by Scientific Writing Team Much of the drug development process focuses on characterizing the activity and safety profile of the drug substance (i.e., the active pharmaceutical ingredient [API] or “parent”…
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How much does PK/PD cost? While a very common question, it is not one that is easy to answer. The cost of PK/PD depends on many factors but, in general,…
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by Scientific Writing Team In our previous blog post, we discussed the revolutionary immunotherapies known as chimeric antigen receptor T-cells (CAR T). The first CAR T therapies, axicabtagene ciloleucel (Yescarta™)…
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by Scientific Writing Team In 2017, the FDA approved two revolutionary drugs known as chimeric antigen receptor T (CAR T) cells. These drugs, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel), which…
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by Scientific Writing Team Monoclonal antibodies (mAbs) are antigen-recognizing glycoproteins that are made by identical immune cells, all of which are clones of a unique parent cell. Since 2014, FDA…
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For the vast majority of therapies, FDA requires a clear demonstration of safety and effectiveness in humans before marketing approval is granted. However, while an adequate demonstration of safety in…
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Immuno-oncology is an exciting but challenging subspecialty that falls underneath the umbrella of oncology research and development. Unlike more traditional oncology treatments that target the tumor itself (albeit sometimes rather…
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