Ingrid Markovic

Ingrid Markovic, Ph.D. served as the Senior Science Advisor at the U.S. FDA CBER. In this role, she provided strategic leadership and direction for the development, implementation, and integration of CMC policies, supporting harmonized and consistent regulatory review. She led FDA efforts to modernize CMC post-approval regulatory reporting categories for complex biological products. Internationally, Dr. Markovic played a pivotal role in shaping the global regulatory landscape to develop a single set of global regulatory standards. She served as the CBER ICH Quality Caucus Lead, overseeing the development of ICH Quality guidelines for CBER and as the FDA Regulatory Chair for the currently developing ICH Q6. She was also the FDA Topic Leader for ICH M4Q, a (co)Leader for the Quality Discussion Group and Q12, and served as Rapporteur for the Q3E Informal Expert Working Group. Previously, Ingrid worked in the industry sector, leading US & EU CMC Regulatory Policy with a focus 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, and is a frequent speaker at national and international conferences.