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Edward Narke, MS, RAC

Principal, Regulatory Affairs

A 25 year career in the pharmaceutical industry that is characterized by its breadth and extensive experience in all phases of drug development, from pre-clinical to post-marketing, with biologics and drugs. With hands-on experience in manufacturing process development, his expertise has been within CMC and Regulatory Sciences. Ed has served as an advisor to emerging start-up and established pharmaceutical companies on development of in-line and pipeline products and opportunities. Starting in process development and technology transfer at Lonza to his years with Pfizer, Inc. he managed the preparation of IND, NDA and the BLA amendments for Enbrel® and Rapamune®, as well as regulatory strategy and submission preparation for the development programs for several biologics. After that, he was in drug regulatory affairs with numerous emerging biotech firms. In 2007 Ed co-founded DSI. Ed holds a BS in chemistry from the University of Pittsburgh and an MA in organic chemistry from Villanova University. He is a co-instructor for several courses on the CTD Module 3 at several major conferences and offers customized in-house training programs on authoring CTD submissions. He is a member of RAPS and AAPS and has chaired the AAPS CMC Focus Group, the RAPS Philadelphia Chapter and the Regulatory Sciences Section Content Advisory Committee for AAPS magazine.