Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?

Posted on June 15th, 2020 by in Pharma R&D

As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and development process, continuing on into post-market surveillance. With drug developers and other researchers becoming more interested in using RWD and the RWE that results from analyzing it, regulatory agencies have had to step up and work on producing guidance.

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Global networks form to take on the problem of drug-induced liver injury (DILI)

Posted on May 20th, 2020 by in Pharma R&D

Drug-induced liver injury (DILI), which is one of the top causes of liver failure in the United States [1], is an adverse reaction that can be caused by a significant number of medications. DILI can be fatal and is not only a major concern post-market, but also during drug development as it is the top safety-related reason for late-stage clinical trial failure.

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Five drug development strategies to combat 2019 novel coronavirus

Posted on April 15th, 2020 by in COVID-19

This article was originally published on Feb 28, 2020, and has been updated on Apr 13, 2020.

Coronavirus disease 19 (COVID-19) has rapidly spread from its starting point in Wuhan, China. As of February 23, 2020, a total of 32 countries and territories have reported 78,811 cases (98% in China) and 2462 deaths [1]. The international scientific community is in a race against time. Researchers across the globe are collaborating to develop antivirals and vaccines to contain the spread of 2019 novel coronavirus (SARS-CoV-2).

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The Beneficial Impacts of Real-World Evidence in Drug Development

Posted on August 1st, 2019 by in Pharma R&D

Advances in technology, increased investment in digital solutions and the creation of more powerful analytics are all contributing to a growing interest in utilizing real-world evidence (RWE) in drug discovery & development. Following up on my previous post that goes into detail on what RWE is and why the industry is increasingly drawn to it, I now want to discuss its role and impact in the drug development life cycle.

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