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03 May 2017

Personalised medicines - which are designed to treat particular groups of patients -  are becoming increasingly prominent. In order to identify patients suitable for treatment a companion diagnostic assay is often needed. The Personalized Medicines Coalition (PMC) recently published an article stating that 25% of NME approved by FDA in 2016 included a companion diagnostic.

This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.

Speakers:

Meijuan Li, CDRH
Peter Cooper, Qiagen
Rachel Hodge, AstraZeneca

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