Parallel Session #3b: Removing the Friction: Emerging Technology and Automation in Clinical Research

Talk title to be announced

Marla Curran

Kardigan

Talk title to be announced

Ali Valcarcel

Genentech

The Game of Chutes and Ladders with AI: Navigating Opportunities and Risks in Regulated Evidence Delivery

Avinash Reddy Pati

Head of Evidence Delivery (Statistical Programming) · Biogen

Artificial intelligence offers significant opportunities to accelerate evidence generation in regulated environments, but its adoption is neither simple nor straightforward. Like a game of chutes and ladders, progress depends on identifying the ladders that enable acceleration while carefully managing the chutes that can slow or redirect implementation. Ladders include document and specification generation, real time review, code development, analysis support, output creation, idea generation, thought partnership, and pattern identification. Chutes include challenges related to GxP expectations, data standards/quality, data privacy/confidentiality, reproducibility, model oversight, and validation and regulatory compliance. This presentation will explore how teams can use AI intentionally and responsibly rather than simply “rolling the dice.”