As an introduction to the SAP Cell and Gene Therapy Orchestration solution, we invite you to view this short video.
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In the last 5-10 years, cell and gene therapies (often also called advanced therapy medicinal products (ATMPs)) have emerged as a promising new therapeutic modality. They offer unique clinical and therapeutic advantages over conventional small molecules and biologics. Specifically, living cells can perform complex biological functions in ways that conventional drugs cannot, thus expanding the spectrum of available therapeutic options to include key cellular functions and processes. As such, cell and gene therapies are currently one of the most investigated therapeutic modalities, with several products having been approved and more than 2000 active clinical trials ongoing (figure above adopted from the Alliance for Regenerative Medicine H12022 report with permission).
New cell and gene therapy (CGT) products will surely emerge from this pipeline, requiring new business capabilities to provide adequate access during the commercialization phase.
To clarify why new business capabilities are required and what they are, let us first review the typical high-level process of delivering an autologous cell therapy. Here, autologous means that the patient's own cells are used as the drug after having been modified to elicit the desired clinical effect.
Briefly, the major steps in the manufacture of a relatively complex cell therapy are as follows:
- First, an eligible patient is identified and the appropriate therapy is selected and ordered at the vendor
- Blood or cells are extracted from the patient (apheresis or biospecimen collection)
- The cells are prepared for further processing or shipments (for example, cryopreservation)
- The cells are shipped to the site of manufacture, which could also be done by a third-party, that is, a contract manufacturing organization (CMO)
- At the site of manufacture, relevant cell populations are isolated, the cells are activated, genetically modified, and expanded before undergoing post-processing, such as washing and purification
- After samples are taken for quality assurance (QA) measures, the cells are concentrated and packaged by dose before being shipped to the treatment site
- At the treatment site, the product is prepared for infusion and the therapy will be administered
- Lastly, the billing and reimbursement steps complete the process
This process is very different to traditional small-molecules or biologicals pharmaceutical manufacturing and involves tight interaction between the cell therapy vendor and numerous external stakeholders. The supply chain is much more complex and requires the ability to follow the patient journey as well as the product journey and ensure that the right product is delivered to the right patient at the right time without errors.
To orchestrate the supply chain and provide this visibility and control, we developed SAP Cell and Gene Therapy Orchestration which supports the process with the following capabilities:
- Order Management
- Biospecimen Shipment
- Processing Activities
- Finished Product Shipment
- Chain of Identity and Chain of Custody Management and Reporting
With these capabilities, SAP Cell and Gene Therapy Orchestration is positioned between the clinical side and the complex supply chain side. Its role is to facilitate, manage, and drive the cell and gene therapy supply chain. It is the hyper-connected conduit between all functions in the supply chain, helping the CGT case manager and related roles to ensure patient orders are fulfilled on time with zero errors.
