Mansoor Khan, R. Ph., PhD FDA

Mansoor Khan, R.Ph., Ph.D., is a Senior Biomedical Research Scientist (SBRS) and serves as the Director of Product Quality Research in the Center for Drug Evaluation and Research (CDER) in FDA. Prior to joining FDA in 2004, Dr. Khan was a Professor of Pharmaceutics and Director of Graduate Program in the School of Pharmacy at Texas Tech University. He has earned his Ph.D. degree in Industrial Pharmacy from the St. John’s University School of Pharmacy in 1992. He has published over 210 peer-reviewed manuscripts, four texts, 15 book chapters, and has been invited to give more than 150 presentations world-wide. Dr. Khan’s research focuses primarily in the area drug formulations design and development of “challenging molecules.”

It encompasses pediatric dosage forms, nanoparticles, modified release dosage forms, biosimilar characterization, particulate engineering, and scientific underpinnings of Quality by Design utilizing novel Process Analytical Technologies. As the Director of Product Quality Research, Dr. Khan serves as the CDER’s principal advisor on all matters related to planning and conducting research to study the impact on product quality, changes in bulk drug substances, formulation component and composition, and manufacturing equipment and processes. As a recognized expert, Dr. Khan participates fully in policy formulation; planning and evaluating programs, including oversight of pharmaceutical science activities to insure that basic and original research are considered in major CDER decisions. He maintains contact with “state of the science” in order to integrate the most advanced research theory or practice in the field of pharmaceutical science into the Center’s new, generic, and biotech drug programs. Dr. Khan is an AAPS Fellow, and serves on the editorial board of several leading journals.