How this PM streamlines 60k-page FDA submissions and saves millions with Claude, Streamlit, and clever AI workflows | Prerna Kaul

Posted on July 14, 2025
Source: Lenny’s Newsletter by Claire Vo. Read the original article

TL;DR Summary of How AI is Revolutionizing FDA Submissions and Life Sciences Operations

Prerna Kaul leverages AI technology to drastically reduce the time and cost of generating complex FDA regulatory documents. Her innovative systems automate the creation of massive submissions, cutting processes from months and dozens of specialists to minutes. She also pioneers AI-driven tools to detect and redact protected health information (PHI) and build user-friendly interfaces for non-technical stakeholders. These advances accelerate drug development timelines and improve communication frameworks in highly regulated industries.

Optimixed’s Overview: Transforming Life Sciences with AI-Powered Regulatory and Communication Solutions

Revolutionizing FDA Submission Processes with AI Automation

Prerna Kaul, a seasoned product and platform leader, has engineered an AI system that automates the creation of 60,000-page FDA submissions. Traditionally requiring 4 to 6 months and a team of 20 specialists, her solution cuts this down to mere minutes, significantly reducing costs and time-to-market for life-saving treatments.

Advanced Tools for PHI Detection and Compliance

  • Claude AI is utilized to identify and redact protected health information within unstructured clinical trial data, ensuring compliance with strict privacy regulations.
  • Techniques such as medical entity recognition help streamline data processing while maintaining accuracy and confidentiality.

Democratizing AI for Non-Technical Users

  • By leveraging Streamlit, Prerna builds accessible, user-friendly interfaces that empower non-technical colleagues to engage with AI tools without coding expertise.
  • This approach enhances collaboration across teams and fosters organizational adoption of AI-driven workflows.

Enhancing Communication and Stakeholder Management

Prerna’s work extends to creating AI-powered communication frameworks and coaching tools that assist product managers in navigating complex stakeholder dynamics. Using prompt engineering and training on classic literature and persuasion techniques, these systems provide personalized strategies to handle competing priorities effectively.

Ensuring Transparency and Ethical AI Implementation

Transparency in AI operational costs is emphasized to secure stakeholder buy-in and measure return on investment. Moreover, a practical framework for AI safety and ethics is applied to maintain compliance within highly regulated life sciences environments.