Dan Takefman

Dan Takefman, Ph.D., is the Principal at Takefman Gene Therapy Advisors LLC. Previously, Dr. Takefman headed regulatory activities at Spark Therapeutics from 2014 until its acquisition by Roche. At Spark, he oversaw 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.