Disclaimer: SAP Cell and Gene Therapy Orchestration (CGTO) is an industry cloud product of SAP with a quarterly release plan. In the below, when discussing specific functionality, I will include available functionality as well as capabilities that are part of the roadmap for CGTO and indicate future direction of the product.

Collaboration with ecosystem partners has been a key pillar of the SAP strategy for many years and we are proud to have partners that help us on our mission to provide our customers with first in class solutions for their mission critical processes. We celebrate every addition to the SAP Ecosystem and I’m excited to welcome the most recent new member, L7 Informatics, Inc. as an official member of the SAP PartnerEdge open ecosystem! We are always looking for great complementary partner solutions that our SAP Industry Solutions for Life Sciences can be integrated with to empower our customers to thrive in the ever-evolving business landscape. While we were wrestling with the intricacies of scheduling, we identified L7’s L7|ESP™ (Enterprise Science Platform) as a complementary partner solution that supports our vision for our customers developing and manufacturing cell and gene therapy products. L7|ESP MES offers advanced capabilities and flexibility to manage early and late-phase clinical to commercial programs with a unified process, data, and knowledge management platform to enable manufacturing, quality, and technology transfer operations end-to-end. To outline how it fits into the picture for SAP CGTO, let’s review the complexity involved in scheduling individual treatments.

In the dynamic world of cell and gene therapies (CGTs, also known as Advanced Therapy Medicinal Products, ATMPs), the orchestration of needle-to-needle operations embodies a complex symphony of processes. Healthcare providers, Biotech companies, and contract manufacturers are constantly navigating the intricacies of seamless scheduling (an interplay between the patient scheduling, treatment scheduling including logistics, and manufacturing scheduling),  resource management, clinical operations, quality control, manufacturing, and batch release operations. The challenge is not just to manage these elements but to integrate them into a unified, efficient, and transparent system. This integration is crucial in an environment where constant changes, disruptions, and unplanned events are the norm rather than the exception.  Our customers, the CGT/ATMP sponsors and manufacturers, as well as their customers, the healthcare providers and patients experience the impact of these challenges daily. The ability to manage, correct, and eventually predict these variations is vital for maintaining the integrity of the supply chain and ensuring the timely delivery of life-saving therapies.

In this context, data  becomes the linchpin of successful operations. Access to real-time, comprehensive data and advanced analytics is not merely an operational need; it forms the backbone of strategic decision-making. This data-driven approach enables our customers to gain critical insights into their production schedules, demand planning, capacity allocation, resource management, and consumption, and overall supply chain efficiency. Moreover, streamlined data access and transparency simplifies reporting for quality, regulatory, and project management teams, allowing for enhanced operations planning and execution while demonstrating regulatory compliance.  The potential to visualize correlations between supply chain, material management, and manufacturing datasets opens new opportunities for optimization and innovation.

In this blog, we will delve deeper into the complexities and solutions of orchestrating individual treatment schedules for cell therapies, we will explore how technologies like SAP Cell and Gene Therapy Orchestration (CGTO) integrated with unified process and data systems play a central role in transforming these challenges into opportunities for efficiency, quality, and patient care.

The Complexity of Autologous Cell Therapy Scheduling

We will use the model of an autologous cell therapy, as it represents one of the most complex examples of a personalized treatment and is a groundbreaking approach in personalized medicine, which demands an exceptional level of precision and coordination in its scheduling process . Today, this process more often than not, is based on a myriad of spreadsheets, emails, scanned forms, phone calls and disconnected portals. Once a patient is identified, enrolled, registered, and qualified for a certain therapy, the order is formally placed with the developer or manufacturer. Each patient’s treatment journey is unique, beginning with the collection of their cells (“apheresis” or “collection of starting material”) and culminating in the delivery of a tailored therapeutic product that must be administered only to the initial patient (hence, the regulatory demand for a “chain of identity” and “chain of custody” solution ). This journey encompasses a myriad of steps, each with its own set of complexities and dependencies.

The Journey from Apheresis to Infusion

• Apheresis The process starts with scheduling the patient for apheresis, a critical step where the patient’s cells are collected. This step must be meticulously timed to ensure cell viability and optimal condition for subsequent processing and should not be imagined as a simple “blood donation”.
• Transportation and Logistics: Post-collection, these cells embark on a time-and temperature-sensitive journey. They are transported to the manufacturing facility, using specialized dewars to maintain optimal conditions for cell viability during transit. The transportation schedule must account for factors like distance, transit conditions, international trade regulations, and immediate availability at the manufacturing site.
• Manufacturing Process: Upon arrival at the manufacturing facility, the cells undergo a sophisticated manufacturing process. Scheduling at this stage must align with available manufacturing slots, resource allocation, availability of processing experts, availability of critical materials, and strict regulatory compliance requirements.
• Quality Control and Release: Before, during and post manufacturing, the transformed cellular material undergo rigorous quality control checks to ensure identity, viability, safety, and potency critical quality attributes (CQAs) before being approved for disposition to the clinical site for patient infusion. This stage requires careful timing to synchronize QC test result and batch release operations with patient treatment schedules.
• Return Journey and Infusion: Finally, the personalized therapy is transported back to the treatment center for infusion into the patient. This last leg of the journey requires as much precision as the first, ensuring the therapy arrives in time and in perfect condition for successful treatment.

Navigating the Variables

• Manufacturing Capacity and Resource Availability: Understanding and predicting manufacturing capacity and resource availability including critical materials such as reagents, buffers, and media, qualified manufacturing and quality personnel, and require cell separation and processing system is pivotal. Delays or misalignments with capacity and resource availability can cause significant scheduling disruptions.
• Regulatory Compliance: Navigating the regulatory landscape is another layer of complexity. Compliance requirements can influence scheduling, often requiring additional time for documentation and approval processes. Just think about international shipments with customs operations.
• Patient Factors: Patient status and availability and clinical site readiness add another variable to the scheduling equation. Ensuring that treatment schedules align with patient needs and clinical timelines is crucial.

The Ripple Effect of Delays or Changes

A delay or disruption in any one of these steps can have a ripple effect, impacting the entire treatment schedule and can easily result in the loss of an available manufacturing capacity slot and hence the chance to treat one more patient. The precision required in scheduling (and rescheduling if necessary!) each step of the autologous cell therapy process underscores the complexity of this endeavor.

In summary, orchestrating the scheduling for autologous cell therapy is akin to conducting a complex symphony, where timing, coordination, and precision are paramount. The next section will discuss how SAP Cell and Gene Therapy Orchestration (CGTO) addresses these challenges, providing an integrated solution to streamline, manage, and execute these multifaceted scheduling needs.

The role of and need for an orchestration layer

In the intricate world of autologous cell therapy, the SAP Cell and Gene Therapy Orchestration (CGTO) acts as an orchestration layer, as a platform of capabilities,  addressing the multifaceted challenges of treatment scheduling. SAP CGTO is designed to bring coherence and efficiency to the scheduling process, transforming a complex web of tasks into a streamlined, manageable operation.

Centralizing Treatment Scheduling

• Unified Platform: SAP CGTO serves as an overarching platform, integrating various aspects of the treatment schedule. From apheresis to the final infusion, each step is meticulously tracked and managed within this system in an interplay between the patient scheduling, courier scheduling, and manufacturing scheduling.
• Visibility and Coordination: It provides unparalleled visibility across the entire treatment pathway, ensuring that each phase of the cell therapy process is coordinated and aligned with the next. This visibility is crucial for timely decision-making and avoiding potential bottlenecks.
• Central Scheduling Service: SAP CGTO provides the central scheduling service. It can adapt to changes and variations in real-time, recalibrating the treatment schedule as needed. This adaptability is vital in a field where delays and unforeseen changes are common.
• Resource Optimization: The platform also plays a key role in resource optimization. It helps in identifying available manufacturing slots and manufacturing teams, allocate resources to patient product lots and manage consumption based on allocation rules, aligning them with transportation logistics, and ensuring that resources are utilized efficiently.

Enhancing Compliance and Quality Control

• Regulatory Compliance: By integrating regulatory compliance into the orchestration process, SAP CGTO ensures an intact chain of identity and chain of custody.
• Quality Control LIMS Integration: The platform also integrates quality control checkpoints into the schedule, ensuring that each batch undergoes necessary testing and approvals without disrupting the overall timeline.

Bridging Communication Gaps

• Inter-System Communication: SAP CGTO acts as a bridge between different systems, such as ERP and MES, facilitating seamless communication and data exchange based on an event-driven architecture approach (see this blog for details). This integration is critical for maintaining up-to-date information on resource availability, batch attributes and analytics, and manufacturing capacity.
• Real-Time Updates and Alerts: The platform offers real-time updates and alerts, enabling quick responses to scheduling changes or adjustments, further enhancing the efficiency of the treatment process.

Exception is the Norm: Managing the Unexpected Effectively

In the complex and highly individualized world of cell and gene therapy, exceptions in the supply chain are not just possibilities; they are expected occurrences. As one moves from concept to execution, especially given the make-to-order operating model of these therapies, navigating through these exceptions becomes a critical component of ensuring seamless delivery and maintaining the integrity of the treatment process.

Anticipating and Addressing Supply Chain Exceptions

• Recognizing the Inevitability: Based on our conversations in the industry consortium for CGTO, experience in the industry highlighted that treatment orders are likely to encounter numerous issues. These can range from patients becoming unavailable for treatment to unforeseen logistical challenges, as well as quality exceptions based on out-of-specification results.
• Beyond Quality Exceptions: It’s important to distinguish supply chain exceptions from quality and manufacturing exceptions. While both are critical, supply chain exceptions pertain to the logistics and coordination aspects of the treatment process.

The Digital Solution

• Current Challenges: A key observation from industry players is the lack of digital capability to manage these exceptions effectively. This gap often leads to manual, paper-based, or surrogate solutions, which are less efficient and prone to errors reliant on email, phone call, and messaging communications
• Exception Management in SAP CGTO: We have added the exception management and task management as core capabilities to SAP CGTO, and we plan to integrate an exception detection and management capability within the SAP CGTO platform to provide a “supply chain control tower”. This integration underlines that SAP CGTO is not just an order management system but a comprehensive solution capable of handling the dynamic nature of cell therapy supply chains.
• Rule Engine for Event Analysis: All events in the treatment process would pass through a rule engine within CGTO to determine if an exception has arisen. For example, if an order takes longer than expected to arrive at a certain milestone, the rule engine would flag this as an exception.
• Managing Exceptions with Pre-determined Workflows: Once an exception is confirmed, it would trigger pre-determined workflows to address and mitigate the exception, which could include re-scheduling of further milestones. This process ensures that deviations are handled swiftly and efficiently. After resolving the exception, the order would continue its journey without further disruptions.
• Communication Integration: Including communications in the process is vital to ensure proper awareness and coordination among all stakeholders involved in the exception management process. 

The Future of Treatment Scheduling in Cell and Gene Therapy

As we look towards the future of cell and gene therapy, it becomes evident that these miraculous therapies will become more mainstream, and more and more patients will hopefully get access to these earlier in their treatment plan and with that, also the processes, including treatment scheduling, are poised for transformative changes. With advancements in technology and a deeper understanding of the complexities involved in these therapies, the potential to improve and “industrialize” the processes of individualized treatments is immense.

Embracing Artificial Intelligence

• AI in Optimization: One of the most significant advancements in treatment scheduling is the incorporation of Artificial Intelligence (AI). AI can play a pivotal role in finding the optimal schedule for each patient’s treatment journey. By analyzing vast datasets, AI can support in scheduling the best times for each step of the process, from apheresis to infusion.
• AI in Re-scheduling: In situations where re-scheduling is necessary due to unforeseen circumstances, AI can quickly recalibrate the entire treatment plan. This capability will be particularly beneficial in managing the ‘exceptions’ that are commonplace in cell therapy, ensuring minimal disruption to the overall treatment process.

Advanced Data Analytics

• Predictive Analytics: Beyond AI, advanced data analytics will provide deeper insights into scheduling efficiency. Predictive analytics can forecast potential bottlenecks and suggest preemptive actions to avoid delays.
• Real-Time Data Utilization: The future of treatment scheduling will also see a greater emphasis on real-time data utilization. This approach will allow for more dynamic and responsive scheduling, adapting to changes as they occur.

Collaborative Ecosystems

• Interoperability Between Systems: The future will likely see enhanced interoperability between different healthcare, operations, and logistical systems, creating a more collaborative and efficient ecosystem.
• Partnerships and Collaborations: Partnerships between technology providers, healthcare institutions, and logistics companies will be crucial in developing comprehensive solutions that address all aspects of cell therapy delivery.

Conclusion: Navigating the Future of Cell  and Gene Therapy with Precision and Innovation

As we conclude our exploration into the complex and evolving landscape of cell and gene therapy scheduling, it becomes clear that this field is at a pivotal crossroads. The challenges inherent in orchestrating individual treatment schedules are matched only by the innovative solutions emerging to address them. The role of technologies like SAP Cell and Gene Therapy Orchestration (CGTO) and the potential of AI and advanced data analytics in this space are not just facilitators; they are game-changers.

Reflecting on the Journey

• Understanding the Complexities: We began by delving into the intricate nature of autologous cell therapy scheduling, highlighting the critical need for precision and coordination at every step of the treatment journey.
• The Role of SAP CGTO: We saw how SAP CGTO has risen as a central figure in streamlining these complex processes, bringing efficiency, compliance, and adaptability to the forefront of cell therapy operations.
• Embracing the Unexpected: We recognized that in this field, exception is the norm. The inclusion of exception management within CGTO and its evolution into a supply chain control tower underscore the need for agility and responsiveness in handling the unexpected.

Looking Forward

• The Promise of Technological Advancements: The future of treatment scheduling in cell therapy is bright with the promise of AI, advanced analytics, and other technological innovations. These tools are set to transform the way we approach scheduling, making it more patient-centric, efficient, and adaptable.
• A Collaborative Ecosystem: The journey ahead also points towards greater collaboration and integration across various systems and stakeholders, from technology providers to healthcare systems, and many others.

The path forward for cell and gene therapy is one of continuous learning and adaptation. As we embrace these new technologies and approaches, we not only improve the efficiency and effectiveness of treatment schedules but also enhance the overall patient experience and access. The advances in this field are a testament to the relentless pursuit of better, more effective industry-specific solutions.

Join Us at Advanced Therapies Week

As we navigate the intricate and evolving world of cell and gene therapy, the exchange of ideas and collaboration among industry leaders, innovators, and practitioners becomes more crucial than ever. To continue this vital conversation and explore these groundbreaking solutions in person, we extend an exclusive invitation to you, meet s at the Advanced Therapies Week in Miami from January 16-19th. This event presents a unique opportunity for you to dive deeper into the world of cell and gene therapy, engage with experts from SAP and our customers as well as our partners, and discuss the latest advancements and challenges in the field. You can meet the L7 Informatics team at their booth #352 and you are welcome to attend the SAP presentation on January 17^th at 1pm in Theatre 4. Don’t hesitate to reach out to arrange a meeting with our team at a time that suits you for a meeting in the SAP Lounge!

Special thanks to Steven Barash, VP of Strategy and Development, L7 Informatics Inc., for the great collaboration and contributing to this blog!