Daniel Takefman, PhD

Daniel Takefman, PhD, has been Principal of Takefman Gene Therapy Advisors since March 2020, where he provides expert regulatory advice for the development and commercialization of cell and gene therapies. Dr. Takefman also assists in due diligence assessments of gene therapy assets for venture capital firms and is a member of multiple scientific advisory boards.

Previously Dr. Takefman was SVP and Head of Regulatory Affairs at Spark Therapeutics for 5 years. At Spark, he supervised the submission through to approval of the FDA and EMA Luxturna® marketing applications. He also supervised the regulatory process for multiple AAV based investigation products including two additional Breakthrough Designation products: SPK-9001 for the treatment of Hemophilia B (marketing applications currently under review by FDA and EMA) and SPK-8011 for the treatment of Hemophilia A.

Dr. Takefman joined the FDA Division of Cellular and Gene Therapy in 1999 as a Postdoctoral Fellow. Dan held multiple positions during his 15-year career at FDA, ultimately becoming Chief of the Gene Therapy Branch. He supervised the Chemistry, Manufacturing and Control (CMC) review process for all gene therapy products and for a variety of therapeutic vaccine products. Dr. Takefman holds a Ph.D. in Immunology from Rush University and a B.S. in Microbiology from the University of Iowa.