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Thursday, November 15 2012, 11:30am - 1:30pm
The Road to the Biologic IND @ Janssen Labs
Date: Thursday, November 15
An in-depth workshop on the ins and outs of filing a successful biologic investigational new drug application. Presentations will highlight the following: Key components of the Chemistry/Manufacturing/Controls - Expression, Purification, Analytics, Formulation, Fill/Finish - Preclinical study design, species selection, material requirements and timelines - Regulatory requirements, strategies to minimize costs and timelines while balancing risk.
LocationJanssen Research &amp; Development LLC, 3210 Merryfield Row, San Diego, CA 92121