Clinical Study Confirms Quantitative Systems Pharmacology (QSP) Prediction, Showcasing the Power of Biosimulation Technology
Princeton, N.J., 2021 年 7 月 23 日: Certara, a global leader in biosimulation, today announced that its Vaccine Simulator accurately predicted that eight weeks was the optimal timing between the first and second dose of COVID-19 vaccines. The Pitch study conducted at Oxford University in the United Kingdom confirmed Certara’s Vaccine Simulator prediction, which was released six months ago. Current dosing for the Pfizer-BioNTech and Moderna vaccines are spaced three and four weeks apart, respectively.
“The Pitch study results further validate that Certara’s biosimulation technology is a powerful, predictive tool to understand how vaccines and COVID-19 therapies work, enabling us to get dosing regimens right the first time,” said William F. Feehery, CEO of Certara. “We continue to invest in innovation to fight this ongoing pandemic and benefit global health.”
The Certara Vaccine Simulator, based upon the Company’s quantitative systems pharmacology (QSP) technology, integrates diverse inputs, including bioinformatics and in-vitro assays, to develop sophisticated models that answer ‘what-if’ scenarios to determine the best dosing strategies for various patient cohorts, such as the elderly and children. The Simulator has been used by a number of global pharmaceutical companies and its findings have been presented to regulatory agencies, including a U.S. Food and Drug Administration (FDA) workshop in June of 2021.
“Our Vaccine Simulator allows us to address critical questions on efficacy and safety of dosing regimens for different types of patients for COVID-19 as well as in other therapeutic areas. We have recently calibrated and validated our Vaccine Simulator with very large clinical data sets and added additional vaccine types,” said Piet van der Graaf, PharmD, PhD, senior vice president of QSP at Certara. “We also already have models to determine the optimal timing of COVID-19 vaccine boosters, what is the best way to mix and match vaccines, and what is required to maintain efficacy against COVID-19 variants.”
Certara accelerates medicines using biosimulation software and technology to transform traditional drug discovery and development. Certara的客户覆盖全球1,650多家生物制药公司61个国家和地区的、领先学术机构和主要监管机构。
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