Traditional cancer treatment methods like radiation/chemotherapy which have tough after effects on patients are becoming less effective today. With advent of technology in biologics, auto immune diseases are treated based on new outcome models in the industry like immunotherapy and CAR-T that leverage a patient’s immune system to fight cancer, infection or provides regenerative medicine that leverages stem cells used to replace, repair, reprogram or renew a patient’s diseased cells. Pharma companies leverage cold chain biologic drugs along with medical product drug delivery mechanisms by collaborating with medical device manufacturers to improve patient lives with such high-end treatments.
Typically, patients are at end of supply chain in linear supply chain model, but in the circular economy, targeted therapy business process starts with a patient focus upfront, which can be at a hospital site that has an affiliation with doctors, and leveraging physicians as business partners who screen patients for cancer therapy treatment options. Based on patient enrollment for such a treatment of commercial drugs or use during clinical trials, demand forecasting is performed for patient kits required for sample collections and adjustments are made based on dropout rates. Based on patient enrollment for therapy treatments, service sales orders trigger manufacturing for “make to order therapies,” with batch size of one. Demand planning is a key aspect of overall supply chain planning, managing the materials and products required to build individual patient kits.
A patient visit is scheduled for sample collection, which can be a blood or tissue biopsy and the clock starts monitoring time as a characteristic or parameter for tracking that patient sample that is being sent to the laboratory for testing. Additional items relevant for manufacturing are procured from suppliers and kits are assembled and procured from outsourced contract manufacturers.
Laboratory reports triggers analysis for a go/no-go decision whether to proceed with sales order or cancel it and halt manufacturing for that patient-specific batches or lots. Based on milestones, recipe development is triggered with operations like cleaning, enrichment, activation, expansion etc., as part of biologics drug manufacturing. Quality control tests monitoring relevant parameters like drug attributes, time out of refrigeration and quality assurance are performed prior to approval for the dispatch of that lot to a medical facility. Cold chain shipping and monitoring manages temperature tracking, leveraging sensors and IoT technology during the logistics process.
Finally, a patient visit is scheduled for drug infusion and the clock stops when patient is happy with treatment and outcome, returning home from the medical facility. The total time for a batch starting with a patient’s immune system input to the lab and ending when that manufactured drug is infused into the patient is between 2-3 weeks for high cost biologics targeted therapies.
SAP has potential to deliver a Targeted Therapy Treatment Management type solution approach to Life Sciences companies. We can offer relevant integration between source systems like C/4 HANA on the front-end along with S/4 HANA on the back end to manage the entire lifecycle of Targeted Therapy Treatments. In addition, SAP can offer strong supply chain planning and manufacturing capabilities, agile billing which is consider service based billing and monitoring of outcomes based on key performance indicators. Financial implications are in every stage of this life cycle with payment to the medical facility, physicians, laboratories and also collaboration with health insurance for invoicing of pharmaceutical sales. The SAP Cloud Platform can be a key technology enabler with a targeted therapy orchestration portal for access to real-time data from key source systems, providing analytics via a Chain of Custody dashboard to orchestrate entire process. For more information, refer https://cloudplatform.sap.com/index.html
New Generation Business Process (NGBP) focus in Life Sciences from SAP aims to have customer validation of such strategic areas to meet industry needs, reinforcing with value of SAP Leonardo technology. Digital transformation in Life Sciences companies enables new ways to provide end-to-end experiences for customer value chain entities like patients, physicians, providers and also suppliers type like CMO, CRO, and testing laboratories leveraging combination of business process and technology offered by SAP along with our comprehensive partner eco-system providing industry best practices for Life Sciences manufacturers.