Cell & Gene Therapy: Implications on Drug Development
What is Cell & 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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Strategies to Keep Drug Development Moving During COVID-19
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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Global Impacts of COVID-19 on Drug Development
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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How Technology Makes Virtual Clinical Pharmacology Phase 1 Studies Possible
With the current COVID-19 pandemic, drug developers and researchers are searching for drug development strategies that limit human contact. For certain drugs and certain types of Phase 1 studies, a…
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Points to Consider in Drug Development of Biologics and Small Molecules
Traditionally, the treatment of human disease has been dominated by small molecule drugs. Small molecules are used to treat a variety of diseases and conditions and can be quite diverse…
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505(b)(1) and 505(b)(2) Pathways for New Drugs: When to Use & Common Misconceptions
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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Developing Vaccines for the Coronavirus Disease (COVID-19) Outbreak
The Power of Vaccinations Every year, vaccines are administered to millions of people to mitigate the spread of a wide variety of infectious diseases. One of the best known and…
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