The Certara Blog

Prescription Drug Pricing: “The Times They Are A-Changin”

“Come senators, congressmen Please heed the call Don’t stand in the doorway Don’t block up the hall For he that gets hurt Will be he who has stalled” Bob Dylan recorded his iconic “The Times They Are a Changin’” in 1963; the song was released on the 1964 album by the same name. One of […]

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The Expanding Role of Natural History Studies in Drug Development

Natural history studies follow a group of people over time who have or are at risk of developing a specific disease. This type of study is an important tool in modern drug development and in assessing new health technologies by payers. This is especially true for rare diseases or diseases with high, unmet medical need […]

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Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

Immuno-oncology – The Breakthrough in Cancer Therapeutics Cancer immuno-oncology (IO) uses the body’s natural defenses to combat cancer. These therapies stimulate an individual’s immune system and restore its ability to identify and destroy cancer cells. Anti-cancer immune responses are often inhibited during the spread of cancer. Ultimately, IO therapy expedites long term responses against cancer […]

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Simulating Viral Dynamics in the New Trial Simulator

Antiviral drug development presents a unique set of challenges. First, viruses are constantly mutating, and drug-resistant viruses emerge easily. Therefore, combination therapies are typically required to maintain a sustained virologic response. In addition, successful treatment requires high medication adherence, which is often a challenge for patients with chronic viral infections such as hepatitis or HIV. […]

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Real World Evidence Marches Forward in Drug Development

The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection of real-world data (RWD) and use of RWE is not new, they are now poised to have a profound impact on our industry.  Today, it […]

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Benefits of Apocalyptic Clinical Pharmacology During Regulatory Review

When developing a drug, pharmaceutical companies need to answer many questions to successfully undergo regulatory review and bring the drug to market. Apocalyptic clinical pharmacology is a framework that drug developers can use to uncover essential relationships between the drug dose and response or outcome. In other recent blog posts, I have covered what the […]

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