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The Global Leader in Biosimulation

Traditional drug development takes too long and costs too much. There are far too many expensive failures, especially in the clinical trial phases, where the majority of drug R&D dollars is spent.

Certara’s mission is to transform this traditional process by using biosimulation to accelerate and improve drug discovery and development. For more than two decades, we have invested in our end-to-end platform powered by biosimulation and technology to advance drug programs from discovery and development to regulatory approval and market access.

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90% of novel FDA drug approvals received by our customers

Our customers, who use our biosimulation software and tech-enabled services, have received 90% of novel drug and biologic approvals by the FDA for the past 8 consecutive years. As the global leader in biosimulation, we work with more than 1,650 biopharmaceutical companies, leading academic institutions, and regulatory agencies worldwide, including all of the top 35 global biopharmaceutical companies by R&D spend.

While most approved novel drugs have used biosimulation in their development pathway, we don’t believe that biosimulation was used to the extent it should have to further accelerate and improve the drug development process. Additionally, our technology keeps getting better and better to expand use cases for biosimulation. We see a significant opportunity for continued future penetration by our products and services.

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Certara Body Content Accelerating Medicines with Biosimulation 1
Galderma's new drug approval for acne

The use of Certara’s Simcyp Simulator allowed Galderma to expedite and inform its drug development program for AKLIEF (trifarotene) Cream for the topical treatment of acne. The Simcyp Simulator also helped to provide safety label claim and pediatric dosing information WITHOUT the need for testing in clinical patients.

“We were pleased to partner with Certara to develop this detailed physiologically-based pharmacokinetic model of trifarotene, which helped to demonstrate the safety of our new drug and also provide additional prescribing information for our new drug label,” said Nathalie Wagner, Senior Clinical PK Manager at Galderma.

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Informing more than 300 labels for 90+ novel drugs

Certara’s biosimulation software has been used to provide valuable information to improve the design of clinical trials, reduce trial size and complexity, and also obtain clinical trial waivers to replace the need for human clinical trials for certain studies. Our Simcyp Simulator has informed 300+ drug labels for more than 90 novel drugs approved by the FDA. Details can be found in the Office of Clinical Pharmacology review on the FDA website that supports each label.

Furthermore, our Simcyp Simulator and Phoenix biosimulation software platforms have been adopted by 17 global regulatory agencies worldwide, including the US FDA, European Medicines Agency, Japan’s PMDA, and China’s NMPA. Regulatory agencies use our software to evaluate submissions by biopharmaceutical companies.

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Certara Body Content Accelerating Medicines with Biosimulation 3b
Leadership William F. Feehery
William F. Feehery Chief Executive Officer

Dr. Feehery joined Certara in June, 2019 as CEO. Dr. Feehery joins Certara from DuPont, where he served since 2013 as president of DuPont Industrial Biosciences, a $2.2 billion global biotechnology business that experienced significant growth and profitability under his leadership. In that role, he had full P&L responsibility for 3,000 people, including 500 R&D staff, 20 manufacturing plants, and worldwide marketing and sales across multiple markets. He joined DuPont in 2002 and served in a series of management roles in high-growth businesses, and he also has prior experience in venture capital and as a consultant for the Boston Consulting Group.

Dr. Feehery also serves as a board member for West Pharmaceutical Services (NYSE: WST), a manufacturer of packaging components and delivery systems for pharmaceutical, biotech and medical device companies.

Dr. Feehery holds both a Ph.D. in chemical engineering and an MBA from MIT. He was a Churchill Scholar at Cambridge University and received his BSE in chemical engineering from the University of Pennsylvania. His doctorate, awarded while he was the recipient of a National Science Foundation Fellowship, involved developing software and mathematical methods for modeling complex systems.

Leaderhip Andrew Schemick
Andrew Schemick Chief Financial Officer

Mr. Schemick joined Certara as Chief Financial Officer in August 2014. He brings 19 years of financial management experience to the company in a wide range of industries, including software and consulting organizations. Before Certara, Schemick served as Vice President of Financial Planning and Analysis for Haights Cross Communications, a holding company for education and media investments, playing a key role in business transformation, strategy, and financial operations on behalf of private equity investors. Schemick also held Chief Financial Officer roles for two divisions of Kaplan Inc, a leading education company, and has significant experience in both public and private equity backed enterprises. Schemick started his career at Arthur Andersen after graduating with an MBA in accounting from Rutgers University. In addition, he has earned the titles of CPA and CTP.

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