Takeda has entered a collaboration to introduce Weave Bio’s AI-native regulatory automation platform across 14 ongoing drug development programmes in various global markets.
The partnership aims to integrate Weave Bio’s AI tools with Takeda’s regulatory experience to streamline workflows within the regulatory process.
The joint effort began with the use of AI to assist investigational new drug (IND) submission preparation and has since expanded to cover health authority question (HAQ) and response to question (RTQ) processes.
A research paper co-authored by scientists from Takeda and Weave Bio that documented the IND phase data revealed a 97% reduction in the time required to draft an initial submission in the evaluated use case, from roughly 100 hours to three.
The deployment of HAQ and RTQ processes has recorded more than 100 questions without any extraction errors in the assessed dataset and achieved an average AI answer quality score of 68%, surpassing the goal of 50%-70%.
Takeda chief regulatory officer and global regulatory affairs head Nahid Latif said: "Takeda is working to become a leader in the responsible application of AI across every area of R&D, helping our teams work more effectively and accelerate the delivery of innovative medicines to patients.
"Our collaboration with Weave is an important example of this ambition in action, enabling us to implement AI-driven regulatory workflows while ensuring that regulatory professionals retain responsibility for content, verification and final decision-making.”
This collaboration comes as global regulatory agencies clarify their stances on the use of AI in drug development, focusing on areas such as safety, validation, and human oversight.
In January 2025, the US Food and Drug Administration (FDA) published draft guidance on using AI in regulatory decision-making, with joint guiding principles from the FDA and European Medicines Agency issued in January 2026.
Both Takeda and Weave Bio state that their approach supports these regulatory expectations.
Last month, Takeda received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orzeyful (oveporexton) to treat narcolepsy type 1 in adults.
