On-Demand Webinar

Virtual Control Groups, Actually: What SEND Makes Possible (and What It Doesn’t)

Learn how SEND enables virtual control groups using historical toxicology data, including key applications, challenges,…

CertaraMarch 4, 2026

Publication

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…

Danielle PillsburyMarch 4, 2026

Blog

ADC first-in-human (FIH) dose selection: Designing FIH studies for success

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

CertaraMarch 3, 2026

Conference

Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development

Danielle PillsburyMarch 2, 2026

Blog

Rare disease day 2026: Accelerating rare disease drug development through cross-functional innovation

On Rare Disease Day 2026, Certara experts share how cross-functional innovation, regulatory strategies for rare…

CertaraFebruary 26, 2026

Live Events

Certara Biotech Forum: Workshop on Developing Investor-Ready Strategies

–

CertaraFebruary 24, 2026

Webinar

Maximizing the Impact of Antibody–Drug Conjugates (ADCs): Model-Informed Labeling, Expansion, and Market Access

Danielle PillsburyFebruary 23, 2026

On-Demand Webinar

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…

CertaraFebruary 23, 2026

Blog

FAQs: The ICH M15 guideline and what it means for model-informed drug development

Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…

CertaraFebruary 18, 2026

Guide

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…

CertaraFebruary 13, 2026

Drug Development

Virtual Control Groups, Actually: What SEND Makes Possible (and What It Doesn’t)

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

ADC first-in-human (FIH) dose selection: Designing FIH studies for success

Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development

Rare disease day 2026: Accelerating rare disease drug development through cross-functional innovation

Certara Biotech Forum: Workshop on Developing Investor-Ready Strategies

Maximizing the Impact of Antibody–Drug Conjugates (ADCs): Model-Informed Labeling, Expansion, and Market Access

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

FAQs: The ICH M15 guideline and what it means for model-informed drug development

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Newsletter sign up

Quick links

Solutions

Contact