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The Critical Need for the End to End Data Flows for Regenerative Therapies

Thu, Nov 08, 2018

The global commercial approval of the first CAR-T therapies (Kymriah® and Yescarta®) has intensified the need for the clear and uninterrupted flow of data from before the patient is ever treated to the mining of data that takes place years after the patient has received their therapy.  This requires collaboration and integration between several different software systems that are involved in the process.

Clinicians at the point of care need to schedule collections, potentially conduct human leukocyte antigen (HLA) typing, capture and record patient data, generate labels, and schedule the administration of the therapy.

Once a collection from the patient has occurred the apheresis or blood is transported to the site of manufacturing.  While in transit a real time logistics system must capture, transmit, record the condition, location and custody of the material, and store the data.

Once at the manufacturing site, software is necessary to manage the multiple processes.  From the supply chain of raw materials and consumables, each step of the process to make the CAR-T, quality adherence, regulatory requirements, and the end process of an automated scheduling for the pickup of the finished therapy. 

From there the logistics system comes back into play as the finished therapy is sent back to the originating point of care.  The real time data during the return shipment is critical for showing efficacy and protocol adherence before the therapy is thawed and the patient is treated.

Once the patient is treated, the process for billing, invoicing, reimbursement, and patient follow up begins. 

A control tower type of software that can integrate all of the different stake holder’s software systems so that the manufacturer or sponsor has the ability to view in real time the status of every patient’s therapy at any point in the process has gone from needed to critical.  Especially now that these therapies have now moved from clinical trials to full commercially available therapies in multiple countries.

One of Cryoport’s main advantages is the cloud-based Cryoportal®.  The Cryoportal® is the backbone of everything at Cryoport and is already integrated with many of the key players in the regenerative therapy ecosystem.  The Cryoportal® provides visibility to the Chain of Custody, Chain of Condition, Chain of Identity, and the Chain of Compliance™ for each shipment.  We understand how important the data that we collect is to the manufacturer, the point of care, the regulators, the insurance companies, and most importantly to the well-being of each and every patient. 

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Written by: Tom Heinzen, VP, Corporate Development & Investor Relations, Cryoport 

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