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
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Certara의 바이오시뮬레이션 소프트웨어와 기술 지원 서비스를 사용하는 고객은 지난 8년 동안 연속으로 FDA(Food and Drug Administration)로부터 90%의 신약 및 생물학적 제제 승인을 받았습니다. 바이오시뮬레이션 분야의 글로벌 리더로서 당사는 R&D 지출 기준으로 35개의 선도적인 글로벌 바이오제약 회사를 포함하여 전 세계 1,650여의 개의 바이오제약 회사, 주요 학술 기관 및 규제 당국과 협력하고 있습니다.
대부분의 승인된 신약이 개발 과정에서 바이오시뮬레이션을 사용했지만, 우리는 바이오시뮬레이션이 신약 개발 공정을 더욱 가속화하고 개선해야 할 정도로 사용되었다고 생각하지 않습니다. 또한, Certara의 기술은 바이오시뮬레이션에 대한 사용 사례를 늘리기 위해 점점 더 개선되고 있습니다. Certara의 제품과 서비스가 미래에 지속적으로 업계를 관통할 수 있는 중요한 기회를 갖게 되었습니다.
Galderma's new drug approval for acne
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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.
Informing more than 300 labels for 90+ novel drugs
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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.
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.
John E. Gallagher III has served as Chief Financial Officer of the Company since April 2023. Prior to joining us, Mr. Gallagher served as Chief Financial Officer of Cue Health, a publicly traded healthcare technology company, from March 2021 to March 2023. Prior to Cue Health, Mr. Gallagher was at Becton, Dickinson & Co. (“BD”), a multinational medical technology company, where he served as Senior Vice President, CFO of its Medical Segment and Treasurer from July 2018 to February 2021. Upon joining BD in 2012, he was named Corporate Treasurer, a role he held throughout his tenure at the company. Mr. Gallagher also had responsibility for corporate finance, including financial planning and analysis, and was Senior Vice President, Controller and Chief Accounting Officer from December 2014 to July 2018. Prior to BD, he served as Vice President, Financial Planning & Analysis at NBC Universal from October 2009 to September 2012. Mr. Gallagher also served as Assistant Controller of Corporate Treasury for General Electric Company from October 2006 to October 2009. He began his career with Ford Motor Company, holding various roles across Treasury, Internal Audit, and Product Development.
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.
John E. Gallagher III has served as Chief Financial Officer of the Company since April 2023. Prior to joining us, Mr. Gallagher served as Chief Financial Officer of Cue Health, a publicly traded healthcare technology company, from March 2021 to March 2023. Prior to Cue Health, Mr. Gallagher was at Becton, Dickinson & Co. (“BD”), a multinational medical technology company, where he served as Senior Vice President, CFO of its Medical Segment and Treasurer from July 2018 to February 2021. Upon joining BD in 2012, he was named Corporate Treasurer, a role he held throughout his tenure at the company. Mr. Gallagher also had responsibility for corporate finance, including financial planning and analysis, and was Senior Vice President, Controller and Chief Accounting Officer from December 2014 to July 2018. Prior to BD, he served as Vice President, Financial Planning & Analysis at NBC Universal from October 2009 to September 2012. Mr. Gallagher also served as Assistant Controller of Corporate Treasury for General Electric Company from October 2006 to October 2009. He began his career with Ford Motor Company, holding various roles across Treasury, Internal Audit, and Product Development.
