Data management for advanced therapies, Part 3: working with living cells
by Heidi Hagen and Christophe Suchet | January 8, 2020
Note: this post is the third 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 the unique aspects of advanced therapy data, here.
When a drug is “alive,” its related data also takes on a life of its own.
One defining characteristic of many advanced therapies is their cell-based, living “raw material.” Many cell and gene therapies are manufactured in small batches from donor or patient cells. This living, human-derived starting material brings new complexities and time constraints into the manufacturing process -- and also results in a tremendous amount of data to manage and analyze.
For each drug product batch – which is a patient-specific “Batch of One” in the case of autologous therapies -- the entire supply chain must be captured, including information about the starting material’s condition, custodians, and viability at each stage of the process. This data must then be tied to the rest of the patient’s clinical trial data, and also be pooled with data from other patients to gauge and demonstrate manufacturing consistency. In the end, the amount of data that has to be documented for the CMC section of a drug filing can add up to hundreds of pages for each patient.
For these reasons and more, the unique data management requirements of living cells must be made a priority at every step of the process. Here are a few factors to consider from our recent whitepaper on data management for advanced therapies.
Patient material must remain traceable
Both the FDA and EMA require traceability systems to be in place for most advanced therapies. Much of the necessary data for patient safety and regulatory filings is captured in two critical data chains -- Chain of Custody and Chain of Identify. The latter is key for linking essential patient identifiers and other data to ensure the right drug product is administered to the right patient.
That linkage process may sound straightforward – until you consider how many stakeholders, geographies, and workflows are involved. Living cells are often collected at an apheresis center or hospital, then may be transported to a manufacturing facility, then perhaps to a storage or transfer facility, and then back to the clinical site for treatment. Each of these facilities and work teams may have their own way of collecting and documenting data, sometimes using manual methods or diverse systems, making data collection and harmonization more challenging.
Why it’s important: Each stage of the patient journey requires multiple types of unique information logged for real-time tracking and review in order to achieve compliance.
Living cells require controlled conditions
Small changes in temperature or environment could render living cells unviable. And more often than not, the manufacturing process for advanced therapies takes place across multiple facilities, with the material or therapy passing through the custody of dozens of different stakeholders. If living cells are subject to delays, their quality and viability is often affected, a problem that should be prevented if at all possible and tracked in all cases.
As a result, tracking the Chain of Condition throughout each drug product’s lifecycle is necessary for both regulatory compliance and patient safety. Orchestration must, therefore, plan for controlled conditions and timely transportation that adheres to GMP standards and local regulations.
Why it’s important: a centralized digital solution will enable data tracking related to patient material and product condition, and eventually be able to use that data to improve transportation, timing, and handling.
Greater variability creates higher risk
When each patient’s biology is unique, and each patient journey is complex, significant risks arise in both manufacturing viability and patient safety. When a specific therapy is created for an individual patient, there is no room for error. The data inherent in each manufacturing batch can be managed in ways that provide transparency and reduce risk – or in ways that greatly create more opportunities for mistakes.
Missing or inadequate data can slow the progress of both individual patient treatments and a clinical trial’s overall progress. A lack of information can also complicate data analysis, leading to decreased operational efficiency and even delays in inspections and filings.
Why it’s important: Effective data management can make data collection and analysis more efficient, speed up regulatory filings, and reduce patient risk.
Next in this series, we’ll discuss the multiple stakeholders involved in advanced therapies, and how your data management solutions can support them. If you have data management questions for us in the meantime, please contact us.
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.