Visiting Associate
U.S. FDA
Dr. Lakshmi Manasa Sakuntala Chekka is a Visiting Associate at the U.S. FDA, working as a Bioinformatics Scientist in the Genomics and Molecular biology lab within the Division of Applied Regulatory Sciences, Center for Drug Evaluation and Research. She works with multiple omics technologies to evaluate their utility to accelerate biosimilar development process and thereby improve patient access to inexpensive alternatives (biosimilars) to lifesaving and costly originator biologics. She started her work as an ORISE fellow, followed by a contractor position, and then transitioned to a full-time role with the FDA. Prior to this, she attained her PhD in Clinical Pharmaceutical Sciences and a graduate certificate in Public Health from the University of Florida. Her dissertation was focused on utilizing clinical and miRNA data to personalize antihypertensive therapy. Specifically, she worked on identifying microRNA biomarkers for predicting response to thiazides in hypertensive patients and studying racial differences in antihypertensive drug response. She is also a trained Clinical Pharmacist with a PharmD degree from Manipal University, India. Dr. Chekka is an active member in several scientific and professional organizations and currently serves on various leadership roles within these organizations and within FDA where she is co-leading a Proteomics and Metabolomics subgroup.
Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval
Monday, October 23, 2023
9:00 AM – 9:30 AM ET