Ross A. Marklein, Ph.D
School of Chemical, Materials, and Biomedical Engineering
University of Georgia
Ph.D. Bioengineering, University of Pennsylvania ’12
Functional heterogeneity is a significant barrier to the clinical translation of many cellular therapies, including mesenchymal stromal cells (MSCs). Though MSCs have shown promise in treatment of immune diseases, the mechanisms of action and critical quality attributes (CQAs, predictors of function) in different therapeutic settings are largely unknown. The overall goal of the Marklein Lab is to develop innovative approaches incorporating high-throughput, therapeutically relevant single cell profiling to assess cellular heterogeneity and accelerate translation of MSC therapies.
Dr. Marklein took a non-traditional path to academia via an extended post-doctoral fellowship and subsequent staff fellow position at the U.S. FDA in the Division of Cellular and Gene Therapies. During his time at the FDA, Dr. Marklein’s duties consisted of performing regulatory science research relevant to many promising cell therapies currently being explored in clinical trials (such as MSCs), as well as regulatory responsibilities such as reviewing pre-clinical and clinical trial submissions involving cell therapies and combination products. Based on his unique background, Dr. Marklein will incorporate his expertise in cell manufacturing, single cell profiling, and biomaterials with knowledge of FDA regulatory framework to help advance cell-based therapies for regenerative medicine.