Oncology/Hematology Archives

Publication

Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination

This study showcases how quantitative systems pharmacology (QSP) and model-informed drug development (MIDD) can transform…

Danielle PillsburyMarch 25, 2026

Blog

Adaptive clinical trials in oncology: Meeting the challenge of Project Optimus

Leveraging adaptive clinical trial designs in oncology can accelerate drug development, while following the FDA…

CertaraJanuary 16, 2026

Case Study

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck leveraged ADC modeling and pediatric ADC dose optimization to enable FDA acceptance and advance…

CertaraDecember 12, 2025

Blog

Using M&S to Evaluate Oncology Drug Dosing

Learn how modeling & simulation improves oncology drug dosing, optimizing safety, efficacy, and personalized treatment…

CertaraNovember 14, 2025

Case Study

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Discover how MacroGenics optimized validation in their clinical data management with our centralized, collaborative Pinnacle…

CertaraNovember 12, 2025

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle PillsburyNovember 12, 2025

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

CertaraNovember 10, 2025

Press Coverage Video

Preparing for the Operational Burden of OS Requirements in Oncology Trials

Ananth Kadambi outlines how clinical operations teams can plan for FDA’s OS requirements—enhancing patient tracking…

CertaraSeptember 26, 2025

Press Coverage Video

How RWE and Predictive Modeling Support OS-Focused Trial Designs

Discover how real-world evidence and predictive modeling strengthen OS-focused trial designs in oncology, improving efficiency…

CertaraSeptember 25, 2025

Press Coverage Video

Using Model-Informed Drug Development to Support OS Endpoints

Ananth Kadambi shares how model-informed drug development helps sponsors predict efficacy and align shorter oncology…

CertaraSeptember 24, 2025

Oncology/Hematology

Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination

Adaptive clinical trials in oncology: Meeting the challenge of Project Optimus

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Using M&S to Evaluate Oncology Drug Dosing

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Preparing for the Operational Burden of OS Requirements in Oncology Trials

How RWE and Predictive Modeling Support OS-Focused Trial Designs

Using Model-Informed Drug Development to Support OS Endpoints

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