Dr. Diaa Shakleya

Dr. Diaa Shakleya is a senior 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, 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 WVU. Prior to joining the FDA, he 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 bioanalytical guidance. Dr. Shakleya has nearly 57 peer-reviewed papers and more than 110 scientific podium and poster presentations. He also moderated national and international conference/workshops on bioanalysis and preclinical testing.