Adoption of Certara’s proprietary technologies and consulting knowledge aligns with FDA’s commitment to modernizing the drug development process
PRINCETON, NJ – Jan. 23, 2020 – Certara®, the global model-informed drug development and decision support leader, today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or consulting services. This result affirms the pharmaceutical industry’s dedication to employing model-informed drug development approaches for informing key clinical testing decisions, resulting in reduced cost and increased speed in bringing new drugs to patients.
“We are thrilled to participate in the modernization of drug development effort that has been spearheaded by the FDA,” said Certara’s CEO Dr. William Feehery. “Certara’s Simcyp®, Phoenix® and Global Submit™ software platforms have been widely used by both the FDA and the biopharmaceutical industry during the past several years for drug development and regulatory review. In addition to the use of our technology, our expert consulting services teams supported the development of therapies for patients with cancer, central nervous system diseases, infectious diseases, and rare diseases in the class of 2019.”
During her speech at the Breakthroughs in Medicine conference in Rancho Palos Verdes, CA last September, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER) spoke of the Agency’s commitment to innovation in drug development. Certara’s mission is closely aligned with that commitment, which was outlined by the Agency in its Congressional testimony on implementing the 21st Century Cures Act:
「米国FDAの広範なイノベーションイニシアチブの一環として、製品の安全性と有効性が評価できるようにするために、アダプティブ試験、モデリング、シミュレーションなど最先端のイノベーションを使用することを奨励しています…CDERおよび米国FDAの生物学的製剤評価研究センター（Center for Biologics Evaluation and Research、CBER）では現在、これらのツールを展開して、臨床転帰の予測、臨床試験デザインのための情報提供、有効性の証拠の裏付け、および有害事象の潜在的機序の評価を支援しています。」
Certara’s innovations have had a profound impact on accelerating and improving the efficiency of drug development. During the past six years, Certara’s technology and/or consulting services have been used to inform and expedite the development of about 250 novel therapies. In 2019 alone, Certara provided technology, consulting and/or regulatory writing and submission support for 11 oncology drugs, 12 drugs for orphan diseases, and 16 drugs that received priority or accelerated review. Certara’s quantitative and integrated approach to drug development has enabled sponsors to reduce the size and duration of clinical trials, develop dosing strategies for special populations, such as pediatrics, evaluate alternative formulations, seek expedited regulatory pathways, and leverage in silico models in lieu of conducting clinical trials.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 過去6年間に米国FDAが承認した新薬承認申請の90%以上をサターラのソフトウェアやサービスがサポートしています。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
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