The days of simply determining the market demand for a new drug as a function of price and choosing the revenue or profit optimizing point are gone. In our new environment, an explicit rationale, the “value-based price” has become a...
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on April 15, 2021 was not any different. The agenda included discussion of a biologics license application (BLA) for donislecel...
This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence and Value Communications Symposium. This session featured the following four speakers: Shawn W. Bates is vice president of US sales and business development, Maximilian Vargas...
Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation impact on drug approval has grown significantly over the past years, with about 45% percentage of new drug approvals including PBPK analyses in 2019 [1]....
Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across multiple functions. Document development is a multistep processwith the regulatory writer acting as project leader. This article describes each of the stages of theprocess and...
Discover Certara's PK/PD Data Programming Services to streamline your drug development process. Leverage expert solutions for efficient, high-quality data analysis.
A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative templates for one of its most complex studies. Historically, the Sponsor’s statistical programming team had generated the PPLs as a resource for reviewers to use...
This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK) of an investigational oligonucleotide drug is an important part of...
Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares how she manages tight deadlines and how she leverages technology to support her daily submission work.
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