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Position
SVP and Head of Regulatory Affairs
Location
Philadelphia PA UNITED STATES
Bio
Dr. Takefman heads the regulatory activities at Spark Therapeutics and has been with the company since November 2014. Dr. Takefman supervised the submission through to approval of the FDA and EMA Luxturna (voretigene neparvovec) marketing applications. Dan also supervised the regulatory process of multiple investigation products including SPK-9001 for the treatment of Hemophilia B (Breakthrough Designation received July 2016 and PRIME Designation received March 2017), and for SPK-8011 for the treatment of Hemophilia A (Breakthrough Designation received February 2018). Previously, Dan was Chief of the Gene Therapy Branch within the U.S. Food and Drug Administration (FDA). He supervised the Chemistry, Manufacturing and Control (CMC) review process for all gene therapy products and for a variety of therapeutic vaccine products. Dan began his career at FDA in 1999 as a Postdoctoral Fellow and became a Staff Fellow shortly thereafter. Dr. Takefman holds a Ph.D. in microbiology from Rush University and a B.S. in microbiology from the University of Iowa.
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