Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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The Many Shapes and Colors of Biomarkers

Posted on August 12th, 2016 by in Pharma R&D

The future is biomarkers. This is an often-cited phrase you will have heard at drug development symposia and printed in articles. The line reminds me of the film, The Graduate, where Mr. McGuire tells young Benjamin that there is a “great future in in plastics.”  Biomarkers are the plastics for personalized medicine, (more…)

Review of Alzheimer’s Association International Conference (AAIC16) Part 1: Focus on Tau

Posted on August 10th, 2016 by in Pharma R&D

I have just returned from the Alzheimer’s Association International Conference (AAIC16) in Toronto, Canada. Toronto is a beautiful cosmopolitan city and a perfect setting for scientists from across the globe to come and share their latest research on Alzheimer’s disease. (more…)

Qualification, Validation, and Fit-for-Purpose Biomarkers

Posted on July 22nd, 2016 by in Pharma R&D

As drug developers we rely greatly on biomarkers for providing information to our drug development programs and supporting submission to regulators.  (more…)

Reducing the Risk of Late-Phase Failures

Posted on July 5th, 2016 by in Pharma R&D

Late-stage failures are common. The likelihood of a phase transition from Phase 2 to 3 is about 30%, and moving from Phase 3 to submission is only about 60% likely. The majority of late-stage failures are due to a lack of demonstrated efficacy (56%), followed by safety issues (28%)[1]. (more…)

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