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Tech-driven Services and Software

Certara Body Content Accelerating Medicines with Biosimulation 3b
바이오시뮬레이션 소프트웨어
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.
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Simcyp Overview Body Content 2
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.
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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
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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
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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.
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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.
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Simcyp Overview Body Content 3
가상 생물학적 동등성(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.
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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.
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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.
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Pediatric
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.
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Simcyp PBPK Case Studies

With more than 90 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:

  • 약물 간 상호작용 시뮬레이션 – 유발 약물과 영향 약물
  • 흡수 모델링 – 제형 효과/생물학적 동등성, 음식물의 영향
  • 특수 집단을 위한 용량 – 소아, 노인, 장기 손상, 질환 상태, 인종 차이
  • 외인성 요인에 의한 약물 효능 평가 – 흡연, 알코올
  • 새로운 투여 경로 – 피부, 진피, 지속성 주사제
  • 생물학적 제제 – mAb, ADC, 기타 단백질, 사이토카인 매개 DDI
  • 가상 생물학적 동등성 및 제형 복합 제네릭 의약품용
  • 조기 PK 예측, FIH 용량
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.

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Certara의 Simcyp™ 코로나바이러스-19 백신 모델이 R&D 100 상을 수상하다

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.

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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

Piet은 Sanofi와 Pfizer의 제약 산업에서 20년 넘게 근무한 경험을 통해 QSP 프로젝트에 있어 상당한 기술과 경험을 제공하며 Certara의 전략적 개발에 기여합니다. 또한 그는 CPT의 편집장이기도 합니다.

Hannah Jones

Hannah Jones, PhD

Vice President, Head of PBPK Consulting Services

Hannah has over 18 years experience in global pharmaceutical organizations, possessing a particularly strong background in PBPK and PKPD modelling, She has over 50 publications in PBPK/PKPD modelling and other DMPK related topics, and considerable experience influencing drug research and development programs through modelling and simulation.

Bio Pic KarenYeo

Karen Rowland Yeo, PhD

Senior Vice President, Client & Regulatory Strategy

2002년부터, Karen은 인간의 생체 내 약동학을 예측하기 위한 생체 외 데이터 외삽과 관련된 프로젝트를 이끌었습니다. 여기에는 Simcyp Simulator에 대한 모델 개발 및 구현이 포함됩니다. 또한 그녀는 생리학 기반 약물동태 및 약물 간 상호작용 예측을 비롯한 특정 연구 분야에 관심이 있습니다.

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