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ISCT 2019: data elements in the cell therapy value chain

by Heidi Hagen | June 12, 2019

I just got back from speaking at the International Society for Cell Therapy annual meeting, where the topic was next-gen data management.

 

I’m sometimes asked, “What’s the big deal? Clinical trials always have data to manage, so what’s new?” But the deeply personalized, patient-centric requirements of most cell therapies have a way of turning standard practices upside down. As we discussed at ISCT19, biopharma is aligning around the fact that new data management approaches will be essential to the continued growth of cell therapies. 

 

The conversation starts with the unique nature of most cell therapy data . What data is being captured in various steps of the value chain, and how can that data be used? We also often hear this question at Vineti, so I thought I’d share some highlights from my talk.

 

A key starting point -- the cell therapy value chain is patient-centric, and more circular than linear. Whether you’re working with a patient-based autologous therapy or a donor-based allogeneic one, the patient is an essential part of the process and the final drug product. 

 

Then, within that autologous cell therapy value chain, there are some key steps. (In the diagram, you’ll also see some of the key data elements that are captured at each step.)

  • Ordering (the ordering of a patient’s personalized therapy by a healthcare provider, which also kicks off a manufacturing “Batch of One” batch run for that patient)
  • Scheduling (the scheduling of a patient’s cell collection, which creates starting material for manufacturing and should be timed to slot into available manufacturing capacity with associated inbound and outbound logistics)
  • Collection (the patient’s cell collection, which must be conducted by a healthcare provider in a regulated, GMP process and becomes part of the batch record of each autologous product)
  • Manufacturing (the process by which the patient’s starting cellular material is manufactured into a final drug product)
  • Infusion (the delivery of the final drug product to the pharmacist and subsequently  the patient for treatment)

 

As these data elements are captured, they often build cumulatively to create an evolving, traceable, transparent view of each patient product. Here’s one example we've shared before, which shows how patient data helps create cell therapy in-process labeling.

 

The labeling process is just one example of data management in action.  The data captured through the cell therapy value chain will not only make or break a clinical trial, but also establish the parameters of commercial operations down the road. 

 

At Vineti, our software platform helps our partners manage complex cell and gene therapy workflow, capture data, and make use of it every day. Please contact us if you’d like to learn more. You can also download a related article  on advanced therapy clinical trials. And thank you to ISCT for the opportunity to share ideas with the CGT community in Melbourne!

 

Heidi Hagen is the Chief Strategy Officer and a Co-founder of Vineti. Over the course of her career, she has overseen the operations and delivery for more than 100,000 doses of cell therapy. If you’d like to learn more about how Vineti’s software platform supports advanced therapy data management, please contact us to schedule a demo.

 

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