Data management for advanced therapies, Part 1: the need for new strategies
by Heidi Hagen and Christophe Suchet | December 4, 2019
Note: this post is the first of an eight-part series on data management strategies for personalized therapies, such as cell therapies, gene therapies, or neoantigen cancer vaccines. You can find the next installment, on the unique aspects of advanced therapy data, here.
Advanced therapies are creating a new paradigm for data management – and biopharmaceutical developers need a strategy that can keep pace.
What makes data management worthy of so much attention in cell and gene therapy? The answer lies in the advanced nature of these treatments. The abundance and complexity of data collected cannot be managed in the same manner as traditional therapies. As a result, new data management strategies are emerging that are built specifically for the unique data needs of personalized therapies. These solutions deliver the ability to capture, manage, and apply large quantities of data, and to do so in an efficient manner that speeds and simplifies the process.
To help those developing personalized therapeutics, Vineti created this series of blog posts and an in-depth data management whitepaper. Here are some of the realities we discuss that you'll be facing as you get ready to manage your clinical trial or commercial filing:
- The personalized nature of these new treatments extends the manufacturing process beyond the traditional “four walls” of the manufacturing facility – and tremendously increases the volume and complexity of data produced throughout the manufacturing process.
- The success of a regulatory submission depends on being able to capture and report on the patient-specific data from throughout the patient journey in order to support the chemistry, manufacturing, and controls (CMC) section of a license application. Yet, a long list of new challenges and obstacles arise around collecting CMC data for advanced therapies.
- When producing personalized treatments, specifically autologous therapies, each batch is limited to a single patient for which a broad range of information must be captured. That includes data from across the supply chain – Healthcare Providers, transportation, manufacturing, patient treatment centers – that must be collected, managed, analyzed, and reported.
- Patient-based starting material requires rigorous traceability and controlled conditions. Orchestration data, such as that around Chain of Identity, Chain of Custody, Chain of Condition, timing, location, and other variables, all has to be planned and logged to meet regulatory requirements for traceability.
Biopharma leaders who implement advanced strategies will recognize benefits across the entire treatment process, including:
- Improved patient safety, patient care, and compliance
- Product and process understanding
- Collaboration with regulatory agencies
- Reduced time to filing
- Reduced cost
Given all the questions that Vineti gets on data management, we’ve identified six fundamental strategies that can improve advanced therapy data handling and deliver greater speed and simplicity. When implemented, these strategies can help users meet operational objectives, streamline the regulatory license application process, and much more.
We’ll be covering these strategies in this series of blog posts. If you’d rather access them all at once, they’re discussed in our Advanced Therapies Guide: Proven data management strategies for greater speed and simplicity in operations and filings.
Next in this series, we’ll be looking at the unique characteristics of advanced therapy data. 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.