The client is a US based developer of both Autologous and Allogeneic cell therapies targeting cancers and autoimmune conditions. The therapy in question is a partial match allogeneic cytotoxic T Lymphocyte (CTL) therapy in late-stage clinical trial.  

Challenge 

The client required an integrated allogeneic therapy cell orchestration platform that could follow their therapy through the multiple cycles of cell selection process. The therapy journey also had stages that required multiple users to undertake the same task independently to compare and verify the outcome. 

Solution 

TrakCel scoped a solution that maintains the chain of identity and chain of custody of both cells and data over the course of multiple donor cell matching cycles if required. The process uses a workflow to determine whether to trigger a new selection cycle, or progress to the next stage of the therapy delivery based on the outcome of a decision made by two, independent stakeholders in the process and then verified by the treating physician. This means that the number of cycles that each therapy requires can differ from patient to patient, but all are included in the audit history that is recorded by the OCELLOS platform. 

The customer’s process above required the creation of bespoke user profiles within the system to allow decision information to be collected ‘blind’ to avoid bias within the key processes that drive the therapy journey. In order for two independently generated decisions to be collected separately so that they can be verified against each other. Keeping this information separate, whilst using the same pool of expert decision makers involved creating bespoke rules in the configuration of the orchestration solution that could govern which data fields were visible to each user. Customized user input screens were designed for each stage of the process to ensure that all the information required for patient safety and the audit trail is still captured but redacted at key points of the process. 

The Client is a US based therapy developer of autologous CAR-T and TIL therapies targeting solid tumors. This project was a multiple indication therapy orchestration of an autologous CAR-T therapy targeting solid tumors and is in Phase 1 clinical trials.  

Challenge 

The client wanted a quick and simple deployment suitable for an early clinical trial of a single therapy with two separate and therefore separate patient sets. The therapy process for each indication was the same other than patient sets needing to be separated, and collaborators (e.g., healthcare and apheresis centres) differing. This presented a data privacy driver as well as a need to facilitate the therapy journey whist maintaining Chain of Identity and visibility for the therapy sponsor. 

Solution 

The OCELLOS therapy switcher was an option for the management of the two therapy processes, but as it is designed to accommodate therapies with different classes or processes, the TrakCel team looked for different solution that was more suited to the similarity of the therapy journeys.  As a result, a simpler solution was designed, allowing a simple drop-down selection of indication at patient enrolment to guide the data-flow to the relevant users and stakeholders for the rest of the therapy journey. This methodology allows the patient populations to be treated entirely separately, even when they are being dealt with by common stakeholders whilst minimizing the cost of ownership of the solution and the validation burden on the client over the course of the phased roll out that was planned. 

Being an early phase clinical therapy, deploying a solution that would be easy for users to adopt as well as cost effective for the client to add features, integrations and functionality as the therapy progresses through the later phases of clinical trials through to commercialization was critical to the client. The client has a number of other therapies in their pipeline that are approaching clinical trial and requires a platform that can manage all of these in the future to minimize the training and maintenance. The OCELLOS solution that has been scoped for the client has been developed in partnership with the client to ensure that it is set up to facilitate planned progression with client led milestones for key phases being mapped out to match the client’s development schedule.  

The client is a US based therapy developer with a pipeline of CAR-T aimed at various cancers and ex-vivo gene therapy products aimed rare paediatric genetic immunodeficiency. The project was an ex-vivo, autologous gene therapy orchestration.  

Challenge 

The therapy process meant that some patients were screened multiple times ahead of being accepted for treatment and there needed to be some way of tying these different screenings together for patient record purposes. The process also involved periods of cell storage during which the location of the cells needed to be proactively recorded as those stored in cryogenic shippers had to be processed within the accepted charged life of the shipper. 

Solution 

The OCELLOS solution was configured to allow multiple screening events against a common unique patient id by adding an incrementing suffix to the id that indicated the screening event that the patient journey started from. This allows relevant users to report where a patient had been screened before, how many times and when; any of which could drive a workflow to alter the enrolment process or later stages of the therapy journey if required.  

This information then feeds into the audit trail for the full therapy journey and can be used with additional information imported documentation to support reviews or audit requests as required. 

Pro-active management of cell location was achieved by configuring workflows to trigger email  notifications to the stakeholders to prompt action once stated parameters were met. For example, cryo-preserved materials are routinely stored within cryo-shippers for a period of time before being mover to the next step of the process. The charge life of the shippers is critical. As such, the OCELLOS system uses this as critical information triggering a custom notification to the manufacturing stakeholder well in advance of potential failure.

The client is a US based therapy developer with a broad pipeline of therapies from preclinical to pivotal/commercial. The system deployed is orchestrating autologous gene editing therapies targeting genetic blood disorders that are readying for commercialization.

Challenge

This therapy often requires multiple apheresis collections from each patient in order to generate sufficient cell volumes to progress manufacturing, what is more, these repeated collections needed to be treated independently of each other but run in tandem with a second cell collection process. This created both a more complex chain of identity and chain of custody solution as multiple patient samples must be managed to produce a variety of lots that are finally combined into a single patient infusion. The structure of the organisation meant matching each healthcare location with a regional ‘cluster’ of apheresis centres that in some cases were shared by other healthcare centres. Ensuring patients were assigned correctly to these centres was an important part of the process.

Solution

The OCELLOS solution was configured to accept and track multiple apheresis collections over a period by assigning a unique identifying number. This apheresis id then relates back to the patient identifier and then the resulting lot number, recording information such as cell counts as those samples progress through the manufacturing process. The system then tracks these individual lots for each patient until they are at the point of being combined into a shipment to form a final dose. This means that all the relevant information relating to the transit, manufacturing and storage of the various lots is available as part of the audit trail for the patient.

The scheduling element of the system also helps healthcare providers offer clarity to patients who are undergoing therapy, giving them better visibility of the schedule for the multiple apheresis collections that are required.

The TrakCel team configured OCELLOS to match the commercial relationships between the prescribing healthcare centre and their corresponding apheresis centres so that healthcare users only see the correct centres when booking client appointments. To facilitate ease of use for all users in the supply chain, the dashboard that the apheresis centre users see then consolidates the patients that they are dealing with, even where they come from multiple treatment centres. This means that each patient journey is processed in the same way for users, with OCELLOS ensuring that the correct parameters are in place for the next step of the journey.

The client is a UK based therapy developer with a pivotal phase autologous CAR-T therapy targeting adult Acute Lymphoblastic Leukemia.

Challenge

The client required a solution that could manage commercial scale up for this pivotal phase therapy aimed to target adult B-ALL which they estimate impacts over 8000 patients annually in the US and EU. This meant considering geographically diverse patient populations with the language, time zone and logistics challenges that increasing volumes of therapies over a wide geography presented.

Solution

A key part of the process was in managing the differences in the shipping times of materials between the leukapheresis centres and manufacturers and then back out to treatment centres at the end of the manufacturing process. This was overcome by setting up relationships in the OCELLOS system between the various sites that specifically indicated where they were physically located in relation to the other sites that they might need to ship to. Once set, the OCELLOS system could use this information to vary the scheduling of the manufacturing slots and other time dependent elements of the therapy journey later in the supply chain.

This means that when scheduling the treatment plan for a patient the healthcare provider can see location specific calculations on the therapy timeline. This both helps to provide a better patient experience but also allows for more precise scheduling and reduces the chance that the process will stray from the most efficient path as a result of unrealistic timescales.