辉瑞Dr Stephanie Johnson在AAPS PharmSci 360谈平台制剂将风险转移至下游

Speaking at AAPS PharmSci 360, Dr Stephanie Johnson, a principal formulation scientist at Pfizer, details how platform formulations save time before commitment, shift risk downstream, and what AI tools need to earn trust.

Speaking at the American Association of Pharmaceutical Scientists’s (AAPS) 2026 PharmSci 360 conference in New Orleans, Stephanie Johnson, PhD, principal scientist of formulation development at Pfizer, discusses themes from her presentation, “Platform Formulations as Tools for Risk Redistribution and Accelerated Development,” including how platform formulations affect development risk and timelines and what is needed to trust artificial intelligence (AI)-guided formulation tools.

Dr Johnson says platform formulations do not eliminate risk. Instead, risk moves downstream and becomes developmental debt. Later stages may require additional understanding of controls and analytical methods to evaluate the drug product presentation and nominate the commercial formulation. She stresses that this outcome does not indicate that the platform formulation has failed, but rather, it reflects continued learning and better formulations as the molecule progresses.

The greatest time savings come before commitment, she emphasizes. Teams begin with a narrower defined space to reach a scientifically defensible position, focusing time and material on what matters.

Can AI-guided tools predict which molecules fit a formulation platform?

Dr Johnson notes that AI tools may not yet be able to predict formulations. She explains they can already help predict which molecules may fit the platform formulation and which will need additional characterization. She further notes that AI has changed so much in the past year that future capabilities are hard to forecast.

Trusting these AI tools requires high-quality training datasets, she adds, along with the ability to trace a molecule's molecular and physical properties to actual stability data. Developers must also connect those molecular characteristics to formulation conditions and the resulting stability and manufacturing data.

"I think it's really important here to have a clear context of use, and, ultimately, the model is only as strong as the consequences that emerge if the model is wrong," Dr Johnson states.

Dr Johnson emphasizes that her work at Pfizer in the past 5 years has predominantly focused on early-stage drug development.

AAPS 2026 PharmSci 360 runs October 25-28. Click here for more conference coverage.

About the speaker

Stephanie Johnson, PhD, Principal Scientist, Formulation Development, Pfizer

In her role at Pfizer, Dr Johnson leads the development of parenteral drug products and delivery systems for biotherapeutics across preclinical through commercialization stages. She received her PhD in Pharmaceutical Chemistry from the University of Kansas, where her research focused on multivalent antigen systems for immunotherapy. Her expertise spans formulation development, analytical characterization, and biophysical methods, with multiple peer-reviewed publications in immunotherapy and drug delivery.