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September 2026
In this episode, the Executive Chair of the 2026 ISPE Annual Meeting and Expo, Jose Caraballo Oramas, and the International Program Committee Chair, Connie Langer, join the podcast to preview the upcoming conference in Washington, D.C. They explore the featured topics, trends, and key highlights of what attendees can expect from the educational content and agenda.
Learn about the five interconnected educational tracks, which delve into topics like how pharmaceutical operations can balance advanced digital innovations, such as artificial intelligence, with robust governance and human accountability, and how modern systems and workforce upskilling contribute to reliable, patient-centric drug manufacturing.
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Welcome to the ISPE podcast, shaping the future of pharma, where ISPE supports you on your journey, fueling innovation, sharing insights,
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thought leadership, and empowering a global community to reimagine what's possible.
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Hello,
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and welcome to the ISPE podcast, shaping the future of pharma.
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I'm Bob Chew, your host.
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And today, we have another episode where we'll be sharing the latest insights and thought leadership on manufacturing, technology, supply chains,
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and regulatory trends impacting the pharmaceutical industry.
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You will hear directly from the innovators, experts, and professionals driving progress and shaping the future.
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Thank you again for joining us, and now let's dive into this episode.
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Our topic today is the upcoming twenty- twenty- six ISPE Annual Meeting and Expo, featuring the topics, tracks, and key
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highlights of what you can expect from the educational content and agenda.
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To share more about this topic, I would like to welcome the Chair of the Conference International Program Committee, Connie Langer, regulatory intelligence
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lead, pharma quality, safety, and environmental operations at Pfizer Global Supply, and the committee executive chair, José
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Caraballo, founder and principal, JCO Global Advisory LLC.
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Welcome to the podcast.
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The twenty- twenty- six annual meeting and Expo theme centers on ensuring that innovation ultimately reaches patients.
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What does 'from science to systems to patients' mean to you personally, and why is this message especially important
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for the industry right now?
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Sure.
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Thank
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you, Bob, for the question, and happy to be here.
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And that theme for the conference, really, for me, it embraces the full arc of innovation.
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If you think about it, we discover things in the labs, we develop them in development, then we figure out the facilities or the systems
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or the processes that are needed to execute that process and to produce medicines.
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We'll still need to get them delivered to the patient.
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So there's a supply component, involving all that is the complexity of new innovation, data, and digital.
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So, the conference theme really covers the full arc of innovation from discovery to bedside.
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And we wanted to make sure that any topic under that umbrella had a place in the conference.
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So it's very inclusive and very comprehensive.
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Well,
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that sounds really fantastic, and it certainly is a well stated theme for the industry today.
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And that allows us to go into this year's program, which is organized around five interconnected tracks.
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First, from breakthrough to bedside, systems that deliver reliability.
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Second, digital data and decision integrity.
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Third, people, capability, and the workforce of delivery.
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And fourth, Governance, risk, and readiness.
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Now, how do these tracks work together to address industry's most pressing challenges?
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Connie?
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Well,
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thank You, Bob.
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I think that's really a good way to frame it, because they aren't five separate conversations.
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They're really one connected story about how we get innovation all the way to the patient.
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So starting with breakthrough to bedside, that's really discovery, the science, and the development side.
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And how we take that discovery and get it to something that can actually be manufactured, scaled, and delivered.
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Then moving to systems that deliver reliably, that picks up right where that breakthrough to bedside leaves off.
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The manufacturing, supply chain, and technology backbone that has to perform every single day.
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Moving to digital data and decision integrity is where AI and analytics come in.
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How we build trusted data into better, faster decisions.
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Then we have people capability and the workforce of delivery, and that's about making sure our workforce has the capability and the upskilling for this AI.
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enabled world, and not just about the technology itself.
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And finally, the governance and risk and readiness, that ties everything together.
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That's the oversight that keeps the whole system in control.
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So a breakthrough doesn't really mean much without a workforce that can execute it and the governance structure that keeps it inspection ready.
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It
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was last week, I think, the news broke about the pancreatic cancer drug, and that is amazing.
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I don't know if either of you have any inside knowledge about how that was developed or any of the manufacturing challenges, if
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any.
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It looked like it was a tablet, in fact, which is pretty amazing in and of itself.
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Any comments that you all wanna make on that?
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I
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don't have any specific insight, but obviously, I'm pleasantly surprised that discovery still happens and that is meeting different patient needs.
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So, you hear about these discoveries and you almost want to applaud and smile and say thank you for
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keep doing what we need to do.
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I think the point is also that once it's discovered, there's still a lot to work on, right?
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How to manufacture it in sufficient quantities that it reaches patients on time consistently.
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But it's always pleasant to see these discoveries and, realizing that you're part of an industry that makes that happen.
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Yeah.
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And
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I would just add to that.
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That one really touches me personally because, we lost my mother-in-law last year to pancreatic cancer, and she was diagnosed late and only had a
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short time to live.
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So it's really exciting to see that they are making progress in this space.
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Well,
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it certainly is wonderful to know what this industry can produce in terms of miracle therapies.
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Artificial intelligence, advanced analytics, and digital technologies are transforming pharmaceutical
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operations.
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How can organizations leverage these capabilities to improve decision making and performance while maintaining trust,
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oversight, and data integrity?
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So
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I think this connects to several of the sessions across many of the different tracks that we've built into the agenda this year.
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And, personally, at my company, we're investing heavily in training and in giving teams access to a lot of these new tools.
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We are partnering with some universities to prepare general training that's mandatory, and it helps really level set us so that we're all understanding the language and the
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risks and the capabilities of those tools.
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And if you want to take that further, colleagues also can opt in to take graduate level classes and get a certificate in the management of AI.
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And I think one of the challenges is the Pace of change is so fast in this area.
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It's not enough just to roll out the technology.
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You really have to build in that literacy and the trust that goes along with it.
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Thank
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you.
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Yeah, Connie, I totally agree.
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And AI is pervasive, right?
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And we still haven't seen all of it.
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More ideas will come in as it goes.
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So I see it as a tool that, for example, will help us be more efficient in things that are standardized.
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Right?
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I was reading the other day the approach of AI that it's taken to create code.
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Right?
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So who would imagine that coding could get benefit from AI and be more efficient about it?
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So that's a standardized task that AI probably can do faster and better.
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But then there's the other parts of the judgment calls, the different decisions, the understanding that really requires still a human to make that call,
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because they're accountable for many things.
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So I see it as a tool to gain efficiency, and then we'll have more time to tackle the harder questions.
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Right?
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The better the size.
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So it's a shift.
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I also agree that if our workforce is not upskilled, sufficiently, that technology will find a wall.
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They will not be able to be adapted or adopted, in the day to day.
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So those are important points, as well, upskilling our workforce.
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Both
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of you emphasize that success depends not only on technology and systems but also on people.
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What skills, leadership capabilities, and workforce strategies do you believe will be most critical for the next generation of
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pharmaceutical professionals?
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Yes.
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I
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always start with, the idea of being curious.
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Be curious, right?
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That opens the door for so many things.
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If you're not curious or you're living in your bubble thinking this would not impact me, you're probably betting on the wrong bet.
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So being curious is a large priority for our quality and pharmaceutical professionals.
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Then the second step will be a little bit of courage to learn something new, right?
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Open the door, enroll in some class, take advantage of the company's trainings.
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They will get you closer to this technology, and you will be able to manage your day to day and your tasks.
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With the help of the technology, right?
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Not against the technology or afraid of it.
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So, courage to learn something new is always good.
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And, for me, my journey was a little bit of playing with it for some time, getting used to it.
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What are their capabilities?
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What I can trust It and what I cannot, right?
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So that understanding of what it can do for you, it can only come from practicing with it, embracing it, touching it, asking the questions.
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So I think those are very good strategies.
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In the future, each professional should be, some way, data savvy, right, to be able to navigate this new environment of
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everything being digital and or digitalized.
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Connie,
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you have any additional thoughts on that?
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I
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agree with what Jose is saying, and I think one of the most valuable things that we can do for the next generation is to help them not only
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build their deep domain expertise, but to pair that along with all these new digital tools.
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I think AI can give you an answer really fast, but it can't tell you whether or not the answer is right or discern if there's any Gaps or
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anything missing.
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So, that accountability still needs to rest with the people who understand the science and the process and the regulatory context.
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So, I guess my hope for the workforce of the future is that we develop that generation of professionals that can have that combination, that technical fluency
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plus the strong critical thinking.
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And I think that's really what's going to set people apart.
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Well,
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that leads us to governance.
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And governance, risk management, and inspection readiness are recurring themes throughout the program that's coming up.
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How are leading organizations moving from a reactive compliance mindset to a more proactive,
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risk- based approach that supports both quality and business continuity?
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I
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think that everyone— industry, academia, and regulators are all moving in the direction of that more proactive mindset.
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One example that I think of is this FDA quality management maturity pilot.
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QMM pilot that's going on right now, the purpose of that isn't just another layer of oversight.
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It's meant to foster this real quality culture, and to recognize organizations that are already operating at that mature level, and even help
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identify where there's some more room to grow.
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So I think, ultimately, we're all working toward the same goal of protecting this reliable drug supply for the patient.
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And then another thing that I can think of, at my company we're really engaged in developing and using the tools that are available to us through ICH quality
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guidelines.
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So we have pharmaceutical development and quality by design, quality risk management, an effective PQS, and leveraging some of the
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lifecycle management strategies that are now available.
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So I know those aren't new concepts, but I think used together, they can give us a real framework for building quality in.
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From the start.
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Yeah.
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I
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would like to add also on governance.
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Some people react to governance as a bad thing.
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But when you have to manage complexity, which is what's happening.
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Right?
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All these new technologies and data, tools, add some complexity to the organization.
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Then you need some kind of rules, some kind of governance to make sure that what's critical for you is well taken care of.
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I compare this with early companies where they may have one product and they may have one
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customer, and the operations manager can manage everything.
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But then as you keep adding products and jurisdictions and customers, the complexity gets to a point that you need help.
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So I think governance is a word and a concept that is being embraced now more than ever because of the complexity.
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And then, one Comment on the readiness.
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Obviously, everyone has plans, we get ready and we get upskilled, but readiness also includes being able to demonstrate that you can execute, right?
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So there's something about readiness that talks to me about practicing what you learn, making sure that you challenge what you think you know.
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That will help you be ready for inspections or other difficult tasks.
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Artificial
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intelligence is really highly complex, sophisticated statistics at work.
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Do you know of organizations that are using AI to actually drive a more
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quantitative approach to quality risk management, as opposed to what has typically been more of a
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qualitative?
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You get people in a room and they...
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Yeah, it's a high risk.
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It's a five.
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It's not a four.
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All right?
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And they're using their judgment, which is valid, but there's really no quantitative
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basis for that.
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Are you collecting information at some points and feeding it into AI to identify
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cases where the risks might have been hidden, and there's additional risks to manage?
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Or where we thought this was a risk, but it's pretty well controlled.
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We're good.
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Yeah.
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That's
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very interesting, for me.
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It's a very active area of investigation for many of us.
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How I look at it is that the model, what it can do, I think we can think about it and assign it properly.
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But what data you use to train the model, I think is so important.
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So, if you train a model to help you categorize risks and you only train them on the good stuff and never on the failures or what
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lessons were learned, then I think you're missing the point.
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Also, operations is so dynamic that for me it Would be very important to keep that model updated, right?
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So that it doesn't assume that only three things can happen.
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The fourth thing also can happen is just that we haven't seen it, so don't assume that it's impossible to happen.
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So to the extent that the model is well trained with good data, good and bad, and that somehow it can
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detect when the limits have been reached.
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Right?
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You're asking me a question that I cannot answer with my data.
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I think it will be more useful.
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At the end, as you say, Bob, there's a judgment call from an expert says thumbs up, thumbs down.
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Right?
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It's a four or a five.
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I think that's also valuable.
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But what AI also brings is the capability of data analytics, identifying signals that then an expert can investigate further,
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or maybe even bringing up relationships.
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Between data that a human never saw because the amount of data is so immense that you will never have a chance to answer that particular question.
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So those are also good uses for AI and risk management.
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Well,
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one of the strengths of the twenty twenty- six ISPE Annual Meeting and Expo is bringing together professionals from science, engineering,
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quality, operations, regulatory affairs, technology, you name it.
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Why is this cross- functional collaboration more important than ever, and what unique perspectives can attendees expect to
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gain from these interactions with their fellow attendees?
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Yeah,
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no, it's a great question because I myself benefit from these interactions.
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Right?
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If you go into a room full of different perspectives, experts in design, suppliers, with innovative ideas and
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products, maybe academics that are studying some area in the science, you will never know about these unless you Start connecting, asking questions,
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and understanding the other perspective.
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So regulators also are in the room.
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So it's a great convention of minds to figure out and solve problems.
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And each one has a different perspective, and innovation will happen as soon as you connect the dots, right, and say, wait a minute, I didn't understand the problem from that perspective.
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That's interesting, right?
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And you follow-up after the conference.
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So it's a great place to engage, to build relationships, but also to understand and
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solve problems.
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So it's excellent in that sense.
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I invite everyone to visit the suppliers, the exhibitions.
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Each one of those exhibitions has a solution for a problem out there.
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So it's just a matter of making the connection.
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I've
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been going to the ISPE annual meeting for about thirty five years.
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I hate to admit that.
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And I've always Come away with a number of new ideas, thoughts about how we could do
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things differently.
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For someone considering attending this annual meeting, what conversations, what emerging trends, what breakthrough
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ideas are you most excited about?
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You're familiar with the speakers and their topics.
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Right?
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And what do you hope participants will take back to their organizations after this event?
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Connie?
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Yeah.
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I
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think one of the things that I'm really excited about this year is how broad the session topics are.
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I think there's really something for everyone to take home.
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But if you want to know what I'm personally most looking forward to, it's actually hearing from the patients.
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Every time that I go and I hear these patient testimonials, it really touches me deeply.
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It's an instant reminder of why we're doing all this work.
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And, no matter how many years I've been doing this work, that connection renews my energy, and it, you know, helps me to keep pushing hard to bring these new medicines to
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people who need them.
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So my hope for the participants is that they leave not just with some new knowledge, but with that same sense of renewal.
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Whether it's something that they hear from a patient or something that they see, like some incredible work happening across the industry, that it renews their sense of purpose.
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You
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know, a few, a few years ago I heard a story from the stage, and it was told by a schoolteacher mother
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about her son.
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And the son had a huge brain cancer tumor.
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And it was actually Pfizer, and I think it might have been somebody from your site, Mike Arnold maybe,
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who was actively involved in getting the compassionate use authorization from FDA to take what was pretty Take
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an adult experimental therapy and apply it to this kid who was seven or eight at the time.
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And the mother describes how it really worked.
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And then the kid walked up on stage, and there wasn't a dry eye in the house.
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I don't know.
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Were you there when that was talked about?
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I
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don't remember that exact story, but there's just so many of those things that you see at conferences.
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Amazing stories.
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But even just when your child has a fever and you give them Tylenol and they're feeling better right away, that's amazing too.
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But the story you just shared, Bob, is really good.
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First
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of all, what to take back home is the patient, right?
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Patient centric.
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That's why we do it.
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At the end, if you think about it, there's a patient waiting.
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for this miracle to happen.
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So, hopefully, the conference gives you that sense of purpose that the patient should be always in the room.
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I think the other message could be, that AI is pervasive.
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Even if we don't have a track on AI, you will see presentations on AI because they're applying it in different solutions.
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Some of the most interesting presentations for me is when they try to apply technology and the lessons learned.
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So that could be a good opportunity to find who is applying the technology so that you then can ask questions.
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Was it good or was it bad?
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And, my final message would be maybe to embrace innovation.
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Learn all you can, right?
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Bring it back home.
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Try to use it because these are really tools and ideas that can help you do your job better and
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faster.
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Summary,
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let me go back over those five interconnected tracks.
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The first, breakthrough to bedside, we talked about the discovery process, and then, systems that deliver reliability, how
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we're gonna actually produce the drug, digital data, and decision integrity about how we keep track of all the information,
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people, capability, and the workforce of delivery, how we need to train our workforce, both young, and upskill those
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of us who are old dogs that have difficulty with new tricks.
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And then, governance, risk, and readiness, and how all these new technologies really have to be put together
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in a responsible way with appropriate oversight, and human intervention, review,
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and approval.
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So in summary, I'd like to thank Connie and Jose for their time with us today and for sharing more about what we can look forward to at the twenty- twenty-
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six ISPE Annual Meeting and Expo.
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It takes place, October 18 through the twenty first in Washington, DC.
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Be sure to register.
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Be sure to get your hotel room before they all sell out, and we'll look forward to seeing you there.
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That brings us to the end of another episode of the ISPE podcast, shaping the future of pharma.
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Please be sure to subscribe so that you don't miss future conversations with the innovators, the experts, and the changemakers driving our industry forward.
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On behalf of all of us at ISPE, thank you for listening, and we'll see you next time as we continue to explore the ideas, trends,
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and people shaping the future of pharma.
