Diaa Shakleya, PhD

Senior Research Scientist, DPQR, OTR, OPQ, CDER

Dr. Diaa Shakleya is a Senior Research Scientist within the Division of Product Quality Research. His areas of expertise include drug products quality, opioids, and regulated bioanalysis and pharmaceutical analysis. In his current role, Dr. Shakleya leads regulatory science research work related to nitrosamine impurities, including projects related to Mitigation strategies to reduce the risk of the NDSRI impurities in pharmaceutical drug products and effect of excipients on the formation of nitrosamines. Dr. Shakleya also leads the Opioids research project on the risk associated with opioids and opioids antagonists and creating an in vitro surrogate model platform to assess in vivo permeation and risk associated with the vaping opioids.

Diaa has been with the Food and Drug Administration (FDA) for over 9 years. Prior to joining FDA, Dr. Shakleya served as an associate director with biotech company where he led a group of scientists in preclinical evaluation of small drug molecules under drug discovery program. Diaa received his Ph.D. degree in Pharmaceutical Sciences from Mumbai University, India and Postdoctoral Fellowship from West Virginia University.
Dr. Shakleya has over 58 peer-reviewed publications and more than 100 scientific podium and poster presentations.

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