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This new partnership provides Japanese biopharma companies greater access to the latest biosimulation and regulatory solutions to accelerate drug development.

RADNOR, PA – 2025 年 3 月 18 日 – Certara, Inc. (纳斯达克股票代码:CERT), a global leader in model-informed drug development (MIDD), today announced a new partnership agreement with A2 Healthcare in Japan. The collaboration will help pharmaceutical companies more easily access drug development, biosimulation, and regulatory software solutions from Certara and select MIDD strategic and scientific services to accelerate their drug development projects in Japan.

MIDD approaches include a range of modeling approaches and supporting technologies, including population pharmacokinetic modeling (PPK), pharmacokinetic/pharmacodynamic modeling (PK/PD), physiologically-based pharmacokinetic modeling (PBPK), and exposure-response (ER) analysis. MIDD has become essential throughout the entire drug development process to answer critical questions regarding formulation selection, safety/efficacy assessment, and dose optimization. Japanese academic and pharmaceutical industry researchers regularly hold discussions and workshops to harmonize with global MIDD guidelines such as ICH-M15.

Together, A2Healthcare and Certara will provide researchers with comprehensive solutions that help accelerate drug development at every development phase. Capabilities include:

  • Rapidly create, review, validate, and submit regulatory documents on a tight schedule with regulatory software solutions like CoAuthor™ Ai-powered regulatory writing software and CDISC Pinnacle 21 Enterprise.
  • De-risk and predict discovery, preclinical, and clinical outcomes faster with Quantitative systems pharmacology (QSP), an approach that combines computational modeling and experimental data to thoroughly examine the relationships between a drug, the biological system, and the disease process
  • Inform portfolio management, trial design, and pricing strategy of a new therapy utilizing curated trial outcome data and modeling to predict potential performance and possible uptake outcomes versus competitive products and the gold standard leveraging Model-based meta-analysis (MBMA)
  • Quantify drug, disease, and trial information and optimize dosing for safety and efficacy across the population with Pharmacometrics solutions that support late-stage trial design and regulatory submissions.
  • Conduct pharmacometrics analyses with the widely used Certara Phoenix Scientific Software Suite which supports simple to extremely complex modeling approaches and data sets.

Roger Williams, Vice President of Commercial APAC at Certara said, “Together, A2 Healthcare and Certara provide even greater access to Certara’s drug development software and services in Japan, enabling researchers to make critical decisions with greater certainty.”

“A2 Healthcare is committed to providing our customers with the best modeling and simulation and regulatory solutions to move their important research forward,” said Yukawa Tomohito, Deputy Executive Director, Data Science Division at A2 Healthcare. “While we both have extensive experience in pharmacometrics, Certara advances our capabilities and helps broaden our scientific portfolio. This partnership will help our clients accelerate the delivery of new, novel medicines to patients.”

Learn more about how to reduce time, save costs, and improve the drug development process with Certara’s solutions at https://www.certara.com/.

关于Certara

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.

About A2Healthcare

A2 is one of the industry’s leading CROs (Contract Research Organizations), conducting clinical trials under contract from pharmaceutical companies, and has been involved in the development of numerous drugs with approximately 1,300 employees in Tokyo, Osaka, Taiwan, and Boston. In addition to the traditional lifestyle-related disease area, A2 in the development of drugs related to cancer, central nervous system, respiratory disease, vaccine, and also promotes the introduction of various advanced solutions such as RBM, eSource Data, eSubmission, and DCT (Decentralized Clinical Trials) to improve the efficiency of clinical trials. A2Healthcare is also a subsidiary of ITOCHU Corporation and forms the core of the group’s healthcare business. A2 Healthcare Corporation: http://www.a2healthcare.com/en

Certara 联系人:

Sheila Rocchio
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媒体联系人:

Alyssa Horowitz
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