Bilal Abuasal PhD

Dr. Bilal AbuAsal is a clinical pharmacology team leader in the Division of Neuropsychiatric Pharmacology in OCP. Bilal received his pharmacy degree from the University of Jordan and a Ph.D. in Pharmaceutical Sciences and Pharmacokinetics from the University of Louisiana at Monroe. The focus of his Ph.D. was on the application of PBPK modeling and simulations in predicting the nonlinear pharmacokinetics of small molecules. After graduation, he completed a two-year postdoctoral training in clinical pharmacology and PK/PD analysis at the University of Cincinnati.

At FDA, Bilal developed a special interest in rare disease drug development and the application of biomarkers and quantitative clinical pharmacology principles to support the approval of neurology drug products. His most significant, recent contribution included the regulatory review of biomarker data from the Tofersen clinical development program in SOD1-ALS. Bilal and his team successfully presented OCP’s views on biomarkers at the PCNS-Advisory Committee meeting for Tofersen in March 2023. He is also an active participant in several working groups and scientific interest groups. He is involved in several ongoing regulatory research projects at FDA. Of those, the most notable is the systematic evaluation of the role of biomarkers in neurology drug development.