Ingrid Markovic

Ingrid Markovic, Ph.D. is the Senior Science Advisor and CMC Lead at the U.S. FDA’s Center for Biologics. She provides strategic leadership and direction for the development, implementation, and integration of CMC policies supporting harmonized and consistent regulatory review. She has led FDA effort for modernization of CMC post-approval regulatory reporting categories for complex biological products. Internationally, Ingrid serves as CBER ICH Quality Lead overseeing the development of ICH Quality guidelines for CBER and FDA Regulatory Chair for currently developing ICH Q6. She is/was FDA Lead for ICH M4Q, (co)Lead for Quality Discussion Group and Q12. She had an opportunity to briefly serve as ICH Q3E Rapporteur. Previously, Ingrid worked in the industry sector leading US & EU CMC Regulatory Policy focusing on technological innovation and Cell & Gene Therapies supporting continual improvement and innovation in the Biopharmaceutical sector. Ingrid earned her Ph.D. from the University of Wisconsin, Madison and completed post-doctoral training at the Laboratory of Cellular and Molecular Biophysics at the NIH. She has published in numerous peer-reviewed journals, including: Blood, EMBO Journal, Journal of Cell Biology, Biophysical Journal, Archives of Biochemistry and Biophysics, etc., and is a frequent speaker at national and international conferences.