Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling 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…Certara2025 年 11 月 10 日
Essentials of model-informed drug development in oncology Blog 肿瘤领域模型引导的药物开发(midd)精要 Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…Certara2025 年 10 月 6 日
Preparing for the Operational Burden of OS Requirements in Oncology Trials Press CoverageVideo 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…Certara2025 年 9 月 26 日
How RWE and Predictive Modeling Support OS-Focused Trial Designs Press CoverageVideo 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…Certara2025 年 9 月 25 日
Using Model-Informed Drug Development to Support OS Endpoints Press CoverageVideo 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…Certara2025 年 9 月 24 日
How FDA’s Focus on Overall Survival Redefines Trial Success Press CoverageVideo 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…Certara2025 年 9 月 23 日
Operational Challenges of Using Overall Survival as a Primary Endpoint Press CoverageVideo 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…Certara2025 年 9 月 22 日
Accelerating Oncology Drug FDA RTOR Submission with Project Management Services Case Study 通过项目管理服务加速肿瘤药物 FDA RTOR 申报流程 Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…Certara2025 年 7 月 2 日
Mechanistic modeling to meet challenges in ADC development Blog 机制建模应对 ADC 开发挑战 2025 年 4 月 4 日 Navigating the challenges in antibody-drug conjugates (ADCs) development requires overcoming complex hurdles…Certara2025 年 4 月 4 日
Mechanistic Modeling Guides Bispecific Antibody Design and Target Selection for Maximizing Therapeutic Window Poster 机制建模指导双特异性抗体设计和靶标选择,最大限度地扩大治疗窗口 Therapeutic antibodies have shown promise in treating diseases such as cancer, but selectivity remains a…Certara2025 年 3 月 28 日