Accelerated ADC Approval Through Expert Modeling and Data Rescue

A mid-size biopharmaceutical company developing an antibody-drug conjugate (ADC) for solid tumors encountered challenges with complicated pharmacokinetic (PK) analyses and large complex datasets that were in older, non-standard formats.​

Originally managed by another service provider, the project was transferred to Certara to ensure quality and meet urgent regulatory deadlines.​

Certara successfully handled intricate ADC modeling, overcame data limitations, and worked within tight timelines to deliver multiple critical analyses, ensuring successful regulatory submissions for two indications.​

Certara managed the entire scope of pharmacokinetics, clinical pharmacology, and modeling deliverables, including:​

• Strategic cross-team collaboration, harnessing Certara’s diverse expertise to ensure seamless execution across scientific and regulatory stakeholders​
• Non-compartmental analysis for both indications​
• Population PK modeling for multiple analytes, including evaluation of genetic polymorphisms effects on PK to refine dosing strategies​
• Exposure-response modeling for safety and efficacy including over a dozen endpoints per analyte​
• Protocol development and data curation to ensure regulatory readiness​
• Managing large and complex datasets under tight deadlines, including PopPK, ER and concentration-QTc programming
• Proactive client and regulatory engagement to ensure data validation, accelerate alignment and reduce review cycles​

• Certara delivered all analyses within four months, allowing the sponsor to proceed with submission on schedule​
• High-quality PK and exposure-response modeling directly contributed to successful ADC approval for two indications, preventing costly delays and demonstrating the scientific robustness expected by regulators​
• Certara team was recognized by sponsor leadership for their pivotal contribution and noted that streamlined modeling eliminated the need for additional trials, saving time, budget, and resources.​

This case showcases how strategic modeling, data validation, and clinical pharmacology expertise can make the difference between regulatory setbacks and fast, confident ADC approval. By delivering rigorous PK insights under tight timelines and providing comprehensive ADC modeling support, Certara ensured a smooth regulatory pathway setting a benchmark for ADC regulatory approval outcomes in complex oncology programs.