Certara

Certara's Simcyp Simulator has become the first and only PBPK modeling platform to receive formal qualification from the European Medicines Agency for regulatory submissions across the EU.

Certara has appointed Dr. Christopher Bouton, founder of Vyasa Analytics, as Chief Technology Officer to lead development of an AI-powered model-informed drug development platform.

Certara and Merck have expanded their clinical technology collaboration to include metadata repository and data standards workflow management through the Pinnacle 21 platform.

The Inflation Reduction Act's 2% Medicare reimbursement boost for qualifying biosimilars has led to measurable increases in adoption, with 45% of surveyed facilities reporting slight increases and 14% reporting significant increases in utilization.

Certara has introduced the Non-Animal Navigator solution to help pharmaceutical companies reduce reliance on animal testing in preclinical safety studies, aligning with FDA's recent roadmap initiative.

Digital twins enable researchers to simulate patient responses in rare diseases like Pompe disease, reducing the need for large patient populations in clinical trials.

AI-driven simulations are improving clinical trial success rates by preemptively modeling trials and optimizing dosing strategies.