Data management for advanced therapies, Part 4: working with multiple stakeholders
by Heidi Hagen and Christophe Suchet | January 30, 2020
Note: this post is the fourth in an eight-part series on data management strategies for personalized therapies, such as cell therapies, gene therapies, or neoantigen cancer vaccines. You’ll find the prior installment, on data considerations when working with living cells, here.
When it comes to cell and gene therapies, production and delivery really do take a village – or several of them.
The manufacturing process, which begins with the collection of patient or donor cells, could involve up to a dozen different locations. And the nature of working with “living” starting material, plus the particular requirements for manufacturing and transporting advanced therapies, means not all of these locations will be typical GMP facilities.
The long list of facilities and physical locations involved could include blood centers, hospitals, in-house manufacturing plants, CMOs, transport vehicles, storage depots, and infusion centers. And despite the fact that all locations are required to follow quality-related procedures and capture data in a compliant way, each will have their own processes and systems in place for collecting, managing, and tracking starting material and related data.
Here are some of the biggest challenges that arise from a dispersed personalized supply chain, from our whitepaper on advanced therapy data management strategy.
Facilities may be subject to different regulations
There are only so many facilities capable of handling and processing living cellular material for advanced therapies. It is not uncommon for starting materials or products to have to be shipped cross-country or even internationally for manufacturing, adding pressure to capacity management, routing capabilities, and timelines.
Since each facility is subject to local regulations, you may be dealing with many different requirements or standards for processing and storing data. This will only become more complicated as manufacturers build more geographically distributed facilities to better serve different regions. Ensuring that data is collected and processed in compliance with all the regulatory bodies involved in each batch is critical.
What’s the solution? Flexibility. You need to be able to easily adapt your data management for varying laws and requirements to ensure information is captured in a compliant manner without a drop in productivity.
Data structure will vary across facilities and stakeholders
The advanced therapy industry is still working toward an established set of data standards. The disparity of systems and practices in place across your range of stakeholders means you are going to be faced with a wide variety of different data types and formats. For that data to be of value both for your license application and day-to-day operational efficiency, it must be harmonized across the standards and regulations governing your application.
What’s the solution? Standardized technologies. Efficient data harmonization requires a technology platform that stakeholders can easily access and integrate into their existing processes.
Some facilities still use paper
It is not uncommon for some trial sponsors and CROs to still use paper case forms for documentation. Manual entry escalates the risk of error, threatens quality, and limits scalability. Getting all parties on board with an automated system, even if you are only working with a dozen patients, will reduce these risks while simultaneously helping to ensure consistent data capture and filing preparations.
What’s the solution? A centralized platform. Consider a cloud-based platform that stakeholders can easily tap into from diverse locations to replace manual pen and paper data collection.
Transportation needs multiply risk
Getting materials from one place to another is one of the riskier steps in the development process for all drugs. When you throw in the added urgency and environmental requirements of working with raw material, the potential for problems skyrockets. A delay in transportation could result in a drug product that is no longer viable, and delays need to be communicated immediately so the rest of the supply chain can adapt.
Logistics providers must follow GMP procedures and satisfy FDA traceability requirements. This includes detailed tracking of a product’s condition and ownership while in transport. Working with logistics companies experienced in handling living patient material, and with the ability to tap into your digital orchestration platform, should be a priority.
What’s the solution? Real-time flexibility. A digital, cloud-based system that allows stakeholders to collaborate in real-time so they can adapt to possible transportation delays.
Need a data management strategy solution that gets all your stakeholders on the same page? Download Vineti’s “Advanced Therapies Guide: From Complex to Controlled.”
Next in this series, we’ll discuss traceability data and its unique requirements in advanced therapies. If you have data management questions for us in the meantime, please contact us.
Data management for advanced therapies series:
Part 1: the need for new strategies
Part 2: unique data features
Part 3: working with living cells
Part 5: traceability
Part 6: efficiencies across the supply chain
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. Christophe Suchet is the Chief Product and Compliance Officer of Vineti, and previously led IT systems for cell therapy pioneer Kite Pharma. If you'd like to see how Vineti's Personalized Therapy Management (PTM) platform can help you solve your advanced therapy data challenges, please contact us to schedule a demo.