Karen Quatromoni, Director of Public Relations at OMG, introduces the podcast series and its focus on the Digital Twin Consortium (DTC). Bill Hoffman, OMG CEO and Chairman, interviews Doug Kiehl, Senior Director at Eli Lilly and co-chair of the DTC's new pharma and regulatory Working Group. Doug discusses his 30-year tenure at Eli Lilly, the formation of the Disruptive/Transformative Technologies team, and the drivers for digital twin technology in pharma, including industry trajectory and regulatory expectations. He highlights the importance of cross-industry collaboration and the potential of digital twins in manufacturing, compliance, and process validation, emphasizing their role in expediting product development and improving patient outcomes.

Action Items

• [ ] Attract other pharmaceutical companies to join the Digital Twin Consortium and contribute to working group efforts.
• [ ] Develop a charter and focus areas for the Pharma and Regulatory Working Group.
• [ ] Explore applications of digital twins across the pharmaceutical product development and manufacturing lifecycle.

Outline

Introduction and Welcome

• Karen Quatromoni introduces herself as the Director of Public Relations for Object Management Group (OMG) and welcomes Bill Hoffman and Doug Kiehl to the OMG podcast series.
• Karen highlights OMG's role in driving industry standards and building tech communities, and introduces the focus on the Digital Twin Consortium (DTC).
• Bill Hoffman introduces Doug Kiehl, Senior Director at Eli Lilly and Company's Disruptive/Transformative Team and Digital Twin Center of Excellence, and chair of the DTC's new pharma and regulatory Working Group.
• Doug Kiehl thanks Karen and Bill for the introduction and expresses his gratitude for organizing the podcast.

Doug Kiehl's Background and Role at Eli Lilly

• Doug Kiehl shares his 30-year tenure at Eli Lilly, his experience in product development, and his roles in various capacities with government and private industry.
• He mentions his background as a mass spectrometrist and analytical chemist, and his role in forming the Disruptive/Transformative Technologies team at Eli Lilly.
• Doug explains the two main drivers for forming the Disruptive/Transformative Technologies team: industry trajectory and regulatory expectations.
• He highlights his involvement with the Product Quality Research Institute (PQRI) and his role as the chair for the PQRI steering committee, which includes FDA and Health Canada stakeholders.

Formation of the Disruptive/Transformative Technologies Team

• Doug discusses the formation of the Disruptive/Transformative Technologies team one year ago, driven by the need for digital transformation in the pharmaceutical industry.
• He emphasizes the importance of cross-collaborative partnerships, mentioning his liaison with various industries, including defense, Air Force Research Labs, Army Research Labs, and NASA.
• Doug expresses his satisfaction with the Digital Twin Consortium for enabling access to these partnerships and advancing their goals.
• Bill Hoffman acknowledges Doug's impressive background and the strong connection between different industries applying digital twin technology.

Charter and Importance of Digital Twins in Pharma

• Doug outlines the charter of the new working group, focusing on attracting other pharmaceutical companies to join the Digital Twin Consortium.
• He highlights the broad application of digital twin technology throughout the pharmaceutical product development and manufacturing life cycle, including supply chain and post-launch life cycle management.
• Doug mentions the importance of modeling clinical trials to minimize human intervention and expedite decision-making using readily accessible data.
• He expresses his enthusiasm for the working group's potential to achieve substantial milestones and bring forward goals aligned with each company's digital transformation roadmap.

Manufacturing and Regulatory Compliance

• Bill Hoffman inquires about the significance of manufacturing as a major application for digital twins in pharmaceuticals.
• Doug explains the regulatory perspective, mentioning the FDA's partnership with PQRI and the publication of a white paper on AI in advanced manufacturing.
• He discusses the prioritization of manufacturing, supply chain, and point-of-care manufacturing by the FDA, emphasizing the importance of developing standards and guidance.
• Doug highlights the role of digital twins in making manufacturing processes more consistent and robust, particularly in distributed, continuous, and agile manufacturing.

Compliance and Process Validation

• Bill Hoffman asks about the role of digital twins in ensuring compliance.
• Doug clarifies that digital twins can help achieve process validation in a virtual environment, reducing the need for physical product demonstrations.
• He explains the potential cost savings and sustainability benefits of using digital twins for process validation, which can expedite the production of life-saving or life-improving medicines.
• Doug emphasizes the importance of digital twins in meeting regulatory expectations and improving overall industry efficiency.

Challenges and Future Outlook

• Doug discusses the challenges of introducing new technology and the importance of education and collaboration.
• He mentions the need for critical mass and the value of showing examples of successful implementation by other companies.
• Doug highlights the role of the Digital Twin Consortium and OMG in providing tools and resources to help bring digital twin technology forward.
• He reflects on the progress made in the past year and the importance of continued collaboration and education to drive adoption and success.

Conclusion and Final Thoughts

• Bill Hoffman and Doug Kiehl discuss the potential impact of digital twins on the pharmaceutical industry and the broader benefits for patients and society.
• Doug emphasizes the importance of passion and commitment in driving innovation and collaboration within the industry.
• Karen Quatromoni thanks Doug for his insights and concludes the podcast, encouraging listeners to learn more about digital twins and their potential impact.
• The podcast ends with a reminder of the benefits of joining the Digital Twin Consortium and the importance of collaboration in driving digital transformation.

SUMMARY KEYWORDS

twin, digital, eli lilly, manufacturing, fda, industry, dtc, doug, pharma, process, absolutely, consortium, other industries, consortia, bringing, partners, omg, company, pharma industry, formed

00:08

Karen, hello. My name is Karen Quatromoni. I'm the Director of Public Relations for Object Management Group, aka OMG. Welcome to our OMG podcast series at OMG. We're known for driving industry standards and building tech communities. Today we're focusing on the digital twin consortium DTC, which drives awareness and accelerates the adoption and development of digital twin enabling technology. We're here today with OMG CEO and Chairman Bill Hoffman, who will lead today's podcast. Hey,

00:51

thanks, Karen. Today we're speaking with Doug Kiehl. Doug's the Senior Director of Eli Lilly and company's disruptive slash transformative team and digital twin Center of Excellence. Doug is chairing the DTCs new pharma and regulatory Working Group. Welcome, Doug.

01:06

Hey. Thank you so much bill. And thank you so much Karen for the very kind introduction and for organizing today. Yeah,

01:12

yeah. So Doug, I got a few questions for you. First one, could you tell us a little bit about yourself and your experience with digital twin technology at Eli Lilly, and why your company joined the digital twin consortia?

01:23

Absolutely. So just to keep it brief, I've, I've been in, actually been at Eli Lilly. This my 30th year. I'm in product development. I had actually worked with other industries. I've worked with DOE, with DOD and EPA, in different capacities, prior to coming with Lily. So I do have both government and private industry, experience in various capacities, but at Lilly and through, through all of my career, I'm actually a mass spectrometrist, analytical chemist, and I do structure elucidation for impurities, but with some of the restructuring that occurred here at our company, and kind of looking for the trajectory of industry and where we need to be in the future, and kind of mapping that out, I formed the disruptive transformative technologies team, and it's been, actually one year since last March, since this team was formed. But really the there were two drivers for forming this team, and it was one is industry trajectory, the pharma industry, which is in some ways playing catch up with other industries in digital transformation, and we can talk about that a more a lot of that is because we're highly regulated industry. So change management, lifecycle management, is a challenge, and then the other driver is, is regulatory expectations. So FDA and other health authorities, and I lead teams externally, product quality research institute, PQRI. I'm actually a chair for the steering committee for PQRI, which has FDA and Health Canada stakeholders, as well as other consortia where we look at the industry landscape and look at where standards and guidance in areas that are rapidly developing and innovating need to be developed and implemented. And so those are really the drivers for forming my team. And you know, there are a lot of other aspects here. One thing I did want to emphasize bill as well and Karen, is that I talk a lot about cross collaborative partnerships, and that is relevant here, because often in pharma, we are trying to invent a wheel, which has been not only invented, but perfected in other industries. And so I liaise with defense. I liaise with Air Force Research Labs, sometimes with Army Research Labs. We have some liaise with NASA. Certainly we look towards the, you know, aviation, aerospace, automotive industry, other industries, which actually digital twin Consortium. I was very pleased when we joined to see that a lot of these access to a lot of these other industries to accomplish this goal was was really at my fingertips. So I was, I was thrilled that this is something that is enabled by DTC as well. So I'll stop right there. Gives a little bit of background about I got here.

03:57

That's great. You have a very impressive background, and we're delighted to have you chairing the co chair of the DTC pharma regulatory group. You know, there's, there's a there is a strong connection between all these, all these different industries trying to apply digital twin. And that's one of the reasons why the consortia, I think, has been so successful, is that we're able to bring in people from all these different disciplines, have them be able to work together under a IPR policy that allows freedom to be able to work together. And off we go, and we're going to solve some great problems here. Can you tell me what the charter is on the on the new working group? And you know why digital twin are so important to pharmaceutical companies?

04:37

Absolutely. Thank you so much. And instead of, you know, just reading off the charter. What I'll tell you is what the charter is about and meant to accomplish, conceptually and practically, which is, well, first of all, we're Lily is very proud to be, you know, kind of one of the, you know, kind of leading the industry and joining, or actually leading the industry and joining digital twin consortium. And what I'm very much wanting to do is pay. The way and attract other pharma, Big Pharma, small and mid sized pharma, as they look forward to new modalities, new therapies. You know, new ways to make and innovate medicines and manufacture and attract, you know, other partners into the consortium and pool our resources and pool our interests and our innovative you know, trajectory and capacity to really collaborate on on, you know, accomplishing our goals together. So that's, that's a big part of the big part of the charter. But the charter, more in more granular sense, also looks at, you know, some of the discrete areas product development, looking at some of the aspects of discovery, since digital twin technology applies, you know, very broadly through, throughout the pharma product development and manufacturing life cycle, including supply chain, including, you know, post launch life cycle management issues. So they're including clinical, you know, clinical supply looking at, maybe modeling clinical trials to minimize human intervention and those and use data that's readily accessible as much as possible to expedite decision making. So these are, these are some of the areas. And again, we've got some more discrete areas that we would be looking at. And certainly, as this, as this working group grows, and very much look forward to people partnering in this and coming up with directions that will result in substantial milestones that we can achieve together, but that will actually bring, you, know, bring forward goals that each of our companies are intending to accomplish in our digital digital transformation roadmaps. Wow, these

06:37

are exciting times. It's really impressive how far this stuff has come in a relatively short period. I'm assuming that manufacturing is one of the big application for digital twin and pharma. Is that correct?

06:48

Bill, that's absolutely right. And one of the reasons for that is, again, going back to the drivers, as FDA is looking and again, the organization that I'm sharing, PKR, I has partnered with FDA, and most recently, last September, FDA and PQRI partnered to put together a and hold a two day workshop on AI in advanced manufacturing. And FDA has actually published a white paper on this to garner stakeholder engagement, because this is an area they realize that we need to start developing standards and guidance and typically, prioritization in the pharma industry with efforts like this is higher as we're closer to the patient. So manufacturing, supply chain, these things are closer to the patient. Manufacturing in the regulated environment, sense, you know, when we're looking at GMP constraints, not constraints, but GMP framework and so on. Really, really guide this and so. So you know, the areas that FDA is really prioritizing industry to start looking towards our distributed manufacturing, continuous manufacturing, agile manufacturing, is subset of that. But then also point of care manufacturing, which is very exciting because that's either at the compounding pharmacy, or, ultimately, at the patient's home, where they would actually be able to additive print a dosage form, or even a device, digital twin. Can, you can really see where digital twin can play a role in making this more consistent and a more, you know, robust process as well. So that's, you know, some, some of the vision that we see this going but why? Why manufacturing is really being prioritized? That's really it's because the regulatory perspective is really looking at that first and moving upstream from there. Sure,

08:29

and you've mentioned the FDA several times now, so clearly, you know, compliance is a big issue. Here are digital twins going to help.

08:36

ou know, just it can be worth: 1000

10:51

going to help patients. So I mean, it's not not only good for Eli Lilly, but this is good for the industry, and frankly, it's good for the final consumer.

10:59

Absolutely, absolutely. So again, you know, the point I was making about expeditious completion of a validation of a process means more expeditious production of a of a life saving or, you know, a life improving medicine,

11:12

and that's great, and that's one of the nice things I like about working with the digital twin consortia, is that we're seeing ways where what we're doing here is helping. It's going to make, it's going to make fundamental changes, yes for Eli Lilly and yes for manufacturing in general, but it will benefit the ultimate consumer and society. And I think that's a that's a that's a great way to spend your day. It

11:34

certainly is now now bill that's not without, you know, as with any new technology. So, so I like a phrase that a colleague of mine who's worked at the University of Montana, has said before, you know, because when you're bringing in a new technology, that you know that your, your maybe your management framework, or your, you know, your your industry is not that familiar with. He said, The plight of the innovator is loneliness. So you know, and I think that's happening. I think that's a great phrase, because, you know, you you are out on the edge and some education. So, you know, in our case, we here in DTC, we understand digital twins, so we're all speaking the same language, but you go somewhere else. And people are looking at this as you know, how is this different from a model based system engineering model or a typical modeling simulation? So that, you know, there's a significant amount of education that occurs. But I see this working group and the DTC overall, and, of course, the network you have within Mo, OMG, excuse me, which is which has a lot of access to different aspects of the entire digital transformation, you know, roadmap this, this really helps provide the tools for those involved with this and trying to bring this forward, you know, to to explain this and and really get the buy in, and, you know, really indicate the the compliance impact and also the productivity impact to to those that would be ultimately making those decisions. Yeah, that's

12:53

great. What happens in five years?

12:56

Well, in five years, that one, okay, Bill, I'm gonna say, right now, in my world, I'm, I'm looking at what's happening in five days, or even five

13:04

years, an awful long region early technology, like where we are today. Look, look back

13:10

five months, you know. And I told folks here when I was bringing, when I formed this group, even just a year ago, and you understand this well, bringing digital twin forward, where a lot of people are saying, you know, I don't even know what that is. And I now, I or pharma 4.0 which we're using as a roadmap, you know, and or even the term digital transformation. Now, a lot of the folks who had really kind of been skeptical, I'm saying, hey, you know, go, got go back and Google all these terms now and see how many more hits you have. Yeah, they're amazed, amazed by that. So, yeah, sure, there's a confirmation there.

13:40

Sure, it took us, I think, four months when we set up the group to get the definition of what a digital twin was. And that's actually pretty quick

13:49

by some standards, if you're working in my intro, even with government. Yeah, true enough.

13:53

True. That's super quick. But that's interesting, though, you know, and I know that not everybody's as far as long as Eli Lilly and Company. But you know, what do you suggest people do if they want to get started? I mean, obviously they should join the Digital Twin Consortium.

14:08

Yeah, absolutely. I think, I think communication, I think collaboration, I think having critical mass in bringing this forward is, is, is key. So actually, agree, you know, it's one of those. And I'll give you a good, very good example. And I think we're similar to a lot of other companies in the industry, and I understand this very well. This isn't a criticism. But, you know, if you bring something new forward, you know, sometimes you may have those that make those decisions at a very high level, say, Hey, listen, Doug, you know, or, you know, whoever you are, bringing this forward, I hear what you're saying. I kind of see what you're the advantage you you're, you know, you've explained it. I see it on a slide, but if you can show me where you know this other company, or this other company, or this other company I've implemented already, and it's already working, then you know, that's, that's an easier, that's an easier buy in for me. But if, if we're way out on the front, and we're, you know, not only you know, being the first in the pool, but we're actually building the pool that you know. That we're gonna be lonely road. Doug, it's a lonely road. But I but if you're committed and you're passionate about it, and you find others that are, you know, from other partner companies in your industry who are also passionate about it, I think that is, you know, that kind of, that kind of, is the spark that lights the fire that becomes, you know, the bonfire that brings you forward.

15:20

Thank you so much, Bill. And also thank you, Doug, for this wonderful podcast. We were just talking with Doug Kiehl, who is the co-chair of our new pharma and regulatory working group the digital twin consortium. And we hope that you learned a lot about how digital twins will make a difference in this industry. Thank you. You're listening to the Industrial Talk Podcast Network. Thank.