Two things are true about emerging cell and gene therapies (C>): They could have a transformative impact on patients’ lives, and ordering and managing them is a complex challenge for providers and manufacturers.
Malik Kaman, ZS principal in oncology, recently sat down with Dr. Matthew Lakelin, TrakCel's co-founder and vice president of scientific affairs and product development, to discuss medicine’s most complex value chain and understand what it takes to ensure their successful delivery.
What have their experiences been teaching them? What challenges are they hoping to solve? How are advanced analytics and digital, platform-based connectivity helping the industry innovate and address its biggest challenges and opportunities? We discussed these issues and more.
Read the conversation below to learn more about ZS and TrakCel's partnership and see how order orchestration platforms are shaping the future of C>.
Malik Kaman (ZS): For those who may be unfamiliar with the supply chain for autologous cell therapies, can you tell us why it was important to improve the process of securing, ordering and delivering C> therapies?
Matthew Lakelin (TrakCel): Absolutely. It’s crucially important that manufacturers get their C> therapies to patients on time and eliminate any lags in their treatment or clinical trial journey. Any error or setback can have a profound impact on patients’ lives, their health outcomes and the organization’s ability to carry out a clinical trial or commercialize a product safely and effectively.
ZS: And starting this process early in your development has its benefits too. We’ve been advising our clients to begin thinking about this as early as phase two of their clinical trials.
TrakCel: It does. When you start early on—during your first-in-human trials, for example—many of the workflows you define in that early phase will stick with you all the way through commercialization, safeguarding your patients and your products well after the guardrails of clinical research are lifted.
ZS: How have the latest digital possibilities evolved your thinking about cell and gene therapy orchestration?
TrakCel: When I think about this question, I think about the ways that digital platform evolution can give pharma companies the connected, predictive, AI-powered insights and analytics they need to innovate and solve problems, improve journeys, and grow in a flexible and sustainable way. In part, this thinking is what led us to develop OCELLOS.
ZS: At ZS, we recognized the need for end-to-end orchestration platforms with our very first clients. We found that their workflows often had more than 50 different hand-offs from team to team and person to person.
TrakCel: Yes, exactly. Our orchestration solutions emerged from the need to simply manage the design of chain-of-identity and chain-of-custody processes to maintain the flow of the therapy journey. From there, it evolved into an automated digital solution that ensures process adherence to keep clients’ schedules on track and secure data sharing to fuel transparency and compliance. This helped us improve the speed and efficiency of our orders within the value chain while reducing errors and product loss.
Then in 2019, we made a critical decision to re-platform our solution so we could accommodate more customized processes and connect our full ecosystem of solutions supporting the C> supply chain. At the time, the platform approach was a rather radical move. But we knew that taking everything we had learned about our industry and our customers and investing that knowledge in a more flexible and sustainable platform was critical to continue our growth.
ZS: How has your platform evolved to meet the needs of the industry?
TrakCel: In the early days, the primary objective was almost always the chain of identity and maintaining the flow of the therapy journey—and these aspects are still essential to our digital solutions. But as more and more complex autologous and ex-vivo therapies emerge in our industry, we began to see the number of clinical trials increase rapidly, which makes the critical job of orchestrating orders more complicated.
ZS: Can you tell us more about the complexity we’re facing and how it’s building?
TrakCel: Today, a much higher volume of therapies is approaching commercialization, which adds new challenges and complexities for manufacturers and life sciences organizations. We’re also seeing value chains with more stakeholders, more geographic diversity and more therapies to manage. On top of that, manual order processes are getting more complicated. Some may have multiple cycles, several samples or even parts of the process where they’re tracking data instead of a physical product.
ZS: Yes, we’re seeing something similar. Within the C> space, we’re expecting to see more than 30 approved indications over the next five years, so it doesn’t make a lot of sense for each manufacturer to build its own bespoke platform. We see a need for standardization across the industry.
TrakCel: Given the rising volume and complexity of C> therapy orders, it’s especially critical for manufacturers and providers to collaborate on every step seamlessly and in the right order and timeframe. Otherwise, it’s simply not possible to deliver therapies to patients safely and manage to innovate in a highly regulated space. What makes companies most vulnerable to error are the infrequently executed, excessively complex manual processes that rely on many contributors. So, we set out to change that with sophisticated, automated tools to optimize order orchestration and improve the flow of the patient journey.
ZS: What does this innovative solution mean for the industry at large?
TrakCel: For the industry to grow successfully, it needs to take the amazing scientific discoveries coming through the pipeline and connect them with large numbers of patients the moment they need them. To do that, we need a robust and repeatable value chain that can mitigate risk to the furthest extent possible.
With an automated system, we can quickly unite patients with autologous therapies and help users navigate a complex therapy journey. Meanwhile, all the materials and data keep moving safely and securely which, in turn, helps us improve patients’ lives and transform outcomes in a range of therapy areas.
ZS: There’s a huge opportunity for life sciences companies across therapy areas to transform the way they manage orders and mitigate risk—the application isn’t limited to the rare disease space.
TrakCel: Exactly. To give you a sense of scale, the first orchestration solution TrakCel delivered was for an ultrarare disease indication with a single-digit annual diagnosis. Today, TrakCel is producing orchestration solutions for an illness that could affect one in three people.
ZS: Can you tell us a bit more about OCELLOS and the partners that helped you bring it to life?
TrakCel: OCELLOS is our second-generation orchestration solution. It’s built on the Salesforce.com platform, with MuleSoft as the middleware provider.
ZS: What led you to choose to work with those partners?
TrakCel: We knew that we wanted to let organizations evolve order processes quickly and sustainably, so we decided to build the solution on the Salesforce platform. That meant our solution could remain modular, which gives us a consistent framework to support many different configurations of client processes and allows our clients to deploy solutions quickly and adapt to changes.
That buildable framework is important because beneath every process configuration, there’s a common core system that can support an array of possibilities. Some of these options may not be required in the early phases of therapy development, but later, as the client approaches commercialization, for example, they can turn them on without altering the underlying structure.
We also built OCELLOS with integration and connectivity in mind, which is why we chose MuleSoft as our middleware provider. A connected ecosystem is essential to advanced therapy supplies, so we prioritized solutions that allowed flexible third-party integration and reliable, secure connectivity across a range of systems. Not only does that save clients time and effort—it also removes fault lines that are prone to instability when either of the adjoined systems needs an update. This makes the solution more stable, sustainable and efficient for all parties, and it lends us the flexibility to have different clients using the same application programming interface (API) integration to drive different processes within their system.
ZS: What led you to partner with ZS?
TrakCel: At TrakCel, we always look to partner with organizations that match our outlook and values. We’re a very customer-focused organization. Our product is centered on offering a good user experience and our values are always to remember that there is a patient at the end of every therapy we help to deliver. Working with partners like ZS that have a similar outlook helps us to maintain the integrity of the product and services that we offer.
Beyond sharing a customer focus, the insights ZS has brought to advanced therapy supply chains shifted our thinking and allowed us to focus on maximizing the value from supply chain data. This innovation will allow developers of advanced therapies to consider additional information regarding the supply chain, not only when responding to data trends of existing supply strategies but also when selecting and expanding clinical sites. We’re really excited about what this means for an industry with access to galaxies of data and insights in therapy areas where a breakthrough could transform lives.
ZS: What’s next? Is your vision expanding or broadening as you learn and grow?
TrakCel: Building on the information ZS shared, we’re focused on maximizing the value of our insights from supply chain data so developers of advanced therapies can take in a broader set of data and use it to expand their universe of clinical sites. Rather than limiting their decisions to the trends they’re seeing in one lane of their existing supply chain, they can tap into a broader data set with predictive insights that alert them to the best-case scenario for getting their therapy to the patient or an opportunity to improve the way they schedule orders.
Furthermore, as personalized immunotherapies become more prevalent, we anticipate aiding in the management of more sophisticated supply chains. TrakCel’s orchestration technology will provide management solutions to the most complex supply cycles observed in the pharmaceutical industry.
ZS: Is there any advice you want to share with readers who may be beginning their journey to C> orchestration?
TrakCel: I’d tell them to invest time in thoroughly understanding their processes before attempting to deploy a system. Whether they do this by analyzing what’s already in place—the potential points of failure or risk, areas of inefficiency, where data flows, where tasks sit and critical timelines, for example—it’s imperative to understand the patient journey, the drug product journey and the data journey.
If they need support, reach out for help. Our strategic partnership with ZS helped us see that there’s more value in developing a solution for a broader context than simply integrating a new piece of software. We’re already conducting detailed discovery assessments with ZS clients to flesh out these processes and design end-to-end solutions that will enable future growth. These systems have to fit into highly complex, existing IT environments, so taking the time to unpack these processes upfront is a valuable investment. Not only does it set organizations up for success at the point of commercialization—it also supports them through clinical trials.
The de facto standard is to have electronic orchestration in place to support commercial C> products throughout their life cycle. Orchestrating processes from the first clinical study onward helps companies keep a clear audit of the records, track how and when things change, keep data in an easily reportable format, and ensure that the processes driving your therapy are consistently and correctly followed. Mistakes can be costly in terms of lost product, time—or worse, negative patient outcome. My best advice is to consider the broader benefits of order orchestration and invest in a solution as soon as possible.
This applies to anyone, not just C> leaders, but the other thing I’d recommend is to stay close to the market, listen and respond to the changing needs of customers and the industry. That’s especially important for those of us working in the C> sector because we’re seeing it grow at a remarkably fast pace and we’re beginning to use cutting-edge technology, so development can and should be dynamic.