Determining Key Personas and Transactional Entities for Processing Treatment Orders

As a platform of capabilities supporting the orchestration of personalized treatment operations, SAP Cell and Gene Therapy Orchestration was built with the needs of the following actors or personas in mind:

• Control Tower
• Patient Operations
• Manufacturing/Processing
• Supply Chain Execution

Let us now better understand the tasks, goals, and other aspects of these actors or personas.

Her role is called the control tower. She oversees the end-to-end order management process from the order entry until the delivery to the customer so that the patient can be treated as planned.

Her main tasks are to:

• Manage orders from order entry until delivery (approval, invoicing, inbound delivery (if applicable), outbound delivery, export documentation, liaison with courier)
• Manage exceptions that can impact the approved order terms

Her goals are to:

• Ensure the treatment center receives the order as approved
• Avoid/mitigate the impact of any exception for the treatment center

What she likes:

• Overseeing the end to end order flow to offer a seamless delivery experience to the customer
• Managing the process/system only by exception
• Proactively being alerted of exceptions by the system

What she finds frustrating:

• Having to consult many systems to know the exact order status
• Not detecting an exception that impacts an order early enough
• Not being able to provide reliable information to customers

She works in the patient operations team. She coordinates CGT orders during clinical trials to ensure the product is available for the Principal Investigators (PIs) and Trial Subjects in clinical trials that are in her scope.

Her main tasks are to:

• Approve orders in supply chain orchestration
• Manage the day-to-day of patient specific batches progress and dosing schedules
• Confirm/reserve manufacturing slots
• Track orders and identify which of them require her attention
• Solve or escalate exceptions
• Assist healthcare providers or principal investigators with order management
• Process improvement through KPI
• Work with CMOs and couriers to coordinate product creation/delivery

Her goals are to:

• Ensure consistent supply of CGT products to treatment centers
• Support healthcare providers and principle investigators
• Maintain clinical/patient schedules as much as possible (supply chain issues don't cause reschedules)

What she likes:

• Knowing the status of the order and identifying issues as soon as possible (in her scope)
• Being able to understand and troubleshoot an issue quickly
• Have all the required information in one place - from all supply chain partners
• Notifications that are on time and clear

What she finds frustrating:

• Not catching issues on time
• Products that are not delivered on schedule
• Having to search for information in multiple sources

She is part of the manufacturing team. She is the one who prepares the final patient kit.

Her main tasks are:

• Printing the labels for the products/samples and cartons
• Label unlabeled vials and pack the patient specific kit in -20° Celsius room conditions
• Packing the final product into the shipper and link the smart sensor
• Document the process and confirm pick-up of shipment

Her goals are to:

• Perform the labeling and packaging activities in fast but safe ways
• Be reliable
• Not lose/break a vial as they are very expensive

What she likes:

• Tools and systems that support her activities
• Lean and efficient operating steps

What she finds frustrating:

Handling the small vials and the label with gloves in the -20° room

He works in supply chain execution. He is responsible for managing the commercial and supply topics in his country.

His main tasks are to:

• Collaborate with the patient operations colleagues to support our customers
• Ensure that the commercial/clinical process is covered and approve the treatment from an affiliate site

His goals are to:

• Ensure high customer satisfaction
• Support the success of the CGT therapies in the country

What he likes:

• Order visibility
• Information that helps him to answer customer requests
• End-to-end visibility that we typically don't have for classical products

What he finds frustrating:

• Silos and limited visibility
• Customer requests that he can't answer
• Country specific requirements that are not addressed by the platform

Next, we will get to know the key entities and their relationships to each other that are used throughout SAP Cell and Gene Therapy Orchestration.

In our discussion about setting up a typical autologous cell therapy program, we have already met a number of key transactional entities that were necessary and that we used to describe the processes.

These transactional entities are:

• Treatment order: This entity is sent from the healthcare provider to SAP Cell and Gene Therapy Orchestration to tell that a certain treatment center wants to order and provide a certain therapy for a certain patient.
• Shipment: This entity is subsequent to the treatment order and controls the physical movement of either the biospecimen, the intermediate, or the finished product. In the shipment, information like pick-up location, drop-off location, courier, date and time is managed.
• Collection: This entity contains the information related to the collection or procurement of the biospecimen (tissue, blood, cell sample, and so on). The collection is always a part of a shipment which delivers the collection from point A to point B.
• Processing activity: This entity controls the manufacturing process/steps within SAP Cell and Gene Therapy Orchestration.

Next, we will take a look at each of these entities in SAP Cell and Gene Therapy Orchestration.

The treatment order view is divided into the header information and the detailed information in the body. In the header, we see the Chain of Identity ID that uniquely identifies this one treatment order. We see which therapy was ordered and by which treatment center it has been ordered. We can also see which status the order is in now (in this example, the status is "created"). Given the correct authorization rights, we can also access the available patient information from here directly. We can edit some of the information associated with the treatment order using the "edit" button at the top right.

The rest of this order overview contains all important information related to this order:

• General Information
• Process Flow
• Order Dates
• Business Partners
• Shipments
• Processing Activity
• Order Texts
• Approval Details
• PPF (post-processing framework) Events
• Documents
• Logs

The shipment overview is also divided into the header information and the detailed information in the body. As this is a shipment for a biospecimen, we see the Biospecimen Shipment ID first in the header. We also see the Chain of Identity ID that uniquely identifies the one treatment order that this shipment belongs to. We see which therapy was ordered and by which treatment center it has been ordered. We can also see which status the order is in now as well as the status of the shipment. Given the correct authorization rights, we can also access the available patient information from here directly. Additionally, we can directly edit the shipment information using the "edit" button at the top right, let the system determine a suitable transportation lane, and book the courier for executing the shipment.

The rest of the view contains all important information related to this shipment:

• General Information
• Location
• Shipment Dates
• Logistics
• Shipment and Receipt
• Biospecimen Materials
• PPF (post-processing framework) Events
• Documents
• ERP Data
• Logs

The collection overview is accessible from the biospecimen shipment view and is also divided into the header information and the detailed information in the body. As this is a collection of a biospecimen, we see the Biospecimen collection ID first in the header. We also see the Chain of Identity ID that uniquely identifies the one treatment order that this collection and shipment belong to. We see which therapy was ordered and by which treatment center it has been ordered. We can also see which status the order is in now. Given the right authorization rights, we can also access the available patient information from here directly.

The rest of the view contains all important information related to this collection:

• General Information
• PPF (post-processing framework) Events
• Documents

The processing activity view is divided into the header information and the detailed information in the body. In the header, we see the type of processing activity (in this case, using a contract manufacturing organization, CMO) and the Chain of Identity ID that uniquely identifies the one treatment order that this processing activity is part of. We see which therapy was ordered and by which treatment center it has been ordered. Importantly, we also see which processing plant is assigned to execute the processing activities. We can also see which status the order is in now. Given the right authorization rights, we can also access the available patient information from here directly. We can edit some of the information associated with the processing activities using the "edit" button on the top right.

The rest of the view contains all important information related to this order:

• General Information
• Manufacturing Location
• Processing Dates
• Process Order
• Process Order Batches
• PPF (post-processing framework) Events
• Documents
• Logs