Advanced therapies require advanced data management. This guide reflects decades of collective expertise in managing the large data volumes and complex multi-directional data flows common in cell therapy, gene therapy, and personalized cancer vaccines. The lessons covered will support both more efficient operations and more streamlined regulatory submissions.
The first half of this paper, written by industry experts involved in multiple, successful cell therapy filings, discussed the new challenges of data management for advanced therapies - why and how data management has become much more complex. The second half outlines the essentials of implementing a successful data management strategy and the inherent benefits.
- The personalized nature of many advanced therapies profoundly changes the nature of clinical development and regulatory filings, requiring a modern data management paradigm.
- Personalized therapeutics bring greatly increased data volume and data complexity to clinical trials, regulatory submissions, and commercialization, especially in the areas of chemistry, manufacturing, and controls (CMC).
- Six designed-for-purpose data management strategies, outlined in this guide, can provide an effective solution, especially in the critical area of CMC.
- These data management strategies will deliver a range of benefits that support more efficient, effective regulatory submissions for advanced therapies.
- Biopharmaceutical sponsors who adopt modern data management will be more in sync with recent regulatory guidances, and well-positioned to benefit from the next wave of innovation.