Case Study: a mid-size biopharmaceutical company achieves rapid ADC approval for two indications with Certara modeling and data rescue

Accelerated ADC Approval Through Expert Modeling and Data Rescue

A mid-size biopharmaceutical company was developing an antibody-drug conjugate for oncology but faced significant challenges with complex pharmacokinetic analyses. Their project, which involved large datasets in outdated, non-standard formats, was behind schedule after being managed by another provider. They turned to Certara to rescue the data and meet urgent regulatory deadlines for submission.

Certara managed the entire scope of pharmacokinetics and modeling deliverables, which included population PK modeling, exposure-response analyses, and strategic regulatory engagement. The Certara team delivered all critical analyses within four months, enabling the client to submit on schedule. This high-quality modeling work directly contributed to the successful approval of the ADC for two indications, preventing costly delays and eliminating the need for additional clinical trials.