Partner with the Experts who have Regulator mind set
We have collaborated on well over 7,000 programs in the last decade.
Most Trusted Partner in Life Science
신약 발견 및 개발 프로세스에는 성공보다 실패가 더 많으며 오랜 시간이 걸리고 비용이 많이 듭니다. At Certara, we partner to understand, anticipate and address your critical drug discovery and development risks and decisions using biosimulation and tech-enabled services.
The benefits of biosimulation are significant. A top ten global biopharmaceutical company by R&D spend, estimated that they saved more than half a billion dollars over three years using Certara biosimulation to inform key decisions. Biosimulation can reduce the size of and cost of human trials, the most expensive and time-consuming part of drug development, and in some cases, eliminate certain human trials completely. An analysis published on Applied Clinical Trials Online, to which Certara contributed, estimated that $1 billion was saved in clinical trial costs using biosimulation for a cancer drug due to consistently shorter completion times in the later phase clinical trials.
More than 1,650 customers worldwide chose Certara as their trusted partner for our gold-standard biosimulation software and tech-enabled services. As your trusted partner, we support confident decision-making throughout the entire biopharma R&D process to reduce cycle times, lower costs, and improve outcomes for patients.
Additionally, 17 global regulatory agencies have adopted our Phoenix™ PK/PD and/or Simcyp™ PBPK Simulator software platforms, including the US FDA and EMA.
90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022, excluding diagnostic agents. 이는 Certara의 바이오시뮬레이션 소프트웨어와 기술 기반 서비스를 사용하는 당사의 고객이 종양학에서 희귀 질환에 이르는 광범위한 치료 적응증에서 9년 연속으로 FDA(Food and Drug Administration)의 신약 승인을 받은 것입니다.
무료 상담 예약하기Scientists and regulators rely on our leading software as the gold standard to inform key decisions.
Learn From Industry Leaders
Visit our library of over scientific 3,000 assets including white papers, articles, posters, presentations, case studies and blogs.
100+ Novel drugs Informed by the Simcyp Simulator
Developed and updated over the past 20 years via the Simcyp Consortium of leading biopharm companies, the Simcyp Simulator is used by our consulting team to support companies of all sizes and stages of drug development. Used by regulators for drug review, Simcyp was leveraged for the first FDA MIDD PBPK project. The Simcyp Simulator has informed dosing decision for 100+ new drugs and 300+ label claims for oncology, rare, CNS, cardiac, and other therapeutic areas.
Leading the Industry in Drug Discovery and Development with gold-standard software platforms
Certara’s quantitative approach to model-informed drug development offers a comprehensive view of the clinical and regulatory possibilities and challenges facing new therapies. 당사는 모델 기반 약물 개발에 필요한 기술을 항상 새로 배우고 소프트웨어 개발에 기술을 적용합니다. These insights help us to anticipate and align our technology roadmap with our customers’ needs and priorities. By providing the clearest picture of both opportunities and risks in the development lifecycle, we remove doubt and inspire confidence at key milestones during the process.
최고 수준의 경험 및 전문성
Certara의 약물 개발 컨설팅 서비스에는 650명이 넘는 의료 및 제약 전문가들이 수십 년간 쌓아온 경험과 최신 기술 솔루션이 녹아 있습니다. 이러한 조합을 통해 시간과 비용을 절약하면서도 규제 및 상업적 성공을 가속화할 수 있는 통찰력과 지식을 제공합니다. 지난 10년간 7,000개가 넘는 고객 프로젝트를 통해 Certara는 고객들의 높은 평가를 받은 광범위한 경험을 쌓았습니다.
Certara 전문가
Karen Rowland Yeo, PhD 고객 및 규제 전략 부서, 선임 부사장
Julie Bullock, PharmD Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine
Piet van der Graaf, PharmD, PhD Senior Vice President and Head of Quantitative Systems Pharmacology
Fran Brown, PhD Senior Vice President, Certara Drug Development Solutions
Karen Rowland Yeo, PhD 고객 및 규제 전략 부서, 선임 부사장
Julie Bullock, PharmD Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine
Piet van der Graaf, PharmD, PhD Senior Vice President and Head of Quantitative Systems Pharmacology
Fran Brown, PhD Senior Vice President, Certara Drug Development Solutions
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.
Julie has over 10 years of drug development experience within the FDA. Dr Bullock’s past appointments include Clinical Pharmacology Team Leader and Senior Clinical Pharmacology Reviewer (FDA). Her regulatory experience was focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, PK/PD approaches for biosimilar products, oncology dose finding strategy and streamlining development for breakthrough therapies and accelerated approval. Dr. Bullock has contributed to over 14 new molecular entity approvals during her 10-year FDA career.
Piet van der Graaf is Senior Vice President and Head of Quantitative Systems Pharmacology at Certara and Professor of Systems Pharmacology at Leiden University. From 2013-2016 he was the Director of Research of the Leiden Academic Centre for Drug Research. From 1999-2013 he held various leadership positions at Pfizer in Discovery Biology, Pharmacokinetics and Drug Metabolism and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology from 2012-2018 before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet received his doctorate training in clinical medicine with Nobel prize laureate Sir James Black at King’s College London. He has been awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and was the recipient of the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet is an elected Fellow of the British Pharmacological Society and has published >200 articles in the area of quantitative pharmacology and drug development.
Fran은 글로벌 신약 개발과 관련하여 초기 발견부터 규제 문서 제출 및 시판 후까지의 전략 및 운영 측면에서 25년이 넘는 경력이 있습니다. 그는 개발 전략 및 모델링에 근거한 약물 개발(model-informed drug development, MIDD) 적용에 특히 중점을 둔 전략적 신약 발견 및 개발에 대한 방대한 지식을 보유하고 있습니다.
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.
Julie has over 10 years of drug development experience within the FDA. Dr Bullock’s past appointments include Clinical Pharmacology Team Leader and Senior Clinical Pharmacology Reviewer (FDA). Her regulatory experience was focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, PK/PD approaches for biosimilar products, oncology dose finding strategy and streamlining development for breakthrough therapies and accelerated approval. Dr. Bullock has contributed to over 14 new molecular entity approvals during her 10-year FDA career.
Piet van der Graaf is Senior Vice President and Head of Quantitative Systems Pharmacology at Certara and Professor of Systems Pharmacology at Leiden University. From 2013-2016 he was the Director of Research of the Leiden Academic Centre for Drug Research. From 1999-2013 he held various leadership positions at Pfizer in Discovery Biology, Pharmacokinetics and Drug Metabolism and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology from 2012-2018 before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet received his doctorate training in clinical medicine with Nobel prize laureate Sir James Black at King’s College London. He has been awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and was the recipient of the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet is an elected Fellow of the British Pharmacological Society and has published >200 articles in the area of quantitative pharmacology and drug development.
Fran은 글로벌 신약 개발과 관련하여 초기 발견부터 규제 문서 제출 및 시판 후까지의 전략 및 운영 측면에서 25년이 넘는 경력이 있습니다. 그는 개발 전략 및 모델링에 근거한 약물 개발(model-informed drug development, MIDD) 적용에 특히 중점을 둔 전략적 신약 발견 및 개발에 대한 방대한 지식을 보유하고 있습니다.
