Certara Strengthens Model-Informed Drug Development Team with Four Executive Hires

New executives bring cross-disciplinary expertise and diversity to the company’s premier global Integrated Drug Development team PRINCETON, N.J.—May 17, 2021. Certara, Inc, (Nasdaq: CERT), the global leader in biosimulation, announced the appointments of four executives to its growing model-informed drug development team: Dr. Matt Zierhut as Vice President, Model-Based Meta-Analysis, Dr. James Dunyak as Senior … Continued

Strategic Evidence & Value Communication Symposium

Join us on Wednesday, April 21, 2021, from12:00 PM – 2:00 PM EDT for Certara’s first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take away messages. We will start by defining the various … Continued

Empowered Patient Podcast: Using Biosimulation to Develop Pediatric Therapeutics with Lynne Georgopoulos Certara

Lynne Georgopoulos, VP Regulatory Strategy, Certara describes the company’s platform to optimize pediatric drug development using biosimulation. With an eye on pediatric diseases, Certara is employing modeling and simulation to determine how a drug developed for adults may be metabolized in children, including neonates. They are also operationalizing clinical trials to be more efficient and … Continued

Scientific Computing World: Connecting Science

Interconnection is an imperative for the modern laboratory, and seamless integration is mandatory from the perspective of the end user, who is generally a scientist. That’s the view of Leif Pedersen, president of software at Certara (…)

Certara Acquires AUTHOR!, a Regulatory and Biostatistics Services Firm in Europe

Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— March 2, 2021– Certara, Inc., a global leader in biosimulation, today announced the acquisition of AUTHOR!, a company that provides medical writing and statistical analysis of clinical trial data to global pharmaceutical and biotechnology companies.  Founded in 1998, AUTHOR! is based near Amsterdam … Continued

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

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

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