Simulations Plus Announces Collaboration with Lonza and U.S. FDA to Advance Predictive Frameworks for Complex Oral Drug Products

Key Takeaways

• Simulations Plus, Lonza, and FDA collaborate on ASD predictive framework
• Project integrates advanced in‑vitro dissolution with physiologically based modeling
• Goal: reduce clinical bioequivalence studies for complex oral drugs
• AI‑enabled workflows will link data, models, and regulatory insight
• Success could reshape FDA bioequivalence guidelines for amorphous solid dispersions

Pulse Analysis

Amorphous solid dispersions (ASDs) have emerged as a powerful strategy to boost the solubility of poorly water‑soluble drugs, yet their performance is highly sensitive to formulation composition, manufacturing processes, and gastrointestinal conditions. Traditional regulatory pathways often demand multiple clinical bioequivalence (BE) studies to address variables such as food effects and gastric pH, inflating development timelines and costs. Industry stakeholders are therefore seeking science‑driven alternatives that can predict in‑vivo behavior early in the development cycle.

The newly funded collaboration between Simulations Plus, Lonza, and the U.S. FDA tackles this challenge by marrying cutting‑edge in‑vitro dissolution technologies—like Controlled Transfer Dissolution—with mechanistic physiologically based biopharmaceutics modeling (PBBM). Simulations Plus will leverage its DDDPlus and GastroPlus platforms to build IVIVE frameworks that translate experimental data into virtual BE assessments, while Lonza supplies the experimental expertise and formulation variants. Embedding AI‑enabled workflows ensures that data, models, and regulatory insights are tightly integrated, accelerating decision‑making and enhancing confidence in model‑informed drug development (MIDD).

If validated, the predictive framework could redefine how regulators evaluate complex oral products, potentially reducing the need for human BE studies without compromising safety or efficacy. This shift aligns with the FDA’s broader push toward modernizing drug development through MIDD and could unlock significant cost efficiencies for pharmaceutical companies. Moreover, the partnership showcases a collaborative model where industry, academia, and regulators co‑create standards, setting a precedent for future AI‑augmented, model‑based approaches across the drug development ecosystem.