Describing Key Actors, Entities, and Process Steps in SAP Cell and Gene Therapy Orchestration

These are the key actors/personas and entities of SAP Cell and Gene Therapy Orchestration

• Commercial Therapy Case Manager
• Clinical Patient Operations
• Manufacturing/Processing
• Supply Chain Execution

SAP Cell and Gene Therapy Orchestration serves as the digital backbone for orchestrating personalized treatment operations, designed around the pivotal roles of key personnel involved in the delivery of cell and gene therapies. The system enhances the collaborative efforts of Commercial Therapy Case Managers, Clinical Patient Operations, Manufacturing/Processing staff, and Supply Chain Execution teams. Each role is empowered with specific capabilities and insights to streamline their individual tasks, ensuring the operational flow is maintained from patient onboarding to therapy delivery. As we review the responsibilities and objectives of these actors, we'll uncover how their interaction with SAP Cell and Gene Therapy Orchestration's features leads to efficient, error-free processes tailored to individual therapy delivery.

This is Cora! In a commercial setting, her role is typically called the "case manager" or also the "control tower". She oversees the end-to-end order management process from the order entry until the delivery to the qualified treatment center so that the patient can be treated as planned.

Her main tasks are:

• 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 on-time delivery of the treatment order

Her goals are:

• To ensure the treatment center receives the order as approved
• To avoid / mitigate the impact of any exception for the treatment center

What she likes:

• Oversee the end to end order flow to offer a seamless delivery experience to the customer
• Manage the process / system only by exception
• Proactively be 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 stakeholders

This is Sara! She works in the clinical patient operations team. She coordinates SAP Cell and Gene Therapy orders with the healthcare professionals at the clinical trial sites.

Her main tasks are:

• Approve orders in supply chain orchestration
• Day-to-day management 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 professionals or principal investigators with order management
• Process improvement through KPI
• Work with internal teams as well as CDMOs and couriers to coordinate product manufacturing and delivery

Her goals are:

• Consistent supply of clinical SAP Cell and Gene Therapy Orchestration products to trial sites
• Ensuring that healthcare professionals and principle investigators are supported
• Clinical/patient schedules are maintained as much as possible (supply chain issues don't cause reschedules)

What she likes:

• Knowing the status of the order and identifying issues ASAP (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: on time, clear

What she finds frustrating:

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

This is Patricia. 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 product in bags or vials.
• Label unlabeled vials and pack the patient specific kit in -20 degrees 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 to lose/break a vial as they are very precious

What she likes:

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

What she finds frustrating: Detecting any last-minute deviations or issues with the finished product packaging.

This is Chris. He manages the supply chain execution. He is responsible for all logistical and processing & manufacturing activities at his plant.

His main tasks are:

• Collaborate with the patient operations and case management colleagues to support the delivery of products to treatment centers
• Ensure that the commercial/clinical process is covered and all logistical and processing & manufacturing steps are proceedings as planned

His goals are:

• to ensure high customer satisfaction
• Support the successful manufacturing and delivery of Cell and Gene Therapy therapies

What he likes:

• Order visibility
• Information that help him to answer customer requests
• End-to-end visibility that typically of patient and product journey

What he finds frustrating:

• Silos and limited visibility
• Customer requests that he can't answer
• Country specific requirements that need to be managed manually

As is evident, each plays a unique part, from managing the intricate details of order processing to the precise execution of manufacturing and supply chain logistics. With this knowledge, we'll next explore the key entities within SAP Cell and Gene Therapy Orchestration that facilitate these roles, examining how they interconnect to maintain the momentum of the Cell and Gene Therapy processes.

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, etc. is managed.
• Collection: This entity contains the information related to the collection or procurement of the biospecimen (tissue, blood, cell sample, etc.). 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 right 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 on the top right.

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

• General Information
• Process Flow
• Order Dates
• Scheduling Request
• 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 right 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 on the top right, let the system determine a suitable transportation lane, book the courier for executing the shipment, or request shipment cancellation.

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 material overview is accessible from the biospecimen shipment view and is also 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 the unique treatment that this collection and shipment belong to. We see which therapy was ordered and by which treatment center it has been ordered. Given the right authorization rights, we can also access the available patient information from here directly.

As this is a material that is part of the collection of a biospecimen, the rest of the view contains all important information related to this material in the collection:

• General Information, like the material description and ID, batch information, quantity information, status information, expiration date, etc.
• Collection information, like the collection ID, quantity, etc.
• Subunit information, like the type, the ID, etc.
• 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, 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
• Processing Location
• Processing Dates
• Process Order
• Process Order Batches
• PPF (post-processing framework) Events
• Documents
• Logs