March 19th - 22nd
New York City
April 30th – May 2nd
Chicago, IL
May 7th
Boston, MA
June 3rd to 6th
Philadelphia, PA
January 7th – 10th
San Francisco, CA
Edward Narke, MS, RACPrincipal, 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.
Chief Financial Officer
Anne Carr is the Chief Financial Officer at DSI, where she manages all aspects of this continually growing company’s finances. Her responsibilities include all financial bookkeeping, the development and management of budgets, and the analysis and preparation of financial statements, as well as payroll and human resources functions. Anne develops and maintains internal controls and helps provide financial clarity while reporting on the company’s financial health to the principals and management team.
Anne joined DSI in 2010 and has been with the company every step of the way during its growth. She has seen the size of the company more than tripled from 15 associates in 2010, to its current count of 49 consulting and support personnel.
Before joining DSI, Anne spent ten years developing herself in the field of accounting and finance. Prior to that, she worked for Prudential Insurance for 14 years in accounting, group underwriting, and small group compliance.
Anne holds a Bachelor of Business Administration, as well as an MBA in General & Strategic Management from Temple University’s Fox School of Business.
