that there's a lot of resources available, but one of the things that I think is super cool, and I would love if you just share a little bit more about this, is you have a course that-- i don't remember the name off the top of my head-- but it's basically sort of Medtech Innovation 101. It's, I think... [00:18:00] Spencer Jones: Yeah, The Playbook. [00:18:00] Lindsey Dinneen: Call it like-- The Playbook! And you call it like the MBA for somebody who needs to learn. So can you just share the value of that and sort of what, what made you go, "Okay. I have, you know, the expertise in all these different areas enough to be able to share the journey from start to finish." [00:18:19] Spencer Jones: Yeah, absolutely. I think like the, the value there partially comes-- I mean, I think speaking about the value, you gotta speak about kind of like why there was a gap there, like how it, why it didn't exist, whatever. There's just a lot of really bad content in medtech. You know, there's a lot of stuff that reads I mean, there's guidance documents, you know, ISO and this and that. Like those are tough reads, right? And then, you know, the, the content around " "here's how you really fundamentally apply these guidance documents and here's how all this fits together." And it just felt like everything was I don't know what the opposite of like inside baseball is, right? Like that kind of " Hey, here's what you really need to know." Whatever the opposite of that is, is how medtech content felt like to me everywhere. It was just like polished press releases, really, like consulting speak. You know, "You gotta be strategic with your analysis." It's okay "You know, you know, you gotta find your champions." "How do I find them? What do I tell them? You know, how do I engage them?" So it was just, that was the big gap. So I think the value, what we tried to do with The Playbook was, you know, give, like I said, pre-seed all the way through Series A, the right information, like the right depth, on the right topics in the right order with the right assets, so resources, downloads, all that stuff along the way so that you can go cradle to grave on this, basically be a novice, or we've had people that have launched products and gone through it and they were like, "Holy crap, I wish I would've had this five years ago." But the whole idea is to basically not make you a supreme expert on any one of those topics. There's 46 different lessons, 47, and like you can get through each one in probably 20 minutes, right, 15 minutes. But not to make you an expert on each individual topic, but to give you like a dangerous level of information on any one, and then make you able to dive deeper on any of them, you know, very quickly and easily. So like when you meet with your, you know, a regulatory consultant or an IP attorney, or go down the list, you are not, they're not saying words you don't know for the most part. You're not paying them $300 an hour or $500 an hour to educate you on definitions and concepts. Right? You're, you're applying principles and evaluating strategy versus " What's that again? Like, how does this, what's the timeline for that?" 'Cause that you know, that's just not good for anybody. You know, so, so that, that's kinda the main, the main value prop thrust of it. And I just, I frankly didn't think it existed, but proof's in the pudding. Like we've sold it to accelerator programs, we've sold it to hospital, you know, innovation departments. We've sold it to incubators, like trade associations that have like their like kind of innovation arms. It works. Like when people do it, it works. It's funny-- we can talk about this too-- but like the, you can lead a horse to water thing. It's funny how many people say they want to be entrepreneurs and say they wanna be innovators and really they just want to just yap. And they don't actually wanna put the time in. I'm telling you, it's like crazy how many, you know, fake entrepreneurs there are out there. But it's okay. It's okay. You know, like there has to be, I think there needs to be some cleaving or weaning or calving of the herd to some degree because we've got, I don't know, and maybe we need to develop 'em more, but it's, it is frustrating seeing it firsthand when it's like "You have a really cool device, but you are so uninvestible and you have no interest in being coachable that it just hurts me." [00:21:30] Lindsey Dinneen: Oh yeah, absolutely. No, I love that you've done that resource and yes, super excited to see hopefully a lot of innovation actually happen and be successful as a result of that. So with, you know, okay, so you have, you have this community now and I'm wondering if there are any moments that kind of stand out to you, maybe as you've built the company, also Medtech Vendors that kind of enforce, "Wow, I am, I am in the right place at the right time." [00:22:00] Spencer Jones: You know, I definitely-- you know, it's, it's, it's really, there's not, I would say, any huge singular moments. I mean, we've had people like get business from coming on the XO Medtech podcast. You know, we've had people meet new clients, new strategic partners type stuff, like in the XO Medtech community. I mean, I've made a ton of friends in the XO Medtech community, people that I talk to you know, every, every week or two you know, Brad Shirley, I'll mention him. He's fantastic. And like I've learned from him, he's learned from me. We've both learned stuff from the community. I, I, I really do think it's though, it's like it's, you know, those-- whether it's a LinkedIn DM or you know, somebody messaging me in XO and they're like, "Hey, I just went through this lesson. It was like, so good. You know, blah, blah, blah." And I think those little things honestly like power me, power me up, give me juice, give me energy. You know, and, and like reading, we, we did a ton of, I mean we probably got 30 people that did kind of like a pre- and post- assessment and they gave their feedback on The Playbook so we could refine it like as we were, you know, after launch and all that stuff 'cause we're constantly trying to improve it. And have reading the testimonials and people just being like, yeah, like "This is, this is killer." People that are brand new, people that have been in the industry for 20 years that went through it. I think so, I think, I think it's kinda like a myriad of those things. I would say some of the stuff on-- and that's on the XO Medtech -- I think some of the stuff on the Medtech Vendor side and what we're doing with, you know, kind of campaigns and the tools that we're developing and the work that we're doing there, like we are fully an AI native organization. Like it, like we, it there is just not at all like a significant amount of people in medtech using AI to like actually do not in their products. I don't care about that. Like I'm talking about like in their day-to-day operations and, and whatnot and like we're trying to change that. And so like in that respect, like we will come out with things, you know, release features, release products, build custom tools for CDMOs and you know, the looks on their faces and like how amazed that they are at X, Y, and Z. And sometimes it's like stuff where it's hey, I'm like building them a just showing them how to do something with not even a tool that we built and like they're blown away. And anyways, all of that stuff, I feel like, man, like this is where I'm supposed to be because like. We, we've gotta make MedTech a more attractive investment opportunity. We've gotta compress the development cycles and the cost to develop and the time to develop and get things to market. You know, and I look at AI drug discovery for the pharma world as like a huge way that that's happening. But we have to have that similar type of like, when you to engage with this, it will be good for our ecosystem and industry as a whole, becoming more investible, becoming more cash efficient and all that stuff because you've seen other sectors, you know, software is taking money from early stage medtech, like nobody's business. You know, people are investing AI and you know, I just looked at the annual report from like HSBC, the Venture Report, and like me, early stage medtech funding continues to be down. You know what I mean? So we just gotta do something like, I, I feel like it's an existential, it's an existential issue for early stage medtech to get better at being scrappy and using AI. [00:25:03] Lindsey Dinneen: And there's so much opportunity there. Yeah, I love that you're helping to promote that. So you've gotten to lead a number of different companies now and through very challenging milestones. And so I'm curious, how has your own leadership philosophy developed over the course of your career so far? [00:25:24] Spencer Jones: Oh, what a good question. You know, I, I hate to say this, but I've almost gotten more cynical, you know. [00:25:30] Lindsey Dinneen: Okay. [00:25:31] Spencer Jones: Well, and it, it's, it's like I try to be very protective of my time and like protective of the time of the people that I work with, right. You know, and that doesn't mean I'm not willing to like go the extra mile and whatnot, but I think it's about respecting people's time. Right? And, and you know, I think honestly my leadership philosophy, I think a lot of it revolves around just like incredibly clear communication and like staying above the fray. No riff-raff, just just executing and moving fast and like keeping expectations really high, because I feel like when you've got complacency, you know, at the top, it just, it like doubles every rung of the ladder lower that you go in the org chart or whatever. You know, so I think like pace, you know, pace and hyper clear communication, like no subversive or passive aggressive or anything. It's just like straight up, like I'll just exactly tell you if I wasn't happy with something or whatever, but I just, I don't know, like I feel, I feel like you know, leadership style too, like I think, I think it, so much of it boils down to communication for me. It's just like really, really clearly communicating and like making sure that people understand what good work looks like and what a, them doing a good job looks like, and where... Yeah, I think, I think being clear about expectations, really clearly communicating those expectations around like work product, what it should look like, how fast it should get done, how many updates I need, or how many questions I expect to get as you're doing this, what resources I expect you to expend and explore before you come to me with something you could Google. Like all of that stuff, but honestly, I, it, it's kind of a tough question thinking in like the more immediate past, just because I feel like there's been such like, almost like a flattening of org charts, frankly, with the way that we're using technology and AI these days where I feel like in the companies I'm operating in right now, like it's mainly just principles and like lower level stuff, like we're either delegating to AI agents or delegating to like VAs that are in a different country or something, you know what I mean? And, and so there's just been a big flattening. You know, seven years ago, six years ago, I was managing, you know, new grads outta college, two or three at a time, and, you know, having to like, have these kind of like, you know, like brotherly, you know, like talks with, you know, these types of things, " Hey, like you really gotta do this" and like coaching and stuff like that, i, you know, there's a, we have to have that stuff. I'm just not in, in organization and honestly, the organizations I'm in right now in startup world I just feel I don't know. Like I, I feel like we're, I haven't seen that and I, I know a lot of organizations that are small and nimble and whatever, and I feel like the org charts are getting real flat in terms of like people that are getting managed, you know, it's a lot of agents getting managed, frankly. [00:28:21] Lindsey Dinneen: Yeah. Yeah, yeah. Interesting. Yeah, that, that's a really interesting insight too. But I really do think that to your point of coaching and mentorship and how much of a difference that makes, but especially, I was just on this conversation earlier today of the critical importance I feel that there is about establishing expectations across the board, whether it's your clients, your employees, your coworkers, just making sure that everybody's on the same page is such a critical aspect of, of setting yourself up for success. So yeah, I love that you touched on that 'cause like I said, literally earlier today. [00:29:00] Spencer Jones: Yeah. And, and can I, can I, quick aside here. It's, it's on topic, but before we move on, I mean, I, I'm not the first person to think this or say this, but I'll, I'll die on this hill. The more you use AI when, when you're using it the right way, right, the better leader and better specifically, the better communicator you'll become, right? Why? So much of interpersonal office drama, bad management, bad leadership is like what we talked about, right? It's poor communication. It's expecting people assumed something or had knowledge they didn't, right? It's not letting them know what you really wanted, what good work looks like, all that stuff. This is all context engineering, right, which is just a similar to prompt engineering, but context engineering is kind of the other more important piece these days with AI. What do I mean by that? Like I'm gonna give a prompt to a chat. Is it in just like a virgin chat or is it in a project? What context, what documents, skills, reference templates, et cetera, access to code bases does that project have, right? What am I telling it to do? How am I breaking that down? How am I, you know, big, high level goal? What do I want it to do? What does the output need to look like? How deep do I want it to go? Right? Like, how many questions I say, "Ask me like five or six questions" when I'm prompting, right, if I want that, right? Give, so giving the other person right in that space to say " What questions do you have?" Right? The, the, the best people at context engineering and leveraging AI in that way end up becoming more, better and better and better communicators because it's-- I mean, yes, you're talking to a machine, but at the same way, like those principles a hundred percent apply to good professional communication. So I'll die on that hill. There's a lot of people that are like brain rott using AI. It's " what's the weather today?" And you know, "how many calories does mayonnaise have?" And those people are not, you know, they're, they're not improving their leadership communication by using app, but the people actually doing it right a hundred percent are, [00:30:52] Lindsey Dinneen: Yes, I could not agree more. I think that is one of the coolest things that AI has taught me personally is-- to your point, to be a better communicator, to be clearer with the way that I communicate, to avoid assumptions that the other person, say, knows what I'm talking about or, or does have the context behind why I asked the question the way I did, or all those kinds of things. So I, I could not agree with you more. Yeah. And it's exciting to see how it continues to evolve. Okay. [00:31:22] Spencer Jones: Yeah. And why, real quick, why, like the AI models, especially with the reasoning models and stuff, Opus 4.6, all this stuff, telling them why they're doing something and why doing it, doing a certain task within that project flow is important is proving to be more effective than telling them how. And I think that's something where, you know, you tell someone what to do, they may do it, but if you tell them and make them believe why it's important, they do it that way, they're really gonna do it that way. [00:31:49] Lindsey Dinneen: Yeah. Love that so much. Okay. All right, so pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want, could be within your industry, but doesn't have to be. What would you choose to teach? [00:32:05] Spencer Jones: Does this, assume-- I have a question. Does this assume that I'm already I'm already capable and you know, have enough expertise to actually teach this class? Or is it like I choose this topic, I'm now an expert in that and I get to teach it? [00:32:19] Lindsey Dinneen: I like, I like I like both options, but I'm gonna go with option B because you have a million dollars to play with, right, so you could build up the expertise. Yeah. [00:32:29] Spencer Jones: You know, I would still say like building AI tools, AI agent systems, you know, skills and subagents and these flows and, and really tactically executing that for medtech. And that that goes from founder, you know, innovator to service provider, reg, quality ,reimbursement, like all the way up through sales and marketing and then like CDMO teams, you know, doing contract manufacturing, doing this. Like I, I just, I'm so passionate about it and I, I just see that there's so much untapped opportunity that that is the thing I think, and, and like we, we are doing that not a masterclass, but like we are working with groups to do some of that. But, I just, it's just so, so, so, so much opportunity to do it. And I think there's like weird structural reasons why it's not being adopted the same, you know, at the same clip it is in other industries. But you know, medtech's very rules-based game. You know, you've got your guidance docs, you've got your predicate devices, you've got your clinical trial protocols, you've got your stats analysis. You got your, you know, X, Y, Z hospitals get paid a certain way. Like lots of formulas, lots of reference material, lots of guidance docs. You know, it's very kind of rules and order based system in a lot of ways. And biology has its own kind of, prescriptive way that things happen, right? So I just feel like it's so primed for it. And anyways, I, I just, I wanna see it adopted more so we can see like what's happening with software now, where, you know, the cost to build and, you know, produce and get software to market has com has almost collapsed, but compressed to, you know, from like months, maybe years to, you know, days and weeks and, you know, you got a $200, 250 bucks worth of like software subscriptions, Claude this, that, the other, you can get it done in a week if you, you know, two weeks if you put your mind to [00:34:21] Lindsey Dinneen: Yeah. Yeah. No, that would be an incredible masterclass. I like it. All right. And then how do you wish to be remembered after you leave this world? [00:34:30] Spencer Jones: Oof. God, what a good question, Lindsey. You know, I hope to be remembered at all. [00:34:35] Lindsey Dinneen: Yeah. [00:34:36] Spencer Jones: You know, 'cause I, I'm definitely one of those people that's " nobody cares, nobody's thinking about you." You know, you may have, I, I mean, I think there's like some healthy main character syndrome that people can have that gives 'em confidence, but at the end of the day, no one cares. They're just, everyone's thinking about themselves. But if I am remembered, which I hope to be I wanna be viewed as like someone that was, I'd say, loved their family was a good dad, good husband. I would say brought people joy, was like fun to be around, but like from a interested in other people sense, you know, you know, genuinely cared about people. But I would say that on the professional side, like somebody that you know, would like consistently just delivered an absurd amount of value whether it was, you know, running a business or coaching and developing people at a company or working on behalf of clients or trying to make a positive change. I would say impactful and valuable, you know, with the work that I'm doing. That's, that's, that's how I wanna be remembered. I mean, we don't have big, I don't wanna be a unicorn billion dollar company. No, we have no desire to do that. We don't even have a, a desire to get acquired at any point. We're not raising money, you know, we've, we've deliberately chosen to bootstrap it. You know, we frankly just wanna employ really awesome smart people that we work with, you know, pay everybody well. And like I said, add a absurd amount of value you know, and joy to the people and the clients that we work with and like work at the company with, you know what I mean? [00:36:05] Lindsey Dinneen: Yeah. Yeah, that's a absolutely wonderful legacy to aspire to. I love it. All right. And then final question. What is one thing that makes you smile every time you see or think about it? [00:36:19] Spencer Jones: Oh, I gotta be, I've got a 1-year-old kid. Banks. Banks Austin Jones. So it's gotta be him, and my wife of course. One thing that makes me smile though, every time I see it, oh... you know, I am, I'll cry at a good TikTok, so I'm so I guess that's like a form of smiling, you know? But I'm a pretty big softie, honestly. You know, this is gonna sound weird, but it's kind of those moments where you know, people usually strangers and usually people that don't look like each other, just show humanity to each other. And that could be like holding a door open for somebody. It could be small things, you know what I mean? But I really love seeing those moments and capturing them like candidly, you know? Just you know, oh, I was in a restaurant, I saw this thing happen. You know? I really love that these days. [00:37:09] Lindsey Dinneen: Yeah. Yeah. We all need more of that these days too, so, yeah. Love it. Alright, well, Spencer, this has been a, a fantastic conversation. I really appreciate you and your time today. I love what you're building in the medtech industry and cultivating community and resources and providing value. So just thank you for everything you're doing to change lives for a better world. [00:37:34] Spencer Jones: Thank you. Can I ask you a question? I feel like you were so good, like with the questions and kind coming on the back of like my responses, but I have a question for you like what? You know, what about the medtech space, like most excites you? It can be a specific technology, it can be a specific, you know, company doing something. It can be anything, but what's most exciting to you, kind of looking at 2026 and, you know, kind of in the realm of medtech broadly. [00:38:00] Lindsey Dinneen: Yeah. Oh, I love that question. So I love this industry in general, but there, there's something really special about the energy of being around people who truly care about making a difference. Part of the reason I started The Leading Difference was because I, when I first joined, had sort of noticed this sort stigma from people from the outside who weren't very familiar with the innovation, what it takes to get from, you know, drawing to commercialization. Just didn't, just didn't know. And there was this stigma that people were here just for the money. And then I started meeting all of these incredible change makers who they had personal stories of what they were seeing, or a family member was impacted. And I just loved the fact that there were so many cool people doing such cool things and getting to play a small role in that was the coolest thing in the world. So, you know, I, I say I happily stumbled into medtech five years ago and found my people and my happy place, haven't looked back. I love it. I love being around people who are genuinely trying to do good things in the world. And I hear about new and you know, new ideas every day, and I get excited probably almost equally about most of them because it's just cool to see. So I don't know. Does that answer your question? [00:39:29] Spencer Jones: No, it, it does. I mean, it, it really the, it all comes back to the patient at the end of the day. And I definitely, I, I feel like when people think of like medical device stuff, like their minds immediately go to like Stryker sales reps or something, you know what I'm saying? And there's just so much more to it than that. And there's one of my favorite things about medtech is like the personalities, you know, like you got your wacky, you got your wacky inventors and you know, you got your straight laced regulatory people. But when you get to know 'em, they're, they're absolutely hilarious. You know, you got your attorneys, you got your like, and I, every industry, every industry has their personalities. But I think medtech, you know, you got your beef head sales reps that are like posting " What's up guys? I'm here in the locker room in my scrubs" and like "Motivation Monday." You're like, "Oh my God." But it's just like all these personalities and you go to these conferences and you just see 50 of the same person, but they're each different, they have their own dreams and conflicts and ideas and whatever, but they're still like so in the same box in some ways. I think that's one of the funnier, like funnier things about medtech that just makes it quirky, you know? [00:40:30] Lindsey Dinneen: I love it. And I also love the amount of respect that I see shared amongst people of very, very different backgrounds and areas of expertise. And that was one of the things that made me fall in love with the industry too. I was like, I, for instance, you know, I'm in, I'm in marketing and business development, so I play a very small role in, in sharing about these devices. But people, the engineers that I work with and the consultants that I work with, and everybody in the ecosystem is always just " Wow, well, I can't do what you're doing. And so I think what you're doing is fantastic." And so there's just, there's this mutual respect that I think is super cool about being here too. So yeah, I'm a fan. [00:41:08] Spencer Jones: Yeah, I agree. I agree. We could, we could keep going for, for days... [00:41:12] Lindsey Dinneen: I know. [00:41:13] Spencer Jones: ...On this. I really, I know, I know we have to wrap it, but but yeah. Well, Lindsey, thank you for having me. Seriously, this was a blast. And you know, I'll just maybe like quick sign off plug or something here. If anybody that's listening to this is like interested in, leveraging AI, leveraging AI in medtech or for you personally or whatever, follow me on LinkedIn and post a lot of content about it. You know, talk about it a lot on the podcast. But then if you're, if you're on the founder side, if you're an innovator, like join XO Medtech. If you're on the CDMO side, if you're, you know, on a sales and marketing team, contract manufacturer, CDMO, even like signed development groups, that kind of stuff like, you are like, "We know we need to be using AI to better leverage X, Y, Z, or do this thing. We have all these, we have HubSpot and this thing and that thing, and none of it works together well and we've got too many tools." Whatever. Just hit me up. Let's have a conversation. We're doing some absolutely incredible things leveraging AI, giving these sales and marketing teams like crazy leverage. So yeah, just drop a dm. I'd love to talk to you. [00:42:08] Lindsey Dinneen: Awesome. Sounds good. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support, and we wish you continued success as you work to change lives for a better world. Looking forward to seeing the future of all the good things that you're doing. All right. Bye. [00:42:41] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

"If you feel the rules are changing every five minutes, that's not going to help you — because this is a long-term industry."Jan Ramakers is an independent consultant with over two decades of experience tracking the fine chemicals and pharmaceutical ingredients market. A chemist by training, Jan has worked across pharma, agrochemicals, and the financial sector, spanning market intelligence, competitor analysis, and M&A due diligence.In this PharmaSource podcast episode, Jan explains why the API outsourcing market is at an inflection point shaped by geopolitical uncertainty, supply chain fragility, and the evolving race among CDMOs to differentiate. Drawing on career-long pattern recognition, he outlines what is actually happening on the ground versus what the industry often gets wrong.Read more.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant updates that highlight the dynamic nature of our industry, driven by cutting-edge science, regulatory evolution, and strategic business innovations. The pharmaceutical landscape is ever-shifting, with recent developments underscoring this fluidity. Pfizer and Arvinas have secured early FDA approval for their breast cancer drug, Veppanu. This move signals the FDA's growing inclination to fast-track promising therapies, particularly in areas with high unmet needs. Interestingly, Pfizer and Arvinas are opting not to commercialize Veppanu independently and are instead seeking a partner. This decision reflects a broader industry trend where biopharmaceutical companies leverage partnerships to maximize the reach and impact of their therapies. Such strategies are becoming increasingly common as companies navigate complex market dynamics. Legal and healthcare domains intersected dramatically when the U.S. Supreme Court temporarily restored online access to the abortion pill mifepristone. This decision underscores the profound influence of legal rulings on healthcare access and distribution channels within the pharmaceutical sphere in the United States. It's a poignant reminder of how regulatory decisions can ripple through healthcare systems, affecting both providers and patients. Meanwhile, Samsung Biologics faces significant financial repercussions—estimated at $102 million—due to an ongoing union strike. This situation reveals vulnerabilities within contract development and manufacturing organizations (CDMOs) regarding labor relations, emphasizing the need for robust operational strategies to maintain production continuity. In a move that underscores its commitment to biologics manufacturing, Amgen announced a $300 million investment in Puerto Rico. This expansion aligns with growing global demand for biologics and biosimilars and highlights Puerto Rico's strategic importance as a pharmaceutical manufacturing hub, thanks to its favorable business environment and skilled workforce. On a different front, Novartis is optimizing its workforce by implementing additional job cuts at its U.S. headquarters. These adjustments are part of a larger multiyear plan aimed at streamlining operations and reallocating resources towards areas with higher growth potential within its portfolio. The potential resurgence of psychedelics is gaining traction, partly fueled by political support from figures like Donald Trump. The regulatory landscape for psychedelics remains complex, with discussions focusing on their therapeutic potential versus societal acceptance and legitimacy concerns. In the competitive weight-loss drug market, Novo Nordisk's Wegovy pill is currently outperforming Eli Lilly's Foundayo in prescription trends. This rivalry highlights the dynamic nature of the GLP-1 receptor agonist segment—a market experiencing rapid growth due to increasing attention on obesity management as a critical public health issue. Deloitte's latest analysis reveals an intriguing shift: obesity drugs have now overtaken oncology as the leading contributor to late-stage pipeline value for the first time in 16 years. This transition underscores a growing recognition of obesity as an essential therapeutic area with significant market potential, driven by advances in drug efficacy and heightened patient demand. Celcuity has reached a pivotal milestone in breast cancer treatment development with its Phase 3 trial success of a pan-PI3K/mTOR inhibitor against Novartis' Piqray. Achieving primary endpoints positions Celcuity favorably for FDA review, further highlighting continuous innovation within oncology research. UCB's acquisition of Candid Therapeutics for $2 billion exemplifies intensified competition Support the show

What does it take to keep pharma & biotech CDMOs inspection‑ready across global sites? Senior VP of Global Quality, Melanie Kearney, reveals how she transforms quality culture, bridges R&D and manufacturing, and turns audits into a competitive advantage.The episode is supported by OXB. OXB is a quality and innovation-led viral vector CDMO, supporting its clients in delivering their life-changing therapies to patients around the world.--------------------------------------------Visit www.qualistery.com for live free webinars for GxP professionals, to stay on top of the latest industry trends.

"If I have one more person talk to me about agentic AI and then realize they're still using paper batch records, I'm going to scream." That frustration captures the central tension in CDMO digital transformation today says Matt Lowe, Chief Strategy Officer at MasterControl.Matt has spent nearly two decades at MasterControl, rising to CSO with responsibility spanning competitive intelligence, strategic partnerships, pricing, and product direction, making him one of the industry's sharpest observers of where life sciences manufacturing technology stands and the distance it still needs to travel.In the latest PharmaSource podcast episode, Matt maps the digital manufacturing journey contract development and manufacturing organizations (CDMOs) must take, from eliminating paper on the shop floor to achieving the industry's most coveted goal: golden batch and real-time release.Read more

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of pivotal events shaping the industry. Starting with Amneal Pharmaceuticals' strategic acquisition of Kashiv Biosciences for $1.1 billion, this move highlights what many are calling the "golden era" for biosimilars. These cost-effective alternatives to branded biologics are becoming increasingly crucial in expanding access to essential therapies. Amneal's acquisition underscores a strategic positioning to enhance its portfolio and market presence, reflecting a broader trend towards embracing biosimilars to potentially reduce healthcare costs. In another significant development, Merck has received FDA approval for its novel HIV treatment pill, Idvynso. This once-daily combination offers a new mechanism of action, reinforcing Merck's position in the HIV market while emphasizing the industry's ongoing innovation aimed at improving patient adherence and outcomes with simpler dosing regimens. Concurrently, Merck's partnership with Google in a billion-dollar enterprise deal underscores a growing trend: the integration of artificial intelligence into drug discovery and development processes. This alliance is part of an industry-wide movement towards leveraging AI to streamline R&D efforts, boost efficiency, and accelerate the time-to-market for new therapies. The competitive landscape for oral GLP-1 weight-loss drugs is heating up as Eli Lilly and Novo Nordisk vie for dominance. Monitoring prescription trends through advanced analytics tools provides insights into market dynamics, shaping future strategies for these companies. Proposed Medicare coverage for GLP-1 receptor agonists faced a setback with major insurers expressing hesitation to participate, which could affect access and affordability of these therapies used in managing type 2 diabetes and obesity. Meanwhile, Kyverna Therapeutics is making strides with CAR-T therapies for autoimmune diseases, presenting comprehensive data from its registrational trial of MIV-CEL for Stiff Person Syndrome. This could lead to the first FDA-approved CAR-T therapy in this domain, illustrating CAR-T's expanding applications beyond oncology and heralding a new era in personalized medicine approaches to autoimmune conditions. Samsung Biologics reports significant revenue growth amidst labor union challenges, highlighting its robust operational capabilities in biopharmaceutical manufacturing. This growth underscores the increasing demand for biologic drugs and the essential role of contract development and manufacturing organizations (CDMOs) in global supply chains. On the regulatory front, Novartis has faced setbacks with its anticoagulant Abelacimab after halting Phase 3 trials due to failure to outperform existing therapies like Eliquis. This highlights the inherent challenges in drug development where clinical efficacy must be clearly demonstrated. Meanwhile, ongoing discussions between regulatory bodies like the FDA and industry stakeholders are vital for aligning expectations with innovative R&D practices. The FDA has authorized clinical trials for ibogaine, a psychoactive substance with potential benefits in treating addiction and mental health disorders. This marks a pivotal moment in psychedelic research that could reshape treatment paradigms for neuropsychiatric conditions if safety standards are maintained. In vaccine news, Moderna has achieved European Union approval for its combination flu/COVID-19 vaccine—a significant stride given global pandemic preparedness efforts. However, its U.S. application remains stalled amid uncertainties about resubmission timelines. Eli Lilly's decision to exit its partnership with Rigel Pharmaceuticals reflects challenges in developing RIPK1 inhibitors for central nervous system disorders. This underscoreSupport the show

What does it take to bring a medical device from idea to reality — faster, smarter, and with less risk?In this episode of the Medical Alley Podcast, Ben Wagner sits down with Jeff Kelly, Chief Commercial Officer at Forj Medical, a newly formed CDMO built from the combination of Intricon and Minnetronix. Jeff shares how the medtech landscape is shifting, from fragmented supply chains to fully integrated partners, and why OEMs are demanding more from their manufacturing relationships. They also dig into what this means for the Medical Alley ecosystem, the importance of building a strong talent pipeline, and where the CDMO model is headed next. Send us a message!Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram. 

As the U.S. government pushes to reshore pharmaceutical manufacturing and rein in drug pricing, the implications for CDMOs and the broader outsourcing ecosystem are coming into sharper focus. While large-scale onshoring investments dominate headlines, questions remain around how policy will account for outsourced manufacturing and whether incentives align with the realities of global supply chains. In this episode of Off Script, we spoke with Gil Roth, founder and president of the Pharma & Biopharma Outsourcing Association (PBOA), about how recent policy developments are impacting CDMOs and their customers. The conversation explores the role of CDMOs in onshoring efforts, the economic and structural barriers to reshoring API and generic drug manufacturing, and what current tariff frameworks signal about policy priorities. Roth also discusses FDA staffing challenges, potential impacts on drug review timelines, and the broader uncertainty shaping R&D, sourcing, and investment decisions across the industry.

Contract Development and Manufacturing Organizations (CDMOs) are using digital twins to optimize operations and enhance efficiency in biopharmaceutical manufacturing. Digital twins provide real-time data insights, aiding in decision-making and expanding into complex biopharmaceuticals and gene therapy. Physical AI, including advanced robotics and AI-driven automation, is streamlining processes and increasing production efficiency. An interview with CellSave Arabia's COO highlights the potential of stem cells and regenerative medicine as a future cornerstone of healthcare.Learn more on this news by visiting us at: https://greyjournal.net/news/ Hosted on Acast. See acast.com/privacy for more information.

“Capacity isn't the biggest gap. It's people. And nobody's talking about it.”For pharma and biotech companies, manufacturing combination devices means coordinating not just fill/finish manufacturing but also primary container selection, device sourcing, final assembly, and serialization — often across multiple specialist partners. As CDMOs expand their service offerings to take on more of that coordination, including final device assembly and primary container management, the boundaries of what a fill/finish partner is expected to deliver are shifting.In the latest PharmaSource podcast episode, Steven Kaufman — who has spent over 20 years in the drug delivery device space and now advises biotech companies and CDMOs on combination product strategy — breaks down where the complexity really lies, why fill/finish capacity remains so tight, and what smart companies are doing differently to protect their programs.Read more.

Why do CDMOs keep building bigger stainless-steel facilities while their margins erode and Asian competitors undercut them on price? And what happens when big pharma decides to stop outsourcing altogether? The business model that sustained the industry for two decades is under pressure from every direction, and for many CDMOs, standing still is no longer a neutral position.In Part 2, Juergen Mairhofer, CEO of enGenes Biotech, shifts from the science to the stakes. Having spent over a decade building a company on licensing proprietary microbial technology rather than selling fermentation capacity, he brings a distinctive vantage point on where the CDMO industry is headed and what it will take to stay relevant.Here are some of the topics discussed:The need for innovation to stay competitive against lower-cost regions, and why capacity-focused business models are running out of road (03:08)How continuous manufacturing creates a competitive edge for CDMOs operating in high-cost regions (05:49)Practical advice for piloting continuous processing, building partnerships, and taking calculated risks before competitors do (06:36)The parallel universe of batch and continuous manufacturing, and how this duality will shape the industry over the next decade (08:24)What scientists need to know before spinning out a technology company: customer focus, cash discipline, and why the team is everything (09:49)Big pharma's return to in-house manufacturing and vertical supply chain integration, and why this creates opportunity for innovation-focused partners (12:12)Smart insight: Technology excellence is necessary but not sufficient. Juergen's closing word was simply "don't be afraid" and it carried weight precisely because it was not a platitude. The companies that will matter in ten years are those that start the hard work of innovation now, before the window closes.If you're interested in exploring more breakthroughs in continuous bioprocessing and the future of biotech manufacturing, check out these past episodes from the Smart Biotech Scientist Podcast:Episodes 85 - 86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 153 - 154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisode 155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes EverythingEpisode 156: The Hidden Economics of Continuous Processing That Most Biotech Companies OverlookEpisodes 181 - 182: Innovating Continuous Bioprocessing with Vibrating Membrane Filtration with Jarno RobinEpisodes 209 - 210: From Batch to Continuous: Building Innovation Culture in Conservative Biotech Environments with Irina RamosConnect with Juergen Mairhofer:LinkedIn: www.linkedin.com/in/juergen-mairhofer-ab27a5benGenes Biotech GmbH website: www.engenes.ccSupport the show

For many biotech innovators, high-throughput screening platforms promise faster discoveries and streamlined workflows. Yet beneath the surface, the reality is more demanding, requiring hands-on expertise, careful assay design, and a sharp understanding of microbial physiology to avoid mistakes that become expensive to fix downstream.David Brühlmann continues his conversation with Sebastian Blum, Market Development Manager in Europe at Beckman Coulter Life Sciences, who brings a practical, unvarnished perspective to high-throughput screening. Drawing on conversations with startups, pharma, and CDMOs, Sebastian digs into what separates "push-button" automation myths from hard-won bioprocess mastery. From evaluating technical fit to troubleshooting real-world applications, he advocates for a nuanced approach, one focused on fit-for-purpose tools and critical thinking over technology hype.In this episode, we discuss:Practical advice for startups considering systems like the BioLector XT Microbioreactor, including the need for technical expertise and tailored applications (02:34)Scenarios where the BioLector XT Microbioreactor is the best fit (flexibility, multiple microorganisms, modular upgrades) (04:22)The most common mistakes scientists make with screening technologies, and why specialized personnel are still essential (06:45)How automation, robotics, and AI are shaping the future of early-stage bioprocess development, and why core engineering principles remain vital (08:14)Tips for evaluating screening tool placement in your process and aligning technology with your application needs (11:13)If you're making decisions about high-throughput screening platforms and want to avoid costly missteps before scale-up, this episode delivers the clarity you need.Connect with Sebastian Blum:LinkedIn: www.de.linkedin.com/in/sebastian-blum-76240b3bBeckman Coulter Life Sciences: www.beckman.comNext step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Why do so many promising biotech ideas stall long before they reach the clinic or marketplace? For many, the answer lies hidden in the earliest phase of bioprocess development: upstream processing. It's where strain selection, media optimization, and culture conditions set the stage for everything that follows. Yet, the smallest missteps here can snowball into expensive roadblocks downstream. This episode of Smart Biotech Scientist Podcast zeros in on why smart screening strategies and the right bioreactor choices early on are the difference between breakthrough and bottleneck.Joining host David Brühlmann is Sebastian Blum, a microbiologist with more than two decades in the life sciences. As Market Development Manager at Beckman Coulter Life Sciences, Sebastian Blum brings firsthand knowledge from collaborating with startups, pharma giants, and CDMOs, bridging theory with the practical realities of modern process development. From commercializing micro-fermentation systems to guiding clients through high-throughput data, his insights come not just from research but real-world applications.Key Topics & Insights:How startups versus large pharma companies differ in process development strategies, including the role of budget, resources, and risk management. (04:27)The importance of designing screening experiments that mirror end-process conditions, and misconceptions around batch versus fed-batch modes. (07:49)Overview of available small-scale bioreactor systems: shake flasks, benchtop reactors, and high-throughput platforms—pros, cons, and ideal use cases. (09:17)Detailed comparison of BioLector XT Microbioreactor, ambr® 15, and ambr® 250 systems, including working volumes, experiment throughput, measurement technology, and cell types suited for each. (13:24)Practical guidance on making the most of high-throughput screening tools and how training, scripting, and collaboration help new users get value from systems like the BioLector XT Microbioreactor. (17:00)This episode offers grounded advice for scientists and founders navigating early-stage bioprocess development, plus a clear look at the technology landscape for microbial screening and optimization. Perfect for those looking to streamline process development and avoid common pitfalls.Connect with Sebastian Blum:LinkedIn: www.de.linkedin.com/in/sebastian-blum-76240b3bBeckman Coulter Life Sciences: www.beckman.comNext step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

“CDMOs and Biotechs will both die,” warns NKILT Therapeutics CEO as he talks candidly about the funding crisis stalling cell therapy development, predicting widespread consolidation across biotechs and CDMOs unless the industry shifts toward risk-sharing partnership models that align manufacturing economics with capital constraints.Raphaël Ognar, CEO and co-founder of NKILT Therapeutics, brings 29 years of pharmaceutical and biotech experience spanning marketing, drug development, and corporate strategy at major pharmaceutical companies. After launching a consulting practice focused on early-stage immuno-oncology biotechs, Raphaël co-founded NKILT Therapeutics.NKILT's off-the-shelf allogeneic approach (as opposed to patient-specific autologous therapies) targets HLA-G, an immunosuppressive molecule expressed across major cancer types including colorectal, breast, prostate, and kidney cancers, providing access to substantially larger patient populations while improving manufacturing scalability and economics.His company's 12-month IND delay exemplifies the systemic pressures that continue to threaten cell therapy innovation, and both sides of the CDMO-biotech relationship.Read more.

Today's topic is a big one: the BIOSECURE Act, signed into law on December 18, 2025, as part of the FY 2026 National Defense Authorization Act. The law restricts federal agencies, contractors, and grant recipients from procuring or using biotechnology equipment or services from what the statute calls “biotechnology companies of concern.” This is more than a procurement rule—it has broad implications for biopharma, device companies, CDMOs, CROs, genomics companies, and even research institutions relying on federal funds. Implementation timelines, designations, and compliance obligations are already starting to take shape.Questions and Comments: wkirton@bakerlaw.com and ahiggins@bakerlaw.com

In this episode of SCW for Pharma, Evren Ozkaya welcomes Tim Tyson, Chairman and CEO of TriRx Pharmaceutical Services.The conversation begins with Tim's professional journey in the pharmaceutical industry. Starting his career in operations and manufacturing, he worked closely with major pharmaceutical companies before rising to executive leadership roles at GSK, where he served as the president of the Global Manufacturing and Supply Division. Tim reflects on what continues to resonate with him about the pharmaceutical industry: the opportunity to contribute to life-altering and life-saving medicines that have a meaningful impact on patients around the world.Evren and Tim then compare the pharma services (CDMO) industry with consumer goods manufacturing. While the industries differ in many ways, Tim highlights a surprising similarity: both operate with relatively tight margins, making operational efficiency and continuous improvement essential for long-term competitiveness.The discussion then shifts to Tim's perspective on the Contract Development and Manufacturing Organization (CDMO) business model. Tim explains that outsourcing specialized manufacturing capabilities allows pharmaceutical companies to increase efficiency and reduce costs, particularly when CDMOs can achieve higher capacity utilization across their facilities. He emphasizes that making the right investments in facilities and technologies is essential for serving both human and animal health markets effectively.A major challenge across the industry, however, is low capacity utilization. Tim notes that average utilization rates can be as low as 24%, while a sustainable business typically requires at least 40–45%. Although many CDMOs target utilization rates closer to 70%, regulatory constraints and market dynamics often make this difficult to achieve. According to Tim, improving utilization and operational efficiency will be critical for the long-term sustainability of pharmaceutical manufacturing.Evren and Tim also discuss the recent wave of investments in new pharmaceutical factories, particularly in the United States. Tim argues that from both an engineering and financial perspective, building new facilities may not always be the most rational solution when significant unused capacity already exists. Instead, he advocates for modernizing existing facilities, adopting new technologies, and improving operational performance to unlock value from current infrastructure. At the same time, the industry is experiencing growing regionalization, with reshoring trends emerging not only in the U.S. but also across Europe, China, and India.The conversation then turns to the role of visibility and digitalization in pharmaceutical manufacturing. Tim emphasizes that successful CDMOs must build strong customer relationships based on trust and consistently deliver products that meet regulatory standards and arrive on time and in full. Achieving this requires moving beyond fragmented spreadsheets toward digital factories that provide real-time operational visibility. With better data and transparency, organizations can identify hidden inefficiencies, drive continuous improvement, and maximize operational performance.Finally, the discussion addresses the growing interest in AI across the pharmaceutical sector. Tim believes predictive tools can provide meaningful value in manufacturing environments, particularly for identifying improvement opportunities and supporting data-driven decision-making. However, he stresses that organizations must first establish strong data foundations before.

Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion.  Everything is coming up Lilly. The Indianapolis-based pharma bested its chief rival, Novo Nordisk in a head-to-head test. In a Phase 3 trial initiated by Novo itself, Lilly's Zepbound generated 25.5% weight loss while the Danish pharma's CagriSema elicited 23%. The results sent Novo's shares plummeting by an unprecedented 20% to a pre-Wegovy valuation while Lilly's market cap continues to climb.   Novo attempted a comeback on Tuesday, announcing that its triple-G agonist UBT251 scored almost 20% weight loss after 24 weeks in a Phase 2 trial in China. By comparison, Lilly's own triple-G competitor retatrutide led to 17.5% weight loss over the same timeframe, according to BMO Capital Markets analysts. Novo also sweetened the pot, announcing that it would slash the prices for all three of its GLP-1 medicines starting in 2027.    Meanwhile, the FDA kicked off Rare Disease Week with draft guidance on the new Plausible Mechanism Pathway for personalized therapies that was first teased in November. Jumping off last summer's Baby KJ success story, the new pathway is aimed at advancing treatments for ultra-rare diseases. And a bipartisan senate hearing on Thursday will focus on the authorization process for rare disease therapies.  While the rare disease space has enjoyed recent regulatory progress, funding these vital therapies remains a challenge. Companies like the Orphan Therapeutics Accelerator (OTXL), a non-profit biotech, are trying to change this with creative approaches including tax exempt status and unique partnerships with CDMOs and CMOs. Finally, in a move that also has implication for the rare disease space, the FDA's official pivot from a two clinical trial requirement to just one for new drug applications is lighting up biopharma social media.   And over at the CDC, there is more upheaval on the leadership front as National Institutes of Health Director Jay Bhattacharya replaces acting director Jim O'Neill as head of the agency, and principal deputy director Ralph Abraham steps down, citing “unforeseen family obligations.”    On the business front, Gilead inked the biggest M&A deal of the year so far, acquiring CAR T partner Arcellx for nearly $8B. And Merck's Keytruda should have a few extra years of dominance thanks to a web of patents, with billions on the line. Check it out in BioPharm Executive, in your inboxes Wednesday.  HostsJef Akst, Managing Editor, BioSpaceHeather McKenzie, Senior Editor, BioSpaceAnnalee Armstrong, Senior Editor, BioSpace

What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market? In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competition for specialized sterile fill expertise is intensifying. Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility. For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.See omnystudio.com/listener for privacy information.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of transformative events reshaping the industry landscape, from scientific breakthroughs to regulatory shifts and strategic corporate maneuvers.Let's start with Insmed's Brinsupri, a newly approved respiratory therapy that has captured attention with its projected $1 billion in sales by 2026. This ambitious forecast is grounded in Brinsupri's robust clinical efficacy and the increasing demand for innovative respiratory treatments. This development reflects a broader industry trend where targeted therapies are not only improving patient outcomes but also driving significant revenue growth. As respiratory conditions continue to be a major health challenge globally, the success of therapies like Brinsupri underscores the potential for innovation to meet these critical needs.In parallel, Merck is working strategically with its RSV antibody, Enflonsia, seeking a second-season approval to bolster its competitive stance against Sanofi and AstraZeneca's Beyfortus. The race in infant RSV prevention is intense as companies vie to establish dominance in this crucial segment of infectious disease management. Merck's efforts highlight the broader push within the industry to develop preventive measures that could significantly alter public health landscapes by reducing the incidence of severe respiratory illnesses in vulnerable populations.Meanwhile, regulatory scrutiny remains a constant for pharmaceutical companies. The FDA's recent review of Johnson & Johnson's advertising for Tremfya, targeting ulcerative colitis, emphasizes the agency's commitment to ensuring that efficacy claims are both truthful and transparent. This serves as a reminder of the importance of maintaining regulatory compliance and ethical advertising practices within the industry—a critical aspect as companies navigate complex marketing landscapes while ensuring patient trust.Shifts in leadership within key health organizations are also noteworthy. Jay Bhattacharya stepping into the role of acting CDC chief after Jim O'Neill's departure could signal changes in public health policy and research priorities. Such transitions can have profound effects on how emerging health challenges are addressed, potentially influencing everything from vaccine distribution strategies to research funding allocations.As we turn to policy discussions, President Donald Trump's most favored nation drug pricing proposal continues to stir debate. This initiative aims to lower drug prices by benchmarking them against international rates, but it faces resistance from free-market advocates who argue it could stifle pharmaceutical innovation. The ongoing discussion around drug pricing reform is pivotal, as it impacts both patient access to medications and the incentives for companies to invest in new drug development.Strategic realignments in the contract development and manufacturing organization (CDMO) sector are also making headlines. Recipharm's sale of its Israeli API plant to Scinai Immunotherapeutics, alongside a new CDMO partnership, illustrates how companies are optimizing resources to focus on core competencies and expand service offerings. This strategic shift highlights the dynamic nature of CDMOs as they adapt to changing market demands and technological advancements.In Alzheimer's research, there's promising news with a study suggesting that a blood test could predict when symptoms will appear, representing a significant leap forward in early diagnosis and intervention strategies. These advancements offer hope for altering the treatment landscape of neurodegenerative diseases through timely therapeutic interventions that could improve quality of life for patients. However, challenges remain as seen with Johnson & Johnson pausing enrollment in itsSupport the show

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing. Together, they explore the realities of GxP compliance in biopharma manufacturing — from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector.   Key Takeaways 02:11 Why biologics manufacturing is fundamentally more complex than small molecule production 04:10 How living cell systems introduce variability and demand tight process control 05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone 10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance 13:06 The growing demand for advanced quality skills in biologics and digital environments 17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches 20:47 Why automation and digitalization are critical to closing the CDMO capacity gap   Contact Paul Michel on LinkedIn here: Paul Michel (He/Him) | LinkedIn Contact us at solabs-podcast@solabs.com for questions or feedback!

As biopharma pipelines grow more complex, manufacturers are under increasing pressure to scale faster, adapt to new modalities, and build resilience into highly regulated operations. Meeting these demands means manufacturing agility is no longer just a competitive advantage, it's a necessity. Yet, structural constraints, talent shortages, and legacy processes continue to impact progress across the industry. In this episode of Off Script, we spoke with Iwan Roberts, vice president of technology and innovation strategy at Cytiva, for a deep dive into Cytiva's latest Global Biopharma Index. The conversation explores why manufacturing agility remains a major industry pain point, why modalities like cell and gene therapy and mRNA are uniquely difficult to scale, and how CDMOs, digitalization, and new supplier relationships are reshaping the path forward.  

In this episode of SCW for Pharma, Evren Ozkaya welcomes Kevin Sharp, Executive Vice President and Head of Sales and Operations at Samsung Biologics. Kevin shares his more than 20 years of experience in the pharmaceutical industry, spanning procurement, manufacturing, supply chain, and business development roles across companies such as GSK, Contract Pharmacal Corp, and Samsung Biologics. With the last decade focused on biologics, he offers a broad and practical perspective on how the industry has evolved.The conversation begins with an overview of Samsung Biologics and its position in the CDMO market. Founded in 2011, Samsung Biologics has rapidly become a leader in biologics manufacturing capacity, leveraging Samsung's deep engineering expertise and manufacturing DNA. Kevin explains how the company's end-to-end CDMO model addresses one of the biggest pain points for biopharma companies: the cost, risk, and time associated with tech transfers across multiple suppliers.Evren and Kevin then dive into the unique complexity of biologics supply chains. Kevin highlights how longer planning horizons, strict quality requirements, and capacity slot management make timing and end-to-end coordination critical. As molecules become more complex and new drug modalities emerge, even small disruptions in sequencing or release timing can have significant consequences for quality and supply reliability.The discussion expands to broader biopharma trends, including the growing share of combination therapies and novel modalities. Kevin notes that a significant portion of products expected to be approved in the coming years will fall outside traditional standards, putting pressure on CDMOs to invest in modern facilities, scalable platforms, and standardized yet flexible production processes. He emphasizes that while there is room in the market for CDMOs of all sizes, larger players differentiate themselves through integrated, one-stop-shop capabilities and scalable capacity.Digitalization is another key theme of the episode. Kevin explains how Samsung Biologics applies its technology-driven heritage to biologics manufacturing, drawing parallels between semiconductor production and biopharma in terms of precision and environmental control. He discusses the use of MES, supply chain visibility tools, AI, and digital twins, and how real-time data transparency creates value for clients while improving consistency and operational performance.Finally, Evren and Kevin explore why digital transformation remains slow across much of the pharma CDMO landscape. Kevin points to investment requirements, long implementation timelines, sunk costs, and concerns about technology obsolescence as major barriers. He also shares advice for younger professionals in the industry, encouraging early exposure to different functions and the importance of building strong, long-term relationships.They conclude by reflecting on how capacity, technology, and adaptability will continue to shape the future of biologics manufacturing, and why companies that commit early to scalable platforms and digital foundations are likely to widen the gap in the years ahead.

Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum.In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later.Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable.A few key takeaways:Early quality work should be right-sized, not commercialized prematurelyDesign space, material variability, and sensitivities must be understood and documented earlyFMEA works best when it evolves with the product—not when it's treated as a one-time exerciseFDA and EU requirements can diverge in ways that materially affect submission timingClear documentation and regular, direct communication prevent avoidable delaysJackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical, a fully integrated CDMO with decades of experience supporting pharmaceutical drug products, medical devices, biologics, and APIs. She has led quality systems and development programs across multiple global manufacturing sites and brings deep expertise in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, validation, risk management, and cross-functional leadership.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/

In this episode of SCW for Pharma, Evren Ozkaya welcomes Andrea Wagner, CEO of PharmaPhixx. The conversation begins with Andrea's professional background, spanning academia and industry. She holds a doctorate in toxicology and a master's degree in analytical chemistry and spent the early part of her career in universities before transitioning into the pharmaceutical industry. Andrea later co-founded a CDMO, built a manufacturing operation from the ground up, and successfully exited the business (Berkshire Sterile Manufacturing). In 2023, she founded PharmaPhixx, a company focused on helping CMOs and CDMOs reduce the negative impact of production downtime by partnering with pharma manufacturers, OEMs, and engineering organizations. Andrea also highlights her commitment to mentoring women in engineering and pharma, noting that the “xx” in PharmaPhixx represents women.Building a CDMO & Market DynamicsEvren and Andrea discuss the high barriers to entry in the CDMO sector, noting it took 18 months post-construction to secure a first client—a testament to the industry's long operational timelines. Regarding domestic capacity shifts in the U.S., Andrea argues that "overcapacity" is relative; while some segments are saturated, others remain constrained. She emphasizes that true capacity isn't just about floor space—it requires years of regulatory approval and trust-building.The conversation highlights a major industry pain point: average equipment utilization (OEE) is only around 35%. Andrea explains how PharmaPhixx uses automation, robotics, and AI to minimize downtime and handle repetitive tasks, freeing engineers for higher-value work. Despite the industry's slow digital adoption, she predicts a total transformation of pharma factories within the next decade, driven by the need for better data to improve P&L performance.Andrea identifies "operational firefighting" and financial constraints as the primary hurdles to modernization. She suggests that instead of relying on external advisors, senior management should empower internal operations teams—who understand the bottlenecks best—with the time and resources to innovate.The shift from paper-based systems to digital batch records is cited as the essential first step for AI applications like automated quality inspection. Andrea expects the FDA and EMA to accelerate the push for paperless systems as a younger, tech-savvy workforce takes over.The episode concludes with advice for young professionals and women in pharma. Andrea encourages them to build strong support networks and seek mentorship, reaffirming her commitment to developing the next generation of industry leaders.

A CDMO plays a crucial role in the pharmaceutical and biotechnology industries by providing comprehensive drug development and manufacturing services, enabling companies to efficiently bring new medicines to market. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Sigma Mostafa, CSO at KBI BioPharma, about the role of CDMOs and the important factors companies should consider when selecting one. Mostafa sets out what a CDMO does, how they help to advance medicine into clinical and then commercial trials, and the critical role of partnership in drug development. You can listen to episode 224 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.

In this episode, Mitch sits down with Travis Christman, a respected operations, regulatory, and quality leader in the orthopedic manufacturing world. Travis has spent his career across Zimmer, Medartis, Nextremity, and now Priority Medical, an end-to-end engineering services organization operating from the orthopedic capital of the world — Warsaw, Indiana.Travis shares details on a major industry event launching December 18th: The “Made Here” Manufacturing Showcase — a first-of-its-kind, hands-on demonstration of the full orthopedic supply chain ecosystem that exists in northern Indiana.You'll hear:Why Warsaw remains the global epicenter of orthopedic innovationWhat OEMs don't see — but need to know — about today's supply chain pressuresHow contract manufacturers can accelerate lead times, nearshoring, and production readinessWhere the biggest growth trends are emerging (AI, robotics, navigation, additive, pre-op planning, and more)How Priority Medical is serving as a connector across surgeons, OEMs, contract manufacturers, and local talentThis is a must-listen if you're involved in: orthopedic product development, contract manufacturing, supply chain, engineering services, regulatory/quality, or OEM commercialization planning.Guest Bio — Who is Travis Christman?Operations & Quality Leader at Priority MedicalFormer leader at Zimmer, Medartis, and Nextremity SolutionsU.S. Army National Guard Captain (10+ years of service)Board member at KEDCO (Kosciusko Economic Development Corporation)Deep expertise in engineering services, supply chain partnerships, regulatory/quality systems, and commercialization for orthopedic productsWhat We CoverThe vision behind the Made Here Manufacturing ShowcaseWhy OEMs are struggling with today's longer lead timesHow Warsaw's supply chain ecosystem drives speed, cost, and qualityNearshoring trends and why U.S. manufacturing is surgingThe rise of robotics, navigation, pre-op planning, and AI in orthopedicsWhat contract manufacturers must do to stay competitiveThe new economy emerging around CDMOs and orthopedic innovation hubsHow Priority Medical is helping OEMs innovate faster and more efficiently

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the dynamic landscape of the industry, exploring significant scientific advancements, regulatory changes, clinical trial outcomes, and strategic investments that are shaping the future of healthcare.Starting with strategic investments, Regeneron is making a bold move with a $2 billion investment to transform a former magazine factory in Saratoga Springs, New York, into a state-of-the-art drug manufacturing plant. This investment reflects a broader industry trend towards enhancing domestic manufacturing capabilities to ensure supply chain resilience. Similarly, CSL is channeling $1.5 billion into U.S. plasma-based manufacturing over the next five years. These investments are critical as plasma-derived therapies continue to play a vital role in treating various conditions, necessitating robust manufacturing infrastructure to meet growing demand.In clinical research, Merck's Winrevair has shown promising results in a proof-of-concept study for heart failure patients. This advancement highlights ongoing efforts to address one of the leading causes of morbidity and mortality worldwide—heart failure. The study paves the way for further exploration of activin signaling inhibitors in cardiovascular therapies.On the regulatory front, Eli Lilly has expanded its market reach with the approval of its Alzheimer's medication for distribution in India. This milestone represents progress in tackling the global Alzheimer's disease burden, an ailment that presents significant challenges to healthcare systems worldwide.The FDA's recent critique of AstraZeneca's Farxiga advertisement underscores the importance of accuracy in pharmaceutical marketing. The agency's concerns about potential misleading impressions emphasize ongoing regulatory vigilance to align marketing practices with approved therapeutic uses and ensure patient safety.Shifting to business strategies, Zymeworks' transition towards becoming a 'royalty-driven organization' marks an evolution in biotech business models. By leveraging successful licensing frameworks, Zymeworks aims to enhance revenue streams while focusing on innovation without the traditional constraints of direct commercialization.In cardiovascular therapeutics, Cytokinetics is positioning itself strategically by funding a heart registry, signaling an intensifying competitive landscape as companies vie for leadership in this critical area of healthcare.Roche's development of giredestrant, an oral selective estrogen receptor degrader (SERD), has achieved success in a phase 3 adjuvant breast cancer trial. This positions Roche to capture an unoccupied niche within the competitive breast cancer treatment market and highlights a trend towards targeted therapies with potentially significant patient outcomes.Addressing side effects associated with GLP-1 receptor agonists, Vanda Pharmaceuticals is making strides with tradipitant to mitigate nausea and vomiting induced by Wegovy. As GLP-1 agonists gain traction for their metabolic benefits, adjunct therapies addressing side effects are becoming increasingly pertinent.In digital health initiatives, Humana's collaboration with Epic aims to automate insurance verification and patient check-ins, aligning with federal interoperability goals. This represents a broader industry shift towards digital solutions designed to streamline administrative processes and enhance patient experience.Meanwhile, Lonza's expansion at its Stein facility in Switzerland underscores ongoing capacity-building efforts among contract development and manufacturing organizations (CDMOs). Such expansions are crucial as they provide biopharmaceutical companies with the neSupport the show

In this episode of Molecule to Market, your host Raman Sehgal discusses the pharmaceutical and biotechnology supply chain with Jean-François Brepson, Chief Executive Officer at PathoQuest. The conversation covers: Navigating 20 years of global leadership roles at Ipsen before moving from the corporate world into an investor-led entrepreneurial adventure The tough decision to refocus PathoQuest from diagnostics into a pure play CRO and pharma services business How a major strategic partnership transformed the company's trajectory and why Jean sees partnerships as a competitive weapon Riding the tailwind of the FDA's move away from animal testing and offering something game-changing in the CMC and GMP space The opportunities ahead for CROs and CDMOs in helping unlock the next wave of innovation Jean-François Brepson is a dedicated leader with deep experience in biotechnology and pharmaceuticals. Since becoming CEO of PathoQuest in 2015, he has built the company into a leading global CRO specializing in quality control of biological drugs using Next Generation Sequencing (NGS). Over his career, he has advanced innovative technologies and solutions that bridge scientific progress with real-world application. Prior to joining PathoQuest, Jean was Senior Vice President at Ipsen, where he led the global GI-Oncology and Endocrinology franchise.   Molecule to Market is sponsored by Bora Pharma, Charles River, and Lead Candidate. Please subscribe, tell your industry colleagues, and help us celebrate the value of the global life science outsourcing space. We'd also appreciate a positive rating!

As the prospect of import tariffs and drug price reform marshals billions of biopharma investment dollars into the U.S., the feasibility of rapid domestic manufacturing buildouts could hinge on a new program cooking at the FDA. How that program, dubbed PreCheck, will work in practice—and on what timeline—are key questions as the U.S. looks to bolster its local pharmaceutical production base. This week on “The Top Line,” we dive into comments from a recent public meeting on the industry’s hopes for PreCheck, which is being designed to streamline the process by which new biopharma manufacturing facilities are built in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics—who attended the meeting—to offer an on-the-ground perspective and explore the aspects of the plan that could have the biggest impact on manufacturers. Shilling also outlines what he sees as FDA’s next steps, plus regulatory considerations that could most benefit CDMOs and the broader industry. To learn more about the topics in this episode: Amid tariff-fueled onshoring push, Trump signs order to boost US stockpiling of certain drug ingredients FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outs Trump signs executive order to boost US drug manufacturing amid threat of tariffs See omnystudio.com/listener for privacy information.

What if the answer to battling antibiotic-resistant infections isn't a new antibiotic, but harnessing viruses that have been quietly dominating bacterial populations?Bacteriophages, viruses that target and kill bacteria, have been saving lives for a century, but their true potential is only now being unlocked by modern machine learning. The race isn't just about discovering effective phages; it's about deploying the right therapy, personalized to the patient, before time runs out.On this episode, David Brühlmann welcomes José Luis Bila, Co-Founder and CEO of Precise Health. Driven by personal tragedy and an engineer's mindset, José is shaping a future where AI-powered phage therapy isn't a niche solution, but a scalable, accessible weapon against the superbugs that evade antibiotics. From building bioreactor capacity to navigating regulatory gray zones, José brings a rare blend of technical vision and practical urgency to a problem that affects families and health systems worldwide.Key topics discussed:The challenge of evolving bacteria and phages, and the question of whether it's possible to keep up with nature's pace through engineering new phages in silico (00:00)Overview of bacteriophage production: complexity, types of bioreactors used, and comparison with chemical synthesis (02:54)Bioproduction logistics: using CDMOs vs. in-house hospital production and the real-world timescales for manufacturing (02:32)Barriers for smaller or less funded hospitals, especially in low- and middle-income countries, with thoughts on hospital infrastructure differences worldwide (04:41)Creative solutions for cost-effective phage production in remote and underserved regions, such as the potential for single-use or mobile bioreactors (06:01)Why downstream processing and ensuring product purity is a bottleneck; the need for miniaturization and economic scalability (06:40)Parallels and differences in downstream processing between bacteriophages and viral vectors (09:15)The vital role of stability and shelf life for phage therapy logistics and economic viability (09:15)Regulatory pathways for phage therapy in Europe and beyond, including magistral preparations, ethical approvals, and adapting to digital tools for selection (12:39)The future vision: routine clinic entry through matching existing phage libraries, with longer-term goals of engineering bespoke phages via AI when necessary (15:52)José's perspective on building global infrastructure and making phage therapy cost-effective and universally accessible (18:08)José Bila's message: solutions to antimicrobial resistance are within reach. The biotech community must build accessible infrastructure, using AI and innovative systems to ensure phage therapy benefits reach every patient, everywhere.Connect with José Luis Bila:LinkedIn: www.linkedin.com/in/josé-luis-bila-phd-3b08a5a7Precise Health SA: www.precisehealth.ioInterested in how scientists are fighting superbugs? Learn how phage therapy and smart bioprocess design are helping outmaneuver drug-resistant pathogens. Check out this interview with one of our previous guests!Episodes 187-188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo RhêmeNext step:Book a 20-minute call to help yo

As we near the end of 2025, the CDMO industry finds itself at a pivotal financial and strategic juncture — shaped by constrained funding, shifting demand, and renewed investor scrutiny.  In this episode of Off Script, we speak with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, to examine how the year's market and investment trends align with his predictions from an earlier CPHI Annual Report. Brian shares his perspective on: How accurately his forecast of stability and growth for clinical CROs and CDMOs has held up amid tighter capital markets; The ongoing softness among early-stage pharma service providers and what it reveals about funding flows across the sector; and Where investor interest is gravitating — from ADCs and small molecules to biologics — and what this signals for the next phase of CDMO evolution.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Gil Roth, President, at Pharma & Biopharma Outsourcing Association (PBOA). Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Gil, covering: How planned FDA budget cuts and the ongoing US government shutdown are impacting the industry. And the potential outlook if those issues remain unresolved... Why positive early-phase clinical trial activity could signal a stronger year ahead Real-life applications of AI and machine learning for GMP in CDMOs through signal and pattern recognition Why Gil is feeling more optimism across the CDMO community And yes… you can also see Gil and Raman together on stage at the industry's very own “Super Bowl” of conferences Gil Roth is the Founder and President of the Pharma & Biopharma Outsourcing Association (PBOA), a nonprofit trade group that advocates for the regulatory, legislative and general business interests of the CMO/CDMO sector. In this role, he brings CDMO perspectives and education to FDA, the US Congress, and other bodies, and brings CDMOs together to share best practices, develop policy positions, and provide briefings on government positions that impact that sector. He also organizes and hosts PBOA's annual members-only Meeting & Conference. Previously, he was the Founding Editor of Contract Pharma magazine. In his alleged free time, he produces a weekly cultural conversation podcast called The Virtual Memories Show (https://chimeraobscura.com/vm).   Molecule to Market is also sponsored by Bora Pharma (boracdmo.com) and Charles River (www.criver.com), and supported by Lead Candidate. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!

What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely?Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to handle.In this deep-dive episode, David Brühlmann sits down with Amanda Hoertz, Vice President of Analytical and Formulation Sciences at KBI Biopharma, where she oversees 300+ scientists across the mammalian network. Amanda's team has cracked the code on some of the industry's most challenging ADC programs, achieving a remarkable 93% batch success rate by rejecting cookie-cutter approaches in favor of molecule-specific development strategies.What you'll discover:The Platform Fallacy: Why treating ADCs like standard monoclonals is costing companies millions and months of development time, and the bespoke analytical framework that's changing everything.Cytotoxic Payload Management: From free drug analysis to employee safety protocols, Amanda reveals the hidden complexities of handling molecules designed to kill cells, including the specialized facilities and analytical methods required for GMP manufacturing.Charge Heterogeneity Mastery: The analytical method that "keeps Amanda up at night," and the development strategies her team uses to achieve robust separation and qualification across multiple sites and analysts.This episode delivers the technical depth and strategic insights that bioprocess engineers need to navigate ADC development successfully. Whether you're evaluating CDMO partnerships, optimizing analytical methods, or scaling complex conjugates, Amanda's proven strategies will transform your approach to these game-changing therapeutics.Ready to master the analytical complexities that make or break ADC programs?Connect with Amanda Hoertz:LinkedIn: www.linkedin.com/in/amanda-hoertz-3aba605KBI Biopharma: www.kbibiopharma.comKBI Portal: www.standalone.kbi.bioNext step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call

Think you can crack the science first and worry about CMC when you "need it"? That's exactly how promising therapies die in regulatory limbo while patients keep waiting.Your breakthrough discovery means nothing if it's trapped in CMC chaos. While you're perfecting your molecular mechanism, competitors with inferior science but superior CMC strategy are racing past you to IND filing and ultimately, to patients.In this episode, I, David Brühlmann, your usual host, expose the dangerous delusion that's quietly bankrupting biotech startups: the belief that brilliant science automatically translates to successful drug development. Drawing from years of watching founders burn through millions because they treated CMC as an afterthought, I reveal why the smartest scientific minds often make the most catastrophic business decisions.Here's the hard truth you'll confront in this episode:The $50M Misconception: Why "CMC is just manufacturing" thinking destroys companies before they ever reach Phase II. While you're debating molecular targets, smart founders are building systematic CMC advantages that compress timelines and slash costs. The FDA doesn't care how elegant your science is if you can't demonstrate consistent, scalable manufacturing.The Brutal Mathematics of Delay: Systematic CMC approach: 10-12 months to IND, 85% hit timelines. "Figure it out later" approach: 15 months or more, and a much lower success rate. Every month you delay isn't just burning cash. If your therapy could help 10,000 patients annually, that's 833 people per month who don't get treatment because of preventable delays.Three Founder Myths That Kill Programs: The misconceptions about CMC being "basically just manufacturing," bringing in experts "when we need them," and CDMOs handling "the complicated stuff." Each myth leads to the same outcome: brilliant science trapped by business incompetence.Your Four-Action Emergency Protocol: Stop hoping CMC will work out. Start implementing systematic approaches. I give you four specific actions to execute this week, not someday when you're "ready," but right now while you can still prevent the crisis that kills 40% of biotech programs.The competitive reality: While you're listening to this episode, your biggest competitor just moved closer to IND filing. Maybe they completed process validation. Maybe they locked in analytical methods. The question isn't whether CMC matters. It's whether you'll master it before your competitors do.Next step:

This week on the podcast, Heather and Matthew are joined by Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA), which represents the regulatory, legislative, and general business interests of Contract Development and Manufacturing Organizations (CDMOs) in the bio/pharma space. Gil shares how CDMOs are navigating regulatory uncertainty, the potential impact of tariffs on drug pricing and supply chains, and what recent executive orders could mean for innovation and access to care. Tune in now!

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Kaan-Fabian Kekec, Partner in Healthcare and Life Sciences at Simon-Kucher. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Kaan, covering: Being on the sunny side of consulting, and helping clients unlock growth. What makes a key strategic partnership both from a CDMO, and a sponsor perspective. The taboo subject of pricing and how it can be used to help unlock commercial positioning, and excellence. Common mistakes in BD teams, and the importance of value positioning. The hottest segments in the market right now, and some of the competitive drivers in today's market. Kaan leads the firm's Healthcare B2B and Pharma Services business globally, encompassing CDMOs, CROs, bioprocessing solutions, drug delivery, packaging, and more. He specializes in delivering end-to-end commercial strategies for CDMOs, advising on growth initiatives and supporting clients throughout the entire lead-to-deal process—from marketing and sales to proposal management and deal optimization. Molecule to Market is also sponsored by Bora Pharma (boracdmo.com) and Charles River (www.criver.com), and supported by ramarketing.  Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!

The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations. Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications 

On this episode Gil Bashe welcomes Craig Martin—former acting CEO of Global Genes and founder/CEO of the Orphan Therapeutics Accelerator—about the urgent need to rescue clinically promising drugs for rare and ultra-rare diseases. Craig shares how his nonprofit model uses AI, CDMOs, CROs, and alternative funding to de-risk shelved therapies and transform them into treatments for patients with unmet needs. including context on systemic inequities and the human cost of stalled innovation. He describes a startling trend: when capital dries up or regulations shift, life-saving drug programs get shelved—not because of safety or efficacy issues, but due to dilution in business incentives. Among those left behind are rare disease candidates that patients and families know work, but simply become financially unviable. Martin joins us to unpack a pressing challenge in rare disease therapeutics: promising clinical‑stage drug programs that have been shelved—not for lack of science, but due to shifting capital and incentives. Through his nonprofit model at OTXL, he's pioneering an entirely new approach to rescue these assets and deliver real impact. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen

In this special episode of Molecule to Market, recorded at this year's CDMO Live in Rotterdam, industry leaders come together to assess the evolving state of the contract development and manufacturing sector. Raman is the panel moderator, joined by:  Gil Roth - PBOA Dr. Jim Li - BioDuro Sundia Kaan-Fabian Kekec - Simon-Kucher They unpack cautious optimism in the face of lingering market uncertainties and geopolitical tension, you'll hear: How CDMOs are adapting to early-stage funding strain and evolving pricing models The impact of rising interest rates, tariffs, and global trade policy on pharma outsourcing Capacity and talent constraints facing CDMOs in new therapeutic modalities Why integrated models and scenario planning are key to future-proofing operations This episode offers timely insight into the challenges and opportunities shaping the next phase of growth for CDMOs worldwide. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is also sponsored by Bora Pharma (boracdmo.com) and Charles River (www.criver.com), and supported by ramarketing.