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Certara Awarded European Medicines Agency Project to Assess Real-World Data Landscape for CAR-T Cell Therapies

Project will evaluate content, quality, and accessiblity of available real-world data sources for six CAR-T cell therapies currently approved for use in the European Union (EU)

Radnor, PA – 1월 22, 2025 – Certara, Inc. 글로벌 바이오시뮬레이션 선두기업(Nasdaq: 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.

Certara 소개

Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. Learn more at certara.com.

Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com

Media Contact:
Alyssa Horowitz
certara@pancomm.com

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