Recently I had the opportunity to participate in the Hanson Wade Future Cell Therapy Commercialization Event in Boston, MA which was overall, a fantastic event. A big thanks to the organizers. With logistics being a cornerstone to the future success of cell therapy commercialization, a significant portion of the overall discussion was focused on supply chain challenges associated with the delivery of autologous therapies.
Due to TrakCel’s well established US and EU compliant, Cloud-based Cellular Orchestration Platform (COP) that pioneers the space and was first to market in 2012, Hanson Wade provided TrakCel and myself the opportunity to help assemble and moderate a panel titled, “Leveraging Cellular Orchestration Platforms and Other Systems to Support the Cell Therapy Supply Chain.”
For those that were not able to attend, this blog post is a summary of the three main takeaway messages of the presentation:
- What is a Cellular Orchestration Platform?
- Where does a Cellular Orchestration Platform fit amongst other IT systems?
- How to go about implementing a Cellular Orchestration Platform?
Over the past several months it’s been evident that the cell therapy community has an acute awareness of Cellular Orchestration Platforms (referred to as COP here forward) but somewhat of an obtuse understanding around what exactly these systems do – hence the intention and main focus of the panel.
As the name suggests, these systems are designed to orchestrate, or manage processes and workflows across the entire supply chain, often driven by various third parties that lie outside the control of drug developers, including collection centers, couriers, manufacturers and infusion centers. To do so, these systems must have flexible configurations that yield prescriptive workflows as well as detailed rules and constraints that are specifically engineered to match the cell therapy company’s product portfolio.
The end result provides cell therapy developers a standardized, automated and controllable needle-to-needle supply chain with functionality including automated scheduling/resource alignment, notifications/alerts, capacity management and customizable dashboards for core users.
When complete, these systems become a drug developer’s “Control Tower” view and the thread that ties the overall process together. By doing so, the COP system provides developers a complete and regulatory compliant electronic record for chain of identity and chain of custody from collection through to infusion.
Another major topic discussed by the panel was around where a COP fits within the universe of IT systems.
Primarily, a COP should not be compared against more traditional internal systems such as ERP, MES or LIMS which are of course intended to support more internal enterprise and manufacturing efforts. This is something that’s often misunderstood by our industry and understandable considering the new and unique manufacturing requirements of autologous cell therapies. Even though when one compares a COP against a more traditional manufacturing system and finds overlap in functional capabilities (such as barcoding, traceability, scheduling, etc.), the environments for which they are intended and the implementation efforts and expertise required are very different.
The second major message was that a COP does not, and should not, interfere with the implementation of customer relationship, enterprise, manufacturing and laboratory related management systems. Too frequently companies feel that major internal systems should be implemented before considering a COP when the strategy should be the exact opposite! Those that have managed mid to late-stage autologous trials understand firsthand how labor intensive and inefficient management of the autologous supply chain can be.
While the traditional systems mentioned above have their place in the commercial environment, COP becomes instrumental early in clinical development when patient numbers are in the 10s, not 1000s. This leads to the last major topic of the presentation, implementation strategy.
So, what’s the first step to implementation? Like building a house, the first effort should be focused on building a solid foundation. In the world of COP implementation that means establishing clinical site workflows for both collection and infusion, generating both starting and final drug product labels, courier integrations and milestone reporting within manufacturing environments.
A successful COP foundation establishes the pathway and major processes conducted across the supply chain while also pinpointing each step in the process where custody of the product is exchanged and/or chain of identity verification if required.
To garner maximum value from the COP, implementation efforts should begin early in clinical development when the number of clinical sites are limited (during Phase I/II trials). This early implementation allows for a validated system to be in place to support mid-stage trials, when clinical site numbers begin to expand and manual in-house systems begin to break down. At this stage of implementation, the combined value of the COP along with the costs saved via introducing the system during early to mid-stage clinical onboarding efforts (instead of onboarding and then backtracking clinical efforts to introduce the COP) can immediately justify investment with a measurable return on investment.
Once the foundation is in place, the next stage of implementation should be focused on scheduling. The simple reason for this is based on the fact that tracking/traceability (established in the foundation) and scheduling are inherently interconnected and dependent on each other.
As patient numbers increase and manufacturing capacity utilization quickly reaches the upward limits of the cleanroom environment, the scheduling system must accurately assess and book capacity while also being able to cancel or reschedule without breaching the limitations of the third-party environments. To do so, implementation of scheduling requires careful analysis of all stakeholders and resources involved in the supply chain followed by applying detailed rules and constraints that subsequently ensures alignment of resources for collection, manufacturing, transportation and infusion.
As we all know too well, Murphy is alive and well in cell therapy – if something can go wrong…it will go wrong. For this reason, the scheduling system must be adaptable to manage change. Lastly, implementation of a scheduling system often requires a detailed understanding of the treatment regime and the manufacturing process.
For this same reason, a COP provider must have a detailed understanding of the collection, logistics, manufacturing process and administration (including patient preparation) of each cell therapy it manages. Without this experience, rules could be built into the platform that would plague the utility of the system.
With the bulk of COP functionality now in place from the Stage 1 and Stage 2 implementations, developers are well positioned to provide an electronic audit file demonstrating chain of identity and chain of custody while also demonstrating capacity management for BLA application. This leads us to the final implementation stage (recommended to occur during Phase III trials) that is focused primarily on the integration of commercial systems to maximize efficiencies across the supply cycle. On the front end of the supply cycle, integrations may occur between the customer relations management software (CRM) – often the initial system used by patient case managers to gather preliminary patient enrollment related information and benefit verifications – with the COP.
To further information automation in the ultimate effort to streamline visibility into the needle-to-needle supply, integrations during Stage 3 may also occur between ERP, MES, QMS and LIMS systems as each system may have independent yet important data to contribute to the COP. The COP then becomes the tool that weaves several standalone systems together to provide the detailed view of the patient and the drug product journey. It can also become an interface for the patient and the physician to provide visibility into the progress of the life-saving therapy. Beyond infusion, drug developers are also considering the lifecycle of the COP to go beyond the delivery of the drug and become a vital tool for the long-term tracking of the patient for reimbursement, therefore requiring integrations with potential downstream payor-related systems. In the end, COP can become the overarching platform that tracks and manages the overall patient journey from identification to final reimbursement for the therapy.
The bottom line message is that Cellular Orchestration Platforms play an instrumental role in cell therapy – especially for autologous therapies. While the functionality they deliver is undoubtedly needed in the commercial setting, I hope this blog emphasizes the incredible value these systems provide in early clinical development and why it makes sense to begin implementation efforts as early as possible. As a final point, Steven Buckanavage one of the panelists, who led commercial efforts at AstraZeneca, GSK and most recently Celyad and now President at Mentoris Advisors, emphasized several times that we as an industry must have flawless execution every time to be commercially successful.
We at TrakCel see COP systems as a vital tool in the effort to bring Six Sigma level of quality to cell and gene therapy.
If you have any further questions or would like to learn more about TrakCel’s Cellular Orchestration Platform please email me at firstname.lastname@example.org.