When You Can Identify Your Risks, You Increase Your Program's Velocity

药物发现和开发过程漫长且成本昂贵,失败往往多于成功。在 Certara,我们使用生物模拟和技术支持服务来预期并解决您的关键药物发现和开发风险以及决策。

在 2020 年,全球超过 1,650 家客户选择 Certara 作为我们金标准生物模拟软件和技术支持服务的可信赖合作伙伴。作为您值得信赖的合作伙伴,我们支持在整个生物制药研发过程中做出可靠的决策,从而缩短周期时间,降低成本并改善患者的治疗效果。

实际上,全球有 17 个监管机构已经采用了我们的 Phoenix™ PK/PD 和/或 Simcyp™ PBPK Simulator 软件平台,包括美国食品药品监督管理局 (FDA) 和欧洲药品管理局 (EMA)。

我们很自豪地说,自 2014 年以来,使用我们的生物模拟软件和服务的客户已获得 FDA 所有新药批准的 90% 以上。

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80+ Novel drugs Informed by the Symcyp Simulator

Simcyp Simulator 是由 35 家领先的生物制药公司的 Simcyp 协会在过去 20 年开发和更新的,我们的咨询团队使用 Simcyp Simulator 为各种规模和阶段的药物开发公司提供支持。Simcyp 被监管机构用于药物审查,并被用于第一个 FDA MIDD PBPK 项目。Simcyp Simulator 已为肿瘤、罕见疾病、中枢神经系统、心脏和其他治疗领域的 200 多个新药和 80 多个标签声明提供了给药决策。

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我们的专家
Patrick F. Smith President, Integrated Drug Development

Dr. Patrick F. Smith is President of Integrated Drug Development at Certara, where he leads a global team of drug development scientists that creates value for clients across the entire life cycle and ultimately accelerates patient access to medicines. With more than 20 years of drug development experience, Patrick has worked across all phases of drug development with deep expertise in infectious diseases, oncology, and inflammation as well as novel early development program design and applying modeling and simulation to solve critical development problems.

Previously, Patrick was co-founder of d3 Medicine (acquired by Certara in 2016), helping to build a healthcare company that specialized in providing strategic support for complex development programs. Prior to d3 Medicine, Patrick was U.S. Clinical Pharmacology Lead at Roche for more than 5 years, where he worked in various roles of increasing responsibility in clinical pharmacology and translational medicine. He has served as an Associate Professor at the University at Buffalo School of Pharmacy and Roswell Park Cancer Institute in Buffalo, NY. Patrick has published more than 125 peer-reviewed articles in journals, including the New England Journal of Medicine and Lancet. He received his PharmD at the University of California, San Francisco and completed his clinical residency at Duke University Medical Center.

Karen Rowland Yeo,博士 客户与监管策略高级副总裁

自 2002 年以来,Karen 一直负责与通过体外数据推断预测人体内药代动力学相关的项目。这包括在 Simcyp Simulator 中开发和实现模型。她的具体研究兴趣包括生理药代动力学建模和药物相互作用预测。

Julie Bullock,药学博士 副总裁兼临床药理学和转化医学部全球负责人

Julie 拥有 10 多年在 FDA 任职的药物开发经验,并为 14 项以上新的分子实体审批做出了贡献。她对儿科发展、用于生物制剂的 PK/PD 分析和方法、肿瘤学给药策略以及突破性疗法和加速审批的发展均有独特的见解。

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