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Service Provider Executive Series #11: Kevin Morgan - Glemser
53 Plays11 days ago
In today’s episode, host Steve Gens is joined by Kevin Morgan (Chief Growth Officer of Glemser). Together, they discuss Glemser’s current focus, differentiating in the clinical space, and what to expect from Glemser in the coming years.
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Transcript
Introduction and Welcome
00:00:07
Speaker
Welcome to the Gens and Associates Regulatory Executive Podcast Series, where we explore innovation in the regulatory space. This is Steve Gens, Managing Partner, and today I'm happy to be speaking with Kevin Morgan, CEO of Glemser.
00:00:21
Speaker
So welcome, Kevin, and I've been looking forward to this. Certainly, I've known the Glemser team over many, many decades and watch the many evolutions which we'll explore today. So before we get started, if you could introduce yourself and the company quickly for our listeners.
00:00:39
Speaker
Great. Well, thank you very much, Steve. Kevin Morgan, Glemser Technologies. I'm the CEO, and I've been working with Ray Glemser for the last six years as we've automated and improved regulatory compliance.
00:00:53
Speaker
Thanks,
Evolution and Modernization of Glemser
00:00:54
Speaker
Kevin. And the ah first area I like to explore is really the evolution of Glemser. And I know in our prep for this podcast, I thought that it was incorporated in the 90s, and you corrected me. It was much earlier. But any successful company that's 20, 30 years old, there's many turns of technology. Things come and go. There's fads.
00:01:16
Speaker
But there's always consistency and in successful companies. So... So I've watched the evolution of Glemser over the last 25 years. In the early days, it did a lot of customization and documentum. It was all about the content management space, the ECTD. You guys have always been in the labeling capabilities, you know, and even...
00:01:36
Speaker
Unfortunately, with the failed PIM initiative with EMA, you've always had a labeling capability. And certainly in the last two or three years, just the acceleration of a fundamental change in the authoring paradigm and the transition of regulatory into fully embracing, because I think people say documents to data, it's really embracing the data from the documents that So I think it'd be great for our listeners to bring us up to date to where what Glemser is doing today, and then we'll take it from there.
00:02:07
Speaker
Yeah, thanks, Steve. And you're correct, Dr. Ray Glemzer has been in business for decades. And Ray and I have known each other since the early 2000 timeframe. And really, we've modernized using newer technologies and methods to be able to bring forth a software product called Compliance Author AI.
00:02:27
Speaker
And really, we have four versions of that today. We have a clinical labeling solution to help clients with phrase libraries, so We've had implementations where we've taken workflows from 40 days down to four.
00:02:40
Speaker
We've got global labeling, as you mentioned, as one of our key products and being able to help our clients with those, specifically with outputs, things to be able to drive the new EPI standards, both FHIR and PharmaLedger.
00:02:53
Speaker
We've also moved and have product quality chemistry manufacturing controls where we have large clients using our system to handle test specifications, analytical methods, really bringing the data in a controlled, compliant manner forward and taking that to be able to look at raw materials all the way through finished goods.
00:03:13
Speaker
And the last thing we offer for our smaller and mid-sized clients is the ability to have these conversion services on demand.
Focus on Labeling and Lifecycle Management
00:03:20
Speaker
So between the four things, we've modernized the approach and we've really made a difference to help with quality, content, and compliance for our clients.
00:03:29
Speaker
Yeah, thanks for that update. And I always enjoyed speaking with Ray at the RSIDM show, the DIA. And the one thing I want to highlight, because we're seeing it just in the last three to four months, that there is there's always been a focus on labeling and regulatory and just the complexity with lifecycle management with labeling.
00:03:48
Speaker
But it's the CMC area. i mean, we're doing a briefing on CMC and AI tomorrow for one of our members. It's just such a growing focus. You have PQCMC, et cetera, et cetera. So a big area of opportunity.
00:04:02
Speaker
The one thing I wanted to, I was really curious about is, and and some of this is we just finished up some client work this spring where one of our clients was, like many, wanted to go through kind of the vendor evaluation. Who should we bring in for a pilot?
00:04:17
Speaker
And they're like, should we just focus on structured content? Should it be generative AI? Should it be both? And it's the first time Greg and I have ah done what I would say a very meaningful analysis of all the niche providers. And some of them have just incorporated in the last two or three years. So there's a lot of them you know that are serving regulatory, clinical, the safety documents. But What I want to focus on is Glemser has been around for decades and has been consistent.
00:04:45
Speaker
And also, there's a lot of these new niche providers on the whole authoring paradigm change. So how is Glemser differentiating itself? And what is the value that Glemser customers are receiving? You already had mentioned, and maybe you can say a little bit more about that use case going from 40 days to four. That's very impressive. But that's some of the stuff we're starting to see with generative AI,
00:05:08
Speaker
combined with structured content authoring and the translation software too. It's kind of you put those three together and if you do it right, it's substantial.
Glemser's Differentiators and Client Stories
00:05:16
Speaker
Yeah, definitely, Steve. So Clemser is really solving clients in a trusted manner.
00:05:22
Speaker
And what we have is opportunities to talk to real use cases that we've been helping our clients. One of those is GSK. We're having a webinar on September 10th talking about how we're using phrase libraries and clinical labeling to support trials.
00:05:37
Speaker
And that's a very important part. But if we were to take it to the three areas where our clients are looking to do more with less, What we're really seeing is the input, unstructured content, structured content, PDF, Word files, data-driven information, table lists, and graph.
00:05:55
Speaker
And really, we've spent a lot of time bringing in SMPCs, core data sheets, and other industry examples that to be able to do that in an automated fashion with the human in the loop. by able to help By helping our clients with the data and the information, it makes a difference.
00:06:11
Speaker
In the processing area, what we really have is the workflows and approvals to be able to make a difference for our clients. And those are all done through configuration. One of the big things that the market has told us is they want a system that's easy to use, easy to manage, and easy to operate.
00:06:28
Speaker
So that's one of the parts in terms of that. The last part is on our outputs. What we've done is we've really used one system to be able to provide omni-channel or many outputs.
00:06:39
Speaker
So whether it's EPI for FHIR, PharmaLedger, SPL, SPM, we all have that coming out of one publishing engine. And it also is a single source of truth. So no matter what you have today for your content management, we're able to publish that in a compliant manner.
00:06:56
Speaker
Really, when you add that all together, it's an end-to-end solution, not just a point solution, brought to you by Proven Technologies. So I want to actually explore this a little bit further. You've mentioned a few things that are really, really interesting and just one reaction on every client we've worked with. If we're going through the software vendor analysis, they always want a system that's easy to use, manage,
00:07:22
Speaker
and operate it. I think part of it is we're in the cell phone world when the smartphones came out 10 or 15 and updates are happening in the background, all this really kind of cool stuff. They expect that from their systems of records. And I think some companies that have been around for a while, it's it's all about ease to use and any new system that you put out there.
00:07:43
Speaker
Some of the biggest challenges are in user adoption. So it really gets into that ease of use. And we always say, especially, you know, like in regulatory, In the local affiliate offices, so maybe there's some labeling work in the local affiliate offices, you know, the deviations, et cetera, et cetera.
00:08:01
Speaker
They are infrequent users. They're not using it every day. It's harder for them. So the the focus on easy to use, easy to manage, easy to operate is really important.
00:08:12
Speaker
So is there any others, and i'm I'm curious about the CMC area as you guys are working more in that, is there any preliminary customer stories there or pilots that you guys are working at that you might share with our listeners? so Oh, absolutely. So on the easy to use, one of the things the market research proved was that Microsoft Word is the most common editor.
00:08:34
Speaker
So what we have is a Microsoft Word plugin where we get all of the XML and all of the structure for data-driven and client-driven documents. with a very easy to use Microsoft Word interface.
00:08:45
Speaker
So globally, people can roll out the system with very little training as everyone is using that technology. On the second part of the question in terms of what is going on with PQCMC, we've been using this system for over a decade.
00:09:01
Speaker
And what has happened is the client has taken in all their raw materials, test specification, analytical procedures, and really all of the data-driven document and all of the data information combined into documents to put into one system for audit and capabilities to test all their methods and analytical procedures.
00:09:22
Speaker
And as you look to the future of where people are going, data-driven is gonna be the next wave as you pass by the documents. So we really call that controlled compliant components in a manner that is coming from a single source of truth in a tested environment. So our end-to-end approach is what clients really appreciate the most.
Publishing Strategies and Efficiency
00:09:43
Speaker
We have a large German pharmaceutical client that uses this system across four major plants on a global basis and has had that in operation for the last few years.
00:09:55
Speaker
Yeah, that's certainly ah very impressive. And I like the other term controlled components because we always think about GXP and controlled documents. But if you control those components and as you're putting it together for different expressions or where used, you know, the infamous where used and regulatory components,
00:10:12
Speaker
That's a very powerful combination. Now, the other thing that interested on this is with, if we think about historic submission content management systems. So is this something where your solution or your capability tools interacts, say, with a document-based, a Viva-based document management systems? And so that that's kind of point one.
00:10:36
Speaker
In point two, what Greg and I are seeing is that, and what we believe, we're not sure, and with our fall research, we're exploring this a lot more with our regulatory operational excellence study that we're doing, is a lot of companies, especially the mid-tier and the larger, are investing in what we call DAPs, the platforms where you're pulling data from different functional systems. So we're pulling regulatory data, clinical data, maybe safety data, some labeling data, and people call it a data warehouse, you know, a data lake, a data fabric, and we call those DAPs, data aggregation platforms.
00:11:12
Speaker
So the belief in what we're seeing, what the data is telling us is that these transactional systems could be going to the background, you know, where the forefront is the DAP and what we would say the place where you play. These kind of innovative tool sets that are getting a lot of the innovation and getting a lot of the benefits. But...
00:11:32
Speaker
ah Your background technology for content could be Viva, could be Documentum, just like SAP is becoming more of a background technology. So I'm just curious that it sounds like you you work with the Vivas, the Documentums of the world, but probably the work and process is actually in your capability.
00:11:51
Speaker
Steve, that's a great question. And we see that with all of our large clients, even our mid-tier. And you're correct that what we have is a concept called an agency-neutral approach.
00:12:02
Speaker
And so what we do with our agency-neutral component is we actually use that to be the aggregator, depending upon regions, countries, or combinations of the business.
00:12:13
Speaker
As well, our clients have been affected by a lot of merger acquisition and divestitures. So they want a system that can actually have an agency neutral approach. And the combination of that, along with an omni-channel publishing, so we know where it's published, to who, at what time,
00:12:30
Speaker
under what implementation guide of all the combinations of the information, really gives us a leg up. This is one of the things that our clients are most impressed with when they look at our system is the combination of an agency-neutral approach for regulatory and the ability to do the omni-publishing in regions for maintenance upgrades and other activities that they use the system
AI Innovations and Future Directions
00:12:54
Speaker
for.
00:12:54
Speaker
And that's really where the efficiencies of time, quality and cost start to come out, you know, as they're making the updates, changes and modifications. Yeah, excellent on that. And I think just to wrap this up before we get into the last part of our conversation is, and as we talk with clients, it's just a different way of saying this, that historically, the focus has been on system-to-system connectivity, where we really see it's the information connectivity, irregardless of where the information and what kind of legacy or transactional system
00:13:28
Speaker
And I think the thing I'm learning from this conversation, you could probably even take it further to the component level connectivity in different areas, because we could imagine a world in five or seven years where an author is authoring over a data mesh or data fabric.
00:13:45
Speaker
You know, with the different pieces, you had mentioned the TLCs and different aspects that you're pulling or the AIs pulling the first draft together. So it's it's just haven't seen in the last 25 years, there's been technologies come and go, but this is some pretty dramatic change. And and we're, as I always say, we're in the early days.
00:14:04
Speaker
So with that said, it's an exciting new world. There's a lot of competitors out there, but Glensar has been very stable over the last 30 years, adding value to your different customers, no matter what technology fad is, or I think in this case, this is a tectonic ship with AI.
00:14:20
Speaker
So what should we expect from Glensar, both in the ah short term, maybe over the next year and longer term over the next three to four years? Yeah, fantastic question. And certainly on the short term, we see further innovation around things like Genitive AI.
00:14:34
Speaker
First draft, first draft with the human in the loop, first draft with suggestions are all things that we do. We also put in the regulatory information to make sure that simply use color coded, easy to understand what needs to go by the sections and the way that the information flows.
00:14:53
Speaker
So we've really continued to make a lot of progress in what I'll call that part of the machine learning and the natural language processing. We're also doing things very much in the area of similarity models, where depending upon the company and the regions,
00:15:09
Speaker
You know, it's kind of the same set of either phrases or concepts that are coming together that they want to look at. Things like SOPs and modernizing those are another area that clients are looking at using this technology for.
00:15:22
Speaker
So short term, we think there's an awful lot of opportunity with the tools that are coming through. We're also doing quite a bit with the automation. RESTful APIs are stable and strong. We can go against many sources of information, like you mentioned earlier, all the different things.
00:15:39
Speaker
and pulling that all together into a trusted workflow and into something that has the full audit trail. And so as clients are looking at that, what their short term is, we want to be able to do more with fewer people, but then we see the future of these controlled compliant components and what that vision can do for us as it's data-driven components moving forward.
00:16:00
Speaker
Yeah, I just want to highlight, because I haven't heard this in a while as far as the technology use case, but modernizing SOPs. I remember we had a project, it had to be six or seven years ago, and ah unfortunately, one of our top process analysts how to read all the SOPs in regulatory and anybody that has to do that. It's a burdensome task, but just that eye for detail really, really important. And they were looking for inconsistency. So kind of what you're suggesting is, and it makes complete sense that it can ingest everything. it can highlight discrepancies and
00:16:37
Speaker
Instead of maybe that would take an analyst couple of weeks to do, probably is done in a couple of hours. Then the analyst you know spends what they're really being paid for about, well, what are the changes? These are all the suggestions. What are we going to go ahead and just clean this all up?
Closing Remarks
00:16:52
Speaker
We're reducing risk, compliance risk, et cetera, et cetera. So, um yeah, that's the first time I've heard that. And maybe ah we're probably days away, Kevin, from locking our fall study. And in the question that we go through use cases, maybe we should slip that in, you know, SOP modernization to see who's trying to tackle that.
00:17:12
Speaker
Yeah, Steve, it's right on with the content, the context and the similarities. are really the combination. yeah And so when you think about the challenge, you know, someone sitting there with a highlighter, we can actually do all that in an automated fashion.
00:17:26
Speaker
So what you can really work off is the variances and then being able to combine those. Big time saver for our clients. Yeah, and I would imagine you could also apply that from a compliance to the labels at the local level to just make sure you're not out of compliance because that's an area I think any head of regulatory keeps them up at night or all my labels in compliance with what's product, what's being shipped.
00:17:49
Speaker
Absolutely. So um thanks for the time. This has been great to get ah update on Glemser. And, you know, it's I think for our listeners appreciating the history of Glemser, but what you guys are focusing on today, which is a very hot area.
00:18:05
Speaker
So best wishes for that. And typically when we end these podcasts, is there a way for our listeners to get a hold of you personally or maybe Glemser generally if they want to follow up on any of our conversations with you?
00:18:17
Speaker
Yeah, absolutely, Steve. I can be reached at kevin.morganatglemzer.com. You can also visit our website and send in an inquiry and find case studies for all the stuff that we're talking about today.
00:18:29
Speaker
And really know that we're a trusted supplier. Our say-do ratio has kept us at the forefront of our clients for many years. So as we really work well with the client to help understand their situation, we certainly are excited about this next era of modernization.
00:18:47
Speaker
So thanks to you and all that you do for the industry to bring forward these kinds of topics. I appreciate that. And I know our listeners just go to our website and our contact page or Steve Gens in LinkedIn. That's the quickest way to get a hold of us. so So certainly next summer we'll revisit. Again, this this area is moving quickly. I'm actually just marking on my calendar that webinar you mentioned with ah GSK. It's always nice to see real tangible results and how, you know, you partner with Glemser and GSK because it's a lot more than the technology. There's the process, the human side of it, and it's a partnership, you know, when you're together with your clients. I certainly appreciate the ah time and and thanks for joining us today, Kevin.
00:19:35
Speaker
Thank you, Steve.