Advancing Topical Formulations With Innovative Preclinical Models

The high attrition rate in drug development (driven by factors like poor efficacy, safety, and developability) necessitates a strategic, early-stage approach to minimize risk and cost. Success is achieved by implementing a robust development strategy and comprehensive characterization aligned with quality standards.

Key Learning Objectives

• Define the principles of topical formulation development and its role in drug success.
• Evaluate the utility of preclinical models (in-silico, in-vitro, and ex-vivo) for formulation optimization and candidate selection.
• Develop a robust and phase-appropriate development package that effectively de-risks a program prior to clinical studies.

A successful formulation approach leverages scientific principles and innovative preclinical models to facilitate early identification of candidates with poor developability, ensuring informed decision-making and mitigating downstream risks.