Accelerated ADC Approval Through Expert Modeling and Data Rescue

A mid-size biopharmaceutical company developing an antibody-drug conjugate (ADC) for solid tumors faced complicated pharmacokinetic analyses and large, complex datasets in older non-standard formats; the project was transferred to Certara from another service provider after quality concerns, under urgent regulatory deadlines. Certara delivered non-compartmental analysis, population PK modeling for multiple analytes, exposure-response modeling across numerous endpoints, and data curation, managing the large complex datasets under tight deadlines while engaging proactively with regulators. Certara delivered all analyses within four months, letting the sponsor proceed with submission on schedule; the ADC was successfully approved for two indications, and the modeling eliminated the need for additional trials, saving time, budget, and resources, with sponsor leadership recognizing the team's "pivotal contribution."

The customer is anonymised in Certara’s own case study — not withheld by us.

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.