Tech-driven Services and Software

Biosimulation Software
Certara’s biosimulation software has been used to provide valuable information to improve the design of clinical trials, reduce trial size and complexity, and also obtain clinical trial waivers to replace the need for human clinical trials for certain studies. Our Simcyp Simulator has informed approximately 250 drug labels for more than 80 novel drugs approved by the FDA. Details can be found in the Office of Clinical Pharmacology review on the FDA website that supports each label.
Tech-driven Services
The past two decades have witnessed transformative changes in model-informed drug development, specifically the embracing of physiologically-based pharmacokinetic (PBPK) modeling to inform drug discovery and development. Simcyp PBPK has led the way, supporting the development of 70+ novel drugs, driving down R&D costs and timelines, eliminating the need for 200+ in vivo clinical studies, and increasing the likelihood of clinical trial and regulatory success.
QSP Software
Quantitative Systems Pharmacology (QSP) examines the relationships between a drug, the biological system, and the disease process via Certara’s proprietary technology platforms, including Immunogenicity, Immuno-oncology, Vaccines, and Gene Therapy. It predicts clinical outcomes in novel targets, modalities and drug combinations by testing therapeutic strategies in virtual trials with virtual patients.
QSP Tech-enabled Consulting
Certara’s expert consulting team provides QSP modeling & simulation as well as regulatory support to address questions around novel modalities, dosing optimization, combination therapy, biomarker determination, target selection, compound repurposing, and target engagement. Therapeutic specialties include oncology, neurology, immunology, gene therapy, vaccines and rare disease.
虚拟生物等效性 (VBE)
Leveraging the Simcyp Simulator and in vitro data, VBE is a proven, cost-effective approach used in lieu of running an in vivo comparative clinical bioequivalence endpoint study. Simcyp has supported a range of VBE and alternative formulation and manufacturing projects, including M&S for the first and only ANDA for a dermal, complex generic using VBE.
QSTS Software
Quantitative Systems Toxicology and Safety (QSTS) provides a quantitative framework to support translational drug discovery and development by integrating knowledge on biochemical, biological, physiological, pharmacological, toxicological and clinical systems with a focus on drug toxicity, safety and toleration. Our Secondary Intelligence predicts likelihood of off-target safety issues that could impede clinical progress.
QSTS Consulting
Certara’s quantitative toxicological team provides services including ADR risk reduction, management of off-target interactions, improved forecasting of the impact of zenobiotic substances on biological systems, strengthening of drug safety assessments, better understanding of drug-induced toxicity, and reduction in required animal studies.
Simcyp 儿科模拟器
Simcyp Pediatric is a module within the Simcyp Simulator that allows for the modeling of pharmacokinetic behavior in neonates, infants and children. This tool is used for dosing decisions, analysis of drug-drug interactions and other safety issues, design and formulation of drugs for children, and the design of pediatric clinical studies to minimize the number of required subjects.
PBPK Software
The Simcyp Simulator is the leading provider of Physiologically-based Pharmacokinetic (PBPK) modeling & simulation. The Simcyp Simulator is used to predict drug performance in clinical studies from virtual populations. Simcyp extrapolates relevant endpoints from in vitro and in vivo data to answer ‘what if’ drug development questions for untested scenarios and patients
Tech-driven PBPK Services
The Simcyp consulting team is the largest and most experienced group of PBPK scientists, working with companies from first-in-human translation through regulatory approval. The team uses the Simcyp Simulator to advise on dosing and safety issues; inform, reduce or eliminate clinical studies, and provide in silico label claims on both small molecules and biologics
Simcyp PBPK Case Studies

With more than 80 novel drugs that leveraged Simcyp for approval and scores of other drugs for which Simcyp answered key regulatory and development questions, a list of key applications include:

  • 药物相互作用模拟 – 引起作用的药物和受影响的药物
  • 吸收模型 – 配方效果/生物等效性,食物效果
  • 特殊人群用药 – 儿科、老年人、器官损害、疾病状况、种族差异
  • 从外在因素评估药物性能 – 吸烟,饮酒
  • 新颖的给药途径 – 皮下、吸入、长效注射
  • 生物制剂 – mAb、ADC、其他蛋白质、细胞因子介导的 DDI
  • 虚拟生物等效性和配方,适用于复杂的仿制药
  • 早期 PK 预测,FIH 给药
Read Simcyp success stories here
Immunogenicity Prediction and Dose Optimization

Immunogenicity (IG), the ability of a therapeutic product to trigger an immune response in the body can be ‘desired IG’ to support vaccine and allergen response or ‘undesired IG’ causing immunologically related adverse events. Certara’s QSP team has developed a regulatory-ready software platform (Simulator) for managing both wanted and unwanted IG, a pivotal tool to guide clinical and regulatory decision-making in drug development. QSP can provide insight early in the development process (for example, predicting IG from protein sequence alone or extrapolating from pre-clinical assays) and ultimately be used to leverage vast amounts of biological and pharmacological data to address larger challenges such as phase 2 failures.

In short, QSP enables the understanding of disease pathophysiology to identify and test therapeutic strategies in virtual trials with virtual patients.

Read more here

Piet van der Graaf, PharmD, PhD

Senior Vice President, Quantitative Systems Pharmacology

Piet 曾任职于赛诺菲和辉瑞,在制药行业拥有 20 多年经验,为 QSP 项目带来了丰富的技能和经验,并为 Certara 的战略发展做出了贡献。他还担任《临床药理学与药物治疗学 (CPT)》主编。

Hannah Jones, PhD

Vice President, Head of PBPK Consulting Services

Hannah 在全球多家制药机构有超过 18 年的工作经验,拥有特别深厚的 PBPK 和 PKPD 建模背景知识,她发表了 50 篇以上关于 PBPK/PKPD 建模和其他 DMPK 相关主题的论文,在通过建模和模拟影响药物研发计划方面有丰富经验。

Karen Rowland Yeo, PhD

Senior Vice President, Client & Regulatory Strategy

自 2002 年以来,Karen 一直负责与体外数据外推有关的项目,以预测人体的体内药代动力学。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。


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