Expert Q&A: Navigating Complexity In Modern Small Molecule Development

By David Hall, Head of Account Management, EMEA

Small molecules still dominate approvals, but the candidates entering development look different from those of a decade ago: larger, more stereochemically intricate, more potent, and increasingly conjugated. At the same time, expedited regulatory pathways are becoming the norm.

This Q&A with a small molecule development expert examines where those forces collide. Topics include why chemistry does not scale linearly under cGMP, how parallel activities and AI-assisted route design are compressing timelines, and why technical expertise and quality are now treated as baseline expectations rather than differentiators. The discussion also looks ahead to the blurring line between discovery and process chemistry and what sponsors should weigh when choosing a long-term CDMO partner.

See where the expert draws the line between must-haves and true differentiators.