What is a 505(b)(2)?
The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
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Cost-Effective Techniques for Creating QSP Models
Quantitative systems pharmacology (QSP) modeling can be an effective tool to solve a variety of drug development questions including understanding a drug’s mechanism of action, determining a drug’s biomarkers, and…
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Fostering Inclusion and Diversity in Clinical Trials
Inaccessibility, inadequate engagement, and lack of trust—these are just some of the issues that limit inclusion and lead to a lack of diversity in clinical trials. So, why is diversity…
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Cellular & Gene Therapy: Implications on Drug Development
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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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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