Case Study: Merck & Co. advances pediatric oncology dosing with Certara ADC modeling

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck & Co. partnered with Certara to address a critical challenge in pediatric oncology. They needed to determine the optimal dosing strategy for an antibody-drug conjugate (ADC) therapy, originally approved for adults, to use in children. The key question was whether to use weight-based or body surface area-based dosing, which required sophisticated ADC modeling that could accurately predict outcomes despite the therapy's complex pharmacokinetics and a lack of pediatric data.

Certara developed a robust population PK model using adult data, which incorporated three separate ADC analytes to characterize the drug's behavior. This model was then used to simulate exposures across all pediatric age groups. The work directly supported FDA acceptance of Merck's proposed weight-based dosing strategy, enabling the advancement of their pediatric investigational plan into Phase III trials. This successful collaboration accelerated development, avoided regulatory delays, and established a scalable framework for future pediatric ADC programs.

Merck & Co.