Simulations Plus, Lonza, FDA Partner to Modernize Drug Bioequivalence Assessment
Event summary
- Simulations Plus, Lonza, and the FDA are collaborating on a funded research project.
- The focus is on developing a predictive framework for complex oral drug products, specifically amorphous solid dispersions (ASDs).
- The collaboration aims to reduce reliance on clinical bioequivalence (BE) studies using advanced in vitro systems and physiologically based biopharmaceutics modeling (PBBM).
- Lonza will lead experimental work, while Simulations Plus will develop and validate modeling frameworks using its DDDPlus® and GastroPlus® platforms.
- The initiative is partially funded by the FDA and seeks to align with evolving model-informed drug development (MIDD) priorities.
The big picture
The collaboration addresses a growing need within the pharmaceutical industry to streamline drug development and reduce the costs associated with clinical trials. Current bioequivalence assessment processes are resource-intensive and often lack predictive power, particularly for complex oral formulations like ASDs. This initiative represents a shift towards model-informed drug development (MIDD), which is gaining traction as a way to improve efficiency and transparency in the regulatory approval process, potentially impacting the timelines and costs for bringing new therapies to market.
What we're watching
- Regulatory Adoption
- The FDA's willingness to formally adopt and integrate the developed predictive framework into its regulatory processes will be crucial for widespread industry impact.
- Model Validation
- The robustness and accuracy of Simulations Plus’s IVIVE frameworks in predicting in vivo outcomes across diverse ASD formulations will determine the framework’s credibility and utility.
- Commercialization
- Simulations Plus’s ability to translate this collaboration into commercially viable AI-enabled workflows and expand its service offerings will be key to realizing long-term revenue growth.
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