How Data Secrecy Is Stalling Progress in Cell and Gene Therapy (2025)

A persistent culture of data hoarding among cell and gene therapy developers is significantly slowing scientific progress and collaboration despite regulatory advances1.

Agencies like the NIH have implemented new policies to promote transparency, such as the 2023 Data Management and Sharing Policy, which requires data sharing plans, but substantial barriers remain1.

Major obstacles to open data sharing include patient privacy concerns, restrictive language in patient consent forms, and the need to protect intellectual property1.

The regulatory stance, especially by the FDA, has historically emphasized process control:
"the process is the product." This led companies to view sharing process-related data as a business risk, reinforcing secrecy1.

Corporate legal teams often oppose data sharing, prioritizing the protection of company assets and seeing little benefit in making proprietary data public1.

This environment creates a significant gap between the widespread recognition of the value of data sharing in accelerating research and the actual low degree of real-world data exchange1.

Sources:

1. https://www.biospace.com/drug-development/how-data-secrecy-is-stalling-progress-in-cell-and-gene-therapy