William Glauser
XtalPi, Inc., USA

Problems associated with polymorphic instability and increasingly insoluble drug candidates represent white space to innovate novel forms and processing methods with better properties in the drug product.  But the journey from identifying new solid forms to creating engineered particles with optimal formulation properties has often been too inefficient to realize this goal.

Industry-wide voice of customer studies have revealed several bottlenecks along the critical pathway and a multicriteria optimization problem similar to that in earlier discovery phases.  These studies suggest solutions that enhance the integration of experiment and computation, which itself integrates both physics-based and AI-based approaches.  It also requires integrating mechanical and processing considerations earlier into the form discovery/selection stage.  This desiloization of effort will require—in many instances—creative partnerships among biopharma, commercial technology providers, and academia to achieve.