Case Study: a small clinical-stage biotech accelerates clinical development and cuts costs with Certara QSP modeling

Optimizing Clinical Development: Saving Time and Costs

The customer, a small-sized clinical-stage biotechnology company focused on oncology, faced challenges in defining a safe starting dose for a T-cell engager therapy and modeling a safe dose for a tumor-localizing molecule. They engaged vendor Certara, specifically its Applied BioMath team and Quantitative Systems Pharmacology (QSP) modeling services, to overcome these preclinical hurdles.

Certara developed semi-mechanistic and mechanistic models to establish safety thresholds and identify pharmacologically active yet conservative doses. This model-informed approach provided the rationale for a safe-starting dose that was approved by the FDA, eliminating the need for a dedicated tox study. The solution saved the biotech company significant time and costs by accelerating their clinical development timelines and delivering major cost efficiencies.