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Author: Certara

The Year 2020 Marks the 7th Consecutive Year Certara Customers Received 90 Percent of US FDA Novel Drug and Biologic Approvals

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Affirms continued regulatory and industry adoption of biosimulation and technology to bring new drugs to patients PRINCETON, N.J.—Feb. 25, 2021– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that 2020 marked the seventh consecutive year where 90% of new drug and biologic approvals by the US Food and Drug Administration (FDA), excluding diagnostic … Continued

Upcoming 2021 Certara University Express Webinars

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Certara University is pleased to announce our complimentary 30-minute Express webinar series: Simplify Your Submission Review Process With an Anywhere, Anytime eCTD Viewer Date/Time: Tuesday, August 24, 2021 at 11:00AM EST Description: Your organization has numerous stakeholders responsible for reviewing the content of your drug submissions which requires approving eCTD submission content quickly, fielding agency … Continued

Expert Tips for Pediatric Drug Development and Regulatory Success

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While the pharmaceutical industry in the US and EU has made tremendous progress in pediatric drug development with over 850 products containing pediatric labeling, there is still a significant lag between attaining approval for a drug for adults and the first pediatric label information. Why is this? Conducting pediatric clinical studies has well-known challenges. From … Continued

BPS Article: Model‐Informed Drug Repurposing: a Pharmacometric Approach to Novel Pathogen Preparedness, Response and Retrospection

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Abstract During a pandemic caused by a novel pathogen (NP), drug repurposing offers the potential of a rapid treatment response via a repurposed drug (RD) while more targeted treatments are developed. Five steps of model‐informed drug repurposing (MIDR) are discussed: i) utilize RD product label and in vitro NP data to determine initial proof of potential, ii) … Continued

RAPS Sponsored Webinar: Efficiency and Technology Pave the Way for the New Age of Narrative Writing

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Narratives are an integral part of medical writing. Sponsors sometimes need to prepare large batches of these deliverables in a short period while most traditional methods prove unsuccessful in providing both consistency and quality. This can lead to questions and potential discrepancies in the reporting of a drugs safety. Fortunately, through the advancement and use … Continued

Certara Publishes White Paper on Leveraging Biosimulation to Optimize COVID-19 Vaccines

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Certara’s COVID-19 vaccine model can be used to investigate dose selection for different populations and determine optimal timing for second vaccine dose PRINCETON, N.J.—February 5, 2021. Certara, the global leader in biosimulation, today announced that it has published a white paper on how biosimulation can be used to optimize the world’s limited supply of COVID-19 … Continued

Certara Announces Pricing of its Upsized Initial Public Offering

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PRINCETON, NJ.— December 10, 2020 – Certara, Inc. (“Certara”), a global leader in biosimulation, today announced the pricing of its upsized initial public offering of 29,055,000 shares of its common stock at $23.00 per share. Certara is offering 14,630,000 shares of its common stock and certain selling stockholders are offering 14,425,000 shares of common stock … Continued

Certara’s Phoenix software supports training of the next generation of the pharmacometricians in China

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The Pharmacy department of the Shanghai Chest Hospital is dedicated to developing and applying model-informed precision dosing (MIPD) and model-informed drug development (MIDD) models to optimize dosing for patients in China.  Certara has partnered with Professor Jiao for 20 years to provide academic training to graduate students and researchers on using its pharmacometric software, including … Continued

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