DCL Learning Series

Marion Sicre

Good morning or good afternoon, everyone, and welcome to today's webinar about "Structured Content in Pharma: The Steps to Take Today to Prepare for Tomorrow." Our speakers of the day, Val, David and Simon, will present how pharma companies can streamline their content processes and reduce risk by standardizing and centralizing the content collation process. During that webinar, if you have any question, please submit them into the question pane in your livestream control panel. And at the end of the presentation, we will also do a short Q&A session.

Also to mention that the presentation is being recorded and will be sent to all registrants within the next 24 hours. So now, without further ado, I would like to introduce you to today's subject matter experts, Val, David and Simon. Let's start with you, Val. If you can quickly introduce yourself, please.

Val Swisher

Sure, sure. Hi everyone. My name is Val Swisher. I am the CEO of Content Rules. We are a consultancy that helps companies build their content strategy, move to structured content authoring, and select tools and technologies to support their structured content ecosystem.

David Turner

Awesome. And I'm David Turner and my company is Data Conversion Laboratory, or DCL, and well, it's nice that I'm in between Val and Simon, because that's kind of where I live. So, I help customers who are trying to execute a structured content strategy or a path down structured content authoring, like what Content Rules helps them to get started. And I also help those who are trying to get into a technology system like Esko's WebCenter. We are experts in converting unstructured content into structured content, and I get to be the moderator today. Simon, how about you? Oh, he's muted. 

Simon Cavanagh

Hang on. Excuse me. Sorry about that. That was a perfect segue, what a shame, into the system. Esko provides the system and I'm Simon Cavanagh. As you can see, I've got a few more gray hairs than when my first, my photo was first taken. We probably need to update that. But I look after Esko's pharmaceutical customers, mostly those headquartered in Europe, but not only there, but some customers in the US, which is, such as Amgen, headquartered in California. We provide the system that David mentioned there, which looks after structured content, enterprise structured content. We're not going to spend too much time on systems today, but we will talk a little bit later about a use case and a few top tips when selecting the system. 

David Turner

Yeah, absolutely. Just to give everybody kind of an idea of the kind expertise, this is a collection of logos that our firms have worked on recently. We do have a lot of experience and hopefully our youthful vigor doesn't make you think that we haven't been around this game for a while, in any case. We're excited to have the opportunity today. Marion said at the very beginning, our goal today is to try to give you some practical steps.

We're trying to give you practical steps that you could take today to start preparing for your structured content journey. To that end, I thought we'd start maybe with a little bit of a story time. There's an author, Lisa Krohn, Crone. I can't remember. She gave a TED Talk and loosely paraphrased, there's a quote she has that says that stories are more crucial to our evolution than opposable thumbs. While opposable thumbs let us hang on, stories tell us what to hang on to. So in that spirit, I thought maybe we'd all sit in a circle and let Auntie Val start with a little story for us. So Auntie Val, we'll turn it over to you.

4:09

Val Swisher

Oh goodness! Goodness, goodness. Thank you, David. All right. I am going to tell you a tale of two writers. This is the story of Formatting Frankie and DITA Dina. Both are medical writers working for different firms. Formatting Frankie's company develops antihistamines, while DITA Dina's company develops vaccines. 

Let us live a day in the content creation cycle of Formatting Frankie. Frankie is asked to write the adverse event information for the latest antihistamine product labels. Frankie's working in an unstructured environment. In this environment, Frankie creates a separate document for each variation of the drug label. She manages separate documents for different health authorities, regulators, regions, and languages. Each document is touched by many people during the content development cycle. Medical writers, clinical SMEs, safety leads, RIM, maybe even a lawyer or two. Everyone has access to the full document to find their relevant content and to provide feedback or update the content accordingly. 

Each document must be created, reviewed, revised, formatted, and approved, typically several times before and after the drug enters the market. When one piece of information changes, each one of these documents must be located, searched, revised, reviewed, reformatted, and approved. Even though much of the content is the same across every variant, Frankie creates and maintains a separate file formatted differently for each label. 

For a while this works; there aren't too many products, and Frankie simply copies existing information from legacy documents and pastes it into new documents and then tweaks the information to modify it for new products. They're only selling in the UK and North America, so there aren't as many regional variants as a global pharma company typically has. So she also copies, pastes, and tweaks existing files to modify them for different devices, such as mobile phones and tablets. 

Frankie ends up with many variations of the same content. And as the firm continues to expand its business, the amount of content that needs to be created and maintained grows with it. Soon, Frankie supervisor alerts her to a change in the adverse event information, but when they started, there were only a few documents that would've needed an update. Now, Frankie realizes the scope of the simple task. To make even a minor change, Frankie must locate, open, and edit every document that she has created individually. The document library has become nearly impossible to update regularly, consistently, or effectively. 

It takes Frankie the entire week to update every label by hand. Frankie is frazzled. She wakes up in the middle of the night in a cold sweat thinking "Was there a label I forgot to update? Is my supervisor going to ask me to make another change soon? What do I do then? How can I keep going like this?" One day, Frankie gets a call from her supervisor, Fred, who wants to meet her immediately. He doesn't sound happy and Frankie wonders why. Her content has always been spectacular.

8:00

Fred tells Frankie that upper management has decided to enter the AsiaPac market. Fred was asked to get a quote from a translation company to have the labels translated. The quote he received was astronomical. The reason, according to the translation firm, is that there are so many documents to translate. Even though the documents are very similar, they are not identical.

There are many cases of fuzzy matches, the same information written in different ways using different words. "You see," Fred said, "you might not realize it, but you've been making small incremental changes to various pieces of content. But those changes have not used exactly the same words. So when we go to translate, those small changes add up to a whole lot of extra cost." Even worse, it appears to Frankie's supervisors that her performance is dropping. Minor changes take Frankie such a long time to make. Even a minor change can take Frankie the same amount of time is creating three new pieces of content. In addition, management wonders why it takes so long to do a minor change and have it reflected across all the content. Poor Frankie: what's she going to do? 

Calling this situation typical would be an understatement. The story of Formatting Frankie plays out in various shapes and forms across all businesses in all industries of all sizes. These problems become exponentially worse if there are multiple content creators and even worse when the business decides to go global and translate. Thankfully, there's a better way. 

DITA Dina's firm uses a DITA-based structured authoring system and hired Content Rules to implement it and train its writers. Like Frankie, Dina is asked to write the adverse event information for the latest vaccine product labels. However, Dina is able to accomplish this in significantly less time. 

First, Dina writes the content in a streamlined authoring interface that resembles a familiar word processor. She doesn't focus on the final formatting or presentation at all. Instead, she focuses on the information she's writing. As she writes, Dina creates topics, reusable chunks of content that are not specific to any single or other output. She writes the adverse event description one time in one topic.

And that topic is slotted into every label that requires the information in the place where that information goes. If it's in section three of one label and section seven of another label, no problem. Thanks to the structured authoring system, the information appears in each label exactly where it goes. While Dina works on adverse event content, another writer's updating the contraindication topics. Meanwhile, a reviewer is validating that the drug product name, IMDP name, dosage, and method of administration are all correct. 

Everyone can work in the same source content using the friendly authoring interface. The system takes care of populating all new and updated content to all the labels that need it. If Dina wants to see the content in context with full formatting applied, she can generate a draft label at any time. That's when the publishing engine marries the content to the formatting. She can publish the same content to any number of formats. From print to PDF, to eLabel, to mobile app.

12:06

With the combination of structured content for the source information and output templates for the formatting, Dina can generate the USPI, the SMPC, the medication guide and the patient information leaflet from the structured content authoring system. She's using and reusing the correct content in the correct order with the correct format every time. 

The benefits of DITA-based structured content become even more significant when Dina is asked to make a revision to the adverse event information found in all outputs. Unlike Frankie, Dina only has to make this change once to the structured source content. The change automatically propagates to all necessary outputs, no matter how many documents Dina is expected to maintain. One change is all it takes.

Each topic is written, stored, updated, managed and translated one time. The same topics can be reused for different types of outputs. Each topic or labeling document can be published to different platforms such as the web, a tablet, a smartphone, an EHR system, and a voice assistant, in addition to more traditional PDF and print outputs. This system is scalable and elegant. It emphasizes ease of use and consistency. Each piece of information exists in one and only one place.

DITA allows Dina to create more final outputs using the same content. Whether it is a new publishing output or a new product, Dina always has previously approved content available to reuse. Only the unique new content must be written at which time, it is written once, reviewed once, updated once, translated once, stored once. Even better, when Dina's company decides to translate the content, each topic is translated once and only once. It is then used in all of the outputs for that language. So much faster, so much cheaper, so much better. 

The differences between Frankie's and Dina's job start with their focus. Dina starts by focusing on the content and the structure, while Frankie starts with focusing on creating content for each format. These different starting points have drastically different effects. Frankie is tired and worried, while Dina sleeps well at night. Dina is consistently impressing her managers with her efficiency, while Frankie works for hours to make changes that her management will probably never notice. Even worse, Frankie's changes are causing an increase in overall translation spend and time to market. Be like Dina: do DITA.

David Turner

There's a great round of applause going out across this entire world for this. I felt like I was back at the library. We really need to get this packaged up into, like, a children's book that you can, you know, show the pictures. Anyway.

Val Swisher

We'll do Library Time.

David Turner

I love it. I love it. Well, actually, you made some great points. You hit on the idea of moving from the document mindset to modular content blocks. You hit on content reuse, and it always strikes me that when you talk about copy, paste, and tweak, everybody's already reusing content. It's just that they're doing it the hard way. Right? And then there's translation. There's the speed of making a revision. Anyways, all of that said, we've put together a slide here that really shows a lot of benefits, and I think there are a lot.

16:02

This is a critical step, and we're talking about steps today. One of the key steps that you can take as you prepare is to start building your business case. If your organization is of any size, what's going to make it compelling is not that it's just one of these benefits, but it's really a collection of benefits. Certainly, faster time to market, faster speed of making a revision. You've got the translation savings, you've got enforced consistency, all of those different pieces that we've listed here.

I think it'd be interesting really here too to hear kind of the difference between Val, what you hear and kind of working as a consultant and Simon, what you hear kind of working more towards that artwork end. Val, when you're talking to pharmaceutical customers, what are the top two, three, or four reasons that they have that you're usually hearing about when it comes to structured content? 

Val Swisher

Well, number one is time to market. We all want to get medicines to people faster. That's what we do. Right? That's why we're in this. That's why we do this. Number two, of course, is the cost. For every day that a drug is delayed to market, pharmaceutical companies lose, the statistic I read was a million dollars a day.

David Turner

Wow.

Val Swisher

So it's really efficiency, time to market, cost, and then there's all sorts of other benefits you get along the way. But really, those are the main ones that I hear over and over again. 

David Turner

Interesting. Simon, what about your end? 

Simon Cavanagh

Yeah. From me, I'd echo what Val says there with cost and inefficien– I mean, particularly things like copy and paste, and eliminating copy and paste, by the way. So eliminating copy and paste is a real important goal, but that's part of the efficiency. But I think the three that we hear is traceability. Fact analysis, being able to say right from the beginning of a project as soon as there's a change, what are all the affected documents right across the organization? That's really important. It saves a lot of time.

I think content reuse, you've already talked about that, David, but that's another real big one, is how do we become more efficient? And if we're going to have one statement translated or one statement approved, let's do that once, as Val said. I think the third big one, perhaps the biggest of all is right first time and getting quality and making sure by eliminating copy and paste, about all the things we've talked about is avoiding errors and eliminating recalls.

David Turner

Yeah. Yeah.

Val Swisher

I forgot that one. Thank you, Simon. Yes. The risk, the risk.

Simon Cavanagh

The risk.

David Turner

Yeah. Another really critical one that I hear, and I would encourage everyone out there who's listening, if you want to throw in the chat in a question, maybe what some of your top reasons are for this. I'd be interested to kind of take an informal poll that way. But another one that I hear sometimes is improving the patient experience or improving that end user experience, trying to create content that looks right on a mobile device, but being able to also have it in different context. Sometimes my reader of the content is a patient and they need certain things highlighted and they need a certain experience.

Sometimes it's a health authority and they need certain things. Sometimes it's a doctor and they need certain things. So, I think that's another really big one there. Anyway, like I said, if you've got others, those of you out in the audience, we would love to hear those and share those and talk about those. But with that, I think I'm going to pick up and move on to this next slide and just kind of give a quick overview of what we're talking about when we're talking about structured content, because I do want to make sure that we're all more or less on the same page.

20:00

And sometimes when we talk about structure, people have a little bit different ideas. Actually in pharma, at least here in the US, a lot of people, when they think of structured content, they think of it in terms of a structured content format. They think of it, "Oh yeah. Structured content. That's that SPL thing that we do for the FDA." And certainly, yes. Structured content is certainly related to formats, but really the definition is getting a little broader. We're trying to move away from kind some old ways where you just thought about structure as something that you've got to do because the FDA requires it. 

If you want your content to be on the DailyMed website, it's got to be in this SPL XML format. And that's been fine. DCL does a lot of conversions for companies who, they take their content all the way through the drug life cycle. And at the end, they pass it over to us. We convert it to SPL and we load it to the FDA for them and that's been fine. But what we're seeing now is that companies are really interested in trying to do a little bit more, not so much, just throw it over the wall to a vendor like us at the end, but really start to try to work a little bit with structured content to get all those other benefits that we've just talked about. 

A big piece of it is what Val alluded to in the story. It's shifting. It's shifting from the idea of a document to managing content components. Quick example. So, think about, like, clinical trials content. There are pieces of your clinical trials protocol documents and there are pieces of the statistical analysis plan that you'll reuse for your clinical study report. And then the idea of moving to this component piece is that instead of creating all of these things as individual documents and trying to manage them all as individual documents, we can start using little pieces of them. 

So maybe we take that clinical study report and take pieces and use some of that as the legal text on the website. Maybe we take some of the demographic step descriptions and we can use them in another CSR or maybe we could take some of the charts and tables and put them into a presentation, or we can roll things out to a mobile device, again, based on being able to put those component pieces together, really in the right places. Any thoughts on that, Val and Simon, before we kind of keep on moving along?

Val Swisher

This is the beauty of it. This is why we're recommending it and this is why pharma as an industry is finally starting to catch up to all the other industries that have been doing this for years.

David Turner

Yeah. Well, and actually the next thing that usually comes up after we start talking about this is people usually ask the question "Okay, what – there's got to be a technology piece in here. What technology do I need?" And this is where Simon starts to get excited. And that's actually the next step, if we're talking about the steps today that we want to highlight. You need to get out and explore what's available in terms of technology, which brings us to this, this "ee-co"system or "eh-co"system, depending on how you say it, slide that I'm going to click on next here. This comes to us courtesy of Content Rules. I think it's a great slide. Val, talk to us a little bit about this ecosystem and related to some of the things that we've talked about, and talk about some of these technologies that you help clients to find.

23:53

Val Swisher

Sure. Absolutely. Well, we created this slide to try to illustrate what the big picture looks like. On the left, we have the content components, and different groups create different components, reuse different components. It could be clinical, labeling, CMC; wherever that content is created, the content is created in these small pieces, these small chunks. And then they are stored in the Structured Content Management System.

 

And this is Esko WebCenter. Esko WebCenter sits in the middle of the entire ecosystem. It provides an authoring interface that is very, very easy to use. It looks just like an authoring interface that everybody uses today. So that's part of the SCM. And the SCM really is that database that is helping store and keep the audit trails and the metadata and all of the things that you need to be successful.

From the SCM, that content can go to any number of places. First of all, it can go into your RIM system, and then your RIM system can take it and send it on to regulatory and do that dance back and forth. If there are changes, everything, the content itself, the source content, this is an important point that people are starting to get confused on. Your source content is stored in your Structured Content Management System.

You assemble it and you can store the assemblies in your RIM system like the documents, but those pieces are stored in that SCM. You can also publish to any number of formats, types of end products, whether it's the labels, the leaflets, other marketing, whatever it is. Changes are made to individual components of content that are stored in WebCenter, which is the center hub of everything. And the system, this type of ecosystem has been around for a really long time. So it's really exciting to see pharma adopting this whole methodology of structured content.

 

David Turner

Yeah, yeah. I think it's really a useful thing here, that, it's another hard thing, I think, for, sometimes, people to get their heads around that might be new to this, is the idea of separating the content from the design and the outputs. When we're working in a more traditional desktop publishing environment, you're choosing the font, you're choosing the colors, you're choosing all of the spacing. And a lot of times companies who are trying to keep that consistent have put out these elaborate style guides, and you have to go look up "Okay, I can't remember, is this heading supposed to be 13 point or 14 point? Wait a second, what font? Oh, we just got to acquired and now they want us to use this font." And you've got to keep up with all of that.

But really, when you move to structured content, you write the content. You mark this as a heading, you mark this as a paragraph, you mark all the different pieces, and then your system on the backend will enforce the style and design, depending on what your output is. Does it need to go to a health authority? Okay. Style it like this. Does it need to go to the website? Style it like this; use these colors, use these fonts, and you don't have to make those decisions, and management can make everything a lot more consistent.

Simon Cavanagh

Yes.

David Turner

Simon, obviously she mentioned WebCenter fits in here. You want to talk a little bit about that?

27:58

Simon Cavanagh

Yes indeed. Before we move off this slide, then, forgive me if you probably notice I keep disappearing. I don't know why he keeps throwing me off the platform. And then I have to click back on, so if I disappear, it's not intended and it's not part of the show. I think you pointed out perfectly there, Val, is that big SCMS, the Structured Content Management System there in the center, that's the WebCenter, that's the platform that manages the content. We've got lots of different use cases there. I don't know if you can see my screen; you probably can't see my cursor, actually, but you can output things like packaging and labeling, documents, educationa; documents, marketing documents, et cetera. Once you've got that content centralized, you can do that.

Drilling down a little bit from that into the use case, we're going to think about the company core data sheet and what we can do with that, looking at the system. Now we're not specifically going to look at the system, but rather really the use case for it. And then three tips on selecting a good system. Really, we're looking here at WebCenter Structured Content Management, which is the system, but this flow is a very simple flow where we've got a request, we're going to make all the content required for that request. We're going to review it. We're going to localize it. We're going to approve it and we're going to – I actually saw a question on there, which is probably what caused me these issues, technical issues, clicking on the question, about how Esko handles languages, and the answer is: we don't. We don't actually –

David Turner

And there he goes. 

Val Swisher

I was waiting. I was hanging on his words. 

Simon Cavanagh

Sorry about that. I'm not quite – 

Val Swisher

Okay.

Simon Cavanagh

So, I'm glad I get to complete that. We do manage the translation, but we don't perform the translation. So translations are performed in other systems, but we do work with XLIFF, so we can communicate and take those translations from another system. Really, when we look at the process, there's a workflow here that we need to follow. It hasn't got language translation in there, but obviously there's a lot more to it than this. But what we've really done is gathered all the content in the system. Traditionally, that's come from legacy, from ERP systems such as SAP, XML, from any other system, however we're getting the content. Scripts from Excel spreadsheets or Word documents, copy and paste. So many different ways at the moment that that information is collated. But what we do is, now, we take it from other systems still. There's still going to be some content that comes from other systems, but we also start to think about how do we manage a company core data sheet, which is a Word document.

And I think as I've said on quite a few of these events, the worst database in the world is Word. And as we know, we have to keep all documents, all content in Word for the health authorities, but it is terrible. It's a terrible, terrible database. So what we do is we take the company core data sheet. If we use an example of that, let's take the QRD in Europe, we take this entire document in its entirety or David does at DCL, and converts it, having got the right structure and way to put the Lego bricks together for Val. We take that document and we create a structured document. 

So that's a document where everything is known and laid out in that document exactly how the authority wants it, with the right titles, the right spaces, everything to the exacting standards that we need to. We structure that document inside the system and then we're able to create an output template and create an output such as Word.

32:03

And that would be, as we said, exactly in the format required for submission. That's created automatically because we've got that in the system in a format we'll show you in a minute. So, we can do all sorts of other clever things, of course, because we don't only have to output Word. With David's help and a transform, we can create an SPL directly from the system so we can submit to the FDA in the US, for example. What we can also do is some other use cases. David mentioned clinical trials. We've looked to education on the global system, but one use case is the leaflet instructions for use or whatever format. But we can also take that as well, and using other packages like InDesign, we can create the output template directly from the system, using the content, into InDesign, and with one click, we create the PDF leaflet. 

Now, I have to be slightly careful because if our technical guys hear me say one click, they'd tell me off because it's probably two or three, because there's a few times that, manipulations, you may need to make in the leaflet. But it's very, very limited. And instead of taking two hours for a change or eight hours for doing a new leaflet, it probably takes about 15 minutes at most. There's a really compelling business case there. The other thing of course is we can do the artwork. Another use case is looking at the artwork and working with Adobe Illustrator and automatically creating artwork –

Val Swisher

Hanging on his words.

Simon Cavanagh

I lasted quite a while there, last time, didn't I? We automatically output the PDF, completing that picture for the artwork. So, what we've got here is a workflow that manages the business process end to end, very complicated process through the regulatory submission, as we say, the documents handled in and the submission is handled by for example, or whatever the RIM system. But the content runs in parallel as a single source of truth in a Structured Content Management System. We manage the workflow, we take all the content. We create it and manage it in WebCenter and we push it through whatever format, whatever output we want to and publish it anywhere that we'd like in whatever format.

A lot of time savings there because of course we get everything we talked about in terms of benefits, the reuse, the traceability, the impact analysis, the right first time, the elimination of copy and paste. Lots and lots of benefits. So how are we doing for time? Oh, we're doing fine actually.

David Turner

Yeah.

Simon Cavanagh

Yeah. So, that's really the flow. That's how the system and the use case works. When you're thinking about selecting a system, what are the important things to look at? We've got a few short slides on that now. So the top three tips when selecting a system. I think the first one, the first thing that I would highlight, is having a good user interface. It's so important in any system to have an easy-to-use system, one that's intuitive. And for that, we recommend a document editor. And the reason for that is that Word isn't going away. Not for quite a long time to come, and everybody's very, very familiar with it.

What we've found over the last couple of decades, I guess, is as an industry in technology, a technology industry, is that putting together complicated user interfaces for managing content gets tremendously difficult for a user to understand the complexity of all the different variations, if you put text in a system and start to try and manage it that way. So a far better way is to use something like a document editor. That's this one here. This is saying that we've got a Word-like editor. It's not Word. It's actually Fonto, this one. I think the Fonto guys are online. This is the Fonto Editor, which we've actually integrated inside WebCenter to facilitate that workflow. But then we make this –

36:12

David Turner

Let's not go on here because I want to talk a little bit more about this because I think, I think this is, this is unique. Obviously, companies still use Word for certain applications, and Word is still going to be a very important part of what you do because your health authorities are still going to use Word documents and they're going to still require that you deliver as Word documents sometimes. That's all there, but Word becomes more of an output. Now, I think as Val can tell you, you can attempt to do structured content with Word on the front end through templates.

 

And you can create Word style after Word style after Word style after Word style. But pretty soon it gets to be where you have hundreds of these styles to manage, and it becomes really, really onerous for people to try to keep up with and in the spirit of keeping them in a tool that they know you're basically asking them – I used this example in another deal last week – you're basically asking them to mow their yard with a pair of scissors.

Scissors can mow your yard, but it's going to take a long time and it's really, really difficult. Why not get a tool that's made for that purpose? So that's what, like, the Fonto XML tool here shows. It's very, very user friendly. They've done a lot of work in pharma. It's kind of the tool of choice. I know they would be willing to give you a demo and Simon could show you a demo definitely on this as well. And it's been something that's been used more than just, just pharma as well. Val, any comments here from you on this UI and that piece?

Val Swisher

Yeah, I think that this is actually the most important part. Pharma companies have tried to make the jump to structured content in the past, and one of the biggest reasons that it didn't work was that we didn't have a tool like Fonto where the experience from the writer side is just the normal experience. It's Word-like, it's Google Docs-like. It looks like you're working in a document and all of the complexity of XML, the components, the tagging, all of this complexity is hidden. Before we had an interface like this, as you can see, I am like the biggest lover of Fonto of all, the types of authoring environments we were asking writers to use, you had to be a coder, you had to be a programmer. I mean, there was coding, all the XML coding all around what you were trying to write. No one, no medical writer that I know is going to want to work in that type of environment. So the ease of use in WebCenter with this interface, it just completely eliminates that entire problem. I think this cannot be stated enough about the same experience. 

Simon Cavanagh

Yeah. Thanks for slowing down, guys, because I'm very nervous I'm going to disappear in a second.

David Turner

Well, take us on down from here. 

Simon Cavanagh

I seem to be stable. I seem to be stable now. Yeah. Thank you very much for pitching that. I think the important thing here is that we got a Word editor, we've got Fonto with all this power and capabilities. But what that means is that when we put this into the WebCenter system, it's managed through the workflow as well, but not just the workflow as an advantage, is that each one of these words in here, letters even, are an object, and as an object they're in the database.

40:11

So it appears like you're working on a Word document, but in fact, you're working on a database, and everything on here is not only kept in the system, but it's also structured as you can see down here on the right, and that's where the real advantage comes in terms of being able to have easy adoption, because everybody's familiar with Word and everything you're doing here, it's as if you're working on a database, but you're doing it with a Word interface. And so I think that's really important for adoption by users so that people are familiar and use it.

And I think it's important because it gives all the benefits, as we said, once you've got all this information in the system and all the power of what you can do with it in the database. Yeah, I'd echo that. I'm glad you said that. That's my number one too. My number two, I would say for, for a system and I think you've already – sorry, I have to press this one – is a universal standard. For us, that's DITA XML and that's important because it needs to be in a format that's recognized, that's used in plenty of places, it's proven. But also a format that's universal that can be transferred. So when you start to want to move content, there's no restriction. It suddenly becomes something that is like liquid. You can move through the organization. I think that's, and it's a very, very, I think you'd agree David, versatile and capable piece of XML.

David Turner

Yeah. Let me address that as well. People are asking us all the time, well, what XML do I need? Right now, in the realm of pharma, there are several XML standards, but they're really more for kind of output standards. They're for a specific purpose, not so much for an authoring standard, if you will. And so, one of the benefits of using a standard like DITA is that it has a large community, it's a good general purpose, it's very hierarchical, and it easily transforms into those others. So if Health Canada has an XML standard, which they're working on, you can transform your DITA into that. For the SPL, you could transform your DITA into that. If HL7 comes out with additional standards, you can transform into that.

Simon Cavanagh

Yeah.

David Turner

You don't have to use DITA, but I think having a standard like that is really, really useful and I'm sure Val probably will echo that as well. 

Simon Cavanagh

Yeah.

Val Swisher

Absolutely. It also makes it easier to integrate other DITA-based tools. A standard schema is really important as well. Agreed. 

Simon Cavanagh

Okay. Then the third top tip, if you're looking for a system, I would put as a single system end to end. So again, you gave that slide, Val, with the core system, the enterprise system in the middle that feeds wherever you want it to out into the organization. I think the more that you can have a single flow end to end where you've got an unbroken workflow, the better your impact analysis.

So, for example, if you have a change or there's some kind of regulatory change introduced, you want to know which documents are affected. It's difficult to do that if you've broken the workflow. So the more that you can keep a single workflow handle in the process for content in parallel to whatever other systems are doing, but the more you can have that workflow handling the process and how that content flows out into other channels, the better because that allows traceability and reuse.

44:11

David Turner

Excellent.

Simon Cavanagh

Yeah.

David Turner

Simon, thank you for walking us through the slides and giving us the idea here. I would just encourage anybody out there who hasn't seen a demo of the structured content functionality in WebCenter to contact Simon on that. I think that's pretty, pretty critical. In fact, it is one of the key steps that I think we're going to talk about here at the end.

With our last few minutes here, we do want to talk about, I want to recap a couple of the ones that we've hit along the way. First of all, I think the first key step that you can take to prepare for tomorrow is you need to start shifting your mindset from this document mindset where I'm managing documents and we've got all these documents that we have to manage to thinking about the components, managing the component pieces. How could we take components, put them together to create documents? How much more flexible could we be with that? How could that change the way that we're doing things? How could that help us to create a reuse strategy? 

All of those pieces. And then the second one is I would suggest that you start building your business case around the benefits of this approach. I was just on a call last week with some other pharma companies. I remember one guy saying to me "Wow! We've been so focused on the patient experience part of this. I hadn't even thought about the fact that it's going to improve our efficiency." And another person was like "Yeah, it's been taking us nine months to make the updates that we need across all the documents. This is going to make it happen in days, not months." And I would say to do those things, one of the main pieces that you're going to need is you're going to need a good consultant, which, so, Val, we'll give you a chance here to just kind of talk a little about how you can help companies with this.

Val Swisher

Sure. Thank you for that slick lead-in to my company. So, this is the kind of thing that Content Rules helps pharma companies with and all kinds of companies on a daily basis. We've been around for 28 years, even though clearly I'm not old enough to have done that. We've been around a long time. We help companies figure out what to do with all that content and how they're going to do it, not just the tools that they use, but creating the content models, creating the taxonomy and the metadata.

Talking about the workflow, working on change management, we do pretty much everything working with the customer. And then these are our services, our middle service content transformation. That's taking your legacy content with help from DCL and getting it into this new ecosystem and environment. So there's lots of things that we want to take into consideration when building a unified content strategy, looking at globalizing it, making sure all your content comes along with you.

We also create content. And then, we haven't spoken much about optimizing content. That is part and parcel of component-based writing, structured content authoring. If we're going to take components written by different people at different times, and we're going to put them together, we need to make sure that we all said the same words to mean the same thing and said them in the same way. It really enhances the quality of all of your content as well across the board if we all use the same style, we all use the same grammar. That really is important. So, I've been doing this a very long time, have worked with several, many, many life sciences companies, many pharma and med device companies. Even some colleges and things like that. So I would be happy to help.

48:15

David Turner

Excellent. I would just say to anybody who's looking at taking a structured content initiative, as you're preparing, it can seem overwhelming. Reach out to Val, have a conversation. She'll help you to get this thing set up into bite-sized chunks that you could start to work through. She can help you get organized. She can help you to build your value proposition. All of those different pieces there.

Val Swisher

You have to have a plan. You have to have a plan. You cannot just do this. You really need to have a strategy for it. Thank you.

David Turner

Absolutely. We mentioned the plan before we mentioned the technology, because we think that that's an important thing. But that said, I still think an important thing that you can do right now, as you prepare, as we talked about before is start investigating what's out there. Every time I've sat in on one of Simon's demos, somebody has sat back and said "Oh! I had no idea you could do that!" So start investigating that. Get the guys at Fonto or get Simon to show you what the Fonto Editor looks like; explore what WebCenter can do. People in pharma have known WebCenter for years for other applications, right, Simon? It's been not just the structured content piece, but you need to check out what's happening in terms of the structured content piece and what's available. With that, Simon, I will let you talk a little bit here about your company. It seems to fit there.

 

Simon Cavanagh

Yeah. Okay. Just a real quick one. We're actually running slightly short on time. I want to leave some time for questions. Yeah, we're a part of Danaher, a US corporation with very healthy turnover and very healthy profits. We have lots of different divisions. As you can see here, we've even got a biopharma division, but don't let that worry anyone. That's no conflict there. There's no competition. Danaher doesn't make any pharmaceutical products. We tend to make devices, medical devices. But in actual fact, we tend to make the machines that make the machines that make medical devices if you know what I mean.

Lots of different companies, lots of different logos, you might recognize like Leica, that's Leica Microsystems, cameras that go into the body, all kinds of different divisions we want to talk about today. But I think what I point out is we work with, actually, that's now eight out of ten. As of March, eight out of ten of the largest global pharma companies in the world and 16, therefore, out of 25. We have a lot of pharmaceutical companies and we've been doing that for many years and we really are about what system, what solution matches and tailors each pharmaceutical customer with a platform that's already there that we configure to meet the solution that can include everything from, for example, structured content, be one of the core capabilities of the system. But there's much, much more as you can see here. I won't spend any more time on that, but just before we, oh, you've got more here, David?

David Turner

Yeah, just a little. I've got one more step and that's just, I think everybody needs to start thinking about what you might want to be moving and who should be moving first. This is certainly something you could talk to your consultant about. But sometimes people are pretty aware. They think "My artwork people, they are really on board. That's where we start." Other people say "It's my labeling people, my regulatory affairs people." Some people say "It's my clinical trials people." Start thinking about where you might want to get started and what you might want to be moving in terms of existing content, and that's certainly something where we can help. We can convert content for a proof of concept. We can convert content for an implementation of a system like Simon's. We can work with you to get that.

52:02

We can also do your SPL work. If you're working in the US and need to give content to the FDA, you can send it our way and we'll convert that for you as well. But with that, I know, Simon, you were about to mention these industry events. So I'll just shut up here and let you kind of pick it up from there.

Simon Cavanagh

Just, just a little bit of a wrap up her today. We've got a webinar, but sometimes you get a little bit more creative and we've been doing this for the last two, three years, and it's gotten quite interesting. I know when I say "industry working group," I get mixed reactions. When you talk to pharmaceutical companies, people sometimes go "gawd, not another one." And other people say "oh, great! What's it about?" It does vary, the response for that. But whatever we call it doesn't really matter. It's not a regularly meeting group, but we've been doing this the last couple of years where we get together on an ad hoc basis. We bring lots of different customers together. Most recently, we did one on the 17th of March, and David and Val both were there too. We had a panel from GSK, Amgen, Novo Nordisk.

I think Astrazeneca didn't make it, but we get a panel of a few customers and then lots of others that join as well, and it really is very much about, about the network and about customers and pharmaceutical companies all sharing ideas, sharing experiences, and really just understanding where we can go together in the industry. It's open for any topic, really, but being, what we do is what we do, so we tend to talk about things like structured content end to end labeling, as you said, Word conversion, David, or what's the strategy in all the topics we've talked about today, but sharing other customers and we do get good conversations and exchange of information. And it really is focused on the customer and on the network and peer to peer conversations. We ran that one on the 17th of March. We're going to run in May and June to be decided, a deeper dive on structured content. We've actually got one on automated artwork, if we've got any artwork people online as well for today's webinar, structured content, deep dive. Anybody that's interested in that, I think we're going to finish the event with a poll. I don't know if you want to call that out now.

Marion Sicre

Yeah, exactly. Sorry, Simon. The poll was submitted. So actually, in DITA, this is, as Simon explained, we are doing deep dive session and we invite you to let us know if you're interested in attending one of our deep dive sessiosn on structured content. You should see it coming up on your control panel. If you can answer, that would be really appreciated. So I guess that concludes our presentation about structured content. Oh, you have –

David Turner

Questions. Do you have questions to ask us?

Marion Sicre

Yes, we have questions. Indeed. So let's go to the question quickly. Okay. The first question: have some of your clients used the SCMS in accordance with the new KASA initiative from the FDA?

David Turner

Well, that's pretty new and I don't think, I don't think that, well, I don't know, Simon, I can't speak for all of your clients; the ones that we've worked with have not been using the Structured Content Management System so far. They've been using this more in terms of kind of with their SPL vendors, et cetera. Are you aware of any of that, Simon, with you guys?

Simon Cavanagh

Of the what? Sorry, David. 

David Turner

The KASA Initiative.

Simon Cavanagh

The what initiative, sorry?

55:58

David Turner

Okay. It sounds like... I don't think you have that. I wouldn't worry.

Simon Cavanagh

Say it again, David? Sorry.

David Turner

It's K-A-S-A.

Simon Cavanagh

Oh, sorry. I can hear you now. I can hear you. I've not come across that one, sorry. No, don't know that one. Yeah.

Marion Sicre

Okay. Let's go to another question. Here is an interesting one. What if a health authority makes a change in the required formatting for a certain document. Is the SCMS alerted to this change and automatically changes the format of the published output for the health authority?

Simon Cavanagh

Well, it won't do that automatically, but obviously when there's a change, we need to incorporate it. You were going to say something, Val? Because I think templates is close to your heart, isn't it?

Val Swisher

Yeah. Yeah. So a lot of it depends on the change. Again, the SCMS isn't going to know anything automatically. It's going to take a person. But often the kinds of changes that are being made are not necessarily something that we have to reprogram in that a lot of times it's moving sections or adding sections and the models already exist. It's a matter of making sure that we put the content in the correct order, which is really super easy to do. Other kinds of formatting might require a change to a cascading style sheet. That's, that's the form that is used in the structure content management system that says "oh, this is supposed to be Helvetica 16 point bold, left, justified," because we're writing without format. So I think it depends upon the kind of change as to even if, if there's much to do at all.

David Turner

I would just add we all see the word "automatically," oh, no, no, no, we – it doesn't automatically make the change, but once you get the email and it says "Hey, we're going to make this change," your programmer goes in and he says "okay, we're going to fix this. We're going to change the style sheet," or whatever. And then at that point, then yes, it can automatically apply those changes to your published output. That's where the automation happens. It's really there on that piece. Yes, it can happen automatically there. It doesn't automatically just create it. Somebody's got to change the style sheet, but then once that's changed, it can automatically do it for everything. Next question?

Marion Sicre

Perfect. Thank you. I think, unfortunately, we don't have enough time to go through a next question. This said, will make sure we'll come back to you and answer to all of the questions that we have received. If you want to continue asking questions, you can also contact us at hello@esko.com and we'll be coming back to you as soon as possible. So just before we conclude, I just want to thank, really, Val, David, and Simon for the presentation. Great presentation. I want to thank all of the people for attending. Again, the webinar is recorded so you will receive the recording within the 24 next hours.

So, again, let me thank you, all of you, and thanks a lot for your special effect animation, Simon, again, with the disappearance and reappearance. That was great. Thanks again, enjoy the rest of your day and we hope to see you next time. Bye, everyone.

Simon Cavanagh

John and Lukas, we saw it. I've got your questions and we will come back to you on that John and Luke. We know. We'll come back to you on those questions.

David Turner

Okay. Thanks, all.

Val Swisher

Bye now. Thank you.

Marion Sicre

Bye, everyone.