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
医薬品開発は成功確率が非常に低い一方で、そのプロセスには多大な労力と費用が必要とされます。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. お客様の信頼できるパートナーとして、サイクルタイム短縮、コスト削減、患者さんのアウトカム改善を目指して、医薬品研究開発プロセスにおける重要な意思決定を確信を持って下すサポートを提供します。
さらに、Phoenix™ PK/PDプラットフォームやSimcyp™ PBPK Simulatorソフトウェアプラットフォームは、米国FDAやPMDA、EMAを含む世界17エリアの規制当局に採用されています。
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. バイオシミュレーションソフトウェアと技術主導型サービスを活用するサターラのクライアントは、腫瘍学から希少疾患に至るまで、幅広い治療適応症で新薬をFDAから承認されています。
専門家に相談するScientists 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. 新薬の開発や承認申請においてお客様が直面する可能性と課題を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.
比類なき実績と専門知識
サターラの医薬品開発コンサルティングサービスは、650人以上の専門家集団の数十年に及ぶ経験と最先端の技術ソリューションを活用しています。技術と経験によって開発計画の時間とコストを削減し、承認申請と上市の成功をサポートしています。過去10年間、7,000件以上のプロジェクトを支援してきました。
当社のエキスパート
Karen Rowland Yeo, PhD Seinor Vice President, Client &Regulatory Strategy
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 Seinor Vice President, Client &Regulatory Strategy
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
Simcypにおいて2002年からin vivoにおけるヒト薬物動態を予測するin vitroデータの外挿プロジェクトを率いてきました。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。
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.
グローバル医薬品開発における創薬早期から承認申請、市販後に至るフェーズの中で戦略策定とオペレーションに25年以上従事した経験を有します。戦略的な創薬および開発計画の幅広い知見を有し、開発戦略やモデルを活かした医薬品開発の活用に特に重点的に取り組んでいます。
Simcypにおいて2002年からin vivoにおけるヒト薬物動態を予測するin vitroデータの外挿プロジェクトを率いてきました。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。
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.
グローバル医薬品開発における創薬早期から承認申請、市販後に至るフェーズの中で戦略策定とオペレーションに25年以上従事した経験を有します。戦略的な創薬および開発計画の幅広い知見を有し、開発戦略やモデルを活かした医薬品開発の活用に特に重点的に取り組んでいます。
