On-Demand Webinars

Webinar Transcript

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Marianne Calilhanna
Hello, and welcome to the DCL Learning Series. Today's webinar is titled "Technology and the Life Sciences: Tool Selection, Systems Implementation, Data Migration and Security." My name is Marianne Calilhanna, I'm the VP of marketing at Data Conversion Laboratory, and I'll be your moderator today. Before we begin, this webinar is being recorded and it will be available in the on-demand section of our website at dataconversionlaboratory.com. Please feel free to submit questions at any time. We're going to try to save some time at the end to answer those questions. And I just want to say that technology plays a very critical role in the life sciences. Accuracy, traceability, compliance, along with speed to market, is critical. Improving content and data management, IT systems, compliance, and program management streamlines research and the drug development life cycle.
 
So Data Conversion Laboratory, Court Square Group and JANA Life Sciences, we all came together to develop this learning series and address how technology can contribute to your success. This is the sixth of seven webinars in our series. You can see the other topics listed here on this page. All of this information is on one area of our website, and we're going to push that URL out to you right now if you want to catch up on others or register for our final webinar in this series. So I am thrilled to have today's panelists here today. We have David Turner, consultant and head of partnerships at Data Conversion Laboratory, Keith Parent, CEO of Court Square Group, and Ron Niland, President of JANA Life Sciences. Welcome so much, gentlemen. 

 

Ron Niland
Thank you.
 
Marianne Calilhanna
Before we begin, I just want to give a real quick overview to Data Conversion Laboratory, or DCL, as we're also known. We've been in business for 40 years and we like to say our mission is to structure the world's content. DCL services and solutions are all about converting, structuring, and enriching content and data. We are one of the leading providers of XML conversion services and an industry expert with SPL conversion for some of the world's leading global pharma companies. So if you have complex data or content challenges, we can help. So now, Keith, can you tell us a little bit about Court Square Group? Keith, are you there?

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David Turner

You're on mute, sir, I think.

 

Marianne Calilhanna

Yeah, there.

 

Keith Parent

There we go. I was talking but you saw me moving there. We are an audit-ready compliant cloud provider. We have a cloud environment that has our environment that can host multiple applications within that environment, anything that, from a life sciences perspective all the way from preclinical, all the way through clinical into manufacturing. We do a lot of work in clinical trials, particularly around document management systems and systems for holding electronic content specifically for regulatory submissions. So if anything like that is what's needed, we can do all of that. We also have what we call RegDocs365, which is a qualified and validated content management solution specifically for clinical trials and for submissions. Okay, onto the next. Ron?

 

4:17

Ron Niland

Thanks, Keith. And thank you very much, Marianne, for enabling us at JANA Life Sciences to take part in this webinar series. We really appreciate it. As a company, we're 48 years old, we're third-generation family owned. We basically do technical services that run the spectrum from technical documentation to the aspects of quality and compliance and operational excellence that sort of are the umbrella that overarch much of what we do. We do project and program management and we do IT systems as well. We work with a variety of standards and formats including XML and DITA. We have project managers at the heart of each and every project that we do. We're ISO 9001:2015 compliant. And we're currently undergoing certification for ISO 13485 which applies to medical devices. So I appreciate the chance to give you an overview, and thank you again, Marianne.

 

David Turner

All right. Well, let me pick it up from here and just kind of say again, thank you, everybody, for coming. One of the things that we were going to be talking about today is we've talked about– we're talking about the tool selections, we're going to talk about systems implementation, we're going to talk about data migration, all these pieces, but I wanted to kind of get into it. First, I was just making sure you kind of understand the perspectives of those of us who are on this call. So Ron has been in pharma for years and years and years, and actually, Ron really only recently, to the vendor side, right? You actually served– you actually, in the life sciences on the client side for most of your career, is that right?

 

Ron Niland

That's correct. Yes. I've had the good fortune to work with a variety of companies all at the headquarters level with Pfizer in New York; Amgen, Thousand Oaks; Genentech in south San Francisco; and Gilead Sciences, among some of the companies I've worked with.

 

David Turner

Excellent. And then you look over here at Keith, and Keith has this environment where he has seen so many different pieces of technology in the pharma realm for so many years, probably more years than you're wanting to admit, right, Keith?

 

Keith Parent

So we've been in business for 26 years. And we started with Pfizer as the first client 26 years ago. And just over time, it's morphed into all sorts of different things that we've done from high performance computing to electronic lab notebooks to hosting SAP HANA in the manufacturing space. So I've seen a lot of the integration aspects of pulling these things together. So the topic for today of all these things with pulling the systems together, it's really relevant for the whole career of what we've been doing with our client base. So I'm really glad that we got through this one and it fits really well into the overall learning series that we put together here.

 

David Turner

And I personally come to the table with, really, from the content side, right? So I've been working with structured content now for more years than I'd like to count as well. And specifically in the realms of component content management and then also with SPL content and pharma content. And I'll also say this as we go into– Yes, while this webinar today is primarily geared towards a life sciences audience, I think a lot of the things that we're going to talk about are also pretty relevant to other markets as well. And so we're not afraid to answer the questions about some other markets as well if those come up. But the way I thought we'd lead into it is let's just start– Before we start talking about here's the best practice for this, here's the best practice for that, let's start by just talking about these trends. So I see a handful of trends here on this slide. Ron, why don't you kind of pick it up from here and talk us through some of these trends and some of the things that you've seen?

 

8:33

Ron Niland

Sure. Precision medicine is increasingly becoming the norm. If I go back in my career like Keith, I've been in the industry longer than maybe I'd like to admit. Definitely it's been 30 years. And having worked in global drug development with companies, but especially in my years at Genentech, where the aspect of a targeted medicine was increasingly the approach taken with biologics, now with genomics as just yet another example of technology and it's the understanding of biology coming up into play, increasingly that aspect of precision medicine is going even further to just totally personalized medicine. And cellular therapy is probably one of the prime examples here.

 

So that's happening on the scientific understanding side, but then what's happening from a regulatory and pharmacoeconomics standpoint as well as actually it's driving this imperative. As we get more global data coming in, those analytics are serving to help the regulatory bodies around the world to understand the value of medicines. So precision medicine is definitely a key component of how companies are approaching their drug development. And toward this end, the idea of an adaptive trial is really critical to help them to understand that particular subset of patients and their ability to respond and in a safe manner to product.

 

Keith Parent

It's interesting, Ron, because we're talking about the precision medicine. I've seen more now with our client base doing stuff with stem cells and I'm actually working with a number of companies now that are looking to put cell processing facilities out there and the whole concept of chain of custody and being able to track a patient's cells all the way from pulling them in, expanding upon the number of cells that they have and then do something with those cells and then sending them back to the patient is really big. And this last year with all the COVID stuff in the adaptive trials, we've got customers that are looking to how do they change the trial midstream because now patients can't get into the clinic and do different things and they're incorporating Zoom and incorporating other technologies to help out, to drive some of that. So it's really important to see what are the tools that we select and how are we working with these customers to try to put some of these things out there.

 

Ron Niland

Yeah, and–

 

David Turner

But I think–

 

Ron Niland

Sorry, David.

 

David Turner

I was going to say I think that it's also from a content perspective, I see things like precision medicine and I think that you've got a couple of problems going on here that are making you need to invest, right? You've got the increasing amount of data, more and more bigger, big data problems. And then you've also got the whole kind of paradox that the more you personalize content, actually the more you need to kind of standardize and make your content modular so that you can start applying content pieces to that. And then even looking down a little further, I think about the content of technology amongst all of this, you're having to make investments there to do this personalization, but then there's also the big piece of regulatory. We've got more and more regulatory requirements with things like Health Canada coming on board, increasing SPOR requirements or IDMP in Europe and on and on. Anyway, so, Ron, what were you going to say?

 

12:18

Ron Niland

So just maybe going back to the aspect of cellular therapy, and what we're seeing there is this chain, if you will, of steps of extracting cells from a patient, bringing them into a facility, manufacturing them, bringing them back. And as I think Keith described, it's sort of, it's needle to needle. And that aspect is sort of a white glove service that's being provided by the healthcare community. It's biologic companies, biotech companies together with those that are providing the healthcare. It could be maybe an academic institution that is really on the cutting edge of cellular therapy. But the point I think that we need to think about is this chain of steps really need to be so well-managed, but especially in terms of the validation of what's happening from one step to the next to have total assurance that as it goes full circle and back to the patient that everything has been in fact done to the rigor of the regulatory requirements and the academic institutions' ethics boards, and what have you.

 

But to your point, David too, with the modularization of the information, right? Because these are very customized, if you will, trials that are happening with patients. In some ways it's like a micronization of a protocol that has to happen and all of those steps. And trying to do it without module or doing a modularization of the content is then going to make it really prohibitively difficult. So I think it's just really important for companies to think about that if they're in that domain and if that's who they are.

 

David Turner

Marianne, I'm going to ask that you go ahead and go to our next slide here so we can kind of continue this on and talk about these trends there. And Keith, you can pick up right there and then lead us into this slide too.

 

Keith Parent

Sure. One thing I was going to talk about was just the fact that AI is one of the big topics here in the industry and what's going on and across the board. I'm actually on a RIM working group right now. RIM stands for regulatory information management, trying to look at different systems in the regulatory world. And one of the things that, as we're putting on these specs, people were talking and said, "We can't make it so FDA-centric because we think here in the US about the FDA." But realistically, to hit on your point before, David, there's so many things going on across the world.

 

Well, one of the other things that we're doing in the RIM working group is also the AI. How does AI affect regulatory? Because right now you don't really think about it as much there. You think about it more with the big data and the analytics early on when they're trying to do high-performance computing early on looking at maybe large images or things like that, and you're pulling those things together. But they all feed in and what's happening is there's just so much more data happening. And with the Internet of Things, we all are using wearables and doing more things as part of a clinical trial, which is generating more and more data to the point where people are even pulling in weather events and things like that, how they affect people's moves and things as part of a clinical trial.

 

So there's lots of things across the board. And if you look at just in this, with the innovation in here, we're talking about real-world data, how is that combined with the data about patients? Adaptive manufacturing, that's again, getting back to dealing with the cells and things like that that we're going to be doing. Augmented reality, I'm working with some– a team out in Denver where they're actually taking the VR headsets and they're actually walking through the molecules, putting those things on. So when you start to look at some of those kinds of things that are happening, there really is a lot of innovation happening now. And the data has to traverse so many different systems that that's why we're a big pusher and that's why early on in the learning series we talked about metadata and we talked about consistency of data because it's so important to be able to use it over multiple systems like that. Ron, you want to jump in on that?

 

16:33

Ron Niland

Yeah. And if I look at this spectrum of innovation and then if I layer it in my mind with the idea of blockchain, all of this information is coming together and increasingly these pieces are being put together where there's a better understanding of what's happening with regards to not just the manufacturer of products, and those could be bio- pharmaceuticals or medical devices, but then the ultimate utilization and the ultimate benefit for patients. And so these are huge datasets that are being mined. And they're being mined by different parties, but including again, the regulatory parties to understand the true safety. With the data that's out there on the internet, if you will, right? Some of this is structured, but a lot of it is unstructured. And the amount of change that's happening in being able to digest that unstructured data is so profound. And the great thing is it's giving us much more transparency into the viability of a product, its safety, its efficacy, and ultimately too the pharmacoeconomic aspects. But yeah, each one of these on their own are very profound, but then when taken together, I think to your point, it's seen as tsunami of data that's coming through and the question is, how do you manage it all?

 

Keith Parent

And I also think that different components are actually being looked at as data. Whereas we used to just think of the numbers that came out of the SAS data sets or the data management group would hand off and we'd be able to put tables together around a drug's efficacy or any of the number of things that we're putting tables together for. We're now also looking at the content themselves. So lots of documents are being used and that's why AI can actually help process volumes of documents way better than just people can ever look it up that much. So that's where this innovation is really starting to take hold of the industry, particularly around things like regulatory and clinical processes.

 

David Turner

So we've got a lot of data, we got a lot of new things to look at here in terms of bringing this in. It's leading to a lot of new systems, which, go ahead Marianne, I think go to the next slide. And what we're trying to get across is that– Go ahead and click to the next one too as well. There's just a ton of system types out there. And a lot of these are systems that maybe we didn't see so much in pharma just a few years ago. I mean, just lots of different kinds of content, lots of different kinds of content management systems, lots of different systems that have to work across each other, which, Marianne, if you want to go to the next one there, leads us to a crazy amount of complexity and we start to have all these different options and all this different functionality.

 

And you begin to wonder, "What exactly do we need? What is it we've got to have?" Because meanwhile, we're trying to produce drugs, not just by IT systems here. So anyway, let's move on to the next slide and let's get in, and let's talk about some of the things that come into play, some of the factors that come into play, some of the questions to consider. And I'll leave it open. Well, here we'll start with Ron again this time.

 

19:58

Ron Niland

Sure. So I think when we look at systems today, they're increasingly large and increasingly complex. I mean, I don't have to tell you that. You know it and you see it through things like Microsoft, which started at very specific applications like Word or Excel. And now today you have Office 365, which literally has dozens of applications that are running together to some degree in a woven manner where you can then get analytics on the backend business engine. But the fact is that each one of these major systems or platforms is then competing, if you will, to some degree or another, with the next. For instance, if we look at the aspects of enterprise content management, this is an aspect that increasingly companies are thinking about and trying to sort of tackle, if you will, but they've got all these different data repositories. And then the question is like, how do you get above that and how do you sort of create a taxonomy for your organization? How do you create an understanding of the metadata so then you can bring this data together and manage it more at an enterprise level, as opposed to down at that individual document level?

 

And so it's sort of like continents shifting, if you will, or plates shifting on the globe, and then when you think of the data, it's like the water. You've got this ocean of data, but you want to create these unique data streams or data lakes, and then really to distill it so that you can analyze it and develop insights to that information to help you to understand how to go forward. So there's an aspect of then bringing these together. And in some ways you need to migrate data and huge volumes of it. In other ways, you need to homogenize your data and then seek to integrate it. And that's a huge task in and of itself that does require you to operate at a much higher level within the organization. I think that's one of the biggest challenges that many companies will have, is they're trying to sort of shift, if you will. And it's a paradigm shift from individual document management to that aspect of enterprise management.

 

Keith Parent

Well, Ron, to talk to some of the– to sign off of some of them, Ron, one of the things I was thinking about, I was just looking at even this one slide in front of us. When you start to think about multiple systems and how they interact together, part of the tool design that you want to look at is: how are my tools going to fit together? When I look at a roadmap of the different systems we need to put in place, we know that we need certain systems at certain times when we're developing our environment. However, we want to make sure that they interact together as well. And part of that is just even on this one screen.

 

When you talk about content management, that content management could feed into a RIM system, which then also can tie in directly with the labeling and the artwork management because you're going to make sure that whatever's showing up on the labels for the patients tie back to the data that's in the content management and in whatever gets submitted to the regulatory authorities. So all of these things kind of work hand in hand. So when you're dealing with any of these systems, you've got to think about the other departments or the other areas within the company. That's where kind of an overall strategy comes in and being able to work that out, I think, to that point. David, you were going to jump on something?

 

David Turner

Yeah, absolutely. And I was going to also add that you see content management in here, whereas we used to see the term "document management system," and even still a lot of, I think organizations are still thinking of their content just in terms of that full document format. So back to what we talked about even earlier, the whole concept of then let's break that down into the modular components, let's think about component content management, let's start applying metadata at those levels so we can reuse those pieces so that we can make so much more of what we've got. And again, not just to meet a regulatory requirement.

 

24:09

I think that's been the biggest difference in our business lately with some of these systems, is companies used to look for a system where they could just store the SPL file that they submitted to the FDA. And so they didn't really care about XML or anything. They would hire a company like us to just create that at the end, submit it just for regulatory. But now companies, I think, are starting to think, "Okay, if I'm going to get a new enterprise content management system, maybe I want to start managing this where I can manage those components instead of everything just at the document level, so that I can start maybe reusing content across a clinical trial, or so maybe I can create my own SPL at the click of a button by synthesizing it together into a document." So I think that leads to a lot of the things that you're trying to pick here.

 

What are some of the questions that, if you guys sat down as a consultant with somebody that was trying to pick a solution, what are some of the questions you might ask them or what are some of the things that you might tell them that they need to consider as they're picking the right tools?

 

Ron Niland

Well, I think some of the first questions would be whether you're looking to develop something that is on premise, in the cloud or hybrid. Increasingly companies are looking to go the lightest way, re the cloud. But that may or may not be the optimal solution in some cases. Obviously that's an easy question. There's this aspect though of internal versus external. When you look at this sort of information that you need to manage, to what degree do you manage it internally or in collaboration with external parties? And that is something that's really critical to understand as well as the companies they're partnering with with regards to that data. And it may be a multitude of companies, and those companies today may be, let's say, a small set but maybe in a year or two, they anticipated being a much larger set.

 

And I think it's really critical to think about that because you need to be architecting to where you have the ability to collaborate and integrate information across systems and across companies. And those companies that can do that better or best are going to have a significant competitive advantage.

 

Keith Parent

And I think also, Ron, on that point, I think that there are a lot of companies that will actually have their vendors providing the systems because they're using those systems. But then all of a sudden, when a trial is over, they have to get that data back, they don't have a system to put it back into it and now they've got to think about, "Well, how am I taking that data back?" Whether it's trial master file data or other data that they're going to be pulling back. So that's where you really have to talk to them and say, "Okay, what is your overall roadmap and what are we looking at? Who is providing what service today and where do you want to be tomorrow? And what happens with the next trial and the next trial after that?" So those are some of the questions that we get into as to where is all the data coming from and how do we integrate that stuff together?

 

Ron Niland

And you touched on one aspect here too, in terms of partners and maintaining data that's at a certain juncture. But as we know in the industry, sometimes you have a 10, 20, 25-year expectation for regulatory bodies to be able to go back and look at your data. And then the aspect of archiving that data and having it managed in a validated state is really important. And by the way, just going back to some of the basic questions, right? To what degree does this need to be validated? Who is going to do the validation? I've seen several companies even more recently get caught in a pinch where they had a presumption that a major company was going to do the validation of their system. But the fact of the matter is the onus rests with the individual companies increasingly to do these kinds of things. And that can create a little bit of a snag if you will, in terms of being able to implement the system as quickly as one might like.

 

28:34

David Turner

Well, honestly, I think we could probably spend an entire webinar just on this topic, but I think we do need to also talk about some of these other things. So once you've selected a tool and you decided you're going to be moving it forward, what are some of the things that you need to think about in terms of systems implementation, systems integration, change management... example? Or actually yeah, and here for this particular example, if you're wanting to deliver modular content to the end user, what is it you need to be thinking about?

 

Keith Parent

So I think the number one thing is when you're implementing a solution you've got to look at, first of all, how is it going to get end to end? So from the beginning, all the way through the end, what are the tools that are going to be used by the end-user or the series of users along the way? If it's an adaptive trial, are they going to be using an ePRO, are they going to be using a tablet, are they going to be using iPhones, a hand phone, phones, smartphones? Where is the data going to be stored? If it is, to Ron's point, if it's a cloud based or an on- premise based solution, how is the data being captured?

 

When you're doing the implementation, are you using the proper dev test prod construct that'd be able to put things down and promote from within? To get to Ron's point earlier about validation, typically you're going to put together the user requirements specs around it, and you're going to make sure that the system fits all of the requirements that you're identifying in a trace matrix to put together when you're putting that system out there. So the concept of an implementation, make sure that when the system gets implemented and you're running through your IQs, your OQs and your PQs, you're going to want to make sure that end user is seeing exactly what they should see based on the test plan that you've put together.

 

Ron Niland

So to add onto some of those thoughts that Keith was sharing there, I would say that with the complexity of the systems increasing and the multi functionality, if you will, of these platforms, there's this question of, to what degree do you adopt the different component parts of that platform? And perhaps it does make more sense to have a phased adoption over time where you say this has six different component parts to it today; maybe in a year, it may have 12. And–

 

David Turner

Marianne, skip to the next slide.

 

Ron Niland

And maybe at the outset you might be just thinking to just adopt three or four of the six that are available and then in a year's time, maybe you're at the point of a half dozen or more. So a phased approach is one thing that I would be advocating for. And another aspect is just the profoundness of change and change management. And often this gets overlooked. And I can tell you again with recent examples, I've noticed that there's the tendency to focus on the shiny object, which is that software, that tool, and to get it implemented as quickly as possible.

 

But the most critical nature element for one to think about is the aspect of one's ability to use that system and to have the reinforcement of their knowledge so that they are adherent to the system and the process. And I think the process is the key word here, really trying to understand the business process and to ensure that from a user perspective, that this system has been configured to best meet or align with the processes that the company envisions the employees utilizing.

 

32:41

And often there's a bit of discordance here where people might say, "Well, that's the process, but this is the way we do it." And as you're adopting a new system, it's a chance to sort of clean the house, if you will, and get those things in order and to align the technical documentation with the way, in fact, the systems will be operating. And so your standard operating procedures in your work constructions, I think, are something that are also overlooked with the implementation and change management.

 

David Turner

So Marianne, I think go to that next slide on change management. I definitely want to hit on this in a little deeper perspective. In my history, I used to work in the technology field. And it's funny, if you interview people after an engagement, usually if something ever fails, they always tell you, "Oh, well yeah, that product just didn't work." Or, "This whole initiative, it was just a bad idea." But for more of a consulting perspective, when you step back and you really look at these things, it seems to me most of the time when initiatives fail, it's because of a change management issue.

 

It's because people were not brought on board in the right way. They were given too much at one time, or maybe they didn't get the content right. You guys have both dealt with change management a lot here. What are some of the things that you've done with both content and technology to help get users to stop pushing back and instead jump on board?

 

Keith Parent

Well, I think there's two different things you have to think about with change management, David. One of them is change management can be an IT or a technology related question, and then change management is also a people related question. So two things that happen in both of those regards. So on the people side of things, we always try to find who is going to be the champion or who's going to be that person who's going to be the primary person within any one department that everybody else looks up to that works with. And we work with them so it's almost like a train the trainer type approach that you know that those people are going to go to that person, that you find that internal champion to work with.

 

And then on the technology side, when we look at technology, people hate change. There is no doubt about it. People hate change. They understand where they're at. So when you first go in there, you look at– you kind of ask them, "What do they do today? What are their process today? What are they going to?" And you try to figure out, can I replicate something that they were using so it becomes familiar to them so it makes it easier to adopt something new, or is it just kind of a– sometimes you go into these places and people will say, "Okay, forget it. Stop using that one, we're going to start using this." And those are typically doomed to failure because people just rebel against some of those things. So when I look at technology and I look at people, I try to figure out what were they doing, how do they do it? How can we take the new system and kind of mold some of what we're doing to help them kind of ease into the new system? So that's a tack that we'll take a lot when we're doing that. Ron, how about your experience in that?

 

Ron Niland

Yeah, I mean, you touched on some of the very elements, the aspect of really understanding whether you have stakeholder buy-in, whether you have the champions at the different levels in the organization to effect the change. If you're talking about something that's much more enterprise-level, then you need the stakeholders bought in at all levels. If it's just within a department, that's something different, right? But I think there's the aspect of understanding how much skin people have in the game. This is where it's a very helpful exercise to go through and talk about the basics of what are we looking for in terms of those capabilities and really to get the end users to weigh in on the user functionality. And then at the same time, to help them understand the benefits of the future state. Yes, enterprise content management is a heavy lift for an organization, but what are the benefits? Well, the benefits are people will be so much more efficient they will be able to develop documents with a modicum of effort.

 

36:56

It's a 90-degree shift in terms of creating modular content, but you are able to move at Mach 3 with parallel publishing and document production if you're embracing the enterprise content management. So I like the idea of reverse engineering in some ways, just getting there with the users right at the outset and say, or ask them the question of, "What are you looking for? If it were the ideal system, what might that look like?" And help them articulate that. And that helps them to sort of understand what they may be looking for in a platform or an application.

 

David Turner

And my two cents on this, I look at this and I think one of the biggest things I would focus on is the champions piece that Keith mentioned a minute ago. And I would say champions as opposed to a champion. Way too often, you get a single champion in a company and that person may get the whole initiative pushed through. But then if they go to another organization a year from now, you might find your implementation in trouble. So you want to really focus on developing champions so that if somebody does leave the organization, you've got somebody to pick up the mantle and run with it.

 

And then the second part of that is a good consultant, a good outside consultant. It could be worth their weight in gold. It's just having somebody who can, first of all, bring experience from other companies that you might not be able to see and that perspective, that bigger picture is enormous. But secondly, a lot of times they can have hard conversations. They could point out things that maybe aren't politically correct for somebody internally to point out or bring up.

 

And so sometimes they can ask the hard questions or they could push the hard things through with their expertise. So we all three know some good consultants in the industry so if anybody has questions on that or wants to follow up, we can certainly talk to you about your project and help you know some good consultants like that. So anyway, again, we could probably spend an entire session just on this one, but we need to talk about data migration now. So let's move on and let's talk about data migration, certainly is a piece here. You've got– actually, just go back, I want to talk about the– I just want to talk about data migration by itself first before we start talking about the personalization.

 

We do a lot of work in terms of helping people migrate data, in terms of getting their content in the right format. You've got typically a lot of issues to think about in terms of how are you going to move this data, how are you going to get it to us? Is this going to be FTP, is it going to be passing us a hard drive? Is it going to be whatever. There typically are some aspects involved with, you need to digitize the data. There's a whole aspect involved with trying to analyze the data for potential reuse. As we've talked about this idea of modular content, breaking down what used to be just documents into their component parts, and then trying to reuse as well. You need to figure out where is there potential for reuse. And so we have some tools that can help with that here at DCL.

 

40:18

And then also being able just to kind of understand where it's going and what it's doing so that you can get an effective migration and make sure that you get the metadata right. Because sometimes the way the metadata is treated in one system, if you move to a similar system, even if you're moving the same kind of formats, the metadata might be housed differently in the new system. And so you got to be thinking about that and map things appropriately. Ron, I'll go you first again here. But before we get into the whole personalization thing we're going to talk about in just a second, just in general, what are some of the best practices you would recommend in terms of data migration?

 

Ron Niland

So the first thing is to ask whether that data needs to be managed in a validated state. I've seen some situations where people might port data from one system to another, let's say system or area, right? Of information management. And it gets compromised. It's not managed in the same validated fashion, if you will. Maybe they're not controlling the access of that data just as an example. So the aspect of the chain of custody of that data needs to be just really well understood and managed.

 

I think there's another element too, is the aspect of redundancy of data. When I've worked with companies and we're looking at documentation, often it's like going up into the attic, I call it the electronic attic. And you never know what you're going to find there, but you find all this– a wealth of information, but a lot of it is redundant. And I know DCL have tools in terms of the Harmonizer to be able to view documents and compare one vis-a-vis another to see whether it in fact is redundant or to what degree it might be redundant. So the redundancy is an element and then there's the other dirty word called dirty data, like dirty documents, dirty data that may be– that needs to be better understood. And then decisions need to be made as to how that gets managed within the pool, if you will, of data and whether maybe some data needs to be extracted because it doesn't meet certain standards or needs.

 

David Turner

But Keith, you've obviously have seen a lot of systems and have dealt with a lot of migrations. What would be some things you would add here?

 

Keith Parent

There's a couple of things that I would think about right away. One, is that a one-and-done type migration or is it an ongoing migration? Am I working with a CRO that's going to be a multi-year study and every couple of months we're going to be pulling data in from that group? So those are kind of things that we think about. If it's a recurring process, do we treat it a little bit differently? To Ron's point, you have to make sure that everything that we do on a migration perspective is also validated. So your validation, you have to validate the migration process and make sure that you understand that it's going to migrate the data the right way.

 

You're checking it, you're looking at your check sums and all the different things you're going to do to make sure the data comes across correctly. So I think those are a couple of really key areas there. One of the technology trends we talked about with AI, and AI can help out a lot in data migration, particularly if you can use some AI techniques to be able to do natural language processing of content and maybe automated metadata tagging, things like that. That's where some of those things really help out a lot when you're moving data from one system to another. Another could be based on where the source data's coming from.

 

43:56

Do I need tools to basically take what looks like a document because somebody sends me a document, but it's really an image file because somebody scanned it in on a scanner and they never OCRed that. So I can't see it. So you didn't use optical character recognition on it, it's actually not even a searchable document. You can't find the data that's on that, there's tables on it that you can't read. You can actually read it if you print it out and look at it and if you look at it online, but when you go to search through things, you can't find it. So automatically OCRing of certain things and bringing data in and classifying that data based on what the content is.

 

Those are tools that I see that we're starting to use a heck of a lot more within data migration specifically to make your life easier and to clean up that data as Ron was talking about, take that dirty data and make it cleaner for the system that you're putting it into. So those are huge things you have to think about. And there's lots of systems out there and lots of migration. Sometimes we even automate the migration process by having automated tools. It may automatically, as soon as people put some things into certain folders, all of a sudden it gets automatically transferred from one place to another and put into the right place. Those are some of the things that we can do as well. So in my mind, I think that that's a great place for technology to be able to help out in that regard.

 

Ron Niland

If I could just add, David, just one quick other point here, or two. One is the aspect of that data in its analysis. And if you are in fact, migrating from perhaps one system or platform to another, at what point do you make that switch for the organization to then go from the analysis in that one system or the other, or is there an overlap between the two? And I've seen that happen in some cases for sure. And the other element here is then just going back to the aspect of having archived data managed in a fashion that's going to last through the years. If you are in fact, migrating a large cube of data, let's say, and it needs to be accessible to regulatory bodies 10 or 20 years from now, there's a question of, do you have the key and the lock to get into that data? So that's something that, if you're thinking about, you need to construct that box for that cube of data to go into so that a data scientist will be able to open it up 10 or 20 years from now and be able to sort of analyze it, if you will.

 

David Turner

Marianne, I want to make sure we get to the topic of blockchain today. So let's get through this part here on this slide. I do want to just emphasize that we do have data from a multitude of sources and that is certainly something that you've got to be thinking about when it comes in. But let's move in and let's talk a little bit about the quality and security piece of this because I think we're seeing with all of this, that the idea of quality and security is going up and up and up and up. Things aren't getting any easier, things are happening more and more worldwide. So Keith, we'll let you go first this time. What are the big things that you think we need to think about in terms of quality and security when we're getting a new system?

 

Keith Parent

Well, at this point, I think there's a couple of things that we have to think about, particularly we talked a little bit earlier about regenerative medicine and needle-to-needle processing. If I'm going to be taking a person's cells out of their body, doing something to those cells, and putting it back into their body, they're going to want to make sure that's their cells going into their own body, right? So the concept of blockchain, which was really something that kind of grew out of the financial world to track monetary transactions now can be used and is being used on a much more wide basis to track those kinds of things within our industry.

 

And I think that that usage is going to continue to grow and continue to drive. And there's a security around the fact that you know that that data has a chain of custody all the way through, and that's what that blockchain is going to help to provide for that. And from a security perspective around data being compromised and things like that, we, within our honorary compliant cloud environment. have to make sure that security is one of those main tenets of everything that we do because the last thing you want is anybody to have access in or be able to get to these things. And now that we've got many more companies working together with external partners or other vendors that they're working with, the security aspects of being able to do that with single sign-on and all the different things that we deal with is just right to the paramount process of being able to work with these multiple companies. Ron, how about you?

 

48:55

Ron Niland

I would say that there have been track-and-trace capabilities that have been applied to different sectors like the food industry and for years, right? If there's a recall on a thousand pounds of beef, we all know about it. We hear about it in the news within 24 hours. And that sort of speaks to what's happened, in some ways, in the back end of things with regards to sort of the Internet of Things and sensors. The whole chain of custody of biopharmaceuticals today is being managed, tracked, and traced all the way down to understanding where pallets are moving within a few feet around the globe. But the regulatory back end of things is really what's also driving this and it's the IDMP, the identification of medicinal product. Governments know that the pharmaceuticals are being produced in over 150 countries. And the question is where all these ingredients coming from, the excipients, the active pharmaceutical ingredients and whatnot?

​

And they need to really understand that what people are saying is going into these products are in fact just that. And so the identification of medicinal products is a global harmonization sort of effort to really understand what is being offered in a product all the way down to enabling regulatory bodies to compare one product vis-a-vis another in terms of its whole offering, if you will. But including, again, going back to the aspect of understanding the safety and efficacy all the way down to a milligram-per-milligram level for different compounds just as an example.

 

David Turner

Well, and I think we're also seeing the whole trend here of needing this information to combat the counterfeit drugs that are in the world. I was reading an article this week that Hindawi had put out a couple of years ago, and there was an estimate of something like 1 in 10 medicinal products in developing countries are fake and that roughly a million people each year lose their lives because of falsified medicines. And being able to put this kind of security around so that that kind of thing can't happen, I think, is huge.

 

Keith Parent

But I think, David–

 

David Turner

So let's– go ahead.

 

Keith Parent

To that point, David, I'm working with a company out in Ireland right now that basically a company called PRONAV Clinical that, they're actually– part of their job has to be to look at the clinical supply chain for phase one. When you're in phase one, phase two trials, they've got to make sure that the companies that they're dealing with, they've got to go through and qualify all those vendors. They've got to look at the way that they're manufacturing. And if you look at the whole supply chain, they've got to qualify that whole thing and validate that whole thing before they can even think about putting a drug out there for a patient. So that's when you start to talk about quality and you start to bring in the security aspects of some of those things. There are companies out there that that's what they do, and that's their goal, is to make sure before it gets you. And something in Europe that we don't have, the QP, something that will actually– they're the ones that are responsible for releasing those lots and making sure they can get out to different countries. And those are things that I think about when I think about the quality aspect of this.

 

52:29

David Turner

Before we get finished, I do want to jump in and hit on that blockchain slide. I think people hear the term block chain and a lot of people will say, "What is it?" And so I guess Ron or Keith, either one can pick up on this. Talk to us a little bit how blockchain works in pharma and how this is going to contribute to the overall quality and security here.

 

Ron Niland

So there's a company here in the Bay Area of California. They've been in the aspect of track-and-trace for several decades now. They've initially started in the food industry but they've been in biopharmaceuticals now for the last decade. And they work in a sort of a multitude of ways, one of which is with regards to the track-and-trace of product going from one logistical point to another. They've got sensors that are developed that can go in to containers that can understand temperature and humidity, the degree to which even the material may be disturbed or shaken. And that's just one small component part.

 

They've then extended their offering to focus on the idea of IDMP to then look at all the individual ingredients coming together in a pharmaceutical product as an example, and to have that sort of ERP-like system, if you will, that helps a manufacturer to understand that the whole chain of procuring those ingredients and then ultimately dispensing them. But this is just one of many companies that are out there. And it's, again, it's just sort of another factor in the Rubik's Cube, if you will, that we're trying to solve of, okay, we need processes and systems. And blockchain is definitely one of the most critical component parts, and it may drive more of the discussions going forward as to platforms of consideration. Earlier on I was talking about, hey, is it an open or a closed system? Maybe it's more like this is fit into the blockchain or not? Anyway–

 

David Turner

Keith, anything to add?

 

Keith Parent

No, I just think that I'm getting asked more and more about it. I think that some of the other systems that we have out there that don't have it built in, it's not something that you see that often in some of the systems. But the more we get down to focusing in on the patients or focusing in on that track-and-trace as Ron was talking about, you're seeing it incorporated almost daily in new technology. So I think it's to be something we're all going to have to learn a lot more about going forward because it's here to stay.

 

David Turner

Excellent. All right. Well, I think we're about to move into some closing thoughts here. We did get a couple of questions. I think we have time for one here. So we'll throw it out here. And Keith, I'll go to you first and then Ron, you can chime in after him. But the question is: What comes first, the shiny object or content/ data strategy and implementation? That is, do you buy the ECM first and then deal with the content, or vice versa?

 

Keith Parent

There's a couple of answers to that, one is it depends on the senior team and how much they like the shiny object. And typically they'll bring the shiny object in and then you're stuck with kind of developing a strategy around it so I see that far too often. A lot of times you'll get senior management that comes in from someplace and they say, "Oh, we have this system, let's get this one." And they bring it in and all of a sudden, the rest of the group has to figure out how to work with it. In my mind, it always comes with the strategy first, laying out that strategy, identifying what it is you're trying to do, and then looking at your requirements and going from requirements forward. If you do this, the shiny object, then you build, then basically what you do is you build around that object and a lot of times that's where things fail. So I would always go with the strategy first and driving the requirements first.

 

David Turner

Ron?

 

56:47

Ron Niland

I, first off, would agree with pretty much everything that Keith said. There's another question that I like to ask companies, and that is, are you ready for this? Because it's easy to think that the solution resides in a new tool or maybe sort of a new approach like enterprise content management. I think there's the question though, as to whether the business is ready for it. In some ways, systems are often thought of and presented to the business by, maybe, IT. Sometimes the business functions might be going to the IT group, but it's a dovetailing that has to happen. And then the question is, if it is a dovetailing, whether both sides of the drawer are ready to do it.

 

And the reality is sometimes the business isn't ready to do it. There may be pressing regulatory filings as an example, or major studies coming up, and maybe the organization's growing by leaps and bounds and they don't have the resources. So if I go back to David's point earlier, it's nice to bring in other parties and, not to pitch too hard here, but if you can't do it within, you need to supplement it. And if you feel that you need to do it, having consultants may be part of the solution for sure, just to ensure that those two folds of the drawer come together and they don't collapse, if you will, because one is bringing in more pressure, more resources, more capability, more desire than the other.

 

Keith Parent

And Ron, sometimes you may want to bring in those outside parties, not to do the new work, but to do the old work so that you can do the new work, so that your people can free up their time to do the new stuff so somebody else will outsource or have somebody else doing the stuff you were doing specifically so you can embrace the change and bring in the change management we talked about earlier.

 

Ron Niland

I couldn't agree with you more there, Keith. I mean, technological revolution is here. And the fact of the matter is people in companies and those that are paid to do the engineering, the design, and the product development, they are the lifeblood of the companies. And they're going to be much– the companies will be much better served if they're helping to innovate, to enable them, those companies to, say, on more of the cutting edge. And yeah, to your point that maybe have reserves come in and manage some of that more perhaps older work, or what might be seen as less exciting for some of these people that want that newer exposure too.

 

David Turner

And I think that's our alarm that we have run out of time here. So I guess with that, I need to turn it over to Marianne and let you close this out.

 

Marianne Calilhanna

Thank you. So yeah, we could keep talking about this, I think, for quite a bit of time. But we will continue again on September 30th with our final webinar in this series. I do want to thank everyone who's taken time out of their day to join us. Please keep apprised of upcoming webinars in this series. You can visit dataconversionlaboratory.com/webinars. This DCL Learning Series is put together for folks like you to continue this conversation around things related to content structure and markup. Thank you so much for your time and we'll see you at the next event. This concludes today's program.

 

Keith Parent

Bye, everybody.

 

Ron Niland

Thank you.