Beyond Compliance: What ICH M15 Means for the Future of Drug Development Blog Beyond Compliance: What ICH M15 Means for the Future of Drug Development Explore how ICH M15 is shaping regulatory expectations for Model-Informed Drug Development (MIDD), including model…CertaraJune 9, 2026
How interactive value communication tools strengthen the value proposition in healthcare Blog How interactive value communication tools strengthen the value proposition in healthcare Learn how interactive value communication tools help demonstrate healthcare value, support payer discussions, and strengthen…CertaraJune 9, 2026
The Case for Simulating Pregnancy Press Coverage The Case for Simulating Pregnancy Pregnant women are routinely excluded from drug trials, leaving clinicians without dosing guidance. Discover how…CertaraJune 9, 2026
The end of the national launch: why regional pharma market access now determines commercial success Blog The end of the national launch: why regional pharma market access now determines commercial success Regional pharma market access is reshaping uptake. Build a regional market access strategy to navigate…CertaraJune 5, 2026
Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients Publication Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients See how a QSP model guided efficacy-proximal FIH dosing for ISB 2001 in the TRIgnite-1…CertaraJune 4, 2026
Applying AI-Driven Biosimulation to Drug Discovery Video Applying AI-Driven Biosimulation to Drug Discovery Certara President Leif Pedersen explains how PBPK and QSP modeling, proven across 125+ FDA-approved drugs,…CertaraJune 2, 2026
Model-Informed Development Accelerates Transformative Treatment for Sleeping Sickness Case Study Model-Informed Development Accelerates Transformative Treatment for Sleeping Sickness Certara’s drug development support enabled a positive scientific opinion from the EMA for acoziborole, a…CertaraJune 2, 2026
Strategies for navigating loss of exclusivity (LOE) in pharma Blog Strategies for navigating loss of exclusivity (LOE) in pharma Learn key strategies to navigate loss of exclusivity with confidence & defend market share throughout…CertaraJune 2, 2026
Review: application and opportunities for machine learning and artificial intelligence in preclinical immunogenicity risk assessment Publication Review: application and opportunities for machine learning and artificial intelligence in preclinical immunogenicity risk assessment This review explores how artificial intelligence (AI), machine learning (ML), and quantitative systems pharmacology (QSP)…CertaraJune 2, 2026
Model Acceptance in Regulatory Submissions: Practical Strategies for Regulatory Success Webinar Model Acceptance in Regulatory Submissions: Practical Strategies for Regulatory Success CertaraJune 1, 2026