Affirms continued regulatory and industry adoption of biosimulation and technology to bring new drugs to patients
PRINCETON, N.J.—Feb. 25, 2021– Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where 90% of new drug and biologic approvals by the US Food and Drug Administration (FDA), excluding diagnostic agents, were received by Certara’s customers. Certara’s customers use its biosimulation software and tech-enabled services to increase confidence in decisions across the entire R&D lifecycle. The data generated from Certara’s platforms helps to advance the safety and efficacy of therapies, accelerating critical medicines to patients.
In 2020, the FDA’s Center for Drug Evaluation and Review and the Center for Biologics Evaluation and Research approved 54 medicines, excluding diagnostic agents. The majority of new drug approvals had orphan drug designation, and approximately half had breakthrough therapy designation.
Certara’s Simcyp™, Phoenix™ and GlobalSubmit™ software platforms have been broadly adopted by the biopharmaceutical industry and global regulatory agencies for drug development and regulatory review. The Simcyp Simulator has now been used to provide approximately 250 drug label claims for more than 75 novel drugs, in lieu of conducting clinical studies. In 2020, the Simcyp Simulator was included in the regulatory submissions for therapies to treat breast cancer, a rare pediatric disease, and gastrointestinal tumors, among others.
“This milestone is indicative of Certara’s impact in transforming the traditional drug development process, which can be costly and take many years,” said Certara’s CEO William Feehery, PhD. “We are proud to be at the forefront of a long-term trend of computer-based modeling that has advanced new treatments in a wide range of therapeutic areas, such as oncology, neurology, and rare diseases. In particular, our unique Simcyp Simulator has allowed our sponsor partners to expand prescribing information for novel drugs with regulatory-accepted science based on biosimulation.”
Certara（サターラ）について
サターラは、バイオシミュレーションソフトウェアと技術を用いて、従来の創薬・開発を変革し、医薬品をよりスピーディーに患者さんに届けることをミッションとしています。バイオ医薬品企業1,650社以上、主要学術機関、主要な規制当局がサターラのソフトウェアやコンサルティングサービスを利用しております。弊社のお客様は61か国以上に広がっております。
本件に関するお問合わせ先
Jieun W. Choe
jieun.choe@certara.com
投資家の皆様：
David Deuchler
Gilmartin Group
ir@certara.com
報道機関の皆様：
Elizabeth Tang, Ph.D.
emi.akatsu@certara.com
elizabeth.tang@finnpartners.com
