In his last blog post, Adam Lester-George briefly explored the roles of two key stakeholders involved in the delivery of autologous cell and gene therapies (CGT) to patients: therapy developers and Contract Development and Manufacturing Organizations (CDMOs). In this latest post, Adam returns to outline how Binocs addresses the distinct operational challenges faced by these critical background players and how the different solutions combine to help enhance patient care via dynamic CGT slot allocation.
Recap: different responsibilities, different challenges
As I briefly described in my previous post, CGT patients are typically unaware of the two principal behind-the-scenes players critical to the successful delivery of their treatments: the therapy developer (who designs, tests, and licenses the cutting-edge therapeutic products) and the manufacturing function (who actually implements the treatment production methods), which is very often outsourced to a CDMO that will handle multiple such contracts simultaneously.
Because of the distinct pace, focus, and diversity of their respective roles, these different stakeholders face distinct challenges, which I have already outlined. The key takeaway should be that both developers and CDMOs require specific solutions to their challenges in order to achieve their primary goal: to ensure that each eligible patient can receive their personalized treatment.
“A Tale of Two Slot Types”
Successfully treating patients with autologous CGT depends on careful coordination within operationally narrow time windows. In particular, it is a tale of two slot types:
- the apheresis slot, during which the patient’s tissue is collected; and
- the production slot, during which the tissue is processed into the final product.
Due to the fresh nature of the tissue, the viable time window between these two slots is 24-48hrs, after which the material will no longer be usable. As such, it is vital that the apheresis occurs at a time that will allow for the tissue to be transported to a (often geographically distant) manufacturing facility and that this facility, in turn, has a production slot available to begin processing the material while it is still viable.
Historically, this has been a very tricky balancing act and it continues to be one of the biggest limitations to approaching 100% treatment rates. At Binocs, however, we have developed a novel system that individually addresses the distinct challenges faced by both developers and CDMOs. Not only does the Binocs approach make life significantly easier for these stakeholders, it also combines their processes into a uniquely effective slot management system that helps to improve the likelihood of successful CGT treatment.
Let’s explore how.
Overcoming CDMO challenges
- High-volume production: juggling multiple clients with different production and development needs can be daunting, however Binocs is the market leader in digital lab scheduling for a reason! With our cutting-edge, AI-enabled scheduling algorithm, fully optimized CDMO production plans can be generated at the click of a button. This ensures that staff and devices can be automatically assigned to the appropriate tasks and personnel can achieve immediate visibility on their workplans across different projects. This enhances resource utilization and significantly reduces complexity in an otherwise highly complicated environment.
- Flexibility: unexpected changes and late-arriving samples are inevitable but, with Binocs’ extensive history of dynamic lab scheduling, this is barely a bump in the road! Our interactive schedule board allows for real-time adaptability, with lab planners able to effortlessly recalculate schedules to accommodate changing circumstances. Whether it’s making quick adjustments or completely reassigning analysts to other projects when starting material fails to arrive, Binocs lets you get it done without disrupting the overall workflow.
- Tracking and enhancing performance: staying on top of the wide range of products, procedures, methods, and devices used across a CDMO production facility is made dramatically simpler with Binocs’ performance-driven KPI dashboards. By bringing all the data together in one place via real-time metrics, CDMOs can monitor performance and progress with our standard visualization tools. These include KPIs measuring First Time Right rates, Due Date Adherence rates, and our Predictive Batch Tracker, all designed to allow users to take corrective measures promptly and to help CDMOs satisfy their client contracts without incurring penalties.
Overcoming therapy developer challenges
- Logistical complexity of slot allocation: as outlined, this is the real sticking point in autologous CGT. Thankfully, by providing services to both the manufacturing and coordinating functions, Binocs is ideally placed to identify the optimum time to plan apheresis. With complete oversight of the production plan, the system ‘knows’ when manufacturer sites will have availability and can therefore propose multiple appropriate apheresis slots directly to treatment centers. This reduces the amount of active coordination required by developer representatives and massively simplifies (and de-stresses) the process for clinical staff.
- Patient-centricity: no therapy developer wants to create delays or bottlenecks that will further jeopardize the health of their already sick patients. By providing a dynamic slot picker directly to treatment sites, Binocs ensures that the patient remains the priority. When clinical staff know in advance that a specific date and time for apheresis means tissue can be shipped to a manufacturer in time for a production slot, they can plan their patient appointments with confidence. It’s not a guarantee but using the Binocs slot picker maximizes the likelihood that patients can be treated without requiring multiple, disruptive apheresis visits.
- Effective communication: in CGT there is a seemingly endless number of moving parts and different stakeholders that need to be connected. With Binocs serving as a centralized platform, providing distinct services to developers, CDMOs, and treatment centers, it also allows these groups to communicate more effectively. Clinical staff and developer reps no longer need to spend hours firing calls and emails back and forth to identify available production slots—this can be handled automatically, allowing everyone to be on the same page.
- Manufacturing capacity management: coordinating manufacturing capacity at one production facility is complex enough but when a CGT product is available in disparate geographies, it can require capacity to balanced across multiple manufacturing sites, potentially both internal and at CDMOs. When Binocs is deployed across the entire network of sites to manage planning scheduling, the therapy developer can achieve deep insights into the overall production status and availability for additional work. Even better than that, however, the Binocs CGT slot allocation system automatically factors-in site-specific capacity, allowing clinical staff to pick the best slot for the patient without worrying about which production site to prioritize. It’s all handled automatically, including the expected shipping time to the different sites.
Binocs: an end-to-end CGT slot allocation system
By ensuring effective slot allocation, Binocs not only optimizes processes but also helps to improve treatment rates by reducing the chance of missing critical manufacturing windows. The real-time data sharing between CDMOs and therapy developers via Binocs ensures that slot allocation is not just a mere scheduling task but a well-orchestrated plan that considers every angle—from patient apheresis to final product delivery.
In summary, Binocs does not just offer a software solution; it provides a strategy, a vision, and, most importantly, peace of mind in the complex world of CGT—and all of this on top of delivering our famous planning and scheduling services!
Ready to see how Binocs can optimize your CGT operations? Contact us today for a demo!
More on CGT
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Adam has two decades of experience working in clinical trials, biomedical research, public health, and health economics, with a particular interest in the intersection between technology and life sciences. For 7 years before joining Bluecrux in 2019, Adam was the director of healthcare innovation consultancy “LeLan” and brings a wide range of insights to his role as Content Specialist for Binocs.