Senior Research Scientist (Pharmacologist)
US Food and Drug Administration
Dr. Diaa Shakleya is a senior research scientist (pharmacologist) works at FDA’s Center for Drug Evaluation and Research with over 17 years of academic, industrial and regulatory experience in the areas of pharmaceutical formulations, opioids and drug abuse, bioanalysis and clinical and pre-clinical pharmacokinetics. He holds a Ph.D. in Pharmaceutical Sciences from University of Mumbai, India and did a Post-doctoral fellowship in opioids bioanalysis and drug metabolism from West Virginia University. Prior to joining the FDA, Dr. Shakleya worked in the biotech industry as an associate director, where he led a group of chemists and Ph.D. level scientists in various R&D and preclinical evaluation studies. His current job involves participation in regulatory bioanalytical projects that implement the recent FDA analytical and bioanalytical guidance. He also leads an office projects on nitrosamine mitigation study and opioi research. Dr. Shakleya has over 53 peer-reviewed papers and more than 110 scientific podium and poster presentations. Dr. Shakleya has moderated national and international conference/workshops on bioanalysis and preclinical testing.