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

Blog

Essentials of model-informed drug development in oncology

Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…

CertaraOctober 6, 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

Press Coverage Video

How FDA’s Focus on Overall Survival Redefines Trial Success

Ananth Kadambi explains how FDA’s emphasis on overall survival reshapes oncology drug trial success metrics…

CertaraSeptember 23, 2025

Press Coverage Video

Operational Challenges of Using Overall Survival as a Primary Endpoint

In this ACT interview, Certara’s Ananth Kadambi discusses the operational hurdles sponsors face as FDA…

CertaraSeptember 22, 2025

Case Study

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…

CertaraJuly 2, 2025

Blog

Mechanistic modeling to meet challenges in ADC development

April 4, 2025 Navigating the challenges in antibody-drug conjugates (ADCs) development requires overcoming complex hurdles…

CertaraApril 4, 2025

Poster

Mechanistic Modeling Guides Bispecific Antibody Design and Target Selection for Maximizing Therapeutic Window

Therapeutic antibodies have shown promise in treating diseases such as cancer, but selectivity remains a…

CertaraMarch 28, 2025

Oncology/Hematology

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Essentials of model-informed drug development in oncology

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

How FDA’s Focus on Overall Survival Redefines Trial Success

Operational Challenges of Using Overall Survival as a Primary Endpoint

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

Mechanistic modeling to meet challenges in ADC development

Mechanistic Modeling Guides Bispecific Antibody Design and Target Selection for Maximizing Therapeutic Window

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