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Member Profiles

 

Edward A. Narke

Regulatory Managing Director

 

Edward Narke has a 15-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 (PD), his expertise has been in the Chemistry, Manufacturing, and Controls (CMC) area. Ed has over 10-years

 

experience within and as an advisor to start-up and major pharmaceutical companies on development of in-line and pipeline products and opportunities.

 

Ed held positions of increasing responsibilities. From 1996 to 2001, he was in PD and technology transfer at Lonza. In his years with Pfizer, Inc. (formerly Wyeth) he managed the preparation of IND, NDA and the BLA amendments for Enbrel® (a fusion protein produced through expression of recombinant DNA.) as well as regulatory strategy and submission preparation for the development programs for several biologics. Subsequent to that, he was in drug regulatory affairs with numerous small to mid-size biotech firms.

 

In 2007 Ed co-founded DS InPharmatics, LLC. While DSI provides a full range of CMC Regulatory and CMC Operational services to the pharmaceutical and biotechnology industry, it is increasingly focused on meeting the significant demand for FDA liaison, CMC due diligence for M&A and venture financing,  and the overall need for interpretation of new Regulatory Guidance. Ed holds a BS in chemistry from the University of Pittsburgh and an MA in chemical engineering 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 AAPS, PDA and currently serves as the Chair of the RAPS Philadelphia Chapter.

 

DSI specializes in assisting clients in adopting an efficient and thorough approach to preparing regulatory submissions using the project team approach, mapping, and gap analysis to identify complete information needed for the submission, prepare a working plan, and resolve issues early to avoid regulatory delays.

 

 

 

 

 

Contact Info:

Edward A. Narke

Regulatory Managing Director


Tel:  610-329-1219

LinkedIn: linkedin.com/in/edwardnarke

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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