34 leading biopharmaceutical companies now participate in this unique modeling and simulation research group
PRINCETON, NJ – July 20, 2016 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that Mitsubishi Tanabe has joined its Simcyp Consortium and licensed its proprietary Simcyp® Population-based Simulator. Mitsubishi Tanabe is the 34th leading biopharmaceutical company and the tenth leading Japanese pharmaceutical company to join the Consortium. In addition to its biopharmaceutical industry members, leading academic institutions from around the globe, and key regulatory bodies, including the US Food and Drug Administration (FDA), European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency are affiliates of the Simcyp Consortium.
“We are thrilled to have Mitsubishi Tanabe as a member of the Simcyp Consortium,” said Stephen Toon, BPharm, PhD, President and Managing Director of Certara’s Simcyp division. “Membership provides numerous benefits, including the opportunity to share knowledge and collaborate in the development of best practices and cutting-edge science for studying drug activity in virtual patients. In addition to creating annual updates to the Simcyp Simulator, Simcyp has also produced models for pediatric, pregnant, obese, hepatic- and renally-impaired populations. These advances have enabled member companies to evaluate new therapies in patient groups and clinical scenarios that might have historically been considered ‘untestable.’”
Simcypコンソーシアムは生理学的薬物動態（PBPK）およびメカニスティックモデリングの共同研究拠点として2001年に設立されました。それ以降、SimcypはPBPKおよびメカニスティックモデリング & シミュレーション (M&S) の科学技術の先駆者としての地位を確立し、Simcyp Simulatorは仮想患者集団における薬物動態予測の分野で最も洗練されたプラットフォームとして進化を続けています。Simcyp Simulatorは、臨床試験デザイン・特定の臨床試験の必要性・製剤設計・特殊集団における用量設定、および薬物間相互作用 (DDI) に関連する主要な意思決定に寄与する貴重な情報を提供します。また、主要な前臨床試験におけるデータ要件を同定する目的でも利用され、それにより早期の医薬品開発過程や手順の再定義および最適化に対して、極めて重要な価値を提供することが可能となります。
過去数年間の実績として、Simcyp Simulatorは、米国食品医薬品局 (米国FDA) によって承認された100件以上の新規医薬品・生物製剤の添付文書における情報提供に活用されています。添付文書へ追加情報として、潜在的な DDI・製剤に関する推奨事項・用法・用量・特殊集団に関する情報が含まれます。
Certara（サターラ）について
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.
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