Tech-driven Services and Software

Certara Body Content Accelerating Medicines with Biosimulation 3b
Biosimulation Software
Certara’s Simcyp team has been developing cutting-edge biosimulation software for 20+ years, supporting the needs of the biopharm industry and its academic and regulatory partners. Software platforms include PBPK-what the body does to the drug; QSP-what you want the drug to do to the body; and QSTS–what you don’t want the drug to do to the body.
Simcyp Overview Body Content 2
技术推动的服务
Leveraging Simcyp’s unique portfolio of biosimulation technology, our expert scientists work alongside biopharm development teams to accelerate time-to-market for drug programs. Focusing on safety, efficacy, toxicology and other challenges, we have performed hundreds of projects on small and large molecules, vaccines, complex generics, and new drug modalities.
Simcyp PBPK v20
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
Certara Body Sec Consulting Tile 2
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 Overview Body Content 4
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.
Simcyp Overview Body Content 5
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.
Simcyp Overview Body Content 3
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.
Certara Simcyp Animal Digital Human Large
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.
CS Body Image 1 A new Sponsor team
QSTS Tech-Driven Services
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.
Pediatric
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.
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
Simcyp PBPK Case Studies
Immunogenicity Prediction and Dose Optimization
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
Certara 的 Simcyp™ 新冠肺炎疫苗模型获研发 100 奖

Our Simcyp COVID-19 Vaccine Model has won an R&D 100 Award, which recognizes the top 100 “R&D pioneers and their revolutionary ideas in science and technology” in the past year. The model, which is incorporated in Certara’s Vaccine Simulator, has been used by major pharmaceutical companies and allows researchers to study how a vaccine is handled by the human body in computer-generated, virtual populations.

Read More
Certara’s Simcyp™ COVID-19 Vaccine Model Wins R&D 100 Award
Bio Pic PietGraaf

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

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。

Bio Pic KarenYeo

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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