Certara 获欧洲药品管理局项目授权，评估 CAR-T 细胞疗法的真实世界数据环境

Radnor, PA – 2025 年 1 月 22 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in model-informed drug development, announced the award of a European Medicines Agency (EMA) project to assess the real-world data (RWD) landscape for Chimeric Antigen Receptor T-cell (CAR-T) therapies.

Challenges in patient recruitment can limit the value of decision-grade evidence obtained from clinical trials. RWD analysis to generate real-world evidence (RWE) can complement and enhance the effectiveness and safety insights derived from clinical trial data to inform regulatory agency submissions. Therefore, available data sources must be reliable, accurate, and comprehensive to meet the high evidentiary standards of these key stakeholders.

“Real-world evidence enriches drug-development decision-making and expedites the entire process in many cases,” said Patrick Smith, President, Certara Drug Development Solutions. “Our team are experts in combining RWD analysis with modeling and simulation technology. This allows us to capitalize on RWE’s vast potential. We are pleased to partner with EMA in this important endeavor.”

The project’s output will help advance the field by

• providing a baseline assessment of fit-for-purpose RWD sources for CAR-T therapies
• identifying key evidence gaps,
• informing EMA recommendations to CAR-T therapy sponsors for supplementary RWE generation activities, and
• enabling more rapid execution of RWD future studies

The project award is part of a previously announced four-year, framework service contract Certara signed with the EMA. That contract aimed to advance regulatory decision-making for human medicines with advanced statistical and pharmacoepidemiological research.

Learn more about Certara’s RWE solutions and health economics and outcomes research (HEOR) services at www.certara.com/evidence-access/real-world-evidence.