Pfizer's 8-Month Path from Candidate to IND: AAPS PharmSci 360 2026

Platform formulations are often treated as a way to remove risk from early-stage protein development. Stephanie Johnson, PhD, principal formulation scientist, Pfizer, sees them as a knowledge-based starting point that redistributes risk rather than removing it. In this interview with PharmTech, at AAPS PharmSci 360, Johnson discusses her presentation, “Platform Formulations as Tools for Risk Redistribution and Accelerated Development,” which draws on two Pfizer programs that move from candidate selection to investigational new drug application in about 8 months.

Johnson says the biggest time savings come before a team commits to a formulation path. “The platform formulation allowed us to save time prior to commitment, specifically allowed us to narrow the starting space from a large number of formulations that we could screen to something that was more manageable, which allowed us to focus the time and material on the questions that mattered most,” she says.

That focus matters when drug substance is scarce. Johnson does not prescribe a fixed data package. She treats platform compatibility as a fit-for-purpose question. “The minimum amount of material is not a set number of grams or a specific study package, but rather what you need to fit the molecule to the platform formulation,” she explains. In practice, teams review degradation pathways and stability over time to decide whether a molecule fits the platform or needs more molecule-specific characterization.

The trade-off between speed and specificity remains. “When the platform formulation redistributes risk, the risk moves downstream and becomes developmental debt,” Johnson says. Her teams manage that debt with:

• targeted conservative controls
• predefined reassessment triggers
• an explicit risk register
• a cross-functional owner for each remaining risk

AAPS PharmSci 360 is being held in New Orleans from October 25-28.