Life Sciences IT Systems: Cloud, Compliance, Regulatory

Webinar Transcript

[Marianne Calilhanna] Hello, everyone, and welcome to the DCL Learning Series. Today's webinar is titled "Life Sciences' IT Systems: Cloud, Compliance and Regulatory – All Together Now!" My name is Marianne Calilhanna, I'm the Vice President of Marketing at Data Conversion Laboratory, and I'll be your moderator today. Before we begin, I just want to let everyone know this webinar is being recorded and will be available in the on-demand section of our website at dataconversionlaboratory.com.

As a reminder, you can submit questions at any time today. There's a questions box in your GoToWebinar control panel. There's also a chat feature, so feel free to use either one. If you're having any technical difficulties, you can use that chat. And Leigh Anne is here to help troubleshoot. And we will save 15 minutes at the end to answer your questions.

1:11

Just want to take a minute to say a few words about this series. Technology plays a critical role in the life sciences where accuracy, traceability, and compliance, along with speed to market, is critical. Improving content and data management, IT systems, compliance, program management, all of that streamlines research and drug development. So, Data Conversion Laboratory, Court Square Group, and JANA Life Sciences all came together to develop this learning series for you, to address how technology can contribute to your success. This is the fourth of seven individual webinars. The other topics are listed here, and today's webinar is about your IT systems and infrastructure.

Moving from a closed internal system to a cloud-based system requires that you understand the support models from your external vendors, rather than rely on your internal IT resources. It's imperative to maintain quality and compliance while shifting that responsibility to others. Reconciling multiple cloud environments, and how to most effectively use them while ensuring secure access enables successful interoperability. By the way, you can catch up on previous webinars and see what's upcoming for this entire series on our website. And Leigh Anne is going to push that URL, that URL out in just a moment via the chat.

2:56

I'm delighted to introduce our panelists today. We have my colleague, Tammy Bilitzky; she is CIO at Data Conversion Laboratory. We have Ron Niland, President, JANA Life Sciences, and Keith Parent, CEO of Court Square Group. This webinar is brought to you by the Data Conversion Laboratory, or DCL, as we are also known. And our mission, really, is to structure the world's content. Our services and solutions are all based on converting, structuring, and enriching content and data. We're one of the leading providers of XML conversion services and an industry expert in structured product labeling, or SPL, conversion for global pharma companies. If you have complex content conversion challenges or data challenges, we can help.

All right, I'm going to turn it over to Keith from Court Square Group. Hi, Keith.

4:05

[Keith Parent] Hi, folks. Thank you for coming out today. Court Square Group, we're a leading provider of audit-ready compliant cloud architecture. We host numerous applications within our environment, and our goal is to help those companies that have on-premise versions of software, and be able to think about cloud-first strategy, kind of moving toward the cloud. Our goal is to help you look at all applications and how they integrate together.

So, we're really proud to be part of this series with DCL and with JANA Life Sciences, because we think that not only is the cloud important to what you're going to do, but the software that's going to run in that cloud, and how it integrates with everything else, is going to pull things together. We also have our RegDocs365 qualified and validated content management solutions that are a big basis of some of the learnings that we've had for this learning management series. Now, on to Ron.

5:01

[Ron Niland] Thanks, Keith, and thank you very much for joining us as well. I'm working with JANA, JANA, Inc.; it's a company that was formed in 1973, and we are focused on technical services, so our 150 or so technical writers, program managers, and engineers work on technical documentation for some of the world's largest companies, and with a very significant focus on technology. We not only do technical documentation, that includes aspects such as user manuals, maintenance manuals, training programs, but we also do specific work around parts lists, parts catalogs, CAD/CAM design, and more.

We focus in the areas of program management, and IT systems, and all of this sort of falls under an umbrella offering of what we label as operational excellence, that's focused in the areas that include business process management. All of our technical documentation is done in an ISO compliant fashion, and this year, we're in the process of adopting ISO 13485 for medical devices. We've published papers on cloud migration that you can view on our website, and we produce what's called Prohibition Suite. It's a parts listing and cataloging software that helps in spare parts prediction. Thank you.

6:37

[Keith Parent] On this webinar, some key concepts we want to kinda go over, I'll echo what Marianne said early on, talking about this as a learning management series. We believe that each one of these webinars that we're doing are building on each other, and will be used as fuel for the next ones that we're going to do. In this particular case, we first talked about best practices for life sciences and technology, and how they came together. We then talked about metadata and taxonomies. We then went to improving time to market, and talked about all the content structure and systems integration.

Today, we're going to talk about the cloud and how that uses all of that functionality. So we're gonna start out with some basics, some definitions, some background for you. We're going to talk about how compliance can happen in the cloud, how you can do it, how you maintain compliance for your cloud-based environments, and then we're going to talk about cloud data usage, integration, data flows, what really happens out there, how you can get multiple applications working together in a cloud-based architecture.

So, Next? [Marianne Calilhanna] All right. And I am having just a momentary technical issue, so if everyone could just bear with me.

8:06

OK, Tammy. [Tammy Bilitzky] OK, thank you. So, in this first section, we're going to discuss, what are these clouds? Cloud has been around for quite a while now, and the full vocabulary has evolved to describe the different cloud strategies, the features, the offerings, and a key strategy in today's discussion is Cloud First, a concept first introduced in the government in 2010. Cloud First is a business practice wherein an organization has declared that they'll first consider using the cloud for any new component, and will only evaluate alternatives at the cloud won't fully satisfy their objectives.

It's not to be confused with the Cloud-Only strategy, which typically refers to a firm corporate mandate to use the cloud under all circumstances. They have no other options. So Cloud First itself is growing in adoption as organizations begin to appreciate the agility and flexibility that it offers when it comes to deployment speed and infrastructure. Instead of large upfront investments that quickly, in technology, that quickly age, we have many options, including pay as you go.

9:17

So, a good analogy I like to use is buying versus leasing a car. When you buy a car, or in our case, hardware, they're locked into the features available at the time of purchase. When you lease, or use the cloud, you can upgrade to take advantage of newer security features and technologies as they become available. Today we're going to discuss different cloud strategies, all with one central theme prevalent throughout: as your data transitions from single, homogeneous systems, it becomes increasingly imperative to have a solid formalized data strategy, a comprehensive plan that includes understanding your data, the best ways to describe your data or your metadata, and applying the metadata to associate it with the relevant taxonomies or classifications.

A data strategy, synchronized with the cloud strategy, will enable your organization to truly leverage and optimize your data, one of your most valuable assets, essential in powering meaningful search, downstream systems, and dynamic data mapping. So there are a lot of terms bandied about referring to off-premise components, each of them being something you want to consider and evaluate for its reference – for its relevance to your organization either now or later in your roadmap.

10:44

So just to make sure we're on the same page, let's run through the definitions. Cloud: cloud is a broader term, it's used to reference a private cloud, a cloud exclusive to your organization, or public cloud with shared computing services, where your data and applications are hidden from other customers. Hybrid is a combination strategy, where you might have a mix of a private cloud – your on-premise data center – and public cloud services, and you use software to manage the authentication and the interactions between the two.

Software as a Service refers to products or applications that are licensed, typically by subscription model, and they're centrally hosted. Think e-mail, instant messaging, things like that. Platform as a Service, part of cloud computing, offers both a computing platform and applications, and it's really designed to help developers of complex, customized solutions get up to speed quickly by offering them the tools and environment necessary to run quickly and efficiently. And Infrastructure as a Service, which I think many people think of when they think of the cloud, is where you're farming out your computing services: storage, networking.

12:02

Examples that come to mind, I think everyone would think of, would be AWS, Google Cloud, Azure. But regardless of the approach you take, the key is that you must maintain control of your data. A data strategy consistent across all the platforms is of paramount importance.

12:24

[Keith Parent] You know, Tammy, it's interesting, when you mentioned on that last slide, you talked about the Cloud First strategy. One of the things that I've noticed over the years within the life science world is the fact that most life science clients, particularly large pharma, were almost laggards in the cloud area, because they had so much work around compliance internally that they had already invested in. And then you saw the shift to where we have these new biotechs, you know, cranking up, and all of a sudden, they're trying to move fast, and they're doing everything really quickly. And they were very fast to embrace the cloud strategy. So we're starting to see now some of those larger institutions looking at it for point solutions, but now really looking at, do we want to have our own data centers? Is it better for us to have things more on the cloud? So I think it's great that we can talk about what the different types are for people, so they can understand that. Marianne?

[Tammy Bilitzky] Yes, that's a great point.

13:14

[Keith Parent] So, and so, one of the things that we want to kind of talk about is, if you look at this wheel on the, on the right hand side here, we've got all the different areas, and we talked about this earlier, in some of the learning management series about discovery, pre-clinical, you've got clinical, you've got data management, regulatory, manufacturing, they each have different systems. Some of those guys are already using cloud-based approach already for certain applications. When you look at some of the, the actual applications in the middle, whether they're regulatory information management, data integration, e-mail, supply chain management, BI, all these acronyms for the different systems that are there, then you'll look on the, on the left-hand side, and you're going to see, these are the kind of documents that are getting created.

We talked a lot about that strategy, where the documents and the contents in the documents have to follow certain taxonomies, things like that. Now, we have this cloud environment out there. How do we get, kind of, pull these things together if we have totally different systems that are out there and doing that? It's almost, almost more important that we have a data management strategy or a, um, information architecture when we're starting to pull these systems together. I know that Ron and I have talked a lot about some of this in some of the past webinars with the metadata and the taxonomies and how those are actually pulled together. Next slide, Marianne?

14:36

[Ron Niland] Just real quick, Keith, to add here. I think there was an aspect of big pharma and biotech having worked there that was very fixated on the document, right? And then with this shift to the cloud, it's now meant shifting to the data. And so as people have started to understand and embrace that, you can imagine suddenly there's going to just be a very, a very significant, and a paradigm shift in an organization that's established that needs to happen. Going from the document to the data, that is.

[Keith Parent] Yeah, I agree, 100%. Next, Marianne? Here we are. So, here, we want to just talk about some of the factors that are gonna drive some of this usage, and Ron and I were actually talking about a lot of these as we were putting this slide together. Talking about early stage. We talked about the volumes of data. And how much we had lot of, a lot of data at the basic research stage, pre-clinical, early clinical, late clinical. And then when you get down to the final drug product, all of that stuff kind of funnels itself down to a limited set of data. But you still have all these different systems that you're pulling this stuff together. Where is the buy-in and all that kind of stuff? Ron, you talk a lot about this stuff; you want to fill in a little bit?

15:52

[Ron Niland] Yeah. So, I think there's a, the aspect of scalability that an organization needs to think about. And if you're more on the research and pre-clinical side, there's this volume aspect of just understanding that, in order to get viable compounds to go through in early research and pre-clinical, you need to play the numbers. The numbers with using high throughput screening and whatnot will mean that you've got inordinate amounts of data to store versus the other end of this funnel when you get to late-stage clinical. So, it's something to just be sensitive to as you speak with people in your, in your company, because they may be thinking more along the lines of late-stage clinical, "I only have to worry about a handful of projects," whereas your folks in research may be saying "I've got hundreds of projects that I need to think about, and the data storage for that."

16:47

[Keith Parent] Yeah, we're gonna get into this in a couple more slides, but if you take this funnel, and you look at what happens after the drug is approved, you now get into all the marketing aspects of the drug, the post approval, all the stuff that's gonna happen when it goes out to the audience, and we start to collect patient-reported outcomes. All the things are going to happen once that drug is actually approved. The data's actually going to balloon up after that, because we're gonna follow that drug for a long period of time after that.

We're seeing that now with some of the Covid stuff that's happening. Now that we've got approved drugs out there, we're starting to gather more and more data from different cohorts of patients. And all that is just lots of data. Lots of cloud systems. And we've got a couple of slides on that, very, toward the end, that we talked a little bit about that, and how Covid has affected some of what, what's happening in the cloud world today. Marianne, next?

We had mentioned during the submission process that we basically go from validated EDMS, which is Electronic Document Management Systems, to, um, the formatted eCTD that's going to be submitted to the FDA. Then it goes through an FDA or an EU gateway. On all that data, you kind of pass it through multiple systems.

17:52

When you deal with different vendors, you may have a data management vendor actually grabbing data, putting it into data sets, coming up with the tables. They're feeding that data off to medical writers. Those medical writers are then taking that formatting document, putting things together, and then they're handing those things off to a submission processing vendor. All that could be happening, used to happen, maybe, on the internal systems.

Now, more and more of this is happening between cloud-based systems, where, where data is passing from one to another, and you have, there's some integration between how those things work together. We're looking at how all of that, that holistic process flow, flow works and gets to the next level. Next, Marianne?

[Ron Niland] If I can just add real quick here, Keith, I think there's another element that's changed in the game, if you will, and that is with that aspect of the, uh, parallelism that will happen in an organization, because suddenly multiple functions can get to the data, it's not happening in a sequential manner. So from a program management perspective, you're, you need to think about that, because if you can work in that parallel sort of processing environment, then you have the potential to really expedite a program.

19:02

[Keith Parent] Yeah, and if you look at this particular slide, one of the things we want to kind of talk about here, you may have multiple companies all with their own different cloud environments. And we try to talk about how it's raining down data, and we're actually, all that data is going into a data lake, and then we're doing some kind of advanced, um, reporting off of those things. And actually, we're starting to use more factors, like AI and things like that, now, with the volumes of data that are out there. Next.

Many times, when we're looking at the data, the data from these different companies could come from different clouds. Tammy had mentioned some of the different Platforms as a Service out there when you start to look at, companies could have their own private cloud. Some companies are in AWS. Some companies are in Microsoft Azure. Some are in Office 365, you've got the Google cloud platform. I just worked with a client that was started out with Office 365, and they switched over to Google. We're working with a data management group that's doing all their stuff in a private cloud environment.

20:00

We have another group that has high-performance computing and bioinformatics coming out of AWS. They're dealing with containers and dockers and all the different things that happen in these worlds out now; it's really shifting to how, what's available in those clouds. I was just on a client call earlier this morning, and we were talking about a company coming out of Europe that's got a thing that uses these containers that tie multiple data together. And you can actually find your data throughout all the different systems within your environment. New technologies are coming out on a very regular basis. It's how you can work with those together. The one question I did ask him when he, when he talked to me about that, I said, well, how do you validate that? 'cause that's what we have to worry about in the life science world: there's always the aspect of qualification validation.

We're going to be getting that, into that in a few more slides. Next, Marianne? [Ron Niland] Keith, if I can just add one word here too, that slide was very focused on data, data-centric aspects. There's another aspect here to just think about with your company, and that is what's happening with the process. The processes increasingly are being automated and being cloud-enabled as well. And then the question is, if you're working with some of these tools, like Automation Anywhere, to develop your processes, then where's your data? And if you can just sort of think about this aspect too, how does the data interact with the process, you're going to be much better served longer term.

21:25

[Keith Parent] Absolutely, 100%.

[Marianne Calilhanna] OK, we're gonna take a quick poll now. So, we just are interested in where you are on the path toward embracing the cloud, so if you can select from the following options, it'd be very interesting to continue our conversation. So I'm just gonna give everyone a couple more seconds. The question is, where are you on the path toward embracing the cloud? You're just starting to think about it, you're well on the way, you're starting with limited processes and systems, or you are all in.

OK, I am going to close the poll, and I'm going to share the results. So, we have a tie. It does seem that almost the majority of you are sort of split in terms of, you're thinking about it, you're on the way. No one is quite all in and about 14% are just starting to think about it. And I think these, um, responses are sort of in line with what we anticipated.

23:03

[Keith Parent] You know, Marianne, I think with those responses, one of the things that we've noticed is the more likely you are that we're working with a virtual company that has no brick and mortar, the more likely they are going to be all in on a cloud-based environment. Whereas people that have been around for a while already have legacy system, things like that, are more hesitant to go toward that environment. So, that is one of the things that we work with out in the field today, is figuring out, how do we get past, you know, legacy-type environments? And we actually have a webinar coming up, and we'll talk about some of those specific things too.

[Marianne Calilhanna] All right. All right. Let's – moving on.

23:45

[Tammy Bilitzky] All right. Thank you. So, this next section is discussing, as Keith mentioned before, how do you maintain compliance in the cloud? So, in this section, we're going to discuss the importance and the best practices for doing that. All of your, bottom line is, all of your data systems, whether they're in the cloud, or not in the cloud, have to be compliant with the organizational standards dictated by your internal policies, as well as legal and regulatory.

As the standards and your business functions inevitably evolve and change over time, so must your compliance services. And again, it's all about your data: where your data's stored, who has access to it, under what circumstances, how the data's created, maintained, protected, and retained or purged. And the cloud offers different approaches to help you assess the various, the impact of these different regulations on your data and your processes. Looking at the holistic view of your system, your procedures, and your individual colleague functions: it all has to come together.

24:50

And while detractors might make and raise concerns about compliance in the cloud, there's actually a very strong position that the cloud enables organizations to better manage compliance. It offers them flexibility to quickly and easily apply new data controls, testing, and monitoring features. It offers different certifications that might be a big challenge for your organization to get up to speed with HIPAA and things like that. Next slide.

So, with so many benefits associated with the cloud, it's easy to understand why so many organizations feel pressured to develop and adopt a cloud strategy. And yet before going there, we need to take the time to determine whether needs can be met by simply enhancing your existing technology, and what's most practical for you in the short term and the longer term. What we always suggest is you start by understanding and assessing the whole picture: your organization needs now and for the projected future. Your data, your resources, human and other, your growth areas, your challenges, your compliance certification needs, and your business differentiators. What makes you stand out as an organization?

26:06

And then you want to explore the different cloud offerings. And as Keith and Ron alluded to, there are many, and there are growing numbers, and you want to understand the advantages and disadvantages of each one of them. So, key factors to consider is, is your organization already trying to react quickly? If it is, you don't want to be the one slowing it down. That creates a compelling case for cloud, where you can provision hardware and applications with the click of a button, and you can scale up or down as your needs change, also with the click of a button.

We also suggest that you consider the total cost of ownership. For example, not just the hardware, but the cost of planning for its redundancy, your needs, just, the space to house the hardware, now and for the future. You have to negotiate pricing, and provision it, and install it, and maintain it, and track it, versus just going to the cloud and provisioning with the click of a button. And if the advantages are there, then an organization should feel comfortable with the idea of embracing the cloud sooner rather

than later.

27:13

[Keith Parent] You know, Tammy, it's interesting, because part of the, part of the things that people look at are the cost, and they all think it's going to be cheaper going to a cloud, because they can get limited resources, what they need. But a lot of times, they don't take in the effect of the cost of compliance, sometimes, around that. I'm gonna get into that in a few slides, but one of the things that we've found is, depending on the type of application that you're putting in, and where you are, if you need to have qualification, you need to have validation, you've gotta really look at, can I do that, and do I have to add that into what's there? Does the orchestration of those, being able to spin up those servers, quickly, and have I thought about that from a validation or a qualification perspective? So those are the things that we want to make sure people think about as they're going to it. Next slide, Marianne?

So, in a qualified environment, there's a lot more than just, in your own environment, you would have taken the hardware, you would have looked at how it's supposed to be installed. You're gonna make sure you've got all your SOPs in place, all that. Now you've got to make sure you're relying on a vendor to do some of that. So it actually ties back to your vendor management SOPs, and do you have a proper SOP for managing that vendor? Can you qualify the environment? Are you allowed to go into that data center where they're going to be at, or do you have to rely on their stock reports?

28:28

You know, there's a lot of different ways that you can qualify a vendor-qualifying environment, and it's going to be up to your quality or IT department to figure out, how do you do that? Do they follow proper change control? Are you part of that change control process? You may not have any control over that, so can you really show control over your data? Those are things you have to justify and talk about.

If your vendors maintain a cloud compliance or maintain a compliance, what is your responsibility to that? You're still responsible for that data. You know, that's the important part to remember. Even if you have multiple vendors out there, you still are responsible when it comes to the data that's going to be submitted to the FDA. How are you qualifying that vendor?

I've just gone through a number of massive qualifications where we had 300-page documents. We had to go through questionnaires to, to answer for vendor qualifications. It's not an easy process sometimes. And then you think about, can we qualify a public cloud vendor? How do we do that? Or the application, if it's a Software as a Service model. Next, Marianne.

29:33

In our world, we still live with validated applications. We still have to understand the concept of IQs, OQs, and PQs. So installation qualification, operational qualification, performance qualification, production qualification, and whatever you wanna call it, or how you want to call it, IQs, OQs, and PQs are the stalwart of what we have in this industry. I still need to make sure that I've got that kind of documentation. I don't think I've met any quality department in any of our life science customers that haven't wanted to see our documentation, our qualification documents, all that kinda stuff.

And qualification is not a one-time, once and done thing. It's an ongoing thing. You have to show that you have a proper change management environment put in place so that when things are changing, even in a cloud environment, are you in control of that, do you have notification of that, or is somebody keeping the artifacts for that? Um, are there forced updates? If it's more than just security or if it's an application-related update, are you involved in that, are you as part of that, a part of that planning process? Those all go into an account for a cloud-based environment.

30:34

I've heard horror stories in the public cloud environment, if you think of a company like a Microsoft, they're so large that their client base outside of life science, when they have a change they have to make, they just blow it all out there and it goes across the board. Many times, you've got custom applications or you've done something in your application that that change will, will obliterate something you put out there, and all of a sudden, you're in a lockdown period, getting ready for a submission. What happens?

Those are the kinds of things that you have to think about when you're looking at what type of cloud, or what type of model do I want to go out? Tammy had mentioned earlier, the Infrastructure as a Service, Platform as a Service, Software as a Service. Each one has their own quandaries around how to validate those applications, and how to deal with them. So, something you have to think about when you do that. Ron?

[Ron Niland] Yeah, and beyond the three Qs here, there's also DQ. And it's not Dairy Queen. But it's the design qualification that can impact a research organization or a medical device company. Meaning, your facilities need to be designed appropriately. And, as they get increasingly automated and you're using sensors, then that's an aspect that is added, if you will, to these other three areas of qualification. Again, design qualification.

31:58

[Keith Parent] Right. Next, Marianne. So, when we, when we talk about the integration, we want to make sure that we're qualifying those vendors. We validate the applications of the vendors themselves, and we're going to maintaining that validated state of the data between the vendors. People think about, well, they just take data from one vendor to another and all that stuff. If you have a validated system, but then you're taking data in from a non-validated system, are you now, in fact, invalidating your data?

So those are the things you have to think about, have you looked at your transfer between systems, and have you looked at, including that, when you talk about validation, it's usually of the system, and that system is all the components of that system. It could be multiple cloud vendors. Can you, have you incorporated that into your thinking? Next?

32:49

[Ron Niland] Yeah, so over the next handful of slides, I wanted to give some sort of more general overviews of things to think about, as you embrace the cloud, for some of you that are sort of in that group. And even for those that are started on the journey, perhaps these insights may, may help you in terms of your approach and your planning.

One aspect of going the cloud is the aspect of scope. And scope, scope creep can kill any kind of project. I think it's imperative that you start with a small scope, and try to minimize the risk of the unknowns. As you go into the cloud, the idea of integrations with other systems and processes is infinite, and yet, that's the, that's the danger of it. So, approaching this in a very phased and purposeful manner, I think, is critical.

Being very explicit with your goals and the acceptance criteria in your project is really important too, meaning as you've developed these in a phased manner, you want to have your sort of gates, or stage gates, for review and approval. The first is just to understand whether this fits into your information architecture. And if that group is, if you have got such a group that would review and approve, that's important, but then, as you go through each stage, each phase of your project, you want to have a clear understanding that you've met the criteria that enable you to then proceed to the next.

34:20

At the same time, when it comes to your scope, you do want to be flexible. You don't want to be so rigid because, in fact, there are a lot of opportunities that are afforded by embracing the cloud, but, you know, it's important that you just be flexible and yet not so fluid, if you will. But at the same time, it's a delicate balance. Having said that, as you go and embrace the cloud, in the earlier stages, you'll find that it's a very distributed nature that you're working with. And distributed systems, while very powerful, are not always the easiest to manage, whether it's from a design or an implementation perspective. Next slide, please.

So what are the key components to success and benefits? I'm here in the San Francisco area, and I think everyone recognizes this particular landmark, but I think it's important when it comes to the cloud, just to really think holistically. And you need to think about sort of the century ahead, in a way, like they did when they were building that bridge there. That's a critical component to connecting San Francisco with the upper part of the Peninsula. Your orientation maybe isn't, you know, for the next century, but it definitely needs to be for the next few years.

You need to really think about how you're going to work as a cross-functional unit in your company and with your partners. Some of your partners may not even have been identified as yet, and so that's, that's the tricky part, if you will. The foundation for this bridge for you in going to the cloud is actually rooted, if you will, in information architecting, in the idea of understanding what master data management is and the component of that is building taxonomies.

36:13

Obviously, by embracing the cloud, it will bring a lot of benefits. One of those is that the onus rests with the likes of Amazon Web Services to weave your needs into their systems. I think we all realize now how distributed the workforce is. And people are working increasingly remotely, and that's only going to continue, and the fact is, again, the integration possibilities are endless. Next slide, please.

So, what are some of the pitfalls? Your infrastructure may not be ready, the timing, just, it may not be the right timing. You may be having some other organizational changes. Flux, if you will, that preclude you from embracing the sooner-than-later. You may not have the, the ability to do the, an appropriate selection of vendors and finding the right solution, and, you know, there's a lot of pre-work that goes into choosing the vendor. First, you need to think about what are your, your functional and, and you know, system-related needs, as well as the user needs. You may not have the right resources in your organization, but including doing things like managing migrations of data.

In some cases, you may actually have stuff in boxes, paper that needs to be electronified, and sort of ported in, especially if you think of the regulatory reporting requirements over time. The scope, you may not be thinking broadly enough, but then again, you may be thinking TOO broadly. If you don't have a backup plan, what happens when you sort of leave the ground, if you will, to embrace the cloud, and yet, you're not ready, and you were planning to retire a particular system. So having that backup plan is really key.

38:07

The automation of this, sort of, the projects related to a cloud endeavor may not be fully automated, and so that's something to think about, and at the same time, your security model may end up being very different. It will be different in the cloud. And so, that could lead you, to some degree, as being exposed, but especially if you're working with multiple vendors, your data may not be ready for prime time, and so that's something to think about. Your older services may need to be cleaned up.

As Tammy alluded to earlier, your procedural documentation in the company, your hierarchy of documentation, those SOPs and work instructions, may be compromised. They may not be fully aligned. And, at the point where you're ready to turn the switch on that cloud-based system, you need to be sure that all the "t"s have been crossed, the "i"s dotted in that procedural documentation. And then, once that's done, only then are you really in a position to put an adequate training program into place. I think it's fair to say that continuous improvement is something that is going to be the mantra in organizations as they embrace the cloud more and more. Next slide, please.

39:25

[Keith Parent] You know, Ron, one of the things, when you talked about some of the documentation, one of the things that we work with a lot of our clients on, the fact that they're going to have documents, their SOPs, some of their SOPs may actually refer back to our SOP because we're the ones that are doing some of the actual work at the, at the cloud level. So, you gotta think about that when you're putting those things together.

39:44

[Ron Niland] Yeah. Yeah, exactly. So, I mean, whose data roles, whose process roles, whose procedural documentation roles? And you'll need to have a mapping of that so you really understand where is the parent data versus child data whose SOP does basically, take precedence in a particular situation. So, you know, when you're embracing the cloud, there's a lot to have, that needs to happen here, and it may be very difficult to get traction at the outset. And that's why it's really important to have that small, focused effort at the beginning, but it's, it's, it's especially difficult, again, if you're working with multiple partners, vendors, because then the question is, who ranks as the higher priority? Because that's something that may dictate how you go forward, and perhaps to some degree, what aspects of infrastructure you adopt. You may have unwillingness in your organization as to adopting such a long-term goal.

People are very goal-centric in companies, but often those goals are predicated on annual cycles. And so, your 3- to 5-year vision may not resonate with them. You also may find people with an intractable mindset saying hey, you know, that's just not the way we do it. And yet, you're, you may find yourself saying yeah, but that's what we NEED to do in order to ensure our vitality as an organization. So, you know, you may not have the personnel in the, in the company that really can appreciate what you're doing, or they may not be able to articulate it, or they may not be able to drive it. It could be any one of these things, but obviously, you know, if they don't know how to drive it, you know, be careful. Because then programs can –

41:33

[Keith Parent] You know, Ron, some of the things that the companies have to deal with are even very simple things, like which browser am I using? You know, or, what's my, my laptop of choice? Do I have a Mac versus a PC? Do I work well with these applications, all those kinds of things. So those are things you may not have thought about before, because you were on site or you were given a company computer and you're doing all that. Now you've got to bring your own device and the device, they're going through different browsers.

And each of these companies that have a cloud approach, how did they get into it? Do I have to use a virtual desktop to get into the application? Do I do it through a web-based HTTPS for our security? All those kind of things are, are issues that you may or may not have had to think about before.

42:15

[Ron Niland] Those are great points. The browser I can totally appreciate, empathize with that one. So, you know, what are the consequences of non-compliance? In the lower right you are seeing a picture. This was from the Tōhoku earthquake, a 9.0 that happened in Japan. It's, you know, the odds of this happening are so slim, right? But, you know, if you liken this to two companies coming together and saying they're going to collaborate and, you know, they've got their own lanes, if you will, that they're operating in, but they need to be aligned procedurally.

You know, here's one company, perhaps it's, you know, maybe a very well established company. They're on terra firma; the other company, they've got all these bumps in the roads, and, and you can see they're not aligned. That may happen with you and your vendors, your partners. Another consequence that you need to be thoughtful of are your champions in the executive management, and whether they are in a position to really advocate, and at the same time, be willing and able to step up to the plate and to effectively articulate the vision and mission, so as to get the different functional groups to buy in, because if you don't get the cross-functional group buy-in, you're going to be, you're going to be caught. Next slide, please.

43:39

So, you know, some of the aspects that we talked about earlier, in terms of the shift that will happen, is the qualification, especially across companies, things that Keith and I talked about that you need to think about for the validity, validation of your data, is that aspect of the audit trail. And to think about the, the aspect of the migration of data across systems, and ensuring there's a validation of that.

You, you, as you embrace the cloud more and more, you'll find that perhaps you're going from this hybrid model for, on premise, to cloud-based systems. But, you know, it's not as, it's not as clear cut, perhaps, and this is where you need to think about your life cycle management and those transitionary plans, for those on-prem systems to cloud-based system. And there are going to be significant implications, but especially in the areas of personnel.

You know, if you're looking to embrace the cloud, one, you know, at one juncture, let's say, two or three years down the line, do you need that IT-based team that you've got there on the ground, supporting those on-prem systems? Some factors to consider that, again, Tammy talked about earlier, to some degree, is the, the, the aspect of, all your data's migrating across the systems, and then who's accessing it? And you know, the egress of information, right? Where someone's exiting your private network boundary to go to the public network. That needs to be considered, as well as the ingress, unsolicited traffic coming from the Internet into your, your sort of private network.

45:27

Latency issues. You know, if you have a publishing group in the regulatory department, latency issues could be a big factor, especially if they're working on something like a filing. Transparency between companies is also important, and there's an aspect of this, meaning the weakest link here. It's hard to hide in the cloud, right? And so, that's something just to think about, because there's effectively that Achilles heel that could bring down a system. Next slide.

46:05

[Keith Parent] Hey, Ron, one of the things that, one of the things to think about today, and it's very pertinent to everybody today in the Covid world now: everybody's doing things from home, and all of a sudden, all of a sudden, now your home link becomes your weakest link for your working at work.

[Ron Niland] Yeah.

[Keith Parent]  You know, a lot of people have had to upgrade their, their cable modems coming in and all the other stuff that they had to do to get to that next level. 'cause now they're contend, contending with the kids playing games, or somebody's running a movie in the other room, and things like that. So, you know, that affect how you work with the cloud systems, even from home, as most of us are doing these days.

46:37

[Ron Niland] Yeah, no, that's a great point. And it's, it's one that maybe we're not so sensitive to until someone starts playing that video game and your speed slows. But, you know, here we are, you know, just maybe to quickly close this, your company is going to go through very significant changes over the coming years, not just because of the cloud, but also because of that other element I was telling you about earlier, the automation of business processes. And it's those companies that can work together, and get their processes, and then their data link, that are going to be at a significant advantage.

So, your company will need to understand really how to operate in this new paradigm, which is leading from a coordinated effort with external bodies, with your partners, as opposed to having that intra-company focus. And, again, as we said many times, the procedural documentation needs to to change, and yet it needs to be really well-governed. Next slide.

47:45

I think this might be the last one. But yeah, earlier we were talking about the Covid example and bringing multiple products to market within a year's time. Typical life cycle for development in the life sciences, I think it's somewhere between five and ten years; maybe oncologic product, products may come to market sooner than, than other products. But, you know, here we saw very significant collaboration. The tightest of timelines that happened from the parallel processing we were talking about earlier, and, you know, at the end of the day, we had multiple vaccines developed and very solid quality associated with those products.

So that's, these are just emblematic of what corporations will be looking for in their ability to develop products going forward. They're going to want that surreal, that parallel processing, if you will, all the slack taken out. And it's just a mandate, a technological change. Thank you.

48:54

[Tammy Bilitzky] OK, so in this next section, we want to build on, you know, the points that Ron and Keith just brought up, and offer some suggestions for managing your data usage in the cloud. We all know the dangers and deficiencies of data silos, so creating business flows, flows that bridge different cloud and on-premise infrastructures, is imperative to keep your organization innovating, differentiating, and improving your time to market. How do you onboard new products and clients? How do you handle communications? How do you manage interactions across business functions?

You can take advantage of the many Software as a Service and Platform as a Service solutions available today. They're optimized for different workflows and business functions, and the number of options and capabilities, as you mentioned before, is constantly expanding. And just as powerful is Infrastructure as a Service. It gives you the control you need to quickly deploy and scale your business applications on hardware that's optimized for your needs. You're not tied into the hardware you bought for a specific purpose in the past and now just want to repurpose.

At the end of the day, we believe that Cloud First puts you in the driver's seat. It eliminates the shackles that are tying into your aging components and dramatically shortens the timelines that historically hindered your ability to define and redefine your organization. And best of all, it really frees you up to focus on your customers, your offerings, and your differentiators. You're not focused on the things that do not differentiate your organization from others. Those are the basic reasons that your organization continues to exist. Next slide.

50:41

So, how exactly do you create these business flows? Again, it's your data strategy. As more organizations are progressing from these on-premise versions of hardware and systems to cloud-based solutions, classifying your data against appropriate taxonomies, and defining your metadata, is becoming more and more business critical. With the right combination of Cloud First and comprehensive data strategy, you can craft solutions that'll employ the right mix of cloud and potentially hybrid services. Those will maximize your value of your data and keep your organization moving forward.

And, best of all, it gives you the agility to redefine your selections as you need them. You're not locked into what you've decided in the past. Once your data's tagged correctly, and you maintain it at the right level, you can always swap out your Software as a Service your Platform as a Service offerings to meet your evolving and changing needs. So, just to explore this concept further, maybe you have half a dozen applications across multiple cloud environments, private and, and public. And data is shared across the applications. It can be created in one, supplemented in another, and often redefined based on different business functions. And the data moves through its life cycle.

So, how do you tie those all together to ensure data integrity? How do you prove that you're in compliance with your access requirements? How do you ensure that no data's lost, its meaning is preserved, your search engines properly interpret your data and all its various semantics across disparate systems and solutions? So, the answer, we believe, is your data strategy, as reflected in your metadata. Defining and redefining the right metadata throughout the journey of the life cycle is essential to maintaining its integrity, and it requires your careful, ongoing consideration and refinements. Next slide.

52:50

So, how does the cloud impact your data life cycle? As your data matures across the workflows and the systems, you have to provide an effective audit trail that preserves the original meaning of your data and allows you to accurately represent its origins and transitions, all while preserving your data integrity and remaining true to your source.

So, using an example, we can all relate to, take an insurance claim. Your claim may start with, as a hard copy document, or more typically an e-mail with attachments. And all the envelope contents, if it's hard copy, have to be scanned and OCRed, or if it's an e-mail, the e-mail header information, all the attachments, have to be extracted. The text, most systems are typically analyzing the texts using AI techniques, and tagging it based on the content and semantic meaning. The tagged data may then be mapped to different taxonomies. It's used for different purposes as we passed to different systems.

You'll have a claim system identifying all the people the file claims, and their, and their geographic factors and things like that. You'll have a claim type system that wants to identify all the different types of claims. You'll have a claim processing system to adjust the validity of the claims, the accounts payable, the compliance systems, the metric systems. Maybe they want to know how long it took from the time the claim was received till it was paid. That list goes on. Without the right metadata preserved and tracked across all these different workflows, you're not going to be able to certify the integrity of your data. And without the right metadata defined up front, and mapped to the right taxonomies, your chain of custody and your ability to demonstrate compliance are compromised. Next slide.

54:40

So, at the end of the day, Cloud First is a consideration that deserves a time focus of every organization. And we really encourage you to closely evaluate your current state, your challenges, your strengths. The business requirements, functional and non-functional. Your response, like your response time, your time to market. And key factors are also – you have to consider your business continuity; we've all woken up on that one in disaster recovery. This pandemic was an "aha" moment for many organizations as they realized how close they came to not being able to staff their on-premise data centers. And in some countries, that was the reality, as strict lockdowns were imposed and people simply could not get in to service the hardware. As a result, lots of organizations are going partially or fully remote.

And as part of that strategy, they might be ready to move all or some of their computing and application services to the cloud to mitigate that risk. Others, not really ready to make that leap, will closely monitor the situation and define the timing that works best for them. Underlying all of this will continue to be the need to review and refine your data strategy on an ongoing basis. And strive to implement seamless business operations regardless of where they're executed.

56:04

[Keith Parent] You know, Tammy, I think one of the first things that we want to do, or one of the things that we want to point out for this particular webinar is: it used to be that going to the cloud was easy for other companies and life science just couldn't do it. Today, there are ways of doing it. It's just working with the right vendors and understanding how to do that. JANA Life Sciences, DCL, and Court Square all have been dealing with this industry. We understand how it works, what can happen there, so we encourage you to just keep looking at the cloud environments and start building that into your, your forward-looking ideas and strategy.

[Tammy Bilitzky] Great point.

56:42

[Marianne Calilhanna] All right. So, we are getting very close to the end of the webinar. We do want to ask one, we want to launch one final poll, because we'd love to understand, if you are working, for those of you who said you are working toward embracing the cloud, are there any aspects from the following list, list from which you could benefit from some help? So if you could just take a moment and, you know, share where you might need some support, is it technology roadmapping? Is it information architecture? Program management, process management, compliance validation? And you can choose from multiple options, whatever applies to you. And I'm going to give folks just a couple more minutes here.

And I'm going to close the poll. And I'm happy to share the results. Compliance validation: a hundred percent. You know, no real surprises, I don't think, with this audience. Keith or Ron or Tammy, any, any thoughts around that?

58:19

[Keith Parent] Yeah, the big thing, from my perspective, Marianne, is, you know, you take your, you also, you obviously have to have your validation routines already, your SOPs. How you're going to do it. You just have to look at, from a cloud perspective, embracing the fact that you now have to qualify vendors, you have to qualify their processes or show that they've got compliance. That can extend to you, because you're still ultimately responsible. And then, understanding, do they, for the applications you're looking at, do they have a validation path? Can you use that as a starting point for what you need to do? If it's a configurable system, do you have to put something specific around the way you are, or is it customized? So those are the things that we think about when we look around compliance and validation.

59:06

[Marianne Calilhanna] All right, well, we've come to the top of the hour. I want to thank everyone for attending this webinar. The DCL Learning Series comprises webinars, blogs, a monthly newsletter. You can access any of this content from our website, and the on-demand section of our website, dataconversionlaboratory.com. We do hope that you will keep apprised of other webinars in this life sciences learning series, and we hope to see you at future webinars. This concludes today's broadcast. Thank you so much.

[Ron Niland] Thank you. [Keith Parent] Thanks, everybody. [Tammy Bilitzky] Thank you.