Manjunath Pai, PHARMD

Chair and Professor, Clinical Pharmacy
Deputy Director, Pharmacokinetics Core

734-647-0006
amitpai@umich.edu

Dr. Pai is a Professor of Clinical Pharmacy with expertise in precision dosage regimen design. He has extensive training in clinical pharmacology and drug development, with specific expertise in clinical pharmacokinetics/pharmacodynamics (PK/PD). During his first academic appointment, he completed a general clinical research center scholars program and subsequently completed a 2-year clinical translational science center scholars program. Dr. Pai has hands-on training with biostatistics, population PK Modeling, physiology-based PK modeling, and technical writing that have supported my academic work and regulatory-level submissions. His research focus over the past decade has been on the design of optimal dosing regimens across the adult and pediatric body weight distribution (1-250 kg). He has served as the PI on six clinical trials dedicated to the evaluation of the PK/PD of antimicrobials in obesity and have developed PK models for 15 compounds in this special population. He has also performed preclinical studies to better inform the exposure-safety relationships of certain drugs. These works have propelled my understanding and passion for the design of safer and more effective treatment regimens in special populations, who are often excluded during drug development. He currently serves as the Deputy Director of the PK Core that is a shared resource for the University of Michigan. Information about the PK Core is detailed on our webpage (www.pkcore.org). The PK support includes: 1) LC-MS/MS assay of small molecules in biological matrices such as serum, plasma, and urine with full validation; 2) PK analyses through non-compartmental and compartmental methods that utilize parametric and non-parametric algorithms; 3) Support of all clinical trial phases that incorporate exposure-response designs including the derivation of optimal time-points for biological sampling; 4) Population PK modeling and simulation to enable dose regimen justification and optimization for clinical trials.