Page 7 | Certara

Publication

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…

CertaraNovember 12, 2025

Announcement

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

Certara’s new survey findings show that 50% of Americans are unaware of FDA and NIH…

CertaraNovember 12, 2025

Brochure

Certara Discovery – Streamline Your Drug Discovery Process

Improve the efficiency and quality of drug discovery with solutions for compound design, registration, property…

CertaraNovember 12, 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

On-Demand Webinar

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

Improve pediatric drug development with Certara’s Pediatric Practice, MIDD expertise for PIPs/PSPs, dose selection, regulatory…

CertaraNovember 10, 2025

Guide

De-Risking Drug Design: How Early Feasibility Assessment Transforms Biotherapeutic Development

Learn how Early Feasibility Assessment and QSP modeling improve drug design, de-risk feasibility studies, &…

CertaraNovember 7, 2025

Publication

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Immunogenicity poses a significant challenge in biotherapeutics development due to the formation of anti-drug antibodies…

Danielle PillsburyNovember 7, 2025

Fact Sheet

Build investor confidence with science-backed strategy

Discover expert insights on biotech funding, startup investment strategies, and securing capital for biotech ventures.…

CertaraNovember 6, 2025

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

Certara Discovery – Streamline Your Drug Discovery Process

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

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

De-Risking Drug Design: How Early Feasibility Assessment Transforms Biotherapeutic Development

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Build investor confidence with science-backed strategy

Newsletter sign up

Quick links

Solutions

Contact