‍Author: Kamal Nahas, PhD
Published by: ​The Scientist | March 25, 2025
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Overview
In this insightful article, Kamal Nahas explores how drug developers are leveraging large language models to draft regulatory documents, aiming to shorten the time to market. The piece delves into the challenges of preparing Investigational New Drug (IND) applications and examines how artificial intelligence can assist in streamlining this complex process.​

Key Highlights

• The Challenge: IND applications require compiling extensive documentation, often involving hundreds to thousands of pages, which is time-consuming and prone to human error.​
• AI as a Solution: Large language models can assist in drafting and summarizing regulatory documents, potentially reducing the time and effort required for IND submissions.​
• Expert Insights: The article features perspectives from industry professionals on the practical applications and limitations of AI in regulatory affairs.​

Why It Matters
Efficient preparation of IND applications is crucial for accelerating the drug development process. By integrating AI tools, pharmaceutical companies can potentially enhance the accuracy and speed of their regulatory submissions, ultimately bringing therapies to patients more quickly.

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