Pharmacogenomics (PGx), which considers the relationship between an individual’s genetics and their response to medications (i.e., drug-gene interactions), is expanding in clinical medicine. There are currently 25 evidence-based guidelines covering…
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What is Cellular & Gene Therapy? Genes are defined by the NIH as the “basic physical and functional unit of heredity.” We receive these valuable sequences of DNA from our…
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Clinical trials require a unique approach to public dissemination. Because clinical trials often involve the collection of sensitive information, sharing clinical trial data should always be conducted through formal and…
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During the current COVID-19 pandemic, it is important to find strategies to keep your drug development program moving forward. With many studies now paused, cancelled completely, or in the early…
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If you missed our live panel discussion on how the drug development industry is being impacted by the COVID-19 pandemic, we have assembled this post to highlight some of the…
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To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the…
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A fundamental question for any drug development program is which regulatory pathway to pursue. The answer is important to determine early on, because it dictates the scope of clinical and…
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