Clinical Pharmacology Reviewer
US FDA
Dr. Nayeem Hossain is currently serving as a Clinical Pharmacology Reviewer at the U.S. Food and Drug Administration's (FDA) Division of Translational and Precision Medicine (DTPM). In this role, he has reviewed numerous marketing applications and many Investigational New Drug (IND) applications. Additionally, he contributes to the agency's mission by implementing AI/ML tools for clinical pharmacology analyses, conducting research projects related to rare diseases, and aiding in policy development. His notable efforts in the field have earned him several awards within the Agency. Dr. Hossain received his PhD in Pharmaceutics from the School of Pharmacy at Duquesne University and completed an ORISE Postdoctoral Fellowship in Clinical Pharmacology at the FDA.
Pharmacodynamic Biomarkers as Confirmatory Evidence in Rare Disease Drug Development
Monday, October 23, 2023
10:30 AM – 11:00 AM ET