Cell and gene therapies (CGT) are a new frontier of patient-centric treatments in the life sciences industry. As of the third quarter of 2021, there were more than 2,000 cell and gene therapies in active clinical trials and just a few dozen approved.
While CGTs offer a potentially promising new option for patients, they are complex to develop, manufacture, and deliver. In contrast to traditional therapies, individualized therapies often involve extracting cells or tissue from the patient or a donor, processing the sample, manufacturing a personalized therapy, and administering the final product to the patient.
There are already many companies working to deliver CGTs to patients, ranging from small startups to large biopharmaceutical companies that are aiming to realize a full portfolio of cell and gene therapies.
There are also specialized IT solutions available that are supporting some CGT business processes and addressing some CGT-specific challenges.
Most life sciences companies are moving away from single-tenant portals and looking for a standardized platform that will allow the GCT industry to scale. Organizations offering cell and gene therapies need a time-sensitive and fault-tolerant orchestration engine to manage the flow of samples from treatment centers to manufacturing locations and then the return of the personalized therapies for administration at treatment centers.
Based on intensive market research and collaboration, SAP realized that there is a significant technology gap that needs to be filled to support the safe and efficient delivery of these specialized products to patients. Therefore, SAP has undertaken the development of an industry-standard CGT orchestration solution. To complement and support the development of this solution, we have initiated an industry consortium to ensure the solution supports emerging industry standards.
The solution will be built on SAP Business Technology Platform and will be delivered as part of SAP’s industry cloud. The CGT solution will integrate with treatment center platforms using open APIs to support the broadest ecosystem possible. It will be pre-integrated with SAP S/4HANA for manufacturing and other processes but will use open APIs to enable interoperability with other manufacturing platforms and contract manufacturing organizations.
The objective of the new cell and gene therapy solution from SAP will be to help ensure that the right patient is treated with the right medicine at the right time without error in the value chain. In order to achieve this result, the planned capabilities include:
- End-to-end chain of identity, chain of custody, and supply orchestration to track CGT products to ensure that patients get the right medicine and can be treated safely as planned
- Facilitating critical value stream management activities and business processes — such as logistics, slot scheduling, labeling, batch release, and invoicing — to reduce overall process lead time and support the short shelf life typical of CGTs
- Ability to manage high order and process variability as well as unpredictability, with exceptions being the standard, and to reduce operational cost due to optimized supply chain execution and fewer manual activities
- Streamlined processes and real-time data to help leaders make informed decisions on every aspect of the CGT supply chain
- Better collaboration and increased satisfaction among all CGT stakeholders, from healthcare providers to life sciences companies, cell labs, contract manufacturers, and logistics providers with real-time, event-driven data exchange based on stable and published APIs
- Supporting post-marketing commitments, such as tracking of outcomes and outcome-based pricing
- Enabling compliance with applicable regulations like HIPAA and GXP
“Life sciences biopharmaceutical companies are working to bring cell and gene therapies to patients and have gained or are about to gain market approval by the regulatory agencies,” said Matt Laukaitis, general manager of Consumer Industries at SAP. “So now they need an industry-standard solution suitable to orchestrate brand new processes required by these therapies. SAP’s industry cloud aims to deliver these capabilities with limited disruption to the current landscape, open integrations to support a broad ecosystem, and with a very short time to value for our customers.”
If you are interested in joining the consortium to shape the future of SAP’s cell and gene therapy solution, please contact the solution management team:
- Mazahir Valikarimwala, Solution Owner, SAP Cell and Gene Therapy
- Tim Hood, Cell Gene Therapy Consortium Lead
SAP today also announced the availability of the SAP Intelligent Clinical Supply Chain Management solution, for which development was also based on an industry consortium of almost 30 life sciences organizations.
Tim Hood is chief technology officer for Consumer Industries at SAP.