Partner with the Experts who have Regulator mind set
We have collaborated on well over 7,000 programs in the last decade.
Accelerating medicines to improve patient lives
Certara’s mission to accelerate medicines to patients using biosimulation, software and services defines who we are as a company, what we do, but also how we achieve success for our customers. As Certara continues to grow, we can be proud not only of what we have accomplished together, but also that we did it the right way.
The drug discovery and development process is long and expensive with more failures than successes. At Certara, we 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. This is the 9th consecutive year that Certara’s customers, who use the Company’s biosimulation software and technology-driven services, have had novel drugs approved by the FDA in a wide range of therapeutic indications, from oncology to rare diseases.
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Learn From Industry Leaders
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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. We derive significant insights that inform the development of our biosimulation software. 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.
Unmatched Experience and Expertise
Our drug-development consultation services reflect decades of experience from more than 650 healthcare and pharmaceutical professionals, as well as leading-edge technological solutions. This combination delivers the insights and knowledge to accelerate regulatory and commercial success while saving time and money. Over the last decade, we have worked on more than 7,000 customer projects, across practice areas and drug development phases, leading to the extensive experience our customers highly value.
Since 2002, Karen has led projects relating to the extrapolation of in vitro data to predict in vivo pharmacokinetics in humans. This has included development and implementation of the models into the Simcyp Simulator. Her specific research interests include physiologically based pharmacokinetic modeling and prediction of drug-drug interactions.
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.
Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing. She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).
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.
Since 2002, Karen has led projects relating to the extrapolation of in vitro data to predict in vivo pharmacokinetics in humans. This has included development and implementation of the models into the Simcyp Simulator. Her specific research interests include physiologically based pharmacokinetic modeling and prediction of drug-drug interactions.
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.
Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing. She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).
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.