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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: Lessons Learned from the 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.

The Precision FDA GenAI Challenge
Samir Lababidi, FDA

FDA GenAI Community Challenge: Low Code Participation
James Averback, Life Sciences Integration Partners

FDA GenAI Community Challenge Pro Code Tier: Lessons Learned
Venkatraman Balasubramanian (Bala), VB Insights, LLC

Learning Objective :

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

  • Describe 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)

Samir  Lababidi, PHD

The Precision FDA GenAI Challenge

Samir Lababidi, PHD

FDA, United States

Statistician

James  Averback, MS

FDA GenAI Community Challenge: Low Code Participation

James Averback, MS

Life Science Integration Partners, United States

President

Venkatraman  Balasubramanian, PHD, MBA

FDA GenAI Community Challenge Pro Code Tier: Lessons Learned

Venkatraman Balasubramanian, PHD, MBA

VB Insights, LLC, United States

Healthcare and Life Sciences Strategic Advisor

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