Tech-driven Services and Software

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.
Tech-Driven Services
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.
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
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.
Virtual Bioequivalence(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 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.
Simcyp Pediatric
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:

  • DDI のシミュレーション – Perpetrator および Victim
  • 薬物吸収モデル – 製剤や食事の影響、生物学的同等性
  • 特殊集団の用法用量 – 小児、 高齢者、臓器機能障害、病態、人種差
  • 外因性要因が薬物の性能に与える影響の評価-喫煙、飲酒
  • 新規の投与経路 – 経皮、吸入、持効性注射剤
  • 生物学的製剤 – モノクロナール抗体、抗体薬物複合体、その他のタンパク、DDI に対するサイトカインの影響
  • 複雑な後発医薬品開発におけるバーチャルの生物学的同等性評価および製剤開発
  • 開発早期の PK 予測、ファーストインヒューマン 試験の投与量選択
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

製薬業界 (Sanofi および Pfizer) において20 年以上の経験があります。QSP プロジェクトに重要な技術と経験をもたらし、サターラの戦略的な開発に貢献しています。He is also Editor-in-Chief of CPT.

Hannah Jones, PhD

Vice President, Head of PBPK Consulting Services

グローバル製薬企業において 18 年以上にわたって研究開発に携わっていました。特に、PBPK や PK/PD モデリングの分野で優れた実績を残しています。PBPK や PK/PD モデリング、DMPK に関連した50 件以上の論文を発表しています。モデリング&シミュレーション手法の活用を通して医薬品研究開発プログラムに多くの貢献を果たしてきました。

Karen Rowland Yeo, PhD

Senior Vice President, Client & Regulatory Strategy

2002 年以来、ヒトの薬物動態を予測する IVIVE(in vitro-in vivo Extrapolation)プロジェクトを率いてきた豊富な経験を有しています。また、Simcyp Simulator に実装される PBPK モデル構築プロジェクトのメンバーも務めていました。特に、PBPK モデリングと DDI 予測といったテーマを中心に研究に取り組んでいます。

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