DCL Learning Series

Marion Sicre

Good morning or good afternoon, everyone, and welcome to today's webinar, "The Impact of Technology on the Future of Regulatory Content Management." Today our speakers, David, Regina, and Simon, will present actions pharma companies can take to prepare for structured content management. Just to let you know that at the end of the presentation, we will host a short Q&A session, so if you have questions during the presentation, please submit them into the question panel of the livestream. Also to mention to everyone, the Esko presentation is being recorded and will be sent to all registrants within the next 24 hours. So without further ado, I would like to introduce you to today's subject matter experts, David, Simon and Regina. And let's start with you, David, if you can take it away.

David Turner

All right, thank you so much, Marion, and welcome, everybody. Today we're talking about the impact of technology, and if there's one thing that new technology tends to do, it is make an impact. It doesn't always cause that change right away, but you can count on it to make an impact. In fact what it usually does is it usually causes fear, so I think about all of the dystopian articles and discussion about ChatGPT lately; we've seen all these things about it taking our jobs and changing everything, and usually that's not actually the case. I think the truth is that many of us have an aversion to change, whether that change comes in technology or process or whatever, but we have an aversion to change and I think we've seen that in the realm of structured content management technology as it relates to to regulatory.

But the good news is there is hope. So I think about, in the 1980s, we think about the advent of the PC. I like to watch old movies, and if you watch old movies and TV and in the 1960s and 1970s, you don't see any computers on the desks, right, but we adapted to that change, and today, personal computer use in an office environment is is pervasive. Everybody uses a computer. Or think about the internet. I guess I'm gonna give away my age here, but my career started about the same time as the internet was was taking off, and I can remember working for a company where if I needed to go and get some information, I would browse Netscape, but not on my computer at my desk. I actually had to go to a special computer lab where there was a dial-up modem so that I could then get on, open up this thing called Netscape, and try to find information, and you contrast that to today. Today, I can't go more than about 10 minutes without doing something connected to the internet.

I can remember my family, I won't give away who in my family, but someone's saying to me “I'm just not sure there's anything out there on the internet that's worth searching for.” But yeah, obviously today that's changed. Another example: I think about the advent of the online meeting. How often did you have a Zoom meeting or a Teams meeting back in 2015? So we can't imagine our lives without these kinds of technologies, but here's an interesting thought: it wasn't simply the availability of the technology that caused that change to the way we do business. I mean, we had computers before the 1980s; we had internet before the 1990s. I personally had a Zoom account in 2013.

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So what is it that actually causes technology to to make a change? I would propose that they're actually two other things: the first thing is you've got to have a compelling reason to use the technology. It could be that everybody else, it's simply that everybody else is starting to use that technology, it could be that the benefits just simply start to outweigh the alternatives, or it could be something more, larger or more tangible, like a global pandemic that drives everybody to work from home. And then I think the second thing that you've got to have is you've got to have the infrastructure. You've got to have the infrastructure and the tools around it so that it becomes easy. I think a lot of people, for example, believe in moving to the idea of an electric vehicle. That'd be a positive thing, but one of the primary factors that is often noted in the media is that most people haven't made the move, in part because they feel like the infrastructure is not quite there yet. In some parts of the country it's further along than others, but it just overwhelmingly is not there.

Or I think about MP3s: we could have moved to MP3s from CDs long before we did, but it took the advent of the iPod, and more importantly, the creation of the iTunes Store before most of us made that kind of a move. So in any case, we're going to talk about that today; we're going to talk about the impact specifically around the realm of structured content management, because structured content management is coming to pharma, and I think for the first time we got our compelling reasons, and there have been the huge advances in infrastructure and tools. So we've set up our presentation to kind of hit on those two things. And with that, I'm going to let Regina take away this first section. The great Regina Lynn Preciado from Content Rules. She's going to talk about strategies towards digital transformation and some of those compelling reasons why we're starting to see SCM change the way that we do business in regulatory. So, Regina, take it away.

Regina Lynn Preciado

All right, thank you, David, and for the walk through memory lane. I have the modem sound, connection sounds playing in my head. So today a lot of regulatory content in life sciences is of course digital, but it's not, really. We're still operating on a very print/publishing paradigm; we are working in word processing documents, typically Microsoft Word. The way we – I want to say reuse information, but that's not what I mean – the way we get information from one place to another place where we need it is often having medical writers copy the content from somewhere, paste that content into their word processing document, and then tweak it – so, copy edit it, or add an image, or add another paragraph or something. So this style of creating, or this tradition of creating documents in this way, is slow, even though it may feel faster than handwriting it on notepads. It is slow. You end up with a lot of redundant content and redundant data throughout a body of work created over a period of years. This method is also risky because, as we all know, it's very easy to copy and miss the last word, or the first sentence, or the last letter, or one digit of a very important number, or one cell of a table. You get the point. So when we have this world that's document-based, with copying and pasting manually by humans, that takes time; it adds risk. The last thing I'll say about the risk is when you need to update the content or the information in some way, people have to go through this whole set of files and search and comb and read through to find:

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Where is that information? It may have been tweaked or edited so much that my search terms aren't finding it in this document like they did in that document, and you run the risk of not finding every area where you need the updates, the content, and then that takes a lot of time. So when we look at the digital transformation of regulatory content, having the biggest foundational piece to get your mind around is to think more granularly, think in smaller pieces of information, which we typically call components. Now, I was just at a DIA conference where people talked about modular content and content modules. That's the same thing as a component, a single unit of information that explains one idea or provides one set of data rather than the full document that kind of wraps around or assembles the components. And you can see on the picture here, what we like to think about is having a library or a repository of components of information that can then be assembled into our more traditional format of documents.

But they're also available for other types of content delivery and content assembly, so if you needed to send just a summary piece of information somewhere, you can pull out that component, send it to its destination, and it doesn't have to be assembled and compiled and formatted into a document. So, really, when we think about digital transformation for regulatory content, we are getting a lot closer to treating our our prose and our narrative information like data. So just to highlight some of the reasons for this industry to really be looking at a digital transformation towards components is, with components we can get single source of truth. It is a – each component is a single source of truth for that information. So instead of having human beings manually copying and pasting, we can have our systems find that component, pull that component into our document or deliver it to another department or deliver it to a health authority, all on its own if needed, but the value here is that we're not copy-paste-and-change and copy-paste-and-change and copy-paste-and-change, and now we've lost track of all of that information and where it is and what it looks like, because we have the one building block, if you will, of content that is the single source of truth. You can update it and make that update available wherever it is published rather than these manual slow and risky processes.

So in a companion to that single source of truth, we can automate a lot of the repetitive manual tasks that humans are doing today. Formatting is really big; we've seen a survey recently that said it takes about 14 hours to format a document for scientific publishing. We have seen surveys in the past that say approximately 20 to 25 percent of an author's time is spent on formatting. The better you have templates and the better you have tools to help with formatting, maybe that time it's not quite that huge of a time sink, but everybody who was taught with a table or nesting a bullet list in a word processing document knows what I'm talking about. So when we go to components, we open up this world of automating the assembly of our documents or web pages or other deliverables from these components.

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We can automate a lot of the formatting; the authors can write and pull the data together and really focus on creating content without a lot of formatting, because the systems can apply consistently all that formatting to meet all the requirements at the time of assembling and publishing the document, rather than at the time of authoring the document.

Another great benefit of going to a component-based structured content management world is we can tag all of these components with enough metadata to make content much more findable, both by humans using keywords and search filters and other searching tricks, but also by the systems. We can have the systems automatically fetching, retrieving, sending, compiling information together based on metadata tagging. And there's very powerful tools that can get that metadata really dialed in so that it is seamless, and the authors are not even having to remember that there is metadata in the background; they can focus on creating the best content. So side-by-side benefits of this digital transformation include: if we look side-by-side between the document and structured content, of course we can still deliver as a document, and I do think we'll be delivering this information as documents for some time. I do think we're moving in a direction of sharing and transferring information with partners, with regulators, with health authorities, with internal business units, as smaller assemblies of components or even just individual components. But ultimately, for some years now we'll still be compiling into documents for the final or the archival copy, but we can also reference components easily. We can integrate data from its sources of truth because data itself becomes a component. We can automate formatting; we can automate the assembly of content based on rules; we define the rules, and the systems can implement the rules over and over and over again.

We get a detailed audit trail, this movement towards more transparency. We want to be able to trace every single single thing that happens to our content. We can do that at a component level so we get much more insight into the content than if we were trying to track a full document. Obviously digital information exchange, exchanging the data, and for the medical info side, which I know is not today's focus, but omnichannel delivery in medical info, and in marketing, really depends on this component idea of content. And should we ever reach a point where we're sharing content that starts maybe with clinical trials, and eventually makes its way to labels, and eventually makes its way to a standard response document, you have a lot of reuse potential if you do this digital transformation. That's not where you start, though. These benefits are not driving the change all by itself. I think a lot of us have known about these benefits for some time, but it is a big change and it does take some thought.

So what is driving change? Well, the most compelling reason right now is speed. With structured content management, you can create the content one time, review it, approve it internally, compile your documents, you get automation all along the way, and this just makes the creation of these important documents so much faster. You also reduce the amount of time spent updating them, revising them, and especially in the case of something like labeling that is a living document for a very, very long time,

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the speed of how you can create and update this content is a huge benefit for getting medicines to people faster.

David Turner

And, Regina, if I could jump in, I guess we had kind of a reset, and I mean we've always wanted to get our our drugs out faster, but with the pandemic and things like Project Warp Speed, there's just – there became this just new expectation, I think, in the industry, and so now companies are looking – they certainly don't want to cut corners and things like that; they they want to look for the places where they can make real change. And I think we're seeing that, at least I'm hearing that from pharma company after pharma company, you know, how can move this once and it doesn't take us months to review this and get it done? How do we get real-time data so we can get this drug out to the market?

Regina Lynn Preciado

It's true, thank you. And I was thinking that one reason I really like this quote, which is from a year or two ago now, but when Dr. Andrew Badley talked about fast-tracking the vaccines and he says these were all paperwork items, and I honed in because I'm like, Paperwork items? That's content! So getting the content faster and faster but without the unsustainable scramble that happened during COVID is a huge compelling reason to change. And then of course there's the cost; the cost savings of being faster is a very compelling reason to change.

The other compelling reason for the businesses to change now is demands from users, and David you just mentioned this real-world information, real-time information, movements towards more electronic deliveries like the electronic product information, making this content more friendly for mobile screens, and providing a personalized experience. Yes, even for health authorities very much appreciate getting the information they need in the format they need it at the time that they need it, and not always just defaulting to these gigantic monolithic documents which, again, are not going away immediately. But I think if you look around the whole industry, the whole landscape of how we're handling this content, is changing to meet these demands.

David Turner

I mean I think about just how you, when you get the product information with whatever drug, how many months it might be behind when it was actually created, and it's not listed here, but I think users also – I saw a presentation one time about security, and that there are lots of products out there that are not the real products, and that advances here in terms of getting more real-time information and being able to have kind of the e-package insert, just really gives you a lot more a chance to make sure you're getting the correct information, and about the right drug.

Regina Lynn Preciado

Yes, I agree. That accuracy piece, the trust-building, the trust which ties right into the regulations which have never been static have been changing at a fast pace and partly – oops, I do not know why the slides are are jumping forward; I didn't touch it. [Laughs]

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So anyway, the regulations change fast, and different areas of the world and different health authorities want different information in different ways, and when you go from full documents to components, you can scale, you can combine the components in the right place in the right order in the right deliverable to meet these regulations. You can send just the information that is needed to the place that needs it and not bog them down with other information. So we're seeing some changes: regulators and pharma companies and CROs working together to figure out How do we make these platforms to increase our ability to exchange information? What are the standards bodies out there looking at? What are the standards we can follow so that all of our information is consumable by the different systems?

David Turner

Yeah. And this is probably the one I hear the most about, is that people are telling us for years we've been, we didn't have to do anything, and then we had to do SPL for the FDA and so we kind of changed our process for that; that compelled us to change, but now there's new regulations in Europe, and now there's new structure formats in Canada and Australia, and, you know, other parts of the world. You hear more and more about all of these things, and I think that's making companies really think long and hard about making this investment.

Regina Lynn Preciado

Definitely. And I'm thinking – we were talking about the increase of emphasis on transparency and making more of this information available to the public. When you go to structured content you have a way to identify in the content itself what can and cannot be shared with public, what can and cannot be shared with partners, and so on, and so based on that tags or that metadata the systems can provide a layer of security and trust on: we're being transparent with everything that needs to be transparent, we are protecting all of that information that has to be protected, maybe, to meet other regulations, in the case of personal health information, or maybe it's intellectual property of the sponsor about their methods or their technologies.

So getting this content into a structured content management world is the only way to deliver the right information to the right place at the right time in the right format at scale, because you can do this by hand very slowly, and probably some errors will creep in, but if you need to do it at scale like an enterprise, this is your only option. But what's so great is there are many different ways to achieve this, and there are best practices, and there are proven methodologies, and there are mature tools, because the technology is mature enough now to do all of this. So I am going to introduce Simon now to talk about this mature technology and all of the benefits that it can bring.

Simon Cavanagh

Fantastic.

Regina Lynn Preciado

So, take it away, Simon.

Simon Cavanagh

Thanks, Regina. So that was a bold promise, and we're probably not going to go into a lot of detail today, so we're just going to talk about, probably glad to hear, technology at a reasonably high level. So, I'm from Esko. So, we're the part within the piece that is the technology, and if all works well I should be able to move on to this next phase here, which is you use an automation to drive transformation, thinking, really, about how the technology fits, and I think you make a really good point, then. This is where we start now, the technology aligns exactly with what Regina's been saying, which is that, really, as well as the content strategy,

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as well as seeing what, how the content should be, you know, put together from a technology standpoint as well, it's the component that’s the important piece. So I mean, this really is saying from a technical standpoint, What is structured content?

And it's really quite simple, although this might look a little bit more complex than you'd think. You could say separating content, really, from how it's created, and by that we mean there's content, and that's the actual content, the data. This is very separate to, for example, the styling, the fonts, the size, the bold, the layout, it's a separate concept. The content is the data. It's not the styling. And also separate to that is the template, the template where you're going to have placeholders for other things as well, such as graphics. So when we talk about structured content, we talk about it in a technical way. What we mean, I've highlighted there in green, text in reusable chunks. I think that's saying exactly what Regina was saying but from a technical standpoint, it’s How do we take one piece of content, one piece of data, and turn it into a chunk that we can reuse? 

For anybody that's not familiar with that, one good way to think about it is that it could be Lego bricks. One of our customers, for example, often with us but not today, and happy for us to share this, at Novo Nordisk, they really like to call it Lego bricks; it's like taking different chunks of content that you can put together and assemble into all kinds of different shapes in the future. And that content, when we talk about structured content, it means taking that content, not the styling, not the template, the content itself, and turning it into an object inside a database, essentially, so that piece is is a chunk in the database. So if you're going to do that you could do that with every single word, you can do with every single letter if you want to, but even with every word would be impractical, which is why we need to think about how to approach this and take those individual objects, those each pieces of data put them into the database, and how do we manage them? And this is something that, Regina, again, you were talking about, is How do we structure this content?

At the simplest level, we really say that to begin with we have a topic, so the Lego brick, the object, is a topic, and that topic could be one word, but it's more likely to be a phrase or a piece of information. Quite often it'll be a paragraph; for example, we've got that as an example here, so from a technical standpoint we have a topic, we then have a map, and the map really says when we're using that topic, where does it go? And then we publish the content, and as, again, Regina pointed out, it nicely flows so that we can do this in an omnichannel way so we can publish to anywhere. I'll say a little bit more about that in a minute, but what we're doing is we’re structuring the content into different topics, into different Lego bits, and then we're mapping them, as you can see, you know, through their entire lifecycle. We've got a single source; a topic is the single source, is the one piece where that piece, one place where that piece of content originates.

You've got the topic, it starts here, but then it's used and mapped into lots of different examples. It could be into the QRD template to create the correct submission document in Europe, it could be to create the CCDS; we've got the use case here of cartons for artwork, patient information leaflets, but as you can see, this topic here is then used in different files around the entire process, which means you can then publish wherever you want to in any format you like. It's omnichannel; I’ll mention that in a moment, but again, here, kindly these are shared by Novo Nordisk,

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who are doing this at the moment. We've got the examples of an insert, a carton, and a QRD. So that's the way we see structured content technically. I'm pressing the wrong button; sorry about that – or on this one today, there we go – how does that look?

So I think, again, we're talking high-level here, but just to give you an idea of what it's like for the user, when we're talking about content online, it needs to be easy to use. It's imperative that people are familiar and able to pick up the content and work with it very easily, and typically regulatory content is in a Word format, so the best way to solve that, and this has been a learning, I think, with content providers over the last 20, 25 years, is if you give users this really highly complex system that has got pages and pages of places to keep data, it becomes too complex and too unwieldy to work with.

One thing that everybody is familiar with, everyone, I think, who works with any kind of PC, is Word, a word processing document, and this is a Word-like editor, everybody's familiar with this, so one of the ways to solve usability is to have this familiar Word-like user interface where you work as if you're in Word, and you can also collaborate here, as you can see down the side, what we haven't got in this view here is behind this is XML, and the user never needs to open up and look at that XML, but behind this here is an XML database, essentially. So every single one of these phrases in the Lego bricks we're talking about is actually inside the system, so it looks like a Word document, but you're actually working on the user interface for the database.

David Turner

Simon, if I could just just jump in here, I think that’s so critical here, and I think this is the biggest thing when we talk about – you have to have the infrastructure and the tools in place, this is what I think about. We had the concept of structured content management 5, 10, 15 years ago, but there was this, the sense that if we're going to take advantage of it, our people have to be technical experts and they have to understand how to use complex pieces of software. And this particular, you know, software here, when you look at it, it is very Word-like, and this is another thing, I think, I've had people ask me But how do I, am I constantly going from component to component to component? And it's No, here's – you're going to open up, it's going to look like a Word document, you don't even have to have the stuff that's there on the right side of the screen. That's just shown for extra. It can open up and literally look like a Word document and it has little boxes that say “title goes here” and “bold,” you know, all those things that you're used to seeing; it's right there. And so it's become easy, and I think that's why we're starting to see such a such a ramp-up in the usage of this technology.

Simon Cavanagh

Yep. That's why just about every one of the customers, and I think we may not have mentioned at the beginning as we often do, we work with eight out of ten of the largest pharmas in the world: top 25, et cetera, et cetera. Just about every customer is coming to us, and I'm starting to ask about this now and inquiring, several of them are already well onto this journey, and I think this is, you're right, David, this is a real key point, is it's just so easy to use because people are familiar with Word. That's what's been the change, the real catalyst to the change we've seen now. Okay, so what that means is, as we've been saying before, you can have all kinds of different use cases, and we've got different customers with different levels of immersion that they've come, you know, brought into their business from the entire process.

For example, at Novo Nordisk, where they start right from a regulatory trigger, and they've got to change in every piece of content that's in the core data sheet,

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whenever there's any kind of change, that content is managed from birth, on the trigger, all the way to actually producing whatever omnichannel that it goes down. That content is handled from start to finish, which of course means this use case here is an example where you've got your regulatory content in the system, you're able to automatically create your outputs, such as your submission documents, and take those through a process where you can do multiple submissions all over the world using the same content, but varying it for different local requirements. I'm not going to go into detail on this today; we'll just explain there is a use case there, really, for submissions.

One example of how you can then leverage the content once you've got control of it. Another one is automated automation possibilities in clinical, which is kind of saying once we start to put documents together, for example, we've got the CTP and the statistical analysis plan using references for content, we can then be able to use those to create the clinical study report, and then once we've got that content, we can again use it for all kinds of different reasons. For example, regulatory text creating new CSRs, charts and tables, reusing the content in a core data sheet again, we've got ePIL here as an example, which we're going to move on to in a moment, and any kind of leaflet or insert. I mean, really, as we said a number of times, it's omnichannel for publishing, but it's also universal for how you can use the content. It can go anywhere, too.

So another use case for anybody that's this way inclined on the call is automated artwork creation, so I think we've mentioned that for one example, one example is Novo Nordisk could do this entire end-to-end core data sheet, all that content from beginning to end in the submissions document, with other customers as well that say Hang on, we're not quite ready for that. We're not ready to take the entire regulatory piece. We could do that, I mean Novo Nordisk could do that, move toward automated artwork creation, and we've got other customers saying We're not quite ready for that yet, but what we want to do is just get control, structure the content and use it for a specific purpose, and again, this is just one example, is using that structured content to automatically create artwork. So if this one at the top here, the simple option, there's a simple web-based user interface, but managing the content and structuring it is a way to control all of the content that you've got from a single source of truth, and automatically output and create artwork documents.

Another use case is automated leaflet creation. So here we've got a template, an InDesign template which anybody who works with this just knows how tremendously challenging and time consuming it is to put a leaflet together. A leaflet change can take half a day, a new leaflet can take a day and a half, even two days, to create and then format as Regina was saying as well. So another use case for structured content: once you've got control of it, or got it into the system where the system controls it, is to do automatic leaflet creation, and this can be real-lights out automation. So in other words you've got the content, you know that it needs to go onto the leaflet, and the leaflet's got a template, and it's just literally one button press to actually create that document. There's a little bit more to set that up, and if my technical team heard me saying there's just one button, I'd probably get in a little bit of trouble, but you get the idea. It really is a simple press and create the leaflet in one go, not just the text but also the IFU as well, so that's another use case.

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Another technical use case is then taking that leaflet that you've created automatically internally and looking how you can publish it and how you can connect with a patient and to generate the ePIL. So once we've got the leaflet, you can see here on the left, there's different ways that you can you can look at actually delivering that leaflet to the patient, and that might be at the bottom there, you've got HTML, so that's your own web page or something that you put together with, to suit the patient where you want to reach them directly, But then there's other joint ventures such as PharmaLedger. I don't know how many people know about that, but there's a lot of pharmaceutical customers involved in it, which is really looking at blockchain technology, but a subset of that is how to put an application together that – I know, David, you're very involved with this, with PharmaLedger, and creating that application that will go on a website, or these days on a phone, so that people can connect with a patient leaflet there.

And David can tell you a lot more about that, perhaps now or at the end, if somebody wanted to know a little bit more, and I know that Lucas is here as well, from Takeda, who's involved in that too. So another another one as well is the FIER option and how it's, you know, I was looking at the PI, and how do we actually use the content for that as well, which can include the leaflet, of course, so this is an extension of the technology. It's not just the creation of a document and alternating that, not just managing the content internally, but how can we then publish that and connect with a patient as well? I think – yeah.

David Turner

Yeah. let me just let me say here, Regina, I think you're going to talk next about this slide, and again, what we're trying to get at here is that, to use the analogy I used earlier, you know, we can move from the CD to the MP3 now because we've got our iTunes Store, and we've got our iPods now; we have real technology now that is being used for real applications that are suitable for pharma. We're not trying to fit some system from another industry in this, we've got tools that are built for pharma, we've got consultants who understand structured content and pharma, we're starting to see all those environments put together, and I think that's partly what what this slide shows. So, Regina, I'll let you kind of take it from there.

Regina Lynn Preciado

Yes, and, I’ll just give people a moment to see, we took three different business units, but just as examples, not try to put the entire enterprise on one slide, and just – you can just see where some of this content traditionally originates with clinical labeling, or CMC quality, different components and how they're all managed in the structured content management system. So those components may be authored in different groups and reviewed by different reviewers, and they're tagged with metadata by a combination of human experts and software, possibly even AI-driven software at this point, so you get a very robust repository of all this information.

And as Simon showed, the authoring interface can feel very document-based, but it's not like you're looking at a component out of context. There's always context, so people can work easily updating and creating this information, and from the structured content management system we also have a publishing setup which, Simon, you just showed about the information flowing from the structure, even into a layout tool like InDesign, to create different, same information in different ways, to different outputs.

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And then for, of special interest to the regulatory folks on this call, is the regulatory content process, which may involve some back and forth with a health authority or someone, can also be set up so that you're exchanging information with your RIM system and with the health authorities, and you get this digital information exchange kind of in a, it looks like a back and forth; it can be a loop. Because the content is structured; you can now do things with it rather than just, Here's a full document; maybe I'll change it from word processing to a PDF and I'll send it somewhere. So I will hand it back to Simon to talk about.

David Turner

No, actually it comes to me.

Regina Lynn Preciado

Oh, it comes to you.

David Turner

Yeah, it comes to me. I'm just going to talk just really quickly, finishing up this section. We were trying to show here that there are real applications that are really happening, and they're making a big difference, and the environment is there, the infrastructure is there. If you want to start taking advantage of this, there are three things that I want you to to take away and just be thinking about as you move forward. First of all, you want to be thinking about a technology. You've got to think in terms of technology, and the technology we're talking about here is a structured content management system, okay.

Esko has a great a great tool and ultimately what that technology does, if we're going to move to a component-based system, you've got to have something that can help you to store those components and organize them for easy use, right? I mean you could store XML components anywhere, but the idea is that you're trying to store them for easy findability, easy assembly, all those kinds of things. So you gotta have the tool for that. That same tool should also provide you an interface to be able to author components, to edit components, to review components, to collaborate on those things, to have, you know, all that, to have the approvals done, the whole review process – something that can manage and say This is the approved version, here are the previous versions, and really be able to to cycle that. Also to have the security to say This person is allowed to see this content, this person is not allowed to see this content, this person is allowed to see it but not update it, this person is allowed to do anything with it. These are the workflows that that, you know, we want to accomplish. Your SCMS is going to do all of those things, and then ultimately it's also going to help you to create your outputs from your components, so when you get this set up you could say All right, I need – I've got something to due to Germany, and it'll pull the components together and create whatever output is needed: a Word document or a PDF or whatever.

I need something for the FDA; it's going to create the SPL for you, and that's what this technology can do, so that's really kind of the first, one of the first things to think about. But you also can't do that without having some targets, right, and this is where a good consultant comes in. And it's important to find somebody who's a consultant like Content Rules, who has a solid understanding of pharma and speaks the language of pharma, but who also understands this realm of structured content, component reuse, things like that. We've had kind of two worlds for a long time, but today now we're starting to see those come together, where there are consultants like Regina and Val and their team at Content Rules that are putting these things together.

44:02

They're going to work with you. Now, you're implementing this structured content system; what does your content model need to look like? How granular are your components going to be? What metadata do you need to capture to ensure findability? What metadata do you need to capture to be able to create the outputs that you want automatically? What do you need to do around your reuse to make sure that it's not just a feature, but it's something that's taking months off of your production process? What's the shared taxonomy that you're going to use? How do you want to set up all of your various workflows? Somebody like that is really critical.

If you get the technology without the targets, you're gonna have a really expensive tool that gets you only so far, right? Having those, having that consultant that can really walk you through all of these pieces of how you want to handle the content, it's really critical. So that's kind of the second piece of the puzzle, and it's there and it's available, and I think one of the reasons that we're starting to see these changes. And then the last thing, this is where my company, Data Conversion Laboratory, or DCL, comes in. Most organizations have some existing content that they want to bring over, right, it's just, there's just too much content in large organizations to just, to think Well, I'm just going to start fresh and just start creating things new. Now, tools like Esko will allow you to create something from scratch. Regina, her team have created these great templates so you can go in, open up a template and create things that are new; that's perfect. But it also really helps to have a reuse library available.

And so what we do is we come in and we help you to figure out what documents you want to bring over. We start to look at how they're structured, then we work closely with somebody like Content Rules to identify What metadata do we want to capture? How granular do we want it to be? And then we start the process of converting so that you're not having to do a bunch of cleanup and a bunch of preparation and things like that. We want to be able to get it into your system so that your system just works. Again, it's supposed to be easy. One of the compelling reasons for change, one of the drivers for change, is supposed to be the ease and the infrastructure. We move forward because the iTunes Store was so easy. So this kind of transformation helps make things easy. So that's kind of bringing those puzzle pieces together. Let's just move in here; I'm going to give a quick summary, but before I do that, I'm going to pass it back to Marion quickly, and I believe you've got a poll.

Marion Sicre

Yes, indeed. Thank you, David. And did we want to hear from the audience, so here is a poll that will appear in your screen. So the question is “What statements below best align with your organization’s approach to structured content management?” So the first option is “Help! We haven't even started strategizing!”; “We need a way to analyze all the content”: “We have to understand some key metrics and put in place a cohesive organizational plan”; “We have an initiative to move to CSM but aren't sure what you do with all of our accountant data and what technology to use”; or the last option, “We deliver already Cpl, IDMP, Health Canada drug info into structure content formats but we would like to move on a structure content workflow in other areas.” So we will ask you to submit your feedback and answer what is the most relevant option for your organization. So we'll give it a minute.

48:00

David Turner

This is where we should have the music in the background.

Marion Sicre

Yeah, I hadn't planned for that.

David Turner

Simon, Regina, any predictions? I – if you're saying what your predictions are, I don't hear you.

Regina Lynn Preciado

I couldn't unmute until – so I'm in the poll, skewing the results. I was just gonna come unmute and say I promise everybody that if they answer the poll, I won't sing.

Marion Sicre

Okay, can you see the results? I think we've given enough time.

Regina Lynn Preciado

I think – ah, yes. So, if we click the “polls” button, look at that.

Simon Cavanagh

That’s split quite uniformly, isn't it?

Regina Lynn Preciado

That reflects the experience that I have had in the past six to 12 months actually, talking at conferences and meeting people and where are you, and there is hardly anybody right now who's going I've never heard of components; I've never heard of structured content. We are in a space of Yes, we're doing it; we're at a pilot; we're looking into it; we're starting our strategies; or even We were an early adopter but we got stuck and now we want to go forward. So it's very, it's a very cool time right now to be working with this technology in this industry.

Simon Cavanagh

It's exciting stuff, isn't it?

Regina Lynn Preciado

Yeah. Right, thanks.

David Turner

Well it does certainly, this certainly aligned with what I was thinking, which – we're seeing so many organizations now talking about doing projects but are in those early stages. They have some sort of initiative and that's what this is showing here as well. I think we could probably complete this poll. Thank you, everybody who did participate; that's interesting. And with that I'm going to jump in and give a quick summary, and then we'll start to get into the questions. So what we tried to show today was that structured content management is coming. We've been talking about it for years but it is actually coming; it's actually starting to happen. And we talked about how just the availability of it doesn't necessarily make it happen; you need to have some pretty compelling reasons and you need to have the infrastructure and the tools.

And so then I passed it over to Regina and she talked about, well, first of all, she gave kind of an overview of where we are and where we're going – this idea of components, not documents; single source, not copy-paste; automated transforms, not manual formatting; and that there's a lot of benefits but that there really are at least three just huge reasons why we're seeing this this uptick. Number one is there's been this reset in our minds about How fast should a drug be able to get to market? And so there's the need for speed. And then secondly, users are just getting the advent of the mobile phone has just been so prevalent all around the world at all socioeconomic levels in every land, you see mobile devices, and so people want mobile content. People are used to now being able to get information in real time and those demands they're pushing for that, and they want that.

And then I think another just compelling reason always comes down to What is the government going to make me do? And we're seeing that there are government regulatory changes, whether it be, you know, directly saying You have to have your content in this format,

52:03

or organizations implementing systems of their own, wanting to take advantage of other technologies like ChatGPT and needing to have structured content to make that happen, and so they push that on the pharma companies. And then we pushed into the last section, which was, Hey is the infrastructure ready? Are the tools ready? And Simon showed us some real live examples of things that are happening now, that we've got tools that understand pharma and understand structured content, we've got editors that are user-friendly, don't require people to be experts, where you can get into a system and you can make a project and you can start attacking use cases that really work. So I think we're ready to get into – oh. No, we – I think we got one more poll before we get into questions, is that right?

Marion Sicre

Indeed, David, indeed. So I'm publishing – it's a simple question, right, just to know from the audience if they are interested in actually getting a deeper dive into structured content management and the technology behind SCM. So, same here: I will give it one minute for you to provide your feedback, please.

Simon Cavanagh

While we're doing that, David, I think you touched, actually, on one of the first questions we got, which was with – mentioning ChatGPT. One of the first questions you can probably see too is “With the current rate of new improvements and rapid development of generative AI, e.g. ChatGPT and Midjourney. How confident are you the automated document artwork creation based on strucured content will still be the way to go in a year's time?” I would say 100%, 1000%. I cannot see in the foreseeable future, I’m probably not phrasing it perfectly, but I cannot see where artificial intelligence, which even now they admit isn't 100% accurate, that artificial intelligence will take over the capabilities of human brain to be able to manage, review, authorize, and check the safety of content and be able to do that without structure that's required at the moment for a system that manages, that tracks, that controls that. I think it's still too early. I mean, let's not discount any future technology, but in the next few years, I think it's a long way off, that, personally.

Regina Lynn Preciado

Yeah, we, Content Rules has been talking about AI and speaking on natural language processing and natural language generation for years and years and years, and what we all know is it learns from what we give it, so if what we give it is 75 years of manually, maybe there's biases inherent in some of the old contents, this, that, and the other thing, then that's what it's gonna get. So the more you standardize the content, structure the contents, keep the most valuable of the content to train your AI content generation and everything, the better results it can give you. And so actually the structured contents, the move to structured content, is a prerequisite for value from the AI, and I think as an industry we can be training these tools to make them better for the industry. We want to do that, but it's going to start with standards and structure.

David Turner

Absolutely. Yeah. I heard a presentation yesterday and it talked about this very thing. It said if we want to take advantage of AI technologies, NLP Technologies, et cetera, then the time is now more than ever to focus on structured content, because the more structure you have and the more context you can give these tools,

56:03

the more power that they have. So the more automation that you want to do, the more that you want to be able to give advantages, yes, the time is now to get into structured content.

Simon Cavanagh

Yeah.

Regina Lynn Preciado

Structure and standards make things interoperable.

Simon Cavanagh

Yep. And the other question was –

Marion Sicre

Wait a minute. Before we continue, sorry, answering the question, I just wanted to mention that Esko will be exhibiting all around the world in the next months. You can find us at the Regulatory Affairs Summit in Boston in May, in one of the biggest Latin American family events in Brazil as well in June, and in Geneva in the event Connect in Pharma as well in June, and you can also contact us anytime at hello@esko.com. So now I think we have three minutes if we want to answer any questions from the audience.

Regina Lynn Preciado

There is another question in there, which is “Rather than create complex workflows and roles in the component management system, is it possible to rely on the existing content-slash-document management system for reviews and approvals?” And I’m literally teaching it, or facilitating a workflow workshop, with a company this week and next week, so I can tell you, yes, you can use your existing process. However, you won't get the benefits of the component-based and structure-based efficiencies if you're still reviewing as a full document and thinking, managing as a full document. Part of the power here is as content is ready for review, it can go through its review, it will always have the context around it if your reviewers want that, because you can send a full label to be reviewed, but they need to focus on just what they're reviewing so it doesn't need to be complex, though.

Simon Cavanagh

I think as well, Regina, from a technical perspective, that's absolutely true, but also you can have workflows that work across different systems, so, like, systems can integrate very easily now and talk to each other, so if you want a content, simple content flow and a component management system, but that you then want to push a document to another system and do something else there, you do lose a little bit. But if you want to manage the workflow, the approvals in the system, there's no reason technically that you can't do that. I think it's trying to understand what's best for you, isn't it?

Regina Lynn Preciado

Yeah. And it doesn't have to be complex. I think often when we do these workflow workshops, we start out too high-level then we get very, very deep and we put in all this complexity, and then we pull it back up to get kind of – “simplify” is the word that – I put a big sticky back here to remind everybody that we don't have to – the goal is to get more efficient, capture those milestones that we need and capture those workflow transitions that we need, but not complicated. So, love that question because this stuff all can look really complicated, but as, David, what you said, our goal is to actually make it easier. Once it is set up, it gets easier, so. 

Simon Cavanagh

Yep.

David Turner

And make people wonder how they ever lived without it. 

Simon Cavanagh

Exactly. Yeah.

David Turner

In any case, if there are other some other questions, we will address those individually. We will make sure that we get back to everybody here that has submitted a question and just touch base, but I think we're pretty much at the end, so Marion, let me pass it over to you to talk us out and all of that good stuff.

Marion Sicre

Thanks a lot to a great presentation, all of you, and thanks for the audience for attending today. As David mentioned, if you have any further question, if you want to interact with one of the presenters of today, you can email us at hello@esko.com. We'll pass all of the questions to all of the speakers. So that leaves me with thanking everybody again. We hope you enjoyed that presentation, and again, it is recorded and you will receive the recording within the next 24 hours. So we hope to see you next time. Enjoy the rest of your day. Thanks again to Regina, David, and Simon for a great webinar. 

David Turner

Thank you.

Simon Cavanagh

Thanks, everybody. Cheers.

David Turner

Bye-bye.