Head of Regulatory CMC Biologics and Gene Therapy
Biogen
Kim Wolfram, Senior Director in Global Regulatory Affairs CMC. She currently leads the biologics and gene therapy team. Her previous regulatory experiences includes acting as the global regulatory lead for programs at various stages in development. She is committed to advancing novel manufacturing technologies and defining the future for regulatory science. Kim is a member of the PhRMA GQM Workgroup and is an active participant in regulatory policy development. She is the Global Co-Chair for ReachOUT and passionate about diversity, inclusion, and belonging. Prior to Biogen, she was in Quality Assurance at Abbott Bioresearch Center (now AbbVie), where she supported the contract manufacturing for Seattle Genetics and Zymogenetics. Kim received her Master of Science degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences and an undergraduate degree in Natural Sciences from Saint Anselm College