Certara
58 Case Studies
A Certara Case Study
CDR-Life, a biotechnology company developing T-cell engagers for cancer, faced the challenge of selecting an optimal first-in-human dose for their therapy. They sought a starting dose that was high enough to potentially show efficacy, which would avoid lengthy dose-escalation trials. CDR-Life partnered with Certara, using their Quantitative Systems Pharmacology (QSP) modeling services to address this.
Certara developed a QSP model based on preclinical data that supported a higher starting dose than traditional methods would allow. This approach was approved by regulators. The result was a significant reduction in both the number of patients needed for the trial and its overall duration, leading to substantial cost savings for CDR-Life in their clinical development.
Melissa Vrohlings
Translational Science Leader