Managing discrete patient groups puts additional pressure on supply chain processes to ensure patient and therapy data can be captured and reported accurately.
As the Cell and Gene Therapy sector matures, both approved commercial products and those that are still in trial phase are increasingly targeting multiple indications, or are looking to separate sub-sets of patients within a trial. There could be many reasons for managing discrete patient groups within the cell orchestration system, it could be because there are different sponsors involved in various parts of the trial, or simply that the data and audit records for the various indications need to be separated out.
A digital cell orchestration solution (COS) like OCELLOS can give developers a great deal more flexibility than a manually managed process and can help users navigate complex supply chain partner relationships. For example, two indications might go through all the same steps but the referring healthcare sites or the clinics and apheresis centres may be restricted based on the condition that the patient is being treated for. This can be easily handled by the system which can configure the views and options that a user sees based on the indication that they have selected.
This has the dual impact of simplifying the choices and user menus by restricting them only to the options that are valid for the patient that the user is dealing with. This also helps to reduce errors or delays in the supply chain. Internal stakeholders and budgets can also be split out, with the system sending notifications to decision makers based on the indications or patient groups that they have direct involvement with. The COS can even assist with internal admin, such as billing, by booking couriers and manufacturing slots to different accounts for each patient subset, should this be required.
The subtle differences within a comparable therapy journey could be patient specific, for example, the qualification criteria for a patient on the trial, or the dosage levels could be different. The timescales might vary if a particular condition means that there is a different set of pre-treatment criteria or treatments that need to be completed before moving to the infusion stages. All of these can be dealt with within the system, ensuring that stakeholders can have the confidence that they are being guided through the correct steps automatically with less room for error. The advantage of creating these subsets of patient groups within a therapy are significant, as the therapy follows largely the same process, the comparable validation and maintenance burden of one therapy process on a single platform is much reduced from historical solutions that would have required multiple therapies or even multiple platforms to segregate the processes and the data.
Next Week – Managing multiple therapies
Article by Helen Hopkins - 26 Jul 2022