Formulating For Complexity: A Strategic Guide For Challenging Early-Phase Molecules

Formulation can look like a minor line item when a program is racing toward tox studies and IND submission. Survey data cited in the eBook suggests otherwise: 60% of companies report formulation-related delays or failures, and over half of those delays exceeded 12 months. The focus is on molecules that make early development harder, including poorly soluble oral candidates, long-acting injectables, HPAPIs, peptides, and high-viscosity products. A case study on a 13-fold bioavailability improvement sits alongside checkpoint questions for candidate selection, IND-enabling studies, and tech transfer. It also considers how phase-appropriate choices can preserve room for new markets and delivery formats, and what to look for in a CDMO partner.

Explore the frameworks to see where early decisions hold up at scale and where they break down.