AI-Assisted Regulatory Writing: Findings from a Top 20 Pharma Case Study
Session details:
This talk presents final, unpublished findings from a collaborative case study between Weave Bio and a Top 20 global pharmaceutical company—one of the first scientific comparisons of AI-assisted and traditionally authored regulatory content. The study focused on the efficiency and quality of outputs from two previously submitted IND applications, specifically Sections 2.6.2, 2.6.4, and 2.6.6, known for their analytical and narrative complexity.
Results show how AI-driven platforms, like Weave, can accelerate content preparation by structuring and formatting source data into draft-ready material. Teams generated first drafts instantly, reduced repetitive tasks, and rapidly iterated, while human oversight remained essential for strategic interpretation and program alignment.
The session will explore:
- Human-only vs. AI-assisted drafting approaches
- A framework for evaluating quality and speed
- Practical insights for improving regulatory workflows with AI-augmented tools
Grounded in measurable outcomes, this talk offers a pragmatic view of how AI can enhance—without replacing—scientific expertise in regulatory writing.