Non-clinical Safety Evaluation of Biotherapeutics – Challenges, Opportunities and new Insights

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Abstract

New challenges and opportunities in nonclinical safety testing of biotherapeutics were presented and discussed at the 5th European BioSafe Annual General Membership meeting in November 2015 in Ludwigshafen. This article summarizes the presentations and discussions from both the main and the breakout sessions.

The following topics were covered in six main sessions:

The following questions were discussed across 4 breakout sessions (i-iv) and a case-study based general discussion (v):

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