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Bethesda North Marriott Hotel and Conference Center

Feb 02, 2026 10:00 AM - Feb 04, 2026 12:45 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 8, Track 3: Industry Lessons Learned from FDA GenAI Community Challenge

Session Chair(s)

Kevin  Tompkins, MBA

Kevin Tompkins, MBA

Executive Director, Regulatory Information & Submission Management

Bristol Myers Squibb, United States

The FDA issued a GenAI challenge for the public to demystify the use of GenAI to promote innovation and enhance processes within the FDA. This session will share lessons learned from industry and the FDA who participated in this challenge using both commercial off-the-shelf and custom LLM solutions. The session will focus on highlighting experiences with different technologies and methodologies as LLM technology continues to evolve quickly and it’s impact on industry.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Understand the impact that LLM solutions are having on our industry
  • Evaluate the difference between off-the shelf and custom solutions
  • See where the evolution of LLM technology continues to grow

Speaker(s)

Venkatraman  Balasubramanian, PhD, MBA

Speaker

Venkatraman Balasubramanian, PhD, MBA

VB Insights, LLC, United States

Healthcare and Life Sciences Strategic Advisor

Representative Invited

Speaker

Representative Invited

FDA, United States

Representative Invited

Speaker

Representative Invited

Life Science Integration Partners, United States

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