Transforming Drug Development with Frictionless Access to Real-Time Preclinical Data

Transforming Drug Development with Frictionless Access to Real-Time Preclinical Data

May 05, 2023PAO-05-23-CL-03

Collecting, sharing, and visualizing the huge volumes of data created during the early stages of drug discovery and development have long represented bottlenecks to accessibility and efficiency in need of smart digital solutions. Charles River Laboratories is an established leader in providing essential products and services to help accelerate preclinical research and drug development, and is well positioned to understand the pain points in data sharing during safety assessment and toxicology studies and their impacts on workflows and efficiency and to develop frictionless, real-time, and customer-centric tools to improve the efficiency of customer interactions and the development process overall. In this Q&A, Charles River’s Corporate Senior Vice President, Sales and Client Services, Kristen Eisenhauer and Corporate Senior Vice President and Chief Information Officer Mark Mintz discuss the company’s development and recent launch of ApolloTM, a secure, cloud-based platform for real-time toxicology study data, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.

David Alvaro (DA): To begin, can you share a bit of background on Charles River and introduce the idea behind Apollo and its origins at Charles River?

Kristen Eisenhauer (KE):  Charles River helps support drug research and product research. The company originally focused on supporting animal studies, but we expanded over time to provide early-stage drug discovery services, middle-stage services used to gain approval from the FDA and other appropriate regulatory agencies, and post-market services, where we test both small and large molecule products for impurities. We are a comprehensive preclinical or nonclinical CRO; we perform sample analysis on clinical trials but otherwise focus on all of our customers’ research needs before they reach clinical phases.

Mark Mintz (MM): Our mission at Charles River is to help accelerate drug development processes to, wherever possible, reduce the time required for those processes. The idea for Apollo came from a larger push at Charles River to update how we work in a more automated fashion.  Obviously, the work that we do to support our customers generates massive volumes of information and data, but before Apollo, all of that information was accessed and shared manually: a customer would send an email asking for information or data or a document, and then somebody at Charles River had to manually send that back –– sometimes requiring multiple steps and multiple people. We had a simple portal in place, but it wasn’t really interactive, and data were manually uploaded and not in real time. We saw a critical opportunity here to digitize, automate, and streamline the way that these data travel from our labs to our customers and back. The underlying goal is to make data sharing as quick, easy, and automated as possible to allow us to focus less on these manual processes and more on the science itself.

DA: Can you expand on the types of data your customers need during these studies and the limitations of not having easier, real-time access to the data? 

KE: Before we developed Apollo, accessing, monitoring, and utilizing data was completely manual. Typically, the client would have to email the study director, who would then need to get access to that data if they didn’t have it at their fingertips. Then, they would have to respond either with an email containing spreadsheets of data or manually put them into the portal, where files could be accessed by the customer. No matter how responsive our people were, this inevitably took time. Additionally, it was virtually impossible for a customer to access these data during off-hours because there needed to be a person working on the other end of the line to support those requests. In many cases, there really was an important unmet need to share data –– things like body weights and observation and pathology findings –– more rapidly than was possible.

Additionally, many customers expressed ongoing and increasing concerns about the limitations of how those data could be shared or transferred. Manual processes unavoidably create opportunities for data to be sent to the wrong person, and in this day and age there are more secure options than using email to share data.

DA: Will giving your customers increased and real-time access to these data create new opportunities and transform how these studies are conducted and what is possible? 

KE:  We believe so. At a very simple level, this allows employees at our customer and client organizations to have more immediate meetings with their management to evaluate data that has already been visualized for them, rather than them needing to take the time to input the data into their database or system to do so. They are able to make decisions very rapidly about the next dose or the next study that otherwise might have taken weeks of back and forth between the study director and the client around the major milestones of the study. We can definitely envision taking that and growing it beyond just an individual study in a programmatic way and seeing timelines continue to shrink as these decisions can be made faster and faster. 

With the self-quoting or ballpark quoting tool we have added to Apollo, people can not only assess what study to run next on the basis of those real-time data but even what budget is likely to be required for that next study. Rather than taking a month to make those determinations, customers can now prepare their next step internally and act much more quickly. As we know, everything these days requires approval, and budgets are incredibly tight –– the faster people can access that type of budget information rather than waiting on our end for a quote, the quicker they can act.

MM: By building this platform to make these data accessible and secure –– and through ongoing dialogues with our customers around how they work with us and how they would like to work with us –– we’re constantly exploring new and different ways to bring additional data together to make it easier to develop new and more meaningful insights and to enable them to make decisions more quickly and optimize how they work.

KE: We are always thinking about the future and what else we can enable. Today, we’re identifying trends very early on with regards to a specific study with a specific drug for a specific customer. Going forward, as we look to free the rest of our data and put it all together as the Western world’s largest nonclinical CRO, the amount of information and data we have access to on a very high-level perspective will absolutely transform the decisions made in the future. Our next step will be to go from an individual client and an individual biologic or small molecule to examining, for example, all of the monoclonal antibody studies we’ve run, and assessing the collective impacts to different tissues. We think that we could ultimately leverage that huge data set on a very holistic basis to help clients make better decisions and/or to better predict outcomes, which help transform the speed and accuracy of drug development.

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Apollo™ is an innovative platform that empowers users with real-time access to study data, milestones, documents and program planning tools.

DA: Was developing something like Apollo inevitable given the bottlenecks you mentioned, or was there a particular inflection point that got things moving?

KE: The real impetus came through feedback from our customers. While a large portion of the Charles River preclinical business comes from large, global pharma companies that have large staffs and lots of resources to conduct research, the majority of our customer base is smaller biotechs that lack these resources. Our initial focus was on providing real-time data in a way that could support these companies that most need help to make these quick decisions. The more we looked into developing solutions, the more we found that data visualization tools were practically nonexistent in the preclinical CRO space, and as a result companies were having to spend money either building teams to do it or outsourcing those activities separately. We had a bit of a eureka moment where we realized that, since we are producing the data, it would add significant value to present it in a way that is both visually pleasing and more easy to grasp, along with a self-help tool that allows people to access it any time that they want.

MM: Like a lot of the digital transformations across the industry, the push for Apollo really came in 2020, during the lockdown phase at the peak of the COVID-19 pandemic, which really emphasized the need for digital experiences, technology enablement, and moving more efficiently with less manual work. That drove the company into a real commitment to a digital journey and digital transformation, and Apollo represents the first big piece. Ultimately, we want to expand this offering, not only help to our safety assessment customers but to create end-to-end access across the portfolio of products and services that Charles River provides so that all of our customers can benefit from these types of experiences and reduce timelines to get results out efficiently and as effectively as possible. Additionally, we want to enable our own employees to spend maximal amounts of time on the science and helping our customers, versus having to do manual things that can be addressed through analytics and automation. 

We developed our minimum viable product (MVP) in 2021, which we then released internally with just a few customers and just a few data sets and features. We then spent the last year-and-a-half growing the MVP exponentially to the point where every preclinical Safety Assessment customer working with Charles River is on Apollo and has access to their data, their study milestones, etc. We launched Apollo publicly this March, which was a big milestone for us. We first wanted to make sure that we felt confident that we could stand behind everything and fully put out there in the marketplace, and we did.

DA: Has the response from both customers and your own teams aligned with your expectations?  

MM:  Absolutely. Apollo truly transforms these workflows in a positive way: people can spend far less time on routine tasks like pulling things together, creating spreadsheets, and sending emails back and more time actually examining the data, discussing them with the customer, or coming up with new insights. There is a change-management component built into Apollo to ensure that everybody understands how to use the new tools, which also creates opportunities to improve workflows and interactions with customers and with internal colleagues. 

The customer feedback we have received has been very positive. Apollo eliminates steps from their workflows by creating these visualizations that ensure they are looking at the data in the way we intend. They don’t have to worry about doing those things; they can just log in and get the data, develop insights, and make decisions without having to do that manual work, which not only saves them time but also makes their processes more effective.

DA: I’d like to circle back around on the point you made about Apollo being the first big step in the digital journey Charles River is embarking on. Can you share anything about that larger vision? 

MM: As I mentioned, in 2020, Charles River embraced the idea that a digital transformation was critical to furthering our mission of accelerating drug development timelines while also creating unique and delightful experiences and industry-shaping opportunities. We set out to bring people, processes, and technology together to reimagine how we work both internally and with our customers toward that goal of meaningfully reducing drug development timelines. 

We will achieve this by implementing best-in-class technologies that are instrumental in optimizing internal processes into more digitally native ones, which enables us to help our clients get their drugs and therapies to patients in less time. The core pillars for our digital transformation and journey are customer-centric design thinking, agile test-and-learn processes, and technology-led innovation. With a strong emphasis on the customer and employee experiences, we’re working to reimagine important processes that could ultimately improve patient care, cost effectiveness, drug discovery, and development and create new and better ways of working. 

From a technology perspective, what we’re doing is tightly aligned with the most important and high-impact customer needs and business opportunities. We assess our customers’ biggest needs and where can we help them to drive their drug development processes as effectively as possible and determine how we can best use technologies like the cloud, artificial intelligence and machine learning, connected devices, digitization, and automation to create these experiences and help get their products and therapies to patients as quickly as possible.

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Apollo™ provides access to study data that empowers users with insights and digital features to enhance decision-making abilities.

DA:  Sometimes, when an interaction shifts from being handled by people into a digital portal, there can be a perception that something gets lost without that human contact. Do you think that’s an issue at all with Apollo, or does it simply free people up and allow them to focus on more meaningful interactions?

KE:  Apollo allows us to spend our time communicating about important things –– like the real science underlying drug discovery and development–– rather than the logistics of running studies, milestones or budget quotes. Everyone’s time is limited, but now, rather than spending 30 minutes of an hour on the logistics of how to share data, we can spend the whole hour discussing the drug itself. The interaction isn’t lost, but the quality is significantly increased.

DA: You mentioned the quoting tool within Apollo and the budget confidence that it adds. Can you expand on how that works and whether it really adds something to the picture that just wasn’t possible previously?

KE: This was an important piece of our evolving ability to respond to the voice of the customer. When we were developing the MVP for Apollo and determining what features to work on first versus what would be deprioritized, we conducted customer interviews, and this kept coming to the top in terms of unmet needs. I manage the group that creates these quotes, and even I was surprised by how important this was to customers. We already had this on our radar for later versions of Apollo, but customer interactions convinced us that it should be a top priority from the beginning.

The feedback on this tool has been tremendous. Customers understand that it provides a ballpark budget rather than a precise quote, but that is what they are looking for at those early stages. However, it is absolutely our goal to continue to refine the tool and eventually get to a place where people can develop their own study online and create a quote document that they can digitally sign right then and there. It was definitely a learning experience for us in terms of what’s important to the customers, and we ended up with a really important and useful tool that we didn’t anticipate.

MM: I think that this is a reflection of things people have become accustomed to doing in their personal lives: you can go online and find the price of something, whether you are making a purchase or just considering budgets; you can buy cars and even houses online now. People expect similar things from their business environments –– to be able to see what things would cost and how might they configure things. Allowing them to do that digitally and enabling them to either complete it on their own or talk to somebody to help do that extends our ability to meet our customers where they are and provide them the tools and capabilities to work in the ways they want to work to enable the most efficient process. I like to use the word “frictionless” a lot: make it as simple as possible for them to engage with us in any way they need to so that we can serve their needs as best as possible. 

DA:  Did any other unanticipated features emerge along the way that have either already been integrated into Apollo or are in the wings for future updates?

KE: One surprising benefit has been how Apollo has increased our understanding of the complexity of our customers’ organizations and how they are structured and organized. While that may not have yet led to a new feature in Apollo, it’s helped us to better identify what will be helpful for them in the future to avoid other speed bumps, like determining the different stakeholders at the customer company that ought to have access to the features for a given project. It been a very good learning moment for us to better understand how they work internally, which has in turn helped our salespeople interact with them in a more productive way to ask the right questions and reach the right people faster. 

Additionally, it’s helped us better understand our customers who are smaller, one-drug biotechs for whom everything really hangs on the development of that drug, which gives them a competitive advantage that they need to maintain. Apollo has helped further solidify to us how important these individual drugs and the corresponding data are to these companies’ lifelines. 

MM: At a very high level, what always fascinates me when we work on projects like this that are strongly driven by conversations with customers is that we often end up somewhere quite different from what we imagined at the onset. Those conversations don’t only happen early on; we also share different mockups and prototypes and have them walk through them and inevitably iterate that many times. 

That direct connection is invaluable. By the time we properly launch the product, we can feel confident that it meets those customer needs, because we have had the conversation multiple times during development. The iterative process is critical, because you keep being able to refine your original concept and understand which elements were spot on and which need to change. It requires being open to ending up in a different place than where you thought you would, but that usually means discovering a lot of great new ideas.

CR-apollo-program-timeline

Currently designed to support safety assessment and toxicology studies, Apollo™ offers complete program oversight to help create efficiencies in the drug development process.

DA: I realize you only just launched Apollo, but I’m curious about what may come next. Are you more focused on further refining the existing features, adding new ones, or extending the portal across the other work that Charles River does? 

MM: It’s really all of the above. We are continuously expanding the scope of Apollo’s features for our safety assessment customers –– including expanding to different study types, as well as different data sets and insights on those data sets –– and continuing to increase the breadth and depth of what’s there. We also plan to do this beyond our safety assessment business and across our entire portfolio of products and services. 

Ultimately, we aspire to create industry-leading digital experiences that more seamlessly enable the drug discovery and development process. We are working to do this across all of our businesses and products; in different ways depending on what different customers need. We aim to delight our users and colleagues with intuitive, easy-to-use experiences that take meaningful time off the drug development cycle and ultimately help our customers create healthier lives. 

DA:  Looking beyond the immediate term, is there a vision for more significant shifts that Apollo and the rest of this digital transformation may enable in the future?

KE: We have a longer-term vision for Apollo to not only support the work that customers do with Charles River but to integrate all of their drug development activities, whether those are services outside of the scope of what we do or simply things for which the client has chosen another provider. We see real value for customers to have a single hub for all of their drug development data; on the other hand, we see value for Charles River in better understanding work outside of our purview, which can help our M&A and digital strategy. 

MM:  Charles River is known for vast scientific expertise, and the work we do for our customers and the trust we have built is second to none. From my perspective, science and technology go hand in hand. Further evolving our technical capabilities to align with our science capabilities and growing as a leader in both the science and the technology enabling that science is not only a great aspiration for us internally –– it’s exciting and motivating and allows everyone to focus on super high-value work. It’s also good for our customers and the industry overall to create these frictionless, high-speed processes that help get these therapies out there more quickly, which is great for patients and the health of society. Becoming a true technology-backed science leader is a real aspiration for us.

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