Identifying the Benefits, Capabilities, Components, and Processes of SAP Cell and Gene Therapy Orchestration

Over the past decade, cell and gene therapies-also known as advanced therapy medicinal products (ATMPs)-have revolutionized the treatment landscape with their unprecedented therapeutic potential. Offering significant advantages over traditional therapies, these living cell-based treatments introduce new mechanisms of action to address diseases at the cellular level. With numerous products already in the market and about two thousand trials underway, they represent a burgeoning area of research. As the pipeline of CGT products transitions from clinical trials to market, new business capabilities will be crucial for ensuring they reach patients efficiently during commercialization.

Examples of Approved SAP Cell and Gene Therapy Orchestration Products are:

• 2017: Kymriah, Yescarta, and Luxturna
• 2018: Alofisel
• 2019: Zolgensma, and Zynteglo
• 2020: Tecartus, and Libmeldy
• 2021: Breyanzi, Abecma, Stratagraft, Skysona, and Carteyva
• 2022: Carvykti, Upstaza, and Hemgenix
• 2023: Elevidys, Roctavian, Imlygic, Omisirge, Vyjuvek, Lantidra, Casgevy, and Lyfgenia
• 2024 (As of Q1 2024): Amtagvi, and Lenmeldy

Understanding the necessity for novel business capabilities begins with examining the sophisticated journey of delivering an autologous cell therapy-where a patient's cells are transformed into a customized therapeutic agent.

This intricate process unfolds in several stages:

• Patient selection and therapeutic matching set the stage for treatment.
• Collection of the patient's cells initiates the therapy's foundational phase.
• Preparation and stabilization of cells, such as through cryopreservation, ensure viability for manipulation.
• Logistics management, potentially involving third-party organizations, moves cells to manufacturing facilities.
• Complex manufacturing processes including cell isolation, modification, and expansion, followed by meticulous QA, ready the cells for patient application.
• Careful shipping conveys the cells to the clinical setting for infusion.
• The concluding phases encompass treatment administration and the critical financial aspects of billing and reimbursement.

The journey from cell collection to therapy delivery is intricate and interdependent, involving a web of interactions between the cell therapy provider and numerous stakeholders. SAP Cell and Gene Therapy Orchestration is engineered to navigate this complexity, providing a synchronized overview of the patient and product pathways, ensuring precision and timeliness in therapy delivery. The system fortifies this process with integrated capabilities such as Order Management, Biospecimen Tracking, Process Workflow, Finished Product Logistics, and a robust framework for Chain of Identity and Chain of Custody, complete with comprehensive reporting features.

SAP Cell and Gene Therapy Orchestration stands as a platform of capabilities between the clinical domain and the intricate logistics of the supply chain. It acts not only as a facilitator and manager but also as the vital connection ensuring the orchestration of diverse functions across the supply chain. The platform is designed to streamline operations, guiding CGT case managers and associated roles in securing the flawless execution of patient orders. With a focus on precision and timeliness, SAP Cell and Gene Therapy Orchestration serves as the critical enabler for end-to-end transparency and zero-error delivery in the cell and gene therapy ecosystem.

In other words; SAP Cell and Gene Therapy Orchestration is a platform of capabilities to facilitate, manage, and drive the cell and gene therapy supply chain. It is the central data hub between all supply chain stakeholders, generating end-to-end visibility and helping ensure patient orders are fulfilled on time with zero errors. Add-ons are provided to handle sensitive patient-relevant data and documents (protected health information data) and the integration to an SAP S/4HANA system.

We built SAP Cell and Gene Therapy Orchestration as an industry cloud solution on the SAP Business Technology Platform (SAP BTP) and it is completely micro-services based. Furthermore, we opted for an event-based architecture approach. Together, this provides the following advantages:

• Keeps the S/4HANA core clean
• Ease and pace of innovation with frequent releases. Provides flexibility to react to quickly changing industry requirements
• Usage of latest innovations in SAP BTP with easier adoption for example, AI services, SAP Cloud ALM, Auto Scaler, and others.
• Auto scalability and deployment flexibility
• Support multiple SAP ERP instances integrations
• Support multiple SAP HANA Cloud Platform integrations
• Support multiple Protected Health Information data vault integrations
• Flexible authorization, access and role access including non-ERP users
• Minimal required enhancements for integration purposes rather than function/features
• Event and micro-services based architecture
• Ease of change of configuration and setup of new therapy models
• Enables more flexible collaboration with external stakeholders, such as, direct integration with couriers, ability to provide access to select apps to Contract Manufacturing Organizations (CMO)
• Ability to add regional deployments later
• End-to-end visibility in one UI allows quick identification and mitigation of exceptions

We see clear benefits that employing SAP Cell and Gene Therapy Orchestration provides are:

• End-to-end supply chain visibility and orchestration in line with regulatory compliance
• Establish and maintain chain of identity and chain of custody
• Orchestrate delivery of finished product to the right patient at the right time with zero errors
• Be compliant with regulatory requirements and reduce compliance costs
• Reducing cost and turn-around time
• Increase efficiency by orchestrating the cell or gene therapy supply chain
• Accelerate setup and roll out of new therapies or products
• Integrate with all relevant business partners - treatment center, cell labs, CMO's, and logistics service providers
• Faster time to market for cell and gene therapies
• Reduce manual effort to onboard new treatment centers
• Achieve your clinical trial recruitment goal faster by working with more sites
• Be ready to scale your cell or gene therapy supply chain for commercial phase

Setting up a typical autologous cell therapy program requires new processes that differs a lot from the traditional "make to stock" manufacturing in the life science industry for small-molecules or biological drugs. Autologous cell therapies are personalized products that require the patient's own cells as input for the manufacturing process.

Thus, the process begins with receiving the treatment order from the treatment center where the patient has been identified and found to be eligible for this therapy. The treatment order manager then needs to determine the exact supply chain for this order, confirm the schedule for it and book the courier for the biospecimen shipment from the treatment center to the manufacturing facility.

The manufacturing organization then takes over to manage the incoming biospecimen. Here, the hangtag label that will be used need to be printed to be ready to be applied. Once the biospecimen shipment has arrived, the receipt is confirmed and the biospecimen dispositioned before the processing activities are started.

The actual manufacturing begins by managing the process order batch details and reporting the processing start. While the manufacturing steps are ongoing, the labels for the finished products are printed. Once processing is completed, this is again reported before the finished product is dispositioned and prepared for the shipment.

The manufacturing organization allocates batches of the finished product to the shipment and the treatment order manager books the courier for the finished product shipment accordingly to the schedule. The last step that the manufacturing organization needs to do is to confirm the finished product pickup once the courier picked up the shipment.

The successful receipt of the finished product shipment is then confirmed by the treatment center before the product is used.

SAP Cell and Gene Therapy Orchestration is composed of core and cross components with distinct capabilities to support this complex supply chain. It is the hyper-connected conduit between all functions in the supply chain, helping the cell and gene therapy case manager and related roles to ensure patient orders are fulfilled on time with zero errors.

• Treatment order: Used to get an overview of a single treatment order for a patient and all related data and documents. It can also be used to manage individual steps like shipments and processing activities.
• Flow version: Used to determine the exact supply chain for a single treatment order based on location rules.
• Goods flow: Used to manage the product journey from the biospecimen collection and shipment, through the processing activities, optional distribution center or depot steps, to the shipment of the finished product.

• Document management: Documents can be added/uploaded for later review or documentation purposes at all major steps in the process
• Chain of identity and chain of custody: All steps of the patient and product journey are recorded to ensure that the right product is delivered to the right patient and to be able to provide a report.
• Exception management: If deviations or delays are noticed, exceptions can be raised to assign somebody to work on a resolution
• Task management: Can be used to assign to-dos to individuals to support the process
• Treatment scheduling: Set up and manage planned dates for the steps of therapy delivery
• Supply chain partner portal: External contributors (for example, contract manufacturers that perform some or all of the steps in the manufacturing process) can be provided access to individual apps of SAP Cell and Gene Therapy Orchestration to manage the steps they are responsible for

Typically, SAP Cell and Gene Therapy Orchestration will be interacting with a number of external systems, mainly with the SAP ERP system of the cell therapy manufacturer and the patient onboarding and management application on the treatment center side. With SAP Cell and Gene Therapy Orchestration, we also deliver an SAP S/4HANA add-on which enables native integration between SAP Cell and Gene Therapy Orchestration and SAP S/4HANA, which provides the following benefits:

• Saves significant number of days of custom effort in developing the custom integration and integration mapping&content (approx. 3000 days)
• Standard integration with increased value over time via roadmap of the product
• Reduction of effort and time in implementation and testing
• Standard SAP support for the integration add-on
• Support for integration add-on for future upgrades of S/4HANA (compatibility)
• Modern enterprise events based asynchronous integration leading to higher resilience and throughput
• Developed by SAP engineering teams to ensure, modification free integration add-on
• Standard extension points allow customers to build their own extensions in compliant way

With the core and cross components as shown in the image below, SAP Cell and Gene Therapy Orchestration provides the four capabilities to support the supply chain of a cell or gene therapy.

1. Order Management
   • Provides Order Management with configurable orchestration of the process from Bio-specimen pickup till delivery of the therapy
   • Approval workflow for orders
   • Enables visibility for Pick-up and Delivery date reservation
2. Manufacturing:
   • Provide visibility of manufacturing status
   • Supports processing, disposition and logistics of product batches
   • Label management with interface to existing printing solutions 
3. Logistics:
   • Manage shipment order lifecycle (soft booking, booking, handovers, and others)
   • Interaction with multiple Logistic Service Providers
   • Provides digital document exchanges
4. Chain of Identity (COI) and Chain of Custody (COC) management and reporting:
   • Generate or capture COI/COC IDs
   • Collect and store COI/COC events
   • Provide COI/COC reporting

As an introduction to the SAP Cell and Gene Therapy Orchestration solution, we invite you to watch this short video.