Therapeutic Specialties Archives

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

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

CertaraOctober 31, 2025

Case Study

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…

CertaraOctober 2, 2025

Conference

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

CertaraSeptember 22, 2025

Press Coverage

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

Explore the top challenges in cell & gene therapy commercialization, featuring expert insights from Fran…

CertaraSeptember 12, 2025

Conference

The Pharmacometrics Africa Conference 2025 (PMXAC-2025)

CertaraSeptember 4, 2025

Case Study

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

Find out how Certara helped a small biotech achieve on-time IND and CTA submissions with…

CertaraAugust 18, 2025

Publication

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Explore updated results from the Phase 3 TROPiCS-02 trial of Sacituzumab Govitecan in advanced HR+/HER2–…

CertaraAugust 13, 2025

Blog

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

GSK shares real-world case studies on how Model-Based Meta-Analysis (MBMA) supports dose selection, virtual control…

CertaraJuly 31, 2025

Press Coverage

Digital twins and virtual trials: A new era in rare disease drug development

Discover how using digital twins in rare disease drug development is improving precision and accelerating…

CertaraJuly 22, 2025

Therapeutic Specialties

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

The Pharmacometrics Africa Conference 2025 (PMXAC-2025)

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

Digital twins and virtual trials: A new era in rare disease drug development

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