Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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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…)

Precompetitive collaboration: Transforming innovation in drug discovery & development

Posted on July 21st, 2016 by in Pharma R&D

In 2013, Barbara Mittleman, former director of the Public-Private Partnership Program at the US National Institutes of Health and colleagues assessed the status of precompetitive consortia. (more…)

A gathering of global perspectives… a look at DIA’s annual meeting: Post 2 of 2

Posted on July 18th, 2016 by in Pharma R&D

As referenced in my last post, the Drug Information Association (DIA), held its annual conference in Philadelphia at the end of June with this year’s theme being “A Gathering of Global Perspectives.” In follow-up to that post, I want to share with you what I gleaned from two additional noteworthy sessions. (more…)

Biosimilars and Pharmacovigilance: What You Need to Know—and Do—Now

Posted on April 26th, 2016 by in Pharmacovigilance

A few weeks ago, the US FDA approved Inflectra (infliximab-dyyb), a biosimilar to infliximab. This is the second US biosimilar approval, suggesting others may soon be on the way—good news for companies with biosimilars pending approval and in development. (more…)

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