Ingrid Markovic, PhD

Ingrid Markovic, Ph.D. serves as Senior Science Advisor and CMC Policy Lead at the Center for Biologics, US FDA where she is responsible for providing leadership, strategic direction, and oversight for development, implementation, and integration of CMC policies for complex biologics. In the international arena, Ingrid is currently CBER ICH Quality Lead and Regulatory Chair for ICH Q6. She is/was FDA Topic Lead for M4Q, and (co)Lead for QDG and Q12. She also had an opportunity to serve as ICH Q3E Rapporteur briefly. Ingrid previously worked in the industry sector leading US & EU CMC Regulatory Policy efforts with focus on Technological Innovation and Cell & Gene Therapies collaborating with Trades Associations to support continual improvement and innovation in the Biopharmaceutical sector. Ingrid completed her Ph.D. at University of Wisconsin, Madison and Post-Doctoral Training at the Laboratory of Cellular and Molecular Biophysics at the National Institutes of Health, Bethesda, MD.