Generating Confidence: How can sponsors and regulators harness generative AI to help improve the IND/BLA submission process?

The advent of ChatGPT and other high performing Large Language Models (LLMs) presents important opportunities for companies and FDA to use generative AI to streamline the design and submission of high-quality NDA/BLA submissions, and even identify early opportunities for assessing potential problems in submissions. Our panel will explore the potential benefits of harnessing LLMs for regulatory submissions; the risks and challenges associated with LLMs in regulatory settings; and how can we mitigate those risks in a collaborative way.

We will begin the program with a fireside chat between

• Paul Howard, PhD, Amicus Therapeutics

• Ram Iyer, FDA

Followed by an interactive discussion with our team of expert panelists:

• Lina Nilsson, PhD, Recursion

• Ari Caroline, Weave.Bio

• Anand Ramasubramaniam, Genentech

• Jason Raeburn, Paul Hastings