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Evaluation ViewAttendees 36

Pharmaceuticals (includes Biologics & Drugs)

Embracing the Age of Generative AI in Drug Development

Wednesday, October 8, 2025
9:15 AM - 10:30 AM EST
Location/Room: 401
In this session, experts from diverse backgrounds will explore the transformative potential of generative AI technologies across the drug development lifecycle. Presenters will delve into use cases demonstrating how AI is reshaping regulatory intelligence, accelerating clinical development, optimizing study design, enhancing trial execution, and improving patient outcomes. Each talk will reflect the speaker’s area of expertise, providing attendees with a broad yet detailed understanding of how AI is revolutionizing the pharmaceutical landscape.

Learning Objectives:

  • Upon completion, participant will be able to describe generative-AI applications across the drug-development lifecycle and list examples in medical writing, plain-language summaries, and data anonymization.
  • Upon completion, participant will be able to compare current U.S. FDA and EU/EMA regulatory initiatives for AI and explain implications for regulatory submissions.
  • Upon completion, participant will be able to plan organizational readiness for AI adoption in medical writing, including change management, role clarity, and KPIs to track efficiency and quality.