Nandini Rakala, PhD

Dr. Nandini Rakala is a Data Scientist and Mathematician, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master's degree in applied mathematics and computing from Manipal University, India; and a bachelor’s degree in mathematics honors from the Sri Sathya Sai Institute of Higher Learning, India. During her 4+ years of experience working with the U.S. FDA, Dr. Rakala has contributed to various multidisciplinary and innovative regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ programs such as the Quality Management Maturity, Quality Metrics, Predictive Modeling of Pharmaceutical Quality System effectiveness, development of a Risk-based Sampling and Testing strategy, Report on the State of Pharmaceutical Quality, Quality Signal Detection, Prioritization, and Topic Modeling of Post-market Surveillance data. Dr. Rakala has had an opportunity to collaborate on various CDER-BAA research projects, presented and served as a co-chair, keynote speaker, and workshop lead at global industry conferences and academic seminars, and she is a recipient of several awards. In her free time, Nandini enjoys volunteering in service activities, judging various mathematical modeling contests, playing tennis, writing, and reading.